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A BILL TO AMEND TITLE 35, UNITED STATES

CODE, TO CONFORM CERTAIN FILING PROVISIONS WITHIN THE PATENT AND TRADEMARK

OFFICE

HEARING

BEFORE THE

SUBCOMMITTEE ON COURTS, THE INTERNET, 

AND INTELLECTUAL PROPERTY

OF THE

COMMITTEE ON THE JUDICIARY 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

ON

H.R. 5120

SEPTEMBER 14, 2006

Serial No. 109–150

Printed for the use of the Committee on the Judiciary

(

Available via the World Wide Web: http://judiciary.house.gov 

(II)

COMMITTEE ON THE JUDICIARY 

F. JAMES SENSENBRENNER, JR., Wisconsin, Chairman 

HENRY J. HYDE, Illinois 

HOWARD COBLE, North Carolina 

LAMAR SMITH, Texas 

ELTON GALLEGLY, California 

BOB GOODLATTE, Virginia 

STEVE CHABOT, Ohio 

DANIEL E. LUNGREN, California 

WILLIAM L. JENKINS, Tennessee 

CHRIS CANNON, Utah 

SPENCER BACHUS, Alabama 

BOB INGLIS, South Carolina 

JOHN N. HOSTETTLER, Indiana 

MARK GREEN, Wisconsin 

RIC KELLER, Florida 

DARRELL ISSA, California 

JEFF FLAKE, Arizona 

MIKE PENCE, Indiana 

J. RANDY FORBES, Virginia 

STEVE KING, Iowa 

TOM FEENEY, Florida 

TRENT FRANKS, Arizona 

LOUIE GOHMERT, Texas 

JOHN CONYERS, JR., Michigan 

HOWARD L. BERMAN, California 

RICK BOUCHER, Virginia 

JERROLD NADLER, New York 

ROBERT C. SCOTT, Virginia 

MELVIN L. WATT, North Carolina 

ZOE LOFGREN, California 

SHEILA JACKSON LEE, Texas 

MAXINE WATERS, California 

MARTIN T. MEEHAN, Massachusetts 

WILLIAM D. DELAHUNT, Massachusetts 

ROBERT WEXLER, Florida 

ANTHONY D. WEINER, New York 

ADAM B. SCHIFF, California 

LINDA T. SA ́ NCHEZ, California 

CHRIS VAN HOLLEN, Maryland 

DEBBIE WASSERMAN SCHULTZ, Florida

PHILIP G. KIKO, General Counsel-Chief of Staff 

PERRY H. APELBAUM, Minority Chief Counsel 

SUBCOMMITTEE ON COURTS, THE INTERNET, AND INTELLECTUAL PROPERTY

LAMAR SMITH, Texas, Chairman

HENRY J. HYDE, Illinois 

ELTON GALLEGLY, California 

BOB GOODLATTE, Virginia 

WILLIAM L. JENKINS, Tennessee 

SPENCER BACHUS, Alabama 

BOB INGLIS, South Carolina 

RIC KELLER, Florida 

DARRELL ISSA, California 

CHRIS CANNON, Utah 

MIKE PENCE, Indiana 

J. RANDY FORBES, Virginia 

HOWARD L. BERMAN, California 

JOHN CONYERS, JR., Michigan 

RICK BOUCHER, Virginia 

ZOE LOFGREN, California 

MAXINE WATERS, California 

MARTIN T. MEEHAN, Massachusetts 

ROBERT WEXLER, Florida 

ANTHONY D. WEINER, New York 

ADAM B. SCHIFF, California 

LINDA T. SA ́ NCHEZ, California

BLAINE MERRITT, Chief Counsel 

DAVID WHITNEY, Counsel 

JOE KEELEY, Counsel 

RYAN VISCO, Counsel 

SHANNA WINTERS, Minority Counsel 

(III)

C O N T E N T S 

SEPTEMBER 14, 2006

OPENING STATEMENT 

Page 

The Honorable Lamar Smith, a Representative in Congress from the State 

of Texas, and Chairman, Subcommittee on Courts, the Internet, and Intellectual Property .................................................................................................... 1

The Honorable John Conyers, Jr., a Representative in Congress from the 

State of Michigan, and Member, Subcommittee on Courts, the Internet, 

and Intellectual Property .................................................................................... 2

The Honorable Howard L. Berman, a Representative in Congress from the 

State of California, and Ranking Member, Subcommittee on Courts, the 

Internet, and Intellectual Property .................................................................... 3

The Honorable William L. Jenkins, a Representative in Congress from the 

State of Tennessee, and Member, Subcommittee on Courts, the Internet, 

and Intellectual Property .................................................................................... 4

WITNESSES 

The Honorable Jon W. Dudas, Undersecretary of Commerce for Intellectual 

Property, Director of the U.S. Patent and Trademark Office 

Oral Testimony ..................................................................................................... 6

Prepared Statement ............................................................................................. 7

Mr. Clive Meanwell, Chief Executive Officer, The Medicines Company 

Oral Testimony ..................................................................................................... 8

Prepared Statement ............................................................................................. 10

Ms. Kathleen D. Jaeger, President and Chief Executive Officer, Generic Pharmaceutical Association 

Oral Testimony ..................................................................................................... 14

Prepared Statement ............................................................................................. 16

Mr. John R. Thomas, Professor of Law, Georgetown University Law Center 

Oral Testimony ..................................................................................................... 25

Prepared Statement ............................................................................................. 27

APPENDIX 

MATERIAL SUBMITTED FOR THE HEARING RECORD

Statement of the Honorable Howard Berman, a Representative in Congress 

from the State of California, and Ranking Member, Subcommittee on 

Courts, the Internet, and Intellectual Property ................................................ 49

Statement of the Honorable Elton Gallegly, a Representative in Congress 

from the State of California, and Member, Subcommittee on Courts, the 

Internet, and Intellectual Property .................................................................... 49

A letter to the Honorable Jonathan W. Dudas, Under Secretary for Intellectual Property and Director, U.S. Patent and Trademark Office (USPTO) 

from the Honorable Lamar Smith, a Representative in Congress from the 

State of Texas, and Chairman, Subcommittee on Courts, the Internet, and 

Intellectual Property, and the Honorable Howard Berman, a Representative 

in Congress from the State of California, and Ranking Member, Subcommittee on Courts, the Internet, and Intellectual Property ......................... 51

Page

IV

A letter to the Honorable Lamar Smith, a Represetative in Congress from 

the State of Texas, and Chairman, Subcommittee on Courts, the Internet, 

and Intellectual Property in response to a letter requesting the United 

States Patent and Trademark Office (USPTO) analysis and assessment 

of H.R. 5120 .......................................................................................................... 59

A letter to the Honorable Jon W. Dudas, Under Secretary for Intellectual 

Property and Director, U.S. Patent and Trademark Office (USPTO) from 

Jane A. Axelrad, Associate Director for Policy, Center from Drug Evaluation 

and Research, Department of Health & Human Services in regard to the 

March 24, 2003 letter from Karin Ferriter requesting FDA’s assistance 

in preparing a response to a request for reconsideration in the application 

for patent term extension for U.S. Patent No. 5, 196, 404 filed by The 

Medicines Company ............................................................................................. 61

A paper on Critical Actions That Relate to The Medicines Company Application for patent Term Extension for U.S. Patent 5, 196, 404 ............................ 64

Requested submission from the Honorable William Jenkins, a Representative 

in Congress from the State of Tennessee; Letters from leading medical 

practitioners and consumer groups .................................................................... 65

Letter from Lawrence Goffney ................................................................................ 79

Testimony from Thomas Schatz, President, Citizens Against Government 

Waste ..................................................................................................................... 85

(1)

A BILL TO AMEND TITLE 35, UNITED STATES 

CODE, TO CONFORM CERTAIN FILING PROVISIONS WITHIN THE PATENT AND TRADEMARK OFFICE 

THURSDAY, SEPTEMBER 14, 2006

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON COURTS, THE INTERNET,

AND INTELLECTUAL PROPERTY, 

COMMITTEE ON THE JUDICIARY, 

Washington, DC.

The Subcommittee met, pursuant to notice, at 11:14 a.m., in 

Room 2141, Rayburn House Office Building, the Honorable Lamar 

Smith (Chairman of the Subcommittee) presiding. 

Mr. SMITH. The Subcommittee on Courts, the Internet, and Intellectual Property will come to order. 

I am going to recognize myself for an opening statement, then 

the Ranking Member of the full Judiciary Committee, Mr. Conyers, 

as well as Mr. Berman and as well as Mr. Jenkins, the author of 

the legislation on which we are having the hearing today. 

Thank you all for your interest. And we will proceed and then 

get to questions for our panelists as soon as we can. 

I will recognize myself for an opening statement. 

Today we begin an examination of H.R. 5120, a bill to amend 

title 35 of United States Code to conform certain filing provisions 

within the Patent and Trademark Office. 

This is an important hearing on a serious subject, and I look forward to the testimony of our witnesses. 

It is the tradition of our Subcommittee to ensure all stakeholders 

have an opportunity to be heard and have their concerns placed on 

the record. This is a critical step to take before we begin to consider what further steps, if any, may be appropriate. 

H.R. 5120 is a highly unusual bill. Its enactment will single out 

a specific company and their legal counsel for special consideration. 

I believe the proponents of the legislation have the burden to establish that a change in public law is necessary. At the same time, I 

want to compliment the company for its commitment to the regular 

legislative process. 

And I appreciate Dr. Meanwell’s willingness to respond to tough 

questions in a public forum, which I believe is necessary to assist 

the Members of the Subcommittee in understanding the circumstances that led this company and their counsel to this point. 

Their view is that the law is inflexible and, in their words, 

should be conformed to other provisions of the patent code that perVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
2

mit parties who have failed to meet statutory deadlines to be 

granted an extension. Further, they believe the public interest in 

spurring innovation and promoting public health is best served by 

providing for the retroactive application of such a change in the 

law in their case. 

Not unexpectedly, there are countervailing arguments. Opponents of this measure maintain there is no good reason the law requires amendment. They note that since this provision was first enacted more than two decades ago, only three of more than 700 applications have ever been denied in any part for having missed the 

60-day filing deadline. 

Further, they assert there is substantial precedent in the Patent 

Act to support the view that no relief should be granted when certain statutory deadlines are not met and that relief should extend 

only to circumstances where it is objectively demonstrated that the 

failure to file was unavoidable rather than merely unintentional. In 

other words, they believe the proposed change would actually make 

this deadline inconsistent with other precedents in the Patent Act. 

This is just a preview of the various arguments that the Subcommittee Members will soon hear and need to weigh for themselves. 

That concludes my opening remarks. And the gentleman from 

Michigan, Mr. Conyers, is recognized for his. 

Mr. CONYERS. I thank you, Chairman Smith. And I join you in 

welcoming all the witnesses: the Honorable Jon Dudas, a very dear 

friend of ours, Dr. Meanwell, and President Jaeger of Generic 

Pharmaceutical Association, and Professor Thomas. 

I wanted you to know as I head for the floor on a judiciary bill 

that is currently up for consideration that the proposal before us, 

legislation that would permit the Patent and Trademark Office to 

consider late applications for an extended term of patent protection 

or marketing exclusivity, currently if a patent owner files for an extension even 1 day late, then the PTO has no discretion to consider 

it. 

I understand that The Medicines Company faced this problem directly in 2002 when it sought patent term extension for its heart 

drug, Angiomax. If it was granted, the extension would have permitted the company to exclude competition to Angiomax for a 

longer period. 

The application for additional patent protection was due 60 days 

after the Food and Drug Administration approved the drug. But 

the application was filed on the 61st day. Because it has no discretion to review late filings, the PTO summarily rejected its consideration. 

Before us today is a proposal that would allow the PTO to consider the application. Contrary to how it has been portrayed, it 

would not automatically extend the term of exclusivity or automatically prevent competitors from entering the market. And in that regard, the bill appears equitable. 

And I look forward to returning to continue the discussion with 

these very able witnesses that are before us. 

And I thank you for your courtesy, Chairman Smith. 

3

Mr. SMITH. Would the gentleman from Michigan yield to the gentleman from California, Mr. Berman, for his opening statement as 

well? 

Mr. CONYERS. Absolutely. 

Mr. BERMAN. Thank you, Mr. Chairman. 

And thank you, Mr. Ranking Member, for yielding. 

I appreciate scheduling this hearing on a bill giving the USPTO 

additional discretion to extend certain patent deadlines. While 

similar measures, bills that have specifically extended the 

Angiomax patent, have been attached to legislative vehicles in the 

past, I am glad that this issue is finally being reviewed by the 

Committee with jurisdiction over patent matters. It is important 

that this Subcommittee be able to analyze the impact of any 

changes this bill may make on the patent system. 

