Open Decision Ledger · IP, data & telecommunications
Term-extended pharmaceutical patent reaching a salt-change product
Supreme Court, Jan. 17, 2019, 2017Da245798 (judgment)
Case name: 특허권침해금지등
Official text on the National Law Information Center
Question
How is the scope of a term-extended pharmaceutical patent decided, and does it reach an accused product that differs from the approved drug only in a pharmaceutically acceptable salt which a person with ordinary knowledge in the art could readily select and whose therapeutic effect or use is substantially the same?
Holding
The scope is judged around whether the active ingredient expected to show a therapeutic effect for a particular disease, the therapeutic effect and the use are the same as in the drug approved under the Pharmaceuticals Affairs Act. Where the approved drug and the accused product differ only in a pharmaceutically acceptable salt or the like, and a person with ordinary knowledge in the art could readily select that change while the therapeutic effect or use shown by the pharmacological action of the active ingredient absorbed into the body is substantially the same, the term-extended patent right must be held to reach the accused product.
Summary of the holding, verbatim
존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다.
Unofficial English translation
The scope of the effect of a pharmaceutical patent right whose term has been extended must be determined by focusing on whether the pharmaceutical product for which item approval was obtained under the Pharmaceutical Affairs Act in order to practice the patented invention is identical in the specific active ingredient expected to exhibit a therapeutic effect against a specific disease, the therapeutic effect, and the use.
Disposition
Reversed and remanded Stated in the decision
원심판결을 파기하고, 사건을 특허법원에 환송한다. 피고 보조참가인의 보조참가신청을 각하한다.
Unofficial English translation
The judgment of the court below is reversed, and the case is remanded to the Patent Court. The application for auxiliary participation filed by the defendant's auxiliary participant is dismissed on procedural grounds.
Form of the test
Elements stated Stated in the decision
이러한 법령의 규정과 제도의 취지 등에 비추어 보면, 존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다.
Unofficial English translation
In light of such provisions of these statutes and the purpose of the system, etc., the scope of the effect of a pharmaceutical patent right whose term has been extended must be determined by focusing on whether the pharmaceutical product for which item approval was obtained under the Pharmaceutical Affairs Act in order to practice the patented invention is identical in the specific active ingredient expected to exhibit a therapeutic effect against a specific disease, the therapeutic effect, and the use.
Factors
- 약학적으로 허용 가능한 염 등에서 차이가 있더라도
- 발명이 속하는 기술분야에서 통상의 지식을 가진 사람이라면 쉽게 이를 선택할 수 있는 정도에 불과하고
- 인체에 흡수되는 유효성분의 약리작용에 의해 나타나는 치료효과나 용도가 실질적으로 동일하다면
- ‘그 연장등록의 이유가 된 허가 등의 대상물건에 관한 특허발명의 실시’로 규정하고 있을 뿐, 허가 등의 대상 ‘품목’의 실시로 제한하지는 않았다
Unofficial English translation
• Even where there is a difference in a pharmaceutically acceptable salt or the like,
• the difference is no more than such as could easily be selected by a person having ordinary knowledge in the technical field to which the invention pertains, and
• if the therapeutic effect or use manifested by the pharmacological action of the active ingredient absorbed into the body is substantially identical,
• it merely provides for "the practice of the patented invention pertaining to the subject matter of the approval, etc. that served as the ground for the extension registration," and does not limit it to the practice of the 'item' subject to the approval, etc.
Relation to precedent
States a new standard Read from the decision
이러한 법령의 규정과 제도의 취지 등에 비추어 보면, 존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다.
Unofficial English translation
In light of such provisions of these statutes and the purpose of the system, etc., the scope of the effect of a pharmaceutical patent right whose term has been extended must be determined by focusing on whether the pharmaceutical product for which item approval was obtained under the Pharmaceutical Affairs Act in order to practice the patented invention is identical in the specific active ingredient expected to exhibit a therapeutic effect against a specific disease, the therapeutic effect, and the use.
Decisions referred to
대법원 2017. 11. 29. 선고 2017후882, 899 판결
Burden of proof
Not addressed Not in the decision
Open question and revisit condition
If a change of salt alters the rate or extent of absorption of the active ingredient without changing its identity, is the therapeutic effect still substantially the same as that of the approved drug?
