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Executive Summary

GENERIC DRUG TESTING BEFORE PIONEER PATENT EXPIRES IS INFRINGEMENT, the U.S. Federal Circuit ruled unanimously April 25 on Roche's challenge to Bolar over development of generic Dalmane (flurazepam). The decision overturns a ruling by Brooklyn, NY Federal Judge Wexler that Bolar's testing in preparation for filing an application with FDA for approval of flurazepam did not violate the Roche patent. Wexler had agreed with Bolar that the studies fell within the scope of judicial precedents which exempted from patient infringement studies conducted solely for "experimental" purposes ("The Pink Sheet" Oct. 17. T&G-7). However, the appellate court concluded that Wexler interpreted the meaning of "experimental" too broadly. "Despite Bolar's agreement that its tests are "true scientific inquiries' to which a literal interpretation of the experimental use exceptional logically should extend, we hold the experimental use exception to be truly narrow, and we will not expand it under the present circumstances," Circuit Judge Philip Nichols Jr., wrote. "Bolar's intended 'experimental' use is solely for business reasons and not for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry," he noted. "Bolar may intend to perform 'experiments,' but unlicensed experiments conducted with a view to the adaption of the patented invention to the experimentor's business is a violation of the rights of the patentee to exclude others from using his patented invention." The judges also rejected Bolar's argument that the court allow the testing on the grounds that regulatory requirements of the FD&C Act effectively extend patent protection beyond the 17 years permitted under patent law. Referring to the ongoing legislative efforts to develop patent extension/post-1962 ANDA legislation, Nichols declared: "Congress is well aware of the economic and societal problems which the parties debate here and has before it legislation with respect to these issues. . . We will not rewrite the patent laws here." The decision remanded the case back to the lower court to determine an adequate remedy. While Nichols noted it is up to the lower court to decide on a remedy, he suggested that money damages, rather than distruction of Bolar's data may be more appropriate. Roche, citing the Pfizer v. Rachelle Labs ruling, urged destruction of data developed during the period of infringement. Nichols pointed out, however, that unlike-Rachelle, Bolar "obeyed all court orders while they were in effect." Additionally, Bolar "says it did nothing clandestine, but notified Roche what it was going to do at all times before doing it so Roche could act promptly to defend what it believed to be its rights," Nichols observed.

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