Fujikawa, v. Wattanasin

93 F.3d 1559 (1996)

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Nature of the Case

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Facts

At issue is a compound and method for inhibiting cholesterol biosynthesis in humans and other animals. At issue is a compound and method for inhibiting cholesterol biosynthesis in humans and other animals. The compound count recites a genus of novel mevalonolactones. The method count recites a method of inhibiting the biosynthesis of cholesterol by administering to a 'patient in need of said treatment' an appropriate dosage of a compound falling within the scope of the compound count. Sandoz Pharmaceuticals Corporation (Sandoz) is the assignee of D. Nissan Chemical Industries, Ltd. (Nissan) is the assignee of P. P invented overseas. P can rely only on his effective filing date, August 20, 1987, to establish priority. In 1979 Sandoz began searching for drugs that would inhibit the biosynthesis of cholesterol. D was assigned to this project in 1982, and during 1984-1985 he synthesized three compounds falling within the scope of the compound count. Test results indicated that, to a high probability, the three compounds 'would be active when administered in vivo to a patient to inhibit cholesterol biosynthesis, i.e. for the treatment of hypercholesteremia or atherosclerosis.' Sandoz shelved D's project for almost two years because the level of in vitro activity in two of the three compounds was too low. In January 1987, D's invention was restarted. Four more compounds falling within the scope of the compound count were synthesized. In October, all four compounds yielded positive results. In December 1987, the three most active compounds in vitro were subjected to additional in vivo testing. Only one of the compounds, compound 64-935, manifested a better ED50 than an existing drug Compactin. In January 1988, Sandoz decided to patent the discovery. Additional data was gathered to prepare the patent application. This data gathering took until the end of May 1988. Sandoz contends that its patent attorney, Ms. Geisser, began the draft as early as August and that she was already working on the draft when she first heard of Picard's patent. The draft was completed in November and, after several turnarounds with the inventor, ultimately filed in March of 1989. P and D requested an interference with Picard. Picard was eliminated and P and D remained. The Board determined that D had reduced the compound to practice, at the latest, as of December 1987. The Board held that D was de facto the first inventor of the compound count. It then found that the seventeen-month period between D's reduction to practice and filing was not sufficient to raise an inference of suppression or concealment given the complexity of the invention. It awarded priority of the compound count to D. The Board determined that D reduced to practice in December 1987 on the date that in vivo testing of the 64-935 compound was concluded. It determined that the in vivo testing met the limitations of the count since the word 'patient' was sufficiently broad to include the laboratory rats to whom the compounds were administered. The in vivo testing also proved that 64-935 had practical utility because the compound displayed significant cholesterol inhibiting activity at doses of 1.0 and 0.1 mg. The Board held that D was the de facto first inventor of the count and that the delay in filing of fifteen months was not sufficient to trigger an inference of suppression or concealment. P appealed.