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Category: Paragraph IV Cases
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Eisai v. Teva Pharms. USA, No. 10-1070 (U.S. 2011) In a little-noticed decision two weeks ago, the Supreme Court vacated the Federal Circuit's decision in Teva v. Eisai and remanded the case with instructions to dismiss it as moot. The Court's decision (found on the Order List of June 13) is significant in that it vacates a…
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"The MMA generally precludes multiple 30-month stays for those applications to which it applies." That is a statement from the FDA in a draft guidance document entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement and Modernization Act of 2003," published in October…
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Obama Administration Urges Supreme Court to Grant Certiorari in Case on Orange Book Patent Use Codes
Caraco Pharm. Labs. v. Novo Nordisk, No. 10-844 (U.S. 2011) Last week, in response to the Supreme Court’s request for its views, the Solicitor General’s office filed an amicus brief in Caraco v. Novo Nordisk and urged the Court to take the case. At issue is the “patent delisting counterclaim” provision of the 2003 Medicare…
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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 Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR Last Thursday, the U.S. District Court for the District of Delaware invalidated the asserted claims of two patents protecting Amrix (cyclobenzaprine), clearing the way for Mylan to launch its generic version (albeit at-risk). On Friday, Mylan announced that it did just that, with 180-day exclusivity. Today,…
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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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AstraZeneca Pharms. et al. v. Apotex et al., No. 10-338 (D. Del. 2010) Crestor (rosuvastatin) is FDA-approved for the treatment of various cholesterol-related conditions, including hyperlipidemia, hypertriglyceridemia, homozygous familial hypercholesterolemia (HoFH) and heterozygous familial hypercholesterolemia (HeFH), and for the prevention of cardiovascular disease in patients with elevated levels of C-reactive protein. The uses of rosuvastatin for…
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Teva Pharm. Indus. v. AstraZeneca Pharms., No. 08cv4786 (E.D. Pa. 2010) Here's something you don't see every day: an ANDA filer suing a brand-name drug manufacturer for patent infringement, claiming that the brand-name drug infringes the ANDA filer's patent. In late 2007/early 2008, AstraZeneca ("AZ") filed suit against nine different ANDA filers, including Teva, who…
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Abraxis Bioscience v. Navinta, No. 2009-1539 (Fed. Cir. 2010) In 2006, Navinta filed an ANDA for a generic version of Naropin (ropivacaine), a drug indicated for use in surgical anasthesia and acute pain management. At the time, there was only one patent listed for ropivacaine in the Orange Book, U.S. Patent No. 4,870,086, which claims…
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Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010) By a vote of 5-4, the Federal Circuit on Monday denied Eli Lilly's petition for panel rehearing or rehearing en banc from the court's July decision that affirmed the invalidity of Lilly's U.S. Patent No. 5,426,826 for obviousness-type double patenting. Judge Newman was…
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