Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 17
appearance of spurring. Generally, slow (even fitful), but inexorable progress toward disclosure
can overcome the inference of suppression from long delay. Fujikawa, 93 F.3d at 1567,
39 USPQ2d at 1902. Significant steps toward perfecting the invention and preparing an
application indicate that the invention was not suppressed. 93 F.3d at 1568, 39 USPQ2d at 1903.
The work used to overcome the inference, however, must not be directed only to
commercialization and should be reflected in the patent application. Lutzker, 843 F.2d at 1367,
6 USPQ2d at 1372. Work to prepare the involved application prior to the issuance of the
allegedly spurring patent can overcome the inference of spurring. Fujikawa, 93 F.3d at 1568,
39 USPQ2d at 1902-03. A showing of intent to file eventually, however, will not negative a
holding of suppression. Shindelar, 628 F.2d at 1342, 207 USPQ at 117.
B. Kundu suppressed the invention of the count
1. Kundu's development work did not show an inexorable
effort leading to disclosure to the public or to USPTO
The FDA has extremely stringent standards for the submission of an ANDA. 21 C.F.R.
§314.94. Among other things, an ANDA applicant must demonstrate the bioequivalence of the
new drug to the listed drug (§314.94(a)(7)), must provide precise details about any variances
from the labeling for the listed drug (§314.94(a)(8)), and must provide details about the plan for
producing commercial lots of the drug (§314.94(a)(9)). Kundu has offered an extensive record
showing efforts to produce a product that would meet the ANDA standards.
Prior to approval, the FDA treats the existence of, and information about, an ANDA as
confidential information. 21 C.F.R. §314.430(b) & (d). Moreover, Alpharma abandoned all
development avenues that did not lead to an ANDA filing. If it had not found a bioequivalent
Page: Previous 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Next
Last modified: November 3, 2007