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
-
Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt. For more: AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis. Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…
-
The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements. For commentary, see FDA Law Blog, Pharmalot. Wyeth sued Sandoz over a generic version of Protonix I.V. The WSJ Health Blog recapped all the Protonix ANDA litigation. India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot…
-
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…
-
Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday. The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product. In what is being reported as a setback for…
-
Earlier this week, FDA Law Blog provided an update on Teva’s suit against the FDA, seeking relisting of Janssen’s patent on Risperdal (risperidone) and confirmation of Teva’s 180-day exclusivity on a generic version of the drug. Last week, FDA Law Blog reported on a recent FDA determination that Watson Labs forfeited its 180-day exclusivity on…
-
Last Friday, Rep. Anna G. Eshoo (D-CA) announced that she and Rep. Joe Barton (R-TX) introduced H.R. 5629, the "Pathway for Biosimilars Act" (click here for summary; click here for text of bill). BIO immediately applauded the bill, while GPhA immediately denounced it. For more, visit FDA Law Blog; Pharmalot; or the WSJ Health Blog.…
-
The New York Times had another article Thursday on the investigation into the Chinese supply of heparin. Pharmalot had this related post Friday. FTC Commissioner Jon Leibowitz wrote an editorial for the Washington Post Monday on "reverse-payment" settlements (or "pay-for-delay" settlements), and the FTC’s recently filed case against Cephalon, in particular. Dow Jones reported Monday…
-
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…
-
Fosamax, Merck’s blockbuster osteoporosis drug, went generic on Wednesday. The In Vivo Blog posted an interesting report on the unusual steps Merck took to promote Fosamax in the last month, before its patents expired. The WSJ Health Blog posted an interesting story this week on contributions from the pharmaceutical industry to the presidential candidates. Apparently…
-
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…
Orange Book Blog 