PTAB Institutes Trial on IPR Petition filed by Lerner David on behalf of Amneal
In companion Decisions issued in favor of Lerner David client Amneal Pharmaceuticals, the Patent Trial and Appeal Board instituted Inter Partes Review on three grounds against all challenged claims of U.S. Patent No. 9,034,376, listed in the Orange Book for OxyContin® (oxycodone HCl). These Institution Decisions follow a pair of decisions issued by the PTAB in November 2016 against a different listed patent.
Lerner David Invalidates Key Prasugrel Patents Before PTAB on Behalf of Dr. Reddy’s Laboratories
In two Final Written Decisions entered by the Patent Trial and Appeal Board, Lerner David attorneys prevailed in invalidating all challenged claims of two Orange Book-listed patents directed to Effient® (prasugrel). Lerner David was one of five firms representing a total of 20 named generic pharmaceutical Petitioners in two related Inter Partes Reviews. These decisions pave the way for the prevailing generics to launch their products as early as October 14, 2017.
PTAB Institutes Trial on IPR Petition filed by Lerner David on behalf of Luye Pharma
In a Decision issued in favor of Lerner David clients Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Shandong Luye Pharmaceutical Co., Ltd., and Nanjing Luye Pharmaceutical Co., Ltd. the Patent Trial and Appeal Board instituted Inter Partes Review of all challenged claims of U.S. Patent No. 6,667,061, listed in the Orange Book for Risperdal®CONSTA® (risperidone).
Amneal and Kashiv Prevail in Two IPRs Invalidating OxyContin® Patent
In a pair of companion cases dated November 8, 2017, the Patent Trial and Appeal Board ("PTAB") issued Final Written Decisions in favor of Lerner David clients Amneal Pharmaceuticals, LLC and Kashiv Pharma, LLC finding unpatentable the asserted claim of U.S. Patent No. 9,060,976. The '976 Patent is listed in the Orange Book for OxyContin® (oxycodone HCl), the blockbuster opioid analgesic marketed by Purdue Pharma, and is one of twelve patents currently asserted against Kashiv's ANDA directed to its own abuse-deterrent formulation of oxycodone. The PTAB held the '976 Patent invalid on all three instituted grounds. The cases are Amneal Pharmaceuticals, LLC v. Purdue Pharma, L.P. et al., Case No. IPR2016-01027, Paper No. 48 (Nov. 8, 2017) and Amneal Pharmaceuticals, LLC v. Purdue Pharma, L.P. et al., Case No. IPR2016-01028, Paper No. 47 (Nov. 8, 2017).
Federal Circuit Affirms PTAB Decisions Holding Prasugrel Patents Invalid
In a Rule 36 affirmance entered just two days after oral argument, the United States Court of Appeals for the Federal Circuit entered judgment upholding two decisions by the Patent Trial and Appeal Board finding invalid all claims of two Orange Book-listed patents directed to Eli Lilly’s blood thinner Effient® (prasugrel). Lerner David represented Dr. Reddy’s Laboratories in the two Inter Partes Reviews before the PTAB and in the consolidated appeals to the Federal Circuit. The appeals are Daiichi Sankyo Company, Ltd. et al. v. Accord Healthcare Inc., USA et al., Nos. 2017-1052, 2017-1053 (Dec. 12, 2017).
Amneal and Kashiv Prevail, Again, in Invalidating Additional OxyContin® Patent
In a Final Written Decision issued in favor of Lerner David clients Amneal Pharmaceuticals, LLC and Kashiv Pharma, LLC, the Patent Trial and Appeal Board ("PTAB") held all challenged claims of U.S. Patent No. 9,034,376 invalid. The '376 Patent is directed to a sustained release formulation of oxycodone HCl, marketed by Purdue Pharma as OxyContin®, and is one of twenty patents that Purdue has asserted against Kashiv's ANDA directed to its own abuse-deterrent formulation of oxycodone. The case is Amneal Pharmaceuticals, LLC v. Purdue Pharma, L.P. et al., Case No. IPR2016-01413, (Jan. 17, 2018).
Kashiv and Amneal Prevail in Fourth IPR, Invalidating All Challenged Claims of OxyContin® Patents
In a Final Written Decision issued in favor of Lerner David clients Kashiv Pharma, LLC and Amneal Pharmaceuticals, LLC, the Patent Trial and Appeal Board ("PTAB") held all challenged claims of U.S. Patent No. 9,034,376 invalid on both asserted grounds. The '376 Patent is directed to a sustained release formulation of oxycodone HCl, marketed by Purdue Pharma as OxyContin®, and is one of twenty patents that Purdue has asserted against Kashiv's ANDA directed to its own abuse-deterrent formulation of oxycodone. This marks the fourth IPR win for Kashiv against this family of patents. Collectively, Lerner David has prevailed in all six grounds asserted over four IPRs. The case is Amneal Pharmaceuticals, LLC v. Purdue Pharma, L.P. et al., Case No. IPR2016-01412, (Feb. 8, 2018). The previous cases are Case Nos. IPR2016-01413, (Jan. 17, 2018), IPR2016-01027, (Nov. 8, 2017), and IPR2016-01028, (Nov. 8, 2017).
Lerner David Achieves Favorable IPR Settlement Granting Amneal Pharmaceuticals Early Market Entry for Vivitrol®
With only a few hours until a scheduled hearing before the Patent Trial and Appeal Board, Lerner David client Amneal Pharmaceuticals LLC reached a settlement with Alkermes whereby both parties agreed to seek termination. Alkermes granted Amneal a license allowing it to market a generic version of VIVITROL® (naltrexone for extended release injectable suspension) in the U.S. beginning in 2028 or earlier under some circumstances in exchange for Amneal agreeing to drop its challenge to U.S. Patent No. 7,919,499 (“the ’499 Patent”), an Orange Book-listed patent for VIVITROL®. The ’499 Patent does not expire until 2029. While the terms of the settlement are confidential, in an analysis by Nasdaq.com, Alkermes’ management was said to have “noted that Vivitrol is a complicated drug to both make and sell, so even if the company loses the patent hearing, it may be hard for makers of generics to enter the market.” You can draw your own conclusions as to Alkermes’ level of confidence in the ‘499 Patent. The case is Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited, Case No. IPR2019-00943.