Exercises in U.S. Statutory Interpretation: Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company 

publication 

Summer 2010 - (Intellectual Property Brief Summer 2010)

Intellectual Property Brief Summer 2010

Ariad Pharmaceuticals, Inc. sued Eli Lilly in the District of Massachusetts alleging infringement of U.S. Patent 6,410,516 ("the '516 patent"). The '516 patent relates to the regulation of gene expression by a previously unknown transcription factor (NF-κB) which was found to mediate certain intracellular signaling underlying the body's immune responses to infection. The scientists/inventors postulated that interfering with NF-kB activity can reduce the symptoms of certain diseases, and they identified three general methods of achieving that reduction: by using decoy cells, dominantly interfering molecules, and specific inhibitor molecules. Although they are discussed in the patent specification, none of these methods was tried and the postulated physiological result was not shown.

The patent employed so-called "genus claims" which encompassed the use of all substances that achieve the desired result of reducing the binding of NF-κB to NF-κB recognition sites. Eli Lilly argued that the asserted claims were not supported by a written description because the specification of the '516 patent failed to adequately disclose how the claimed reduction of NF-κB activity is achieved, and the disclosure amounts to little more than a research plan. Ariad took the position that as there is no term in the asserted claims that corresponds to the molecules, it is entitled to claim the methods without describing the molecules.

An initial District Court jury trial found infringement by Eli Lilly, and held all of Ariad's disputed claims valid. Subsequently, a panel of the Court of Appeals for the Federal Circuit (the "Federal Circuit") held the asserted claims invalid for lack of written description. Ariad successfully petitioned for a Federal Circuit en banc rehearing, challenging the panel's interpretation of 35 U.S.C. § 112, first paragraph, as containing a separate written description requirement. The relevant portion reads:

The 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 which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Ariad argued that a plain reading of § 112 reveals two description requirements for a specification: (i) what the invention is, and (ii) how to make and use it. Ariad argued that "ordinary rules of English grammar" and a "plain reading" of the section show that the description of the invention exists, not for its own sake as an independent statutory requirement, but only to identify the invention that must comply with the enablement requirement. Ariad further argued that the requirement to describe what the invention is does not apply because the original claims, as part of the original disclosure, constitute their own written description of the invention.

According to Eli Lilly, the statute requires that the specification: (a) contain a written description of the invention, (b) describe the manner and process of making and using the invention, and (c) set forth the best mode contemplated by the inventor for carrying out the invention. Eli Lilly further asserted that this separate written description requirement applies to all claims, both original and amended, to ensure that inventors have actually invented the subject matter claimed.

The Federal Circuit affirmed, en banc , the District Court's finding that § 112 includes a separate written description requirement for the specification. The Federal Circuit further held that the written description requirement applies to all claims and that the test for written description 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.

The Federal Circuit also spoke on the topic of "possession", reiterating the passage from Regents of the University of California v. Eli Lilly & Co. , 119 F.3d 1559 (Federal Circuit 1997), stating that the hallmark of written description is disclosure. In the words of Circuit Judge Lourie, who delivered the opinion for the Federal Circuit:

Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. Thus, although 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.

Ariad had complained that the doctrine disadvantages universities to the extent that basic research cannot be patented, but the Federal Circuit countered that the patent law has always been directed to the "useful arts". Per Circuit Judge Lourie, reiterating Fiers v. Revel, 984 F. 2d 1171 (Federal Circuit 1993):

The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not "attempt[s] to preempt the future before it has arrived."

The Federal Circuit found that the claims of the '516 patent were invalid for failure to meet the statutory written description requirement. According to the Federal Circuit, the specification should have demonstrated that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity so as to "satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed."

The written description requirement in the United States raises the bar for research-based genus patents, demanding that applicants have demonstrated practical knowledge of the application of the invention instead of hypothesized results. This may lead to the delayed filing of many patent applications based on university and other institutional research, as such institutions may not have the resources or inclination to work out the practical implications of all such research; i.e., finding and identifying compounds able to affect the mechanism discovered. The Federal Circuit was not concerned with this consequence because in its view "a patent is not a reward for basic research, but [rather] compensation for its successful conclusion."

This article appeared in Lang Michener's Intellectual Property Brief Summer 2010.