Patents are a cornerstone of innovation. The Constitution provides a limited period of time of protection in order to promote innovation. Therefore, the patent process provides the exclusive right 

for an invention for 17 to 20 years generating incentives for an inventor to continue to create after which the invention becomes 

available for public use. 

There is a delicate balance here: providing enough of an incentive to the inventor to spend the time, energy and money to create 

new inventions and on the other hand, the value of allowing the 

invention to be used by the public enabling others to develop new 

products or provide similar products for lower cost. Therefore, 

when considering the effect of allowing the PTO discretion to extend certain patent deadlines there is a natural tension between 

providing the flexibility to extend the deadline and maintaining a 

hard date for specific types of filings. 

While providing greater elasticity may prevent Draconian results, does that come at the expense of stability in the market? 

There are to be other instances—there appears to be other instances where the PTO has discretion to extend deadlines. But the 

situation in this bill is designed to address is not one of those sections. Why? Is there something different about this type of filing 

that the PTO should not have discretion in this case? 

Unfortunately, the PTO, I am sorry to say, Jon, hasn’t provided 

much guidance in its response to the letter from the Chairman and 

myself about the policy questions posed by this bill. So I look forward to this hearing to hear the witnesses discuss the policy implications of this bill on the patent system and possibly on HatchWaxman. 

Just to conclude, originally this legislation began as an effort to 

address one particular late filing of one patent. There has been no 

demonstrated need or request from any other patent owners, as far 

as I know, to provide discretion to the PTO for these types of filings. Moreover, from the way the bill has been written, it is clear 

this bill would affect the late filing of a particular company, which 

occurred about over 4 years ago. Some have even suggested that 

the better alternative to this bill is a private bill. 

However, this bill and this particular circumstance does raise 

some questions about why there are inconsistencies in the discretion afforded to the PTO to determine when filings are timely. I 

look forward to this opportunity to explore those issues. 

4

I yield back, Mr. Chairman. 

Mr. SMITH. Thank you, Mr. Berman. 

The gentleman from Tennessee, Mr. Jenkins, is recognized for an 

opening statement. 

Mr. JENKINS. Thank you, Chairman Smith, for holding this hearing. 

And thank you, Mr. Berman, for your participation. I look forward to the views of our witnesses, like you, sir. And I am grateful 

for their appearance this morning. 

H.R. 5120 has drawn bipartisan sponsorship from 23 of our colleagues, including three Members of the full Judiciary Committee: 

Mr. Hyde, Mr. Delahunt, and Mr. Meehan. I introduced this measure because I believe it is both good patent policy and sound health 

care policy. It corrects an inequity in the patent law and will encourage important innovation in medical research, precisely the 

purpose that Congress sought to accomplish in enacting the HatchWaxman Act. 

In the course of this hearing, I hope that you will hear several 

examples of relief that is available for late payments, late filings 

and deficient filings. By enacting H.R. 5120 we are continuing to 

promote the basic purpose of Hatch-Waxman, and we are strengthening Hatch-Waxman. It is important to do this so that our nation 

will continue to lead the way in medical research and so that patients will not be denied promising new, innovative developments. 

Mr. Chairman, I am submitting letters from leading medical 

practitioners and consumer groups, including a letter from the 

Cleveland Clinic, the University of California at Los Angeles, and 

the Emory Health Care Center in Atlanta, Georgia, from across our 

country endorsing H.R. 5120 to include in the Committee report. 

Their credentials and their views are impressive. They emphasize the health care advantages of this measure, particularly its effect on opening up new avenues of medical research to prevent and 

treat strokes. 

Mr. Chairman, I would like to ask unanimous consent to introduce these letters and that they be made a part of the record. 

Mr. SMITH. Okay. Without objection, those letters will be made 

a part of the record. 

[The letters follow in the Appendix] 

Mr. JENKINS. Thank you. 

H.R. 5120 is a narrowly tailored bill. It simply confers discretion 

on the patent office to consider an unintentionally late filed patent 

term restoration application submitted to the patent office within 

5 days of the 60-day deadline in current law. It does not confer any 

substantive rights on any applicant but merely allows the applicant 

to present the facts surrounding the late filing to the patent office. 

The director of the patent office then has 30 days to rule on the 

petition. Honest mistakes should not cause irreparable hardship for 

innovators or patients. A few days unintentional late filing mistake 

at the patent office should not be a cause for blocking promising 

medical research that could lead to important health care advances. 

Mr. Chairman, I appreciate all the efforts you and the Subcommittee have invested in preparing for this hearing. I hope that 

5

we can move as quickly as possible through the Committee process 

and proceed with the enactment of H.R. 5120. Thank you. 

Mr. SMITH. Thank you, Mr. Jenkins. 

And, without objection, other Members’ opening statements will 

be made a part of the record, as well as a statement by Representative Elton Gallegly, a letter from Lawrence Goffney and testimony 

by Thomas Schatz, president of Citizens Against Government 

Waste. 

Mr. SMITH. Before I introduce our witnesses, I would like to ask 

you all to stand and be sworn in. 

[Witnesses sworn.] 

Thank you. Please be seated. 

Our first witness is Jon Dudas, who is the Undersecretary for Intellectual Property and Director of the United States Patent and 

Trademark Office. Mr. Dudas is the lead policy adviser to the Secretary of Commerce, the President of the United States and Administration agencies on intellectual property matters. 

As Director of the USPTO, he is responsible for administering 

the laws that relate to the issuance of patents and trademarks and 

day-to-day management of the agency’s $1.7 billion budget and 

8,000 employees. 

Prior to joining the Administration, Mr. Dudas served 6 years as 

Counsel to this Subcommittee and as Staff Director and Deputy 

General Counsel to the Committee on the Judiciary. Mr. Dudas is 

a summa cum laude graduate of the University of Illinois where he 

earned a bachelor of science in finance. He is an honors law graduate from the University of Chicago. 

Our second witness is Clive Meanwell, who is the Chairman and 

Chief Executive Officer of The Medicines Company, a pharmaceutical company based in Parsippany, New Jersey that specializes 

in acute care hospital medicines. In 1996, Dr. Meanwell co-founded 

TMC to develop medicines for specialized patient populations. 

TMC’s only product is marketed under the name Angiomax and 

is used to prevent blood clots in patients from cardiovascular disease. Dr. Meanwell oversaw the acquisition, development and successful regulatory review of Angiomax, which culminated with the 

Food and Drug Administration’s approval in 2000. Dr. Meanwell 

holds both an M.D. and a Ph.D. from the University of Birmingham in the United Kingdom. 

Our next witness is Kathleen D. Jaeger, who has served as the 

President and CEO of the Generic Pharmaceutical Association 

since 2002. Before joining that organization, Ms. Jaeger was a partner in the Washington office of several law firms where she developed a specialty in food and drug practice. In addition to earning 

her J.D. from Catholic University Law School, Ms. Jaeger also has 

a bachelor of science in pharmacy and a minor in chemistry, which 

she earned at the University of Rhode Island. 

Our final witness is John R. Thomas, who is a professor of law 

at the Georgetown University Law Center. Professor Thomas formerly served as an associate or visiting professor on the faculties 

of George Washington University, Cornell Law School and the University of Tokyo. Professor Thomas has written extensively on intellectual property law co-authoring both a patent law case book 

and a one-volume treatise on intellectual property. 

6

Welcome to you all. 

As you know, we have your entire written statements, which, 

without objection, will be made a part of the record. But please 

limit your testimony to 5 minutes. 

And, Mr. Dudas, we will begin with you. 

TESTIMONY OF JON DUDAS, UNDERSECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY, DIRECTOR OF THE 

U.S. PATENT AND TRADEMARK OFFICE 

Mr. DUDAS. Thank you, Mr. Chairman, Ranking Member Berman, Congressman Jenkins and Congressmen Meehan and 

Delahunt, for inviting me to testify today on H.R. 5120. 

This bill would amend patent law to permit the USPTO to consider certain late-filed applications for patent extension under 

Hatch-Waxman if such applications are filed no later than 5 days 

after the current 60-day time period and applicants file a petition 

showing that the delay was unintentional. 

Mr. Chairman, the USPTO does not at this point have a position 

on this bill. Certainly, there could be some benefits and at least one 

direct beneficiary of providing the flexibility proposed in the bill. 

But there are also benefits to maintaining a certainty inherent in 

the current law. 

While we have a sense of the potential impact on the possible direct beneficiary to this legislation and while we know very well our 

own abilities to enforce the law, we do not yet have a full sense 

of the impact on other interested parties. Therefore, I commend you 

for holding this hearing to help determine the potential impact and 

to otherwise examine the possible merits and limitations of this 

proposal. 

Although I am unable to give you a clear reading of support or 

opposition, I would like to share with you a number of observations 

that may be helpful to the Subcommittee as it reviews the bill. 

First, this type of legislation is not without precedent. As indicated in my written statement, current patent and trademark law 

provides the USPTO with discretionary authority to accept latefiled submissions in a number of situations. 

Also, while we currently do not believe the legislation requires 

additional restrictions or limitations in order to ensure a neutral 

application if enacted, further review of the issue may be helpful 

as the legislative process continues. 

In terms of application, we are aware of one current application 

for patent term extension that would immediately benefit from enactment of the bill. You will be hearing from the owner of that patent shortly. But our review of the over 700 applications for patent 

term extensions filed since 1984 indicates that one other application filed 5 days late may have benefited from this bill if it had 

been in effect. 

So after a review of 700 applications since 1984, there are a total 

of four patent term extension requests that were over 60 days, two 

that were within 65 days but older than 60 days and one that is 

currently pending. 

I should note that it is not unprecedented for newly enacted patent legislation to apply to issued patents and pending applications. 

But prospective or retrospective discretionary authority as proVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
7

posed in this bill should involve a careful balancing of all relevant 

interests involved. Again, we are pleased that the Subcommittee is 

reviewing input with an eye toward that balancing. 

Mr. Chairman, if granted the authority proposed in the bill, I 

would not foresee any implementation problems at the USPTO. 

The USPTO would, of course, follow the policies reflected in our administration of areas currently subject to discretionary review of 

delayed filings. 

Mr. Chairman, in closing I want to thank you, Ranking Member 

Berman, and the Members of this Subcommittee for your continuing and strong support for the USPTO operations and for your 

efforts to maintain and improve our system of intellectual property 

protection and enforcement. And I look forward to answering your 

questions. 

[The prepared statement of Mr. Dudas follows:]

PREPARED STATEMENT OF THE HONORABLE JON W. DUDAS

Chairman Smith, Ranking Member Berman, and Members of the Subcommittee: 

Thank you for inviting me to testify today on H.R. 5120, a bill ‘‘to amend title 

35, United States Code, to conform certain filing provisions within the Patent and 

Trademark Office.’’

The bill would amend patent law to permit the USPTO to consider certain latefiled applications for patent extension under section 156 of title 35 if such applications are filed not later than five days after the current 60-day time period and the 

applicants file a petition that shows that the delay in filing the application was unintentional. 

Mr. Chairman, as indicated in our recent letters to you and Ranking Member Berman, the United States Patent and Trademark Office (USPTO) does not at this time 

have a position on this proposed legislation. 

While there could be some benefits, and at least one direct beneficiary, of providing the type of additional flexibility provided by the proposal, there are also benefits to maintaining the certainty inherent in the current law in this area. 

While we have a sense of the potential impacts on the possible direct beneficiary 

to this legislation, we do not yet have a full sense of the impact on others in the 

invention, manufacturing, consumer, and intellectual property communities. 

Accordingly, we commend you for holding this hearing to help determine the potential impact on all interested parties and to otherwise examine the possible merits 

and limitations of the proposal. 

I am pleased to share with you a number of our observations that may be helpful 

as the Subcommittee reviews the bill. 

PRECEDENT

This type of legislation is not without precedent. Currently, patent laws provide 

the USPTO with discretionary authority to accept late-filed submissions in a number of situations, including: payment of maintenance fees (35 USC § 41(c)(1)); abandonment of applications (35 USC § 133); and payment of issue fees (35 USC § 151). 

The trademark laws have similar language, for example, regarding timely filing of 

a verified statement of use (15 USC § 1051(d)(4)) and abandonment of an application 

for failure to reply or amend (15 USC § 1062(b)). 

Similarly, while we currently do not believe the legislation requires additional restrictions or limitations in order to ensure neutral application if enacted, further exploration of the issue may be informative as the legislative process continues. 

