In March, we blogged about the settlement of the patent case between Bristol Myers Squibb/Sanofi-Aventis and Apotex relating to Apotex’s generic version of Plavix.  At some point in the last week or so, the parties revised the settlement agreement.  On June 24, the Wall Street Journal reported that agreement was revised (print article is behind a firewall, sorry about the lack of a link).  The Journal reported:

A Bristol-Myers spokesman wouldn’t confirm that the deal that it announced in March was dead, nor that it had worked out a revised deal. But an assistant attorney general in Maryland involved with reviewing the deal said the first one was rejected and the company has since submitted a new plan. Whether the new proposal includes a shorter time for patent protection for Plavix than was agreed to in March couldn’t be determined. … After having the first agreement rejected, Bristol-Myers submitted a “revised agreement,” said Meredyth Smith Andrus, assistant attorney general in the antitrust division in Maryland, who is working with the FTC in the matter. Ms. Andrus wouldn’t say which way the states or the FTC were leaning, nor when a decision is expected. Generally, the states have as many as 60 days to make a determination, but Ms. Andrus wouldn’t say when the revised agreement was submitted. Ms. Andrus said it was “highly unlikely” that the states and the FTC would come to conflicting conclusions about whether to approve the revised deal. In the past, the FTC has voiced opposition to branded-drug companies’ frequent settlements of patent challenges with generic makers, contending that they stymie competition and hurt the consumer.

Later that day and on the following day, the wires picked up the story (Bloomberg, AFX and Reuters).  And APX and Reuters report that (quoting Reuters  ”Under the terms of the agreement, Apotex will get the license to manufacture and sell its generic product on June 1, 2011, rather than the previously agreed-on date of Sept. 17, 2011.” 

I find it interesting that moving the date forward by three-and-a-half months would/could affect the FTC’s and state attorneys general’s decision.  Nonetheless, the parties are sophisticated entities with quality counsel and perhaps they have calculated the this three-and-a-half month reduction will result in the pro-competitive effects outweighing the anti-competitive effects.

[Update: Bristol has issued a press release.]

Technorati Tags: antitrust, Plavix

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