Posts Tagged: "Gilead Sciences"

PGR Petition Alleges Gilead Sciences Made Inconsistent Section 112 Arguments

This past week, IPWatchdog was made aware of a petition for post-grant review (PGR) proceedings at the Patent Trial and Appeal Board (PTAB) that raises interesting arguments about allegedly inconsistent statements on patentability made during legal proceedings by pharmaceutical firm, Gilead Sciences. Filed in early August, the PGR petition from Atea Pharmaceuticals cites 35 U.S.C. § 112 arguments previously raised by Gilead in other cases to challenge the validity of Gilead’s own patent claims that were allegedly obtained to block Atea’s competing hepatitis C virus (HCV) treatments.

Gilead Wins Injunction in Counterfeit HIV Meds Case as Coons Recognizes August as National Anticounterfeiting Month

The U.S. District Court for the Eastern District of New York, in a decision published Monday, denied the defendants’ motions to vacate asset freezes in a case brought by Gilead alleging a massive HIV drug counterfeiting ring that involves “hundreds of millions of dollars’ worth” of fake medications. In January 2022, the court unsealed documents in the suit against a slew of defendants who Gilead said sold, marketed, and distributed counterfeits of its HIV medications. Gilead’s complaint sought immediate monetary and injunctive relief, including seizure at certain of the defendants’ premises, as well as relief for trademark and trade dress infringement and trademark dilution, among other alleged violations.

Court Unseals Documents in Gilead Lawsuit Alleging Massive Counterfeit HIV Drug Scheme

The U.S. District Court for the Eastern District of New York yesterday unsealed documents in an anticounterfeiting suit filed last year by Gilead Sciences, Inc. against a slew of defendants who Gilead alleges sold, marketed, and distributed counterfeits of its HIV medications. Gilead’s complaint seeks immediate monetary and injunctive relief, including seizure at certain of the defendants’ premises, as well as relief for trademark and trade dress infringement and trademark dilution, among other alleged violations…. According to the unsealed complaint and motion for relief, the accused companies sold “authentic-looking bottles of Gilead HIV and other medication to distributors and pharmacies throughout the United States, including in New York City, who in turn dispensed them to patients.”

Federal Circuit Invalidity Determination for Idenix Underscores Continuing Intra-Circuit Split

One day before the now-famous Arthrex decision was issued, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided an appeal by Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively “Idenix”) against Gilead Sciences, Inc. (Gilead) that reiterates the extent to which the Court is split in its approach to so many issues. The precedential opinion was authored by Chief Judge Prost, with Judge Newman dissenting. In 2013, Idenix sued Gilead for infringement of U.S. Pat. No. 7,608,597 (the ‘597 patent), which claims a drug directed to the treatment of the hepatitis C virus (HCV). In response, Gilead argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements. At trial, the jury found for Idenix and upheld the validity of the patent. Gilead filed a renewed motion for Judgment as a Matter of Law (JMOL) on the written description and enablement requirements, and the court granted the motion only on enablement grounds, thus holding the patent invalid. The decision overturned the jury’s award to Idenix of $2.5 billion.

Inequitable Conduct and Unclean Hands: Is There a Difference and Does it Matter?

Inequitable conduct remains the most powerful defense to patent infringement. In contrast to other defenses to patent infringement that require a claim-by-claim analysis, the defense of inequitable conduct is global. A finding of inequitable conduct renders the entire patent unenforceable. For this reason, the U.S. Court of Appeals for the Federal Circuit has referred to the defense of inequitable conduct as the “atom bomb of patent law” Aventis Pharma S.A. v. Amphastar Pharmaceutical, Inc., 525 F.3d 1334, 1349 (Fed.Cir.2008). Given the tremendous impact of the inequitable conduct defense, the Federal Circuit, in Therasense, Inc. v. Becton, Dickinson and Co., 649 F. 3d 1276 (Fed. Cir., 2011), has significantly increased the burden on patent infringers who assert this defense. Rather than needing to prove materiality in the context of 37 C.F.R. § 1.56 and intent to deceive, Therasense now requires an infringer prove “but for” materiality and a specific intent to deceive—a much higher burden than before. To the disappointment of those who believed that Therasense would spell the demise of inequitable conduct, this defense to patent infringement remains alive and well, although less prevalent than before. See Energy Heating, LLC v. Heat On-The-Fly LLC, 889. F.3d 1291 (Fed. Cir. 2018). Moreover, the Federal Circuit, in Gilead Sciences, Inc. v. Merck & Co. 890 F.3d 1231(Fed. Cir 2018), now seems to recognize an equitable defense (“business misconduct”) separate from inequitable conduct to penalize patentees for unethical behavior committed outside of the confines of patent prosecution before the United States Patent and Trademark Office (USPTO).