Supreme Court Declines Apotex Appeal Of Plavix Suit

By Richard Vanderford

Law360, New York (November 02, 2009) -- Apotex Inc.'s legal dispute with Sanofi-Aventis over blood-thinning drug Plavix has hit a dead end, with the U.S. Supreme Court refusing to hear the generic-drug maker's arguments over whether substances produced by so-called obvious-to-try experiments should be patentable.

The Supreme Court denied Apotex's petition for a writ of certiorari Monday, the last in a string of decisions against Apotex in the dispute.

Sanofi sued Apotex in 2002, shortly after the generics maker filed an abbreviated new drug application to market clopidogrel bisulfate, sold by Sanofi and Bristol-Myers Squibb Co. as Plavix.

Both the district court and the U.S. Court of Appeals for the Federal Circuit had previously found against Apotex, shooting down the generics makers' arguments as to what should be given more weight: the predictability of an experiment's outcome, or the novelty of trying the experiment in the first place.

Plavix petitioned the Supreme Court on May 28, after the Federal Circuit denied its request for rehearing.

According to Apotex, the case hinged on whether Plavix’s active ingredient is obvious in light of an earlier discovery, the racemic mixture containing that ingredient.

A racemic mixture contains two enantiomers — chemicals whose structures are exact mirror images that cannot be superimposed on one another, like a person’s left and right hand.

Plavix patented the racemic mixture containing Plavix’s active ingredient, the enantiomer clopidogrel, before patenting the isolated active ingredient itself several years later.

Apotex contended that isolating an enantiomer from a mixture is an obvious step for a researcher, and that Plavix’s extra eight years of exclusivity gained by the grant of the second patent was unjustified.

Based on the Supreme Court’s decision in KSR International Co. v. Teleflex Inc., the second patent should be ruled obvious, Apotex said.

“The basic lesson of KSR is that not every incremental advance should qualify for 20 years of exclusivity,” it said.

The company also pointed to what it called “intractably inconsistent” rulings of Federal Circuit panels with respect to the issue, saying the Supreme Court should weigh in to settle it.

Sanofi countered that Plavix's own experts admitted they could not predict the properties of the isolated chemical without running the experiments, and that that unpredictability affirmed the substance's patentability.

The KSR precedent requires that an experiment deemed obvious to try has a “predictable” outcome and “anticipated success,” Sanofi said.

Beyond that, Sanofi's approach in making Plavix was inventive in itself, and so the case was an “especially poor vehicle” for considering the question Apotex presented, Sanofi claimed.

Representatives for Apotex and Sanofi did not immediately respond to requests for comment.

The patent-in-suit is U.S. Patent Number 4,847,265.

Robbins Russell Englert Orseck Untereiner & Sauber LLP represents Apotex.

Cravath Swaine & Moore LLP represents Sanofi.

The case is Apotex Inc. et al. v. Sanofi-Synthelabo et al., case number 09-117, in the U.S. Supreme Court.