Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex moved to stay the litigation pending resolution of two IPR proceedings the PTAB instituted on February 15, 2018 (IPR2017-01879 and IPR2017-01884) regarding the sole asserted patent: U.S. Patent No. 8,679,487….
Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims of the ’115 patent, which is directed to methods for treating cancer in a patient comprising administering an effective amount…
Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe. Ontruzant® is a biosimilar of Roche’s Herceptin® and is approved to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer. This launch follows…
Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents. First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc. These IPRs sought to challenge U.S. Patent Nos. 8,911,737 and 8,974,790, respectively, both owned by AbbVie Biotechnology Ltd., and…
We previously reported on the announced agreement to enter into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). As previously announced, the final version of the CPTPP suspended all of the biologics provisions (Article 18.51) that appeared in the TPP. According to past reports, the biologics provisions were heavily…
Yesterday, Senator Tom Cotton (R-Arkansas) announced the introduction of proposed legislation, Preserving Access to Cost Effective Drugs Act, which would permit the Patent and Trademark Office and the International Trade Commission to review patents regardless of any claim of tribal sovereign immunity made as part of sham transactions. The announcement explained…
Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C. In his speech, Commissioner Gottlieb highlighted a 2017 study by QuintilesIMS that observed significant cost savings and dramatically expanding patient access in the EU from biosimilars…
Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441 patent has claims directed to methods of treating a malignant progressing tumor or cancer characterized by overexpression of ERBB2 receptor. IPR2017-02063…
Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea. Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…
South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product. According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the biosimilar must be “interchangeable” with the prescribed biological product under 42 U.S.C. § 262(k)(4) to qualify…