Thermolife International, LLC v. Hi-Tech Pharmaceuticals, Inc. et al., Civil Action No. 1:15-CV-00892-ELR (N.D. Ga. May 17, 2022)

Plaintiff ThermoLife International, LLC filed suit against various manufacturers and retailers of various supplement products including Hi-Tech Pharmaceuticals, Inc. et al. on March 27, 2015 alleging that Defendants were directly and indirectly infringing four U.S. patents—U.S. Patent Nos. 8,455,531, 8,466,187, 8,183,288, 8,178,572—generally directed to nitrate or nitrite forms of various amino acids and combinations of nitrate or nitrate salts with amino acids as well as methods for administering those compositions for increasing vasodilative characteristics, athletic performance, and bioabsorption. Defendants filed motions to dismiss for failure to state a claim and Plaintiff filed motions to dismiss counterclaims asserted by Defendants. Defendant Hi-Tech Pharmaceuticals filed a motion to stay pending reexamination of the four asserted patents by the USPTO on September 14, 2015, which was granted. The stay was lifted on August 7, 2017 upon resolution of the reexaminations and Plaintiff filed its Second Amended Complaint on September 25, 2017. The Court dismissed the claims against all Defendants except Advanced Performance, Hi-Tech Pharmaceuticals, Inc., Innovative Laboratories, Jared Wheat, and Prime Nutrition on September 24, 2018. Plaintiff filed a motion to stay pending reexamination of two asserted patents on June 21, 2019, which the Court denied on October 3, 2019. Defendants filed a motion for summary judgment that the asserted patents were invalid under 35 U.S.C. § 101 and § 112 on July 19, 2019, which the Court denied on June 23, 2020. The Court issued its Markman order construing disputed claim terms on April 28, 2020. On June 25, 2021, Plaintiff filed a motions for summary judgment of direct infringement of the ʼ531 Patent and induced infringement of the ʼ572, ʼ288, and ʼ187 Patents. Plaintiff also filed a motion for summary judgment of no-invalidity under 35 U.S.C. § 101 or 112, which the Special Master denied with respect to written description and enablement and granted with respect to invalidity under Section 101 on February 7, 2022. 

In his Report and Recommendation (“R&R”) issued on May 17, 2022, the Special Master granted Plaintiff’s motion for summary judgment with respect to its claims for direct infringement of the ʼ531 Patent and denied its motion for summary judgment of induced infringement as to the ʼ572, ʼ288, and ʼ187 Patents.

Specifically, the Special Master found that the accused products satisfied the “solid supplement formulation” limitation of the ʼ531 Patent, rejecting Defendant’s argument that the accused products did not include a pharmaceutically effective amount of an active ingredient because the claims of the ʼ531 Patent did not include a “pharmaceutically effective” limitation and the argument was not raised during claim construction. The Special Mastert also found that the accused products satisfied the “at least one nitrate salt compound” limitation because the accused products contained the ingredients creatine nitrate and sodium nitrate, which are nitrate salt compounds. Further, the Special Master found that accused products contained “agmatine compounds” not chemically bonded to and isolated from the nitrate salt compounds and satisfied the remaining disputed claim limitations.

Regarding induced infringement, Plaintiff relied on the accused products’ advertisements and labels to satisfy the specific intent element, arguing that the advertisements and labels instructed users to use the accused products in an infringing manner. Defendants argued that their mere knowledge that customers may use the accused products in an infringing manner was not sufficient. The Special Master agreed, finding that Plaintiff “has not pointed to evidence that supports Defendants’ actual knowledge (or willful blindness) that the allegedly induced acts constituted patent infringement. At best, the product labels, advertisements, and third-party representations show that Defendants may have induced its customers to perform the allegedly infringing acts—but, without more, such evidence does not sufficiently support the proposition that Defendants had actual knowledge or will willfully blind that the customers’ acts constitute patent infringement.”

The Special Master cited Global-Tech Appliances, Inc. v. SEC S.A., 563 U.S. 754 (2011), a Supreme Court case holding that induced infringement under Section 271(b) requires knowledge of the patent and knowledge that the induced acts constitute patent infringement. While circumstantial evidence submitted by Plaintiff suggested that Defendants may have marketed and actively encouraged use of the accused products in an infringing manner (i.e., to increase vasodilation and athletic performance), unlike in the cases cited by Plaintiff, there was no evidence that Defendants did to knowing that they were inducing acts of infringement or that Defendants were willfully blind to that fact. As a result, Plaintiff was not entitled to summary judgment of induced infringement.