Posts in Biotechnology


Amgen v. Sanofi: A well characterized antigen insufficient for written description of an antibody

In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that …

Pity the Patients if Exclusive Licensing is Undermined

We've learned from experience that just because a theory's off base doesn't mean it won't take root, particularly when it involves patents and medicine. "No Vaccines Before …
By Joseph Allen
24 days ago 1

The Immunotherapy Patent Landscape: Types of patent claims for immunotherapeutic inventions

Immunotherapy has emerged as one of the most promising mechanisms to combat diseases like cancer and microbial infections. Since 2000, multiple antibody drugs have reached blockbuster status, including …

Federal Circuit declares Regeneron patent unenforceable due to inequitable conduct

The Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Merus N.V. upholding the determination that the patent owned by biotech firm Regeneron was unenforceable. …
By Steve Brachmann & Gene Quinn
4 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
4 months ago 36

Horizon Pharma patents covering Vimovo arthritis pain relief treatment have validity upheld at district court and PTAB

Irish biopharmaceutical firm Horizon Pharma announced that two of its patents covering Vimovo, a pain relief treatment for arthritis patients, had their validity upheld in a patent …
By Steve Brachmann
5 months ago 0

Supreme Court of Canada rules on Promise Doctrine in favor of Pharma Patent Owners

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual …
By Steve Brachmann
5 months ago 1

Lex Machina PTAB report highlights top petitioners, patent owners and law firms appearing in cases

Some of the reports most interesting findings involve which entities are most active at the PTAB as well as the law firms representing parties most frequently during …
By Steve Brachmann
5 months ago 0

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry …
By Gene Quinn
5 months ago 2

Lefstin, Mossoff critique SCOTUS’ sense of history and negative impacts on today’s patent system

“The Supreme Court has told us, and told itself, a particular story -- a story based in history to justify its current regime,” Lefstin said near the …
By Steve Brachmann
6 months ago 8

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
6 months ago 3

PwC patent litigation study shows recent drop in lawsuits despite increasing patent grants

About 5,100 patent infringement cases were filed in the U.S. during 2016, according to the PwC litigation study. This represents a 9 percent drop in lawsuits from 2015’s totals …
By Steve Brachmann
6 months ago 2

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

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
7 months ago 0