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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Cephalon, Inc. v. Watson Pharms., Inc., No. 2011-1325 (Fed. Cir. 2013) by Katherine H. Johnson In Cephalon v. Watson, decided earlier this month, the Federal Circuit reversed a finding of invalidity for lack of enablement where the factual record of undue experimentation was insufficient. The patented invention involved methods of oral mucosal administration…
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Eurand v. Impax Labs., No. 2012-1280 (Fed. Cir.) by Alex Menchaca In Eurand v. Impax, decided last week by the Federal Circuit, a generic defendant, Impax, settled with the patent owner, Cephalon, and a settlement agreement provided for Impax's entry date into the market. One of the entry date triggers occurred if Cephalon licensed…
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Bristol-Myers Squibb v. Teva Pharms., No. 10-805-CJB (D. Del.) by Aaron F. Barkoff Today, in the District of Delaware, Judge Burke issued a 171-page opinion holding that claim 8 of U.S. Patent No. 5,206,244, covering the entecavir molecule, is invalid as obvious. Entecavir is the active ingredient in Baraclude tablets, which are indicated for…
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Eli Lilly & Co. v. Teva Parenteral Medicines , No. 2011-1561 (Fed. Cir.) by Aaron F. Barkoff Lilly's anticancer drug Alimta (pemetrexed) is approved for the treatment of mesothelioma and non-small cell lung cancer. Teva, Barr and APP filed ANDAs seeking approval to market generic versions of Alimta prior to the expiration of…
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On Friday morning, the USPTO pre-published its proposed rule changes implementing the provisions of the America Invents Act that convert the U.S. patent system from a "first to invent" to a "first inventor to file" system. The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn…
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Sciele Pharma v. Lupin, No. 2012-1228 (Fed. Cir.) In a precedential decision today, the Federal Circuit vacated a preliminary injunction that had been entered against Lupin in the ANDA litigation over Lupin's generic version of FORTAMET (metformin extended-release tablets). This is the second preliminary injunction against Lupin that the Federal Circuit has vacated in the…
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Bone Care Int'l v. Roxane Labs., No. 09-cv-285 (GMS) (D. Del.) In an opinion this past Monday, the U.S. District Court for the District of Delaware found in favor of Genzyme and against ANDA applicants Roxane, Sandoz, and Anchen in the paragraph IV litigation concerning HECTOROL (doxercalciferol), Genzyme's drug for the treatment of secondary hyperparathyroidism…
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Bayer Schering Pharma et al. v. Lupin et al., Nos. 2011-1143, -1228 (Fed. Cir.) by Malaika D. Tyson In a 2-1 opinion this past Monday, the Federal Circuit affirmed a district court decision dismissing Bayer's patent infringement claims against Watson, Sandoz and Lupin because their ANDAs did not seek approval for the patented use. At…
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Caraco Pharm. Labs. v. Novo Nordisk, 566 U.S. ___ (2012) In a unanimous opinion today, the Supreme Court held that an ANDA applicant may employ the counterclaim provision of 21 U.S.C. § 355(j)(5)(C)(ii)(I) not only to seek the delisting of a patent from the Orange Book, but also to force amendment of an Orange Book "use code."…
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Aventis Pharma S.A. et al. v. Hospira, Inc. et al., No. 2011-1018 (Fed. Cir.) In a precedential decision earlier this week, the Federal Circuit affirmed a district court decision holding two patents on TAXOTERE (docetaxel), U.S. Patent Nos. 5,750,561 and 5,714,512, unenforceable for inequitable conduct. The Federal Circuit also affirmed findings that claim 5 of the…
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