Over the weekend I read the new, third edition of "The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management," by Martin A. Voet ($28.95 at Amazon).  Mr. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for Allergan. Like the first two editions, the book is short (162 pages), easy to read, and…

In re Tanaka, No. 2010-1262 (Fed. Cir. 2011)     by Nabeela Rasheed Once a patent issues it behooves the patentee to scrutinize the claims to ensure that it has claimed all that it had a right to claim.  Where the patentee discovers that without deceptive intent the patent claims more or less than it should…

Dear Readers, I am happy to report that I recently joined McAndrews Held & Malloy, a large IP law firm in Chicago.  The left sidebar of the blog is updated with my new contact information. I will soon resume regular posting on Orange Book Blog, and I anticipate that some of my new colleagues will…

Aventis Pharma v. Amphastar and Teva, S. Ct. Appeal No. 08-937 (2009) The Supreme Court on Monday denied Aventis Pharma's cert petition in a long-running dispute with generic biopharmaceutical manufacturer Amphastar.  In its petition, Aventis had asked the Court to review a Federal Circuit decision affirming the unenforceability of its patent on Lovenox.  In particular,…

Shashank Upadhye has written a new text, Generic Pharmaceutical Patent and FDA Law, that anyone reading Orange Book Blog will certainly find useful.  Mr. Upadhye is Vice President & Global Head of Intellectual Property for Apotex. The book provides a nice overview of patent law–especially as applied to pharmaceuticals–and the drug approval process.  In addition, it includes…

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…