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?
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Section viii Statements
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GlaxoSmithKline v. Teva, No. 18-1976 (Fed. Cir. 2020) by Alex Menchaca In our last post, we reported that Chief Judge Stark of the District of Delaware granted Judgment as a Matter of Law of no induced infringement in a case concerning Coreg® (carvedilol) tablets, wiping away a $200 million jury verdict in favor…
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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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AstraZeneca Pharms. v. Apotex et al., No. 11-1182 (Fed. Cir.) In a precedential decision today, the Federal Circuit held for the first time that an ANDA applicant who files a Section viii statement with respect to a method-of-use patent and, accordingly, does not seek approval of its ANDA product for the patented use, cannot be…
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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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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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