Par Pharmaceuticals v. Roxane Labs, No. 2007-1093 (Fed. Cir. 2007) In the early 1990s, Bristol-Myers Squibb developed and patented Megace, a liquid pharmaceutical composition of megestrol acetate indicated for the treatment of anorexia, cachexia, or an unexplained weight loss.  Par Pharmaceuticals sought to design around the claims of BMS’s patent and introduce a generic version of…

These features aren’t actually that new.  They’ve been on Orange Book Blog for months–and you may have noticed or even used them.  But I never really drew attention to them, and I think they’re useful so I wanted to do that now. "Search 32 Pharma/Patent News Sites":  Until today, this was called "Pharma Patent News…

Festo v. Shoketsu Kinzoku Kogyo Kabushiki Co., No. 2005-1492 (Fed. Cir. 2007) In a decision that appears to diminish the value of pharmaceutical formulation patents, today the Federal Circuit held that "[a]n equivalent is foreseeable if one skilled in the art would have known that the alternative existed in the field of art as defined…

KSR Int’l v. Teleflex, 550 U.S. ___ (2007) In a unanimous decision released this morning, the Supreme Court reversed the Federal Circuit’s decision in KSR v. Teleflex.  The Court rejected the Federal Circuit’s rigid application of its "Teaching, Suggestion or Motivation" ("TSM") test in this particular case, but stopped short of discarding the test entirely. …

Synthon IP v. Pfizer, No. 05-1267 (E.D. Va. 2007) Last month the Federal Circuit invalidated three key claims of Pfizer’s Norvasc patent and currently a district court in Washington, D.C. is deciding whether to allow a flood of Norvasc generics on the market.  But the news for Pfizer hasn’t been all bad lately.  Though it…

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  Already, FDA Law Blog is reporting on recent FDA warning letters, draft guidance, and ANDA suitability petitions.…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…