Open Decision Ledger · IP, data & telecommunications
Test examples with pharmacological data for medical use inventions
Supreme Court, Apr. 29, 2021, 2017Hu1854 (judgment)
No holding summary · checked against points at issue. The official text publishes no summary of the holding for this decision. The quotation and factors in this record are copied verbatim from the points at issue; the evidence for each axis is taken from the points at issue, the order and the reasons.
Case name: 등록무효(특)
Official text on the National Law Information Center
Question
Where a medical use invention claims a new therapeutic use for a compound, must the specification disclose the compound's pharmacological effect for that use with test examples showing pharmacological data, or concretely enough to replace them, unless the mechanism was already clearly elucidated before the filing date?
Holding
Yes. Unless there are special circumstances, such as a mechanism for the stated pharmacological effect being clearly elucidated before the filing date, the specification must state that a specific substance has that effect by test examples showing pharmacological data, or concretely enough to stand in their place. Here the description said only that the carbostyril compound of Formula 1 would be useful for various central nervous system disorders, without test examples or an equivalent concrete disclosure, and the Court found no evidence that the mechanism for treating bipolar disorder was clearly elucidated, so the invention did not meet the description requirement of Article 42(3) of the former Patent Act.
Points at issue, verbatim
청구범위 제1항에 기재된 화학식 1의 카르보스티릴 화합물이 5-HT1A 수용체 작용물질 활성에 따라 양극성 장애를 치료하는 약리효과를 가진다는 것이 약리데이터 등이 나타난 시험례 등으로 구체적으로 기재되어 있지 않은 사안에서, 위 특허발명은 구 특허법 제42조 제3항에 정한 명세서 기재요건을 충족하지 못하였다고 한 사례
Unofficial English translation
In a case where it is not specifically stated, through test examples showing pharmacological data or the like, that the carbostyril compound of Chemical Formula 1 as recited in claim 1 has the pharmacological effect of treating bipolar disorder by virtue of its activity as a 5-HT1A receptor-subtype-acting substance, the patent invention does not satisfy the description requirement under Article 42(3) of the former Patent Act
Disposition
Dismissed Stated in the decision
상고를 기각한다. 상고비용은 피고가 부담한다.
Unofficial English translation
The appeal is dismissed. The costs of the final appeal shall be borne by the defendant.
Form of the test
Elements stated Stated in the decision
약리데이터 등이 나타난 시험례로 기재하거나 또는 이에 대신할 수 있을 정도로 구체적으로 기재하여야만 명세서의 기재요건을 충족하였다고 볼 수 있다
Unofficial English translation
the description requirement may be regarded as satisfied only if it is stated in test examples showing pharmacological data or the like, or is stated concretely to a degree that may substitute therefor
Factors
- 약리효과의 기재가 요구되는 의약의 용도발명에서 특허출원 명세서의 기재 정도
- 5-HT1A 수용체 서브타입과 관련된 중추 신경계의 장애로서 양극성 장애가 있는 환자의 치료라는 새로운 의약용도를 발명의 대상으로 하는
- 약리데이터 등이 나타난 시험례 등으로 구체적으로 기재되어 있지 않은 사안에서
- 구 특허법 제42조 제3항에 정한 명세서 기재요건을 충족하지 못하였다고 한 사례
Unofficial English translation
• the degree of description required in a patent application specification for a use invention of a medicament where the description of pharmacological effects is required
• the subject of which is a new pharmaceutical use, namely the treatment of patients with bipolar disorder as a disorder of the central nervous system related to the 5-HT1A receptor subtype,
• in a case where it is not specifically stated through test examples showing pharmacological data or the like,
• a case where the patent invention was held not to satisfy the description requirement under Article 42(3) of the former Patent Act
Relation to precedent
Follows earlier decisions Stated in the decision
대법원 2001. 11. 30. 선고 2001후65 판결(공2002상, 216)
Unofficial English translation
Supreme Court Decision 2001Hu65 decided November 30, 2001 (Gong 2002 Sang, 216)
Decisions referred to
[1] 대법원 2016. 11. 25. 선고 2014후2184 판결(공2017상, 47), 대법원 2001. 11. 30. 선고 2001후65 판결(공2002상, 216), 대법원 2015. 4. 23. 선고 2013후730, 2015후727 판결(공2015상, 769)
Burden of proof
Not addressed Not in the decision
Open question and revisit condition
How concrete must a disclosure be before it can stand in place of a test example showing pharmacological data?
A later Supreme Court decision defining what counts as disclosure replacing a test example would require this entry to be read again. An amendment to Article 42(3) of the Patent Act, or a record showing that the mechanism for treating bipolar disorder with 5-HT1A agonist activity was clearly elucidated before the priority date, would do the same.
Cross-family AI independent reading & axis check
7 of 8 axes matched GPT-6 Astra (OpenAI, codex CLI) · 2026-10-25
A reader from another model family (GPT-6 Astra), given the official text but not the primary reading, agreed on 7 of the 8 axes; the readings differed on axis 4 (form of the test).
