Idenix Pharmaceuticals LLC, et al. v. Gilead Sciences, Inc.

The Patent Act provides that patents must “contain a written description of the invention” in “such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” 35 U.S.C. § 112(a). The law has long recognized that patents including “genus” claims—i.e., claims that identify a class of substances—can satisfy § 112(a). In the field of pharmaceuticals, inventing a genus of compounds is often the key to lifesaving medical innovation, and spelling out each potential embodiment—that is, every chemical variant with the same property—can be practically impossible. This petition presents two related questions:

1. Whether, as the Federal Circuit has held, a genus claim is not enabled “as a matter of law” if it encompasses a large number of compounds—or whether, as this Court has recognized, enablement is a context-specific jury question; and

2. Whether, as the Federal Circuit has held, § 112(a) contains a separate “possession” requirement—or whether, as the statute provides, § 112(a) sets forth a single substantive requirement of “a written description of the invention” sufficient “to enable any person skilled in the art … to make and use the same.”