Friday, August 27, 2010

Teva Claims Merck Has "Double Patented" Its Levitra® ED Drug

Teva is in the process of bringing a generic form of Merck's (really legacy Schering-Plough's) erectile dysfunction drug Levitra® to market. To slow this process, Schering-Plough/Merck had filed a patent infringement lawsuit in April of last year, adding counts in April of this year, because additional patents had been granted that were arguably germane to the manufacture of Vardenafil Hydrochloride (the agent in Levitra). [Just to remind readers, as comtemplated by the various Hatch-Waxman amendments to the patent statutes, competing manufacturers (like Teva) are allowed to launch generic versions of branded patented drugs, "at risk" -- on the earlier to occur of (1) a favorable outcome in patent litigation, (2) 30 elapsed months from the filing of a patent lawsuit, coupled to FDA approval of an abbreviated new drug application, or (3) the formal expiration of the relevant as-granted patent(s).]

Teva formally answered (a 1 Mb PDF file) the latest complaint yesterday, in the United States District Court for the District of Delaware. Teva asserts, among other defenses and counterclaims, a "double patenting" counterclaim -- essentially saying that Merck cannot file two patents on the very same part of one single invention, solely to improperly extend the life of its desired monopoly-by-patent, thus:

. . . .The claims in the '206 patent are invalid under 35 U.S.C. § 103 because the subject matter claimed therein was described in one or more prior patents or publications. . . .

It is often the case that branded drug manufacturers file additional, later-dated patent applications -- on blockbuster franchise drugs (like Levitra), to delay the arrival of generic competitors (like Teva). In some cases, those later "add-on" patents are of less-than-robust novelty, strength, and/or value. This may be one of those times.

In any event, we'll keep you informed as this matter. . . um, rises. . . erh, progresses.

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