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: Pharma Business News
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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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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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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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FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website. The comments come in response to FDA's request last month. A summary of the new comments is in the works. FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues. This too follows an FDA request made…
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Last Friday, FDA Law Blog wrote about yet another 180-day exclusivity letter from the FDA, this one requesting comment on the "failure to market" forfeiture provisions of the MMA. FDA Law Blog also posted a very nice summary of the FDA Amendments Act, which, among other changes, revises the citizen petition process. GSK sued the…
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FDA Law Blog has a great post about a very interesting district court decision concerning Apotex’s attempt to market generic Prilosec before AstraZeneca’s pediatric exclusivity expires. Congress passed FDA reform legislation this week, albeit without provisions for biosimilars. (AP article; FDA Law Blog; PhRMA release). In the Pipeline is a great blog by a medicinal…
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Novartis announced last week that European regulators have approved its follow-on biologic epoetin alfa, which is biosimilar to J&J’s Eprex. Pharmalot posted this story today about J&J’s reaction. The WSJ Health Blog had this interesting post last week reporting that more clinical trials are now under way in China than in India. Adams Respiratory Therapeutics…
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The Wall St. Journal Health Blog had an interesting post Thursday on how Genzyme’s struggle to produce enough Myozyme heightens worries about generic biotech drugs. The New York Times published an interesting article Wednesday on the recent "tidal wave" and the coming "golden era" of generic drugs. Novartis lost its challenge to India’s drug patent…
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FDA Law Blog had a post Thursday about "The Dog Ate My Homework Act," which would give a reprieve to companies that miss the deadline for filing a patent term extension request. Pharmalot had this post Wednesday, reporting that Congress has delayed the FDA bill until September. Patently-O reported Wednesday on the Federal Circuit’s decision…
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