PREVIOUS APPLICANTS THAT WOULD BENEFIT FROM ENACTMENT

We are aware of one current application for patent term extension that would immediately benefit from enactment of the bill. That application is related to patent 

number 5,196,404 owned by the company represented at the table here today. More 

generally, a review of our records indicates that, of the over 700 applications for patent term extension filed since 1984, three other applications were not granted due, 

at least in part, to timeliness issues. One of these applications was filed within 65 

days of the ‘‘approval date,’’ and thus may have been eligible for a petition to have 

the delay excused, if the proposed provision had been in effect. 

8

PROSPECTIVE VS. RETROSPECTIVE

It is not unprecedented for newly enacted patent legislation to apply to issued patents and pending applications. That fact noted, prospective or retrospective discretionary authority, as proposed in the bill, would have to involve a careful balancing 

of all relevant interests involved. We are unable to make a particular recommendation in this regard because we are unaware of any substantive input by interested 

parties, other than the 404 patent owner. 

EXERCISE OF DISCRETION

With respect to the circumstances under which we would expect to exercise discretion under this bill, we believe it is premature to attempt to list or identify particular examples at this point. We would, of course, if granted the subject authority, 

be likely to follow the policies reflected in the administration of areas currently subject to discretionary review of delayed filings. 

PATENT REFORM

Although our survey of patent term extension applications reveals few issues related to timeliness, this legislation would be of use to at least one current applicant 

and could be utilized by future applicants who miss the patent term extension application deadline due to unintentional delay. As noted above, the discretionary authority contemplated by H.R. 5120 is similar to other deadline-extending provisions 

in patent law. 

As indicated in testimony before your Subcommittee in April, the USPTO supports enactment of two patent proposals pending before the Subcommittee that are 

widely supported throughout the intellectual property community, namely, a postgrant review procedure and a new procedure for submission of prior art. We continue to review other proposals before the Subcommittee. 

Thank you.

Mr. SMITH. Thank you, Mr. Dudas. 

Dr. Meanwell. 

TESTIMONY OF CLIVE MEANWELL, CHIEF EXECUTIVE 

OFFICER, THE MEDICINES COMPANY 

Mr. MEANWELL. Thank you, Mr. Chairman and Members of the 

Committee. I am pleased to be here and appreciate the Committee’s invitation to testify. My name is Clive Meanwell. I come before you today both as a physician and as the chairman and CEO 

of The Medicines Company, a young company devoted to developing 

medicines for acutely ill patients. 

The subject of today’s hearing may seem dry and technical, but, 

as you know, it is actually about ensuring the potential to save 

lives and reduce health care costs. Our company serves as a poster 

child for why this legislation is needed. Relying on incentives in the 

patent law, we spent more than $200 million developing Angiomax, 

an intravenous blood thinner that has proven to be effective and 

safe for patients while actually saving hospitals an average of $400 

per use compared with more established therapies. 

Once FDA approved Angiomax, we applied for patent term restoration to recover time lost while seeking approval. The 60-day 

deadline was mistaken for a 2-month limit, and the application was 

filed 1 day late. Unlike most other patent provisions, current law 

gives the PTO no discretion to accept a late filing. So our application was denied. 

This drastic penalty took away 41⁄2 years of patent rights we had 

earned and cut off our ability to invest tens of millions of dollars 

more in research to confirm promising new uses of Angiomax in 

open heart surgery and stroke. 

Mr. Chairman, this is a good bill for three principle reasons. 

9

First, the existing deadline provision imposes hugely disproportionate penalty like having your home repossessed when you are a 

day late with the last mortgage payment. Deadlines are important, 

but most patent law provisions like Federal court rules recognize 

that human beings make mistakes and that catastrophic consequences should not flow from them. 

Second, this legislation is consistent with most patent laws and 

regulations, which allow minor mistakes to be excused. 

Third, the bill could benefit millions of seriously ill patients. Only 

companies with a period of exclusivity can make the large-scale investments necessary to develop new uses of the drug beyond the 

scope of its initial FDA approval. 

Some critics suggest this bill will disrupt the decision making 

process of generic manufacturers who pursue their own applications on relatively tight timelines. I am on the board of a company 

that sells generics, and I know how important these tight timelines 

are. But they have nothing to do with the patent term restoration—with when patent term restoration applications are filed. The 

only dates really important to a generic firm are the date of FDA 

approval and the date a patent expires. 

Similarly, the claim that this bill might interfere with settled expectations is a fallacy. There are no settled expectations 60 days 

after a drug has been approved, nor would the time added by this 

bill, a maximum of 35 days, have the slightest impact on a 

generic’s business plans. It is the pioneers’ settled expectations 

that get blown to bits if its patent rights are lost over a minor filing error. 

It is also suggested that since the filing of Hatch-Waxman application triggers an elaborate sequence for calculating the registration period—the restoration period, ensuring that this triggering 

event happens in a seasonable manner is somehow important. But 

calculating the restoration term typically takes 3 years after the 

application is filed. So the few extra days this bill could add at the 

start of the process are just trivial. 

This bill will not—and let me repeat that—will not upset the 

delicate balance that Hatch-Waxman strikes between innovators 

and generics. In fact, it preserves the balance. Generics retain all 

their rights. And the patent owners get nothing more than the restoration period that they already earned under Hatch-Waxman. 

Without this bill, however, an innovator who makes an unintentional filing mistake loses what Congress intended to provide: an 

opportunity to recover time lost during FDA approval. 

I just don’t believe that Congress intended to throw this careful 

balance overboard in the event that an innovator trips on their way 

to the patent office. Some say this is a single company bill. But 

that is a red herring. This bill would fix a legal pothole for all other 

patent holders and could potentially help millions of patients who 

will benefit from new drugs and new uses of drugs. 

In summary, this bill enhances the fundamental bargain struck 

by Hatch-Waxman. It removes a Draconian penalty for minor error. 

It is consistent with current law. And it will potentially improve 

the lives of millions of needy patients. 

Thank you very much. 

[The prepared statement of Mr. Meanwell follows:]

10

PREPARED STATEMENT OF CLIVE MEANWELL

Thank you Mr. Chairman and Members of the Committee. 

My name is Clive Meanwell, and I am the Chairman and Chief Executive Officer 

of The Medicines Company, a young pharmaceutical company based in New Jersey 

where we develop acute care medicines for hospital patients, a small segment of the 

market often considered unattractive by big drug companies. I am also a doctor. And 

I am pleased to be here and appreciate the Committee’s invitation to testify. 

Mr. Chairman, the subject of today’s hearing—filing deadlines for certain patent 

applications—might seem like a dry and technical one, but it is actually about creating the potential to save lives. It is about amending a provision of the Hatch-Waxman Act that, if left unchanged, will right now kill the further development of a 

drug that is helping thousands of heart disease patients every month and has the 

promise to help hundreds of thousands more patients with life-threatening cardiovascular conditions, including stroke victims. Beyond our case, if the provision is left 

unchanged, it will also put at risk the development of other drugs that will save 

lives in the future. 

The purpose of this hearing, at least as I see it, is to weigh the distinct benefit 

of the proposed filing amendment against whatever benefit there may be to retaining the existing, inflexible provision. In my view, what H.R. 5120 does, in a nutshell, is to preserve the fundamentally sound bargain Congress struck in the HatchWaxman Act between encouraging innovation and bringing generic drugs to market. 

In preserving Hatch-Waxman’s incentive to develop new drugs and new uses for 

drugs—without curtailing provisions that benefit generic manufacturers—this bill 

also stands solidly on the side of patients. 

BACKGROUND

To date, The Medicines Company’s only marketed product is a new blood thinning 

drug called Angiomax. The FDA has already approved Angiomax for use in 

angioplasty—a procedure often used to treat coronary artery disease, including 

heart attacks. Catheters, inflatable balloons, and stents are used to open up a coronary artery that is narrowed or blocked by arteriosclerosis or blood clots. Approximately one million angioplasties are performed each year in the United States, and 

in this setting Angiomax has been shown effective and safe, and is also associated 

with a significant reduction in bleeding complications compared to other treatments. 

More than 250,000 patients benefited from Angiomax last year alone. These positive 

results have been seen in both clinical trials and real-world use, in many different 

groups of patients, from diverse ethnic backgrounds, with a range of risk factors and 

a variety of life-threatening coronary artery disease states. And Angiomax—a product of high technology research—is particularly useful for people who cannot tolerate heparin, an extract of pig intestines discovered in 1916, that until the last decade was the only injectable anticoagulant available. 

In addition to its established effectiveness in coronary angioplasty, Angiomax may 

also have important uses in patients undergoing cardiac surgery, those with preheart attacks and those with strokes. Each of these conditions represents enormous 

public health problems in the United States today. Coronary artery disease and 

stroke combine to kill well over a half million Americans each year—more than the 

deaths caused by all cancers combined, and therefore by far the leading cause of 

death in this country. The initial promise of Angiomax in these new research areas 

is exciting. For example, results of an Angiomax pilot trial in open heart surgery 

were reported in the Annals of Thoracic Surgery in 2004, where an expert commentator stated, ‘‘bivalirudin [i.e., Angiomax] could be the ‘holy grail’ eagerly sought by 

cardiac surgeons and anesthesiologists (and hematologists)....’’ Ann. Thorac. 

Surg. 2004; 77:925–31. In another example, early studies involving carotid artery 

stenting—a procedure used to unblock the arteries in the neck that can throw off 

blood clots to the brain—have shown that Angiomax can reduce the risks of bleeding 

and effectively prevent embolic strokes during this delicate life-saving procedure. 

We have already committed, and hope to continue committing, substantial resources to research and development of these significant new uses for Angiomax. 

And that brings me to the point of my testimony today. 

Our company serves, I am sorry to say, as a poster child for why this bill is needed. 

In developing Angiomax, we did what research-based biotech and pharmaceutical 

companies regularly do in responding to the incentives of the U.S. patent system: 

we spent large amounts of time and money to bring a new product to market. In 

total, development of Angiomax for angioplasty took eight years and cost more than 

$200 million. We anticipate that the clinical trials needed to establish the safety and 

effectiveness of Angiomax in patients for cardiac surgery and for stroke will take 

11

at least 4 more years and cost tens of millions of dollars. These investments are not 

viable without the patent exclusivity provided by the Hatch-Waxman Act. 

As you know, the U.S. patent law framework—including Hatch-Waxman—is designed to provide incentives for the investment of such time and money. Hatch-Waxman, of course, enables research-based pharmaceutical companies to recoup some of 

the time spent in the FDA approval process so that the patent exclusivity period 

is not unfairly curtailed. Often, it is the possibility of qualifying for Hatch-Waxman 

patent term restoration that provides innovators with the incentive to invest in 

drugs that no one else wants to develop. Moreover, once such restoration has been 

granted, innovators have added incentive to pursue further research on drugs to 

broaden their approved use, an important step in the development process, since it 

is not unusual for FDA to grant a narrow approval in the first instance. 

The FDA approved Angiomax for the narrow initial use in coronary angioplasty 

on December 15, 2000. Under the Hatch-Waxman formula, we calculated that we 

were entitled to a restoration period of approximately 41⁄2 years. We quickly set 

about preparing our application for patent restoration, completing a first draft of the 

100-plus page application package by the first week of January 2001 and then working steadily along with our counsel on further drafts. But then human error intervened. The current filing provision of Hatch-Waxman requires an application to be 

filed within 60 days of FDA’s approval of the drug in question. Unfortunately, the 

60-day requirement was evidently mistaken for a two-month requirement, and our 

patent restoration application was filed on February 14, 2001, within a two-month 

window, but one day late for the actual 60-day deadline. Unlike other filing provisions of the patent laws, this provision of Hatch-Waxman does not allow for any discretion to accept late applications, no matter the reason and no matter how close 

to the actual deadline. So, the Patent and Trademark Office denied the petition as 

untimely. We filed a motion for reconsideration which is still pending, but the PTO 

lacks the authority to grant it. 

So, because of an inadvertent administrative error, The Medicines Company—and 

the patients who could be helped by Angiomax—are facing a drastic and disproportionate penalty. The basis for a $200 million investment that powered development 

of a life-saving drug in coronary angioplasty has been completely cut out from under 

us. And our hope of extending the benefit of Angiomax into critically important new 

areas is in tatters. Without patent restoration, our patent will expire in 2010, not 

nearly enough time to make possible the investment of years and tens of millions 

of dollars needed to confirm the efficacy of Angiomax in treating stroke and serious 

heart disease to the satisfaction of ourselves, the FDA and medical practitioners. 

And others who make accidental filing mistakes in the future, may face a similar 

predicament. 

Making the consequences of a minor mistake so catastrophic, both to a patent 

owner and the public, simply cannot be good or wise public policy. 

