Month: June 2007
-
On Monday, the Supreme Court followed the Solicitor General’s advice and denied certiorari in Joblove v. Barr Labs, which concerned the legality of a "reverse payment" settlement of Hatch-Waxman litigation. Last year, the Court denied certiorari in a similar case, FTC v. Schering. Dow Jones reports that the FTC has vowed to press forward in…
-
Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) In an opinion released today, the Federal Circuit affirmed the validity of Takeda's U.S. Patent No. 4,687,777, which covers pioglitazone HCl (among other compounds). Pioglitazone HCl is the active ingredient in ACTOS, Takeda's blockbuster drug for the treatment of type 2 diabetes. The decision is particularly important…
-
MarketWatch.com is reporting this afternoon that the Senate Committee on Health, Education, Labor and Pensions has voted in favor of the Biologics Price Competition and Innovation Act of 2007. It is unclear whether the Committee amended the bill before voting on it. The bill will now move to the Senate floor. RELATED READING: Bloomberg Pharmalot
-
After several previous bills went nowhere, lawmakers may have finally reached a viable compromise on follow-on biologics legislation. Last Friday, a bipartisan group of Senators led by Ted Kennedy (D-MA) and Orrin Hatch (R-UT) announced an agreement on a new bill that would establish an abbreviated pathway for FDA approval of biologic drugs. The Senate…
-
Informa Life Sciences will hold its 2nd annual "Legal Strategies for Developing Generic Medicines" conference July 9-11 in Amsterdam, The Netherlands. ILS announces that the conference offers "the unrivalled opportunity to hear how the latest updates in the European Pharmaceutical Legislation and issues in patent litigation will affect your generics business." According to the conference…
-
Pharmalot had this post Friday about a new bipartisan follow-on biologics bill in the Senate. MarketWatch reported Friday that European regulators have moved a step closer to approving Sandoz’s follow-on version of J&J’s blockbuster Eprex, sold in the U.S. as Procrit. On Thursday, a House committee marked up the PDUFA reauthorization legislation (Pharmalot). PhRMA reacted…
-
Sanofi-Synthelabo et al. v. Apotex, No. 02-2255 (S.D.N.Y. 2007) Following a month-long trial held earlier this year, in an opinion released today a federal district court upheld the validity of Sanofi's U.S. Patent No. 4,847,265. The '265 patent covers clopidogrel bisulfate, the active ingredient in Plavix. The court permanently enjoined Canadian generic drug maker Apotex…
-
Novartis v. Teva, No. 04-4473 (D.N.J. 2007) Yesterday, a federal judge denied a preliminary injunction motion filed by Novartis to protect Lotrel from generic competition. With the decision, Teva likely resumed shipping its generic version of Lotrel before nightfall. After all, Teva had already made an initial launch on May 18 – a launch that…
-
SCOTUSblog reported on Wednesday that the Supreme Court has denied Pfizer’s emergency application for relief from the Federal Circuit’s ruling in the Norvasc case. TheStreet.com also has an article on the Supreme Court’s decision. On Tuesday, the Federal Circuit granted Mylan’s motion for summary reversal of the district court decision that had found Pfizer’s Norvasc…
Orange Book Blog 