Weekly Patent Litigation Roundup

Weekly Patent Litigation Roundup

Amgen Wins Patent Case On Enbrel® (etanercept)

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen’s favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz). Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz’s challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid.…
Novartis Pharma A.G., Novartis Pharmaceutical AG and Novartis AG v. TEVA Nederland B.V., District Court The Hague, The Netherlands, Judge in Interlocutory Proceedings, 5 July 2019, Case No. ECLI:NL:RBDHA:2019:7792

Teva holds a Dutch marketing authorization for the generic version of everolimus, named Everolimus Teva. In the SmPC and and the Patient Information Leaflet of Everolimus Teva, it is stated that everolimus in combination with exemestane is indicated for the treatment of hormone receptor positive advanced breast cancer. Novartis invokes EP 603 and EP 246 and requests an injunction against Teva for medicines containing everolimus that are indicated for hormone receptor positive advanced breast cancer, or -alternatively-, that Teva is ordered to remove the indication hormone receptor positive advanced breast cancer from the marketing authorization. The injunction is denied as the PI judge rules that there is a real and serious chance that the invoked patents will be held invalid in proceedings on the merits (or in opposition / appeal proceedings at the EPO) as it is sufficiently plausible that the man skilled in the art would have tried the combination of everolimus and exemestane / aromatase inhibitor with the expectation that this would work in treating breast cancer…
Gilead loses key patent claims for Sovaldi in China, opening door to earlier generic entry

A partial patent invalidation by Chinese authorities has shaken the case Gilead has been building for its hep C star Sovaldi by removing a key barrier to generic entry. The decision means knockoffs of the highly effective hep C treatment can arrive as early as next year — rather than 2024, when the patent was originally set to expire — according to the Initiative for Medicines, Access, and Knowledge, or I-MAK. I-MAK filed one of the two requests for patent invalidation cited in the ruling, together with Chinese drugmaker Fujian Cosunter Pharma.…
Akebia Therapeutics® Announces Settlement of Auryxia® Patent Litigation with Par Pharmaceutical

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced that its wholly-owned subsidiary, Keryx Biopharmaceuticals, Inc., and its licensor Panion & BF Biotech, Inc., have entered into a Settlement and License Agreement (Agreement) with Par Pharmaceutical, Inc., an Endo International company (Par). This settlement resolves patent litigation brought by Keryx and Panion in response to Par’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Auryxia (ferric citrate) tablets prior to the expiration of the applicable patents. Pursuant to the terms of the Agreement, the companies will grant Par a license to market its generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature…
Allergan to pay $2.7m to settle antitrust suit over Asacol

A subsidiary of Irish pharmaceutical company Allergan is to pay a combined total of $2.7 million to three organisations that were part of an antitrust class against the drugmaker…
Alkermes Grants Amneal Generic Rights for Vivitrol

Irish drugmaker Alkermes has entered into a settlement and license agreement with American generics company Amneal in order to end the generics maker’s inter partes review of a Vivitrol (naltrexone for extended-release injectable suspension) patent. The deal wraps up Amneal’s challenge of the patent and grants the company the non-exclusive right to manufacture and market a generic version of the narcotic and alcohol addiction treatment in the U.S. “sometime in 2028 or earlier under certain circumstances,” Alkermes said. While there are additional terms to the agreement, they remain confidential. Alkermes’ patent in question is set to expire in 2029.…

https://www.fdanews.com/articles/192221-alkermes-grants-amneal-generic-rights-for-vivitrol

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