Source: https://www.patentdocs.org/2008/10/index.html
Timestamp: 2019-04-18 10:33:58+00:00

Document:
In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Thursday, October 30, 2008, the U.S. Patent and Trademark Office published its burden and cost analysis for proposed continuing information collection relating to maintenance fee submissions, and requested comments to the proposed collection.
The Office breaks its analysis down into terms of costs associated with "burden hours" (correlating to attorney billable hours) and costs associated with PTO-related fees and surcharges. The PTO estimates the total number of burden hours to be 33,426 hours per year, which incorporates a split of time for tasks performed by attorneys (primarily petitions) and paraprofessionals. Those hours correlate to a total cost of $4,632,630 per year (at $310/hour for associates, $100/hour for paraprofessionals). The PTO estimates the total respondent cost burden relating to PTO-based fees and surcharges to be $614,571,323, which includes costs such as filing fees, surcharges for late payments, petition fees, postage costs, and recordkeeping costs (see, e.g., 37 C.F.R. §§ 1.20(e)-(i); 1.17(g)-(f)). The bulk of this estimate relates to payment of the actual maintenance fees.
In the Notice, the PTO requests submission of comments on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents (e.g., the use of automated collection techniques or other forms of information technology). A summary of these comments will form part the request for OMB approval of this information collection and will become a matter of public record.
Comments can be submitted by e-mail to Susan.Fawcett@uspto.gov (Include "0651-0016 Comment" in the subject line of the message); facsimile: 571-273-0112 (to the attention of Susan Fawcett; U.S. mail (addressed to Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, Customer Information Services Group, Public Information Services Division, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450) or by the Federal Rulemaking Portal at http://www.regulations.gov. Comments must be submitted on or before December 29, 2008.
Requests for additional information should be directed to Robert A. Clarke, Director, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7735; or by e-mail to Robert.Clarke@uspto.gov.
The preliminary program for PTO Day, which includes an agenda and list of speakers, can be obtained here.
• Luncheon Address by Carl B. Horton of General Electric Co.
The preliminary program for this conference, which includes an agenda and list of speakers, can be obtained here.
The registration fee for each conference ranges from $225 (government/academic) to $650 (general registration); individuals registering for both conferences will receive a $100 discount. Those interested in registering can obtain a registration form here.
The decision of the Court of Appeals for the Federal Circuit in Abbott Laboratories v. Sandoz, affirming the District Court's grant of a preliminary injunction, nicely illustrates the way the Federal Circuit exercises its prerogatives in applying the abuse of discretion standard. In our previous post, we discussed the portion of the decision relating to how the CAFC reviewed the District Court's determination of the first prong of the preliminary injunction standard, establishing a reasonable expectation of success on the merits, with regard to invalidity. This post will discuss how the Federal Circuit conducted its review of how the District Court evaluated Sandoz's contentions that the patents-in-suit, U.S. Patent Nos. 6,010,718 and 6,551,616, were unenforceable due to inequitable conduct during patent prosecution.
Since 1) no claim of the '718 patent requires the extended release formulation to have a statistically significant lower Cmax than the immediate release formulation; 2) the data in fact shows the Cmax of the extended release formulation to be lower (albeit not statistically significantly lower) than the Cmax of the immediate release formulation; and 3) the extended release formulation was in fact pharmacokinetically different from the immediate release suspension formulation, it is more likely than not that the PTO would not have found the "statistically significantly lower" statement to be important.
The District Court also found no evidence of an intent to deceive under these circumstances, rejecting Sandoz's contention that the combination of the false statement and the materiality of the information was sufficient to infer intent. The Federal Circuit's majority opinion, written by Judge Newman and joined by Judge Archer, found no abuse of discretion in the District Court's weighing of the evidence of materiality and intent and refusing to find inequitable conduct.
Sandoz's second assertion related to clinical trial evidence obtained after the filing date of the application that was granted as the '718 patent, concerning the results of "taste perversion" experiments, i.e., the tendency of different formulations to have an unpleasant metallic taste. These test results were submitted to the FDA and included on Abbott's Biaxin® XL product label but were not disclosed to the examiner during prosecution. Sandoz contended that these test results showed a higher incidence of taste perversion for ER formulations compared with prior art IR formulations, contrary to the disclosure in the '718 patent specification. Abbott opposed this contention (supported by an expert declaration) on the grounds that the taste tests were done at different API concentrations in the formulation and were thus not directly comparable. The District Court found that this information was material under Rule 56, but that a reasonable examiner would not have considered the information "important" in deciding whether to grant the '718 patent because the dosages were not comparable (and the reasonable examiner would have required a comparison at equivalent dosages in order for the information to be "important" to making a patentability determination). Moreover, the District Court found no intent to deceive, because there was no evidence of deliberate withholding of information from the examiner, once again refusing to infer intent from the degree of materiality of the undisclosed information. The Federal Circuit agreed with the District Court that under its precedent (including Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) and Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995)), materiality and intent to deceive must be independently established, and that there was no abuse of discretion in the District Court's refusal to find inequitable conduct on this basis asserted by Sandoz.
