What happens if patent doesn’t teach you how to make the invention?

A patent is a set of exclusive rights granted to an inventor for an invention. The public policy for granting patents is to encourage the sharing of knowledge. Inventors that apply for, and are granted a patent, are rewarded for sharing their knowledge with the public. Inventors are rewarded with a monopoly on the invention for a limited period of time. But in exchange for that monopoly inventors must teach the public all the details about an invention. This is known as the enablement requirement.

The enablement requirement is codified in 35 U.S.C. 112(a) of United States patent law. That section of the code requires that the specification of the patent describe how to make and how to use the invention. The enablement requirement is fulfilled when the patent discloses enough information about the invention to enable one skilled in the art to make the invention defined by the claims of the patent application.

The claims of a patent are like property lines on a map. Elements of an invention can be described in the disclosure section of the patent, but if those elements are not claimed then the patent does not cover those elements. Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? If undue experimentation is needed, then the patent should not be granted.

Normally the United States Patent and Trademark Office will refuse to issue a patent when there is a problem with the enablement requirement. The inventor will be required to amend the patent application to provide enough information so that the enablement requirement is satisfied. But sometimes the United States Patent and Trademark Office misses something and a patent gets issued which does not fulfill the enablement requirement.

Take for example: Idenix Pharmaceuticals LLC et al v. Gilead Sciences Inc, U.S. District Court, District of Delaware, No. 14-cv-00846. In that case Merck owned a patent on hepatitis C treatments. Gilead produced a drugs for hepatitis C treatment named Sovaldi and Harvoni. Merck sued Gilead for patent infringement and won a record jury verdict of $2.54 billion in damages. But the judge invalidated the jury verdict because he found that the patent was invalid for lack of enablement. In his opinion the judge explained that the “only reasonable finding, based on the trial record, is that Gilead met its burden to prove nonenablement by clear and convincing evidence.”

Given the amount of time money and effort that goes into getting a patent on an invention, it is important to make sure that the patent is complete. Even after United States Patent and Trademark Office grants a patent it can still be invalidated by the courts.

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