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: Validity–Obviousness
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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 The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn…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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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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Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., No. 2010-1264 (Fed. Cir. 2011) by Scott P. McBride In 2000, Genetics Institute obtained a patent term extension under 35 U.S.C. § 156 on U.S. Patent No. 4,868,112, based on the time consumed by testing and regulatory review of its commercial recombinant Factor VIII product, ReFacto®,…
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Unigene Labs and Upsher-Smith v. Apotex, No. 2010-1006 (Fed. Cir. 2011) In a decision yesterday, the Federal Circuit affirmed a district court opinion granting Unigene's motion for summary judgment that claim 19 of U.S. Patent No. RE40,812 is not invalid for obviousness. Claim 19 of the '812 patent covers the pharmaceutical formulation of FORTICAL (calcitonin…
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Mitsubishi Chemical Corp. v. Barr Labs., No. 2010-1432 (Fed. Cir. 2011) Mitsubishi Chemical owns U.S. Patent No. 5,214,052, which claims a "method for dissolving an arginineamide, comprising dissolving [argatroban] and/or its salt in a solvent containing ethanol, water and a saccharide"; and a "pharmaceutical composition for injection, comprising [argatroban] and/or its salt together with ethanol,…
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Tyco Healthcare Group LP v. Mutual Pharm. Co., No. 2010-1513 (Fed. Cir. 2011) by Scott P. McBride RESTORIL (temazepam) is a hypnotic (sleep-inducing) drug marketed for the treatment of insomnia. In a decision last month, the Federal Circuit affirmed the invalidity of two claims of U.S. Patent No. 5,211,954 directed to temazepam formulations. Claim 1 recites:…
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In Re: Cyclobenzaprine Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR (D. Del. 2011) In a strange turn of events, the district court that just eight days earlier found the asserted claims of the patents on Amrix invalid, granted a motion for a temporary restraining order against Mylan. As we previously reported, on May 12, following…
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In Re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR (D. Del. 2011) In an Opinion and Order issued today, the U.S. District Court for the District of Delaware found in favor of ANDA applicants Mylan, Barr and Anchen in the Amrix (Cyclobenzaprine HCl extended-release capsules) Paragraph IV litigation. The decision follows a bench trial that took…
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