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.
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.
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.
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.
In Norman IP Holdings, LLC v. Lexmark Int’l, Inc., a recent Eastern District of Texas decision, Chief District Judge Leonard Davis provided guidance on the application of Fed. R. Civ. P. 20 (“Rule 20”) joinder and Fed. R. Civ. P. 42 (“Rule 42”) consolidation in patent infringement cases post-enactment of the Leahy-Smith America Invents Act (“AIA”). Norman IP brought suit against Lexmark and others on September 15, 2011, one day before the AIA was signed into law. Norman IP later added an additional 23 defendants. The defendants filed a motion to dismiss for improper joinder or to sever, and Norman IP alternatively requested that any severed cases be consolidated under Rule 42. The Court granted defendants’ motion to sever and issued an order consolidating the cases for pretrial issues excluding venue.
According to a press release from the Governor’s office, a recent review issued by Business Facilities magazine reported that New Jersey jumped eight positions to rank second for biotechnology strength among U.S. states. Some of the factors cited as responsible for this improvement include increases in R&D tax credits (from 50% to 100%) and the adoption of a new single sales factor formula for corporate tax liability, which will reduce company costs.
Gibbons is proud to once again sponsor lunch at the Rutgers Business School’s Blanche and Irwin Lerner Center for Pharmaceutical Management Studies Program on Thursday, April 26, and Friday, April 27, at Rutgers Business School – Newark, One Washington Park, Room 1027, 10th Floor.
On Monday, the United States Supreme Court granted certiorari in the well-publicized Assn. For Molecular Pathology v. Myriad Genetics, et al. case (“Myriad”) for the purpose of vacating the underlying Federal Circuit decision — finding isolated DNA sequences from human genes as patentable subject matter — and remanding the case for reconsideration in view of its recent ruling in Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc. (“Mayo”).
Gibbons P.C. will once again sponsor lunch at the upcoming Rutgers University/Blanche and Irwin Lerner Center for Pharmaceutical Management Studies Program on Thursday, October 27, from 12:00 – 1:00 pm at Rutgers Business School – Newark.
The Federal Circuit’s Myriad Genetics decision, Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, 99 U.S.P.Q. 2d 1938 (Fed. Cir. 2011), which invalidated most of the method claims in the patents at issue, brings to mind a concern about the value of method claims, particularly to the pharmaceutical industry. The Myriad Genetics patents at issue included two types of method claims relating to human genetics: one involved determining whether a female patient had abnormal BRCA1/2 genes by comparison of BRCA1/2 gene and BRCA 1/2 RNA from the patient’s tumor sample to those from a non-tumor sample; the second was an activity screening method for anticancer drugs that compared the growth of a host cell transformed with a cancer-causing BRCA gene in the presence and absence, respectively, of the test compound.