Posts in Pharmaceuticals


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
21 days 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
22 days 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
1 month 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
1 month 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
1 month 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
1 month 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 …

Idenix Loses Patent on HCV Treatment that Supported $2.54 Billion Infringement Verdict

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case …
By Steve Brachmann
2 months ago 4

Despite Discovery Violations, Amneal Prevails on against Merck in Nasonex Patent Dispute

Merck appealed the lower court’s finding of non-infringement of U.S. Patent No. 6,127,353 (“the ‘353 patent”), which is directed toward mometasone furoate monohydrate (“MFM”), commercially used in …

Distribution Agreement Considered a Commercial Offer and On-Sale Bar

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of …

A Fleeting Glimpse of Reason in the Drug Development Debate

Despite the difficulties, the private sector is far and away the best bet for developing the desperately needed medicines of the future. Government is a critical partner …
By Joseph Allen
3 months ago 2

Analyzing obviousness and anticipation challenges to claims directed to an isolated component of a prior art mixture

Based on the governing Federal Circuit case law, where the patent claim at issue is directed to a specific component (such as a specific enantiomer) of a …
By Theodore Chiacchio
4 months ago 1

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
4 months ago 0

When Post-Filing Evidence to Determine Written Description Support Is Admissible: Amgen v. Sanofi

May a court rely on post-priority-date evidence offered to show that a patent lacks written description support even though written description is judged based on the state …

Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
By Zachary Silbersher
5 months ago 3