Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 18
formulation, there is no indication the public would ever have benefitted from its discovery.
Thus, work toward an ANDA is weak evidence of an inexorable effort to place the invention in
the possession of the public since an ANDA development program would not necessarily become
public or lead to a publically used product. Kundu’s patent application was the only alternative
strategy that Kundu pursued that would have placed the invention in the hands of the public in
the event that Alpharma’s ANDA failed.13
The first evidence14 of Kundu’s intent to file a patent on any megestrol formulation comes
in November 1999, more than two years after Kundu’s alleged actual reduction to practice.
Kundu does not rely on this evidence in its brief, but instead points to work starting in
March 2000, more than two and a half years after Kundu’s alleged reduction to practice. It is not
clear whether the difference in start dates for the patent application reflects an oversight on
Kundu’s part or a significant shift in the focus of the patent application being drafted. Since
Kundu has the burden of proof to show it was making inexorable progress toward filing, we
cannot make any assumptions in Kundu’s favor regarding what, if anything, the patent
application work before March 2000 means. A 2-2½ year delay before beginning work on a
patent application would defy characterization as even fitful progress toward public disclosure
13 The courts have repeatedly noted that the patent and drug-approval processes are distinct. E.g., Juicy Whip,
Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1368, 51 USPQ2d 1700, 1703 (Fed. Cir. 1999), citing In re Watson, 517 F.2d
465, 474-76, 186 USPQ 11, 19 (CCPA 1975). Just as the use of utility and enablement rejections to police drug efficacy
improperly confuses the respective roles of USPTO and FDA, strict adherence to the process for filing an ANDA cannot
by itself justify a delay under §102(g). Each body of law must be approached on its own terms.
14 For reasons explained below, the exhibits showing earlier patenting efforts has been suppressed. In any case,
Kundu did not show a nexus between what was then being considered for patenting and the present count.
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