Pharmaceutical companies often develop new uses for known drugs, including orphaned drugs — i.e., promising drugs that have failed during some stage of clinical trials. Patent protection for a new use is typically sought in order to extend the proprietary life of the drug. Many patent practitioners have long believed that a patent application directed to a new use could be properly filed without experimental data, so long as the application describes how to make and use the drug. After the recent decisions in Eli Lilly & Co. v. Actavis (Lilly I), 2010 U.S. Dist. Lexis 83292 (D.N.J. Aug. 12, 2010), and Janssen Pharmaceutica N.V. v. Teva Pharms USA Inc. (In re ’318 Patent Litig.), 583 F.3d 1317 (Fed. Cir. 2009), patent practitioners should no longer assume that experimental data are not required. Determining the proper time to file a method-of-treatment patent can be critical to its validity.

Patent protection is not intended for “vague intimations of general ideas that may or may not be workable.” In re ’318, 583 F.3d at 1324. U.S. law, therefore, requires that a patent application include “a written description of…the manner…of making and using [the invention], in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.” 35 U.S.C. 112, ¶ 1. This is known as the “how to use” prong of the enablement requirement. Enablement must be established as of the filing date of the patent. In re ’318, 583 F.3d at 1323.

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