H.R. 5120-WEIGHING THE BENEFITS

H.R. 5120 is a modest bill that would correct this unduly harsh result for us and 

for any other innovators who make the same mistake. The bill would not give a patent owner anything other than what it has already earned under the Hatch-Waxman system—a credit for the portion of a patent term effectively lost while seeking 

FDA approval. The bill would not, by its own terms, grant patent term restoration. 

It would simply give the PTO authority to accept an application that was filed late 

on account of an unintentional error. 

Mr. Chairman, I think a reasoned analysis of the potential costs and benefits of 

this legislation argues powerfully in its favor. Let me begin with the benefits of 

modifying the existing deadline provision. 

First, the effect of the existing provision is like having your home repossessed for making your mortgage payment a day late—a completely disproportionate punishment for a minor, administrative mistake. As a matter 

of wise public policy, this does not make sense. Years of highly valuable, hard 

earned patent rights—in our case more than a third of our total patent period—

should not be forfeited on account of a minor clerical error. 

Second, this legislation is entirely consistent with typical patent law and 

practice and supports the purpose of Hatch-Waxman. Recognizing the obvious 

importance of patent rights and the national interest in promoting pharmaceutical 

innovation, the great majority of relevant patent laws and regulations actually do 

give the PTO discretion to excuse inadvertent mistakes. For example: if an applicant 

files an incomplete application for patent term restoration, the PTO can grant up 

to two extra months to correct the errors in the application. This is not an isolated 

example. There are more than 30 such examples where the PTO has the authority 

12

to excuse errors that could otherwise deprive an applicant of its rights. We have 

submitted a memorandum detailing these examples to the Committee. Thus, the 

rigid statutory 60-day deadline, allowing PTO no discretion to excuse an inadvertent 

error is, in fact, an anomaly, which this bill would rightly correct. Moreover, by preventing the automatic forfeit of years of patent protection for minor clerical errors, 

the bill supports an important purpose of the Hatch-Waxman system—to make sure 

patent owners have an opportunity to recover the portion of their exclusivity period 

that would otherwise be lost while awaiting FDA approval. 

Third, this bill would potentially benefit millions of seriously ill patients.

Only a company that can assure itself of a significant period of exclusivity will take 

the risks and make the substantial investment necessary to obtain the approval of 

new uses of a drug beyond the scope of its initial FDA approval. In our case, no 

generic manufacturer would do what we are prepared to do—invest years and tens 

of millions of dollars to test promising new uses of Angiomax for heart disease and 

stroke—because the manufacturer would have no financial incentive to do so. If the 

initial promise we have seen for such applications is realized, Angiomax could potentially provide vital help to hundreds of thousands of seriously ill patients. And 

what is true for us will be true for others in the future. So this is an important, 

potentially life-saving bill for patients. 

Now, I understand that concerns have also been raised about this bill, but they 

do not, individually or together, begin to measure up to the bill’s substantial benefits. 

Settled expectations/certainty. First, it has been said that H.R. 5120 might 

interfere with settled expectations about when a drug would come off patent, and 

that there are legitimate benefits to maintaining the certainty inherent in current 

law. In principle, there are of course benefits to certainty in laws. But the interest 

of ‘‘settled expectations’’ is more effectively served by this bill than by the status 

quo. 

The fact that a patent owner might get an additional 5 days to file a patent restoration application, and that the PTO could take 30 days to decide whether to 

grant this additional time, will not have the slightest impact on the business plans 

a generic manufacturer has or has not made to enter a new market. The truth is 

that neither generics manufacturers nor anyone else can know what the duration 

of a possible patent term restoration period might be until the proposed patent term 

extension is published for public comment, often years after the application is filed. 

That is the first notice that a generic manufacturer is likely to rely on in terms of 

its own planning, and this bill would have no impact on the content or timing of 

such notice. 

I am very sympathetic to the value of generics companies in our healthcare system—indeed I sit on the board of directors of one, and I am proud of what we do 

there. But the claimed disturbance to certainty and settled expectations entailed in 

H.R. 5120 would not even amount to a ripple upon the water for a generic firm. 

By contrast, the settled business expectations that are obliterated are those of a 

patent holder that devises its business and investment strategy in reliance on the 

opportunity for Hatch-Waxman restoration, if those rights are lost on account of a 

minor filing error. 

The delicate balance. Second, some have said that enacting this bill would 

upset the delicate balance in Hatch-Waxman between (a) spurring innovation by assuring that a patent holder retains its exclusivity rights despite the years it takes 

to get FDA approval, and (b) allowing generic manufacturers to produce cheaper 

drugs. I’m neither a lawyer nor a legislator, but it seems to me that the ‘‘balance’’

argument cuts in favor of H.R. 5120, not against it. 

The Hatch-Waxman balance was premised, as I understand it, on the following 

five elements: first, a generic manufacturer can study a drug during the patent term 

without infringing the patent; second, a generic manufacturer can rely upon the investment and testing done by the innovator, rather than incurring the time and expense required to test the drug itself; third, a generic manufacturer who files an 

ANDA (Abbreviated New Drug Application) successfully challenging an existing patent is eligible for a six-month period of marketing exclusivity; and fourth, generic 

manufacturers benefit from the five-year limit on the patent restoration term and 

the 14-year cap on the overall patent term; while, fifth, the innovator is provided 

an incentive—through the grant of patent term restoration—to undertake the risk, 

expense, and delay of drug testing and FDA approval. 

Under H.R. 5120, this balance is fully preserved. Generic manufacturers would retain all of the benefits I just described—study during patent term, benefiting from 

others’ R&D investments, ANDA opportunity, and limited patent terms—and the innovator would retain its benefit of term restoration in exchange for conducting clinical testing. Without this bill, however, an innovator who makes a minor, inadVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00016 Fmt 6633 Sfmt 6621 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
13

vertent filing error loses its entire Hatch-Waxman benefit—the opportunity to seek 

the patent term restoration that was already earned. 

I simply cannot believe that, as Congress constructed this careful balance, it 

meant to throw it overboard in the event that the innovator tripped on the way to 

the Patent Office. That was manifestly not part of the bargain Congress intended 

to strike. 

Deadlines. Third, some say simply that 60 days means 60 days, full stop. I understand the importance of deadlines, and I understand that penalties are an important way to enforce deadlines. But, the problem here is that the punishment does 

not remotely fit the crime. As I have noted, the PTO has extensive discretion to extend deadlines in most situations encountered in patent examinations. And I understand that a similar rule applies in federal civil litigation, where the relevant rule 

(6(b)) gives judges broad discretion to extend a deadline or permit a filing ‘‘where 

the failure to act was the result of excusable neglect.’’ The flexibility found in the 

patent law and the rules of civil procedure is built on a fundamental and simple 

recognition—that people are human and sometimes make inadvertent mistakes, and 

thus draconian consequences ought not to flow from such errors. An argument that 

comes down to the claim that a rule is a rule and should not be changed no matter 

how inappropriate its effect seems to me unworthy of this great legislative body. 

The PTO, of course, cannot change such a rule in a statute, but Congress can if it 

concludes, as a matter of policy, that a wise amendment is available. I think H.R. 

5120 constitutes just such an amendment. 

Single company. Fourth, the notion that this is just a bill to help one company 

is a red herring. Of course, our company would potentially be helped by the bill, 

since the PTO would then have the discretion to accept our filing and consider our 

application on the merits if it so chose. But, as the PTO has noted, others in the 

past have had timeliness problems with regard to Hatch-Waxman filings, and, because people will always make mistakes, others will have this problem in the future. 

Our company is the one that has stumbled, inadvertently, into this legal pothole. 

But that does not change the reality that the pothole ought to be fixed. Most laws 

passed by Congress benefit some companies and disadvantage others—that is just 

a fact of life. If there is any difference here, it is that most of the beneficiaries of 

this law will be found in the future and no one is likely to be disadvantaged. 

Going to court. Finally, some have said to me that we should just file a lawsuit 

rather than advocating an amendment to Hatch-Waxman. But that course of action 

would fail in fundamental ways that I care about a great deal. First, there is a bona 

fide public policy problem here. This really is not just one company’s concern. The 

immense disproportion between a relatively trivial mistake and the enormous consequences that flow from it is just not right—not for us and not for any other companies that follow in our wake. 

In addition, I care deeply about pursuing the promise of Angiomax to heart and 

stroke applications, which as I have explained, we will not be able to do absent patent term restoration. As I said at the outset, I am not just a businessman, I am 

also a doctor. I have made a lifelong commitment to improve patient care, and I 

would hate to let that promise go unexplored. Money that we might recover in a 

lawsuit would be useful to the company, but it would not save a single life. So that 

is not the answer to this problem even for us, much less for future patent owners. 

CONCLUSION

In summary, this is a small but important piece of legislation. I think the answer 

to the question I posed at the start of my of my testimony—whether the benefits 

of the bill outweigh the benefits of the status quo—is clear. H.R. 5120 would provide 

palpable benefits both to innovators and to patients in a manner that is fully consistent with patent law and practice. The only harms identified—a negligible effect 

on certainty and the loss of an unintended, unplanned and unearned windfall for 

generic manufacturers—in my judgment are definitively outweighed by those benefits. 

Mr. Chairman, I have been impressed by the thorough and diligent manner in 

which this Subcommittee has carried on its work. I hope that, with a single-minded 

focus on the public interest, the Subcommittee will see fit to move the bill forward 

toward ultimate enactment. 

Thank you very much and I look forward to your questions.

Mr. SMITH. Thank you, Dr. Meanwell. 

Ms. Jaeger. 

14

TESTIMONY OF KATHLEEN JAEGER, PRESIDENT AND CHIEF 

EXECUTIVE OFFICER, GENERIC PHARMACEUTICAL ASSOCIATION 

Ms. JAEGER. Chairman Smith, Ranking Member Berman and 

Members of this Committee, my name is Kathleen Jaeger, and I 

am the president and CEO of the Generic Pharmaceutical Association. On behalf of GPhA and our 130 members, I want to thank you 

for convening this hearing and allowing GPhA to express its views 

on H.R. 5120. 

Mr. Chairman and Members of this Committee, what we are essentially discussing here this morning is playing by the rules and 

whether Congress is willing to turn its back on the rules because 

one company decided it just didn’t want to play by those rules. 

The fact is that Congress established specific criteria in both title 

1 and title 2 of the Hatch-Waxman amendments on how brand and 

generic pharmaceutical companies should operate when in the 

Hatch-Waxman system, including how and when a brand company 

could apply for a patent term extension, or a PTE. 

Congress worked hard to ensure that they established a system 

that addressed two competing yet equally important goals: encouraging innovation and expediting the public’s access to more affordable generic medicine. The system was designed to foster both 

goals, and a process was put in place that hundreds of companies 

have been following since 1984. 

As with any system, the Hatch-Waxman system is replete with 

rules and deadlines. And they need to be followed to achieve these 

important public health goals. In the case of The Medicines Company, it simply chose not to follow the rules that says there is a 

deadline for submitting the PTE application. And now it is asking 

for a change of the rules because it didn’t follow them. 

Mr. Chairman, that is simply not the way the system works. We 

all know the rules, and we all know that if we don’t play by them 

we could be benched, we could be penalized or lose an extraordinary opportunity. 

Congress cannot create a system where if a company misses a 

deadline it can come running to Congress to fix it. If that was the 

case, I daresay this Committee would have an even busier hearing 

calendar than it does now. 

For example, several brand companies have lost the opportunity 

to secure a 30-month automatic stay under title 1 of Hatch-Waxman because the brand companies failed to file a lawsuit against 

a generic patent challenger within the statutory mandated 45-day 

deadline. 

Likewise on our side of the industry, a generic company is eligible for 180 days of generic exclusivity provided that among other 

things, the company is the first to file a generic application with 

FDA that contains a paragraph four patent challenge. If another 

company files 1 day after the first generic company filed its application, that subsequent firm gets nothing because those are the 

rules. 

If Congress approves this legislation, rules go out the window. 

You would basically be saying that the deadlines don’t mean anything. Under this legislation, the PTO would be given a discretion 

to accept a P.T. application filed up to 5 days after expiration of 

15

statutory deadline. And by its terms, this bill would have the practical effect of automatically extending a deadline to 65 days. 

This extension not only undermines the intent of Congress, it ultimately delays the ability of more affordable generic drugs to be 

brought to consumers. And this Committee needs to ask itself what 

happens when some other company misses the new deadline and 

files on day 66. Do we extend the deadline again? And what are 

the consequences to the health care system when several of the 

Hatch-Waxman system deadlines get extended and the system 

unravels? 

