How does Korea examine pharmaceutical inventions?

Chanjoong Kim, Partner · Published 9 November 2026

Last verified 10 October 2026

Examination items at a glance

As of October 2026. The numbers in the Basis column are the section numbers of Chapter V, “Pharmaceutical Field”, of the Examination Practice Guidelines by Technology Field. [2]

A violation of Art. 29, Art. 32 or Art. 42(3) or (4) of the Patent Act is a ground for rejection (Art. 62, subparagraphs 1 and 4). An amendment that goes beyond the scope of Art. 47(2) is also a ground for rejection (Art. 62, subparagraph 5). [1]

The standard is Chapter V, “Pharmaceutical Field”, of the Practice Guidelines

Pharmaceutical inventions are also examined under the general provisions of the Patent Act. The provisions are the requirements for patentability (Art. 29), unpatentable inventions (Art. 32) and the description requirements for the specification (Art. 42). The word “의약” (medicine) does not appear in these three articles. [1] The standards of determination specific to pharmaceuticals are in Chapter V of the Examination Practice Guidelines by Technology Field. [2]

The introduction to Chapter V states its history. The examination guidelines for the pharmaceutical field were established in 1970. The Examination Practice Guidelines in the Pharmaceutical Field were established in December 2020 and revised in December 2021. The division stated in the introduction as responsible for revision and management is the Pharmaceutical Chemistry Examination Division (약품화학심사과). [2] The MOIP website carries these Practice Guidelines as “기술분야별 심사실무가이드 (2026.03)” (Examination Practice Guidelines by Technology Field (March 2026)). Chapter V of the file downloaded on 10 October 2026 is the version revised in December 2021. [2]

The nature of the Practice Guidelines is stated in the foreword. The foreword of December 2020 states that the Practice Guidelines were prepared in order to present examination standards tailored to the characteristics of each industry. It states the hope that they will serve accurate and consistent examination work in examination, and will serve as a guide for applicants. [2] The Patent Examination Guidelines (특허·실용신안 심사기준, “Examination Guidelines” below) have an Established Rule number. The Practice Guidelines did not come up in the administrative rules search of the Ministry of Government Legislation (법제처) on 10 October 2026. [3]

Chapter V applies to “pharmaceutical inventions” (의약발명). The Practice Guidelines state that a pharmaceutical invention is an invention that has a medicine as an element of the invention and whose use is directly or indirectly concerned with the human body (1.2). [2] In the Practice Guidelines, a medicine is a product used for the purpose of the diagnosis, treatment, relief, therapy or prevention of diseases of animals, including humans. Instruments, machines and apparatus, cosmetics, and (health) foods are excluded (1.3). [2]

The Practice Guidelines state that the use of a medicine is expressed in two ways (1.3). One is applying a pharmaceutical substance to a specific disease. The other is applying it to a specific disease with a limitation of the administration and dosage or of the target patient group. The examples of the administration and dosage that the Practice Guidelines give are the administration interval, the time of administration, the order of administration, the site of administration, the route of administration and the amount administered. [2]

The Practice Guidelines divide pharmaceutical inventions into four (1.3.2). They are compound pharmaceutical inventions, natural product pharmaceutical inventions, biopharmaceutical inventions and pharmaceutical formulation inventions. [2] Where the sections below refer to a type, they mean these four.

Whether an invention is a pharmaceutical invention is determined by whether the claims state a use as a medicine (1.3.1). An invention can be handled as a pharmaceutical invention even where the medical use is not clear in the claims. This is the case where the description of the invention includes a use as a medicine and an amendment can affect the scope of the right as a medicine. [2]

Chapter V has no Addenda and no applicability provision. Chapter V does not state from which applications these standards apply. [2]

Claims: the use is stated as efficacy, in the form of a composition

A medical use invention is in principle claimed in the form of a composition (2.2.1.1). The example in the Practice Guidelines is “a pharmaceutical composition for treating disease B, comprising compound A as an active ingredient”. [2] A claim written as “compound A for treating disease B” is viewed differently. The Practice Guidelines determine that this claim claims compound A, not a medical use. [2]

