This afternoon, the 11 active judges of the Federal Circuit will hear argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. The issue is whether 35 U.S.C. § 112, ¶ 1 contains a written description requirement that is separate from the enablement requirement.
A patent must include a description that would enable one of ordinary skill in the art to make and use the invention. This is the disclosure part of the bargain for which we grant the limited monopoly of a patent. Without the incentive of a patent, many inventions might be kept secret. To ensure sufficient disclosure of the invention to the public in exchange for the limited monopoly, the patent must be enabling.
Is there a separate requirement that the patent contain a written description of the invention to ensure that the inventor was “in possession” of the invention at the time he invented it? If so, what does that mean?
The problem is that the statute is not written as a model of clarity.
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.
Two Interpretations of the Statute
One way to read the statute is that the specification shall include a written description (1) of the invention, and (2) of the manner and process of making and using it. What does it mean to describe the invention other than by the manner and process of making and using it? Does this mean that examples are required? If so, how many? Does this mean that actual reduction to practice of the invention is required? Is a working model or prototype a requirement?
Or does this mean that the patent must describe exactly how the invention works? Sometimes the inventors do not know exactly why a new discovery or invention works the way it does. This can be especially true in the case of a relatively new discovery or endeavor. They know what they did, but are not sure of the scientific explanation of why they achieved the result they did. It may take years of additional testing and experimentation to determine how or why the invention works as it does. They may still, however, be able to adequately describe how to make and use the invention, just not how or why it works. Should they be denied patent protection for their discovery?
Another way to read the statute is simply to read it as requiring a written description that enables one of ordinary skill in the art ot make and use the invention. Unless such a description is inadequate or would require undue experimentation to reproduce, examples, working models, and prototypes are not required. Moreover, it is not necessary for the inventor to know why the invention works as it does in order to gain patent protection for it.
Which of these views is correct? There has been disagreement in recent years on the issue at the Federal Circuit. This afternoon, the court will begin trying to answer this question.