Now, this legislation has been labeled, ‘‘Sorry I am Late, the Dog 

Ate My Homework Act,’’ by Citizens Against Government Waste. 

While this label is quite amusing, there is nothing funny about the 

consequences of this legislation. It isn’t as simple as saying my dog 

ate my homework. 

This is a major change in the law with enormous negative implications, a change that would offset the delicate balance Congress 

created under the Hatch-Waxman Act between the brand and generic pharmaceutical companies. That balance has stimulated 

pharmaceutical innovation while ensuring that consumers are able 

to receive safe, effective and affordable medicines in a timely manner. 

In the end, statutory deadlines have meaning. They have consequences. Allowing 5 extra days to file a patent term extension application renders that deadline meaningless and treats certain patentees differently than everyone else who respects statutory deadlines. And all to the benefit of one company who by its own inactions failed to file a simple form within the statutory timeframe. 

Mr. Chairman and Members of this Committee, we thank you for 

giving GPHA the opportunity to present our concerns about this 

legislation. This legislation opens a Pandora’s Box that simply 

should not be opened because one company didn’t get its paperwork 

done on time. Thank you. 

[The prepared statement of Ms. Jaeger follows:]

16

PREPARED STATEMENT OF KATHLEEN JAEGER


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Mr. SMITH. Thank you, Ms. Jaeger. 

Professor Thomas. 

TESTIMONY OF JOHN THOMAS, PROFESSOR OF LAW, 

GEORGETOWN UNIVERSITY LAW CENTER 

Mr. THOMAS. Thank you, Mr. Chairman and other distinguished 

Members of the Subcommittee. I am pleased to testify today on my 

personal behalf. My views are my own rather than those of Georgetown University or other institutions with which I am affiliated. 

The Hatch-Waxman Act represents an effort to refine within the 

pharmaceutical industry the central problem of any intellectual 

property regime: encouraging the labors that lead to innovation on 

one hand and disseminating the fruits of those labors on the other. 

Thus the Hatch-Waxman Act created an expedited generic marketing approval protocol, but also called for term extensions for 

patents on approved drugs. 

Patent term extension is unquestionably a fundamental part of 

the Hatch-Waxman Act, a statute that for all its perceived flaws 

has been highly successful in both encouraging the generic drug industry and promoting the discovery and development of new drugs 

by brand name firms. 

As the Committee considers modifications to the 60-day period 

provided by section 156, the term extension statute, a few basic 

subjects and points may be worthy of review. 

First, the Federal circuit has long interpreted the 60-day deadline strictly. Its 1989 decision in Unimed v. Quigg held that an 

NDA holder was not entitled to patent term extension even though 

it filed promptly after having the drug cleared by the Drug Enforcement Administration. 

It held that, in fact, the date for term extension calculation was 

the FDA approval date, which had occurred more than a year before. It is a 17-year-old case, and I simply know of no other circumstance during that period in which anyone has come to Congress requesting a term extension. 

Second, U.S. PTO regulations already provide some flexibility in 

meeting the deadline standards. And so, there is already some ability for NDA holders to follow an expedited application that can 

then be filled out. 

Third, term extension determinations do not entail merely a ministerial calculation. The filing of an application for term extension 

potentially triggers a fairly elaborate proceeding potentially involving the USPTO, Secretary of Health and Human Services, Secretary of Agriculture, the patent proprietor and third hearings—

third parties. There may even be an informal hearing to discuss 

qualifications for the term extension. 

And that somewhat distinguishes this case from other sorts of 

deadlines that the USPTO deals with, for example, responding to 

an office action. So ensuring that these deadlines are met promptly 

would arguably serve important administrative goals. 

Finally, it is true that some deadlines of the USPTO can be 

waived or extended. Though, of course, many of those extensions 

entail third party rights, for example, user rights in favor of those 

who may have a reliance interest on the expiration of diminution 

of patent rights. 

26

As you know, the Patent Reform Act of 2005 retains the 1-year 

deadline. Anyone who discloses an invention more than a year before filing forfeits their patent rights. And that is a provision that 

can work very hard against independent inventors and small firms. 

The Hatch-Waxman Act is replete with deadlines that impose 

even tighter timeframes. A brand name firm has to file a patent 

infringement suit within 45 days of receipt of notice of a paragraph 

four ANDA, otherwise it loses its entitlement to a 3-month stay by 

the FDA. 

On the generic side, a paragraph four ANDA applicant who files 

1 day after another such applicant potentially loses its entitlement 

to a 180-day period of generic exclusivity. So there already are a 

lot of tight deadlines and even shorter deadlines in the Hatch-Waxman Act. 

Now, in view of those principles, allow me to offer a few observations. 

First, one question is the extent of the problem. How many times 

has this occurred? Is this a recurring issue or one that we think 

might change? 

Second, what is the standard for the USPTO to resolve whether 

there ought to be an extension or not? The statute right now says 

the delay in—or the bill says that whether the delay in filing the 

application is unintentional. 

I am sort of reminded of Aristotle and the Nicomedian ethics. No 

one can suffer injustice voluntarily because no one can wish to be 

harmed, Aristotle says. Well, if that is so, what does this mean? Is 

this an automatic 5-day deadline for everyone? If that is so, better 

just to change the period to 61 days, 65 days or something else. 

If, in fact, the USPTO is supposed to do a malpractice style inquiry, I would suggest this is not a situation where the USPTO is 

well suited. And it ought to retain its core responsibilities. 

There are a lot of other section 156 issues that seem to me to 

be more compelling. For example, the applicability of patent term 

extension to combination therapies. And the Committee may wish 

to consider that. 

Thank you again for the opportunity to submit this testimony. I 

would be delighted to answer any questions. 

[The prepared statement of Mr. Thomas follows:]

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PREPARED STATEMENT OF JOHN R. THOMAS


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Mr. SMITH. Thank you. Thank you, Professor Thomas. 

And let me say this is the first panel where every witness has 

kept within their 5-minute limit. So that is appreciated. It is appreciated in part because we have a Judiciary Committee bill on the 

House floor right now. We are actually trying to expedite this hearing. 

Mr. Dudas, let me direct my first question to you. The PTO has 

had under consideration for 4 years now a request by The Medicines Company for reconsideration. You have also said that the 

statute is clear and you have your hands tied. Why is it that the 

PTO has not acted in 4 years on the request by The Medicines 

Company? 

Mr. DUDAS. Thank you. We have acted within 4 years, and I will 

explain. 

This is a rather administrative procedure back and forth between 

the USPTO and other agencies, the FDA and Department of Agriculture. But that question came up in my mind as well. How many 

of these do we have that are over 4 years old? How long does this 

process take? 

I talked to the woman who is in charge of this process. The average time period is a little bit over 3 years. It is a series of back 

and forths with the FDA and the Department of Agriculture. We 

now have 30 cases. I have a list of them that I had compiled—30 

cases where they are active over 4 years old. 

The second question is, well, do we want things to be active for 

4 years. We are very careful in every case measuring everything at 

the USPTO to make certain we protect rights. 

Mr. SMITH. And you are just as careful in issuing patents as well, 

right? 

Mr. DUDAS. Absolutely, absolutely. And so, the answer to that is 

basically both referred to it here. These are patent term extensions. 

The date that really matters is when the patent term originally expires. So you look at this case. It is the year 2010, 2015, et cetera. 

Mr. SMITH. Yes, right. 

Mr. DUDAS. So the back and forth—certainly, if we get close to 

that time period we accelerate the process. 

Mr. SMITH. Okay. Thank you, Mr. Dudas. 

Mr. DUDAS. Sure. 

Mr. SMITH. Dr. Meanwell, this is a particularly litigious society 

that we have today. I am sure there are any number of plaintiff’s 

attorneys who would be happy to file a malpractice suit, contingency fee or not, on your behalf. Why haven’t you simply resorted 

to those means and filed a malpractice suit? 

Mr. MEANWELL. Mr. Chairman, a lawsuit won’t solve this problem. We will still be left with the underlying pothole in the law. 

I think there is a real policy problem to solve here. 

Of course, I would like the money. The money would be useful 

to help me build my company. But it wouldn’t save a single life. 

I don’t think at this stage that a lawsuit is going to move any of 

us forward. Certainly, it is not going to move forward the wellbeing of any patient. 

So for us, at this point, we would rather come here and debate 

the merits of fixing this hole in the law than suing our law firm. 

Mr. SMITH. Okay. Thank you, Dr. Meanwell. 

35

Ms. Jaeger, you said in your written and opening statement that 

severe harm would be caused to both consumers and taxpayers if 

this legislation were to be passed. That is in distinction to what Dr. 

Meanwell has said where he said that actually consumers would be 

benefited by having an extension to the patent. 

You made that assertion. Can you support it with evidence that 

consumers and taxpayers would be harmed by passing this legislation? 

Ms. JAEGER. Absolutely, Mr. Chairman. 

There are two issues here. The first one is the broader piece on 

harm having to do with the statutory framework of Hatch-Waxman. As I said in my testimony, the Hatch-Waxman system is a 

very complex system. And it is based on an intellectual propertybased generic approval system. In that system, there are numerous 

rules and deadlines. 

We were very concerned that with respect to this particular issue 

we start moving deadlines, they start to be very clouded. We do 

not, well, actually we will not have a system. The system will totally unravel to the detriment of the generic industry and to consumers. These deadlines need to be met, and they need to be there 

for the administration of the orderly conduct of all parties in the 

system. 

Mr. SMITH. Right. But wouldn’t consumers be benefited by the 

continuing research and development of additional benefits that 

might accrue from this particular type of drug? And would that be 

halted by The Medicines Company not getting their extension or 

reconsideration? 

Ms. JAEGER. I think the broader issue is that the rules need to 

be followed is more imperative to consumers. Again, we have had 

situations where other deadlines in the Hatch-Waxman system 

have been missed by brand companies even by 1 day. Yet they did 

not get the benefit and the opportunity of that other provision. 

And again, it goes to the benefit of consumers and ensuring that 

everyone plays by the rules. And in this instance, what we are 

talking about also, getting down to more of a specific issue, is we 

do have a situation where the patent will expire in 2010. 

Our members do a lot of research and development many years 

prior to bringing a generic to the marketplace. They rely on that 

information that has been posted. They are relying on the information that the PTE extension has been rejected. They have made 

business decisions on reliance on that decision. 

Mr. SMITH. Okay. Thank you, Ms. Jaeger. 

Professor Thomas, would you respond to two issues that I 

brought up so far, that being the possibility of and the advisement 

of filing a malpractice suit? And second of all, whether you think 

real harm is being done to consumers if we do not grant discretion 

to the patent holder. 

Mr. THOMAS. Yes, sir. The malpractice suit is part of patent practice. As someone who used to spend his time prosecuting patent applications, my experience was the docketing clerk was the most important colleague I had. And he would come and tell me, ‘‘Look, you 

have got a deadline up here, and it is irremediable.’’

And so, any first-year associate at a patent law firm is advised 

about this in no uncertain terms. And you can read the law books. 

36

They are full of malpractice cases where regrettably deadlines have 

been missed. So that has traditionally been the method of compensation for those who have missed deadlines. Alternatively, 

shareholder suits against company management—— Mr. SMITH. And what about harm? 

Mr. THOMAS. Harm to patients? 

Mr. SMITH. Harm to consumers if extension is not granted. 

Mr. THOMAS. Well, we are deciding here, I guess, essentially is 

wealth transfer between patient populations that will pay lower 

prices for generic versions of drugs versus, you know, surplus that 

would go to the firm due to its super-competitive profits that are 

based on a patent. Harm to patients, it is hard to say. We have already got this medication in hand. 

But the patent law is about incentives. We have got the patent 

in hand. The question is how The Medicines Company chooses to 

use its resources and whether, in fact, it is the best actor to further 

develop this medication. 

Mr. SMITH. Okay. Thank you, Professor Thomas. 

The gentleman from California, Mr. Berman, is recognized for his 

questions. 

Mr. BERMAN. Well, thank you, Mr. Chairman. I guess I have a 

set of questions for Dr. Meanwell and Ms. Jaeger. 

Ms. Jaeger, I thought maybe your testimony went a little far in 

saying that the company chose not to meet the deadline. My guess 

is they don’t feel they chose not to meet the deadline. Somebody 

screwed up big time. Maybe somebody at the company screwed up 

by not watching who was in charge of not screwing up. And bad 

things happened. And this is clearly a case. 

