The Court of Appeals for the Federal Circuit (“CAFC”) recently upheld a decision of the Patent Trial and Appeal Board (“PTAB”) that found some claims of U.S. Patent 8,815,830 (“the ’830 patent”) unpatentable as anticipated....more
On March 6, in Regents of the University of Minnesota v. Gilead Sciences, Inc., the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) invalidating claims of the...more
Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more
REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC. Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: For drug patents, adequate written description of a broad genus...more
One of the more fascinating developments in group health plan law has been the growth of antitrust claims by group health plans against drug manufactures who allegedly agree to delay the production of generic drugs once a...more
Update: see our article here regarding the dismissal of ViiV’s appeal. On April 6, 2020, the Federal Court granted Gilead’s motion for summary trial and dismissed ViiV’s action: ViiV Healthcare Company v Gilead Sciences...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more
On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more
The Federal Circuit’s recent decision in Idenix Pharmaceutical v. Gilead Sciences (October 2019) demonstrates the difficulty of adequately supporting broad pharmaceutical claims and provides a potential roadmap to invalidity...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
Last week, the Federal Circuit confirmed that Idenix Pharmaceuticals will not be the proud recipient of what was previously regarded as the largest damages award ever recorded in a U.S. patent case. In fact, the majority’s...more
Neal Gerber Eisenberg and Wolters Kluwer have teamed up to bring you NGE IP Focus, a quarterly newsletter dedicated to intellectual property-related legal decisions. ...more
The Court of Appeals for the Federal Circuit issued two opinions on December 7 that address two unsettled questions relating to obviousness-type double patenting (OTDP). These issues are of particular interest to...more
The Federal Circuit recently issued a pair of decisions concerning the Gilead doctrine, which allowed later-issuing patents to be obviousness-type double patenting (ODP) references against earlier-issuing patents....more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
Case Name: Idenix Pharms. LLC v. Gilead Sciences, Inc., Civ. No. 14-846, 2018 U.S. Dist. LEXIS 25663 (D. Del. Feb. 16, 2018) (Stark, J.)....more
Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more
On February 16, 2018, Judge Stark of the District of Delaware overturned the largest patent verdict in history. This extremely contentious patent infringement suit between Idenix Pharmaceuticals LLC (“Idenix”), a subsidiary...more
Last month, following a jury verdict in federal district court in Delaware awarding Plaintiff Idenix Pharmaceuticals LLC $2.54 billion in damages—“the largest damages verdict ever returned in a patent [infringement]...more
Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the Court declared Idenix’s Patent No....more
Universities have traditionally been reluctant to enforce their intellectual property (IP) against third parties. There are many reasons for this position, including adverse publicity associated with such suits, the time...more
Merck Ordered to Pay $14 Million in Attorneys’ Fees to Rival Gilead After a Patent Infringement Trial Involving Hepatitis C Drugs - On July 14, 2017, in a stunning reversal of fortune, a federal court in San Jose, CA,...more
Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more
Chapter 93A, with its low and vague standards of liability and powerful remedies of multiple damages and attorneys, is playing an increasingly central role in intellectual property disputes in Massachusetts. ...more