IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: Hatch Waxman

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

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

Mutual Pharmaceutical Co., Inc. v. Bartlett

Posted in Pharmaceuticals
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 … 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 … 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

Supreme Court to Examine Pay-For-Delay Settlements

Posted in Patent
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… 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

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

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

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

Posted in Intellectual Property, Patent
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… 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 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

Biosimilars: Data Exclusivity and the “Patent Protection Gap”

Posted in Biotech, Patent, Pharmaceuticals
Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor's drug application relying on the innovator's data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the "patent protection gap."… Continue Reading

Hatch-Waxman Settlements: Under Attack on Many Fronts

Posted in Patent, Pharmaceuticals
Is an end coming for reverse payment settlements of Hatch-Waxman litigations? The FTC, like Wile E. Coyote chasing The Road Runner, has been doggedly challenging settlements between brand name pharmaceutical companies and generics to resolve Hatch-Waxman litigations. Reverse payments settlements, which the FTC calls "pay-for-delay" deals, where Hatch-Waxman litigations are settled by the brand name drug company's payment to the generics to stay off the market, have been the main target of the FTC since the late 1990's. The FTC's position is that reverse payments impermissibly thwart less expensive generic drugs from timely reaching consumers. While there is a circuit court split on the issue, the recent trend of courts, including the Federal Circuit, has been that reverse payments are acceptable because they are "within the exclusionary zone of the patent and thus [cannot] be redressed by federal antitrust law." In re Ciprofloxacin ("Cipro") Hydrochloride Antitrust Litig., 544 F.3d 1323, 1327 (Fed. Cir. 2008), cert. denied 129 S. Ct. 2828 (2009)… Continue Reading
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