Sandoz's last inequitable conduct contention regarding the '718 patent was based on Abbott's failure to disclose another set of clinical trial results obtained after the '718 patent was filed, relating to pharmacokinetics of clarithromycin administered under different conditions. These test results concerned comparisons between IR formulations and "modified release" (MR) formulations in the prior art for mean DFL (degree of fluctuation) values. The District Court did not find these studies material because, inter alia, the MR formulations were different from the claimed ER formulations. The majority opinion did not find clear error in this determination by the District Court.
Turning to the '616 patent, the District Court rejected Sandoz's first inequitable conduct contention because it was directed to taste perversion claims cancelled before examination in the application that resulted in the granted '616 patent. The majority opinion cited Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991), for the proposition that "[a] reference that is material only to withdrawn claims can not be the basis of a holding of inequitable conduct" and agreed with the District Court's conclusion that the "withheld" information was not material to patentability of any claims in the '616 patent.
Sandoz's second inequitable conduct contention was based on another undisclosed set of clinical trial results, which Sandoz's expert testified did not support formulations useful in claimed methods for reducing gastrointestinal side effects. Again in this instance, these clinical trial results were submitted to the FDA but not to the PTO. The District Court determined that there was sufficient evidence in the '616 patent specification to support claimed to methods for reducing gastrointestinal side effects of clarithromycin administration and that the clinical trial data did not contradict this disclosure. Thus, the clinical trial results were not material according to the District Court, and in the absence of any affirmative evidence of an intent deceive, the '616 patent claims were not unenforceable for inequitable conduct on this evidence.
This is not a case of new information that affects the fundamental invention; this is a case of challenging every action or inaction of the "conduct" of patent solicitation, although patentability is unaffected. The purpose of Kingsdown was to bring patent practice into the mainstream of the law and administrative practice. The law severely punishes fraudulent practices, and the patent practice includes recognition that the inventor usually knows more about the field than does the "expert" patent examiner. However, routine actions that do not affect patentability and that are devoid of fraudulent intent are not subject to a different standard than other inquiries into fraudulent procurement. The Administrative Procedure Act governs patent examination, see Dickinson v. Zurko, 527 US 150 (1999), and actions of patent examiners are reviewed with recognition of examiner expertise so well as recognition of the occasionally imperfect examination process. "It was to mitigate the 'plague' whereby every patentee's imperfections were promoted to 'inequitable conduct' that this court reaffirmed that both materiality and culpable intent must be established." Allied Colloids, Inc. v. American Cyanamid Co., 64 F.3d 1570, 1578 (Fed. Cir. 1995).
This succinctly states the majority opinion's philosophical view, shared by other members of the Court (most notably, Judge Rader) that a finding of inequitable conduct results in such a draconian remedy (patent unenforceability) that it should be found only on those rare occasions where a defendant can bear the heavy burden of establishing both prongs, materiality and intent to deceive, by clear and convincing evidence.
The dissent illustrates the opposite philosophical stance, wherein a court is justified in using circumstantial evidence to support a determination of an intent to deceive, said circumstantial evidence including the materiality of the withheld information. In this regard, Judge Gajarsa (at right) points to two of Sandoz's inequitable conduct contentions that were persuasive to him that granting a preliminary injunction was an abuse of discretion. The first, was Dr. Gustavson's admission that she did not perform any statistical analyses of her experimental data but nonetheless asserted in her declaration that the differences in Cmax between ER and (prior art) IR formulations were statistically significant. Here, the affirmative nature of the misrepresentation was sufficient, because according to Judge Gajarsa the District Court "created such a high bar for materiality that in essence no statement or withholding of information would be material if it would not change the ultimate outcome of allowing the patent." This, according to the dissent, was inconsistent with such precedent as Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003), where "[t]he fact that the examiner did not have to rely on the purity representations in issuing the patent is not inconsistent with a finding of materiality. Although the inventors' statements regarding purity were not the principal focus of the office action response, they were clearly an important aspect of it. Under the circumstances, a reasonable examiner would have wanted to know that the patentability argument based on purity was unsupported by the experimental results cited by the inventors."
Judge Gajarsa also took issue with the District Court's finding that Abbott's withholding clinical trial evidence on DFL values was not material, since (according to the dissent) "the extent the PK parameters of the ER formulation differed from the clarithromycin formulations in the prior art was the primary focus of the examiner's concerns regarding patentability, and Abbott's ability to establish sufficient differences was the basis for allowing the claims." Judge Gajarsa objected to a materiality standard the would permit a patentee to selectively disclose "one set of studies that supported patentability and therefore could ignore studies reaching the opposite result," citing Paragon Podiatry Lab., Inc. v. KLM Labs., Inc., 984 F.2d 1182 (Fed. Cir. 1993). Thus, in Judge Gajarsa's estimation, Sandoz had raised sufficient doubts about the enforceability of the patents in suit that its grant of a preliminary injunction was an abuse of discretion.
