Interference No. 104,843 Paper 51
Kundu v. Ragunathan Page 6
batches [0017] & [0023]. Ultimately, Alpharma appears to have concluded that
dissolution was not a useful test for bioequivalence to MEGACEŽ [0026] [2016
& 2018]. Kundu has not pointed to any disclosure of the dissolution studies. Ragunathan
argues that they were not disclosed (Paper 41 at 17).
[16.2] Stability and resuspendability studies. Alpharma conducted numerous 3-month stability
and resuspendability studies on 3 kg and 40 kg batches for various formulations [0016]-
[0018]. Six- and 12-month stability studies were conducted on 40 kg "pre-pilot" batches
[0018] & [0019]. In the summer of 1999, Alpharma tested the stability of 500 kg batches
of a docusate sodium formulation [0038] & [0039]. Kundu notes that stability and
resuspendability are desirable aspects in implementing the invention (Paper 31 at 22). In
Kundu's disclosure, Examples 6 and 11-15 provide stability and resuspendability data for
specified formulations [2001 at 21-23 & 25-27].
[16.3] Physical and assay testing. Alpharma also purports to have done physical and assay
testing on the 40 kg batches [0017]. Kundu does not explain the nature and significance
of the testing except by broad references to the record, which appear to provide little
additional illumination, and does not correlate this testing to disclosure in Kundu’s
specification.
[16.4] Viscosity. Alpharma purports to have developed a method for determining viscosity for
flocculated megestrol suspensions [0021]. Kundu does not explain the significance of
viscosity to its disclosure. The disclosure appears only to make passing reference to
viscosity [2001 at 12-13 & 15].
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