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Executive Summary

NIH TAKES AZT CO-INVENTOR CLAIM PUBLIC in a May 28 statement from National Institutes of Health Director Bernadine Healy, MD. "Over the last few months, NIH and Burroughs Wellcome have openly discussed their contrary positions regarding the inventorship of AZT, although no agreement was reached," Healy declared. As a result, Healy indicated that NIH supports Barr Laboratories' challenge of the patent. NIH is initially considering granting Barr a nonexclusive license to AZT. With the statement, the new NIH director is staking out a politically-attractive position with the AIDS patient groups. Healy has been the head of NIH for less than two months. The NIH challenge to B-W's position with AZT comes at a time when the drug's exclusive position as the only AIDS treatment appears to be nearing an end. If the price of AZT can be lowered via the introduction of a generic version, NIH may play an indirect role in pricing decisions on the next generation products, Bristol-Myers Squibb's ddl and Hoffmann-La Roche's ddC. Both companies filed NDAs this year for their products. Healy said licensure of AZT will depend on whether it is determined in litigation between Barr Labs and Burroughs Wellcome that NIH is co-inventor of the drug. If NIH is given inventorship status and Burroughs patent is ruled invalid, then NIH can grant a nonexclusive license to Barr. "NIH believes that investigators at the National Cancer Institute should have been named as co-inventors on the AZT- related patents issued to Burroughs Wellcome," Healy reiterated. She said NCI scientists evaluated the possible therapeutic value of AZT in early 1985 when Burroughs Wellcome had no facilities for research with live AIDS virus. "The intellectual and scientific contributions made by NCI to the evaluation of AZT were essential components of the invention of AZT therapy for AIDS," Healy asserted. "Given the relatively uncertain state of knowledge about AIDS and its treatment in late 1984 and early 1985, NCI's unique contributions of scientific acumen and evaluation systems cannot reasonably be characterized as conventional or confirmatory, a characterization that might preclude NCI's participation as being considered a part of the inventive process." Barr requested a nonexclusive license from NIH in connection with an ANDA for generic AZT it submitted to FDA on March 19. Barr notified Burroughs Wellcome on April 9 that it would be challenging the AZT patent ("The Pink Sheet" April 22, T&G-4). Barr's patent challenge followed an AZT patent suit filed in D.C. federal court by Public Citizen on March 18. The suit was filed on behalf of two AIDS patients and the People With AIDS Health Group ("The Pink Sheet" March 25, T&G-1). Public Citizen has asked the court to invalidate Burroughs Wellcome's patent, arguing that the use of AZT as an AIDS therapy was actually discovered by NCI scientists. The lawsuit contends that AZT could be imported by the PWA Health Group at a lower cost to patients if the AZT patent held by Burroughs Wellcome is invalidated. Burroughs Wellcome filed a motion to dismiss Public Citizen's suit May 13, and filed a lawsuit against Barr for patent infringement on May 14 in the Raleigh, N.C. federal court. Burroughs Wellcome alleges that the PWA Health Group has "no right or interest in illegally importing, distributing or consuming forms of AZT that have not been approved by the FDA" and therefore, the case is invalid. In the suit against Barr, Burroughs Wellcome argues that Barr's intent to manufacture and sell generic AZT would violate its patent. In a statement released by Burroughs Wellcome, the company maintained that the "basic conception of the use for the compound AZT for the treatment of human immunodeficiency virus infection was made by Burroughs Wellcome scientists."

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