Posts Tagged: Drug


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
23 days 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
1 month ago 1

Novartis acquires French radiopharmaceutical firm for oncology drug after losing patent protection for Gleevec

Novartis has agreed to acquire French radiopharmaceutical firm Advanced Accelerator Applications (AAA) in a deal which values AAA at $3.9 billion USD. The deal, funded through short- and …
By Steve Brachmann
1 month ago 0

St. Regis Mohawks, BIO send letters to Senate Judiciary slamming the unfair playing field of IPRs at PTAB

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on …
By Steve Brachmann
2 months ago 22

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
2 months ago 0

Report shows drug patents fare better in IPR proceedings at PTAB

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma …
By Steve Brachmann
5 months ago 36

Restricting Patents on New Combinations and Uses of Medicines Makes No Sense

IP-skeptics charge that these inventions are little more than a way for pharmaceutical companies to cynically prolong patent life and maximize profits, without providing any meaningful innovation. …
By Philip Stevens & Jack Ellis
5 months ago 5

Superbugs Require New Weapons: Strong, Effective Intellectual Property Rights May Be Our Best, Last Hope

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the …
By Dr. Kristina Lybecker
7 months ago 3

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
7 months ago 0

Lex Machina ANDA litigation report shows recent decline in case filings and top parties in filings

Lex Machina recently released a Hatch-Waxman/ANDA litigation report detailing trends and key findings from pharmaceutical cases filed in U.S. district courts between January 1st, 2009, and …
By Steve Brachmann
7 months ago 0

Drug Product Pipelines: Potential Blockbusters?

Drug manufactures spend billions of dollars in R&D and it takes years to get FDA approvals and patent protection. It is vital that these companies keep …
By Angélique McCall
8 months ago 0

Focus on Stronger IP Incentives: Price Setting is Not the Cure for Healthcare Spending

The WHO is gathering governments, academics and activists in Amsterdam next month to discuss price setting options for medicines. But the so-called Fair Pricing Forum ignores the …
By Dr. Kristina Lybecker
8 months ago 0

Regeneron, Sanofi-Aventis sue for declaration that dermatitis treatment Dupixent doesn’t infringe Amgen patent

Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s …
By Steve Brachmann
9 months ago 0

The FDA process, patents and market exclusivity

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and "exclusivity" separately. "Exclusivity" refers to exclusive marketing rights granted by the …
By Angélique McCall & Gene Quinn
9 months ago 1

Will President Trump directly negotiate Medicare prescription drug pricing?

The savings impact of directly negotiated drug costs is considered negligible, but intrusion into biomedical pricing will destabilize life science commercialization... Any way you slice it, added …
By Chris Gallagher
10 months ago 2