Appeal No. 2006-3234
Application No. 90/006,410
controlling drug release, and a water soluble drug such as
niacin. (Evenstad at 1:63-2:42).
35. Evenstad discloses that “the hydrophobic component blend, the
sustaining hydroxypropyl methylcellulose, and the medicament
are granulated using the binding agent solution to a final
moisture level of less than about 7 percent, preferably less than
about 5 percent.” (Evenstad at 5:42-46).
36. Evenstad does not disclose tablets containing metformin.
Vilkov declarations
37. Appellant submitted two declarations of Dr. Zalman Vilkov.
38. Dr. Vilkov identified himself as an employee of “Purepac
Pharmaceutical Co., a subsidiary of Alpharma Inc.”, said to be
Appellant’s real party in interest. (Vilkov declaration at ¶ 1 and
Brief at 2).
39. In the first declaration, Dr. Vilkov testified as follows:
a) In tablets with a relatively high proportion of active
agent, the tabletting characteristics of the active agent, as
opposed to the excipient (such as a hydrocolloid-forming
polymer), dominate. Metformin exhibits very poor
tabletting characteristics, including poor compressibility
and a high tendency to cap.
(Vilkov declaration at ¶ 9).
b) Pharmaceutical formulation is a very unpredictable
art. Every active agent and excipient has unique
tabletting properties. Data pertaining to one active agent
and type of excipient does not necessarily apply to a
different active agent and type of excipient. Modifying
one tablet parameter can further more affect more than
one tablet property in an unpredictable way. As a result,
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