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IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: Life Sciences

The FDA Releases New Draft Guidance for Demonstrating Biosimilarity

Posted in Biotech
On May 13, the Food and Drug Administration released a new draft guidance on the data needed to establish that a proposed therapeutic biological product is biosimilar to an approved reference product. This new guidance gives sponsors a roadmap, detailing the procedures needed to demonstrate biosimilarity between a proposed drug candidate and a reference product, and highlighting the types of data needed to support such a demonstration… 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

Big Pharma Mutating from Small Molecules into Biotech Drugs

Posted in Biosimilars, Biotech
According to the Tufts Center for the Study of Drug Development, the pharmaceutical industry, particularly Big Pharma, has decidedly changed course, shifting its R&D focus away from small molecule drugs towards biotech products. Such biotech products are muscling out small molecules' prior domination of the top 10 drug product sales. For example, in 2012, biotech products accounted for 71% of the revenues generated by the world's top selling biopharmaceutical products. This remarkable growth mirrors the successful evolution of biotech research over the last three decades. Drilling down further, the Tufts Report notes that monoclonal antibody (mAb) biotech products saw the largest increase in growth over the last decade and now account for almost 60% of the biotech products being clinically developed by the largest pharmaceutical companies… Continue Reading

California Moves to Limit Biosimilar Substitution

Posted in Biotech
California Senate Bill 598, which would prohibit pharmacists from substituting biosimilars for a prescribed biologic, unless the biosimilar is an interchangeable product which would not need physician consent or if the biosimilar exceeds the cost of the brand-name drug, recently passed the California State Assembly by a vote of 58-4. The bill which has since passed the Ca. State Senate by a vote of 30-2 has yet to be signed into law by Governor Jerry Brown and has prompted extensive lobbying efforts both in support of and against its passage… 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

Obama Administration’s Latest Crackdown on Patent Trolls

Posted in Patent
We have recently posted on various developments relating to the surge of litigations involving non-practicing entities, or patent assertion entities, also called "patent trolls." Last week, the Obama administration launched its latest attack on these litigious parties. Last Tuesday, the President issued seven legislative recommendations and five executive orders aimed to reduce the number of patent troll cases being filed in federal court. Those recommendations and orders can be found at the White House's website… 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

NJ Seeks Partner to Create Life Sciences/Healthcare IT Accelerator

Posted in New Jersey High Tech Business Development
The New Jersey Economic Development Authority (EDA) has announced its search for a private partner to manage the launch of a Life Sciences/Healthcare IT Accelerator. According to yesterday's EDA Press Release, New Jersey is looking for a business partner to oversee the Accelerator, whose goal is to use the region's business acumen to engender innovation and entrepreneurship. This announcement follows the recent enactment of the New Jersey Angel Investor Tax Credit Act, an investment stimulus measure for high tech start ups that provides investment incentives for "angel investors."… 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

New Jersey Law to Stimulate High Tech Investment

Posted in High Technology
This past week, Governor Christie signed into law S. 581, entitled the "New Jersey Angel Investor Tax Credit Act." The new law is designed to stimulate investment in New Jersey's high tech start ups by providing investment incentives for "angel investors."… 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 Takes on Myriad

Posted in Patent
As anticipated, the Supreme Court has granted certiorari in Association for Molecular Pathology v. Myriad Genetics, et al. (the "Myriad" case) to review the Circuit Court's opinion. The Court previously granted certiorari to vacate and remand the Federal Circuit's Myriad decision for reconsideration in view of the Court's 2012 decision in Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc. ("Mayo"). Notwithstanding Mayo, the Federal Circuit reached the same result on remand as its initial decision… 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

Wrigley v. Cadbury: Judge Newman Emphasizes Commercial Success and Copying

Posted in Patent
In WM. Wrigley Jr. v. Cadbury Adams USA, a recent Court of Appeals for the Federal Circuit decision related to chewing gum patents, Wrigley brought suit against Cadbury for infringement of its U.S. Patent Number 6,627,233 ("the '233 patent") claiming a chewing gum including a combination of menthol and a physiological cooling agent, WS-23. Cadbury counterclaimed against Wrigley for infringement of Cadbury's U.S. Patent Number 5,009,893 ("the '893 patent") claiming a chewing gum including menthol and a similar cooling agent entitled WS-… 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

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
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