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: Orange Book Issues
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The Federal Circuit today affirmed the D.N.J. decision that Teva's inhaler patents cannot be listed in the Orange Book, because they do not claim the drug for which the application was listed. As I wrote in my last post below, I thought Teva would have a hard time prevailing given that the patents at issue…
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As readers of this blog surely known, parties seeking to launch a generic drug must address the patents listed in the Orange Book for the reference listed drug. Listing of a patent in the Orange Book is a powerful tool for pharmaceutical patent owners, as it gives the right to an automatic 30 month stay…
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by: Rocco J. Screnci This is the second post in a two-part series on obviousness-type double patenting (“ODP”). Part one summarized the two recent precedential Federal Circuit decisions in this area. To sum up where last post left off: The Federal Circuit’s decision in Cellect initially seemed to drastically expand the application of ODP,…
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by: Rocco J. Screnci This post is the first in a two-part series about recent developments in the law of double patenting. This post provides relevant background and summarizes the Federal Circuit’s recent decisions in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023) and Allergan USA, Inc. v. MSN Laboratories Priv. Ltd.,…
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by Aaron F. Barkoff Novo Nordisk recently became the fourth company to ask FDA for guidance concerning whether patents on pre-filled drug delivery devices should be listed in the Orange Book. Novo markets several drug products as pre-filled pen-injector systems, including insulin and growth hormone products. In a Request for Advisory Opinion dated November…
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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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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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Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is a schizophrenia drug marketed by…
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As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief. Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA. Also last Friday, FDA appealed the D.C. district court’s decision requiring relisting of Janssen’s…
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Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete. The decision was affirmed without an opinion, under Rule 36. Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a…
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