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Pharmaceutical Industry › Food and Drug Administration (FDA) › Gilead Sciences

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

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The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

A&O Shearman

PTAB Decision Invalidating Claims Finding Lack of Written Description and Later Priority Date Upheld by Federal Circuit

A&O Shearman on

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

Knobbe Martens

Description Prescription

Knobbe Martens on

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

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #7

Hogan Lovells on

In Washington: Sens. Ben Cardin (R-MD) and Marco Rubio (R-FL) led a letter from a group of 31 senators calling on Senate leadership to include an international response to COVID-19 in the next coronavirus package....more

Mintz - Intellectual Property Viewpoints

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

Mintz - Intellectual Property Viewpoints on

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

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma under fire over quality, safety, and patents on costly brand drugs

Patrick Malone & Associates P.C. | DC Injury... on

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

McGuireWoods LLP

Ninth Circuit Ruling Weakens Materiality Standard under the FCA

McGuireWoods LLP on

Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded...more

Arnall Golden Gregory LLP

Ninth Circuit Holds that FDA Violations Can Lead to FCA Liability

Arnall Golden Gregory LLP on

On July 7, 2017, the Ninth Circuit Court of Appeals issued an opinion in United States ex rel. Campie v. Gilead Sciences, Inc., holding that violations of Food and Drug Administration (FDA) regulations could create liability...more

Robinson+Cole Health Law Diagnosis

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

Robinson+Cole Health Law Diagnosis on

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Searcy Denney Scarola Barnhart & Shipley

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Baker Donelson

Federal Circuit Expands Doctrine of Double Patenting

Baker Donelson on

Gilead Sciences, Inc. (Gilead) owns United States Patent No. 5,763,483 and United States Patent No. 5,952,375. The patents feature common inventors and disclose similar material in the field of anti-viral compounds. Natco...more

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