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Description:
In a 9-0 decision, the U.S. Supreme Court on April 17, 2012, allowed Caraco Pharmaceutical Laboratories Ltd. to employ the counterclaim provision of the Hatch-Waxman Act to challenge as overbroad Novo Nordisks use code for a patent covering the diabetes drug Prandin®. The FDA uses the use codes provided by branded drug manufacturers to determine whether a generic companys proposed use of a drug would infringe a method-of-use patent held by the manufacturer of the branded drug. The breadth of the use code can make the difference between approval and denial of a generic companys application. Thus, the expansion of the counterclaim provision to challenge use codes is significant and impacts the dynamic in Hatch-Waxman Act litigations. Furthermore, two recent decisions by the Federal Circuit, AstraZeneca v. Apotex and Bayer v. Lupin, have opened new avenues for generic companies to come to market. In AstraZeneca v. Apotex, the Federal Circuit held that an ANDA containing a section viii statement and carving out the method of use claimed in the patents at issue does not infringe. AstraZeneca v. Apotex, the Federal Circuit held that for an ANDA to infringe a method-of-use claim, the label of the branded company must indicate that the FDA has determined that the drug is safe and effective for the claimed method.
This webinar will:
Discuss the key factors that led to Caraco and the recent Appellate decisions
Address how Caraco and the recent Appellate decisions will impact patent litigation and prosecution
Provide practical strategies for pharmaceutical companies to anticipate and address, both before and during litigation, the issues raised by Caraco and the recent Appellate decisions
Highlight likely action by Congress and the Federal Food and Drug Administration in light of Caraco
| Practice Areas: | | Corporate & Securities, Healthcare & Pharmaceutical Law, Industry Regulation & Compliance, Pharmaceutical & Medical Device Litigation, Trial Skills | | Online Media Type: | | Audio | | Production Date: | | 06/07/2012 12:00 PM EDT | | Level: | | Intermediate | | Category: | | Standard | | Duration: | | 1 Hours, 0 Minutes | | Online Format: | | Live | | Course Type: | | Public |
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| • | Sapna W. Palla - Counsel - Kaye Scholer LLP, New York, NY | • | Benjamin C. Hsing - Partner - Kaye Scholer LLP, New York, NY |
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