Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 7
[16.5] Floccule size. Alpharma purports to have developed a method for determining particle
size [0022] and floccule [floc] size [0035] in megestrol suspensions. Alpharma
subsequently determined that floc size was its best indicator of bioequivalence with
MEGACE® because it relates to the drug’s absorption rate into the patient’s blood [0026]
& [0028] [2018]. Kundu purports to have discovered that floc size is a function of
wetting agent concentration [0027]. From February to May 1999, Alpharma focused on
optimizing floc size in its docusate sodium formulations [0033]-[0037]. In November
1999, Alpharma looked at floc size in batches that had been tested for 24-month stability
[0041]. Kundu’s specification discusses the importance of floc size and discloses
preferred embodiments in terms of floc size [2001 at 2 and 9-10]. Examples 2, 3, and 6-
10 disclose information about floc size and a method for its measurement [2001 at 19
& 21-25].
[16.6] Lead formulations. After manufacturing 40 kg batches, Alpharma manufactured 35 gal.
batches of "lead formulations", which it describes as those using docusate sodium (which
is in the count) or PLURONIC® F127 (which is not) [0024]. Alpharma subsequently
made a test batch for its ANDA with the PLURONIC® F127 formulation [0025].
Alpharma considered this batch to be a failure because it was not bioequivalent to Bristol-
Myers Squibb’s product [2016]. Kundu does not explain the significance of this step.
The batch size does not appear related to the disclosure. One could speculate that this
process led to the identification of docusate sodium as a particularly preferred
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