Fujikawa v. Wattanasin

• Decision Date: 28 August 1996
• Docket Number: 95-1425,Nos. 95-1418,s. 95-1418
• Citation: 39 USPQ2d 1895,93 F.3d 1559
• Parties: Yoshihiro FUJIKAWA, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita and Masaki Kitahara, Appellants, v. Sompong WATTANASIN, Appellee. (Two Cases).
• Court: U.S. Court of Appeals — Federal Circuit

Page 1559

93 F.3d 1559

39 U.S.P.Q.2d 1895

Yoshihiro FUJIKAWA, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita and Masaki Kitahara, Appellants, v. Sompong WATTANASIN, Appellee. (Two Cases).

Nos. 95-1418, 95-1425.

United States Court of Appeals Federal Circuit.

Aug. 28, 1996.

Steven B. Kelber, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., Arlington, Virginia, argued, for appellants.

Diane E. Furman, Sandoz Corporation, East Hanover, New Jersey, argued, for appellee.

Before MAYER, CLEVENGER, and RADER, Circuit Judges.

CLEVENGER, Circuit Judge.

Yoshihiro Fujikawa et al. (Fujikawa) appeal from two decisions of the Board of Patent Appeals and Interferences of the United States Patent & Trademark Office (Board) granting priority of invention in two related interferences to Sompong Wattanasin, and denying Fujikawa's motion to add an additional sub-genus count to the interferences. We affirm.

I

These interferences pertain to 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.

The real parties in interest are Sandoz Pharmaceuticals Corporation (Sandoz), assignee of Wattanasin, and Nissan Chemical Industries, Ltd. (Nissan), assignee of Fujikawa.

The inventive activity of Fujikawa, the senior party, occurred overseas. Fujikawa can thus rely only on his effective filing date, August 20, 1987, to establish priority. 35 U.S.C. § 102(g) (1994). Whether Wattanasin is entitled to priority as against Fujikawa therefore turns on two discrete questions. First, whether Wattanasin has shown conception coupled with diligence from just prior to Fujikawa's effective filing date until reduction to practice. Id. Second, whether Wattanasin suppressed or concealed the invention between reduction to practice and filing. Id. With respect to the first question, Fujikawa does not directly challenge the Board's holdings on Wattanasin's conception or diligence, but rather contends that the Board incorrectly fixed the date of Wattanasin's reduction to practice. As for the second question, Fujikawa contends that the Board erred in concluding that Wattanasin had not suppressed or concealed the invention. Fujikawa seeks reversal, and thus to establish priority in its favor, on either ground.

II

The Board divided Wattanasin's inventive activity into two phases. The first phase commenced in 1979 when Sandoz began searching for drugs which would inhibit the biosynthesis of cholesterol. Inventor Wattanasin was assigned to this project in 1982, and during 1984-1985 he synthesized three compounds falling within the scope of the compound count. When tested in vitro, each of these compounds exhibited some cholesterol-inhibiting activity, although not all the chemicals were equally effective. Still, according to one Sandoz researcher, Dr. Damon, these 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." Notwithstanding these seemingly positive results, Sandoz shelved Wattanasin's project for almost two years, apparently because the level of in vitro activity in two of the three compounds was disappointingly low.

By January 1987, however, interest in Wattanasin's invention had revived, and the second phase of activity began. Over the next several months, four more compounds falling within the scope of the compound count were synthesized. In October, these compounds were tested for in vitro activity, and each of the four compounds yielded positive results. Again, however, there were significant differences in the level of in vitro activity of the four compounds. Two of the compounds in particular, numbered 64-935 and 64-936, exhibited in vitro activity significantly higher than that of the other two compounds, numbered 64-933 and 64-934.