Axis 4 (Form of the test): Primary “Elements stated” vs Independent “Existing test applied”
The primary frames the holding as stating a requirement (disclosure by test examples or equivalent), while the independent reading frames it as applying the requirement to the facts of this specification.
위 특허발명은 구 특허법 제42조 제3항에 정한 명세서 기재요건을 충족하지 못하였다고 한 사례Raw responses and comparison record: Protocol · Blind readings (JSONL) · Axis comparison (JSONL) · SHA-256 (JSON)
Lower-court contrast & scope of application
Lower-court reading vs. Supreme Court holding
Lower-court context: The Patent Court, in its judgment of 21 July 2017 (2016Heo8414), held that the description of the patented invention, titled '5-HT1A receptor subtype acting substance', did not disclose by test examples or equivalent concrete means that the carbostyril compound of Formula 1 treats bipolar disorder through its 5-HT1A receptor agonist activity, and that the invention therefore failed the description requirement of Article 42(3) of the former Patent Act. The official text does not say how the Patent Court disposed of the invalidity claim itself.
Supreme Court standard: The Supreme Court agreed, though it noted that some of the lower court's statements were not entirely apt. It held that the court below had not misapprehended the law on the description requirement or erred in any way that affected the judgment. It added that the Supreme Court decisions the appellant cited concerned different matters and could not be applied, and dismissed the appeal with the concurrence of all participating Justices.
Distinguishing conditions
- A specification in which the pharmacological effect for the claimed use is stated through test examples showing pharmacological data.
- A case where the mechanism producing the stated pharmacological effect was clearly elucidated before the filing date, which the Court treated as a special circumstance.
- A specification whose disclosure substitutes for a test example with concrete detail sufficient to stand in its place.
Record verification notes
Set the priority date first, then ask what was known about the mechanism for the specific disorder claimed, since the Court treated the mechanism for unipolar depression as distinct from that for bipolar depression, and noted what was known about aripiprazole's D2 receptor activities. Compare the description in the file with the standard the Court gave: test examples showing pharmacological data, or disclosure concrete enough to replace them. Also confirm which version of the Patent Act governs, since the Court applied Article 42(3) of the version before the amendment of 3 January 2007 (Law No. 8197).
From the official text
Points at issue
[1] 약리효과의 기재가 요구되는 의약의 용도발명에서 특허출원 명세서의 기재 정도 [2] 5-HT1A 수용체 서브타입과 관련된 중추 신경계의 장애로서 양극성 장애가 있는 환자의 치료라는 새로운 의약용도를 발명의 대상으로 하는 “5-HT1A 수용체 서브타입 작용물질”이라는 명칭의 특허발명 명세서의 발명의 설명에 청구범위 제1항에 기재된 화학식 1의 카르보스티릴 화합물이 5-HT1A 수용체 작용물질 활성에 따라 양극성 장애를 치료하는 약리효과를 가진다는 것이 약리데이터 등이 나타난 시험례 등으로 구체적으로 기재되어 있지 않은 사안에서, 위 특허발명은 구 특허법 제42조 제3항에 정한 명세서 기재요건을 충족하지 못하였다고 한 사례
Unofficial English translation
[1] The degree of description required in a patent application specification for a use invention of a medicament where the description of pharmacological effects is required [2] A case where, in a patent invention titled "5-HT1A Receptor-Subtype-Acting Substance," the subject of which is a new pharmaceutical use, namely the treatment of patients with bipolar disorder as a disorder of the central nervous system related to the 5-HT1A receptor subtype, the description of the invention in the specification does not specifically state, through test examples showing pharmacological data or the like, that the carbostyril compound of Chemical Formula 1 as recited in claim 1 has the pharmacological effect of treating bipolar disorder by virtue of its activity as a 5-HT1A receptor-subtype-acting substance, and thus the patent invention was held not to satisfy the description requirement under Article 42(3) of the former Patent Act
Summary of the holding
The official text publishes no summary of the holding for this decision. The quotation and factors in this record are copied verbatim from the points at issue; the evidence for each axis is taken from the points at issue, the order and the reasons.
Order
상고를 기각한다. 상고비용은 피고가 부담한다.
Unofficial English translation
The appeal is dismissed. The costs of the final appeal shall be borne by the defendant.
Provisions referred to
[1] 특허법 제42조 제3항 [2] 구 특허법(2007. 1. 3. 법률 제8197호로 개정되기 전의 것) 제42조 제3항
Read 2026-10-25 · Cross-read 2026-10-25. All quotes matched against the official text. The Chinese-character placeholders the court used for anonymised parties are given in their Korean readings, and parenthetical Chinese-character glosses are omitted.
Every entry is published only after all quotes have been matched character by character against the official text, and audited by an independent second reading from a different model family across all eight axes. Both agreed axes and text-grounded interpretive divergences are recorded openly. The ledger is a research record, not an assessment of the court or advice on any matter.
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