The use is stated as efficacy (2.2.1.2). The Practice Guidelines do not accept the comprehensive statements “medicine” (의약) or “therapeutic agent” (치료제) with no limitation of the use. [2] The indication of the use must in principle be expressed as efficacy that corresponds to the diagnosis, treatment, relief, therapy or prevention of a disease. [2]

Stating the use only by a pharmacological mechanism is allowed only when a condition is met. This is the case where a person skilled in the art recognizes that expression as specific efficacy and the use is found to be clear (2.2.1.2). [2] As an example that is not allowed, the Practice Guidelines give an expression of inhibition of signal transduction from which the pathological symptoms that can be treated cannot be known. As an example that is allowed, they give a mechanism expression that is recognized in the industry as efficacy. [2]

Under this item, the Practice Guidelines cite Supreme Court Decision 2003Hu1550 Decided December 23, 2004. It was a case contesting a decision of rejection (decision to reject a patent application), and the Supreme Court dismissed the final appeal of the Commissioner of the Korean Intellectual Property Office. The Supreme Court held that, in a use invention of a medicine, the use of the medicine is an element of the invention. It therefore held that, in the claims, the medical use must be “clearly stated by the target disease or the efficacy”. [5] The claim in this case stated the inhibition of a mechanism as the use, not the name of a specific disease. The Supreme Court found that, in light of the statements in the specification and in documents from before filing, that statement expresses efficacy and its content is also clear. It held that the use was clearly indicated regardless of whether the correlation between that mechanism and the disease was publicly known. [5]

A pharmacological mechanism stated together with the efficacy does not separately limit the claims (2.2.1.3). The Practice Guidelines do not regard that expression of the pharmacological mechanism as unclear in itself. However, they do not recognize it as an independent element, and they interpret the use by identifying from the specification what efficacy that mechanism produces. [2] The decision that the Practice Guidelines cite is Supreme Court Decision 2012Hu238, 245 (intervention as co-litigant) Decided May 16, 2014. The Supreme Court held that a pharmacological mechanism is no more than a property inseparably inherent in a specific substance. It held that a pharmacological mechanism stated in the claims has meaning as an element of the invention only to the extent that it specifies the medical use. In its words, “the pharmacological mechanism itself cannot be regarded as an element that limits the claims”. [6] This case is an invalidation case. In the proceedings of the trial for invalidation, the patentee requested a correction that added a pharmacological mechanism to the medical use. The lower court found that this correction did not meet the requirements for correction in the subparagraphs of Art. 136(1) of the Patent Act, and the Supreme Court dismissed the final appeal. [6]

The way the active ingredient is specified differs by type (2.2.2). [2]

• Compounds: a compound is specified by its compound name or chemical structural formula. Markush-type expressions are accepted. If it cannot be specified in that way, it can be specified by its physicochemical properties, and the manufacturing process can be added (2.2.2.1).
• Natural product extracts: the claim is written as “a pharmaceutical composition for the treatment or prevention of …, containing an extract of … as an active ingredient”. “An extract of … for the treatment of …” is regarded as claiming the extract. An extract can be limited by its physical properties, a specific manufacturing process, its constituent components or a mixture of these (2.2.2.2).
• Peptides and nucleic acids: the amino acid sequence or the nucleotide sequence is specified. For a protein variant, the position and content of the deletion, substitution or addition are stated clearly (2.2.2.3).
• Antibodies: the principle is to specify an antibody by the amino acid sequence of its variable region or by the nucleotide sequence of the nucleic acid that encodes it. Specifying a monoclonal antibody by the antigen that it recognizes and the hybridoma that produces it is also within the principle. Properties such as cross-reactivity can be stated as an additional means of specification (2.2.2.3).

