ThermoLife International, LLC v. Hi-Tech Pharmaceuticals, Inc. et al., Civil Action No. 1:15-cv-00892-ELR (N.D. Ga. July 28, 2022):

On July 28, 2022, Special Master Anthony B. Askew recommended the denial of Plaintiff ThermoLife International LLC’s Motion for Summary Judgment of No Invalidity Under 35 U.S.C. §§ 102 or 103.

First, in denying Plaintiff’s Motion for Summary Judgment with respect to the anticipation (§ 102) issue, the Special Master deemed Plaintiff’s broad arguments that none of Defendants’ anticipation challenges are based on a single reference “inappropriate”, noting that Defendant’s pointed to at least two anticipation challenges that are “clearly based” on a single prior art reference.

Second, in denying Plaintiff’s Motion for Summary Judgment with respect to the obviousness (§ 103) issue, the Special Master noted that there exist genuine issues of material fact left to be resolved since the parties and their experts dispute the interpretation of many references that may or may not provide the motivation to combine specific references. Construing the evidence in a light most favorable to Defendants as the non-moving party, the Special Master held that a reasonable jury could find a motivation to combine based on the evidence of record.

Notably, the Special Master’s recommendation of denial with respect to Plaintiff’s Motion for Summary Judgment of No Invalidity comes shortly after the Court adopted the Special Master’s recommendation to grant in part and deny in part Plaintiff’s motion for summary judgment. Namely, the Court agreed with the Special Master’s recommendation to (i) deny Plaintiff’s motion for summary judgment regarding Defendants’ written description invalidity defense and enablement invalidity defense (§ 112), finding that a genuine dispute of material fact remains regarding whether the written description is adequate in light of the alleged incorrect chemical structures; (ii) grant summary judgment in Plaintiff’s favor regarding Defendants’ § 101 invalidity challenge; (iii) deny Plaintiff’s motion for summary judgment with regard to Plaintiff’s claims for induced infringement given Plaintiff’s failure to proffer evidence to support the specific intent element; (iv) deny Plaintiff summary judgment on on infringement as to “all formulations” of Mesomorph since the only allegedly infringing Mesomorph products and corresponding product labels included in the Second Amended Complaint are “Mesomorph” and “Mesomorph v. 2.0″; and (v) grant summary judgment in Plaintiff’s favor of infringement on Claims 4–6 and 16 of the ’531 Patent since there is no genuine dispute of material fact as to whether the amino acids are isolated in the Accused Products.

The suit dates back to March 2015 when Plaintiff initiated this suit against Defendants, alleging that Defendants were infringing claims of several U.S. patents related to nitrate or nitrite forms of various amino acids and combinations of nitrate or nitrite salts with amino acids as well as method claims covering administration of those compositions for increasing vasodilative characteristics, athletic performance, and bioabsorption: U.S. Patent Nos. 8,178,572 (“the ’572 Patent”); 8,183,288 (“the ’288 Patent”); 8,455,531 (“the ’531 Patent”); 8,466,187 (“the ’187 Patent”); and 8,952,046 (“the ’046 Patent”). The case was stayed pending the outcome of a number of reexaminations before the U.S. Patent Trial and Appeal Board. Upon resolution of those reexaminations, the stay was lifted, and Plaintiff filed its Second Amended Complaint in September 2017.