WARNER-LAMBERT FILES SUIT TO INVALIDATE THA PATENT

WARNER-LAMBERT FILES SUIT TO INVALIDATE THA PATENT held by California physician. The complaint, filed in Los Angeles Federal Court the week of May 7, seeks declaratory judgment that a patent held by Arcadia, California psychiatrist William Summers, MD, for the use of THA (or tacrine) as a treatment for Alzheimer's disease is "invalid, not infringed by plaintiff...and unenforceable against plaintiff." The complaint asked that Summers be "permanently enjoined from suing or threatening to sue, or making any charge against" the firm. Warner-Lambert is claiming that Summers "failed to disclose and/or misrepresented knowledge, information, prior art and data pertinent to the examination" of the patent. The company said it has been in licensing negotiations with Summers for four years, but that those recently broke down with Summers threatening to bring a patent infringement suit against the firm. The complaint adds that Summers "sent proposals for licensing the patent to some 82 other pharmaceutical companies on or immediately prior to the day of defendant Summers' last meeting with Warner-Lambert." The firm said it plans to file an NDA for THA (Cognex) for treating Alzheimer's disease "in the immediate future, and no later than June 15." Denying that he has been in negotiations with Warner-Lambert for four years, Summers contended that he and company representatives met only twice, in 1987 and on May 3 of this year. Negotiations broke down, in part, because Warner-Lambert offered to pay one-fourth of 1% of sales as royalties rather than the "normally expected" range of 5-15%, Summers told "The Pink Sheet." He has not yet responded to the lawsuit. However, Summers maintains that the patent is fully valid: "We can't find anything to disparage this patent." The California psychiatrist acknowledged that he sent booklets discussing the patent to 82 PMA member companies to counter Warner-Lambert's alleged contention that no one else would be interested in the patent rights. The booklet discusses the patent, which covers the chemical composition of THA and its variations, as well as THA's use in treating Alzheimer's. Summers said that he had an agreement with Pfizer on the patent, but the agreement was terminated last year. Although he maintains that he talked seriously with four other companies, he said that he had agreements only with Pfizer and the British firm, Shire Pharmaceutical. Warner-Lambert recently acquired Shire's data on THA clinicals ("The Pink Sheet" April 23, "In Brief").