Books CAFC Courts District Courts Federal Circuit Federal Circuit Review Guest Contributor Guest Contributors innovation intellectual property Inventors Information IP News IPWatchdog Articles Litigation patent patent eligibility patent eligible Patent Litigation Patentability patentability requirements patentable subject matter Patents Technology & Innovation

CAFC Reverses Patent Ineligibility Finding at Pleading Stage

Federal Circuit

Held: On the pleading stage of a patent infringement motion, the CAFC performs patent eligibility evaluation beneath the patent proprietor’s proposed declare constructions. Claims overlaying a selected technique of remedy for particular sufferers utilizing a selected compound at particular doses to realize a selected outcome are thought-about remedy claims and are patent eligible.

In Pure Options Int’l, Inc. v. Artistic Compounds, LLC, the Federal Circuit reversed the choice of america District Courtroom for the Southern District of California, which had held that a collection of patents owned by Pure Options Worldwide, Inc. (“Pure Options”) have been directed to legal guidelines of nature and lacked an creative idea adequate to render them patent eligible beneath 35 U.S.C. § 101. Pure Options Int’l, Inc. v. Artistic Compounds, LLC, No. 18-1295, 2019 U.S. App. LEXIS 7647 (Fed Cir. March 15, 2019) (Earlier than Moore, Reyna, and Wallach, Circuit Judges) (Opinion for the Courtroom, Moore, Circuit Decide) (Concurring-in-part and dissenting partially, Reyna, Circuit Decide).

The patents at difficulty have been directed to using beta-alanine in dietary dietary supplements to “increas[e] the anaerobic working capability of muscle and different tissue.” After Pure Options asserted the patents in a number of lawsuits in California, Artistic Compounds, LLC (“Artistic Compounds”) moved for judgment on the pleadings. The district courtroom granted the movement. In performing its eligibility evaluation, the district courtroom accepted Pure Options’ proposed declare development and held that the asserted claims have been patent ineligible. Pure Options appealed, and the Federal Circuit reversed and remanded.

Wanting on the Claims

The Federal Circuit held that “the grievance’s factual allegations, along with all affordable inferences, plausibly set up the eligibility of the consultant claims.” In conducting its evaluation, the Courtroom utilized Pure Options’ proposed declare constructions,  defining “efficient” as “elevates beta-alanine above pure ranges to trigger a rise within the synthesis of beta-alanylhistidine dipeptide within the tissue”; “dietary complement” as “an addition to the human eating regimen, which isn’t a pure or typical meals, which successfully will increase athletic efficiency when administered to the human over a time period”;. and “growing anaerobic working capability” as “growing the quantity of labor carried out by a muscle beneath lactate producing circumstances.”

A lot of the asserted patents declare strategies of remedy utilizing beta-alanine (“the Technique Claims”). Consultant Declare 1 of the ‘596 patent recites:

  1. A way of regulating hydronium ion concentrations in a human tissue comprising:

offering an quantity of beta-alanine to blood or blood plasma efficient to extend beta-alanylhistidine dipeptide synthesis within the human tissue; and

exposing the tissue to the blood or blood plasma, whereby the focus of beta-alanylhistidine is elevated within the human tissue.

Patent Eligibility Evaluation

Though the claims coated a pure product—beta-alanine—they coated the product in unnatural portions so as to alter a affected person’s pure state and deal with a affected person with particular dosages, stated the Courtroom. As such, the Federal Circuit discovered the tactic claims patent eligible remedy claims—directed to “a selected technique of remedy for particular sufferers utilizing a selected compound at particular doses to realize a selected consequence.”  Because the Courtroom defined, “[a]dministering sure portions of beta-alanine to a human topic alters that topic’s pure state. Particularly, homeostasis is overcome, and the topic’s physique will produce larger ranges of creatine. . . . This, in flip, leads to particular physiological advantages for athletes engaged in sure intensive train. . . . The claims not solely embody this discovery, they require that an infringer truly administer the dosage type claimed within the method claimed, altering the athlete’s physiology to offer the described advantages.”

