Appeal No. 98-1591
Application 08/417,625
include any purity limitations and thus does not exclude
clavulanic acid present in a fermentation broth.
Appellants argue that Lilly discourages use of
fermentation times greater than 72 hours by noting that the
maximum production of antibiotic occurs within 36-72 hours
(brief, page 18). Appellants point out that fermentation
times of 3 to 5 days are desirable for the production of
clavulanic acid (see id.). Appellants also argue that the
declaration by Holmes (exhibit 15) indicates that small
changes in fermentation conditions have a profound effect on
the products formed (brief, page 19). These arguments are not
convincing because the relevant question is not whether Lilly
carried out the fermentation for the time which is most
desirable for making clavulanic acid but, rather, whether,
when fermentation is carried out for 66 hours as in Lilly’s
example 17 and the products desired by Lilly are produced,
clavulanic acid necessarily is also produced.
Appellants argue, in reliance upon the Pfizer
tetracycline cases, that a trace amount of clavulanic acid in7
7The Pfizer tetracycline cases relied upon by appellants
are (brief, page 23): United States v. Pfizer Inc., 498 F.Supp
-10-10
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