Posts Tagged: generic drugs


Hatch-Waxman and BPCIA Cases and Trends to Watch in 2021

As we turn the page to 2021, we expect at least two major cases to be resolved that could have long-lasting effects on where and how Hatch-Waxman and …

China’s NMPA and CNIPA Propose Draft Measures on Patent Linkage for Public Comment: Implications for the Future of Innovative and Generic Drugs

The National Medical Products Administration (NMPA), in conjunction with the China National Intellectual Property Administration (CNIPA), recently solicited public comments on the draft of “Measures For the …
By Susie Cheng, Ph.D
7 months ago 0

Federal Circuit Says Teva Induced Infringement of GSK Patent on Congestive Heart Failure Drug

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit (CAFC) on Friday reversed a district court’s motion …
By Rebecca Tapscott
7 months ago 0

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 …

Why should we encourage generics to challenge pharma patents?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same …
By Gene Quinn
3 years ago 1

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

Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned …
By Zachary Silbersher
4 years ago 1

Patent settlement between AbbVie and Amgen delays Humira generic until 2023

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm …
By Steve Brachmann
4 years ago 0

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

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …
By Chittam Thakore Ph.D.
5 years ago 1

Winning the Drug Development Debate

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration …
By Joseph Allen
5 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
5 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
5 years ago 0

Are Patents the Reason Poor Countries Lack Healthcare?

A consistent charge against the patent system is that it denies the poor access to critical medicines. This belief led the UN Secretary General to launch his …
By Joseph Allen
5 years ago 3

Reverse Payment Settlements and Holdup Under PTAB

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow …
By Erik Hovenkamp & Jorge Lemus
5 years ago 8