Patent Law Weblog
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- USPTO Issues Memoranda on Subject Matter Eligibility
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Category: Hatch-Waxman
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U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility By Andrew Williams — The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday, June 7, 2016. Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion,…
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By Kevin E. Noonan — In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. While the Commission has been issuing these…
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By Kevin E. Noonan — The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc.…
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By Kevin E. Noonan — Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the innovator (branded) drug company to the generic challenger as part of a "reverse…
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By Andrew Williams — The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are "solely for uses reasonably related to the development and submission of information" to the FDA. Even though the…
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By Kevin E. Noonan — Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion, AstraZeneca's lawsuit against Apotex was part of the "second wave" of ANDA litigation, wherein the…
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By Kevin E. Noonan — Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences LLC v. Lee. This litigation was collateral to Exela's ANDA case against Cadence, and involved an attack on one…
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By Andrew Williams — Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v. Daiichi Sankyo, Inc. case, at least if you are in the wild world of the Hatch-Waxman statute. …
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By Andrew Williams — Is the ability to obtain personal jurisdiction against an ANDA filer for a Hatch-Waxman-type litigation going to become exceedingly more difficult? In the past, jurisdiction against such a defendant was often predicated on general jurisdiction, analyzing whether the party's contacts with the forum "are so continuous and systematic as to render…
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By Kevin E. Noonan — Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that provides a slew of statistics ripe for interpretation (or at least speculation). Written by Brian C. Howard…
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