While it may appear that Judge Gajarsa's criticisms of the District Court's consideration of the evidence regarding inequitable conduct has logical force (particularly in view of the Federal Circuit's recent decision, in Aventis Pharma S.A. v. Amphastar Pharma, Inc., that misstatements in a declaration evinced an intent to deceive sufficient to support an inequitable conduct determination), the issue here is the same as that raised by the differing views on the standard for establishing vel non a likelihood of success on the merits based on invalidity. The Federal Circuit clearly views its mandate to include plenary review of a district court's decisions for which the lower court is entitled to a deferential, abuse of discretion standard of review. As was seen in our earlier post, this has led to conflicting decisions from different appellate panels on whether the likelihood of success prong of the preliminary injunction analysis can be defeated by a defendant raising a substantial question of unpatentability. Here, the Federal Circuit appears committed to reviewing the evidence presented in support of the twin requirements of materiality and intent, and then further reviewing the subtle balancing by a district court in determining whether a defendant has established (or a likelihood of establishing) inequitable conduct sufficient to preclude grant of a preliminary injunction. In addition to seemingly squandering significant judicial resources in performing this review, the CAFC's behavior raises questions about whether it is giving appropriate deference to areas properly within the sound discretion of the district court.
In a memorandum dated October 20, 2008, the U.S. Patent and Trademark Office announced that it will expand the patent prosecution highway (PPH) pilot program to include the Danish Patent and Trademark Office (DKPTO). The PPH program becomes effective on November 3, 2008 for a term of one year, and is extendable for another year. The DKPTO becomes the seventh patent office to become a participant with the USPTO in a PPH program (along with Europe, Japan, Canada, Australia, Korea and the U.K.). As with the other PPH programs, the PPH pilot program between the US and DK Patent Offices allows applicants to request accelerated examination in one Office (the "Office of second filing" (OSF)), based on claims that were determined patentable in the other Office (the "Office of first filing" (OFF)). On November 3rd, the DK Patent Office will publish the procedures and requirements for filing a request to participate in the PPH (available here).
(c) a "bypass" application filed under 35 U.S.C. § 111(a) that validly claims benefit under 35 U.S.C. § 120 to a PCT application that validly claims priority to a DK application; or validly claims priority to a PCT application that contains no priority claims; or contains no priority claims.
(2) The DK application(s) have at least one claim that was determined by the DKPTO to be allowable and Applicant must submit a copy of the allowable claims from the DK application(s), along with an English translation thereof and a statement that the English translation is accurate.
(3) All the claims in the U.S. application must sufficiently correspond or be amended to sufficiently correspond to the allowable claims in the DK application(s).
(5) Applicant must file a request for participation in the PPH pilot program and a petition to make the U.S. application special under the PPH pilot program (sample form PTO/SB/20DK available from the USPTO website on November 3, 2008).
(6) Applicant must submit a copy of all the Office actions relevant to patentability from each of the DK application(s) containing the allowable claims that are the basis for the request, along with English translations thereof, and a statement that the translations are accurate.
(7) Applicant must submit an information disclosure statement (IDS) listing the documents cited by the DK examiner in the DK Office action, unless an IDS citing those references has already been filed in the U.S. application.
Questions concerning the Notice or the PPH program can be directed to Magdalen Greenlief, Office of the Deputy Commissioner for Patent Examination Policy, by phone 571-272-8800 or e-mail: magdalen.greenlief@uspto.gov.
Patent owners enjoy most of the same benefits, including the right to exclude and the freedom to contract, as the owners of other types of personal property. Balanced with these ordinary rights, however, is Congress's concern that the property rights of the patent owners do not conflict with the underlying purpose of patent grants: "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."(1) At times, this allowance for inventors to enjoy their exclusive rights is in opposition to the right of the public to enjoy the benefits of new technology. This conflict becomes most apparent in situations where a patent may have been issued erroneously due to undisclosed prior art or inequitable conduct during the course of prosecution. In these instances, courts step in and attempt to rectify the situation accordingly. These trial determinations of patent validity can either result in invalidation of the claims at issue or an affirmation by the court that the patent is valid as claimed. In either case, the public wins because the quid pro quo of patent law has been maintained.
This balancing of patent owner rights with the rights of the public becomes even more precarious in instances where the party challenging the patent is a licensee. Patent licensing represents a merger of contract and property law whereby the patent owner grants a licensee the right to make or use the patented invention during the patent term for some present or future consideration. Problems can arise when issues pertaining to patent validity surface during the term of such licenses. In granting a license, the patent owner has allowed another party to also benefit from the exclusive nature of the patent term, but this exclusive nature is valuable only so long as the patent is valid. When issues of patent validity arise during the course of the patent term, licensees are rightfully concerned because they may be getting a reduced benefit of return on the consideration paid. On the other hand, patent owners, having contracted in good faith with the licensees, expect the licensees to honor the terms of the contract. It is here where the public interest aspect of patent law separates itself from conventional contract and property law.
This paper will examine the history of Declaratory Judgment Act jurisprudence in patent cases. Part Two of the paper will provide a general background on the Declaratory Judgment Act as well as how declaratory judgments were applied in patent cases. Part Three will focus on the Federal Circuit's declaratory judgment jurisprudence and the development of its two-part case or controversy test. Part Four will examine the Supreme Court's decision in Medimmune as well as the ensuing Federal Circuit cases establishing the new Federal Circuit test. Part Five will be an examination of district court trends in the determination of case or controversy thresholds following Medimmune.
