We're excited to announce the relaunch of the Orange Book Blog! First off, a huge thank you to blog founder Aaron Barkoff! While Aaron has moved in-house, he has generously passed the blog along to an expanded team of authors who will provide you with regular updates on what's happening in the ANDA field. We're…

    by Alejandro Menchaca I've previously written about the Minerva assignee estoppel case, currently pending at the Supreme Court: here. In case you don't have time to read my article, I've summarized the parties' arguments in the following short poem. Patent Assignor: In daytime, I write up the patents. By nighttime, the patents are…

Mayo Collaborative Services v. Prometheus Labs., Inc., No. 10-1150 (U.S. 2012) by Nabeela Rasheed On Tuesday, in a unanimous opinion authored by Justice Breyer, the United States Supreme Court addressed the issue of patent eligibility of diagnostic method claims.  The issue was simple:  is a claim to a method of optimizing a particular therapy using…

    by Scott P. McBride President Obama signed the America Invents Act last Friday, bringing the most sweeping reform to U.S. patent law since 1952.  The 150-page act makes dramatic changes to many aspects of patent law, including (1) the definition of prior art under 35 U.S.C. § 102, (2) procedures available at the…

American Conference Institute is holding their 2nd annual "Biosimilars" conference in New York City on July 7th and 8th, at the Millenium UN Plaza Hotel.  According to ACI, this is "the definitive forum on the legal, regulatory, and commercial realities of generic biologics." The agenda includes the following presentations: Update on current FDA position and…

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…