Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

 
APPEAL NO.
08-1248
OP. BELOW
DCT
SUBJECT
Patent
AUTHOR
Lourie

Question(s) Presented

1. “[W]hether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?” 2. “[I]f so, [what is] the scope and purpose of that requirement?”

Holding

1. “We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement.” 2. “[T]he description must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’ . . . In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. . . . The term ‘possession,’ however, has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed. . . .[A]lthough written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described. . . . The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts.”

Date
Selected Proceedings and Orders
February 6, 2009
December 7, 2009
March 22, 2010