This paper stands for the proposition that the new test for Article III jurisdiction will create an uneven body of law due to differing interpretations of the requirements for the finding of a case or controversy. This proposition has been demonstrated in recent district court decisions that have defined the doctrines of standing and ripeness in various ways based upon the courts' insular interpretation of the individual case-specific facts.
The Court of Appeals for the Federal Circuit affirmed grant of a preliminary injunction in Abbott Laboratories v. Sandoz on October 21, and also affirmed the District Court's determination that the patents-in-suit were not rendered unenforceable by inequitable conduct during prosecution (although defendant Sandoz will be able to pursue this defense at trial). In coming to both conclusions, the majority decision illustrated nicely the appellate penchant (and prerogative) of deciding where lines are to be drawn when considering equitable issues.
Abbott's patents-in-suit, U.S. Patent Nos. 6,010,718 and 6,551,616, relate to extended release formulations of clarithromycin, the active ingredient in Abbott's Biaxin® XL product. Abbott filed suit after Sandoz file an ANDA having a Paragraph IV certification that Abbot's patents were invalid or unenforceable.
1. A pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment, comprising an erythromycin derivative and from about 5 to about 50% by weight of a pharmaceutically acceptable polymer, so that when ingested orally, the composition induces statistically significantly lower mean fluctuation index in the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability substantially equivalent to that of the immediate release composition of the erythromycin derivative.
1. A method of reducing gastrointestinal adverse side effects comprising administering an effective amount of extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer.
2. The method according to claim 1, wherein the erythromycin derivative is clarithromycin.
The District Court granted Abbott a preliminary injunction "to preserve the status quo" using the conventional four-factor test: whether there was a "(1) likelihood of success on the merits of the underlying litigation, (2) whether irreparable harm is likely if the injunction is not granted, [considering] (3) the balance of hardships as between the litigants, and (4) factors of the public interest." The Federal Circuit reviewed the grant of preliminary injunction based on an abuse of discretion standard. Sandoz alleged that Abbott's claims were anticipated and/or obvious over several prior art references, which the District Court found were not sufficient to establish that the claims were invalid. An interesting feature of the District Court's analysis was a reconsideration of the obviousness question in view of the Supreme Court's KSR v. Teleflex decision, which came down after the District Court originally considered Sandoz's obviousness contentions.
The question decided by the Federal Circuit was not concerned with the merits per se of the District Court's decision on the substantive question of whether Abbott's claims were anticipated or obvious; the panel found no clear error in the lower Court's factual determinations and no errors of law in its legal conclusions. The Federal Circuit also found no error in the District Court's claim construction or determination that Abbott was likely to establish at trial that Sandoz's product infringed at least one asserted claim of the patents-in-suit. Rather, the question before the Federal Circuit was the extent of the showing sufficient to preclude a district court from granting a preliminary injunction based on the likelihood of success on the merits prong of the four-factor test. This discussion was cast in Section VI of the decision, where Judge Newman was joined in her opinion upholding the injunction by Judge Archer, and from which Judge Gajarsa dissented.
Judge Newman (at left) rejected Sandoz's contention, and the dissent's, that a defendant must merely "[raise] a substantial question concerning either infringement or validity" to render grant of a preliminary injunction to be an abuse of discretion. Rather than being merely a question of whether a defendant could show claims were "vulnerable" to an invalidity challenge, at this stage Judge Newman said that sound precedent made the question whether there was a likelihood of success on the merits. In making this determination, the opinion sets forth what Judge Newman termed "the law governing the grant of a preliminary injunction." This precedent includes Supreme Court, "every regional circuit, and controlling Federal Circuit precedent," including Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005); Ranbaxy Pharmaceuticals., Inc. v. Apotex, Inc., 350 F.3d 1235 (Fed. Cir. 2003); Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552 (Fed. Cir. 1994); and Smith Int'l, Inc. v. Hughes Tool Co., 718 F.2d 1573 (Fed. Cir. 1983). The opinion characterized a "substantial question" as "more than a scintilla but less than a preponderance of evidence in support of its side," and further noted that there are also equitable factors that "are of particular significance at a preliminary stage," citing University of Texas v. Camenisch, 451 U.S. 390 (1981), and that a court must consider these factors in addition to whether a defendant has raised a "substantial question." The opinion also cited the Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), that patent cases are not deserving of unique treatment" when courts consider these equitable factors in deciding whether to grant a preliminary injunction.
