Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 9
[16.11] ANDA batches. In early December 1998, Alpharma decided to produce "ANDA batches"
[0031], but these were considered a failure [2003, ¶37] because they indicated a failure to
maintain bioequivalence with MEGACE® [2020]. A December 1999 attempt to prepare
a 1489 kg ANDA batch failed from a lack of drug substance uniformity, which created
manufacturing difficulties [0042]. Instead, in early 2000, Alpharma simulated a full
ANDA batch by making 500 kg batches [0043]. Manufacturing difficulties continued,
leading Alpharma to repair its entire processing line [0044]. Finally, on 1 March 2000,
Alpharma attempted a 1489 kg ANDA batch, which Alpharma reports resulted in the
desired drug substance uniformity and filling accuracy [0045]. Kundu does not identify
where the ANDA batch data is reflected in Kundu’s specification.
[17] On 31 December 2000, over five months after Kundu’s filing date, Alpharma filed an
ANDA with the Food and Drug Administration. According to Dr. Capella, Alpharma
expects approval of its ANDA this year [2003, ¶7]. Kundu has not shown that
Alpharma's ANDA will necessarily lead to a public disclosure or that its work has
otherwise been publically disclosed.
[18] Key requirements of an ANDA are showings of bioequivalence to an already approved
product, in this case MEGACE®, and a detailed manufacturing plan, including
specification of equipment to be used. 21 C.F.R. §314.94(a)(7) & (9).
[19] Alpharma’s efforts on the subject matter of the count appear to have been principally
directed to preparation of its ANDA. Some of the results of Alpharma’s years of
development appear in Kundu’s specification, but often in the form of very broad
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