The Patentability Black Hole

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An inventor faces a number of significant hurdles and pitfalls in patenting his invention. Having a patent specification providing proper and sufficiently thorough disclosure of the invention being claimed by the patentee can, by itself, be a large hurdle, especially in the biosciences where experimental data is essential. Section 112, first paragraph, of Title 35 of the United States Code sets forth the disclosure requirements that all patentees must meet. This section is commonly interpreted as requiring that a patent specification contain a full written description showing that the inventor was in possession of the claimed invention at the time the patent application was filed (the “written description” requirement) and that a patent specification enable a person of ordinary skill in the relevant field to make and use the invention based on the specification (the “enablement” requirement). See Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company, 598 F.3d 1336, 1340 (2010).

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While patentees in all fields must meet both of these requirements, the bioscience fields and other “unpredictable arts” are effectively held to a heightened standard of disclosure that can be a challenge to meet. Courts have repeatedly held that “actual” reduction to practice (i.e., experimental data) is not required for patentability. Nonetheless, inventors in the unpredictable arts are routinely required to provide experimental data showing that a compound or method does have the effect claimed (known as a “working example” ) in order to satisfy the disclosure requirement for their inventions. Ariad, 598 F.3d at 1352. In the race to get a patent application filed as early as possible, however, an inventor may only have time to acquire a limited amount of experimental confirmation of his invention. Commonly, the inventor only possesses in vitro experimental data or possibly in vivo data from animal model experiments, as testing in a human population can take years and millions of dollars. Yet, with only in vitro experimental data, the USPTO will often reject a claim to an invention that is broad enough to cover in vivo methods. Furthermore, even in vivo animal-model data may not support a claim that encompasses methods involving humans. See USPTO Training Materials for Examining Patent Applications with Respect to 35 U.S.C. Section 112, First Paragraph-Enablement Of Chemical/Biotechnical Applications, Sections III.A.1, III.A.2.c.ii, III.C. Thus, the inventor may only have enough data to provide working examples supporting a narrow, less desirable claim to his invention.

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