The opinion then sets forth what the dissent characterizes as "a superfluity of citations" to decisions from all the regional circuits and the Supreme Court in support of it thesis that the "likelihood of success on the merits" is the principal criterion used by district courts in deciding whether to grant a preliminary injunction, and by reviewing courts when deciding whether a lower court has abused its discretion. The opinion specifically cites Hybritech Inc. v. Abbott Laboratories, 849 F.2d 1446 (Fed. Cir. 1988); Roper Corp. v. Litton Systems Inc., 757 F.2d 1266 (Fed. Cir. 1985); Pretty Punch Shoppettes, Inc. v. Hauk, 844 F.2d 782 (Fed. Cir. 1988); Nutrition 21 v. United States, 930 F.2d 867 (Fed. Cir. 1991); and Texas Instruments Inc. v. Tessera, Inc., 231 F.3d 1325 (Fed. Cir. 2000) (as well as another dozen cases) as Federal Circuit precedent in support of the "likelihood of success" standard for preliminary injunctive relief, all of which are in accord with the principles the Supreme Court enunciated in eBay, according to the majority opinion. The opinion contrasts this standard with the adequacy of the "substantial question" standard for averting judgment on the pleadings or summary judgment, citing Christianson v. Colt Industries Operating Corp., 486 U.S. 800 (1988).
In resisting a preliminary injunction, however, one need not make out a case of actual invalidity. Vulnerability is the issue at the preliminary injunction stages, while validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing necessary to establish invalidity itself.
Judge Gajarsa's point is that the District Court imposed a requirement that Sandoz show, by clear and convincing evidence, that the asserted claims of the patents-in-suit were invalid in order to defeat the grant of a preliminary injunction to Abbott, and that this burden was improper at the preliminary injunction stage. The precedential basis for his contention that Sandoz merely needed to raise a substantial question as to validity includes E.I. du Pont de Nemours & Co. v. MacDermid Printing Solutions, L.L.C., 525 F.3d 1353 (Fed. Cir. 2008); Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997); Tate Access Floors v. Interface Architectural Res., 279 F.3d 1357 (Fed. Cir. 2002); Erico Int'l Corp. v. Vutec Corp., 516 F.3d 1350 (Fed. Cir. 2008); and PHG Techs., LLC v. St. John Cos., 469 F.3d 1361 (Fed. Cir. 2006). Moreover, Sandoz having established to Judge Gajarsa's satisfaction that its claims were vulnerable to being invalidated on obviousness grounds, the burden was on Abbott to show that Sandoz's invalidity contentions lacked "substantial merit."
The differences in opinion, and copious citation of authority by both the majority and the dissent, perhaps suggest that there is a split in the Federal Circuit's jurisprudence that requires the Court to revisit this question en banc (or for the Supreme Court to weigh in on the quanta of evidence required to uphold vel non the likelihood of success on the merits for preliminary injunctions). It is equally likely, however, that these cases illustrate how courts must balance the evidence presented by each party in making a determination of whether the patentee is likely to succeed on the merits. The majority and dissent each assert different opinions on whether Sandoz's obviousness contentions have merit and raise a "substantial question" of invalidity. For the majority, the deficiencies in Sandoz's evidence lead to the conclusion that Abbott is likely to prevail on the merits, and hence the majority upholds the District Court's grant of a preliminary injunction. The dissent, on the other hand, believes Sandoz's contentions have merit, and that granting a preliminary injunction under these circumstances is an abuse of discretion. The perhaps inevitable consequence of this equitable balancing is that the Federal Circuit applies its "abuse of discretion" standard to questions of whether a district court's grant of a preliminary injunction is upheld or overturned by substituting (or imposing) its judgment for the judgment of the district court. It is reasonable to ask, as it has been asked in other contexts, whether the Federal Circuit's mandate justifies this result, and whether its penchant for so extending its plenary authority is contrary to the behavior and outcome in the other regional circuit courts of appeal. It is also reasonable to ask whether this penchant is precisely the kind of jurisprudence that has so motivated the Supreme Court to review, and reverse, the Federal Circuit so often over the past ten years.
The American Intellectual Property Lawyers Association (AIPLA) reported today that two of the pending U.S. Patent and Trademark Office rules packages, regarding changes in the rules governing Information Disclosure Statements ("the IDS rules") and claims encompassing multiple alternative embodiments ("the Markush rules") will not be published as final rules (and thus, will not go into effect) before the end of the Bush administration. This outcome was announced by Margaret Focarino (at right), Deputy PTO Commissioner for Patent Operations, during her appearance before the AIPLA Committee on Patent-Relations with the USPTO.
The proposed IDS rules would have changed the rules of practice to require "additional disclosure" (in the form of the dreaded Patentability Justification Document (PJD); see "More on Second Letter to OMB Criticizing the IDS Rule") for applicants submitting more than 20 documents, any English-language document over 25 pages in length, or any foreign language document. The requirements for PJDs making them excessively burdensome included requirements that they: "(1) identify the feature, showings or teachings that caused a document to be cited; (2) include a representative portion of the document where those features, showings or teachings may be found; and (3) correlate the features, showings or teachings to related claim or specification language." In addition to the excess burden, these requirements raised the specter of inevitable accusations of inequitable conduct against applicants or their representatives forced to submit them. These rules were published in the Federal Register for public comment on July 10, 2006 (71 Fed. Reg. 38808).