For antibody claims, the Practice Guidelines state one thing separately. It concerns a claim that refers to an antibody whose CDR combination is specified and limits it by sequence identity to the variable region. The Practice Guidelines regard the antibody as clearly specified only if the CDR combination of the heavy-chain and light-chain variable regions is specified together within that claim (2.2.2.3). [2]

A claim that states the active ingredient only by its function runs into the support requirement. The Practice Guidelines regard the case where a compound is expressed functionally as not supported by the description of the invention. They also regard it as not stated so that a person skilled in the art can easily practice the invention (2.2.2.1). [2] The decision that the Practice Guidelines cite is Supreme Court Decision 2004Hu1120 Decided May 11, 2006. It was a case contesting a decision of rejection, and the Supreme Court dismissed the applicant’s final appeal. The claim stated the active ingredient as a “selective inhibitor”, not by a chemical name or chemical formula. In the description of the invention, the pharmacological effect was stated in figures for only 2 of the 16 compounds listed. [7] The standard that the Supreme Court stated is based on the common general technical knowledge at the time of filing. It held that the claim is not supported where, even in light of that common general technical knowledge, the content of the description of the invention “cannot be extended or generalized” to the claimed scope. [7]

A biopharmaceutical invention is also regarded as not supported if the active ingredient is expressed only by its function or characteristics. However, there is a proviso. One case is where there is a sufficient number of specific embodiments across the whole of the claimed invention. The other is where the common structural features of the sequences that produce that function or characteristic are stated. In addition, it must be possible to extend or generalize the content of the description of the invention to the claimed scope in light of the common general technical knowledge at the time of filing (2.2.2.3). [2]

Pharmaceutical formulation inventions are different. There are cases where the technical feature lies in the physical form of the formulation, the excipients or the like, and not in the efficacious ingredient or the medical use. In such a case, the efficacious ingredient and the medical use do not necessarily have to be stated in the claims (2.2.3). [2]

Expressions that do not follow scientific terminology are in principle not accepted (2.3). There are two exceptions. One is where the term is defined in the description of the invention and used as a provisional name, and there is no other suitable term. The other is where, at the time of examination, the term is accepted in the academic community as indicating that medicine. [2]

Description of the invention: the pharmacological effect is stated by pharmacological data at the time of filing

The specification of a medical use invention must state the pharmacological effect at the time of filing (2.1.1.1). The exception is where there are special circumstances, such as where the pharmacological mechanism that produces that pharmacological effect was clearly established before filing. [2] What must be stated is the pharmacological effect that supports the medical use. The Practice Guidelines include in the medical use all the limited elements, such as the disease, the administration and dosage, and the target patient group. [2]

The Practice Guidelines state that the pharmacological effect must in principle be supported by clinical trials. However, they state that, depending on the content of the invention, it may be stated by animal tests or in vitro tests in place of clinical trials (2.1.1.1). [2]

This standard is also in the general examination guidelines. Part 2, Chapter 3, 2.3.2 (2) of the Patent Examination Guidelines (MOIP Established Rule No. 7 (지식재산처예규 제7호), in force from 13 March 2026) states the same standard. [3] The provision is Art. 42(3), subparagraph 1 of the Patent Act. The description of the invention must be stated clearly and in detail so that a person with ordinary knowledge can easily practice the invention. [1]

The decision on which the standard is based is Supreme Court Decision 2001Hu65 Decided November 30, 2001. It was a case contesting a decision to dismiss the amendment (decision to reject an amendment), and the Supreme Court dismissed the applicant’s final appeal. What the Supreme Court required is a statement that the specific substance has that pharmacological effect. It held that this must be stated “by test examples showing pharmacological data or the like”, or stated specifically enough to take their place. [4] The exception is special circumstances, such as where the pharmacological mechanism that produces that pharmacological effect was clearly established before filing. The Supreme Court held that only when it is so stated can the invention be regarded as completed and the description requirements for the specification also be met. [4]

