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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In re Andrx Pharmaceuticals, Inc., Misc. Docket No. 943 (Fed. Cir. 2010) In 2002, Astra prevailed over Andrx in Paragraph IV litigation concerning Andrx's ANDA for a generic version of Prilosec (omeprazole). Shortly before and during the course of the bench trial, Astra learned that Andrx had manufactured multiple batches of its ANDA product on…
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Teva Pharms. USA v. Eisai et al., No. 2009-1593 (Fed. Cir. 2010) In a 3-0 decision last week, the Federal Circuit held that Teva has standing to challenge four of Eisai’s Orange Book-listed patents on Aricept (donepezil)–notwithstanding that Eisai statutorily disclaimed two of the patents and granted Teva covenants not to sue on the others. The Federal…
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Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010) The principle behind the doctrine of double patenting is simple: a person may not obtain two patents on the same invention. The doctrine "is intended to prevent a patentee from obtaining a timewise extension of [a] patent for the same invention or…
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Sanofi-Aventis, et al. v. Food and Drug Administration, et al., No. 09-1495 (D.D.C. 2010) The question in this case is "whether a vacatur entered by an appellate court overrides the terminating effect that the entry of district court judgment has on the thirty-month stay under the FDCA." The answer is "no" — the thirty-month stay…
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Pfizer Inc. et al. v. Apotex Inc. et al., No. 08-7231 (N.D. Ill. 2010) The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case,…
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ALZA Corp. v. Andrx Pharms., No. 2009-1350 (Fed. Cir. 2010) Earlier this week, the Federal Circuit affirmed a district court decision finding ALZA's U.S. Patent No. 6,919,373 invalid for lack of enablement. The '373 patent claims methods for treating Attention Deficit and Hyperactivity Disorder ("ADHD") and is listed in the Orange Book for Concerta, an extended-release formulation of…
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AstraZeneca v. Dr. Reddy's, No. 07–6790 (S.D.N.Y. 2010) After Dr. Reddy's filed an ANDA for Prilosec OTC (omeprazole), AstraZeneca filed suit, alleging infringement of U.S. Patent Nos. 5,690,960 and 5,900,424. The patents claim omeprazole formuilations comprising a magnesium salt "having more than 70% crystallinity" and related processes of manufacture. In response, Dr. Reddy's provided independent test…
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Millenium Pharms. and Schering Corp. v. Teva, No. 09–105 (D. Del. 2010) Under the “failure to market” forfeiture provision, the first ANDA filer forfeits its exclusivity is it fails to market its ANDA product within 75 days of a Federal Circuit decision of patent invalidity or noninfringement. See 21 U.S.C. 355(j)(5)(D)(i)(I)(bb)(AA). This presents a dilemma…
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Novo Nordisk v. Caraco Pharm. Labs. et al., No. 2010-1001 (Fed. Cir. 2010) In the Medicare Modernization Act of 2003, Congress gave ANDA applicants who have been sued for patent infringement the statutory right to file a counterclaim seeking the delisting of the patent from the Orange Book: If an owner of the patent or the holder of the…
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In re '318 Patent Litigation, Nos. 2008-1594, 2009-1070 and 2009-1088 (Fed. Cir. 2009) Eli Lilly & Co. v. Actavis Elizabeth LLC, et al., No. 07-3770-DMC (D.N.J. 2009) Two recent cases illustrate how owners of pharmaceutical method-of-use patents may find themselves walking a tightrope when their patents are attacked simultaneously on enablement and obviousness grounds. First, in a…
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