Tagged: ANDA

FTC Petitions for Certiorari in Reverse Payments Dispute

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

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?

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

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

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

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 . . . .

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.

The Hatch Waxman Act and Induced Infringement

Oral argument was recently heard before the Federal Circuit in the appeal of AstraZeneca Pharms. LP. v. Aurobindo Pharma Ltd. AstraZeneca, along with IPR Pharmaceuticals, Inc., and The Brigham and Women’s Hospital, Inc., (“Plaintiffs) sued ten generic drug companies alleging infringement of US Patent Nos. 6,858,618 (“the ‘618 patent”) and 7,030,152 (“the ‘152 patent”) under the Hatch-Waxman Act. These patents claim methods of treatment using rosuvastatin calcium, which Plaintiffs market as Crestor®.