United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/9/14)

Case Name: United Therapeutics Corp. v. Sandoz, Inc., Case No. 12-cv-01617, 2014 U.S. Dist. LEXIS 49488 (D.N.J. Apr. 9, 2014) (Sheridan, J.)

Drug Product and Patent(s)-in-Suit: Remodulin® (treprostinil sodium); U.S. Patent No. 6,765,117 (“the ’117 patent”)

Nature of the Case and Issue(s) Presented: This matter arises from a motion for summary judgment by Sandoz alleging that the ’117 patent is invalid since it was previously disclosed in the prior art U.S. Patent No. 4,668,814 (“the ’814 patent”). More specifically, Sandoz claims that treprostinil was previously disclosed within the ’814 patent, and accordingly, the ’117 patent should be declared invalid by virtue of the defense of anticipation. The court found that “there are too many disputed facts to grant summary judgment” and addressed at least four of them in its opinion.

Why United Therapeutics Prevailed: First, Sandoz argued each of the four claims of the ’117 patent described a process for preparing treprostinil by a process that is stereoselective and requires fewer steps than the prior art. While United Therapeutics acknowledged that treprostinil was known in the prior art, Sandoz misrepresents the invention by ignoring the “stereoselectively produced isomeric compound” claimed by the ’117 patent. Moreover, United Therapeutics argued that each claim is also directed to a source limitation being the novel starting material enyne as well as a novel claimed cyclized claimed intermediate. “In short, the stereoselectively produced isometric compound is an important factual difference between the oversimplified statement of Sandoz and UTC’s description of the ’117 patent.”

Second, Sandoz claimed that the ’117 patent and the ’814 patent are the same. United Therapeutics responds that the two patents are substantially different in that: (i) the ’814 patent does not disclose the claimed enyne starting material; (ii) the intramolecular cyclization step disclosed in claims 1-4 of the ’117 patent is not disclosed in the ’814 patent; (iii) the ’814 patent does not disclose a “stereoselectively produced isomeric compound” of treprostinil; (iv) the overall yield of the treprostinil product of the ’814 patent is different; (v) the product of the ’814 patent is structurally and/or functionally different.

Third, Sandoz argued that all of the ’117 patent asserted claims describe one compound, namely, treprostinil. United Therapeutics disagreed. For example, Sandoz alleged that claim 1 is directed to a genus of stereoselectively produced isomeric compounds. United Therapeutics responded that claim 1 is not only directed toward a genus of stereoselectively produced isomeric product compounds according to the molecular formula shown in the claim, it is also a specified process for making such compounds, which comprises a step of cyclizing a starting compound into an intermediate compound via an intramolecular enyne-cyclization. Moreover, claim 1 is also directed toward a genus of starting compounds and a genus of intermediates compound, both specified in the claim, for use in the claimed process. The court held that “at the very least, the distinctions made by UTC are factually different and must be evaluated at trial.”

Finally, the court found that a fourth area of factual dispute concerned the scope of the prior art. The parties agree that there was some prior art in circulation before the issuance of the ’117 patent. But while Sandoz argued the prior art squarely resolve the anticipation argument in its favor, United Therapeutics claimed that the ’117 patent was different from each reference because none of the alleged prior art discusseed the “stereoselectively produced isomeric compounds” resulting from cyclizing a starting enyne compound.