Pozen Inc. v. Par Pharmaceutical, Inc. et al.

Docket Nos. 2011-1584, -1585, -1586

September 28, 2012

Brief Summary: Patents relating to combination product found not obvious, in part due to teaching away, and infringed (both directly and under the DOE (where 85% was found to be equivalent to “at least 90%”)).

Summary: Par appealed from DJ bench trial determination that Pozen’s patents relating to a combination of sumatriptan and naproxen (Treximet®) are not invalid for obviousness and were infringed (direct and under DOE) by Par’s ANDA. The DC found that the prior art “did not…’teach or suggest the simultaneous administration of sumatriptan and naproxen…[n]or…otherwise disclose to one of ordinary skill in the art that the combination…produces a longer lasting efficacy reducing migraine relapse compared to the administration of [either] alone.” The FC panel agreed, finding no clear error in the conclusion, for example, that one reference “discourages combining sumatriptan and naproxen to achieve the claimed efficacy benefits” (e.g., teaching away (In re Gurley, FC 1994 (one would be discouraged or led in a divergent direction) and Spectralytics, FC 2011 (jury could find that prior art taught away from one solution because all prior art taught a different solution)). Certain claims related to bilayer tablets in which “dissolution of said naproxen occurs independently of said triptan”, which the DC also found not to be obvious (“While multilayer tablets were commonly used, Pozen’s dosage forms of naproxen sodium and sumatriptan were not obvious. Nor do the references render obvious the specific tablet architecture as Pozen argued to the PTO and claimed in the ’183 patent.”) Par also unsuccessfully argued that the “therapeutic packge”, “finished pharmaceutical container”, and “labeling directing the use” limitations lacked adequate written description. The FC found no error with the DC findings, pointing out that “the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter” as long as it “convey[s] with reasonable clarity to those skilled in the art that…[the inventor] was in possession of the invention” (Ariad, FC 2010 (en banc), Purdue, FC 2005). The DOE issues related to the “independent dissolution” and “substantially all” (“substantially all of said triptan is in a first layer of said tablet and substantially all of said naproxen is in a second, separate layer”) limitations of the bilayer tablet claims. The DC concluded that “testing of its [Par’s] product confirms its independent dissolution”. And the “substantially all” limitation was construed to mean “at least 90%, and preferably greater than 95%” of each compound are in distinct layers of the tablet, which was found to be drawn from the specification and infringed ((e.g., Kemin Foods, FC 2006) (“Pozen never stated that “at least 90%, and preferably greater than 95%” should be an absolute floor…a tablet layer with 85% of the agent can be fairly characterized as an insubstantial change.”) Judge Clevenger’s dissent argued against the “substantially all” analysis (“How can a layer with only 85% of the necessary ingredient in it be an equivalent of a layer with at least 90% and preferably 95% of the required ingredient in it?”) (Note: the opinion also repeatedly referred to Microsoft (US 2011) (“[a] party asserting invalidity must present clear and convincing evidence to overcome a patent’s presumption of validity”)).

This entry was posted in Generics / ANDA, Obviousness. Bookmark the permalink.

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