Federal Circuit Reverses Patent Ineligibility Finding at Pleading Stage in Natural Alternatives
In Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, the Federal Circuit reversed the decision of the United States District Court for the Southern District of California, which had held that a series of patents owned by Natural Alternatives International, Inc. (“Natural Alternatives”) were directed to laws of nature and lacked an inventive concept sufficient to render them patent eligible under 35 U.S.C. § 101.…
Assertio therapeutics announces favorable NUCYNTA® patent ruling
LAKE FOREST, Ill., March 28, 2019 (GLOBE NEWSWIRE) — Assertio Therapeutics, Inc. (NASDAQ: ASRT) today announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Assertio with respect to the company’s patent litigation against three filers of Abbreviated New Drug Applications (ANDAs) for the NUCYNTA® franchise. The Federal Circuit’s ruling affirms the decision of the United States District Court (D.N.J.), which found U.S. patent No. 7,994,364 (the ‘364 Patent) to be valid and infringed by the defendants. The ‘364 Patent covers the entire NUCYNTA® franchise until December 2025….
Teva Wins Patent Case Related to Orexo Opioid-Treatment Drug
A U.S. jury on Friday rejected a claim by Sweden’s Orexo AB that two generic opioid-addiction treatments created by Teva Pharmaceutical Industries Ltd. infringed a patent for Orexo’s biggest drug, Zubsolv. A Teva unit had created copies of the drugs Suboxone and Subutex, which are made by a third company, Indivior Plc, which wasn’t party to the lawsuit. Orexo had argued that the Teva products used the same essential formula as that covered by the patent for Zubsolv. After a trial in Wilmington, Delaware, federal court jurors disagreed….
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified
On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA, a metformin formulation: Valeant Canada v Generic Partners Canada, 2019 FC 253…..
C-443/17 – Abraxis CJEU Judgement
The CJEU has today handed down judgment in the case C-443/17 (Abraxis Bioscience), link here (English version). Thank you to Andrew Hutchinson and Nicholas Fischer of Simmons & Simmons for providing some commentary on the decision. The CJEU’s full answer is as follows:
“Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.”
Higher Regional Court Düsseldorf, 15 March 2019, docket no. I-2 U 62/18 – (Ezetimibe/Simvastatin)
On March 15, 2019 the Higher Regional Court Düsseldorf finally dismissed MSD’s request for a preliminary injunction based on their SPC for ezetimibe and simvastatin and thereby confirmed the result of the first instance decision of the Regional Court Düsseldorf of October 2018. The facts and background of the case, including the course of the proceedings before the Regional Court Düsseldorf, have already been reported on the EPLAW blog previously here….
Celgene settles Revlimid patent dispute with Alvogen
Celgene has settled its patent infringement litigation with would-be generic competitor Alvogen Pine Brook, LLC related to top seller Revlimid (lenalidomide). Under the terms of the settlement, Alvogen will be licensed to sell volume-limited amounts of generic lenalidomide in the U.S., assuming the FDA nod on its ANDA, on an undisclosed date after the March 2022 date the company previously granted to Natco. Alvogen will be able to sell its offering without restrictions beginning January 1, 2026.
Impax Blocked Access to Generic Version of Endo Drug, FTC Finds
Impax Laboratories LLC prevented access to a generic version of Endo Pharmaceuticals’ opioid pain reliever in an unlawful reverse payment scheme, the Federal Trade Commission announced March 29. Impax entered into an agreement with Endo, which is the brand maker of Opana ER, to block a generic version of the drug. Opana is an extended-release pain reliever. Its generic is called oxymorphone ER. The FTC sued Impax for allegedly accepting more than $100 million to delay its release of a…
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