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Executive Summary

BOOTS ATTEMPTING TO FLOOD U.S. MARKET WITH GENERIC IBUPROFEN, West Virginia Federal Judge William Kidd maintained in a July 16 ruling on Mylan v. Boots. Kidd noted that after analyzing the potential post-patent market for generic ibuprofen, Boots established a "generic ibuprofen task force" which recommended "a plan by which Boots would immediately develop its own line of generic ibuprofen and flood the American market with it at or prior to patent expiration before the generic companies could receive FDA approval." Kidd stated that the "market flooding" plan was approved on or about April 10, 1985 and Boots is "presently shipping vast quantities of generic ibuprofen all over the U.S. in an effort to monopolize the sub-market for generic ibuprofen." The court denied a Boots preliminary injunction which sought to delay Mylan's marketing of ibuprofen. Boots alleged that Mylan infringed two ibuprofen patents held by Boots. The infringement claim was in response to a March 12 filing by Mylan requesting a declaratory judgment that the Drug Price Competition and Patent Term Restoration Act authorized its making and using of ibuprofen in advance of FDA approval. Kidd stated that "the Hatch-Waxman Act 'expressly prohibited' the injunctive relief sought by the Boots parties." Under a provision of the law, firms may begin testing a drug prior to patent expiration. "Kidd further declared that "patent misuse bars the Boots parties' claim for infringement." He said Boots' "own marketing documents show that they used their patent to seek to extend their monopoly power into the post-patent period -- - the essence of patent misuse." In addition, he said "there is substantial evidence that the Boots parties 'market flooding' plan, which concededly lacked any legitimate business purpose, violates the statutory prohibition against attempts to monopolize." The court order pointed out that Boots has known for years that other companies were testing ibuprofen but took no action. For instance, the court noted that in 1982 Zenith "openly advertised in a trade journal that it was developing ibuprofen products." The court stated that in 1983 and 1984 bulk ibuprofen was sold by Conray Chemicals to at least Avon (Mallinckrodt), Chattem, Interchem, Mentholatum, Procter & Gamble, SmithKline, and Miles. In addition, the court said Bristol-Myers, Central Pharmaceuticals, Johnson & Johnson, Playtex USA, Rich-Vicks, and Thompson Medical also acquired quantities of ibuprofen for experiments prior to the Roche v. Bolar ruling in April 1984. According to the court, J&J has been testing ibuprofen in Switzerland since 1983 and "is likely to enter the market shortly." The court said ibuprofen has been "openly offered for sale in the Chemical Buyers Guide since at least 1979." Ibuprofen suppliers cited in the order include ACIC Ltd., Borge Internatl., Chugai Internatl., Conray Chemicals, European Manufacturing Associates (EMA), Flavine Internatl., GYMA, Interchem and SST. Kidd noted that in May 1984, Boots' Washington law firm Wiley & Rein sent letters to each of the companies who had advertised in the Chemical Buyers Guide but the letters "did not specifically claim infringement and did not demand that they cease importing or selling bulk ibuprofen." In December 1984, Kidd stated, Boots' parent, Boots PLC, entered an agreement with SST that released SST from liability in exchange for disclosure of the companies to whom SST had sold ibuprofen.

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