Posts in Pharmaceutical


FTC v. Actavis: Where We Stand After 5 Years

It has been five years since FTC v. Actavis. In that landmark ruling, the Supreme Court held that settlements by which brand-name drug companies pay generics to …
By Michael Carrier
1 day ago 4

Mayo/Alice ‘Directed to’ Inquiry and a Split Federal Circuit: Vanda Pharma v. West-Ward Pharma

In Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being …

The Myth of ‘Trivial’ Drug Patents

Critics of drug patents often claim that when initial drug patents expire, drug companies stuff their patent portfolios with “trivial” patents that unjustifiably extend their patent monopoly …
By David Forman
19 days ago 6

China extends drug patent exclusivity to 25 years

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the …
By Steve Brachmann
21 days ago 0

Federal Circuit Affirms Dismissal of Patent Challenges Filed by Drug Consumer

AIDS Healthcare Found., Inc. v. Gilead Scis., Inc., the Federal Circuit affirmed the dismissal of patent challenges filed by drug consumers. The Court noted that a declaratory …

Petitioner Has Standing to Appeal PTAB Decision Where Litigation is Inevitable

Altaire filed two complaints against Paragon: (1) alleging a breach of the non-disclosure clause of the Agreement, and (2) seeking declaratory judgment that the ‘623 patent was invalid. Paragon, in …

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of …
By Stephanie Sivinski
1 month ago 18

Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (…
By Steve Brachmann
1 month ago 0

Drug Patents and the High Cost of Healthcare: Case of Over-Advocacy for Under-Patentability

The price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to …
By Arie Michelsohn
1 month ago 11

Mohawks appeal PTAB denial of Sovereign Immunity defense

The appellants are appealing from a series of inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) where the Board made the controversial …
By Steve Brachmann
1 month ago 3

Merck Hepatitis C Virus Treatment Patents Unenforceable due to Unclean Hands

On Wednesday, April 25th, the Court of Appeals for the Federal Circuit issued a precedential decision in Gilead Sciences v. Merck & Co. et. al., which affirmed a …
By Steve Brachmann
1 month ago 0

Undermining Innovation Is Not A Victory: Hepatitis C Drug Center Stage in Global Patent Battle

Thanks to a number of new Hepatitis C drugs (Sofosbuvir Ledipasvir, Ladispavir) the disease is curable for many patients. While this is an undeniable victory for patients …

Unleashing American Innovation, Oil States and Eroom’s Law

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private …
By Joseph Allen
2 months ago 7

The Abuse of Orange Book Listings by Branded Pharmaceutical Companies

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, …
By Arie Michelsohn
3 months ago 20

The Federal Circuit’s Approach to the Infringement Analysis in Hatch-Waxman Cases

35 U.S.C. § 271(e)(2) provides that it shall be an act of infringement to submit an Abbreviated New Drug Application (“ANDA”) “if the purpose of such submission …
By Theodore Chiacchio
3 months ago 3