Soon after, in December 1987, the three most active compounds in vitro were subjected to additional in vivo testing. For Sandoz, one primary purpose of these tests was to determine the in vivo potency of the three compounds relative to that of Compactin, a prior art compound of known cholesterol-inhibiting potency. From the results of the in vivo tests, reproduced in the margin, ¹ Sandoz calculated an ED sub50 ² for each of the compounds and compared it to the ED sub50 of Compactin. Only one of the compounds, compound 64-935, manifested a better ED sub50 than Compactin: an ED sub50 of 0.49 as compared to Compactin's ED sub50 of 3.5. All of the tests performed by Sandoz were conducted in accordance with established protocols.

During this period, Sandoz also began to consider whether, and when, a patent application should be filed for Wattanasin's invention. Several times during the second phase of activity, the Sandoz patent committee considered the question of Wattanasin's invention but decided that it was too early in the invention's development to file a patent application. Each time, however, the patent committee merely deferred decision on the matter and specified that it would be taken up again at subsequent meetings. Finally, in January 1988, with the in vivo testing completed, the Committee assigned Wattanasin's invention an "A" rating which meant that the invention was ripe for filing and that a patent application should be prepared. The case was assigned to a Ms. Geisser, a young patent attorney in the Sandoz patent department with little experience in the pharmaceutical field.

Over the next several months the Sandoz patent department collected additional data from the inventor which was needed to prepare the patent application. This data gathering took until approximately the end of May 1988. At that point, work on the case seems to have ceased for several months until Ms. Geisser began preparing a draft sometime in the latter half of 1988. The parties dispute when this preparation began. Fujikawa contends that it occurred as late as October, and that Ms. Geisser was spurred to begin preparing the draft application by the discovery that a patent to the same subject matter had been issued to a third party, Picard. Fujikawa, however, has no evidence to support that contention. In contrast, Sandoz contends that 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 evidence of record, and in particular the testimony of Ms. Geisser, supports that version of events. In any event, the draft was completed in November and, after several turn-arounds with the inventor, ultimately filed in March of 1989.

Both Wattanasin and Fujikawa requested an interference with Picard. The requests were granted and a three-party interference between Picard, Fujikawa, and Wattanasin was set up. Early in the proceedings, however, Picard filed a request for an adverse judgment presumably because he could not antedate Fujikawa's priority date. What remained was a two-party interference between Fujikawa and Wattanasin. Ultimately, for reasons not significant to this appeal, the interference was divided into two interferences: one relating to the method count and one relating to the compound count. The Board decided each of these interferences adverse to Fujikawa.

With respect to the compound count, the Board made two alternative findings regarding reduction to practice. First, it found that the in vitro results in October 1987 showed sufficient practical utility for the compound so as to constitute a reduction to practice as of the date of those tests. ³ In the alternative the Board held, the in vivo tests which showed significant activity in the 64-935 compound at doses of 1.0 and 0.1 mg were sufficient to show practical utility. Consequently, Wattanasin had reduced the compound to practice, at the latest, as of December 1987. Since Fujikawa did not challenge Wattanasin's diligence for the period between Fujikawa's effective filing date of August 20, 1987 and Wattanasin's reduction to practice in either October or December 1987, the Board held that Wattanasin was de facto the first inventor of the compound count. Finally, the Board found that the seventeen month period (counting from the in vitro testing) or fifteen month period (counting from the in vivo testing) between Wattanasin's reduction to practice and filing was not sufficient to raise an inference of suppression or concealment given the complexity of the invention, and therefore awarded priority of the compound count to Wattanasin. In reaching this conclusion, the Board rejected Fujikawa's argument that Wattanasin was spurred to file by Picard because it held that spurring by Picard, a third party, had no legal effect in a priority dispute between Fujikawa and Wattanasin.

With respect to the method count, the Board determined that Wattanasin reduced to practice in December 1987 on the date that in vivo testing of the 64-935 compound was concluded. In reaching that conclusion, the Board first noted that a reduction to practice must include every limitation of the count. Consequently, Wattanasin's early in vitro testing could not constitute a reduction to practice of the method count, since that count recites administering the compound to a "patient." The in vivo testing, however, 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. Given this date of reduction to practice, the Board again held that Wattanasin was...