This decision also dealt with amendment. It held that, where a statement of test examples is necessary, supplying by a later amendment what was not in the original specification goes beyond the scope of the matters stated in the specification. [4] According to the lower court, the original specification in this case contained only such things as a method of measuring the pharmacological effect indirectly and a general range of activity values for the compounds as a whole. The applicant added measured values for individual compounds by amendment. The lower court determined that this amendment had to be dismissed, and the Supreme Court held that this determination was justified. [4]

The law that this decision applied is the former Patent Act (구 특허법) before its amendment by Act No. 6411 of 3 February 2001. The decision called the amendment one that “changed the gist of the specification”. [4] Art. 47(2) of the current Patent Act provides that an amendment is to be made within the scope of the matters stated in the original specification or drawings. [1] The Practice Guidelines cite this decision in 2.1.1.1. They state that supplying by amendment test examples that were not in the original specification goes beyond the scope of the matters stated in the specification. [2]

Supreme Court Decision 2003Hu1550 also stated the same wording on the statement of the pharmacological effect. The specification in that case had data on an inhibitory effect obtained by a representative test method. The Supreme Court held that the lower court’s determination was justified in finding that the effect at other sites could also be sufficiently predicted from that data. [5]

The Supreme Court stated this standard again in 2021. Supreme Court Decision 2017Hu1854 Decided April 29, 2021 gave Decision 2001Hu65 as a reference case in an invalidation case. The phrase of Decision 2001Hu65, that the invention “can be regarded as completed”, is not in the sentence of this decision that states the legal principle. [4][11] The description of that patented invention had no test examples showing pharmacological data or the like, and no statement specific enough to take the place of test examples. The Supreme Court held that, even if the pharmacological mechanism for another disease had been established, it could not be said that the pharmacological mechanism for the claimed disease had also been clearly established. Whether the pharmacological mechanism had been established was assessed as of the priority claim date of that patented invention. [11] The Supreme Court found that the description requirements were not met and dismissed the patentee’s final appeal. The provision that this decision applied is Art. 42(3) of the former Patent Act before its amendment by Act No. 8197 of 3 January 2007. [11] This decision is not cited in Chapter V of the Practice Guidelines. [2]

The Practice Guidelines give examples of cases where the description requirements are not met (2.1.1.1). The examples in the Practice Guidelines, in shortened form, are as follows. [2]

• The pharmacological effect is stated only qualitatively, and there is no pharmacological data or the like
• Only the measuring method and the range of activity values are stated, and the compound that shows that activity is not specified
• There are test examples, but they are not sufficient to confirm the pharmacological effect related to the medical use in the claims
• There is only a statement that clinical trials are in progress, or only a presumptive or abstract statement about the results of clinical trials

The Practice Guidelines state three more things here. The effective amount and the method of administration must in principle be stated at the time of filing. It must be possible to see clearly that the active ingredient in the claims shows the pharmacological effect. If there are two or more active ingredients, the pharmacological effect that the combination shows must be stated specifically (2.1.1.1). [2]

The statement of the active ingredient also differs by type (2.1.1.2). [2]

• Compounds: for a publicly known substance, it is enough to identify that substance. For a novel substance, content from which it can be seen that the compound actually exists must be stated.
• Natural products: the Practice Guidelines state that, for a natural product that is difficult to obtain, it is desirable to state the scientific name and the origin. Where an extract or a fraction is the active ingredient, its manufacturing process must be stated specifically.
• Biological materials: a sequence is stated together with its sequence number, and a sequence listing is submitted. A starting material or final product that is difficult to obtain is deposited before the patent application is filed. For this part, the Practice Guidelines refer to Part 2, Chapter 6 of the Patent Examination Guidelines.
• Active ingredient of a biopharmaceutical expressed only by its function or characteristics: if a person skilled in the art cannot accurately understand and reproduce the whole of the claimed invention without undue trial and error or repeated experiments, the description requirements for the description of the invention are regarded as not met.

The procedures for deposits and sequence listings are covered in “How are biological deposits and sequence listings handled in Korea?”.

