Apotex Inc. must be confident the patent on Plavix will be held invalid. In a gutsy move for a generic drug maker, Apotex (the Welterweight from Winnipeg) started shipping a generic copy of the blood thinner Plavix in the U.S., ahead of a likely patent infringement trial. A New York judge has denied a request for a temporary restraining order. For an injunction, the drug makers need to prove that their patent infringement action is likely to win on the merits, that they will be irreparably harmed by sale of the generic, and that it is in the public’s best interest to stop the generic’s release.

This is the latest development in a legal morass that has developed between Apotex and the brand name drug co-marketers, Sanofi-Aventis SA and Bristol-Myers Squibb Co., after their deal that would have delayed bringing a generic to market for another five years was blocked.

Earlier, Apotex agreed to delay selling its drug until 2011, the year that the patent protecting Plavix expires, in return for a minimum of $40-million from Bristol and Sanofi. In return, Apotex would be allowed to introduce its version of Plavix before the patent expired sometime in 2011.

However, the U.S. Federal Trade Commission and state attorneys-general rejected the three-way deal, leading to a criminal investigation by the Department of Justice. The DOJ’s Antitrust Division has already served subpoenas on Bristol, its CEO and another executive.

Under the revised settlement agreement that the attorneys general rejected, Bristol and Sanofi could collect damages equal to 40-50% of Apotex’s net sales of the generic drug. In addition, the companies waived their right to seek triple damages under applicable patent laws if they were to prevail in the pending patent litigation.

As described in the 10-Q filing by Bristol-Myers Squibb, the settlement terms included that in the event of Regulatory Denial, the litigations will be resumed, and:

If the litigation results in a judgment that the ‘265 patent is not invalid or unenforceable, Sanofi agrees that its actual damages for any past infringement by Apotex, up to the date on which Apotex is enjoined, will be 50% of Apotex’s net sales of clopidogrel products if Sanofi has not launched an authorized generic and 40% of Apotex’s net sales if Sanofi has launched an authorized generic. Sanofi further agrees that it will not seek increased damages under 35 U.S.C.§284.

There’s quite a bit at stake, though, given last year’s sales of Plavix of $6.3 billion. That’s a lot of $4-a-day pills.

The FTC has looked into “reverse payment” deals before, where brand-name pharmaceutical companies pay generic drug makers to keep generics off the market. According to the FTC, half of the top 20-selling brand-name drugs are covered under such deals, and lawsuits have been filed challenging deals that delay generic versions of Lipitor, Celebrex and Protonix.

At least a dozen U.S. lawsuits have also been filed against Bristol, Sanofi and Apotex on behalf of direct purchasers over trying to keep a cheaper generic version of Plavix off the market. A trial on the patent had been set for June and was cancelled because of the earlier settlement. No new date has been set.

The disputed patent, U.S. Patent No. 4,847,265 (the ’265 patent), covers Plavix’s main ingredient and does not expire until 2011. The first patent covering Sanofi’s oral antiplatelet chiral drug clopidogrel bisulfate (US 4,529,596), was filed in 1983 and expired in July 2003, and claims both enantiomers and their mixture, whereas the ‘265 patent, due to expire in 2011, claims only the (+)-enantiomer.

The earlier patent claimed, but did not describe, the (+)- and (–)-enantiomers, although it states that “the invention relates both to each enantiomer and their mixture.” In the description of the activities of each enantiomer in the ‘265 patent, data show that the (+)-enantiomer is pharmacologically superior in activity and less toxic than both the (–)-form and the racemate. Apotex claims the ‘265 patent is either invalid or would not be infringed by its proposed generic product.

Contrary to earlier signs, this latest round of events may portend that the ability of patent holders to settle disputes may be moving away from favoring branded drug firms.

Get ready to rumble.

  Print This Post Print This Post  

Comments are closed.