Posts in Food & Drug Administration


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

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

Patent battle over generic Inomax leaves five Mallinckrodt patents invalid as naturally occurring phenomenon

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s …
By Steve Brachmann
3 months ago 4

Wrigley sues Chicago area e-cig firm over Doublemint, Juicy Fruit liquid vapor products

Chicago-based chewing gum company Wm. Wrigley Jr. Company filed a trademark infringement suit against e-cigarette seller Chi-Town Vapers LLC of Bensenville, IL. The suit targets Chi-Town for …
By Steve Brachmann
5 months ago 1

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

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
7 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

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
8 months ago 0

What happens when lifestyle drugs like Viagra and Cialis lose patent protections?

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. …
By Angélique McCall
8 months ago 19

Federal Circuit limits breadth of claims based on definition in specification, prosecution history

On April 6, 2017, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in The Medicines Company v. Mylan, Inc. (2015-1113, 2015-1151, and 2015-1181) …
By John M. Rogitz
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

PTAB ends Kyle Bass IPRs targeting Acorda patents on Ampyra MS treatment with no findings of obviousness

A panel of administrative patent judges (APJs) at the Patent Trial and Appeal Board (PTAB) issued a final written decision ending a series of inter partes review (…
By Steve Brachmann
9 months ago 2

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

Other Barks & Bites for Wednesday, March 1st, 2017

Another covered business method review is overturned by the Federal Circuit because the Patent Trial and Appeal Board instituted a CBM on a patent that was not …
By Steve Brachmann
10 months ago 2

Merck agrees to $625 million payment, royalties to Bristol-Myers Squibb for sales of Keytruda cancer treatment

On January 20th, NYC-based drugmaker Bristol-Myers Squibb Co. (NYSE:BMY) and Kenilworth, NJ-based pharmaceutical firm Merck & Co. (NYSE:MRK) announced that the two companies had entered into …
By Steve Brachmann
10 months ago 0