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Amicus Briefs and Other Advocacy
Amicus Briefs
- In re Ciprofloxacin Hydrochloride Antitrust Litigation, No. 08-1097 (Fed. Cir.) (January 25, 2008)
Amicus brief before the United States Court of Appeals for the Federal Circuit, in support of appellants and urging reversal of a decision by the United States District Court for the Eastern District of New York dismissing plaintiffs-appellants' federal antitrust claims on the ground that defendants' challenged patent settlement agreement was immunized by the patent laws. The case, filed by direct and indirect purchasers of the wide-spectrum antibiotic drug ciprofloxacin hydrochloride (“Cipro”), involves agreements between defendants Bayer AG and its U.S. subsidiary Bayer Corporation – manufacturer of Cipro and assignee of U.S. Patent No. 4,670,444 which claims the active ingredient in Cipro – and generic manufacturers Barr Laboratories, Inc., The Rugby Group, Inc., Hoechst Marion Roussel, Inc., and Watson Pharmaceuticals, Inc. Under the terms of those agreements (executed in January 1997), Bayer paid the generic companies approximately $398 million in exchange for their agreements not to manufacture any form of Cipro and for Barr’s agreement to terminate its challenge to Bayer's patent by converting its Abbreviated New Drug Application for a generic form of Cipro to permit Barr to market its generic drug only upon expiration of the ‘444 patent in December 2003. In its amicus brief, the Commission argues that the district court's ruling is not compelled by the patent laws, and it conflicts with fundamental antitrust principles.
- Department of Justice and Federal Trade Commission As Amici Curiae Supporting Plaintiffs-Appellants in In Re DDAVP Direct Purchaser Antitrust Litigation Concerning Suits By Direct Purchasers Of A Patented Product To Recover Certain Damages Resulting From Enforcement of a Patent Obtained Through Intentional Fraud (In the United States Court of Appeals for the Second Circuit, On Appeal From the United States District Court For The Southern District of New York)(Case No. 06-5525-cv) (May 2007)
- In re Tamoxifen Citrate Antitrust Litigation, No. 03-7641 (2nd Cir.) (Nov. 30, 2005)
An amicus brief in support of plaintiffs-appellants’ petition for panel rehearing and rehearing en banc. The case concerns a decision by a divided panel of the appeals court upholding the dismissal, pursuant to FRCP 12(b)(6), of an antitrust challenge to a Hatch-Waxman patent settlement between AstraZeneca, the manufacturer of a branded drug, and Barr Labs., an FDA applicant for a generic counterpart. The Commission argues that the panel did not properly consider the Hatch-Waxman Act, which encourages challenges to pharmaceutical patents to facilitate the early entry of generic drugs, and that, if not corrected, the panel decision would permit the holder of a challenged drug patent to harm competition, and thus consumers, substantially by impermissibly paying a would-be generic rival to stay off the market.
- Illinois Tool Works, Inc. v. Independent Ink, Inc., No. 04-1329 (S. Ct.) (Aug. 4, 2005)
Joint brief of the United States, the Federal Trade Commission, and the Patent and Trademark Office, as amici curiae, urging the Court to reverse the ruling of the court of appeals, which was based on a presumption that the possession of a patent conveys market power for purposes of adjudicating a claim of tying.- Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., No. 04-1186 (Fed. Cir.) (Feb. 8, 2005)
In this amicus brief in support of Teva’s combined petition for rehearing and rehearing en banc, the Commission argues that the court erred in affirming the district court’s dismissal of Teva’s complaint in this Hatch-Waxman Act case. The brief argues that the court applied the wrong test to assess jurisdiction under the Declaratory Judgment Act. The court only considered the likelihood that Teva would face a patent infringement suit, but failed to take account of the injury Teva will suffer. The brief argues that Teva will face injury even in the absence of a patent infringement suit because the FDA cannot approve Teva’s generic sertraline hydrochloride drug unless Teva can obtain a court decision regarding Pfizer’s patent.
- Edward H. Phillips v. AWH Corporation, No. 03-1269, 1286 (Fed. Cir.) (en banc) (Sept. 20, 2004)
Amicus Brief of the United States and the Federal Trade Commission addressing the proper methodology for construing the claims of a patent. This brief was filed in response to an order of the Court of Appeals for the Federal Circuit taking the case en banc and inviting the government to submit its views on the questions of the en banc order. The brief argues that in construing patent claims a court should primarily rely on a patent’s intrinsic evidence (its description of the invention and its prosecution history) rather than dictionaries and other external sources. This approach is more likely to result in claim constructions that are closer to those used by the Patent Office in issuing patents and that reflect the inventions as described and enabled.
