In re Omeprazole Patent Litigation, No. 04-1562 (Fed. Cir. 2007) In a 2-1 decision released today, the Federal Circuit affirmed a 2004 district court decision finding AstraZeneca's U.S. Patent No. 6,013,281 invalid as inherently anticipated.  The '281 patent covers a process for making Prilosec, Astra's blockbuster anti-ulcer medication. The case arose from the efforts of…

Jeffrey Wasserstein and Kurt Karst of Hyman, Phelps & McNamara, PC, recently launched FDA Law Blog, a new site promising to provide timely updates on FDA enforcement actions, proposed rules, and important topics in food and drug law.  Already, FDA Law Blog is reporting on recent FDA warning letters, draft guidance, and ANDA suitability petitions.…

Apotex et al. v. Eon Labs Mfg., No. 01-0482 (E.D.N.Y. 2007) Apotex and its CEO, Bernard (Barry) C. Sherman, were ordered by a federal district court last week to pay Eon Labs $3.1 million in attorney fees and expenses in a patent case they pursued for years before admitting that their patent was invalid.  In…

Synthon IP v. Pfizer, No. 05-1267 (E.D. Va. 2007) As we previously reported, last year a jury in the Eastern District of Virginia found that Pfizer does not infringe Synthon IP, Inc.'s patent on processes for making the active ingredient in Norvasc (amlodipine besylate) and also that the patent is invalid.  Now, following a bench…

Generic drug makers typically set their litigation sights on brand-name drug companies.  Their goal is to invalidate the brand companies’ patents and earn the right to market their generic drugs before the patents expire.  Increasingly, however, generics are suing each other to protect or gain market share. For instance, Teva Pharmaceuticals announced today that it…

In a case of first impression, the U.S. District Court for the Southern District of New York held, on cross motions for summary judgment regarding available remedies, that an Orange Book listing of patents protecting an approved drug was not effective public notice under the patent marking statute, 35 U.S.C. 287(a).  Merck & Co. v.…

This weblog will focus on issues at the intersection of patent law and FDA law.  For example, I aim to discuss drug development and patenting; Hatch-Waxman litigation; and antitrust issues in pharmaceutical patent cases.  I am a patent lawyer, and therefore I will be looking at these topics from that perspective.  Others, such as those…