Gibbons Law Alert

Gibbons Law Alert

Tagged: Life Sciences

Depending on the Circumstances, Claim Construction May Be Subject to Clear Error Review on Appeal

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Posted in Patent

On February 10, 2015

Traditionally, claim construction, which can be an important phase in patent litigation for setting the metes and bounds of a patent, has been viewed as a pure question of law and subject to de novo review by the Federal Circuit on appeal. This was considered problematic by some because the district court’s findings on claim construction, which the parties had been relying on throughout the litigation, were not given any deference on appeal.

The FDA Releases New Draft Guidance for Demonstrating Biosimilarity

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Posted in Biotech

On May 27, 2014

On May 13, the Food and Drug Administration released a new draft guidance on the data needed to establish that a proposed therapeutic biological product is biosimilar to an approved reference product.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.

It Ain’t that Obvious to Try

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Posted in Patent / Pharmaceuticals

On May 9, 2014

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.

Big Pharma Mutating from Small Molecules into Biotech Drugs

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Posted in Biotech

On November 25, 2013

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.

Rutgers Pharma MBA Program Ranked One of Best in World

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Posted in Pharmaceuticals

On October 17, 2013

Rutgers Business School’s MBA in Pharmaceutical Management was recently ranked as one of the top 10 MBA programs for Health Care/Pharmaceuticals/Biotechnology in the world, based on a survey done by Find-MBA.com. According to a press release from Rutgers, the program earned its ranking due to its success in assisting MBA grads to earn internships and jobs focused in the health care, pharmaceuticals and biotechnology industries. This was a function of the quality of the program, complemented by Rutgers Business School’s proximity to, and relationship with, top tier pharmaceutical companies and several large hospitals in the region.

California Moves to Limit Biosimilar Substitution

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Posted in Biotech

On September 25, 2013

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.

Mutual Pharmaceutical Co., Inc. v. Bartlett

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Posted in Pharmaceuticals

On July 10, 2013

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 FDA.

Obama Administration’s Latest Crackdown on Patent Trolls

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Posted in Patent

On June 10, 2013

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.

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

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Posted in Pharmaceuticals

On March 8, 2013

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. Last week, the Gibbons Institute of Law, Science & Technology, among 16 other amici, filed briefs in support of respondents and the lawfulness of these payments. The other amici included: Antitrust Economists; Bayer AG and Bayer Corp.; Health Economics and Law Professors; Mediation and Negotiation Professionals; Law Professors Gregory Dolin, Kent Bernard, et al.; The American Intellectual Property Law Association; Enavail, LLC; The Generic Pharmaceutical Association]; Intellectual Property Owners Association; Merck & Co., Inc.; National Association of Manufacturers; Pharmaceutical Research and Manufacturers of America (Phrma); New York Intellectual Property Law Association; Shire plc; Washington Legal Foundation; Generic Manufacturers Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA, Inc.; Ranbaxy Pharmaceuticals, Inc.; Mylan Pharmaceuticals Inc.; and Impax Laboratories, Inc.

NJ Seeks Partner to Create Life Sciences/Healthcare IT Accelerator

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Posted in Biotech

On February 13, 2013

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.”

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