Appeal No. 98-1591
Application 08/417,625
Lilly’s fermentation broth would not render unpatentable
appellants’ claim to clavulanic acid (brief, pages 20-22).
This argument is not well taken because appellants’
specification (page 19, lines 3-7) indicates that clavulanic
acid is effective at a peak blood level as low as 0.1 Fg/ml,
whereas in the Elson declaration (exhibit 16), when cephamycin
C is produced, the level of clavulanic acid is 0.536 to 373.0
Fg/ml. Thus, the clavulanic acid produced in the experiments
in the Elson declaration does not appear to be a non-
recoverable, trace amount of no practical
significance as in the Pfizer tetracycline cases. See Chas.
Pfizer & Co. v. Barry-Martin Pharmaceuticals, Inc., 241 F.Supp
191, 193, 145 USPQ 29, 31 (S.D. Fla. 1965).
For the above reasons, we find that appellants’ claim 42
is prima facie anticipated by Lilly. Appellants argue that
clavulanic acid produces unexpected results (brief, pages 25-
28, 210 USPQ 673 (E.D. Pa. 1980), aff’d, 676 F.2d 51, 216 USPQ
1056 (3d Cir. 1982); North Carolina v. Chas. Pfizer & Co., 384
F.Supp 265, 182 USPQ 657 (E.D.N.C. 1974), aff’d, 537 F.2d 67,
189 USPQ 262 (4th Cir.), cert denied, 429 U.S. 870 (1976);
Chas. Pfizer & Co. v. Barry-Martin Pharmaceuticals, Inc., 241
F.Supp. 191, 145 USPQ 29 (S.D. Fla. 1965).
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