The judgment of the Patent Court on remand, deciding whether the defendant's fumarate product falls within the scope, will show how the test is applied on the facts. Any amendment to Article 89 or Article 95 of the Patent Act or to the Patent Act Enforcement Decree would require this entry to be read again.
Cross-family AI independent reading & axis check
6 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 6 of the 8 axes; the readings differed on axis 6 (relation to precedent), axis 8 (open question and revisit condition).
Axis 6 (Relation to precedent): Primary “States a new standard” vs Independent “Cannot be determined”
The primary reading treats the decision as setting a new standard, while the independent reading records no precedent confirmed because the text alone does not show a cited earlier decision; the difference turns on whether prior case law could be verified from the text.
이러한 법령의 규정과 제도의 취지 등에 비추어 보면, 존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다.Axis 8 (Open question and revisit condition): Primary “If a change of salt alters the rate or extent of absorption of the active ingredient without changing its identity, is the therapeutic effect still substantially the same as that of the approved drug?” vs Independent “What degree of difference in therapeutic effects or uses defeats substantial identity despite an easily selectable salt substitution?”
Primary asks whether a salt change that alters absorption rate still yields the same therapeutic effect, while independent asks how large a difference in effect or use defeats substantial identity; they share the limit of substantial identity but focus on different variables.
존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다.Raw 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 30 June 2017 (2016Na1929), held that the effect of a term-extended patent right extends only to the drug specified by the manufacturing or import item approval and to drugs so substantially identical that a separate item approval is unnecessary. It therefore held that the defendant's product, approved as a fumarate product, was outside the scope of the term-extended patented invention.
Supreme Court standard: The Supreme Court held that this misread the legal principle in Article 95 of the former Patent Act on the scope of the term-extended patent right, since the statute refers to the exercise of the patented invention in relation to the goods that were the object of the approval, not to the approved item alone. It found that the fumarate of solifenacin is a Class 1 pharmaceutical salt in common use, that the intake and absorption process is the same as for the succinate, and that the change was one any person with ordinary knowledge could readily choose, so the defendant's product falls within the scope. The Court reversed and remanded the case, and separately dismissed the defendant's co-participant's application to intervene, because the interest asserted was only a factual interest, not a legal one.
Distinguishing conditions
- A difference in salt or the like that a person with ordinary knowledge in the art could not readily select, since the Court required the change to be within easy reach of the skilled person.
- A product in which the therapeutic effect or use shown by the pharmacological action of the active ingredient absorbed into the body is not substantially the same, since the Court turned on that identity.
- An act other than the exercise of the patented invention in relation to the goods that were the object of the approval, or an article used for a purpose other than the use specified in that approval, which Article 95 of the former Patent Act excludes from the effect.
Record verification notes
Set the approved drug and the accused product side by side on the active ingredient, the salt, the dosage form and the approved use, and check the approval dossier for the biological equivalence data and for the safety and efficacy materials that were dispensed with. Then read the specification for the organic acids it lists as selectable, and confirm which versions of Article 89 and Article 95 of the Patent Act and of the Patent Act Enforcement Decree govern the extended term in question.
