U.S. District Judge Sidney H. Stein in Manhattan issued an injunction blocking the sale of generic Plavix® (clopidogrel bisulfate) after a two-day hearing (Sanofi-Synthelabo v. Apotex Inc., 02cv2255, U.S. District Court for the Southern District of New York). Sanofi-Aventis SA and Bristol-Myers Squibb sought the preliminary injunction against Apotex Inc . to stop sales of the generic drug citing the likelihood that they will prevail in the patent case and that Apotex’s launch last week is causing them irreparable harm. The judge also denied demands by the companies that Apotex be forced to remove from the market the generic product it had already sold to distributors.

The judge said Sanofi had demonstrated that questions Apotex raised as to the validity and enforceability of its patent were without substantial merit and he also concluded Sanofi would suffer irreparable harm if Apotex were permitted to continue selling the generic while any detriment to Apotex was a result of the company’s own calculated risk-taking. The judge also considered the public interest of permitting competition to continue noting that “although there are competing — and substantial — public interests at stake on both sides of this litigation, the balance of those competing public interests slightly favors Sanofi, the public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market.”

The judge said he based his decision on the chances that Apotex could ultimately prove it is entitled to sell its generic drug; the level of irreparable harm each side might suffer; the balance of hardships; and the impact on the public. He also ordered Sanofi to put up bond of $400 million, an amount meant to cover losses Apotex will have suffered if it eventually wins the case. The Canadian drug maker had requested $4 billion; Sanofi and Bristol-Myers argued for $25 million. Apotex said the bond amount was “grossly inadequate” to compensate for the damages it was in jeopardy of incurring, which gives you a glimpse at just what’s at stake in this case – last year’s sales of Plavix were $6.3 billion. It didn’t hurt that an accountant testified for Apotex that the company stood to lose up to $4 billion in costs, future sales and lost opportunity if it was forced to withdraw its drug from the marketplace.

Earlier, Apotex agreed to delay selling its drug 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. State attorneys general, who must approve arrangements between Bristol-Myers and generic drug makers as a result of earlier litigation, rejected the deal between the drug companies. As we said before, this is far from over since the U.S. Federal Trade Commission has initiated a criminal investigation by the Department of Justice. FBI agents have already confiscated documents at Bristol-Myers’ New York headquarters, and both companies received grand jury subpoenas to determine if the agreement broke antitrust laws.

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. Apotex claims the ‘265 patent is either invalid or would not be infringed by its proposed generic product.

While Sanofi could win the suit against Plavix over the generic, the preliminary injunction may only buy some extra time. Then again, even if the patent is later upheld in court, penalties would be limited under the terms of its deal with Sanofi and Bristol-Myers.

Apotex said it will appeal and it is filing an emergency motion with the Court of Appeals for the Federal Circuit to stay the injunction pending the appeal.

See earlier posts from the Patent Baristas:

Update: Sanofi and Bristol-Myers File for Preliminary Injunction Against Apotex
Apotex To Launch Generic Plavix At Its Own Risk
FTC Rejects Patent Deal by Bristol-Myers and Sanofi
Does Sanofi-Aventis Patent Settlement With Apotex Reveal a Trend?

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