But the central public policy point from not the company’s wellbeing or the shareholders’ well-being—but, Dr. Meanwell, when 

you came a long time ago, I think it was, to my office, you made 

the point, which you have repeated here, that not having what was 

your settled expectation regarding the delays caused by the FDA 

and added on to your patent term is going to keep you from investing the funds to do the trials and the research in the trials to find 

where you think there are beneficial uses from this drug or some 

slight variation of this drug and that you believe that that is the 

real harm to the public in a way that you see, apart from your own 

interests, your company’s interests, your shareholders’ interests, 

that a new use of this drug will be precluded. 

And I guess what I am asking is you originally developed 

Angiomax based on raising funds to do the research and trial runs 

for the blood thinning use that it is now used for. Why can’t you 

do that same process for the new uses of this particular drug, even 

though I recognize a huge amount of revenue, if nothing changes, 

is going to be lost to you by not having what was your settled expectation of exclusivity? 

And maybe, because my time might run out, let me just ask Ms. 

Jaeger very specifically. Apart from all the generalized talk, what 

generic drug company thought that this patent term would expire 

4, 41⁄2 years earlier than you would have normally assumed and 

has made an investment based on what didn’t happen on the 60th 

day to produce an alternative that is going to end up in a lower 

cost drug? 

37

I would like you to be specific about your members that you sort 

of generalized have made investments based on their, what you 

claim to be, their settled expectation of when this thing would come 

on the market, especially given that at least for, it seems like, 

years, but maybe it is only two since there has been a great deal 

of public discussion about this issue that would unsettle anyone’s 

expectations about anything. 

So those are my two questions. 

Mr. MEANWELL. Thank you for the question. Indeed, there has 

been quite a lot of public disclosure about this. It is not so much 

the loss of money and revenue, Mr. Berman. It is the loss of time 

that is the critical component in research here. 

By not having the extension that we had expected, I cannot 

launch the kind of programs that are required today to prove that 

this drug, to my satisfaction, to the satisfaction of the FDA, to the 

satisfaction of doctors and their patients, will meet the needs of patients with, for example, stroke or undergoing open heart surgery. 

I need several years to do that in. 

It was our plan that we would follow—and this is not unusual 

for hospital products—the initial research program with the FDA. 

Mr. BERMAN. Explain that to me. 

Mr. MEANWELL. Yes, sir. 

Mr. BERMAN. Why does the fact that the patent will expire in 

2010 if nothing is done have anything to do with the time needed 

to run the clinical tests to determine if there are other uses? 

Mr. MEANWELL. Because, sir, if I start the trials today—and 

some of them have preliminarily started—and then we held it, I 

would have 2, 3, 4 years to do it, 1 year to get it through the FDA 

and, at that point, would happily hand over those indications to my 

colleagues in the generic industry. I would not benefit from them 

at all. And I simply don’t have time to get them done. 

Mr. BERMAN. Don’t you need a patent for new uses of——

Mr. MEANWELL. No, sir. But I need an FDA approval in order to 

promote those new uses, and I don’t have that today. I need to 

work hard to get a new indication for the drug beyond its existing 

use. And I don’t have time to do that unless the patent term is restored, which, of course, is what under Hatch-Waxman we believe 

we had earned in the normal way. 

So our expectations were to get that. We set our programs up sequentially. We now cannot pursue that research in what looked 

like very promising new indications in important illnesses. 

Mr. BERMAN. Thank you. I have to say, I think it is me, but I 

am not fully understanding why. But just to get my second question answered——

Ms. JAEGER. May I just add, Ranking Member Berman, regarding that issue, is that a number of companies, a lot of brand companies, do actually pursue their brand products to subsequent clinical trials and do get new indications of use. When they do bring 

those indications of use, and the Food and Drug Administration 

does approve those new indications of use, they will get 3 years of 

exclusivity under the Hatch-Waxman system. 

At the same time, there are also generally speaking, on average, 

there are also some patents that also will be issued protecting that 

particular product for that new indication of use. Generally speakVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00041 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
38

ing, there will be new I.P. protection for those new indications of 

use as they bring those products to the marketplace. 

As to your question, I cannot sit here and tell you specifically one 

company, or if there are 10 companies in our industry. Unfortunately, our pipelines, our companies’ pipelines, are proprietary information. 

What I can tell you is what they do utilize for business decisions 

and that is the CEOs and their R&D teams are looking at what 

we call the Orange Book, which is a publication by FDA that puts 

forth all the products as approved by FDA, the market exclusivity 

that is generated that protects the brand company, the 5 years to 

3 years, as well as all patents that the brand company claimed this 

particular—that claim to protect this particular product and that 

are eligible for listing in that system. We look at those patents 

based upon that information, we then turn around and make business decisions on what products we will start our R&D investment 

on. 

A 2010 product is something our companies are considering and 

have been considering for many years. That is something they are 

now looking at and will bring a product through the appropriate 

R&D process and do the necessary application process to have 

something ready to go when that, when that patent expires in 

2010. 

Mr. BERMAN. —perhaps 10 generic drug companies are spending 

money on research in developing this generic product in the hope 

that one of those 10—each one of those 10 will be the first guy to 

file that thing and get the 180 days exclusivity? That seems like 

high-risk ventures. 

Ms. JAEGER. No, there is two different issues here in Hatch-Waxman. What happens is there is a patent challenge process. And 

what the patent challenge process is, that Congress, in their wisdom, basically said the brand companies are to file all patents they 

deem that claim that particular drug product with FDA. 

If there is a patent that gets filed with the Food and Drug Administration that a generic company believes is either filed wrongly, or it is frivolous, or it is questionable, meaning that they believe 

their product will be outside the scope of that patent, then they 

will file a paragraph four challenge, which means they are challenging the patent. And then we go into a very complicated HatchWaxman patent challenge process. However, if a generic company 

looks at a patent and believes it is valid, it may not challenge it. 

What the companies are going to do then is under the statute file 

a paragraph three patent certification, which basically says to the 

Food and Drug Administration, we will not be seeking approval 

until that patent expires. But indeed, these companies are looking 

at the patents. They are looking at the market, and they are making determinations many years prior to the patent expiring. 

As you imagine, our generic companies want to get FDA approval 

the day the relevant patent expires. So they are going to back in 

at least 2 years of FDA review of a generic application, which is 

2008. 

Their application has to be in by 2008. We are in 2006 now. That 

means a lot of R&D work has to be done now or could have been 

done last year as well. 

39

So our systems are, we back in from where patent expiration and 

the market exclusivity periods will expire. We back in at least 2 

years for FDA review of a generic application. And then we back 

in our R&D schedules. 

Mr. SMITH. Thank you, Mr. Berman. 

The gentleman from Tennessee, Mr. Jenkins, is recognized for 

his questions. 

Mr. JENKINS. Thank you, Mr. Chairman. 

Mr. Dudas, you mentioned several instances in which relief can 

be given for the late payment of fees, late filings or deficient filings. 

I have been told that there may be as many as 30 instances under 

our patent law in which this is the case. Is that a pretty accurate 

number of cases where relief can be given for late filings? 

Mr. DUDAS. We have not compiled each and every one of them, 

but that seems very much a reasonable estimate of how many 

there are. 

Mr. JENKINS. Now, well, let me ask Ms. Jaeger. 

Ms. Jaeger, you have been in law school much more recently 

than I have. But my memory is—and I am sure you will correct 

me if I misspeak—but in England, there was a court known as the 

keeper of the king’s conscience. What was it, exchequer came to us 

in our country as the chancellory system. And it was basically a 

system where there was no laches adequate remedy at law. And it 

brought with it the doctrine of—now, I am not recommending that 

be applied in this instance. 

But I would ask you with the prospect of this particular medicine—and it has not been denied, and there is ample medical evidence that the prospects for it in the treatment of strokes and 

heart disease are very promising. 

So I would ask you, what is wrong with 30 instances under our 

patent laws where relief can be given, what is wrong with us departing from the rigidity that you stick with and going to a more 

humane situation where we can go ahead, this company can spend 

those tens of millions of dollars that they spoke about and get on 

with the prospect of benefiting? 

You know, some of us—and you may feel this way when you get 

older, but some of us have family backgrounds that kind of indicate 

that we need to be on the lookout for strokes coming on one of 

these days. And millions and millions of Americans would welcome 

any prospect to have their prospects for the future improved. 

So what is wrong with us departing from rigidity? We already 

have flexibility in the law in, I say, at least 30 instances. So what 

is wrong with us departing and seizing this opportunity that we 

have? We seize too few in this country in advancing genuine and 

good. We seize many, but there are many that we miss. 

What is wrong with us departing from rigidity and going to a 

more humane system? Would you not, would you not be an advocate of a—and perhaps we are the keeper in this instance of the 

king’s conscience. And so, would you fault us then if we went to 

a more humane system? 

Ms. JAEGER. To that question I have three points. And I think 

the first point is, it is quite important that with respect to the PTE 

filing deadline, it is truly consistent with other substantive statuVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00043 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
40

tory provisions that establish deadlines for patentees seeking to expand the scope or lengthen the term of the patent. 

For example, a patentee seeking to enlarge the scope of the 

claims in the original patent by invoking PTO’s reissuance proceedings must apply within 2 years from the grant of the original 

patent. Likewise, a patentee seeking to claim priority to the date 

of an early filed foreign patent must file with the U.S. within 12 

months of the earliest day on such foreign application was filed. 

And these governing statutes do not allow PTO to extend those 

deadlines much like the PTE applications. 

And then, too, these statutes don’t have what we call equitable 

tolling provisions. Now, GPHA is not supporting nor endorsing the 

concept of moving forward an equitable tolling statute for this particular situation. But even assuming that there was an equitable 

tolling statute here, this situation would not rise to that level. 

Unfortunately, it is an administrative error. An administrative 

error would not rise to a level of inequitable conduct, in an equitable tolling statute, much like that for the Federal circuit, and 

there we are talking about the Federal rules of civil procedures, 

which state a failure to take the proper steps at the proper time 

not in consequence of the party’s own carelessness, inattention or 

willful disregard of the process of the court but in consequence of 

some unexpected or unavoidable hindrance or accident or reliance 

on the care of his counsel or a promise made by an adverse party. 

In that situation, we apply just a general equitable tolling statute 

or this particular civil rule of procedure. 

Under either scenario, this situation doesn’t rise to that level. 

And therefore, redress was not appropriate. We do believe—my 

third point is that redress should not be found here with respect 

to a retroactive amendment, but that there are other recourses that 

the company can pursue outside this Committee. 

Mr. SMITH. Thank you, Mr. Jenkins. 

The gentleman from Massachusetts, Mr. Meehan? 

Mr. MEEHAN. Thank you, Mr. Chairman. 

And to the Ranking Member, thank you very much for putting 

this hearing together. I think we all can agree that somebody didn’t 

file a form on time, whether it is incompetently or—I doubt they 

intentionally didn’t file it. And I can only assume that whoever 

failed to file is somewhere in an unemployment line somewhere. 

I am interested—because we all agree it wasn’t filed on time. 

And we could go on and on about that, although I am—it is interesting how when we have a Conference Committee how we reach 

these magical numbers, whether it be 50 or 60 or 45. I can assure 

you it is usually the House wants one number, the Senate wants 

another, and we split the difference in the middle. 

But in any event, I think it would be important, Dr. Meanwell, 

just for the record, that you could talk about the public health benefits of this drug and what it means for the future. Because I really 

haven’t heard it for the record here. And if you could do that. 

Mr. MEANWELL. Yes, I will do that. I would like to also add something I said to Mr. Berman, which I missed in my attempt to be 

brief. But let me first get to the point of the drug. 

This is an intravenous blood thinner. It is a very unique, hightechnology product. It is one which has proven in heart procedures 

41

called angioplasty to be highly effective and to substantially reduce 

the risk of bleeding among these patients. Typically patients today 

are receiving a mix of powerful blood thinners in a hospital intravenously. And the big risk is bleeding. And the other big risk is 

having a heart attack. And then there is a minor risk, if you wish, 

of dying. 

This drug has reduced all of those: bleeding, dying and heart attacks relative to the alternative therapy, which in this case is heparin, which is a 60-year-old product made of pig intestines and 

which has a lot of side effects, most notably, bleeding and allergies. 

We have basically knocked out all of those issues. 

Now, we found in the course of our research in coronary 

angioplasty that doctors started to try to experiment with the drug 

in stroke and cardiac surgery. One report from a doctor described 

this drug as—and I quote, and I am willing to put this into the 

record—‘‘the holy grail of drugs for cardiac surgery in patients who 

are allergic to heparin.’’ We cannot complete that research right now because we don’t 

have the money, the time, the incentive that Hatch-Waxman originally saw we would and which we expected to get but for our error 

in filing. 

