IP Law Daily, PATENT—E.D.N.Y.: CoQ10 supplement maker’s patent claims invalid for lack of utility and enablement, (Sep 3, 2026)

By Ravindra Kumar Singh, B.L.

The patent owner had no pre-filing test data showing that CoQ11 provided the claimed composition with a useful stabilizing effect.

Two claims of a patent covering compositions of coenzyme Q10 (CoQ10) and a method for producing them were invalid because the patent owner had not established the utility of compositions containing reduced coenzyme Q11 (CoQ11) when it filed its patent application, the federal district court in Brooklyn found. Although Kaneka Corporation had tested a related compound, CoQ9, it had conducted no pre-filing testing of CoQ11 and could not rely on later testing to establish that its claimed invention was useful at the relevant time. The court also concluded that the patent failed the enablement requirement because its broad claims covered compositions containing any amount of CoQ11 while leaving skilled artisans to determine through experimentation whether those embodiments worked. However, the court granted Kaneka summary judgment on the accused infringers’ tortious interference and Walker Process antitrust counterclaims (Kaneka Corp. v. Cocrystal Technology (Jiaxing) Co., Ltd., No. 1:23-cv-07483-SJB-SDE (E.D.N.Y. Sep. 2, 2026)).

CoQ10 patent. Kaneka, a Japanese producer and supplier of CoQ10 supplements, sued Cocrystal Technology (Jiaxing) Co., Ltd. and Cocrystal Health Industry (Zhejiang) Co., Ltd. for infringement of U.S. Patent No. 7,829,080 (the ’080 patent). The human body uses CoQ10 to produce the energy needed for cell growth and maintenance. The patent addressed ubiquinol, the reduced form of CoQ10, which is more easily absorbed by the body but readily oxidizes when exposed to air.

Claims 5 and 15 were at issue. Claim 5 covered a ubiquinol composition containing specified amounts of reduced CoQ9, reduced CoQ11, or both. Importantly, there was no minimum amount of CoQ11 required: even a single molecule could satisfy that portion of the claim. Claim 15 covered a method for producing the composition recited in claim 5.

Cocrystal initially challenged the claims on numerous grounds, including lack of enablement, lack of utility, anticipation, obviousness, indefiniteness, and the on-sale bar. In October 2025, however, the companies stipulated that Cocrystal infringed claims 5 and 15, leaving validity as the central patent issue. The parties then filed cross-motions for summary judgment.

No pre-filing testing. The validity dispute centered on an important gap in Kaneka’s research. Although the patent claims did not expressly require CoQ11 to stabilize ubiquinol, Kaneka relied principally on that stabilizing effect to demonstrate the usefulness of including CoQ11.

The undisputed evidence showed that Kaneka had tested CoQ9 before filing the patent application in April 2007 but had not conducted testing specifically addressing CoQ11’s stabilizing effect. The CoQ11 testing on which Kaneka relied occurred in 2008 and later. One inventor testified that the company undertook the 2008 testing because it lacked data for reduced CoQ11 and recognized that the absence of such data could create problems during patent prosecution.

Utility. The court concluded that Kaneka had not demonstrated a specific utility for the full scope of the claims as of the filing date. Under Section 101, an invention must be useful, while Section 112(a) requires a specification that enables a skilled artisan to make and use the claimed invention. The requirements are closely related because an invention that lacks demonstrated utility can also fail the “how-to-use” component of enablement.

Kaneka argued that stabilization was not a claim limitation and identified other possible uses, including employing the composition as a carrier for beneficial ingredients and improving absorption of reduced CoQ10. The court was unpersuaded. Those asserted possibilities did not establish a specific utility for CoQ11-containing ubiquinol and lacked supporting testing or data.

Nor could Kaneka establish utility by showing that CoQ11's stabilizing effect would have been apparent to a person of ordinary skill. Kaneka's own expert testified that it was surprising that CoQ9 and CoQ11 had stabilizing effects and that a skilled artisan would not have expected those effects in 2005 or 2006.

The court similarly rejected Kaneka’s attempt to establish utility through analytical reasoning. During the litigation, Kaneka explained that because the stabilizing mechanism was unrelated to the length of the molecules’ side chains, CoQ9's stabilizing effect permitted an inference that CoQ11 would behave similarly. But those critical analytical steps were not disclosed in the patent. Moreover, one inventor testified that he believed the length of CoQ9's side chain might contribute to stability, undermining the proposed inference.

Undue experimentation. Lack of utility did not automatically resolve enablement, so the court separately considered whether practicing the full claimed scope would require undue experimentation under the factors established in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

That inquiry also favored Cocrystal. The patent disclosed one example involving a precise quantity of CoQ11, yet the claims encompassed ubiquinol compositions containing any amount of CoQ11. Chemistry was an unpredictable art, and even Kaneka's expert acknowledged that the mechanism by which CoQ11 improved CoQ10 stability was not understood.

Kaneka maintained that a skilled artisan could formulate different CoQ11-containing compositions and test their stability using techniques disclosed for CoQ9. But the court said that approach improperly left the skilled artisan to determine whether the claimed embodiments worked at all. The patent could permit reasonable adaptation or testing; it could not shift the fundamental research needed to establish operability to the public.

In the court's assessment, Kaneka had proved that CoQ9 stabilized ubiquinol and then hypothesized that CoQ11 would do the same, without testing that proposition or explaining why it should be true before filing. Later experiments may have confirmed the hypothesis, but they could not transform what was effectively an object of further research at filing into an enabled invention. Claims 5 and 15 therefore failed both utility and enablement. The court did not reach Cocrystal's remaining invalidity theories or the parties’ infringement-damages arguments.

Counterclaims. Kaneka nevertheless prevailed on Cocrystal's remaining tort and antitrust claims. Cocrystal's tortious-interference theory rested on Kaneka's assertion of its patent rights. Such a state-law claim required a showing that the patent-enforcement activity was objectively baseless and undertaken in bad faith.

That showing was absent. The ’080 patent had previously survived different invalidity challenges in Kaneka Corp. v. Designs for Health, Inc., 760 F. Supp. 3d 152 (D. Del. 2024). Combined with the complexity of the present validity dispute and Cocrystal's stipulation to infringement, that history prevented a reasonable finding that Kaneka had no reasonable basis for believing its patent valid.

Cocrystal's Walker Process antitrust counterclaim also failed. It alleged that Kaneka fraudulently procured the patent by withholding information concerning CoQ11 as an impurity, failing to disclose potentially relevant prior sales, and representing that its inventors had conducted intensive studies concerning stabilization.

The record showed that Kaneka had informed the USPTO during prosecution that CoQ9 and CoQ11 could be present as impurities. As to the other alleged omissions or misrepresentations, Cocrystal produced no evidence from which the required specific intent to deceive the USPTO could be established. Mere nondisclosure, without separate evidence of deceptive intent, was insufficient for Walker Process fraud.

Accordingly, the court granted Cocrystal summary judgment invalidating claims 5 and 15, but granted Kaneka summary judgment dismissing the tortious-interference and antitrust counterclaims. With no claims remaining, the court directed entry of judgment and closure of the case.

The Case is No. 1:23-cv-07483-SJB-SDE.

Judge: Bulsara, S.

Attorneys: Leonardo Trivigno (Carter Ledyard & Milburn LLP) for Kaneka Corp. Gary M. Hnath (Mayer Brown LLP) for Cocrystal Technology [Jiaxing] Co., Ltd.

Companies: Kaneka Corp.; Cocrystal Technology [Jiaxing] Co., Ltd.

MainStory: TopStory Patent NewYorkNews GCNNews