The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of lower cost generics or biosimilars. Currently some branded companies are using safety requirements, including restricted…
On March 19, 2018, Novartis and Grifols sued Regeneron in the Southern District of New York, asserting that Regeneron’s manufacture of its EYLEA® and ZALTRAP® products infringes U.S. Patent No. 5,688,688. Previous cases in which Novartis asserted the ’688 patent against MedImmune, Biogen, and Alexion have all been concluded.
A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication regimen, which is due in part to high drug costs. This, in turn, “is…
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…