Battle Over Plavix Patent Settlement Continues

In the past few weeks, two new chapters have been written in the ongoing dispute among the generic manufacturer Apotex and innovators Sanofi-Aventis (Sanofi) and Bristol-Myers Squibb (B-MS), over blood thinner Plavix. As previously discussed in E-TIPS®, Apotex reached a patent settlement agreement with Sanofi and B-MS, in which it would delay market entry of generic Plavix in exchange for remuneration. The deal was subsequently rejected by US state Attorneys General (See E-TIPS®, "Questions Remain Over the Legality of Patent Settlement Agreements" Vol 5, No 5, August 30, 2006). Shortly after rejection of the agreement, the Antitrust Division of the US Department of Justice launched an investigation into the negotiating practices of B-MS. On June 11, 2007, B-MS plead guilty in the US District Court for the District of Columbia to two criminal counts of violating the Federal False Statements Act (18 USC §1001). It has agreed to pay the maximum fine of $1 million. B-MS conceded that a former B-MS executive made statements to Apotex during the negotiation of the agreement, alluding to the fact that BMS would not launch an authorized generic if Apotex entered into the settlement agreement. These statements were later withheld from the Federal Trade Commission (FTC) during an investigation. Despite the guilty plea, B-MS continues to assert that it never entered into a side agreement with Apotex. Other events also unfolded quickly after the rejection of the agreement. Apotex attacked the validity of the Plavix patent, and flooded the market with its generic Plavix until it was barred from doing so by injunction (See E-TIPS®, "Plavix Ruling is Good News for Innovator Drug Companies" Vol 5, No 6, September 13, 2006). The bar prevented further sales until a decision was reached regarding the validity of the Plavix patent. On June 19, 2007, this highly anticipated validity decision was brought down in favour of Sanofi and B-MS (Sanofi-Synthelabo v Apotex Inc, 02cv2255, US District Court, Southern District of New York). Apotex's main attack on the Plavix patent, the argument that the patent was anticipated by a prior patent that claimed a class of compounds to which Plavix belonged, was given little credence by the Court because the class included millions of members. The ruling bars Apotex from selling generic Plavix until the expiry of the Plavix patent in 2011. Despite these recent events, the book in this dispute is far from closed. B-MS continues to be investigated by the FTC and New York State's Attorney General for its actions surrounding the negotiation of the settlement agreement, and Apotex has appealed the decision of the District Court. For a news release about the BMS guilty plea, see: http://biz.yahoo.com/prnews/070611/nym147.html?.v=84 For a news release about the validity decision, see: http://tinyurl.com/2pkmzj For the full reasons for judgment of the US District Court, visit: http://tinyurl.com/2ofcps Summary by: Michael Migus