The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.[1],[2],[3]  The treatment costs for patients administered biologic drugs are very high relative to historic drug prices.  The one year average treatment costs for patients ranges from $20,000 – $30,000[4], but can be as much as $100,000 per…

In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes. On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in IPR2017-01884, holding invalid all claims of U.S. Patent No. 8,679,487 (“the ’487 patent”) assigned to Immunex. The ‘487 patent is drawn to an isolated “human antibody” that binds to the human interleukin-4 (IL-4) receptor in competition with a reference antibody defined…

The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of carvedilol. The case concerned GSK’s United States Patent No. 4,503,067 (“the ’067 patent”) and Reissue Patent No. RE40,000 (“the ’000 patent”). The ’067 patent covers carvedilol and related compounds, and expired March 5, 2007.  The…

Updated October 12, 2020 FDA has only approved two biosimilars in 2020. No biosimilars have launched in the U.S. since April 2020. EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin® (trastuzumab) biosimilars. As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales for the top ten branded…

Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®. As explained in the petition, Immunex was the first to make etanercept, the tumor necrosis factor (TNF) receptor fusion protein that is the active ingredient in Enbrel® (used to treat chronic inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis). Immunex launched Enbrel® in 1998 and its…

Pharmaceutical companies Biocon Biologics and Mylan announced at the end of last month the U.S. launch of their long-acting insulin glargine product Semglee.  Semglee was approved in June as an equivalent to Sanofi’s reference product insulin glargine, Lantus. The companies are launching Semglee at a “65% discounted list price,” calling it the lowest wholesale acquisition cost for any long-acting insulin glargine on the market. Mylan, the distribution partner, is offering Semglee at the wholesale acquisition…

Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in the United States.  This partnership aims to combine Teva’s long-standing commercial presence and extensive infrastructure in the U.S. market with Alvotech’s scientific experience and state-of-the-art biologics manufacturing. Under the agreement, Alvotech will be responsible for the development, registration, and supply of the biosimilars, while Teva…