Federal Circuit Opinion on the Need For and Timing of Enabling Data

In a recent Federal Circuit case, In re '318 Patent Infringement Litigation, 583 F.3d 1317 (Fed. Cir. 2009), a split panel decision underscored the importance of working examples in a patent application claiming a method of clinical treatment. The majority, despite a sharply worded dissent, affirmed the district court's decision that the claims of U.S. Patent No. 4,663,318 were invalid as lacking sufficient enablement. The case demonstrates the delicate balance an applicant faces when establishing nonobviousness and enablement, especially in the absence of working examples.

The claims of the '318 patent relate specifically to the use of galanthamine, an acetylecholinesterase inhibitor sold by Janssen Pharmaceutica under the names REMINYL® and RAZADYNE®, in the treatment of Alzheimer's disease and related dementias. The patent application has a short one-page specification and no in vivo or in vitro data. Rather, the specification summarizes several prior art references and refers to a known animal model of Alzheimer's disease. The cited references describe administration of galanthamine and its positive effect on memory in normal subjects. Faced with an obviousness rejection during prosecution, the patent owner argued that the previously reported effects of galanthamine in normal subjects were completely unpredictive of its usefulness in the treatment of dementia. The patent owner also promised to provide supporting animal data to the examiner as soon as the data were available. The opportunity never arose, however, because the examiner allowed the claims in the absence of any data showing an effect in an Alzheimer's animal model.

The district court held that the claims were invalid for lack of enablement because no utility was demonstrated, and stated that, since Janssen Pharmaceutica relied exclusively on the prior art to establish enablement, the patent could not be both nonobvious and enabled. On appeal, the majority rejected Janssen Pharmaceutica's argument that utility was established by "analytical reasoning" and refused to consider data unavailable "at the time of the application," even though the later-generated data obviously was enough to satisfy the FDA that the drug was useful for treatment of Alzheimer's disease. The majority opinion, however, fails to make clear whether the applicant must provide supporting data in the application as filed, or whether such data provided during prosecution is sufficient to establish utility.

In view of this case, we suggest that our clients take heed of certain practice tips:

First, in biotechnology or pharmaceutical cases, which are generally considered within the "unpredictable arts," applicants should provide working examples in the patent application whenever possible. One cannot assume that data generated after the filing date will be considered. Animal data or in vitro data should be sufficient to establish utility and, thus, "how-to-use" enablement for a method of treatment claim, so long as the animal model or in vitro system bears a reasonable correlation to the disease to be treated.

Second, if no data are available at the time of filing, we suggest that the application include the inventor's novel and nonobvious insights and reasoning, based on whatever evidence is available at that time, that support the claimed methods of treatment.

Third, in applications lacking working examples, in vivo or in vitro data acquired after the application's filing date should be provided to the examiner as soon as possible during prosecution, even in the absence of an enablement or utility rejection. Consider committing the resources to generating such data early in prosecution, even if the applicant's current commercial priorities lie elsewhere.

Finally, we recommend carefully crafted arguments during prosecution so that the delicate balance between nonobviousness and enablement is maintained.