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Latest Federal Court Cases, 3/18/19

March 18, 2019



Natural Alternatives Int’l v. Creative Compounds, LLC, Appeal No. 2018-1295 (Fed. Cir. Mar. 15, 2019)

In an appeal from a judgment on the pleadings, the Federal Circuit reversed, issuing an opinion that clarifies when a medical treatment may be patent eligible notwithstanding that it implicates natural phenomena.

The patents at issues all relate to dietary supplements containing beta-alanine, an amino acid found in nature. In general, the claims relate to the use of beta-alanine in a dietary supplement to “increas[e] the anaerobic working capacity of muscle and other tissue.” Three categories of claims were at issue—method claims, product claims, and manufacturing claims. Creative Compounds moved for judgment on the pleadings that the claims were all ineligible for patenting under 35 U.S.C. § 101. The district court accepted the patentee’s proposed claim constructions and granted the motion.

The Federal Circuit reversed. With respect to the method claims, the Federal Circuit compared the case to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) and Vanda Pharms., Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), contrasting those cases against each other. The method claims generally disclosed methods to alter the body’s functions by providing beta-alanine “effective to increase beta-alanylhistidine dipeptide synthesis in human tissue.” The district court held that the claims were directed to the natural law that ingesting certain levels of beta-alanine, a natural substance, will yield natural physiological results.

The Federal Circuit disagreed, holding that the claims were “treatment claims” that were therefore patent eligible, consistent with Vanda. The Court held that “unlike the claims held ineligible in Mayo, which required only the observation of a natural law, the Vanda claims required a doctor to affirmatively administer a drug to alter a patient’s condition from their natural state.”

Although the claims, like those in Mayo, relied on a natural law, the Court held the method claims at issue here were distinguishable: “[T]he Method Claims require specific steps be taken in order to bring about a change in a subject altering the subject’s natural state … the Method Claims at issue are treatment claims.” Like those in Vanda, “the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law … they specify particular results to be obtained by practicing the method.” Like the claims in Vanda, “the Method Claims specify a compound to be administered to achieve the claimed result [and] contain a dosage limitation.” And although beta-alanine exists in nature, the claimed amounts far exceed natural levels. The Federal Circuit summarized: “The Method Claims at issue are treatment claims. They cover using a natural product in unnatural quantities to alter a patient’s state, to treat a patient with specific dosages outlined in the patents,” and for that reason are patent eligible.

The Court also held that the product claims were patent eligible because they “are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.” Specifically, the claims recited specific dosage forms and amounts. The Court further distinguished the Supreme Court decision in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), because there was evidence suggesting a synergistic benefit from the asserted claims reciting both beta-alanine and glycine. Thus, it was not a case like in Funk Brothers in which the claimed combination of two chemicals “had the same effect it always had” and the “combination of species produced … no enlargement of the range of their utility.”

The Court also found the manufacturing claims to be patent eligible based on similar reasoning.

Judge Reyna concurred in part and dissented in part, questioning whether the claim constructions offered by the patentee should have been accepted at the pleading stage without further analysis.

The opinion can be found here.


Forest Labs, LLC v. Sigmapharm Labs, LLC, Appeal Nos. 2017-2369, et al. (Fed. Cir. Mar. 14, 2019)

In an appeal from a district court judgment that patent claims directed to a pharmaceutical that was to be dissolved under the tongue or in the cheek were obvious, the Federal Circuit vacated and remanded. The district court found that there was no motivation to combine the art to arrive at the claimed invention. The Federal Circuit reversed for the district court to address a particular motivation to combine argument raised by defendants. The analysis concerning a second claimed motivation to combine, however, was affirmed.

The Court also held that it was appropriate for the district court to treat the invention “as providing a solution to an unrecognized problem in the art.” The Court noted that it has “recognized that where a problem was not known in the art, the solution to that problem may not be obvious, because ordinary artisans would not have thought to try at all because they would not have recognized the problem.” Because there was no evidence in the art of the problem, it was proper for the district court to treat the invention in part as identification of the problem.

The Court also addressed various objective indicia factors, and affirmed a finding that the claims were not invalid for a lack of written description. The Court also remanded for further consideration of infringement based on a revised claim construction.

The opinion can be found here.

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