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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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:…
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BNA "Pharmaceutical Patent Laws" Conference, Arlington, VA, November 12
BNA Legal & Business Edge is presenting a conference entitled "Pharmaceutical Patent Laws: A Prescription for Success in Challenging Times, November 12 in Arlington, VA. According to BNA, this will be a "fast-paced conference on…
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C5 "EU Pharma Law and Regulation" Conference, Geneva, November 4-5
C5 is presenting a conference next month entitled "EU Pharma Law and Regulation." It will take place November 4-5 in Geneva, Switzerland. According to C5, "From the EU Pharma Sector Inquiry to recent parallel trade…
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Federal Circuit Affirms Dismissal of Declaratory Judgment Counterclaims in Trusopt/Cosopt Case
Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008) In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt. Hi-Tech filed paragraph…