Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: 271(e)(1) Safe Harbor
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Momenta and Sandoz v. Teva, No. 2014-1274 (Fed. Cir.) Momenta and Sandoz v. Amphastar, No. 2014-1276 (Fed. Cir.) by Aaron F. Barkoff In a precedential opinion today, in companion cases concerning generic enoxaparin, the Federal Circuit reached two decisions that pharmaceutical companies should take note of: 1. Teva's enoxaparin is not "made by" a patented…
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by Aaron F. Barkoff Following through on its plan announced earlier this month, Momenta Pharmaceuticals recently filed a petition for a writ of certiorari in Momenta v. Amphastar. As we reported previously, the Federal Circuit's decision in this case appears to conflict with its 2011 decision in Classen v. Biogen IDEC. Both cases…
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Momenta Pharms. v. Amphastar Pharms., No. 2012-1062 (Fed. Cir.) by Aaron F. Barkoff Last year, in Classen v. Biogen IDEC, a three-judge panel of the Federal Circuit held that the safe harbor of Section 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has…
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Classen Immunotherapies v. Biogen IDEC et al., Nos. 2006-1634, -1649 (Fed. Cir. 2011) In a 2-1 opinion today, the Federal Circuit held that the Section 271(e)(1) safe harbor "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." 35 U.S.C. § 271(e)(1) states: It shall not…
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Proveris Scientific Corp. v. Innovasystems, No. 2007-1428 (Fed. Cir. 2008) 35 U.S.C. § 271(e)(1) states: It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development…
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Amgen v. Int'l Trade Comm'n and Roche, No. 2007-1014 (Fed. Cir. 2008) Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (EPO) and processes for making EPO, protecting the Amgen drugs Aranesp and Epogen. Sales of Aranesp alone topped $3.6 million last year. Roche produces EPO in Europe and has…
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Patent Protection for Research Tools Remains Unclear After Federal Circuit Revisits Integra v. Merck
Integra Lifesciences v. Merck KGaA, No. 2002-1052 (Fed. Cir. 2007) Last Friday, the Court of Appeals for the Federal Circuit decided Integra v. Merck, on remand from the Supreme Court. Click here for the opinion. The case has important implications for owners of "research tools" patents. In the mid-1990s, Integra sued Merck KGaA (the German…
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The Antitrust & Competition Policy Blog reports on a new paper by Prof. Christopher Leslie of Chicago-Kent College of Law advocating the use of antitrust law to challenge the licensing of invalid patents. Richard Epstein, my law school Property professor, has a new book out entitled Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. Judy…
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Amgen dodged a bullet last week when Judge William G. Young of the U.S. District Court for the District of Massachusetts denied Hoffman-LaRoche’s motion to dismiss Amgen’s complaint alleging infringement of its patents on erythropoeitin (EPO). Hoffman-LaRoche based its motion to dismiss on the assertion that all of the allegedly infringing activities fell under 35…
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As reported in a post last week, the Federal Circuit recently heard oral arguments in Merck KGaA v. Integra LifeSciences following remand from the Supreme Court. Since the hearing, both Merck and Integra have submitted letters to the Federal Circuit, urging the court not to decide the issue of whether Merck’s use of Integra’s patented…
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