Orange Book Blog

There’s been a lot of news lately in pharmaceutical patent cases.  Summaries are below.  I’ve updated the Hatch-Waxman Tracker to include the new lawsuits.

New lawsuits filed:

• Biovail Laboratories filed a new lawsuit against Andrx Pharmaceuticals over Andrx’s attempt to market generic Cardizem.
• Novartis sued Par Pharmaceuticals, the third and most recent company to file an ANDA for generic Lotrel.
• Schering-Plough sued over a dozen companies who filed ANDA’s to market generic versions of Clarinex.

New settlements reached:

• Alza Corp., a subsidiary of Johnson & Johnson, dropped its lawsuit against Impax relating to Impax’s ANDA to market a generic version of Concerta.  Concerta, a treatment for Attention Deficit Disorder (ADD), had sales of $846 million last year.  Alza had also sued Andrx over its own ANDA, but the Stipulated Order dismissing the suit did not mention the case against Andrx.  Source:  Impax press release.
• Solvay Pharmaceuticals settled patent litigation with generic drug makers Par Pharmaceutical Cos. and Watson Pharmaceuticals Inc. over Solvay’s AndroGel drug product.  AndroGel, a treatment for testosterone deficiency, had sales of $225 million in 2002.  Watson, the first ANDA filer, will be allowed to begin marketing its generic product no later than August 31, 2015, which is five years before Solvay’s patent on AndroGel expires.  Par will co-promote AndroGel for $10 million a year beginning in 2006 and will.be allowed to launch its generic product no later than February 28, 2016.  Source:  Solvay press release.
• GlaxoSmithKline and Dr. Reddy’s settled their litigation over generic Imitrex, with the parties agreeing that Dr. Reddy’s will sell an authorized generic version of Imitrex in late 2008, before GSK’s patents on Imitrex expire in February, 2009.  Imitrex, a medication to treat headaches, had sales of $890 million last year.  Source:  MarketWatch article.

New court decisions:

• Eisai won summary judgment of patent validity in its lawsuit against Teva and Dr. Reddy’s over generic Aciphex (rabeprazole).  Aciphex is a proton-pump inhibitor indicated for the treatment of ulcers, and had sales of $1.2 billion last year.  The opinion by Judge Gerard E. Lynch of the Southern District of New York states that the claims of Eisai’s U.S. Patent No. 5,045,552, would not have been obvious because there was no teaching, suggestion, or motivation to combine three prior art references.  Some observers believe the “suggestion test” will be discarded by the Supreme Court in KSR v. Teleflex, currently pending before it, which would affect this case.  Source:  Eisai press release.

As always, please e-mail me with any new information to add to the Hatch-Waxman Tracker.