File No Patent Before Its Time: Test Results That Issue After Filing of Application Cannot Be Used to Meet Enablement Requirement

 

By Jonathan Lovely

 

The Federal Circuit has reinforced the principle that a patentee cannot rely on test results that were not available at the time of application to establish the validity of her patent.  This is because enablement—one of the criteria for validity—is determined as of the filing date of the application.

 

Janssen Pharmaceutica N.V. sued a roster of leading generic-drug manufacturers for infringement of its patent directed towards a method for treating Alzheimer’s disease using galanthamine. This small-molecule compound is known to inhibit an enzyme that breaks down the neurotransmitter acetylcholine. At the time of the application in question, researchers had observed a correlation between the symptoms of Alzheimer’s disease and the level of acetylcholine in the brain.

In In Re ‘318 Patent Infringement Litigation, the Federal Circuit affirmed a trial judge’s conclusion that, while the patent claims were not anticipated or obvious (two hallmarks of invalidity), they were invalid for lack of enablement. 

The specification of the ‘318 patent barely exceeded one page in length and essentially summarized six scientific papers regarding the use of galanthamine in humans and animals. The specification did not refer to any test results regarding the use of galanthamine in connection with Alzheimer’s disease.

The relevant statute requires that a patent’s specification describe the invention in such terms as to enable a person of ordinary skill in the art to make and use the invention. 35 U.S.C. § 112, paragraph 1. As the Federal Circuit emphasizes, enablement is determined as of the effective filing date of the application. This echoes the court's 2003 opinion in Plant Genetic Sys., N.V. v. DeKalb Genetics Corp.

The court points out that the enablement requirement is closely tied to the utility requirement under 35 U.S.C. § 101. The latter requirement aims to prevent the patenting of mere ideas by requiring that the invention be useful and therefore operable.

If a claim within a patent does not meet the utility requirement because it is not operable, that claim also fails to meet the how-to-use aspect of the enablement requirement. See Process Control Corp. v. HydReclaim Corp. Together, the utility and enablement requirements prevent patenting a research proposal or an invention that is merely an object of ongoing research.

In affirming the district court, the Federal Circuit stressed that the test results involving the use of galanthamine to treat Alzheimer’s disease were not available until after the patent issued. The court also pointed to comments that the inventor made during prosecution and to trial testimony of several experts.

In particular, the inventor, Dr. Bonnie Davis, and Janssen’s other witnesses conceded that the utility of the invention could not be inferred from the prior art testing described in the application. The Federal Circuit added that “the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis.”

In view of this extremely limited description, which summarized a mere handful of scientific articles; the lack of test results at the time of application; and the inventor’s own remarks, the Federal Circuit justifiably invalidated the asserted patent claims.

This case highlights the tension between grabbing an early filing date and waiting for additional support for the claimed invention. Had Dr. Davis waited for test results, she might have owned a valuable, and more importantly, a valid patent (and Janssen Pharmaceutica might have warded off its generic adversaries). At the same time, she would have risked being scooped by another inventor.

The Janssen case underscores the need for careful patent drafting, prosecution, and filing strategies. Had Dr. Davis been able to provide additional support within the specification, the district court and the Federal Circuit may not have found her claims invalid. Instead, the court was moved to observe that some of the analytical reasoning and insights relied upon by Janssen were not described at all within the specification.

The remarks made during prosecution and trial provided some of the most damning evidence in support of the court rulings. It cannot be known whether or not the claims would have been valid if Dr. Davis had included her reasoning and insights in the specification and more carefully crafted her remarks during prosecution. At the very least, however, she would not have been her own worst enemy.