Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Paragraph IV Cases
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Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008) In an opinion released today , the Federal Circuit affirmed a district court decision granting summary judgment that Roche’s U.S. Patent No. 5,110,493 is valid and infringed by Apotex’s ANDA for a generic version of Acular LS (ketorolac tromethamine opthalmic solution). Acular LS, marketed…
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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 Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting. Mirapex, indicated for the treatment of Parkinson’s disease and Restless Leg…
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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 ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing. The case concerns Mutual Pharmaceutical’s generic version of…
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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 (omeprazole) does not infringe two AstraZeneca patents, U.S. Patent Nos. 4,786,505 and 4,853,230. Omeprazole is difficult to formulate because it…
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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 WSJ Health Blog recapped all the Protonix ANDA litigation. India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot…
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As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief. Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA. Also last Friday, FDA appealed the D.C. district court’s decision requiring relisting of Janssen’s…
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Aventis Pharma v. Amphastar and Teva, No. 2007-1280 (Fed. Cir. 2008) Earlier today, the Federal Circuit affirmed a district court decision holding Aventis's patent on Lovenox (enoxaparin) unenforceable. The district court had found that renowned Aventis scientist, Dr. Andre Uzan, committed inequitable conduct during the prosecution of U.S. Patent No. 5,389,618, later reissued as RE38,743. …
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Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir.) In February 2006, the U.S. District Court for the Southern District of New York determined that Takeda’s patent on pioglitazone, the active ingredient in ACTOS, is neither invalid for obviousness nor unenforceable due to inequitable conduct. In the court’s 124-page opinion, the court remarked, "The…
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Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday. The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product. In what is being reported as a setback for…
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