As far as stroke is concerned, it is one of the biggest causes of 

death in Americans today. It affects all ethnic groups, particularly 

African-Americans, as we know. It is a deadly disease, of course, 

and something that really needs to be worked on. We have shown 

that this drug in preliminary trials can enable the positioning of 

the carotid stents, stents in the neck to prevent stroke better than 

any other product that is currently out there. Most experts believe 

this is a drug that should be developed extensively in that situation. 

Mr. MEEHAN. Thank you. 

Secretary Dudas, I want to make sure that I understand the current law correctly. As I understand it, an application which contains a number of technical errors submitted on time within the 60 

days can be returned to the applicant who has a number of months 

to correct these mistakes. But a perfectly filed and complete patent 

resolution application mistakenly filed 1 day late—and I have been 

counting how many days have—how many months have 30 days 

and how many have 31, which apparently is part of the problem. 

Do you know quickly how many have 30 days? 

Mr. DUDAS. I have to count it on my hand. 

Mr. MEEHAN. Right. But I am interested is that case. In other 

words, in other words, if you file an application with mistakes on 

time, can you make corrections? 

Mr. DUDAS. Yes, you can. 

Mr. MEEHAN. How does that work? 

Mr. DUDAS. Well, there is a variety of different instances. 

Mr. MEEHAN. So, in other words, so even if somebody files with 

mistakes, as long as they file within the 60 days, they will get a 

period of months to correct those mistakes? 

Mr. DUDAS. There is an opportunity to correct mistakes in some 

cases with applications and also in other areas in the office, yes. 

Mr. MEEHAN. Do you, do you believe that PTO can waive the 60-

day filing requirement on its own inherent authority? Or is it your 

42

belief that an extension must be legislated through a measure such 

as H.R. 5120? 

Mr. DUDAS. It is our belief that it would have to be legislated. 

Mr. MEEHAN. Do you agree with the discretionary authority in 

5120? Do you agree that it is similar to other deadline-extending 

provisions presently in patent law? And if so, approximate—well, 

I think the question was asked. But you said maybe 30. But you 

agree that there is already discretionary authority with other deadlines? 

Mr. DUDAS. There is definitely discretionary authority with some 

other deadlines. And this is not in some way that we find to be fundamentally inconsistent with some of the other deadlines. 

Mr. MEEHAN. Okay. So there are other deadlines that it is okay, 

this discretion that you guys have? There are other mistakes that 

are filed that somebody has a period of months to correct. Would 

you agree with the description of H.R. 5120 that the bill simply 

gives the PTO the discretion to review a patent term restoration 

application filed a few days late to determine whether that filing 

was delayed intentionally? Would you agree? 

Mr. DUDAS. I think that is correct, as I read it. It would depend 

on what—and I am not familiar with the legal standard of unintentional. And we have folks in our office that could determine, whether or not it would be automatic. But the bill on its face says discretion to determine whether it is unintentional. 

Mr. MEEHAN. Would you agree that the legislation doesn’t by 

itself add any additional patent term restoration? 

Mr. DUDAS. The bill itself does not add any patent term restoration. 

Mr. MEEHAN. Finally, some people have characterized this bill as 

automatically extending—I heard some of the witnesses say that it 

automatically extends the 60-day filing deadline by 5 days. Do you 

agree with that? 

Mr. DUDAS. I think the only way that would be true is if the 

term unintentional—no, it can’t be that, because if someone did it 

intentionally it wouldn’t be automatic, either. So I think a lot depends on the standard of unintentional. But, no, there is at least 

that standard there. 

Mr. MEEHAN. And I read it, and I share Mr. Berman’s feeling. 

I read the material from you, the letter from you. One thing I think 

we can be clear is the PTO doesn’t have any reason to oppose this 

legislation. Is that correct? 

Mr. DUDAS. From a PTO perspective, an administrative perspective and an ability to carry it out, no, we don’t have a reason to 

oppose. 

Mr. MEEHAN. Thank you, Mr. Chairman. 

Mr. SMITH. Okay. Thank you, Mr. Meehan. 

I am going to ask, Mr. Dudas, you another question and in doing 

so, give other witnesses, if they so desire, an opportunity to answer 

the question as well. And what I am trying to do here in asking 

a question about precedent is to find out exactly what the facts are, 

and be a little bit more specific when we talk about those precedents. 

I have a list in front of me which may or may not be entirely 

comprehensive of all the instances where discretion has been alVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00046 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
43

lowed in the case of unintentional mistakes. And so far as I can 

see from this list in front of me, which, as I say, may not be completely extensive, is that in all the instances where discretion has 

been allowed in the case of unintentional mistakes that deal with 

the statute as opposed to PTO rules generally fall into two categories: discretion being allowed in the case of late fees and discretion being allowed in the case of failure to reference earlier applications. 

Clearly, discretion in those instances don’t rise to the level of significance of discretion in the case of extending a patent. Do you 

know of any instance where there would be a precedent directly on 

point where discretion would be allowed in the case of an unintentional mistake dealing with the approval of a patent and dealing 

with discretion being allowed in the case of the statute as opposed 

to PTO rules? 

Mr. DUDAS. I am not aware of that, but I would give the following caveat that we have in our deputy office of operations and 

policy within Patent and Trademark Office—I would like to followup——

Mr. SMITH. Okay. It would probably be useful to the Committee 

to realize two things. One, most of the discretion that is being 

given is of relatively minor infractions or deadlines dealing with 

PTO rules, not the statute. And if you have any case in point, I 

think that would be helpful. But there is precedent perhaps on 

both sides. I just haven’t seen the precedent yet on the side of extending a patent. 

Dr. Meanwell, do you have any examples you could give? And 

then we will ask Ms. Jaeger and Professor Thomas. 

Mr. MEANWELL. I would like to say that the hard and fast deadlines that we have reviewed—and I am no patent attorney, so I 

am——

Mr. SMITH. Neither am I. 

Mr. MEANWELL. The ones that seek to expand the scope of a patent, the breadth of the intellectual property, are indeed often hard 

and fast. I know at least of three. In fact, they were mentioned earlier, I think, 102-B, 251 and 119-A are the things related to establishing a patent, either here or in foreign territories. But actually, 

that is establishing new grounds for a patent. That is establishing 

the breadth of a patent. 

Here we are talking about the time life of a patent. We are not 

talking about the breadth of the patent in any way. The breadth 

of the Angiomax patent will remain exactly the same. 

And one of the things I should have said to Mr. Berman is that 

that means that we are not looking for a new patent to do what 

we are doing. We are hoping to use this one as long as we need. 

And we will need to invest $100 million to do so. So we obviously 

would like to recoup that with exclusivity thereafter. So just to 

clarify. 

But there are certainly situations where expanded the scope of 

a patent is hard and fast. But this is a procedural situation, in my 

opinion, not expanding the scope of the patent in any way. And by 

the way, the revision here would not in any way give us a single 

day more on our term than would be normally envisioned under 

Hatch-Waxman. And, you know, frankly for such a Draconian penVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6601 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
44

alty to be hammered out for the sake of this dumb mistake, we feel 

would be, would be inequitable. 

Mr. SMITH. Okay. Thank you, Dr. Meanwell. 

Ms. Jaeger or Professor Thomas, any precedents to cite or examples to give? 

Mr. THOMAS. Mr. Chairman, I believe the most apt analogy 

would be with respect to maintenance fees, which may well be the 

first element on the chart you have referenced. As you know, the 

patent 20-year term is not automatic. You have to pay periodic annuities essentially to the patent office to retain the term and the 

3 and-a-half, 7 and-a-half and 11 and-a-half years from the date of 

issuance. Some of those deadlines aren’t met, so there are provisions for coming in late and asking for your patent to be maintained in a sense, sort of a term extension. 

Mr. SMITH. You are right. Okay. 

Mr. THOMAS. However, and those applications are entertained by 

the U.S. PTO. However, if there is a late maintenance fee accepted, 

that gives some right with respect to third parties that are rather 

vaguely defined by the statute, for example, something that would 

be akin to the first inventor Defense Act, which you are considering 

modifying to encompass all sorts of inventions, not just——

Mr. SMITH. Okay. Thank you, Professor Thomas. 

Mr. THOMAS. You are welcome. 

Mr. SMITH. Ms. Jaeger? 

Ms. JAEGER. I just want to reiterate for the record, I know we 

see three particular situations where patentees are seeking to expand the scope or lengthen the term that do not, do not have any 

discretion for PTO. And, of course, that is the—— Mr. BERMAN. Expand the scope. 

Ms. JAEGER. Expand the scope of patent with a reissuance proceeding or a PTE, which is extending the length of the patent as 

well as, of course, you know, the foreign early filed foreign patent 

provision as well. 

Mr. SMITH. Okay, okay. Thank you, Ms. Jaeger. 

Let me explain to the panelists that I have to leave for another 

engagement. I am going to ask the gentleman from Tennessee to 

chair the rest of the hearing. And thank you all again for being 

here. 

Mr. JENKINS. [Presiding.] Mr. Berman, were you finished? 

I am sorry. Go ahead. 

Mr. BERMAN. I was just interrupting somebody else. 

Actually, now I understand, Dr. Meanwell, you are not seeking 

a new patent. You will need to get FDA approval for the new uses. 

You won’t need to get a new patent. And it makes a heck of a difference whether it expires in 2010 or 2014 whether you have some 

exclusive period for marketing this drug that FDA would have approved for additional uses. Okay. I have got it. It is not about a 

new patent. 

Professor Thomas, you made a point in your initial testimony. I 

forget exactly how you put it, but a policy reason perhaps to not 

provide discretion in this provision is because it implicates not just 

the patent office, but the Secretary of HHS and the head of FDA 

and the Secretary of Agriculture. And I don’t know what other 

agencies you mentioned. 

45

But realistically, what is the difference if under the limited nature of this extension in terms—I am trying to understand why is 

that a policy argument against doing it when in the limited nature 

of the relief proposed in this legislation. 

Mr. THOMAS. It is a good point. It is only 5 days. But it does create a lot of reliance interest upon other actors. And that is something that is not as commonly the case with other missed PTO 

deadlines. So in short, there are a host of actors out there that 

have to engage in a fair amount of steps. 

Another distinction that may be salient to you—and again, let 

me first once more acknowledge you are right about the 5 days. It 

is only 5 days from that perspective. But there are any number of 

other deadlines that if missed are irremediable under the Patent 

Act. And again, they often impact small entities that are not sophisticated players in the patent system. They have long been a 

part of our law. That really—— Mr. BERMAN. That are not, that are not——

Mr. THOMAS. That cannot be correctable. And that is really not 

the case here. Right? We are really talking about very sophisticated 

actors that are well-advised. And that may be why this is not a situation that has recurred. 

One of my colleagues at Georgetown often uses the phrase ‘‘big 

boys’’ that I don’t like because of its gender implications. But nonetheless, do we need in a sense really a protection statute for sophisticated actors who have just been gifted with a watershed event for 

their firm, FDA marketing approval? 

Mr. BERMAN. Well, no, look, one cannot help but avoid the notion 

that in life there are a lot of deadlines that every day because some 

little person or company or whatever missed them and opportunity 

was lost or harm was done and, I mean, you can’t, you can’t but 

avoid thinking at this. And at the same time, it is hard to avoid 

thinking about the enormity of, you know—I mean, there is a disproportional aspect of what has happened here, too, on the other 

side in terms of just nature of mistake versus money lost. So I 

guess that is part of the consideration. 

Ms. Jaeger, my last question—in the context of, somewhere companies in your association, unknown to you because of the proprietary interests may have spent money, and in some cases considerable money, thinking that notwithstanding all the hullabaloo in 

2010 this thing is coming out there and we want to be ready to fill 

that void with a lower cost consumer benefit therefore protection. 

Are there situations—somebody mentioned in the context of some 

other statute the maintenance fees. In the context of things, are 

compensation for money spent in reliance on something that Congress subsequently changed—is there any precedent for those kinds 

of arrangements? 

Ms. JAEGER. Well, I think when we are looking at this retroactively—we are looking at this retroactive bill. And in so doing, 

the job, I think, of everyone here is to sort of do the analysis of 

weighing the benefits and the risks. 

And here, yes, absolutely, the benefit would inure to The Medicines Company and would provide them with 5 additional years of 

market exclusivity in the United States. It is adding to their patent 

that they have today, which expires in 2010. It is not taking away 

46

their patent. It is just going to extend the terms of that particular 

patent and give them this extraordinary benefit. 

At the same time, the burden that would be placed on our industry would be that we relied upon the 2010 patent expiration date. 

We went through and did some performance research and development, which costs money from our industry side. 