- Andrx Pharmaceuticals, Inc. v. Kroger Co., No. 03-779 (S. Ct.) (July 8, 2004)
Joint brief of the United States and the Federal Trade Commission, urging the Court to deny a writ of certiorari in this case, regarding private patent litigation and the legal standards applicable to “reverse payment” patent litigation settlements in the Hatch-Waxman context.
- Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc. No. 04-1186 (Fed. Cir.) (March 31, 2004)
The Commission argues that the district court erred by dismissing Teva's complaint against Pfizer in this Hatch-Waxman Act case. Teva sought a declaratory judgment that its generic version of sertraline hydrochloride would not infringe a patent held by Pfizer (or that the patent was invalid). The brief argues that the court applied the wrong test to assess jurisdiction. It failed to take account of the fact that, unless Teva can obtain a court decision regarding Pfizer's patent, the FDA cannot give Teva approval to market its generic drug until 180 days after the first generic applicant (Ivax Pharmaceuticals) enters the market with its version. The brief also explains that the district court’s holding will leave subsequent generic applicants (such as Teva) powerless to prevent brand-name manufacturers and first generic applicants from greatly delaying other generic manufacturers from entering the market.
- SmithKline Beecham Corp. v. Apotex Corp., No. 99-CV-4304 (E.D. Pa.) (Jan. 28, 2003)
Memorandum of the Federal Trade Commission, as amicus curiae, addressing the propriety of de-listing a patent from FDA's "Orange Book," as a remedy for patent invalidity. The brief explains that improperly-maintained Orange Book listings may serve as a barrier to competition, and that there may be substantial consumer benefits to a de-listing remedy.
- In re: Buspirone Antitrust Litigation MDL Docket No. 1410 (JGK) (January 8, 2002)
Amicus brief for the Federal Trade Commission, supporting argument of generic drug manufacturer that allegedly wrongful listing of patents in the FDA's "Orange Book" is not immune from antitrust liability.
- Brief of the Federal Trade Commission as Amicus Curiae in American Bioscience, Inc. v. Bristol-Myers Squibb Co., No. CV-00-08577 WMB (AJWx) (C.D. Cal.,September 1, 2000)
American Bioscience, Inc. (ABI) sued Bristol-Myers Squibb, the maker of Taxol, a drug used to treat cancer, to force it to list a patent on the FDA Orange Book, and obtained an unopposed temporary restraining order (TRO). As part of a proposed settlement between ABI and Bristol, the parties agreed that (1) the court would enter a finding that ABI’s patent should be listed in the Orange Book, and (2) Bristol would maintain the listing of the patent in the Orange Book. In its amicus brief, the Commission asked the judge to consider the anticompetitive ramifications of the proposed settlement. First, another court might find any judicial finding that the patent met the statutory requirements for listing on the Orange Book persuasive, or even conclusive, thus hindering a generic company’s attempt to challenge the listing. Second, the order to maintain the listing would conflict with any later court order requiring Bristol to delist the patent, and resolving the conflicting court orders could further forestall generic entry. The brief also announced the Commission’s investigation of ABI and Bristol, and asked the court to consider its pendency when deciding on the proposed settlement. The court ultimately determined that ABI could not maintain a private action under the Food, Drug, and Cosmetics Act, dissolved the TRO, and ordered Bristol to delist the ABI patent.
OTHER ADVOCACY
- Before the United States Department of Commerce, Patent and Trademark Office
In the Matter of Changes to Practice for Continuing Applications, Requests for Continued Examination Practice,and Applications Containing Patentably Indistinct Claims
Comments of theUnited States Federal Trade Commission
May 3, 2006- Response to Citizen Petition by IVAX Pharmaceuticals, Inc. (Regarding IVAX’s objection to FDA’s delisting of two patents from the Orange Book for which IVAX had previously filed Paragraph IV certifications, April 5, 2005)
- The Bureau of Competition and the Policy Planning Staff of the Federal Trade Commission submitted a Citizen Petition to the Commissioner of Food and Drugs on May 16, 2001, in which it requested guidance on the FTC staff’s interpretation of certain FDA regulations related to patent listings in the Orange Book. The petition sought the FDA’s views on the two prong criteria that a patent must meet under 21 C.F.R. § 314.53 (b) before it can be listed in the Orange Book. The petition also asked for guidance on other patent listing issues, including whether an NDA holder can list a patent for an unapproved aspect of an approved drug, or a chemical compound not approved for use as the drug substance in an approved drug product, and the meaning of the term “drug product” as it relates to infringement analysis under the regulation. FDA never formally responded to our citizen’s petition, but instead issued proposed regulations on October 24, 2002, to modify in part its regulations concerning Orange Book listings. Staff submitted comments to the proposed regulations on December 23, 2002. FDA’s proposed regulations remain pending.
Related documents:
- FTC Comment Before the Food and Drug Administration Concerning Applications for FDA Approval to Market a New Drug (Relating to Abbreviated New Drug Application Procedures) (Dec. 2002)
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