On February 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed the decision of the International Trade Commission (ITC) in US Synthetic Corp. v. International Trade Commission, issuing a precedential decision regarding subject matter eligibility important to the pharmaceutical and other life science industries. The ITC had previously ruled that US Synthetic's composition of matter claims reciting measured properties of a composition were directed to a patent-ineligible abstract idea under 35 U.S.C. § 101. The CAFC found that the claims were indeed related to concrete structures, not patent-ineligible abstract ideas, and affirmed the lower court's finding regarding enablement.
US Synthetic's patent recited composition-of-matter claims for a "polycrystalline diamond compact" diamond drill bit composition. The claims recited structural components of the composition, including the composition's grain size and the presence of cobalt, as well as magnetic properties. The specification indicated that the magnetic properties "may be correlated" with structural and compositional properties such as the amount of metal catalyst present and the level of diamond-to-diamond bonding.
In December 2020, the ITC instituted a Section 337 investigation to review patent infringement allegations by US Synthetic against several Chinese companies for infringing their diamond drill bit composition claims contained in U.S. Patent No. 10508502. While the ITC concluded that the Chinese companies had infringed claims of the '502 patent, they also ruled that the claims were ineligible under 35 U.S.C. § 101. Even though the claims were not directed to a patent-ineligible natural phenomenon, the ITC found that the magnetic behavior of the composition had only a loose causal connection to the structural properties of catalyst concentration and diamond grain size.
This judgment garnered wide interest due to the potentially broad implications for chemical and life sciences, especially pharmaceuticals. Many pharmaceuticals, biotechnologies, and other advanced industries often rely on composition-of-matter patents which recite claim limitations regarding measured properties or functionality that distinguish the invention over the prior art. Due to the danger this ruling represents to these types of claims, the Pharmaceutical Research and Manufacturers of America filed an amicus brief in the appeal, in which they said the lower court's ruling was a "troubling expansion of the abstract idea exception to patent eligibility."
The court reversed the ITC's decision, finding that the claims recited many structural elements that were correlated in the specification to the claimed magnetic properties. The court distinguished this case from the 101 issues in Diamond v. Chakrabarty (1980), regarding patents claiming laws of nature. In applying Step 1 of Alice/Mayo test to the '502 patent, the CAFC found the claims "directed to a specific, non-abstract composition of matter" and that the claimed composition "is a physical composition of matter defined by its constituent elements, dimensional information, and inherent material properties." In its decision the court determined that the magnetic properties "are integrally and necessarily intertwined with the structure", invalidating the lower court's ruling that the claims were merely directed toward the abstract idea of the relationship between the magnetic properties and the composition's structure.
In addition, the court affirmed the ITC's determination of enablement. During the Section 337 review, the intervening respondents argued that the claims were not enabled, and that undue experimentation was necessary to practice the claims. The ITC found that only attorney's arguments were relied on to show lack of enablement during the review, noting that the intervening respondents did not address the undue experimentation factors discussed in the 1988 In re Wands decision. Upon appeal, the respondents argued that the ITC's determination that the casual connection between the claimed structure and the magnetic properties was "loose and generalized" is tantamount to unpredictability, thereby supporting a conclusion that the claims are not enabled. The court did not find the arguments against enablement persuasive and remanded the case to the ITC.
The court's decision is important for the life science industries, as it means that composition-of-matter claims are unlikely to be found ineligible under Section 101 as abstract ideas in the common situation that the recited properties or functions are correlated to the structure in the specification. This enables patent protection for many key technologies that rely on claims combining structural elements and compositional properties, such as in pharmaceuticals.
This decision is available here.
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