The Markush rules would require an applicant to limit claims to a "single invention" for claims reciting distinct embodiments in the alternative. These rules were complementary to the now-enjoined continuation and claims rules, since one purpose of the Markush rules was to prevent applicants from "circumvent[ing the rules] that limit the number of claims that may be asserted by presenting a single claim that sets forth multiple independent and distinct inventions in the alternative." The rules would require an applicant to limit such claims to a single invention, defined as one "where all the species encompassed by the claim: (i) share a substantial feature essential for a common utility, or (ii) are prima facie obvious over one another. These rules were published for public comment on August 10, 2007 (72 Fed. Reg. 44992).
We need to continue this principled approach to regulation [balancing the need for regulation with the peoples' right to be allowed to make their own decisions] as we sprint to the finish, and resist the historical tendency of administrations to increase regulatory activity in their final months.
Mr. Bolton directed agencies, including the Patent Office, that "[e]xcept in extraordinary circumstances," any regulations to be promulgated by the Bush Administration must be proposed no later than June 1st and implemented no later than November 1st. In addition, Mr. Bolton affirmed that "[i]n identifying priorities and establishing schedules, agencies should provide adequate time for necessary analysis, interagency consultation, robust public comment, and a careful evaluation of and response to those comments."
This decision does not preclude the Office from publishing either of these rules after January 20, 2009, however. With the change of administration, the current occupant of the Director's chair, Jon Dudas, will leave the Patent Office, perhaps to be replaced (in the interim or longer) by current Patent Office officials. That individual could decide to publish the "final" version of the rules at any time thereafter. But any such attempt to implement these rules would need to overcome the impediment presented by the Paperwork Reduction Act (PRA) and approval from the OMB. For yet another set of rules, relating to rules of practice before the Board of Patent Appeals and Interferences, the Patent Office has not complied with the PRA and those rules have not gone into effect. The period for public comment to the Office of Management and Budget on the administrative and paperwork burdens of those rules remains open until November 10, 2008.
Patent Docs thanks Hal Wegner for alerting us to the AIPLA notice and David Boundy for reminding us of continuing efforts to force the Patent Office to comply with the PRA rules.
Endo Pharmaceuticals Inc. et al. v. Barr Laboratories Inc.
Infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. et al. v. Watson Laboratories, Inc. et al.
Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Ortho Tri-Cyclen Lo® (norgestimate and ethinyl estradiol, used for oral contraception). View the complaint here.
Novartis Pharmaceuticals Corp. v. Mylan Pharmaceuticals Inc., et al.
Infringement of U.S. Patent No. 5,354,772 ("Indole Analogs of Mevalonolactone and Derivatives Thereof," issued October 11, 1994) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Lescol® (fluvastatin sodium, used to treat hypercholesterolemia). View the complaint here.
• Identifying action plans to successfully work with the ITC courts, commission and counsel’s office.
• Passing the Domestic Industry test with the rise of licensing and trademark cases.
An additional pre-conference workshop entitled: "Drafting an ITC Complaint: Developing Strategies and Composing the Necessary Documents" will be offered on January 26th. In this workshop, ACI faculty will instruct attendees on the essentials of drafting an ITC complaint, to ensure that it provides a concise and formidable argument.
The agenda for the ITC Litigation conference can be found here. A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.
The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and workshop). Those registering by November 28, 2008 will receive a $300 discount off the registration fee and those registering by December 26, 2008 will receive a $200 discount off the registration fee. Those interested in registering for the conference can do so here, by calling 888-224-2480, or by faxing a registration form to 877-927-1563.
Patent Docs is a media partner of the Advanced Forum on ITC Litigation.
• Exit strategies for life sciences companies.
The agenda for the Commercialization of Life Sciences Inventions conference can be found here. A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.
The registration fee is $622.50 for students and new employees, $945 for government employees, or $1,245 for all other attendees. Those interested in registering for the workshop can do so here, by calling 800-854-8009, or by faxing a registration form to 206-567-5058.
Last week, the U.S. Patent and Trademark Office and USPTO Director Jon Dudas filed their reply brief in the Tafas v. Dudas appeal. On the same day that the Patent Office filed its reply brief, Patently-O provided links to the fifteen amicus briefs filed in the appeal, thirteen of which support Plaintiffs-Appellees Dr. Triantafyllos Tafas, SmithKline Beecham Corp., SmithKline Beecham plc, and Glaxo Group Ltd., and two of which support Defendants-Appellants the USPTO and Director Dudas. In August, Patent Docs reported on one of the amicus briefs filed in support of Defendants-Appellants by the Public Patent Foundation (PUBPAT), AARP, the Computer & Communications Industry Association (CCIA), Consumer Watchdog, Essential Action, Initiative for Medicines, Access & Knowledge (I-MAK), Prescription Access Litigation (PAL), Public Knowledge (PK), Research on Innovation (ROI), and the Software Freedom Law Center (SFLC) (see "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal"). With oral argument scheduled for December 5, 2008, Patent Docs will be reporting on a number of the other amicus briefs filed in the Tafas appeal in the coming weeks. Today, we will be addressing the other brief filed in support of Defendants-Appellants.
