72 Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices

from providing, discussing, exchanging,

circulating or otherwise furnishing

competitive information about such

business to or with any person whose

employment or agency involves the

Cordis Neuroscience Business.

Any violation of the Consent

Agreement or the Agreement to Hold

Separate, incorporated by reference as

part of the Consent Order, may subject

Johnson & Johnson to civil penalties and

other relief as provided by law.

Analysis of Proposed Consent Order To

Aid Public Comment

The Federal Trade Commission

(‘‘Commission’’) has accepted subject to

final approval an agreement containing

a proposed consent order from Johnson

& Johnson under which Johnson &

Johnson would divest the Cordis

Neuroscience Business, which includes

Cordis’ neurological shunt product line.

The proposed consent order has been

placed on the public record for sixty

(60) days for reception of comments by

interested persons. Comments received

during this period will become part of

the public record. After sixty (60) days

the Commission will again review the

agreement and the comments received,

and will decide whether it should

withdraw from the agreement or make

final the agreement’s proposed order.

Johnson & Johnson, a New Jersey

based corporation, has proposed to

acquire Cordis Corporation, a Florida

based corporation, in a stock for stock

exchange worth $1.8 billion.

The proposed complaint alleges that

the proposed merger, if consummated,

would constitute a violation of Section

7 of the Clayton Act, as amended, 15

U.S.C. § 18, and Section 5 of the FTC

Act, as amended, 15 U.S.C. § 45, in the

market for neurological shunts.

Neurological shunts are medical devices

used to treat hydrocephalus, a brain

disorder that primarily afflicts young

children. The merger will substantially

increase concentration in the already

highly concentrated U.S. shunt market:

two firms will control over 85% of the

market. Anticompetitive effects, such as

increased prices and decreased services,

are likely to result. In addition, timely

entry by other companies, both in the

United States and overseas, is unlikely

to defeat these anticompetitive effects.

Entry cannot occur in a timely fashion

because of the difficulty of developing

competitive neurological shunt designs,

establishing manufacturing facilities,

organizing a sales and service network,

receiving Food and Drug Administration

approval, and gaining physician

acceptance in the market.

The proposed consent order would

remedy the alleged violation by

replacing the lost competition that

would result from the merger. It

provides that Johnson & Johnson shall

divest the Cordis Neuroscience Business

within twelve (12) months of the date

the proposed order becomes final. The

Cordis Neuroscience Business is a single

operational unit that sells neurological

shunts, intracranial pressure drainage

systems and neuroendoscopy

equipment. Significant synergies

between the products manufactured and

sold by the Business exist, and Cordis’

shunts are sold as part of the broader

product line. Therefore, a divestiture of

the whole business is necessary to

maintain competition in the shunt

market. The proposed order requires

Cordis Neuroscience Business to take all

the steps necessary to assure the

viability, marketability, and

competitiveness of the Cordis

Neuroscience Business, and to prevent

the destruction, removal, wasting,

deterioration, or impairment of the

Cordis Neuroscience Business.

If Johnson & Johnson is unable to

divest the Cordis Neuroscience Business

within twelve (12) months, then a

trustee may be appointed by the

Commission to divest the Cordis

Neuroscience Business within an

additional twelve (12) month period. If,

at the end of that twelve (12) month

period, the trustee has submitted a plan

of divestiture or believes that divestiture

can be achieved within a reasonable

time, the time period for divestiture can

be extended up to two (2) times by the

court.

A Hold Separate Agreement signed by

Johnson & Johnson provides that, during

the time period from the date the Hold

Separate is accepted until the

divestiture of the Cordis Neuroscience

Business is completed, the Cordis

Neuroscience Business shall be held

separate and operated independently of

Johnson & Johnson.

Under the provisions of the order,

Johnson & Johnson is also required to

provide to the Commission a report of

compliance with the divestiture

provisions of the order within sixty (60)

days following the date this order

becomes final, and every sixty (60) days

thereafter until Johnson & Johnson has

completely divested its interest in the

Cordis Neuroscience Business.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

[FR Doc. 95–31558 Filed 12–29–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95E–0301]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PREVACID

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PREVACID and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration,5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the
Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices 73

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product PREVACID

(lansoprazole). PREVACID is indicated

for short-term treatment (up to 4 weeks)

for healing and symptom relief of active

duodenal ulcer. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for PREVACID (U.S. Patent

No. 4,628,098) from Hiroshi Akimoto,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

September 25, 1995, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of PREVACID represented

the first permitted commercial

marketing or use of the product. Shortly

thereafter, the Patent and Trademark

Office requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

PREVACID is 2,870 days. Of this time,

2,328 days occurred during the testing

phase of the regulatory review period,

while 542 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: July 3, 1987. FDA has

verified the applicants’s claim that the

date that the investigational new drug

application (IND) became effective was

July 3, 1987.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: November 15, 1993. The

applicant claims November 12, 1993, as

the date the new drug application

(NDA) for PREVACID (NDA 20–406)

was initially submitted. However, FDA

records indicate that the applicant

submitted NDA 20–406 on November

12, 1993, and FDA received the NDA on

November 15, 1993, which is

considered to be the NDA initially

submitted date.

3. The date the application was

approved: May 10, 1995. FDA has

verified the applicant’s claim that NDA

20–406 was approved on May 10, 1995.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,706 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 4, 1996, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before July 1, 1996, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: December 21, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–31557 Filed 12–29–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0303]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ADENOSCAN

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ADENOSCAN and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product

ADENOSCAN (adenosine).

ADENOSCAN is indicated as an

adjunct to thallium-201 myocardial

perfusion scintigraphy in patients

unable to exercise adequately.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

ADENOSCAN (U.S. Patent No.

5,070,877) from Medco Research, Inc.,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

September 25, 1995, FDA advised the

Patent and Trademark Office that this