Federal Circuit Affirms Preliminary Injunction in Plavix Case

Last Friday, a unanimous panel of the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision that granted a preliminary injunction against Apotex in the Plavix case.  The result is not a surprise, given that the Federal Circuit took over five weeks to release its opinion.  The court heard the appeal on an expedited schedule and likely would have released an opinion sooner had it reversed the district court.

Apotex conceded that its generic version of Plavix infringes Sanofi's U.S. Patent No. 4,847,265, leaving the validity and enforceability of the '265 patent as the key issues.  In a twenty-seven page opinion written by Judge Lourie, the Federal Circuit methodically discusses each of Apotex's invalidity arguments (anticipation, obviousness, and obviousness-type double patenting) and its unenforceability argument (inequitable conduct), and concludes that the district court properly disposed of each one.

Apotex's lead argument was that Sanofi's own U.S. Patent No. 4,529,596 anticipated the '265 patent and rendered it obvious.  Apotex argued that claim 2 of the '596 patent, directed to the free base of a compound the parties called "MATTPCA," inherently anticipated claim 3 of the '265 patent, directed to the d-enantiomer of the bisulfate salt of MATTPCA (clopidrogel bisulfate, the active ingredient in Plavix).  The Federal Circuit, however, determined that the district court correctly found that "a person of ordinary skill in the art would not be led to the bisulfate salt."  The court likewise found that the district properly rejected Apotex's obviousness argument, noting "the extensive time and money Sanofi spent developing the racemate before redirecting its efforts toward the enantiomer, and the unpredictability of salt formation."

Thus, the Federal Circuit agreed with the district court that Sanofi had satisfied the first of four factors required to obtain a preliminary injunction:  likelihood of success on the merits.  The second factor, whether there would be irreparable harm if an injunction did not issue, is often presumed in patent cases upon a showing of liklihood of success.  Interestingly, in this case Apotex suggested that the district erred by applying a presumption of irreparable harm, arguing that such a presumption directly conflicts with the Supreme Court's recent decision in eBay v. MercExchange.  However, the Federal Circuit sidestepped this argument, concluding that the district court properly found several kinds of irreparable harm in any event, including irreversable price erosion.

The next stage of the case will be a trial before Judge Sidney H. Stein of the U.S. District Court for the Southern District of New York, the same judge who granted the preliminary injunction against Apotex back in August.  The trial is scheduled to begin on January 22, 2007.

RELATED READING:

• More at Patent Docs
• Dec. 8, 2006 Bloomberg.com article
• Nov. 28, 2006 OnThePharm post: Pharmacy supplies of generic Plavix run low
• Earlier Orange Book Blog posts on the Plavix case: Aug. 8, 2006; Sept. 21, 2006; Nov. 2, 2006