Supreme Court Clarifies the Standard for Assessing the “Enablement Requirement” in Patent Specifications

Case Where Compliance with the Specification Requirements (Enablement) Was at Issue(Supreme Court Decision, rendered on January 15, 2026, 2024Hu10658)

The defendant filed a trial for invalidation of the plaintiff’s registered patent titled “Pharmaceutical Combination of an Angiotensin Receptor Antagonist and an NEP Inhibitor,” arguing, among other grounds, that the patent violated the specification disclosure requirements (enablement requirement) because it was not described in a manner that would allow a person skilled in the art to readily carry out the invention.

The court below held that the patent violated the specification requirements because (i) the “Description of the Invention” did not contain a direct disclosure of the Claim 1 invention, and (ii) it was not written to a degree that would allow Claim 1 to be accurately understood and reproduced.

The Supreme Court reaffirmed the following principle:

Applying this standard, the Supreme Court reasoned as follows:

The Claim 1 invention concerned a chemical invention whose scope encompassed multiple compounds and various solid forms (crystalline, semi-crystalline, amorphous, polymorphic). It was defined as excluding only the crystalline 2.5-hydrate (2.5-hydrate supramolecular complex) among various solid-form supramolecular complexes with the following characteristics: two pharmaceutically active agents—valsartan and sacubitril—associate via non-covalent interactions with sodium cations and water molecules, behaving like a single chemical substance ex vivo but separating into individual components in vivo to produce effects.

However:

1. The specification did not expressly disclose, as experimental examples, any working examples of supramolecular complexes falling within the scope of the Claim 1 invention.

2. The specification also did not include technical disclosure sufficient to explain the principle by which valsartan and sacubitril, as a dual-acting compound, form a supramolecular complex, or to explain all non-covalent interactions among the components.

3. Given the technical level at the time of the priority date, it could not be readily concluded that a person skilled in the art would recognize that even when (i) the number of water molecules differs from that of the 2.5-hydrate supramolecular complex, or (ii) no water molecules are included, the non-covalent interactions among the chemical species (valsartan, sacubitril, sodium cations, and water molecules) would still be balanced so as to form a supramolecular complex in crystalline or amorphous form—and that the person skilled in the art would have been able to manufacture such complexes.

Accordingly, the Supreme Court held that, without undue experimentation or special knowledge, a person skilled in the art could not be said to accurately understand and reproduce the compounds of the Claim 1 invention based on the matters described in the specification. The Supreme Court therefore affirmed the judgment below and dismissed the appeal.

• Patent Act Article 42(3)(1) requires that the description of the invention be written clearly and in sufficient detail so that a person having ordinary skill in the relevant technical field (a “person skilled in the art”) can easily practice the invention. This serves to disclose the content of the filed invention so that third parties can understand it from the specification alone, thereby clarifying the technical content and scope for which patent protection is sought.
• The level of disclosure required is such that a person skilled in the art, based on the state of the art as of the filing date, can accurately understand and reproduce the invention from the specification, without undue experimentation or the addition of specialized knowledge (citing, inter alia, Supreme Court Decision 2003Hu2072 rendered on November 24, 2006, and Supreme Court Decision 2021Hu10886 rendered on October 8, 2024).

This decision is meaningful in that the Supreme Court clearly articulated both the purpose and the standard for evaluating the specification disclosure requirements (enablement) under Patent Act Article 42(3)(1).