In a final written decision (IPR2015-01773), the Patent Trial and
Appeal Board (PTAB) found claims of U.S. Patent No. 8,858,996 (the ‘996 Patent)
directed to a tablet of naproxen and esomeprazole to be valid
(non-obvious). Claim 1 of the '996 Patent
states:
1. A pharmaceutical composition
in unit dosage form in the form of a tablet, said composition comprising: naproxen
in an amount of 200–600 mg per unit dosage form;
and esomeprazole in an amount of
from 5 to 100 mg per unit dosage form,
wherein upon introduction of said
unit dosage form into a medium, at least a portion of said esomeprazole is released
regardless of the pH of the medium, and release of at least a portion
of said naproxen is inhibited unless the pH of said medium is 3.5 or
higher.
Petitioner contended that the claims
of the ‘996 patent were obvious over the combination of U.S. Patent 5,698,225 and WO 00/26185. Despite the PTAB
finding that there was teaching/suggestion/motivation in the prior art, the PTAB found the claims of the '996 patent to be
non-obvious because a person of ordinary skill would not have had a reasonable expectation of success. Below are
relevant excerpts from PTAB’s decision:
Teaching/Suggestion/Motivation
[W]e find that an ordinarily
skilled artisan, seeking to avoid the significant disadvantages associated with
misoprostol, and to create a combination acid inhibitor-NSAID pharmaceutical
composition that could be prescribed to women of childbearing potential, would
have been motivated to seek a replacement acid inhibitor for misoprostol and would
have turned to the PPIs omeprazole and its (-)-enantiomer, esomeprazole. Indeed,
as Petitioner further points out, WO ’185 expressly teaches that omeprazole
possesses “a very good safety profile,” , and is a “‘logical choice’” for
stress ulcer prophylaxis.
Reasonable Expectation of Success
Petitioner has not adequately
rebutted Patent Owner’s argument that the skilled artisan would have expected,
based on the teachings of WO ’185, that the sodium bicarbonate would completely
break down the enteric coating protecting the naproxen core of the ’225 patent
in a medium. In this scenario, Patent Owner reasonably explains, no portion of
naproxen would remain to release only after pH reached 3.5. Again, challenged claim 1 recites a tablet
where release of “at least a portion of said naproxen is inhibited
unless the pH of said medium is 3.5 or higher.” Thus, although claim 1 allows for release of
at least some naproxen immediately (i.e., at any pH), claim 1 also requires that
at least some naproxen releases only when pH is 3.5 or higher.
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