From the official text
Points at issue
존속기간이 연장된 의약품 특허권의 효력이 미치는 범위를 판단하는 기준 및 특허권자가 약사법에 따라 품목허가를 받은 의약품과 특허침해소송에서 상대방이 생산 등을 한 의약품이 약학적으로 허용 가능한 염 등에서 차이가 있으나 통상의 기술자가 쉽게 이를 선택할 수 있는 정도에 불과하고, 인체에 흡수되는 유효성분의 약리작용에 의해 나타나는 치료효과나 용도가 실질적으로 동일한 경우, 존속기간이 연장된 특허권의 효력이 상대방이 생산 등을 한 의약품에 미치는지 여부(적극)
Unofficial English translation
The criteria for determining the scope of the effect of a pharmaceutical patent right whose term has been extended, and whether the effect of the patent right whose term has been extended extends to a pharmaceutical product produced or otherwise made by the opposing party in a patent infringement action where the pharmaceutical product for which the patentee obtained item approval under the Pharmaceutical Affairs Act and the pharmaceutical product produced or otherwise made by the opposing party differ in a pharmaceutically acceptable salt or the like, yet the difference is no more than such as could easily be selected by a person having ordinary skill in the art, and the therapeutic effect or use manifested by the pharmacological action of the active ingredient absorbed into the body is substantially identical (affirmative)
Summary of the holding
구 특허법(2011. 12. 2. 법률 제11117호로 개정되기 전의 것, 이하 같다) 제89조는 “특허발명을 실시하기 위하여 다른 법령의 규정에 의하여 허가를 받거나 등록 등을 하여야 하고, 그 허가 또는 등록 등(이하 ‘허가 등’이라 한다)을 위하여 필요한 활성·안전성 등의 시험으로 인하여 장기간이 소요되는 대통령령이 정하는 발명인 경우에는 제88조 제1항의 규정에 불구하고 그 실시할 수 없었던 기간에 대하여 5년의 기간 내에서 당해 특허권의 존속기간을 연장할 수 있다.”라고 규정하여 약사법 등에 의한 허가 등을 받기 위하여 특허발명을 실시할 수 없는 기간만큼 특허권의 존속기간을 연장해주는 제도를 두고 있다. 위 조항에서 말하는 ‘장기간이 소요되는 대통령령이 정하는 발명’의 하나로 구 특허법 시행령(2007. 6. 28. 대통령령 제20127호로 개정되기 전의 것) 제7조 제1호는 특허발명을 실시하기 위하여 구 약사법(2007. 4. 11. 법률 제8365호로 전부 개정되기 전의 것) 제26조 제1항 또는 제34조 제1항의 규정에 의하여 품목허가를 받아야 하는 의약품의 발명을 들고 있다. 한편 존속기간이 연장된 특허권의 효력에 대해 구 특허법 제95조는 ‘그 연장등록의 이유가 된 허가 등의 대상물건(그 허가 등에 있어 물건이 특정의 용도가 정하여져 있는 경우에 있어서는 그 용도에 사용되는 물건)에 관한 그 특허발명의 실시 외의 행위에는 미치지 아니한다.’라고 규정하고 있다. 특허법은 이와 같이 존속기간이 연장된 특허권의 효력이 미치는 범위를 규정하면서 청구범위를 기준으로 하지 않고 ‘그 연장등록의 이유가 된 허가 등의 대상물건에 관한 특허발명의 실시’로 규정하고 있을 뿐, 허가 등의 대상 ‘품목’의 실시로 제한하지는 않았다. 이러한 법령의 규정과 제도의 취지 등에 비추어 보면, 존속기간이 연장된 의약품 특허권의 효력이 미치는 범위는 특허발명을 실시하기 위하여 약사법에 따라 품목허가를 받은 의약품과 특정 질병에 대한 치료효과를 나타낼 것으로 기대되는 특정한 유효성분, 치료효과 및 용도가 동일한지 여부를 중심으로 판단해야 한다. 특허권자가 약사법에 따라 품목허가를 받은 의약품과 특허침해소송에서 상대방이 생산 등을 한 의약품(이하 ‘침해제품’이라 한다)이 약학적으로 허용 가능한 염 등에서 차이가 있더라도 발명이 속하는 기술분야에서 통상의 지식을 가진 사람이라면 쉽게 이를 선택할 수 있는 정도에 불과하고, 인체에 흡수되는 유효성분의 약리작용에 의해 나타나는 치료효과나 용도가 실질적으로 동일하다면 존속기간이 연장된 특허권의 효력이 침해제품에 미치는 것으로 보아야 한다.
Order
원심판결을 파기하고, 사건을 특허법원에 환송한다. 피고 보조참가인의 보조참가신청을 각하한다. 보조참가신청으로 인한 소송비용은 피고 보조참가인이 부담한다.
Unofficial English translation
The judgment of the court below is reversed, and the case is remanded to the Patent Court. The application for auxiliary participation filed by the defendant's auxiliary participant is dismissed on procedural grounds. The litigation costs arising from the application for auxiliary participation shall be borne by the defendant's auxiliary participant.
Provisions referred to
구 특허법(2011. 12. 2. 법률 제11117호로 개정되기 전의 것) 제89조(현행 제89조 제1항 참조), 제95조, 구 특허법 시행령(2007. 6. 28. 대통령령 제20127호로 개정되기 전의 것) 제7조 제1호
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.
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