IPR2015-01344 (U.S. Pat. No. 8,858,996 B2)
December 17, 2015
Brief Summary: CAD’s Petition alleging obviousness or anticipation 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”, and the “Patent Owner provides a sufficient showing of entitlement to the filing date of” its parent application.
Summary: CAD petitioned for invalidation of Pozen’s US 8,858,996 B2 B2 encompassing the arthritis drug Vimovo® (naproxen and esomeprazole magnesium) (nine additional patents are listed on the Orange Book; IPRs pending against 8852636 and 8945621; IPRs against 6926907, 8557285 and 8858996 denied 12/8/15, 10/9/15, and 12/17/15, repsectively). CAD alleged claims 1-19 are invalid for obviousness (two combinations of references) or anticipation. Claims 1 and 12 were presented as representative. Claim 1 is to a “unit dosage form in the form of a tablet” of naproxen and esomeprazole “where 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 at least a portion of said naproxen is inhibited unless the pH of said medium is 3.5 or higher.” Claim 12 is to a “unit dosage form in the form of a tablet” of naproxen and esomeprazole with “a core layer comprising naproxen” and a “coating that inhibits release…unless…in a medium with a pH of 3.5 or higher”, and “a layer comprising esomeprazole” with a “coating that, upon ingestion by a patient, releases said esomeprazole into the stomach”. The term “inhibit”, not expressly defined by the specification, was determined by the Board to mean “prevent (stop), hinder, or restrain” (e.g., “‘unless’ the dosage form is exposed to a pH of 3.5 or higher”). “Acid inhibitor” was interpreted by the Board as not excluding prostaglandins in general, or [the prior art compound] misoprostol in particular” (“the specification describes H2-blockers and PPIs as illustrative, rather than exclusive, acid inhibitors”). CAD argued the prior art showed the combined use of acid inhibitors and NSAIDs, esomeprazole is an acid inhibitor, and “conventional techniques” and low pH-stable delayed-release enteric coatings that “readily ionize when the pH rises to about 4 or 5” (Remington’s). The Board concluded that CAD did not establish the cited art “would have given an ordinary aristan a reason to formulate a tablet with the [claimed] structural and functional features” (i.e., “why one would have prepared, for any reason, a composition as claimed” and nothing “that points to any particular dosage form among the many disclosed”). A second combination of references was argued to render the claims obvious because the claims represent only “a simple substitution of one known element for another to obtain predictable results”. But the Board was unpersuaded by CAD’s expert declaration that “repeats the statements presented in the Petition on this point, without citing any evidence themselves” (“conclusory and unsupported statements” (37 CFR § 42.65(a)). This combination was concluded not to be persuasive for essentially the same reasons as the first (i.e., no “reason to formulate a tablet with the [claimed] structural and functional features”). Regarding anticipation, the ‘996 patent is a 5th generation descendant, including a CIP, of the ‘216 application (and provisional) which published as the ‘255 publication.
In its anticipation arguments, CAD argued the publication of the first parent application in the ‘996 priority application chain (including a CIP) was prior art as it published more than one year before the CIP was filed and provided written description support for “only a species…of a broader genus”. While acknowledging this to be an issue that may be raised during IPR, the Board concluded CAD cited “nothing in the record to support its assertions…other than to refer to those pre-2003 application generally”, “does not identify, specifically, the features or claims that allegedly lack written description support” and “the Patent Owner provides a sufficient showing of entitlement to the filing date of at least the ‘216 application” (“’255 Publication as a whole conveys to one of ordinary skill in the art, either explicitly or inherently, that the inventors of the ‘996 patent invented the subject matter claimed” (Reiffin, FC 2000); “every species in a genus need not be described in order for the genus to meet the written description requirement” (Regents of U. Cal., FC 1997; Hynix, FC 2011)). Thus, CAD’s Petition was denied.