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BURROUGHS WELLCOME WINS PATENT LAWSUIT

 NEW BERN, N.C., July 22 /PRNewswire/ -- The United States District court in New Bern, N.C., today ruled in favor of Burroughs Wellcome Co. and granted judgment upholding the designation of company employees as the sole inventors on patents for the use of the AIDS medication Retrovir(R) brand zidovudine (AZT) as a treatment for people with HIV disease. The decision rejected the contention of the defendants that employees of the National Institutes of Health should be named as co-inventors with the Burroughs Wellcome scientists.
 The court found that "the evidence in this case is overwhelming and conclusive that the B.W. Co. inventors, and only the B.W. Co. inventors, first conceived of the idea of using AZT as a therapy for treating persons infected with HIV."
 In his ruling, Judge Malcolm Howard, Eastern District of North Carolina, stated, "The pleadings in the case and the evidence presented in three weeks of trial testimony satisfy the court without doubt that no legally sufficient evidentiary basis exists for a reasonable jury to find that the B.W. Co. inventors did not have a complete conception of the invention independent of the testing performed by Dr. Broder and Dr. Mitsuya.
 Patent position was strong
 "We never had any doubt that Burroughs Wellcome scientists alone discovered the use of AZT as a treatment for HIV infection and AIDS," said Philip R. Tracy, president and chief executive at Burroughs Wellcome Co. "This litigation has been a heavy burden to the company both in terms of time and resources, and we are pleased that our scientists will be able once again to turn their full attention to their search for new medicines for poorly understood and inadequately treated diseases."
 Paul A. Holcombe Jr., vice president and general counsel for Burroughs Wellcome, said the company's invention of AZT as a treatment for HIV infection is exactly what the patent laws are designed to protect. "This decision is a total rejection of the government's often-cited argument that NIH employees should have been named as inventors on the AZT patents. We knew from the beginning that this was not true," he said.
 "This decision is well-reasoned, thoughtful and consistent with more than 100 years of patent law," he continued. "We are grateful to the Court for the time and attention given the issues in the case. We are also grateful to the 12 people who have served as jurors. Each of them has been listening intently to the facts and paying close attention to what at times has been very complicated evidence."
 Court adopts Wellcome position
 The Court held that Burroughs Wellcome had established that its scientists had a definite and permanent idea of the invention of the use of AZT as a treatment for HIV infection by Feb. 6, 1985, weeks before the NIH employees knew what it was. Judge Howard's decision reaffirmed that the patent law does not require that the inventors prove that their invention will work at the time when the discovery is made.
 During the course of the trial, Burroughs Wellcome proved that the written record of its research, including the selection and testing of AZT, and its decision to promptly obtain patent protection were well-documented. All of these events occurred before the NIH scientists screened AZT at the company's request and under an agreement of confidentiality.
 In addition, the court ruled that the evidence supporting Burroughs Wellcome's position is equally compelling with respect to the particular patent claiming the use of AZT to increase a patient's T-lymphocyte count, a point challenged by the defendant Novopharm. The Court also dismissed Novopharm's claim that Burroughs Wellcome engaged in inequitable conduct before the U.S. Patent and Trademark Office saying it failed as a matter of law.
 Progress of the trial
 Burroughs Wellcome sued two generic manufacturers for patent infringement on AZT more than two years ago and the trial began June 28. Barr Laboratories and Novopharm Inc. and Ltd., the two defendants in the case, had contended that the AZT patents are invalid because they did not name scientists at the NIH as co-inventors.
 The ruling came in the fourth week of the trial following vigorous arguments about the legal standard to determine inventorship.
 The Court's ruling means that the validity of the Burroughs Wellcome patents has been upheld, and generic manufacture and sale of AZT by the defendants and their affiliates is prohibited until the patents expire in the year 2005.
 Litigation background
 Burroughs Wellcome filed a Complaint for Patent Infringement against Barr in May 1991 after Barr made an application to the U.S. Food & Drug Administration (FDA) for approval to manufacture and sell a generic copy of AZT before the expiration of Burroughs Wellcome's patents. Under the law, this was an act of infringement that required Burroughs Wellcome as owner of the patents to bring a lawsuit to determine the merits of the infringer's challenge.
 A lawsuit was filed against Novopharm in September 1992 following that company's similar application to the FDA, and the two cases were subsequently consolidated for trial.
 Company background
 Burroughs Wellcome Co. began its AIDS research program in 1983 and currently invests approximately one-third of its research and development effort on antiviral and infectious diseases. Last year, Wellcome spent approximately $464 million on research and development worldwide.
 Burroughs Wellcome has marketed Retrovir since March of 1987 and has developed four other medications used in the management of HIV and related opportunistic infections including Zovirax(R) brand acyclovir for the treatment of genital herpes, herpes encephalitis and shingles, Septra(R) brand trimethoprim/sulfamethoxazole and Mepron(R) brand atovaquone for the treatment of Pneumocystis carinii pneumonia and Daraprim(R) brand pyrimethamine for the treatment of toxoplasmosis. Several other compounds are presently in various stages of clinical and preclinical development.
 Burroughs Wellcome Co., located in Research Triangle Park, N.C., is Wellcome's U.S. subsidiary. The Wellcome Group discovers, develops, produces and markets quality innovative healthcare products worldwide.
 -0- 7/22/93
 /EDITOR'S NOTE: A b-roll package, including a statement by Paul A. Holcombe, Jr., vice president and general counsel for Burroughs Wellcome Co., and production footage of AZT, will be broadcast Thursday, July 22, 1993, from 1-2 p.m. (EDT) and again from 4-5 p.m. (EDT).
 Coordinates are:
 C band - Galaxy 6, Transponder 5H, Downlink Frequency 3800,
 Audio 6.2/6.8
 Ku band - SBS 6, Transponder 15H, Downlink Frequency 12068
 Audio 6.2/6.8/
 /CONTACT: Kathy Bartlett, 919-638-7622, or Doug Stokke, 919-315-8611, both of Burroughs Wellcome Co./
 (WEL)


CO: Burroughs Wellcome Co.; Novopharm; Barr Labs; National Institutes
 of Health ST: North Carolina IN: MTC SU:


CM-SB -- CH010 -- 4533 07/22/93 12:17 EDT
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Date:Jul 22, 1993
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