Posts Tagged: pharmaceuticals


Nasal Spray Patents Covering Migraine Drug Zomig Not Invalid As Obvious

The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court …

Reflections on Drug Patents and the High Cost of Healthcare

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest …
By Arie Michelsohn
5 days ago 1

Denying Inducement to Infringe in Face of a Drug Label: A Fool’s Errand?

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent …

Why should we encourage generics to challenge pharma patents?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same …
By Gene Quinn
1 month ago 1

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
2 months 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
2 months 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
2 months ago 11

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
3 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
4 months ago 3

Controversy Over Restasis Patents is Misplaced

Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan …
By Josh Malone
4 months ago 6

Drug-Patent Abuse and the High Cost of Healthcare: Case of the Double-Half Dose-Time Injection

Ever since the Supreme Court decided KSR v. Teleflex, it has been appropriate to reject a patent claim because it was obvious to try. If twice the …
By Arie Michelsohn
4 months ago 15

Some Observations on Drug Patents – A Response to Arie Michelsohn

Nothing in my own experience leads me to believe that the PTO applies a lower anticipation or obviousness standard to pharmaceuticals, and I expect this would be …
By Hans Sauer
4 months ago 10

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