At the same time, we also have a downstream effect of the others 

in the health care distribution channel, which are the insurers and 

the PBMs and the consumers, that have relied upon that date as 

well for forecasting and in trying to figure out what health insurance premiums will be in 2010 and the like. So this does have a 

negative implication downstream in the health care distribution 

channels. 

At the same time, among the broader issue, we are just very concerned about the many, many deadlines in Hatch-Waxman. And, 

you know, we say, we all hope to move the deadline to, 65 days. 

When we get to another situation when someone comes in at 67, 

68, are we going to move it again? And then do we move the 45-

day window? And does that move—— Mr. BERMAN. We are very good at saying it is this time only, 

never again until——

Ms. JAEGER. And we think it is a Pandora’s Box that doesn’t 

need to be opened, sir. 

Mr. BERMAN. Just in closing, Mr. Chairman, as I heard Dr. 

Meanwell describe the drug, I realized that this fit perfectly with 

what happened to my father, who died from an allergic reaction to 

heparin during a heart surgery where he had to have a blood thinner at that time. This is 16 years ago or something. Not from the 

heart surgery, not from the heart attack, but from not having—so 

I could personally testify there is something valuable about what 

you have produced here. 

And I yield back. 

Mr. JENKINS. Professor Thomas, let me go back to the flexibility 

that you spoke about with respect to the payment of fees for continuation. If that flexibility was not in the law, then this patent 

continuation would be just as dead as any of the other instances 

that could kill its continued life. Isn’t that true? If we had the same 

rigidity in the law with respect to the payment of those fees that 

we have, let us say, in this instance, then that would put an end 

to that patent and its continuation just as surely. 

Mr. THOMAS. Sir, I don’t know all the facts of the case. I am not 

aware of how long the patent has been extant and whether they 

have paid maintenance fees or not. So in good faith I can’t answer 

that, sir. 

Mr. JENKINS. Well, let me ask it not on a comparative basis, but 

just on the basis of if the law was different and said you had to 

pay these fees on time, you couldn’t pay them a day late, then your 

continuation would be just as dead, would it not? It would be dead. 

Mr. THOMAS. That is right, if the maintenance fees were paid 

late, right. 

Mr. JENKINS. Okay. 

Mr. Meehan, do you have any questions, sir? 

Mr. MEEHAN. Mr. Chairman, I just want to point out on this 

issue of unintentional error in standards that are, that are used by 

47

the PTO, there is a letter in the record from Lawrence Goffney that 

specifically says that the agency is extremely familiar with the unintentional error standard that is being proposed in H.R. 2150. Indeed, this is a standard most commonly used by the PTO in determining whether to accept late filings under the statutory provisions. And I would refer that to Members of the Committee. 

Just one more thing that I want to ask Ms. Jaeger. So you can’t 

provide us with a company that is ready to develop this drug or 

has had an investment or anything of that nature? 

Ms. JAEGER. No, sir, not at this time I cannot because, again, our 

companies’ pipelines are proprietary. As you can imagine, they are 

fierce competitors. And so, it is not something they are about to 

disclose, what products they are or are not going to bring to the 

market in a few years. 

Mr. MEEHAN. Right. And that is basically for some of us—the 

question is, you know, what is the future going to be of this particular drug and the advances that have been made? 

It is my understanding that clinical data demonstrates that up 

to 23,000 transfusions could be saved if these results move forward, 

more than 1 million of these performed each year, these procedures. So from my perspective, that is why we are balancing interests here. 

We are balancing a lawyer at a firm who messed up with what 

the public health effect would be in the end. And for me, that is 

a significant thing that we should weigh. 

So I thank the Chairman. I just want to point out those unintentional error standards into the record. 

Mr. JENKINS. Thank you, Mr. Meehan. 

Does any other Member of the Committee have any additional 

questions? 

Mr. Berman? 

Mr. BERMAN. No. 

Mr. JENKINS. Any? 

Well, the Chairman has already complimented this panel of witnesses. And let me add to that and say that your remarks were 

very informative. Your answers were very direct and cogent, and 

we certainly appreciate that. 

I think that this Committee has learned quite a bit today. I hope 

that we can use it to the benefit of the people across the United 

States of America. It is a difficult situation. 

And, Ms. Jaeger, let me say I have the utmost respect for you 

and what your association members are doing. We shouldn’t let it 

pass without saying that your members provide a really valuable 

service to millions and millions of Americans. 

As I understand it, Dr. Meanwell is also on the board of directors 

of a generic company. Was that brought out? Is that true? 

Mr. MEANWELL. Yes, I am, sir. I am on the board of a company 

that sells generics. I absolutely agree with your remarks. 

Mr. JENKINS. All right. Well, thank you very much for coming. 

And the Committee will be adjourned. 

[Whereupon, at 12:35 p.m., the Subcommittee was adjourned.] 

(49)

A P P E N D I X 

MATERIAL SUBMITTED FOR THE HEARING RECORD

STATEMENT OF THE HONORABLE HOWARD BERMAN, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF CALIFORNIA, AND RANKING MEMBER, SUBCOMMITTEE ON

COURTS, THE INTERNET, AND INTELLECTUAL PROPERTY

Mr. Chairman, 

Thank you for scheduling this hearing on a bill giving the USPTO additional discretion to extend certain patent deadlines. While similar measures (bills that have 

specifically extended the Angiomax patent) have been attached to legislative vehicles in the past, I am glad that this issue is finally being reviewed by the committee 

with jurisdiction over patent matters. It is important that this Subcommittee be 

able to analyze the impact of any changes this bill may make on the patent system. 

Patents are the cornerstone of innovation. The Constitution provides for a limited 

period of time of protection in order to promote innovation. Therefore, the patent 

process provides the exclusive right for an invention (for 17 to 20 years) generating 

incentives for an inventor to continue to create after which the invention becomes 

available for public use. There is a delicate balance of - on the one hand- providing 

enough of an incentive to the inventor to spend the time, energy and money to create new inventions - and on the other- the value of allowing the invention to be used 

by the public enabling others to develop new products or provide similar products 

for lower cost. 

Therefore, when considering the effect of allowing the PTO discretion to extend 

certain patent deadlines, there is a natural tension between providing the flexibility 

to extend a deadline and maintaining a hard date for specific types of filings. While 

providing greater elasticity may prevent seemingly draconian results does it come 

at the expense of stability in the market? There appear to be other instances where 

the PTO has discretion to extend deadlines but the situation this bill is designed 

to address is not among them. WHY? Is there something different about this type 

of filing that the PTO should NOT have discretion in this case? 

Unfortunately, the PTO has not provided much guidance in its response to the 

(letter from the Chairman and myself about the) policy questions posed by this bill. 

I look forward to hearing from the other witnesses to discuss the policy implications 

of this bill on the patent system and possibly Hatch-Waxman. 

Originally this legislation began as an effort to address one particular late filing, 

of one patent - there has been no demonstrated need nor request from any other 

patent owners to provide discretion to the PTO for these type of filings. Moreover, 

from the way the bill has been written it is clear that this bill would effect the late 

filing of a particular company which occurred over 4 years ago. Some have even suggested that the better alternative to this bill is a private bill. However, this bill and 

this particular circumstance does raise some questions about why there are inconsistencies in the discretion afforded to the PTO to determine when filings are timely. As such I look forward to further exploring the issues.

STATEMENT OF THE HONORABLE ELTON GALLEGLY, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF CALIFORNIA, AND MEMBER, SUBCOMMITTEE ON COURTS, THE

INTERNET, AND INTELLECTUAL PROPERTY

Mr. Chairman, I would like to begin by thanking you for holding this hearing on 

H.R. 5120. I appreciate your interest in this important issue. I would also like to 

commend Congressman Jenkins for the introduction of this legislation. 

H.R. 5120, which I strongly support, deals with what seems to be a narrow issue 

in our nation’s patent law, namely the question of patent term restoration applicaVerDate 0ct 09 2002 12:39 Dec 07, 2006 Jkt 000000 PO 00000 Frm 00053 Fmt 6601 Sfmt 6621 G:\WORK\COURTS\091406\29871.000 HJUD1 PsN: 29871
50

tions submitted to the Patent and Trademark Office. However, although the change 

to the law is relatively minor, the passage of this legislation would both provide 

greater fairness to patent holders and encourage innovation by companies in the 

medical research field and in other industries. 

H.R. 5120 would amend the Hatch-Waxman Act to provide the U.S. Patent and 

Trademark Office with modest discretion to accept late-filed patent term restoration 

applications. In a recent letter to the Subcommittee, the Director of the Patent and 

Trademark office confirmed that under current law the PTO already enjoys discretion in numerous instances to accept late-filed applications. However, Congress has 

not given the PTO similar discretion to accept late-filed patent restoration applications. 

This strikes me, and other cosponsors of H.R. 5120, as an unfortunate and 

undeserved inconsistency in our patent law. 

Mr. Chairman, failure to allow an innovator that has earned patent term restoration to qualify merely because of a clerical or other unintentional error discourages 

innovation and ultimately harms patients who rely on research into new medicines. 

We must keep in mind that for a company to qualify for patent term restoration, 

it must already have successfully completed an incredibly rigorous drug testing and 

development regime, ultimately obtaining FDA approval of its drug. The HatchWaxman Act offers patent term restoration as an incentive for innovators to invest 

their time, effort, and resources in this arduous drug development and approval 

process. 

I can think of no area in the patent law where permitting discretion on the part 

of the PTO too accept late-filed applications is more important that in the case of 

patent restoration applications. Yet, this is one area where Congress has not granted the PTO such discretion. It is imperative that we correct this situation by the 

passage of H.R. 5120. 

I understand that some oppose H.R. 5120, arguing that giving the PTO any discretion will somehow disadvantage generic manufacturers. 

In my view, the Hatch-Waxman Act provides generic manufacturers with clear, 

enumerated benefits. However, Congress never intended one of those benefits to be 

the ability to take advantage of unintentional clerical errors, thereby gaining years 

of marketing time at the expense of innovative companies that have satisfied all of 

the many processes required by Hatch-Waxman. 

Mr. Chairman, I want to thank you again for holding this hearing today.

51

A LETTER TO THE HONORABLE JONATHAN W. DUDAS, UNDER SECRETARY FOR INTELLECTUAL PROPERTY AND DIRECTOR, U.S. PATENT AND TRADEMARK OFFICE

(USPTO) FROM THE HONORABLE LAMAR SMITH, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF TEXAS AND CHAIRMAN, SUBCOMMITTEE ON COURTS, THE

INTERNET, AND INTELLECTUAL PROPERTY, AND THE HONORABLE HOWARD BERMAN, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA, AND RANKING

MEMBER, SUBCOMMITTEE ON COURTS, THE INTERNET, AND INTELLECTUAL PROPERTY


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A LETTER TO THE HONORABLE LAMAR SMITH, A REPRESETATIVE IN CONGRESS FROM

THE STATE OF TEXAS, AND CHAIRMAN, SUBCOMMITTEE ON COURTS, THE INTERNET, 

AND INTELLECTUAL PROPERTY, IN RESPONSE TO A LETTER REQUESTING THE UNITED

STATES PATENT AND TRADEMARK OFFICE (USPTO) ANALYSIS AND ASSESSMENT OF

H.R. 5120


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A LETTER TO THE HONORABLE JON W. DUDAS, UNDER SECRETARY FOR INTELLECTUAL

PROPERTY AND DIRECTOR, U.S. PATENT AND TRADEMARK OFFICE (USPTO) FROM

JANE A. AXELRAD, ASSOCIATE DIRECTOR FOR POLICY, CENTER FROM DRUG EVALUATION AND RESEARCH, DEPARTMENT OF HEALTH & HUMAN SERVICES IN REGARD TO

THE MARCH 24, 2003 LETTER FROM KARIN FERRITER REQUESTING FDA’S ASSISTANCE IN PREPARING A RESPONSE TO A REQUEST FOR RECONSIDERATION IN THE APPLICATION FOR PATENT TERM EXTENSION FOR U.S. PATENT NO. 5, 196, 404 FILED

BY THE MEDICINES COMPANY


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A PAPER ON CRITICAL ACTIONS THAT RELATE TO THE MEDICINES COMPANY

APPLICATION FOR PATENT TERM EXTENSION FOR U.S. PATENT 5, 196, 404


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REQUESTED SUBMISSION FROM THE HONORABLE WILLIAM JENKINS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE; LETTERS FROM LEADING MEDICAL PRACTITIONERS AND CONSUMER GROUPS


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LETTER FROM LAWRENCE GOFFNEY


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TESTIMONY FROM THOMAS SCHATZ, PRESIDENT,

CITIZENS AGAINST GOVERNMENT WASTE


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Æ


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