Coalition for Affordable Drugs VII LLC (Petitioner; “CAD”) v. Pozen Inc. (Patent Owner)

IPR2015-01241 (U.S. Pat. No. 6,926,907 B2)
December 8, 2015

Brief Summary: CAD’s Petition alleging obviousness in view of four different cominations of references denied because, e.g., the cited art “would [not] have given one of ordinary skill in the art a reason to formulate a tablet with the structural and functional features required by the challenged claims.”

Summary: CAD petitioned for invalidation of Pozen’s US 6,926,907 B2 encompassing the arthritis drug Vimovo® (naproxen and esomeprazole magnesium) (nine additional patents are listed on the Orange Book; IPRs pending against 8852636, 8858996 and 8945621; IPR against 8557285 denied 10/9/15). CAD alleged four separate combinations of references render different sets of ‘907 claims obvious. Claim 1 is presented in the decision as representative and claims “[a] pharmaceutical composition in unit dosage form suitable for oral administration, comprising…an acid inhibitor…effective to raise the gastric pH…to at least 3.5…; a…NSAID…; and wherein said unit dosage form provides for coordinated release such that: i) said NSAID is surrounded by a coating that…prevents release…unless the pH of the surrounding medium is 3.5 or higher; ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and…is release regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.” The only term interpreted by the Board was “acid inhibitor”, which was “not persuaded that the broadest reasonable interpretation…excludes prostaglandins in general, or misoprostol in particular.” The Board was not persuaded by first alleged combination of references because “Petitioner has not explained adequately why one of ordinary skill in the art would have had a reason to formulate Gimet’s tablet to increase gastric (i.e., stomach12) and/or duodenal pH to at least 3.5 in the first place, when Gimet explicitly teaches that the enteric coating on its tablet ‘direct[s] the dissolution of the NSAID core in the lower G.I. tract as opposed to the stomach’” (or in Chiverton suggesting “the desirability of increasing the dose…to raise gastric pH to at least 3.5”). Regarding the second combination, CAD argued that those in the art “would know that a typical patient would have a pH in the stomach in a range of from about 1.5 to 3.5” and “that the typical therapeutic effect of known acid inhibitors is to increase the gastric pH”. The Board rejected these arguments as well for similar reasons as the first combination (“[W]e are not persuaded that Petitioner presents adequate support in the record for this point.”) The third obviousness allegation that the skilled artisan “would have been motivated to look to clinical studies showing results of fomatidine on gastric acid pH such as those shown in Abe to provide predictable results of an increase in gastric pH associated with the administration of the known acid inhibitor”, with disclosures regarding the conventional tablet preparation techniques, was also rejected because the cited art “would [not] have given one of ordinary skill in the art a reason to formulate a tablet with the structural and functional features required by the challenged claims.” CAD’s arguments regarding the fourth combination were similar except these relate to the effects of omeprazole on gastric acid pH, and were similarly rejected by the Board. Thus, the Board denied the Petition.

This entry was posted in Generics / ANDA, Inter Parties Review (IPR), Obviousness. Bookmark the permalink.

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