Endo Pharma. Solutions Inc. v. Custopharm, Inc.

Defendant failed to meet its burden in proving a motivation to combine prior-art references and also failed to establish the claimed compound as inherently present in the prior art.

April 26, 2017

GENERICally Speaking

Case Name: Endo Pharma. Solutions Inc. v. Custopharm, Inc., 14-1422-SLR, 2017 U.S. Dist. LEXIS 19035 (D. Del. Feb. 10, 2017) (Robinson, J.) 

Drug Product and Patent(s)-in-Suit: Aveed® (testosterone undecanoate); U.S. Patents Nos. 7,718,640 (“the ’640 patent”) and 8,338,395 (“the ’395 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claimed a method for treating male hypogonadism (low testosterone) by injecting the patient with a testosterone undecanoate (“TU”) serum, and further claimed the use of benzyl benzoate as a co-solvent in a particular ratio. Plaintiffs marketed their TU injection under the name Aveed.

Defendant filed an ANDA seeking approval to market a generic TU injection. In response, Plaintiffs filed suit, alleging that defendant’s ANDA infringed the patents-in-suit. Defendant argued that the patents-in-suit were invalid in light of the prior art, and thus the ANDA did not infringe. The court found in favor of Plaintiffs.

Why Plaintiffs Prevailed: The prior art was not clear in its disclosure. First, defendant did not provide evidence that one of ordinary skill would be motivated to combine TU with benzyl benzoate. The court found there was no evidence in the prior art suggesting that benzyl benzoate would stand out as a co-solvent amongst a myriad of other potential co-solvents. Nor was there any disclosure in the prior art regarding the ratio of TU to benzyl benzoate. Thus, a person of ordinary skill would not be motivated to combine the two compounds. The court rejected defendant’s argument that the prior art inherently disclosed the claimed invention: the claimed invention was not inherently disclosed because the prior art did not bar the use of alternate combinations in its process. Accordingly, defendant did not establish that the claimed combination was necessarily present in the prior art. For those reasons, the court upheld the validity of the patents-in-suit and found in plaintiffs’ favor.

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