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: Antitrust
-
Tyco Healthcare et al. v. Mutual Pharm. et al., No. 2013-1386 (Fed. Cir.) by Aaron F. Barkoff In 2006, Mutual filed an ANDA for a generic version of Restoril (temazepam), including a paragraph IV certification to Tyco's U.S. Patent No. 5,211,954. Tyco filed suit against Mutual under 35 USC 271(e)(2), Mutual responded with antitrust…
-
Federal Trade Comm'n v. Actavis, Inc., 570 U.S. ____ (2013) by Aaron F. Barkoff The U.S. Supreme Court, in a 5-3 opinion, decided today that "reverse payment" settlements of ANDA litigation shall be analyzed according to the "rule of reason." Thus, the Court compromised between the positions urged by the parties: that such settlements…
-
by Alex Menchaca "Product hopping" is the practice of changing the formulation of an approved Reference Listed Drug to stay one step ahead of the generics seeking to compete with the RLD. In July, Mylan Pharmaceuticals filed an antitrust complaint accusing Warner Chilcott of engaging in product hopping in connection with its Doryx product,…
-
In Re: K-Dur Antitrust Litigation, No. 10-2077 (3d Cir.) In what antitrust experts are calling a "landmark" decision, the Third Circuit Court of Appeals on Monday held that so-called "pay-for-delay" or "reverse payment" settlement agreements are presumptively anticompetitive and illegal. In 2005, the Eleventh Circuit Court of Appeals, analyzing the same settlement agreements at issue…
-
In a press release today, the Federal Trade Commission announced that it "has notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V., that it believes the companies violated federal law by failing to inform antitrust authorities about drug patent agreements involving Sanofi's insomnia drug Ambien CR." According to the release, "the FTC staff…
-
On Tuesday, the Federal Trade Commission released its report on Paragraph IV litigation settlements filed in Fiscal Year 2010 (Oct. 2009 through Sept. 2010). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires pharmaceutical companies to file certain agreements, including settlements of Paragraph IV litigation, with the FTC and Department of Justice. …
-
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…
-
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…
Orange Book Blog 