Orange Book Blog
This blawg "reports on Hatch-Waxman litigation and other pharmaceutical patent cases, as well as regulatory and legislative developments."
Author: Aaron F. Barkoff is a partner at McDonnell Boehmen Hulbert & Berghoff.
Blawg Related Categories: Government Law • Intellectual Property Law • Patent Law • Legislation & Lobbying • Partners • Product Liability Law
Recent Posts from Orange Book Blog
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ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 7-8
American Conference Institute is hosting a special 10th Anniversary Edition of its annual "Maximizing Pharmaceutical Patent Life Cycles" conference on October 7th and 8th in New York. According to ACI, this is "the one and…
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Federal Circuit Affirms Invalidity of Bayer Patent on Yasmin
Bayer Schering v. Barr Labs, No. 2008-1282 (Fed. Cir. 2009) A divided panel of the Federal Circuit today affirmed a district court decision holding Bayer's U.S. Patent No. 6,787,531 invalid due to obviousness. The '531…
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ACI's FDA Boot Camp Coming to Chicago and Boston
American Conference Institute's popular "FDA Boot Camp" conference is coming to Chicago next week, July 21-22, and to Boston on September 15-16. The conference is billed as "basic training for products liability and patent lawyers."…
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Supreme Court Denies Cert Petition in Lovenox Case
Aventis Pharma v. Amphastar and Teva, S. Ct. Appeal No. 08-937 (2009) The Supreme Court on Monday denied Aventis Pharma's cert petition in a long-running dispute with generic biopharmaceutical manufacturer Amphastar. In its petition, Aventis…
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FDA: Under the QI Act, No 30-Month Stay Will Apply to ANDAs Referencing "Old Antiboiotics" and Containing a P.IV Certification to a Later-Listed Patent
I'll have a post later. For now, here is FDA's citizen petition response, released yesterday.
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Federal Circuit Affirms Extension of 30-Month Stay Against Teva's Generic Evista
Eli Lilly & Co. v. Teva Pharms. USA, Inc., No. 2009–1071 (Fed. Cir. 2009) Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files…
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Sanofi and BMS Prevail Over Apotex in Plavix Appeal
Sanofi-Synthelabo et al. v. Apotex, No. 2007-1438 (Fed. Cir. 2008) In an opinion released last Friday, the Federal Circuit affirmed the decision of the U.S. District Court for the Southern District of New York, following…
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Federal Circuit Affirms $16.8 Million Award of Fees to Takeda in Pioglitazone Case
Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir. 2008) In an opinion released Monday, the Federal Circuit affirmed a district court decision granting $16.8 million for attorney fees, expenses and expert fees to…
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FTC Roundtable, "Competition Issues Involving Follow-On Biologic Drugs," Washington, November 21
The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington. Speakers include industry leaders, government officials, outside counsel and others. The agenda…
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ACI "Paragraph IV On Trial" Conference, New York, November 19-20
American Conference Institute is presenting its first-ever "Paragraph IV On Trial" Conference, November 19-20 in New York. This is a unique conference, with the format of a mock trial in a Hatch-Waxman case. ACI states:…