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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Altana Pharma AG and Wyeth v. Teva Pharms. USA, No. 04-2355 (D.N.J. 2007) Last Thursday, a federal district court denied Wyeth’s motion for a preliminary injunction that would have prevented generic drug manufacturer Teva from launching its generic version of Protonix. The opinion denying Wyeth's motion was filed under seal; only the order is publicly…
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Forest Labs. v. Ivax Pharms. and Cipla, No. 2007-1059 (Fed. Cir. 2007) In an opinion released today, the Court of Appeals for the Federal Circuit affirmed a district court decision that upheld the validity of Forest Labs’ U.S. Reissue Patent 34,712, which covers (+)-citalopram, the active ingredient in Lexapro. Teva, seeking to market a generic…
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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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As The Wall Street Journal reported last week, the U.S. Patent and Trademark Office has issued an initial rejection of Pfizer’s application for a reissue patent of U.S. Patent No. 5,273,995–one of two Pfizer patents covering Lipitor. In a decision last August, the Court of Appeals for the Federal Circuit upheld one Pfizer patent on…
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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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Indian generic drug manufacturer Ranbaxy announced last week that the company has settled its litigation with GlaxoSmithKline over generic Valtrex. Ranbaxy received final FDA approval for its generic drug earlier this year. Under the agreement, the generic will launch in the second half of 2009 and Ranbaxy will retain 180-day exclusivity. GSK's U.S. Patent No.…
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FDA Law Blog reported Monday that the proposed follow-on biologics legislation is in serious jeopardy in Congress. Pharmalot had a similar report last Friday. Meanwhile, European regulators recently granted approval to three new biosimilar drugs, as Patent Docs reports today. The San Francisco Chronicle recently published a nice article summarizing the debate over generic biotech…
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In re Metoprolol Succinate Patent Litigation, No. 2006-1254 (Fed. Cir. 2007) On Monday, the Federal Circuit affirmed a district court summary judgment decision that AstraZeneca's U.S. Patent No. 5,081,154 is invalid for double patenting. The '154 patent claims metoprolol succinate, the active ingredient in Astra's blockbuster cardiovascular drug Toprol-XL. KV Pharmaceutical, Andrx, and Eon Labs…
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Daiichi Sankyo Co. v. Apotex, No. 2006-1564 (Fed. Cir. 2007) In a nonprecedential opinion released today, the Federal Circuit reversed a district court decision that held Daiichi Sankyo’s U.S. Patent No. 5,401,741 not invalid for obviousness. The ‘741 patent claims a method for treating bacterial ear infections by topically administering the antibiotic ofloxacin (marketed by…
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Last week, the U.S. District Court for the District of Columbia denied Mylan’s emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer’s Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer’s patent, Mylan and Apotex had the only approved ANDAs for generic Norvasc. Bloomberg reported…
Orange Book Blog 