As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more
The Court of Appeals for the Federal Circuit recently addressed the issue of “analogous prior art,” a patent law doctrine fundamental to the legal determination of whether a patent is invalid as obvious over the prior art....more
In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more
The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more
The Federal Circuit reversed a Patent Trial and Appeal Board (“Board”) decision finding the challenged claims of Sanofi-Aventis’ ’614 patent unpatentable as obvious....more
The Unified Patent Court (UPC) opened its doors on June 1, 2023. Nineteen actions were initiated during the first six weeks, across a range of subject areas and case values. It had been widely assumed that large companies...more
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more
The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged...more
Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
The Paris Court has ruled against Sanofi in the Depakine case on the class action initiated by an association. According to a parliamentary report dated 11 June 2020, only twenty-one class actions have been brought to court...more
On March 26, 2021, the PTAB issued its Final Written Decision in Mylan Pharmaceuticals, Inc. v. Sanofi-Aventis Deutschland GMBH, IPR2019-01657, which involved Sanofi’s Patent RE47,614 (“’614 patent”) relating to its LANTUS...more
Deutsche Bank to Pay Over $130 Million to Resolve Foreign Corrupt Practices Act and Fraud Allegations - Deutsche Bank Aktiengesellschaft (Deutsche Bank) has agreed to pay more than $130 million to resolve the government’s...more
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...more
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...more
The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser...more
In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more
PLAINTIFF’S DISCLAIMER OF CLAIMS FOUND INVALID BY THE PTAB MOOTED ANY CONTROVERSY BEFORE THE APPELLATE COURT ASSOCIATED WITH THAT PATENT, AND A SECOND PATENT-IN-SUIT WAS NOT INVALID BECAUSE THE DISTRICT COURT DID NOT ERR IN...more
The Federal Circuit applied the constitutional principle under Article III that there must be a case or controversy for a federal court to enter judgment (in this case, of invalidity) in ANDA litigation that can be vitiated...more
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...more
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...more
The US Court of Appeals for the Federal Circuit affirmed that inducement of infringement can be shown based on encouragement and inferred intent of infringing use from a drug label. Sanofi-Aventis U.S., LLC v. Watson Labs....more
Federal Circuit Summaries - Before PROST, WALLACH, and TARANTO. Appeal from the District of Delaware Summary: (1) A party may not avoid inducement based on “substantial non-infringing uses,” and (2) prosecution history...more
On August 8, Sanofi-Aventis filed a complaint for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s...more
Sanofi-Aventis has filed a petition for IPR of Immunex Corporation’s U.S. Patent 8,679,487, directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. The...more
Mylan has filed two petitions for inter partes review of Sanofi’s patents related to insulin glargine: IPR2017-01526 on U.S. Patent 7,476,652, and IPR2017-01528 on U.S. Patent 7,713,930. Insulin glargine is marketed under...more