Category: Uncategorized

  • By: Rocco Screnci The Supreme Court heard oral argument yesterday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. This is a case and an issue that we (and many others) in the pharma-patent world have been watching for a while. But for those who haven’t followed this case, here is a recap of what…

  • Last week the Federal Circuit decided Teva v. Lilly, restoring the jury’s verdict that Teva’s claims to methods of using CRGP antagonists to treat headache were not proven invalid under 112. The facts are at a high level, relatively straightforward. Teva’s patent family claimed CGRP antagonists as well as methods of using such antagonists to…

  • I wrote previously about the difficulty challengers to pharmaceutical patents face in proving standing at the Federal Circuit to appeal unfavorable decisions under the Federal Circuit’s view of what constitutes “concrete plans.” Thus, pharma companies may justifiably be hesitant to file petitions for PTAB review too early, lest they have no chance for appeal. However,…

  • TypePad has shut down on us, so we’re moving the blog to WordPress. Thank you for your patience as we learn how to navigate this new blog!

  • Following up on Rocco's discussion of obviousness-type double patenting (OTDP), I have some thoughts on the PTO's proposed rule changes to OTDP and terminal disclaimer practice. In May, the patent office proposed a rule in which "to overcome double patenting the patentee would need to agree that the patent with the terminal disclaimer will be…

  • 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…