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.
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.
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.
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.
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.
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.
Gibbons Institute of Law, Science & Technology Files Amicus Brief in “Pay-for-Delay” Case Before Supreme Court
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.
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.”
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.” The law provides credits against corporation, business and gross income taxes for investing in New Jersey’s emerging technology businesses, including: advanced computing; advanced materials; biotechnology; electronic devices; information technology; life sciences; and mobile communications, among others. Angel investors in these start-ups will be eligible for tax credits equal to 10 percent of their investments, up to a maximum allowed credit of $500,000 for the tax year. Other criteria for the start-ups require that they employ fewer than 225 employees, 75 percent of whom must work in New Jersey. The overall program has an annual cap of $25 million.
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”).