The Brief Amici Curiae of Intellectual Property and Administrative Law Professors in Support of Appellants was signed by Stanford Law School Professor Mark Lemley (at left) on behalf of Prof. Stuart Benjamin (Duke Law School), Prof. Robin Feldman (U.C. Hastings College of the Law), Prof. Marshall Leaffer (Indiana University School of Law, Bloomington), Prof. Mark McKenna (Notre Dame Law School), Prof. Peter Menell (University of California at Berkeley School of Law), Prof. Joseph Miller (Lewis & Clark Law School), Prof. Craig Nard (Case Western Reserve University School of Law), Prof. Arti Rai (Duke Law School), Prof. Michael Risch (West Virginia University College of Law), Prof. Katherine Strandburg (DePaul University College of Law), and Prof. John Thomas (Georgetown University Law Center). The Law Professors' brief argues that the Patent Office's continuation and claims rules (Final Rules), which District Judge James C. Cacheris of the Eastern District of Virginia enjoined on April 1st, should be evaluated under Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984); are a reasonable interpretation of the statute; and are not arbitrary and capricious.
The Law Professors begin by arguing that the Supreme Court's decision in Dickinson v. Zurko, 527 U.S. 150 (1999), establishes that standard administrative law principles developed in Chevron and its progeny govern judicial review of the USPTO. With respect to the Tafas appeal, the brief contends that the Federal Circuit should first decide whether Chevron is applicable. Not surprisingly, the Law Professors believe that the Patent Office is owed Chevron deference with respect to the Final Rules. According to the brief, "[t]he rules at issue are unquestionably directed at the control of PTO procedures -- under what circumstances applicants can file continuation applications, and what information applicants must disclose along with those applications that are particularly large," and the Patent Office acted using notice and comment rulemaking. As a result of the procedural nature of the Final Rules, and the PTO's use of notice and comment rulemaking, the Law Professors argue that the Final Rules must be analyzed in accordance with Chevron.
The brief takes the District Court to task for determining that the Final Rules must be substantive because they "constitute a drastic departure from the terms of the Patent Act as they are presently understood." The Law Professors argue that Judge Cacheris "wrongly assumes that the rules in fact represent a drastic departure," contending that "the PTO already uses the doctrine of prosecution laches to limit continuation applications" (as a result of the Federal Circuit's decision in In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002)), and that the Patent Office used "its procedural rulemaking authority to promulgate Rule 105, which authorizes examiners to require additional information from applicants not simply in cases of large applications but in all cases" (emphasis in brief).
Tackling the Final Rules limit on continuations, the Law Professors contend that 35 U.S.C. § 120 "does not compel the PTO to give applicants an unlimited number of bites at the apple," but rather merely "allow[s] applicants that file continuation applications to benefit from the priority date of the first application." With respect to Rule 265, which would require applicants to submit an Examination Support Document (ESD) in order to prosecute more than five independent claims or 25 total claims in a single application (the 5/25 rule), the Law Professors draw an analogy to "the PTO's promulgation of Rule 105, which allows an examiner to require the submission of 'such information as may be reasonably necessary to properly examine or treat the matter,'" and which was "explicitly approved" in Star Fruits S.N.C. v. United States, 393 F.3d 1277 (Fed. Cir. 2005).
This case is hardly the rare exception that fails under step 2. It is perfectly reasonable for the PTO to attempt to manage its ever-burgeoning case load by preventing the repeated filing of applications directed at the same subject matter. It is also reasonable for the PTO, which has only a small amount of time to review any given application, to seek additional information on applications with large numbers of claims.
The Law Professors conclude their brief by arguing that the Final Rules are not arbitrary and capricious, stating that "[e]ven if the PTO's solution to the problem it faces is not necessarily the optimal one, it is satisfactory." The Law Professors note that in crafting the Final Rules, the Patent Office collected more than 500 comments and spent more than a year analyzing them. The brief points out that in response to these comments, the Patent Office "changed its proposal from one that would have automatically allowed only one continuation, continuation-in-part, or request for continued examination to a proposal that automatically allows two continuations or continuations-in-part as well as one request for continued examination," and "[f]ollowing the recommenation of various commentators, . . . changed its original proposal for 'representative claims' designation into the current '5/25' rule." The brief also states that the Final Rules "permit applicants to seek additional continuations beyond the three allowed automatically on a showing of good cause" (although the brief conveniently omits any discussion about the impossibly high standard the USPTO set forth for showing "good cause").
[T]he PTO has accommodated these conflicting concerns, in fact bending over backwards in its final rulemaking to ensure that applicants have abundant opportunity to use continuations for these legitimate purposes while still trying to impose some limits on abuse of the continuation process. The final rules permit applicants an original application, two continuation applications, an RCE, and an unlimited number of divisionals. Those who have already exhausted all those applications can seek additional continuations; they simply need to come up with a reason why they need a fifth (or more) bite at the apple.
