Category: Patent Term Extension

  • Since it has been a while since my last post, I’m going to do something a little different and do a quick run down of ten Federal Circuit cases that have issued in the past few months and highlight some key takeaways. I’ll give a quick bullet point review of the cases, with slightly more…

  •   by: Rocco J. Screnci This is the second post in a two-part series on obviousness-type double patenting (“ODP”). Part one summarized the two recent precedential Federal Circuit decisions in this area. To sum up where last post left off: The Federal Circuit’s decision in Cellect initially seemed to drastically expand the application of ODP,…

  •     by: Rocco J. Screnci This post is the first in a two-part series about recent developments in the law of double patenting. This post provides relevant background and summarizes the Federal Circuit’s recent decisions in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023) and Allergan USA, Inc. v. MSN Laboratories Priv. Ltd.,…

  • On Friday morning, the USPTO pre-published its proposed rule changes implementing the provisions of the America Invents Act that convert the U.S. patent system from a "first to invent" to a "first inventor to file" system.  The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn…

  • Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., No. 2010-1264 (Fed. Cir. 2011)     by Scott P. McBride In 2000, Genetics Institute obtained a patent term extension under 35 U.S.C. § 156 on U.S. Patent No. 4,868,112, based on the time consumed by testing and regulatory review of its commercial recombinant Factor VIII product, ReFacto®,…

  • Ortho-McNeil and Daiichi Sankyo v. Lupin, No. 2009-1362 (Fed. Cir. 2010) Photocure v. Kappos, No. 2009-1393 (Fed. Cir. 2010) In separate cases decided today, the Federal Circuit upheld two patent term extensions under 35 U.S.C. § 156–one relating to LEVAQUIN (levofloxacin) and the other relating to METVIXIA (methyl aminolevulinate).  The cases were argued on the same day last year…

  • Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt.  For more:  AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis.  Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…

  • On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years.  For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill’s Congress Blog. Bayer…

  • Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008) Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim’s patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting.  Mirapex, indicated for the treatment of Parkinson’s disease and Restless Leg…

  • Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday.  The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product. In what is being reported as a setback for…