In Endo Pharmaceuticals Solutions, Inc. v. Paddock Laboratories, LLC, C.A. No. 14-1422-SLR (D. Del. Feb. 10, 2017), Judge Robinson held that the testosterone injection patents at issue were not invalid for obviousness under 35 U.S.C. § 103. This decision followed an ANDA bench trial on invalidity.
Although Judge Robinson credited the defendant with “successfully identif[ying] the elements of the asserted claims (but not the specific quantities of [testosterone undecanoate] and solvents) in the prior art,” the Court held that the defendant failed to establish by clear and convincing evidence that a person of ordinary skill in the art would combine the elements in the manner claimed. In addition to finding insufficient evidence of motivation to combine, Judge Robinson rejected the defendant’s inherency argument, noting that inherency will only “supply a missing claim limitation . . . if the limitation at issue is the ‘natural result’ of the combination of prior art elements.” Despite the defendant’s argument to the contrary, the Court held that the presence of benzyl benzoate or its ratio with castor oil was not inherent in the prior art.
Judge Robinson also commented that the plaintiffs presented sufficient evidence of long-felt need as a secondary consideration of non-obviousness. The defendant’s evidence that the difficult administration of the drug made it cumbersome and seldom used was rejected as more indicative of a lack of commercial success, a secondary consideration not advanced by the plaintiffs.
Key Points: Defendants continue to have mixed success in invalidating patents in ANDA cases.