Posts in Biologics

Embrace IP That Works: Importance of Supplementary Protection Certificates (SPCs) in the European Union

The European Union suffers from an investment deficit relative to other industrialized nations. A recent report by the European Commission emphasizes this impact, “the EU needs to …
By Dr. Kristina Lybecker
2 months ago 0

CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar …
By Aubrey Haddach
3 months ago 1

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 months ago 1

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
5 months ago 1

CAFC denies Amgen discovery in biosimilar patent dispute

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery …

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 …

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
8 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
8 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(…

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
9 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
10 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
10 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
10 months ago 0

Bristol-Myers Squibb, Pfizer file ANDA lawsuits against makers of generic Eliquis

American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a …
By Steve Brachmann
11 months ago 0

FTC revives complaint, files motion for stipulated order over pay-for-delay agreement for generic Lidoderm

On January 23rd, the Federal Trade Commission (FTC) announced that it had taken steps to resolve antitrust charges involving business activities employed by Irish/U.S. drugmaker …
By Steve Brachmann
1 year ago 2