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Category: Hatch-Waxman
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By Kevin E. Noonan — The practice of "reverse payments" in ANDA litigation (where, typically, the branded drug manufacturer settles litigation brought under 35 U.S.C. § 271(e)(2) with a generic challenger) have been a thorn in the side of the Federal Trade Commission for several years. Despite judicial, legislative, and administrative attempts to ban the…
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By Kevin E. Noonan — On April 17th, the Supreme Court overturned a Federal Circuit decision construing statutory language involving the 2003 Medicare Prescription Drug Improvement and Modernization Act, which amended the 1984 Drug Price Competition and Patent Term Restoration Act (colloquially known as the Hatch-Waxman Act). The decision was certainly not a surprise, to…
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By Andrew Williams — In a second case involving the Hatch-Waxman regulatory scheme decided by the Federal Circuit on Monday, the Court held in Bayer Schering Pharma AG v. Lupin, Ltd. that for an ANDA filing to infringe a method-of-use claim, the proposed label must indicate that the FDA has determined that the drug is…
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By Andrew Williams — On Monday, in Dey Pharma, LP v. Sunovion Pharmaceuticals Inc., the Federal Circuit affirmed a District Court's conclusion that it had subject-matter jurisdiction over a declaratory judgment action of a second ANDA filer, and as a result also affirmed the District Court's final judgment of non-infringement (based on a stipulation of…
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By Donald Zuhn — In February, the U.S. Patent and Trademark Office announced the establishment of the Thomas Alva Edison Visiting Professionals Program, which is designed to tap into the expertise of distinguished IP professionals and academics who are able to devote up to six months of service to the Office on a full time…
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By Kevin E. Noonan — On February 9th, Congressman Bobby Rush (former "defense minister" of the Black Panther Party and representative for the Illinois 1st Congressional District; at right) joined Congressman Henry Waxman (below) in introducing the latest legislative measure directed at preventing reverse payment settlements of lawsuits under 35 U.S.C. § 271(e)(2) between branded…
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By Andrew Williams — Last week, in AstraZeneca Pharmaceutical LP v. Intellipharmaceutics Corp., Civil Action No. 11-2973 (JAP), Judge Pisano of the U.S. District Court for the District of New Jersey dismissed a Hatch-Waxman Act patent infringement action based on a lack of personal jurisdiction because the ANDA filer did not have the requisite minimum…
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By Donald Zuhn — Last week, President Obama unveiled his 2013 budget, and at least with respect to aspects of the budget proposal that would impact drugmakers, the President's 2013 proposal looks a lot like his 2012 proposal. In a section of the budget proposal entitled "Health Savings," the Administration sets forth eighteen proposals, the…
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By Andrew Williams — On Thursday, the Federal Circuit affirmed the dismissal of a § 271(e)(2) patent infringement action based on method-of-use claims because the ANDA filer was only seeking FDA approval for non-patented uses. In AstraZeneca Pharms. LP v. Apotex Corp., the Court held that alleging infringement under 35 U.S.C. § 271(e)(2) was sufficient…
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Statistics Illustrate Costs of Generic Drugs to Innovation By Kevin E. Noonan — The question of whether the Hatch-Waxman generic drug regime is a net positive for innovation and drug development has been the subject of recent study, particularly in view of the costs attendant on litigation between branded ("innovator") drug makers and their generic…
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