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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The Biotechnology Industry Organization CEO, Jim Greenwood, spoke with reporters and bloggers Thursday morning about follow-on biologics and patent reform. Mr. Greenwood sounded optimistic that a forthcoming bill sponsored by Reps. Eshoo and Barton will represent a reasonable compromise between earlier proposals that stalled in Congress last year. Patent Docs has two posts summarizing the…
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Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity. This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA. FDA Law Blog posted a nice summary of FDA’s response. FDA Law Blog also posted on a very interesting case recently filed by…
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Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials). Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva’s citizen petition–namely, whether Teva’s failure to market its generic product within 30 months of ANDA submission caused forfeiture…
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Eisai announced yesterday that the district court in New Jersey recently dismissed its lawsuit against Mutual Pharma concerning Aricept ODT. The case was dismissed on jurisdictional grounds because Mutual has not challenged Eisai’s patent. The Wall St. Journal had an interesting article Wednesday about Sun Pharma’s generic version of Wyeth’s blockbuster antidepressant Effexor XR. AP…
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Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007) Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The ‘893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the ‘574 patent…
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Prof. Chris Holman, who has contributed to this blog in the past, recently started his own blog: Holman’s Biotech IP Blog. Formerly in-house counsel at a biotech company, Chris offers valuable insights on biotech IP law. “Big Pharma Faces Grim Prognosis” was the top story on the front page of the Wall Street Journal Thursday. …
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District Court Upholds Validity of Pfizer’s Accupril Patent, Rejecting Teva’s Nonenablement Argument
Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007) Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva’s ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva’s 2002 approval letter, Teva…
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The Lovenox patent infringement litigation between Aventis and Teva/Amphastar is making its second trip to the Federal Circuit. In February, following remand from the Federal Circuit last year, a federal district court in California held that the Lovenox patent is unenforceable due to inequitable conduct. The appeal may emerge as a litmus test of how…
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Merck v. Apotex, No. 06-5789 (D.N.J. 2007) Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998. In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent…
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King Pharmaceuticals filed its 10-Q statement with the SEC on Friday, revealing that Cobalt Pharmaceuticals, the first ANDA filer for Altace (ramipril), recently notified King of its intent to launch its generic ramipril product, notwithstanding the settlement agreement between the two parties (see pages 12 and 20 of King’s 10-Q filing). Ranbaxy submitted new comments…
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