LifeScan Global Corporation Prevails in PGR
The Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision in favor of our client, LifeScan Global Corporation, denying Patent Owner’s Motion to Amend and invalidating US. Patent No. 9,976,125. The ‘125 Patent is directed towards a biosensor for blood sugar monitoring, common in diabetes management, that uses flavin adenine dinucleotide conjugated glucose dehydrogenase (FAD-GDH) to determine the presence of glucose by a pH change. After the Petition requesting post grant review of claims 1-10 was filed and before institution, the Patent Owner disclaimed claims 1-7, 9 and 10. Patent Owner then attempted to amend the patent by cancelling claim 8, the only remaining claim, and proposing substitute claim 11. In the Final Written Decision, the Board found Patent Owner’s proposed substitute claim 11 obvious over the cited art, invalidating the ‘125 Patent. The case is LifeScan Global Corporation v. Ikeda Food Research, Ltd. et al., Case No. PGR2019-00032, Paper No. 38 (August 12, 2020).
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.
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).
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).
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 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).
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.
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).
PTAB Institutes Trial on Two IPR Petitions filed by Lerner David on behalf of Amneal
In two related Decisions issued in favor of Lerner David client Amneal Pharmaceuticals, the Patent Trial and Appeal Board instituted Inter Partes Review on three grounds challenging U.S. Patent No. 9,060,976, listed in the Orange Book for OxyContin® (oxycodone HCl).
Lerner David Succeeds in Having IPR Instituted on Behalf of MVG, Inc.
On October 12, 2016, Lerner David received a decision from the Patent Trial and Appeal Board instituting Inter Partes Review on behalf of MVG against an ETS-Lindgren patent (IPR2016-00879). The patent, U.S. Patent No. 8,331,869, generally relates to complex radiation pattern measurements for testing the radiated performance of wireless devices. The Board found that MVG had made a showing that all challenged claims of the patents were either anticipated or obvious in light of the prior art. Indeed, the Board decided that the IPR should be instituted on all seven different grounds requested by MVG, including different combinations of prior art against many of the same claims.
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 Denies Petition for IPR of Lambeth Magnetic Structures
In a decision in favor of Lambeth Magnetic Structure, the Patent Trial and Appeal Board denied TDK Corporation’s request for Inter Partes Review of U.S. Patent 7,128,988 (IPR2016-00013). The ‘988 patent relates to magnetic structures used in devices such as memories. In its decision on April 12, 2016, the Board decided that TDK had not met its burden to show a reasonable likelihood that TDK would prevail with respect to at least one challenged claim. Instead, the Board ruled in Lerner David’s and Lambeth’s favor in finding that the petitioner provided insufficient evidence to show certain claim limitations were taught or suggested by the prior art.
Lerner David Succeeds In Instituting IPRs On Behalf Of Sony
On December 25, 2015 and January 4, 2016, Lerner David received decisions from the Patent Trial and Appeal Board instituting Inter Partes Review on behalf of Sony Corporation against two Imation patents. The patents, U.S. Patent Nos. 6,908,038 and 6,890,188, are directed to multi-connector portable memory cards. The Board found that Sony had made a showing that all challenged claims of the patents were either anticipated or obvious in light of the prior art. The Board’s institution of IPRs follows Lerner David success in obtaining a stay of related district court proceedings involving the same patents. Imation sued Sony in the District of Minnesota in 2014, alleging that Sony’s MicroVault Smartphone USB Flash Drive infringed both the ‘038 and ‘188 Patents. Following initial contentions, early discovery and the filing of the two IPR petitions, the case was stayed, allowing invalidity issues at the heart of the case to be litigated in the PTAB, with its favorable burden of proof and claim construction standards. The PTAB cases are Sony Corp. v. Imation Corp., Case No. IPR2015-1556, Paper No. 8 (Dec. 29, 2015) and Sony Corp. v. Imation Corp., Case No. IPR2015-1557, Paper No. 7 (Jan. 4, 2016).
Lerner David Successful in Early IPR
Lerner David filed one of the initial Inter Partes Review ("IPR") back in November 2012. On May 1, 2014 the Patent Office Patent Trial And Appeal Board ruled in favor of our client, St. Jude Medical, Cardiology Div., Inc. in IPR 2013-00041. The IPR had been filed by St. Jude against the patent owner, The Board of Trustees of the University of Michigan, regarding U.S. Patent No. 5,746,775. St. Jude was a licensee of the ‘775 Patent. The Board’s decision found that St. Jude had met their burden of proof in establishing that all of the claims of the ‘775 Patent which were the subject of the IPR were invalid on the basis of obviousness over the prior art. That decision was then appealed, but resulted in an advantageous settlement on the part of St. Jude. The entire process resulted in a net savings of substantial amounts by St. Jude.
Lerner David Charges Forward in IPR
On January 27, 2014, Lerner David won a complete victory for our client, LG Chem, in an Inter Partes Review filed by Ube Maxell Co., Ltd. against LG Chem's U.S. Patent No. 7,709,152. Ube Maxell challenged the '152 Patent as anticipated and obvious on more than six different grounds. The Patent Trial and Appeal Board relied on Lerner David's arguments in a Preliminary Response as to why Ube Maxell's prior art references were deficient to show unpatentability of LG Chem's ‘152 Patent. Accordingly, the PTAB denied Ube Maxell's petition as to all challenged claims and ordered that no IPR trial be instituted.