Posts Tagged: 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
15 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
16 days 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
29 days 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
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

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 …

Litigants May Not Use a DJ to Obtain Piecemeal Adjudication

The Federal circuit heard the case on AbbVie Inc. v. MedImmune Ltd. AbbVie and MedImmune entered a development and licensing agreement in 1995. The agreement stemmed from a …

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

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
3 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 …

Avoiding drug development clinical trials from being an invalidating public use

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the …
By Theodore Chiacchio
5 months ago 4

WIPO and pharmaceutical industry joining forces to improve meds patent info

Protecting innovation through patents is the lifeblood of the global pharmaceutical industry. Without patents the world and its expanding population would be deprived of new and, ultimately, …
By Thomas Cueni
6 months ago 1

Think Twice Before Pulling the Plug on Tech Transfer

Most assaults on public/private sector R&D partnerships are launched by those who believe patents are inherently bad and that through some undefined magic publicly funded …
By Joseph Allen
7 months ago 0

IP Strategy is a Tricky Balancing Act for Pharmaceuticals

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from …
By Shai Jalfin
8 months ago 2