In contrast to the claims in Mayo, which merely described an present pure relationship, the tactic claims not solely “depend on the relationships between the administration of beta-alanine and beta-alanylhistidine dipeptide synthesis, however . . . require particular steps be taken as a way to convey a few change in a topic, altering the topic’s pure state.”  The Courtroom elaborated that “

Equally, though the asserted claims directed to a dietary complement have been directed to particular remedy formulations that included the pure product beta-alanine, they nonetheless have traits and can be utilized in ways in which beta-alanine in nature does and can’t. For instance, in declare 1 of the ‘084 patent, the “dietary complement” makes use of beta-alanine at a dosage of “between about zero.four grams to 16 grams” to “successfully improve[] athletic efficiency.” The Courtroom stated that Pure Options had sufficiently alleged that the claimed dosage varieties could possibly be used to extend athletic efficiency in a means that naturally occurring beta-alanine can’t and that the claimed mixture of glycine and beta-alanine might have results far larger than the sum of its elements.

Lastly, the bulk held that claims directed to the manufacture of a human dietary complement containing beta-alanine with sure traits weren’t directed to a regulation or product of nature, however as an alternative to an software of a pure regulation and new use of the product.

Decide Reyna Concurs-in-Half, Dissents-in-Half

In response to Decide Reyna, the bulk’s evaluation relied on an misguided declare development. Decide Reyna concurred within the choice to remand, which might allow the courtroom to conduct formal declare development and revisit the Part 101 evaluation beneath a correct declare development. Decide Reyna additional invited the Courtroom to think about whether or not conducting a Part 101 evaluation on the pleading stage is acceptable: “


Dustin Weeks

Dustin Weeks

is a Associate within the mental property follow group at Troutman Sanders. His apply spans all areas of mental property regulation, together with patent prosecution, patent litigation (together with Hatch-Waxman litigation), and shopper counseling. He represents shoppers starting from start-ups and solo inventors to Fortune 500 corporations. Dustin works intently together with his shoppers to study their enterprise aims in order that he can tailor methods to acquire, shield, and implement their mental property. Dustin focuses on post-grant proceedings (e.g. Inter Partes Evaluations) earlier than the Patent Trial and Attraction Board (PTAB) the place he has in depth expertise representing each patent house owners and petitioners throughout a variety of applied sciences, together with wi-fi networking, prescription drugs, MEMs units, medical units, and electro-mechanical shopper units. Dustin’s broad expertise in patent prosecution, counseling, and patent litigation uniquely positions him to navigate the blended apply of post-grant proceedings.

For extra info or to contact Dustin, please go to his Agency Profile Web page.

Dustin Weeks

Robert Schaffer & Joseph Robinson


Robert Schaffer is an mental property companion at Troutman Sanders. Bob applies greater than 30 years of expertise to IP counseling and litigation. His work consists of patent procurement, strategic planning and transactional recommendation, due diligence investigations, district courtroom patent instances, and Federal Circuit appeals. He commonly handles complicated and high-profile home and worldwide patent portfolios, mental property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed courtroom instances Bob’s work consists of representing and counseling shopper in ANDA litigations, complicated patent infringement instances and appeals, and multidistrict and worldwide instances. In disputed Patent Workplace issues his work consists of representing and counseling shoppers in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For extra info and to contact Bob please go to his profile web page on the Troutman Sanders web site.

Joseph Robinson has over 20 years of expertise in all elements of mental property regulation. He focuses his apply within the pharmaceutical, life sciences, biotechnology, and medical system fields. His apply encompasses litigation, together with Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in quite a lot of patent and trademark disputes in many various jurisdictions, and has additionally served as appellate counsel earlier than the Courtroom of Appeals for the Federal Circuit. Joe additionally focuses on complicated inter partes issues earlier than the united statesPatent and Trademark Workplace, inventorship disputes, reexaminations and reissues. His expertise consists of quite a few interferences, a specific benefit in new U.S. Patent and Trademark Workplace post-grant proceedings. He additionally counsels on patent–associated U.S. Meals and Drug Administration points, together with citizen petitions, Orange Ebook itemizing, and trademark points. For extra info and to contact Joe please go to his profile web page on the Troutman Sanders web site.

About the author