Last week, Immunomedics, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,435,803, which is directed to humanized and chimeric anti-CD20 antibodies and CD20 antibody fusion proteins. Such antibodies are useful for the treatment and diagnosis of B-cell disorders, such as B-cell malignancies and autoimmune diseases. The '803 patent is Immunomedics' 131st U.S. patent, which is also named as an assignee on 111 U.S. patent application publications. CD20 is a non-glycosylated phosphoprotein that is expressed on the surface of all mature B-cells, and which plays a role in the development and differentiation of B-cells into plasma cells.
According to the Morris Plains, NJ-based biopharmaceutical company's press release, the '803 patent encompasses Immunomedics' veltuzumab antibody, which targets the CD20 antigen present on B-lymphocytes, leukemias, and lymphomas. Veltuzumab is currently being tested for the treatment and diagnosis of B-cell disorders, such as B-cell malignancies and autoimmune diseases. A subcutaneous formulation of veltuzumab has also been recently licensed to Nycomed GmbH for use in all non-cancer indications.
1. A chimeric or humanized monoclonal antibody that binds to CD20, said antibody having a light chain variable region CDR1 comprising the sequence RASSSVSYIH (SEQ ID NO:1); CDR2 comprising the sequence ATSNLAS (SEQ ID NO:4); and CDR3 comprising the sequence QQWTSNPPT (SEQ ID NO:5); and said antibody having a heavy chain variable region CDR1 comprising the sequence SYNMH (SEQ ID NO:8); CDR2 comprising the sequence AIYPGNGDTSYNQKFKG (SEQ ID NO:9); and CDR3 comprising the sequence STYYGGDWYFDV (SEQ ID NO:10) or the sequence VVYYSNSYWYFDV (SEQ ID NO: 13).
In a Notice dated October 14, 2008, the U.S. Patent and Trademark Office announced that the Korean Intellectual Property Office (KIPO) has become the third participating foreign intellectual property office in the electronic priority document exchange program. This complements our prior report based on information provided by one of our Korean foreign associates. As of the date of the Notice, the USPTO will be able to electronically retrieve Korean priority documents from KIPO through the Priority Document Exchange (PDX) system. Similarly, the KIPO will also gain the ability to electronically retrieve U.S. priority documents from the USPTO.
For U.S. applications filed under 35 U.S.C. § 111(a) on or after October 14, 2008, the USPTO will automatically attempt to electronically retrieve a copy of any Korean (KR) priority document without the need for the applicant to file a request to retrieve in a separate document (no need to file Form PTO/SB/38) provided that the application claims foreign priority to the KR application and identifies the KR application in the oath or declaration, or in an application data sheet. The same situation applies for priority applications originally filed in the EPO or JPO. If the copy of the KIPO (or EPO or JPO) application is received by the USPTO prior to the payment of the issue fee, the requirement under 37 C.F.R. § 1.55 for a certified copy of the foreign priority application is satisfied. While the USPTO will make the requests automatically, the request may not be fulfilled until several months after the filing of a qualifying new U.S. application.
For U.S. applications filed prior to October 14, 2008, applicants must file a request to retrieve Form PTO/SB/38. This program does not include design patent applications and PCT applications. Similarly, the USPTO will not retrieve copies of priority applications filed in U.S. national stage applications under 35 U.S.C. § 371 unless the applicant files a separate Form PTO/SB/38, since the USPTO already receives copies of such priority applications from the International Bureau.
The Notice also advises that Applicants will be ultimately responsible for ensuring that the priority document is filed by the time of patent grant as required under 37 C.F.R. § 1.55(a). Applicants are encouraged to check Private PAIR to confirm receipt of appropriate documents.
Similarly, if a KR (or EP or JP) application claims foreign priority to a U.S. provisional or nonprovisional application, the KIPO (or EPO or JPO) will automatically attempt to retrieve an electronic copy of the U.S. application. Importantly, the USPTO will release copies of U.S. applications upon such request only if the U.S. priority application has received a foreign filing license in accordance with 37 C.F.R. § 5.11, and (1) the applicant of the U.S. application provided an appropriate written authority to permit access to application by participating offices (Form PTO/SB/39 or Form PTO/SB/01); or (2) the U.S. application has been published or patented.
As with the USPTO, applicants are advised that KIPO (as well as EPO and JPO) regulations require a copy of a priority document to be filed with the corresponding KIPO (or EPO or JPO) application no later than 16 months from the priority date. The USPTO advises that because U.S. applications are ordinarily published by the USPTO after the time period of 18 months from filing, most U.S. applications that are the basis for a foreign priority claim in a KR (or EP or JP) application will not be published at the time the applicant is required to provide a copy of the U.S. application to the KIPO (or EPO or JPO). Accordingly, in most situations it will be necessary for applicants to provide the USPTO with appropriate written authorization for the foreign offices to access the U.S. application and obtain a copy by submitting either (1) Form PTO/SB/39; or (2) Form PTO/SB/01 in which the "Authorization to Permit Access by Participating Offices" has been checked.
For further information regarding the PDX program, the USPTO asks that you contact either Don Levin (TDA Project Manager) at 571-272-3785, or Diana Oleksa (Legal Advisor for IT Policy) at 571-272-3291, or by sending an e-mail to PDX@uspto.gov.

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