Gibbons Law Alert

Gibbons Law Alert

Tagged: ANDA

U.S. Supreme Court Will Not Review Lead Compound Test for Obviousness Analysis

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Posted in Pharmaceuticals

On January 15, 2013

On Monday, the Supreme Court denied the petition for writ of certiorari filed by Apotex seeking review of the Federal Circuit’s May 7, 2012, ruling that affirmed the District Court of New Jersey’s judgment that Otsuka’s patents covering its blockbuster drug Abilify© are valid and not obvious. In that ruling, the Federal Circuit found no error in the District Court’s application of the so-called lead compound test; an analytical framework in chemical art cases that seeks — in an obviousness inquiry under 35 U.S.C. § 103 — to determine whether a POSA (“person of ordinary skill in the art”) would select the proffered prior art as a “lead compound.” Specifically, in a lead compound analysis, the Court will consider: the hypothetical person of skill in the art’s identification of a lead compound, structural differences between the proposed lead compound and the claimed invention, motivation or teachings in the prior art to make the necessary changes to arrive at the claimed invention, and whether the person of skill in the art would have a reasonable expectation of success in making such structural changes.

DNJ Rejects Double-Patenting Claim

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Posted in Patent

On December 27, 2012

Last week, in Gilead Sciences, Inc. v. Natco Pharma Ltd., the District of New Jersey ruled on summary judgment that Gilead Sciences did not unlawfully extend its patent protection on oseltamivir (Tamiflu), a neuraminidase inhibitor used to treat the flu, covered by U.S. Patent No. 5,763,483 (“the ‘483 patent”). Natco Pharma sought to invalidate the ‘483 patent for obviousness-type double patenting in its attempt to market a generic version of Tamiflu prior to the patent’s expiration. Natco had alleged, inter alia, that the claims of the ‘483 patent were invalid due to obviousness-type double-patenting over Gilead’s later issued U.S. Patent No. 5,952,375 (“the ‘375 patent”).

FTC Petitions for Certiorari in Reverse Payments Dispute

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Posted in Patent

On October 5, 2012

As we anticipated, the Federal Trade Commission (“FTC”) filed a petition for certiorari yesterday with the Supreme Court in FTC v. Watson Pharmaceuticals, Inc. In that case, the Eleventh Circuit upheld reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry under the scope-of-the-patent approach, i.e., as long as the anti-competitive effects fall within the scope of the exclusionary potential of the patent, absent sham litigation or fraud), as lawful. The Second and Federal Circuits follow that approach. In contrast, the Third Circuit has held that such payments are presumptively anti-competitive under the “quick look rule of reason analysis” that may be rebutted by showing that the payments was for something other than delay or that the payment has a competitive benefit, and thereby increases competition.

Will the Supreme Court Weigh in on Reverse Payments in ANDA Cases — Revisited

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Posted in Patent

On September 28, 2012

We have written previously on numerous developments concerning reverse payments in Hatch-Waxman litigation settlements (i.e., payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of proposed generic products). Earlier this month, we reported that Merck & Co. had filed a petition for a Writ of Certiorari seeking to challenge the Third Circuit’s decision in In re K-Dur Antitrust Litig. holding that reverse payments are prima facie evidence of an antitrust violation.

Will the Supreme Court Weigh in on Reverse Payments in ANDA Cases?

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Posted in Patent

On September 4, 2012

We previously reported on developments in various United States Courts of Appeal decisions concerning reverse payments in Hatch-Waxman litigation settlements – that is, payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of the generic product. Most recently, as we reported here, the Third Circuit in In re K-Dur Antitrust Litig. bucked prior holdings of the Eleventh, Second, and Federal Circuits, ruling that a reverse payment is prima facie evidence of an antitrust violation and, therefore, serves as evidence of unreasonable restraints of trade. In light of the Third Circuit’s divergent decision from other circuit precedent, many predicted a subsequent Petition for Certiorari.

New Jersey Ranked No. 2 for Biotechnology Strength

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Posted in Biotech

On July 18, 2012

According to a press release from the Governor’s office, a recent review issued by Business Facilities magazine reported that New Jersey jumped eight positions to rank second for biotechnology strength among U.S. states. Some of the factors cited as responsible for this improvement include increases in R&D tax credits (from 50% to 100%) and the adoption of a new single sales factor formula for corporate tax liability, which will reduce company costs.

Save the Date: Rutgers Pharmaceutical Management Program, July 19-20, 2012

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Posted in Pharmaceuticals

On July 13, 2012

Gibbons P.C. is again proud to announce a two-day program for Pharmaceutical Management at the Rutgers University Blanche and Irwin Lerner Center for Pharmaceutical Studies in Newark, NJ. The program, which is open to the public, includes in-depth presentations relating to topics including intellectual property, regulatory, financial and marketing issues relating to the pharmaceutical industry, as well as drug development and the role of biotechnology in pharmaceutical development.

Astra v. Apotex: CAFC Affirms Non-infringement of Method of Use Claims

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Posted in Pharmaceuticals

On February 13, 2012

In AstraZeneca Pharms. LP. v. Apotex Corp., the Federal Circuit ruled that an Abbreviated New Drug Application (“ANDA”), filed under § 355(j)(2)(B)(ii) and limited to FDA approved, but unpatented uses of a medication, is not an act of infringement of Orange Book-listed patents covering approved but different uses of the same medication. The Court did find that Plaintiff’s allegation that its listed patents are infringed was sufficient to establish subject matter jurisdiction over the generic Defendants.

IP Law 2012: A Look Ahead . . . .

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Posted in Patent / Pharmaceuticals / Trademarks / USPTO

On January 4, 2012

Coming off a year that included the Smith-Leahy “America Invents Act,” 2012 portends to have some significant developments in IP law. Decisions for IP practitioners and industry to watch for include: the Supreme Court’s decision in Caraco Pharm. Labs. Ltd. v. Novo Nordisk A/S, regarding “use codes” and section viii carve-outs under the Hatch-Waxman Act; the Supreme Court’s decision in Mayo v. Prometheus, regarding patentable subject matter, post-Bilski; and the Federal Circuit’s upcoming en banc decisions in McKesson and Akamai, regarding joint infringement liability.

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