Med. Diagnostic Labs., L. L.C. v. Protagonist Therapeutics, Inc.

Plaintiff Medical Diagnostics Labs alleges that Defendant Protagonist Therapeutics, Inc.'s development of a drug called PTG-200 infringes on its patent for polypeptides that bind to IL-23 receptors. These polypeptides, including PTG-200, have therapeutic potential to treat inflammatory and autoimmune diseases. Protagonist has entered into a multi-million dollar agreement with third-party pharmaceutical company Janssen, Inc. to develop the drug, perform testing necessary for regulatory approval, seek regulatory approval, and, if regulatory approval is obtained, to manufacture and commercialize the drug.

Defendant moves to dismiss, arguing that the activities alleged in the complaint all fall under the safe harbor provided by 35 U.S.C. § 271 (e)(1). For the reasons below, the Court agrees that all activity alleged-with the exception of future commercialization plans-falls within the safe harbor provision. Insofar as future commercialization may infringe on Plaintiff's patent, however, the issue is not sufficiently concrete or immediate to create a case-or-controversy because several contingencies may never materialize. Thus, the Court GRANTS Defendant's motion to dismiss.

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