Posts in Pharmaceutical


IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
By Tulip Mahaseth
17 days ago 3

In Sickness and In Health: Comparing Patent Protection for Pharmaceuticals and Dietary Supplements

Once composition of matter claims have been obtained for a new compound, or the composition of matter claims for an old compound have expired, what is next? …

Compulsory Licensing for Medicare Drugs– Another Bad Idea from Capitol Hill

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by "competitive licensing" Rep. Doggett means compulsory licensing …
By Joseph Allen
2 months ago 42

Federal Circuit Treatment of ‘Commercial Success’ in Hatch-Waxman Cases

In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects …
By Theodore Chiacchio
2 months ago 1

Federal Circuit Affirms District Court’s Finding of Validity of Claims Directed to Aveed®

When relying on scientific guidelines to support an obviousness rationale, practitioners should offer evidence for why contradictory guidelines should be discounted. A claimed constituent is not “necessarily …

Prescription Tracking Patents Confirmed as Unpatentable After IPR Appeal

The Federal Circuit reviewed whether certain prior art was “publicly accessible,” because Jazz alleged the material was not a “printed publication” under Section 102(b). Jazz argued that …

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
6 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
7 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
7 months ago 3

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
7 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
7 months ago 10

Law Professors Urge CAFC to Uphold Cleveland Clinic Diagnostic Method Patents

A group of six patent law professors filed an amicus brief with the Court of Appeals for the Federal Circuit in Cleveland Clinic v. True Health Diagnostics. …
By Steve Brachmann
7 months ago 1

To Make Healthcare More Affordable, Fight Drug Patent Abuse with a Fury

If a drug company plants a more than 100-patent thicket to protect market exclusivity, then it had better be able to justify why it should deserve the …
By Arie Michelsohn
7 months ago 32

Patenting Antibodies: Obviousness Considerations

This article analyzes obviousness issues related to antibody patents at the Patent Trials and Appeal Board (PTAB) and in federal courts. We review several cases categorized by …

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