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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In a "Surprising" Victory, Barr and Mylan Invalidate Boehringer Ingelheim's Patent on Mirapex
Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008) Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim's patent on…
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After Court Victory over FDA, Teva Receives Final Approval of Risperidone ANDA and Launches With 180-Day Exclusivity
Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately…
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Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA
GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008) The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the…
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FDA Denies King Pharma's Citizen Petition Concerning Altace, Approves Ramipril ANDAs
We reported last month that King Pharmaceuticals filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7.…
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Federal Circuit Refuses to Rehear Caraco v. Forest
We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even…
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Mylan Prevails Over AstraZeneca in Appeal of Prilosec Case
In re Omeprazole Patent Litigation, Nos. 2007-1476, -1477, -1478 (Fed. Cir. 2008) Yesterday, the Court of Appeals for the Federal Circuit affirmed a June 2007 district court decision finding that Mylan's generic version of Prilosec…
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OBB News Briefs
The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements. For commentary, see FDA Law Blog, Pharmalot. Wyeth sued Sandoz over a generic version of Protonix I.V. The…
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C5 "Pharma Patent Lifecycles" Conference, London, June 26-27
C5 will be holding a "Pharma Patent Lifecycles" conference June 26-27 in London. According to C5, "since 2001, thousands of life sciences patent professionals have made C5's Pharma Patent Lifecycles conferences their source of information…
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King Pharmaceuticals Files Citizen Petition Relating to New Patent on Altace (Ramipril)
King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from…
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Patent Litigation Under a Future Biosimilars Act
Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about $40 billion in 2006 and are expected to rise to over…