Gibbons Law Alert

Gibbons Law Alert

Tagged: Pharmaceuticals

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.

PhRMA Opposes FTC’s Proposed Rules for Reporting Certain Pharmaceutical Licensing Transactions

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Posted in Pharmaceuticals

On November 7, 2012

We recently reported that during the August doldrums the Federal Trade Commission (FTC) proposed for comment amendments to the Hart-Scott-Rodino rules that would require reporting of licensing agreements under which a patent holder grants an “exclusive” license, but retains the limited right to manufacture solely for the recipient of the patent rights, or a right to assist in developing and commercializing the product covered by the patent (“co-rights”) and the value of the license exceeds the HSR minimum (currently $68.2 million).

Reckitt Benckiser v. Tris Pharma — New Jersey Magistrate Finds No Trade Secret Misappropriation

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Posted in Pharmaceuticals

On August 30, 2012

In a recent “not for publication” Memorandum Opinion and Order relating to Reckitt Benckiser’s (“RB”) over-the-counter cough syrup, Delsym® (dextromethorphan polistirex), United States Magistrate Judge Douglas E. Arpert of the District of New Jersey found that RB failed to establish trade secret misappropriation, unfair competition, and tortious interference with business expectations claimed against Tris Pharma, following a four-day bench trial.

FTC Proposes Rules to Codify Reporting of Exclusive Patent Right Transfers in the Pharmaceutical Industry

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Posted in Patent / Pharmaceuticals

On August 21, 2012

Is the sale or assignment of a patent reportable? The Hart-Scott Rodino Antitrust Improvements Act of 1976 (“HSR”) and related rules require that all acquisitions of voting securities or assets exceeding a threshold amount be reported to the Federal Trade Commission (“FTC”), as well as the Antitrust Division of the Department of Justice. The current threshold is $68.2 million.

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.

The Hatch Waxman Act and Induced Infringement

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Posted in Patent / Pharmaceuticals

On December 7, 2011

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®.

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