Intellectual Property Attorneys


The New Patent Law in New Zealand

Ariad v. Lilly - Underscoring the Fundamentals

12 years ago

In March 2010, the patent community was anticipating an en banc decision of Ariad v. Lilly by the Federal Circuit.  The decision had the potential to change the written description requirement of 35 U.S.C. §112, first paragraph and/or provide clear guidance regarding that requirement.  When the decision issued, it didn’t make the splash that was anticipated, but rather quietly affirmed what the community already knew and what was summed up so well by Judge Gajarsa in the concurring opinion:

“[t]he text of section 112, paragraph 1 is a model of legislative ambiguity…”[1]

Despite this affirmation of ambiguity in the statute itself in a concurring opinion, the majority opinion offered an interpretation of the statute that affirmed the existence of two separate description requirements: one for written description of the invention and one for enablement.  The statutory basis for the two separate requirements was interpreted as follows (written description in bold, enablement in italics):

[t]he specification shall contain a written description of the invention, and [a written description] 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 which it pertains, or with which it is most nearly connected, to make and use the same…[2]

The interpretation of the statute by the majority appeared to rest largely on a desire not to disrupt established policy.  The opinion included an analysis of the existence of the written description requirement “since 1793…”[3] 

The majority further explained the need for two separate requirements as follows:

“…a separate requirement to describe one’s invention is basic to patent law.  Every patent must describe an invention.  It is part of the quid pro quo of a patent: one describes an invention, and, if the law’s other requirements are met, one obtains a patent.  The specification must then, of course, describe how to make and use the invention (i.e., enable it), but that is a different task.”[4]

To the patent community, Ariad confirmed that the first paragraph of 35 U.S.C., §112 is far from clear, but the majority decision confirmed that, in practice, particularly in drafting of new applications, both written description and enablement must be present.  Accordingly, in drafting a new application, the following considerations are apposite:

1) The specification should be prepared with an objective view of one of skill in the art.[5] Sufficient written description remains a fundamental requirement of patent applications.  An applicant must demonstrate possession of the claimed invention, or “possession as shown in the disclosure,” noted by the majority in Ariad to be “a more complete formulation.”[6]

2) Examples/description of what has actually been done should be included that satisfy the requirements for enablement and best mode. 

3) The scope of each claim should be rigorously considered, and claims included of varying breadth, which are fully consistent with and supported by the description in the specification.

Ariad did not change the law, but reconfirmed the fundamental requirements of showing that an invention has been made by the patent applicant, and setting out that invention in a manner sufficient for one of ordinary skill in the field of the invention to implement in operable form.

Kelly K. Reynolds

June 22, 2011

[1]  Ariad Pharmaceuticals, Inc., et al. v. Eli Lilly and Company, 598 F. 3d 1336, 1360 (2010).

[2] Id. at 1344.

[3] Id. at 1345.

[4] Id. at 1345.

[5] “…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.”  Id at 1351.

[6] Id at 1351.

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