IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: ANDA

New Jersey Follows Federal Circuit in Finding Jurisdiction Over Hatch-Waxman Defendants

Posted in Patent, Pharmaceuticals
We recently reported on the Federal Circuit’s holdings in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and AstraZeneca AB v. Mylan Pharm., Inc., where it held that Mylan was subject to jurisdiction in Delaware because “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.” Earlier this month, the first decision from the District of New Jersey District applying the Federal Circuits ruling was rendered. In Helsinn Healthcare S.A., et al. v. Hospira, Inc., No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. April 5, 2016), Judge Mary L. Cooper held that sufficient minimum contacts is to find specific jurisdiction is established by the fact that Hospira filed an ANDA seeking to market a generic version of Helsinn’s Aloxi® product that if approved, the marketing of will take place in New Jersey.… Continue Reading

Interesting Trends in Establishing Personal Jurisdiction in Hatch-Waxman/ANDA Litigations

Posted in Patent, Pharmaceuticals
Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.… Continue Reading

Need to Construe “Plain and Ordinary Meaning”?

Posted in Patent, Pharmaceuticals
In 2005, the Federal Circuit established the framework for the construction of patent claim terms. In its landmark holding in Philips v. AWH Corp., the Federal Circuit stated that “words of a claim ‘are generally given their ordinary and customary meaning . . . [and] that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art . . . ."… Continue Reading

The Patient Survives: Third Party Challenge to PTO Revival of Patent Application Barred under the Administrative Procedures Act

Posted in Patent
The Federal Circuit Court of Appeals recently held that a third party may not challenge a decision by the United States Patent and Trademark Office (“PTO”) to revive an application under the Patent Cooperation Treaty and enabling statutes (“PCT”) through the Administrative Procedures Act (“APA”). See Excela Pharma Sciences, LLC v. Lee, No. 13-1206 (Fed. Cir. Mar. 26, 2015). In combination with the Federal Circuit’s prior holding in Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 543 F.3d 657 (Fed. Cir. 2008), this holding puts such decisions beyond the reach of third parties, whether affirmatively attacked under the APA or defensively raised in a later infringement action.… Continue Reading

Heightened Pleading in Patent Complaints to Frustrate Trolls – Exception for Hatch-Waxman/ANDA Cases

Posted in Patent
All branches of government have worked to decrease frivolous litigation by non-practicing entities (“NPEs”), or patent trolls, in order to both encourage developing technology and allow businesses to utilize that technology without a looming threat of disruptive and costly litigation. In the course of our coverage of these efforts, we have seen state and federal legislative bodies, as well as the United States Patent and Trademark Office (“USPTO”), the executive branch, and the courts, suggesting potential solutions. Congress is currently weighing a revamped version of House Judiciary Committee Chairman Bob Goodlatte’s Innovation Act bill, which seeks to reform patent litigation by focusing on pleading standards.… Continue Reading

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

Posted in Pharmaceuticals
In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..… Continue Reading

Heartburn Relief: AstraZeneca Wins Nexium Antitrust Trial

Posted in Patent
On December 5, 2014, an 11-person jury decided in favor of defendants AstraZeneca PLC and Ranbaxy Laboratories, Inc. in the first pay-for-delay class action trial since the United States Supreme Court in FTC v. Actavis, Inc. opened the door on antitrust suits based on patent settlements. Teva Pharmaceutical Industries, Ltd. was also defending the suit before reaching a settlement shortly before the trial ended. United States District Court Judge William Young of the District of Massachusetts last year permitted certification for the class members, including union health plans and insurance companies, based on an alleged injury of supracompetitive prices for AstraZeneca’s brand name heartburn drug, Nexium®.… Continue Reading

NJ District Courts Bar Defendants’ Indefiniteness Argument During Claim Construction Because Not Alleged in Invalidity Contentions

Posted in Patent
We previously reported that New Jersey District Court Judges will limit a patent infringement defendant’s discovery to the claims and defenses identified in its Invalidity Contentions served under Local Patent Rule 3.3. For the same reasons, a defendant may be barred from taking certain positions during claim construction. In an opinion issued last week, Judge Jose L. Linares held in Auxilium Pharmaceuticals, Inc. & FCB I LLC v. Watson Laboratories, Inc., No. 12-3084 (JLL) that a defendant that does “not raise an indefiniteness defense in its invalidity contentions . . . cannot seek a determination that the patents-at-issue are invalid for indefiniteness through claim construction.”… Continue Reading

It Ain’t that Obvious to Try

Posted in Patent, Pharmaceuticals
In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.… Continue Reading

Complaint Means Complaint For Purposes of Triggering the Time Bar Under 35 U.S.C. § 315(b)

Posted in Patent
The United States Patent Trial and Appeal Board ("PTAB") recently interpreted what constitutes a "trigger" under 35 U.S.C. § 315(b). The PTAB concluded that under the statute, a "complaint alleging infringement of the patent" does not include arbitration proceedings.… Continue Reading

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

Posted in Pharmaceuticals
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.… 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 FTC.… Continue Reading

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

Posted in Pharmaceuticals
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.… 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

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

Posted in Patent
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.… 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
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