What exactly does 35 U.S.C. §112 require?

The Court of Appeals for the Federal Circuit vacated its decision in Ariad v. Lilly, granting en banc rehearing of the case. In its petition, Ariad Pharmaceuticals asked the court to answer two questions: first, whether the court erred by engrafting a separate written description requirement onto §112 ¶1; and second, what is the proper test to satisfy the requirement in Section § 112?  

In its patent on regulation of a transcription factor NF-κB activity, Ariad claimed all methods of reducing NF-κB function but only hypothesized three classes of molecules potentially capable of reducing NF-κB activity. The court held that Ariad’s patent was invalid on the ground of lack of written description.

The focus of current debate is whether 35 U.S.C. §112 supports a separate written description requirement in addition to enablement requirement. The statute provides that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to . . . make and use the same . . . ” (emphasis added). One way of reading the statute is that there is no separate written description requirement so long as the enablement requirement is satisfied. The other way is that written description and enablement are separate and distinct requirements under §112. The purposes of these two requirements are different; the enablement requirement polices the balance between the private value of an excluding right to the patentee and public value of the gain to society. The written description requirement has a “notice” function of ensuring that the inventor “processes” what she invented, and prevents overreaching. Practically, the written description can prevent the applicants from broadening or amending their claims during prosecution to embrace subject matter they did not invent (usually called new matter). For example, in Gentry v. Berkline, Gentry amended and then construed its claim covering a sofa with a pair of reclining seats in parallel relationship at any place, though the initial filing specification was only limited to side-by-side reclining seats with a fixed console. The enablement requirement is not adequate by itself to stop this, because Gentry had never contemplated the new subject matter. But such amended claims might be enabled because those of ordinary skill in the art could put the control of reclining seats at any place based on the initial disclosure.

The Ariad court emphasized the importance of the written description requirement of ensuring that the scope of the right to exclude does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. But the current enablement requirement requires that the specification must enable the full scope of claim invention, and such full-scope enablement requirement seems to be sufficient to address this concern. The Ariad court invalidated patent even without reaching the enablement question.

Many interested groups have filed amicus briefs to the court, the en banc decision will have a huge impact on patent drafting and prosecution, especially for the biotech industry.