As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…
Lannett has announced that it will meet with the FDA on June 9, 2020, to “plan next steps for the clinical advancement of” its insulin glargine biosimilar product. According to the press release, “[i]nsulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as…
We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December 2-6, 2019, the U.S. District Court of New Jersey found U.S. Patent No 9,526,844, a pen-type injector…
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological products will be “deemed to be a license” as if approved under BLAs as of March…
This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…
On June 5, 2019, Lannett Company, Inc. announced they would begin human clinical trials for an insulin glargine biosimilar. According to Lannett’s press release, “[i]nsulin glargine is a long-acting insulin used to regulate the blood sugar of adults with Type 2 Diabetes, as well as adults and pediatric patients with…
Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …
Yesterday, December 12, 2018, the Board issued Final Written Decisions finding Claims 1-25 of U.S. Patent No. 7,476,652 (IPR2017-01526) and Claims 1-20 of U.S. Patent No. 7,713,930 (IPR2017-01528) unpatentable as obvious over the prior art. IPR2017-01526 and IPR2017-01528 were two of a number of IPR petitions filed by Mylan against…
As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement based on Merck’s proposed follow-on versions of Sanofi’s Lantus® and Lantus® SoloSTAR® ([rDNA origin]…