IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: Biotech/Biotechnology

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

First Biosimilars Ruling is Out … Industry, Take Heed!

Posted in Biosimilars
In a decision of first impression, Judge Maxine M. Chesney of the Northern District of California dismissed Sandoz's declaratory judgment action against Amgen for lack of jurisdiction. Sandoz had brought its suit on June 24, 2013 seeking a ruling that its biosimilar version of Amgen's patented arthritis drug Enbrel (etanercept) would not infringe and that the patents are invalid. Amgen moved to dismiss the case for lack of subject-matter jurisdiction or, alternatively, to decline to exercise Declaratory Judgment jurisdiction.… 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

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

Jersey Strong: Biotech’s Continuing Strength in New Jersey

Posted in Biotech
According to a recent e-mail alert by BioNJ, some of the top Biotechnology and Pharmaceutical companies in the world call New Jersey home, just as other Life Sciences and high tech businesses continue to move into the Garden State. As a corollary, New Jersey boasts one of the top ten regions for recent STEM graduates to work, and venture capital investing in the technology sector grew in the second quarter of 2013.… 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 FDA.… 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

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

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

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

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