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Patent Claiming a Method of Treatment Was Not Enabled Where It Failed to Establish Utility

September 25, 2009

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Last Month at the Federal Circuit - October 2009

Judges: Mayer, Gajarsa (dissenting), Dyk (author)

[Appealed from: D.N.J., Judge Pisano, and D. Del., Judge Robinson]

In In re ’318 Patent Infringement Litigation, Nos. 08-1594, 09-1070, -1088 (Fed. Cir. Sept. 25, 2009), the Federal Circuit affirmed the district court’s judgment against Janssen Pharmaceutica N.V., Janssen L.P., and Synaptech, Inc. (collectively “Janssen”), holding that the claims of U.S. Patent No. 4,663,318 (“the ’318 patent”) were invalid for lack of enablement.

The ’318 patent claims a method for treating Alzheimer’s disease with galanthamine. At the time the ’318 patent application was filed in 1986, researchers had observed a correlation between Alzheimer’s disease and reduced levels of the neurotransmitter acetylcholine in the brain. During neurotransmission, acetylcholine is released by a transmitting neuron and binds to receptors acetylcholinesterase, an enzyme that breaks down acetylcholine. Accordingly, acetylcholinesterase inhibitors such as galanthamine increase the amount of acetylcholine available for binding to receptors on receiving neurons.

The specification of the ’318 patent application was just over one page in length and provided short summaries of six scientific papers in which galanthamine had been administered to humans or animals. The Court found that the specification did not provide analysis or insight connecting the results of any of these six studies to galanthamine’s potential to treat Alzheimer’s disease in humans.

During prosecution, the examiner rejected the claims in the ’318 patent application as obvious in light of the cited animal studies. In response, the inventor stated that because the brains of the animals in the cited studies were normal rather than having physiological changes similar to Alzheimer’s disease, the studies had no relevance to Alzheimer’s disease. As a result, the inventor stated that it would be “baseless” to predict that galanthamine would be useful to treat Alzheimer’s disease from these studies. The inventor then stated that “experiments [are] underway using animal models which are expected to show that treatment with galanthamine does result in an improvement in the condition of those suffering from Alzheimer’s disease.” Slip op. at 7 (alteration in original) (citation omitted). Because the inventor did not learn the results of the animal testing experiments until after the ’318 patent had issued, the results were never submitted to the PTO.

In 2005, several generic drug manufacturers filed ANDAs and Paragraph IV certifications with the FDA, seeking approval to market generic versions of galanthamine. Janssen sued each manufacturer for infringing the ’318 patent and the actions were subsequently consolidated. The defendants conceded infringement of claims 1 and 4, but asserted that the ‘318 patent was invalid based on anticipation, obviousness, and lack of enablement. After a bench trial, the district court held that the patent was neither anticipated nor obvious, but that it was invalid for lack of enablement.

On appeal, the Federal Circuit noted the close relationship between enablement and utility. The Court stated that, “[i]f a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-touse aspect of the enablement requirement.” Id. at 10 (emphasis omitted) (quoting Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1358 (Fed. Cir. 1999)). The Court observed that the utility requirement prevents mere ideas from being patented. In addition, the Court noted that the utility requirement prevents the patenting of mere research proposals or an invention that is simply an object of research.

The Federal Circuit also observed that patent applications claiming new methods of treatment typically demonstrate utility by providing test results. But the Court affirmed that such testing need not be conducted by the inventor. Further, human trials are not necessary to support the utility of a therapeutic invention. Instead, in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, may provide a reasonable correlation sufficient to satisfy the utility requirement.

Here, the Court found that neither in vitro test results nor animal test results involving the use of galanthamine to treat Alzheimer’s-like conditions were provided. In addition, because the proposed animal test results were not available at the time of the application, they could not be used to establish enablement. Janssen argued, however, that the specification established utility by analytic reasoning. Janssen asserted that the prior art tests summarized in the specification would lead one skilled in the art to infer that galanthamine affected the ability of acetylcholine to bind to receptors in the brain. Since these receptors involve the ability to learn, Janssen argued that the specification suggested that galanthamine could have beneficial effects on learning.

The Federal Circuit was not persuaded by these arguments, noting that these insights were not described in the specification. The Court also found that there was no evidence that a person skilled in the art would infer galanthamine’s utility from the specification, even if such inferences could substitute for an explicit description of utility.

Moreover, the Court found the testimony of Janssen’s expert witnesses fell far short of demonstrating that a person of ordinary skill in the art would have recognized that the specification conveyed the required assertion of a credible utility. The Court also noted the inventor’s testimony revealed that an ordinary skilled artisan would not have viewed the patent’s disclosure as describing the utility of galantamine as a treatment for Alzheimer’s disease.

Accordingly, the Court found that “at the end of the day, 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.” Id. at 16. This was insufficient to establish utility. As a result, the Federal Circuit held that the ’318 patent did not satisfy the enablement requirement because it did not establish utility.

Judge Gajarsa dissented, stating that that the district court did not undertake the required legal analysis to determine whether an ordinary skilled artisan reading the patent would understand it to reveal a credible utility for the invention. Further, Judge Gajarsa found that the district court failed to make the factual findings necessary to support the ultimate legal conclusion regarding enablement. Judge Gajarsa noted the majority’s finding that where the record would not support a finding of utility, the absence of findings by the district court on the issue of whether a person skilled in the art could infer utility from the prior art described in the specification was not error. In response, Judge Gajarsa stated that because there was evidence of record that supported a conclusion that the ’318 patent claims were not invalid, it was inappropriate for the Court to weigh the evidence and make contrary factual findings, especially in the absence of any consideration by the district court of numerous prior art references that were specifically discussed in the patent. Thus, Judge Gajarsa would have vacated the judgment and remanded the case to the district court to make the required factual findings and perform the necessary legal analysis.

Summary authored by Jared D. Schuettenhelm, Esq.