Gibbons Law Alert

Gibbons Law Alert

Tagged: Hatch-Waxman

Mutual Pharmaceutical Co., Inc. v. Bartlett

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Posted in Pharmaceuticals

On July 10, 2013

The generic pharmaceutical industry faced a Catch-22 when a serious adverse reaction arose from use of a generic drug product, and the manufacturer was restrained from unilaterally amending the product label to conform to state requirements, due to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). PLIVA held that state requirements to change a label are pre-empted by the Federal Food, Drug and Cosmetic Act’s prohibition of changing labeling without authorization by the FDA.

Gibbons Institute of Law, Science & Technology Files Amicus Brief in “Pay-for-Delay” Case Before Supreme Court

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Posted in Pharmaceuticals

On March 8, 2013

We previously reported on the battle over so-called “pay-for-delay” settlements, which puts the pharmaceutical industry versus the Federal Trade Commission (“FTC”) before the Supreme Court, to decide the legality of reverse payments in Hatch-Waxman cases. The case is FTC v. Actavis, Inc., et al. Last week, the Gibbons Institute of Law, Science & Technology, among 16 other amici, filed briefs in support of respondents and the lawfulness of these payments. The other amici included: Antitrust Economists; Bayer AG and Bayer Corp.; Health Economics and Law Professors; Mediation and Negotiation Professionals; Law Professors Gregory Dolin, Kent Bernard, et al.; The American Intellectual Property Law Association; Enavail, LLC; The Generic Pharmaceutical Association]; Intellectual Property Owners Association; Merck & Co., Inc.; National Association of Manufacturers; Pharmaceutical Research and Manufacturers of America (Phrma); New York Intellectual Property Law Association; Shire plc; Washington Legal Foundation; Generic Manufacturers Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA, Inc.; Ranbaxy Pharmaceuticals, Inc.; Mylan Pharmaceuticals Inc.; and Impax Laboratories, Inc.

Gibbons Institute Program to Cover Biosimilars

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Posted in Biotech

On February 12, 2013

Why all the buzz about biosimilars? Biosimilars, also known as follow-on biologics, are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. The evolving biosimilars landscape is of concern to companies here in the U.S. and worldwide.

Proposed Bill Seeks to Answer the Pay for Delay Debate

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Posted in Pharmaceuticals

On February 7, 2013

As the so-called pay for-delay case is ripening for Supreme Court oral argument on March 25, 2013, on Tuesday a bi-partisan group of senators introduced legislation meant to strongly deter such arrangements. The introduction of the bill, known as the “Preserve Access to Affordable Generics Act,” follows an annual FTC report disclosing 40 potential pay-for-delay deals struck in the 2012 fiscal year — a jump from 28 such deals in 2011. The goal of the bill is “to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.” Such reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry) are considered lawful by some, and anti-competitive by others, including the FTC.

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.

Supreme Court to Examine Pay-For-Delay Settlements

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Posted in Patent

On December 17, 2012

The battle between the pharmaceutical industry and the Federal Trade Commission (“FTC”) over so-called “pay-for-delay” settlements will finally be examined and decided by the Supreme Court. Last Friday, the Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with filed certiorari petitions involving Hatch Waxman reverse payment settlements. The petition in the other case, In re K-Dur Antitrust Litigation, is still pending.

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.

Intellectual Asset Management Ranks Gibbons Among Top IP Law Firms and Practitioners Worldwide

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Posted in Intellectual Property / Patent

On July 12, 2012

Intellectual Asset Management (IAM) ranks Gibbons among the top IP law firms and practitioners worldwide in its guide – IAM Patent Litigation 1000 – The World’s Leading Patent Litigators. David E. De Lorenzi, Chair of the Gibbons Intellectual Property Department, and Sheila F. McShane, a Director in the Department, were two of only five intellectual property lawyers featured as leading individuals in this practice.

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