Enablement easier to satisfy for broader patent claims

With patents, everything starts and ends with the claims which means that the specification, the arguments presented during prosecution and all of the patent applicant’s efforts affect the language of the claims.  For example, a patent specification must enable one of ordinary skill in the art to make and use the invention as recited in the claims.

Alcon Research Ltd. v. Barr Lab., Inc. (Fed. Cir. 2014) illustrates what is required to satisfy the enablement requirement.  In Alcon, the claimed technology was directed to a method for enhancing the stability of a glaucoma and ocular hypertension drug Travatan Z, which uses prostaglandin.  The claims defined the method of “adding a chemically stabilizing amount of polyethoxylated casteor oil [(“PECO”)] to the prostaglandin composition.”  This is very broad claim language.  Infringement is not dependent upon the level of stability achieved but only that stability is increased regardless of the amount of stability that has been achieved.  The Defendant attempted to invalidate the claims contending that the specification did not enable one of ordinary skill in the art to make and use the invention without undue experimentation.  Defendant’s primary argument involved the fact that a number of other variables affect chemical stability besides PECO, such as pH, preservatives, and buffers.

Under current U.S. patent laws, the patent specification does not need to be such a detailed manual that no experimentation is required to make and use the claimed invention.  Rather, some experimentation may be required to practice the claimed invention.  But any such experimentation must not be excessive or undue according to the factors stated In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988).

In the Alcon case, the Federal Circuit stated that the District Court erred because its enablement analysis did not address the threshold showing of whether any experimentation is necessary to practice the claimed invention.  Yes, there may very well be variance when optimizing the chemical stability by adding PECO but the claims do not specific the level of stability.  The claims only require an increase in stability regardless of the amount of increase.  The variability in stability due to pH, preservatives and buffers that the Defendant discussed each affects the level of stability but the claim language does not recite a level of stability and only recites that the stability is increased.  Put simply, it is easier to show that broad claims satisfy the enablement requirement. (But see Magsil v. Hitachi).

For the foregoing reasons, the Federal Circuit reversed the District Court’s judgment that the claims at issue are invalid for lack of enablement.

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