IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: ANDA

A Rare Inter Partes Review for an Orange Book Listed Patent

Posted in Patent
Ranbaxy Laboratories, Ltd. ("Ranbaxy") and Vertex Pharmaceutical, Inc. ("Vertex") recently settled an inter partes review ("IPR") proceeding regarding Vertex's U.S. Patent No. 6,436,989 ("the '989 Patent"). Vertex had listed the '989 Patent in the FDA's published Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the Orange Book, as covering its HIV drug, Lexiva®. The significance of this event is the rarity of the use of IPR on patents typically challenged under the Hatch-Waxman framework. Recent statistics show that the majority of IPR have involved electrical/computer patents. Less than 6% of IPRs have been directed to biotechnology/pharmaceutical patents. The likely reason for the limited use of IPR on pharmaceutical patents, particularly those listed in the Orange Book, is the estoppel provisions of the IPR proceedings. See 35 U.S.C. §§ 315(e)… Continue Reading

ANDA Product Controls Infringement Analysis In Hatch-Waxman Framework

Posted in Patent
Last week, the Federal Circuit, in Sunovion Pharm. v. Teva Pharm. USA, et al., addressed the appropriate infringement analysis in the context of Hatch-Waxman (aka "ANDA") litigation. It held: Although no traditional patent infringement [occurs] until a patented product is made, used, or sold, under the Hatch-Waxman framework, the filing of an ANDA itself constitutes a technical infringement for jurisdictional purposes. But the ultimate infringement question is determined by traditional patent law principles and, if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue… Continue Reading

GAO Report Fails to Make it “Open Season” on Trolls

Posted in Patent
We have reported frequently in the past on IP law developments relating to so-called Nonpracticing Entities, or NPEs, including the Leahy-Smith America Invents Act's mandate that the Government Accounting Office ("GAO") conduct a study on the consequences of patent litigation by NPEs. On August 22, the GAO issued its 54-page Report, "Intellectual Property: Assessing Factors That Affect Patent Infringement Litigation Could Help Improve Patent Quality" (hereafter, "Report"). In view of the GAO's mandate, some of the Report's findings are surprising… Continue Reading

Gibbons Institute Program to Cover Biosimilars

Posted in Biotech
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… Continue Reading

Proposed Bill Seeks to Answer the Pay for Delay Debate

Posted in Pharmaceuticals
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 … Continue Reading

DNJ Rejects Double-Patenting Claim

Posted in Patent
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")… Continue Reading

District of New Jersey Stays Pay-For-Delay Cases Pending High Court’s Decision in K-Dur

Posted in Patent
Defendants in reverse-payment actions pending in the Third Circuit (New Jersey, Pennsylvania, and Delaware) take note: in In re Effexor XR Antitrust Litigation the Honorable Joel A. Pisano, U.S.D.J., of the District of New Jersey has stayed several class-action litigations challenging the legality of certain reverse-payment settlement agreements between Wyeth and generic drug manufacturer Teva Pharmaceuticals, pursuant to which Wyeth allegedly paid Teva to delay its marketing of a generic counterpart to Wyeth's Effexor XR drug… Continue Reading

FTC Petitions for Certiorari in Reverse Payments Dispute

Posted in Patent
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… Continue Reading

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

Posted in Patent
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… Continue Reading

Update – Hatch-Waxman Settlements: The FTC Regains Traction After Third Circuit Rules That Reverse Payments Violate Antitrust Law

Posted in Patent
As a follow-up to a previous article, the FTC has finally gotten an Appeals Court to take its view of reverse payments - Wile E. Coyote won this one. The FTC previously unsuccessfully attempted multiple avenues to invalidate reverse payments as part of Hatch-Waxman settlements - via the District Courts, proposed legislation, state court systems, and even the Supreme Court - but the Third Circuit has finally bitten, setting a clear circuit split… Continue Reading

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

Posted in Pharmaceuticals
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… Continue Reading

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

Posted in Pharmaceuticals
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… Continue Reading

IP Law 2012: A Look Ahead . . . .

Posted in Patent, Pharmaceuticals, Trademark, USPTO
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… Continue Reading

Federal Circuit Vacates Grant of Preliminary Injunction on Procedural Grounds

Posted in Patent, Pharmaceuticals
Last week in Warner Chilcott Labs Ireland Ltd. v. Mylan Pharms., the Federal Circuit vacated a grant of preliminary injunction in a Hatch-Waxman case by the District Court of New Jersey. The Federal Circuit acted after the lower court granted a preliminary injunction without either holding an evidentiary hearing or making any findings as to the defendants' invalidity defense… Continue Reading

The Hatch Waxman Act and Induced Infringement

Posted in Patent, Pharmaceuticals
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®… Continue Reading

The Federal Circuit Affirms in AstraZeneca v. Apotex, Finding Induced Infringement Based On Use of FDA-Mandated Labeling

Posted in Patent, Pharmaceuticals
The Federal Circuit's recent decision in AstraZeneca LP v. Apotex Inc. illustrates the tension that generic drug manufacturers may face between complying with FDA labeling requirements and avoiding trespassing on others' patent rights. In that decision, the Federal Circuit affirmed the District Court of New Jersey's ruling enjoining Apotex's "at risk" launch of a generic version of an inhaled corticosteroid for asthma patients. In short, AstraZeneca owned a method patent on once-daily dosing of the drug at issue. Although Apotex omitted all references to once-daily dosages from its product label, it was required by the FDA to include "downward titration" language that encouraged patients to reduce their daily intake of the drug to the lowest dose that provides a beneficial effect. AstraZeneca argued that this language induced patients to infringe its method patent, and the court agreed… Continue Reading

Southern District of New York Denies Request for Advance Notice of an at Risk Launch

Posted in Patent, Pharmaceuticals
Recently, the U.S. District Court for the Southern District of New York ruled that a generic drug manufacturer may not be required to provide advance notice to the innovator of their intent to launch at-risk a competing product. This decision is noteworthy in that it contrasts with the practice in the District Court of New Jersey where at least one generic company has been ordered to provide advance notice to the brand companies of an impending at-risk launch… Continue Reading
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