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Executive Summary

PMA AMICUS FILING WITH SUPREME COURT asserts that allowing generic firms to conduct pre-patent expiration testing would deprive research companies of licensing income. The amicus brief, prepared for the Pharmaceutical Mfrs. Assn. (PMA) by D.C. attorneys Peter Hutt and Ellen Flannery (Covington & Burling), was submitted in opposition to Bolar's request for Supreme Court review ("The Pink Sheet" July 30, p. 9) of an appellate court ruling that drug testing before a patent expires is infringement ("The Pink Sheet" April 30, T&G-1). By testing Roche's patented product, Bolar is in effect, "appropriating unto itself a compulsory license without compensation" PMA argued. "The patent law nowhere provides for such an extraordinary result. Congress has on several occasions explicitly declined to enact legislation that would require compulsory licensing either for all patents generally or for new drug patents in particular, even with compensation." Declaring that the case "strikes at the heart of patent protection," PMA contended that the Federal Circuit Court's decision "is clearly correct in holding that the unlicensed use of a patented drug for development, testing, and other purposes in order to satisfy regulatory requirements is an illegal infringement." The previous ruling presents no issues warranting further review, PMA added. PMA cited a number of studies, e.g. by Wardell, Schwartzman, and the Natl. Academy of Engineering, which found a decline since 1962 in effective drug patent lives. The brief maintained that the circuit court ruling prevents further erosion of patent protection for pioneer drugs. "By preserving the integrity of the patent term of pioneer new drugs against attempted encroachment by generic drug companies, the court of appeals has preserved the current and necessary stimulus to innovation in the pharmaceutical industry," PMA argued. The Generic Pharmaceutical Industry Assn. (GPIA) argued in an Aug. 31 amicus brief that courts historically have upheld "the public's right to use a patented article for purposes which do not disturb" the patent holder's gain. The circuit court erred, GPIA contended, in that "it permitted itself to be unduly influenced by the fact that Bolar's purpose in doing FDA testing was to ultimately engage in a commercial enterprise while totally failing to consider the fact that this commerce would not begin until long after the Roche patent expired." If Bolar "obtained FDA approval during the first year of the Roche patent and thereafter engaged in no other activity for 16 years until the patent expired, its actions would clearly be characterized as de minimums," the assn. said. "Surely the fact that Roche's patent was about to expire did not give Roche greater rights or change the de minimum character of Bolar's pre-expiration acts.

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