Posts Tagged: Generics


FDA Issues Request for Comments on Modernizing Patent Listings in the Orange Book

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt …
By Steve Brachmann
5 months ago 0

Federal Circuit Decision Delays Generic Osteoarthritis Drug

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the …
By Nancy Braman
1 year ago 2

Examining the Truvada #BreakThePatent Debate: Gilead Responds

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure …
By Steve Brachmann
2 years ago 3

Denying Inducement to Infringe in Face of a Drug Label: A Fool’s Errand?

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent …

Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
By Zachary Silbersher
3 years ago 3

WIPO and pharmaceutical industry joining forces to improve meds patent info

Protecting innovation through patents is the lifeblood of the global pharmaceutical industry. Without patents the world and its expanding population would be deprived of new and, ultimately, …
By Thomas Cueni
3 years ago 1

Big Pharma, Generics and Trade Related Aspects of Intellectual Property Rights (TRIPS)

Generic drug manufacturers can pose major financial threats to those companies that invent and develop the copied drugs both domestically and internationally... Before TRIPS, most of the …
By Angélique McCall
4 years ago 0

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug …
By Gene Quinn & Steve Brachmann
4 years ago 0

95 percent of WHO’s essential medicines are off-patent

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). …
By Steve Brachmann & Gene Quinn
4 years ago 0

A Simple Way to Lower Drug Prices

Consumers suffer the scourge of high drug prices. Brand-name drug companies reap monopoly profits. But generic drugs, which promise lower prices, are often nowhere to be found. …
By Michael Carrier
4 years ago 4

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. …

BIO, PhRMA lobby for IPR fix to insulate their patents from challenge

Greenwood and Castellani will have two major problems as they seek relief. First, the IPR provisions do not include a standing requirement, which means that anyone can …
By Gene Quinn
5 years ago 7