The description requirements for a pharmaceutical formulation invention follow the standards for an invention of a product (2.1.2). The Practice Guidelines look at three things. The first is whether the formulation can be produced by general formulation technology. The second is whether it can be administered and used as a medicine. The third is whether the pharmaceutical effect can be sufficiently predicted from the specification. [2] One of the examples that the Practice Guidelines give is Supreme Court Decision 2016Hu601 Decided October 25, 2018. The standard that the Supreme Court stated has two parts. A person skilled in the art must be able to produce and use the product itself from the matters stated in the description of the invention. And it held that, even if this is not proved by specific experiments or the like, the description requirements are met if a person skilled in the art “can sufficiently predict that the effect of the invention will arise”. [9] In this case, the pharmacological effect of the active ingredient on the target disease was already widely known before the priority date. The specification had data from measuring blood concentration after administration to animals. The Supreme Court held that the description requirements can be regarded as met even without clinical trial results in humans. [9] The provision that the decision applied is Art. 42(3) of the former Patent Act before its amendment by Act No. 8197 of 3 January 2007. [9]

For a formulation invention whose feature lies in the physical form of the formulation, the excipients or the like, the pharmacological effect does not necessarily have to be stated. The reason that the Practice Guidelines give is that such a formulation invention is not related to a new medical use (2.1.2). [2] Conversely, it is not accepted if it is not confirmed that the intended dosage form was manufactured. The same applies where the technical configuration of the formulation is not stated specifically and only the effect is stated. [2]

Industrial applicability and unpatentable inventions

Medical practice performed on humans is regarded as an invention that is not industrially applicable (3.1.1). The same applies if the method is in substance a method of treating or diagnosing a human disease, even where the claims are not written as a method of treatment. [2] This is also in Part 3, Chapter 1, 5.1 of the general Examination Guidelines. [3] The details are covered in “Are method-of-treatment claims allowed in Korea?”.

What Chapter V of the Practice Guidelines states separately for pharmaceuticals is as follows. [2]

• An invention that shows both a cosmetic effect and a therapeutic effect is treated as one whose industrial applicability is not recognized (3.1.1).
• An invention of a method of treating, diagnosing, relieving, giving therapy for or preventing a disease of mammals other than humans by using a medicine is treated as an industrially applicable invention (3.1.2).
• An invention of manufacturing a medicine from material that has already been collected, removed or discharged from the human body is regarded as an industrially applicable invention. Examples are blood, serum and placenta (3.1.3).
• A claim to an amino acid sequence, a nucleotide sequence or the atomic coordinates of the three-dimensional structure of a protein as such is regarded as a mere presentation of information. The Practice Guidelines do not regard it as an industrially applicable invention (3.1.4).

Art. 32 of the Patent Act grants no patent for an invention that violates public order or sound morals or is likely to harm public health. [1] The standard in the Practice Guidelines is whether working (practice) for the original purpose of the invention inevitably harms public health (3.2.2). Something that is harmful or not depending on how it is worked is handled as not falling under this provision. [2] The Practice Guidelines do not regard a pharmaceutical invention for which permission was obtained under the Pharmaceutical Affairs Act as harmful to health. However, an invention related to a drug for which the Minister of Food and Drug Safety has taken a measure of voluntary recall or of prohibition of manufacture or import is in principle regarded as an invention likely to harm public health (3.2.2). [2] The Practice Guidelines also state that an invention cannot be said to be an invention under Art. 32 merely because its manufacture or sale is prohibited by law (3.2.1). [2]

Novelty: a different use is a different invention

An invention concerning a medical use of a publicly known substance is not regarded as identical as long as the use is different (3.3.1). The use here includes a medical use limited by the administration and dosage or by the target patient group. [2]

The Practice Guidelines state two cases that are regarded as lacking novelty (3.3.1). [2]

• The medical use is expressed differently, but the pharmacological effect is judged to be identical or to be based on a closely related pharmacological action
• The subject to which the medicine is applied, the means of application, the time of application and the like cannot be distinguished in substance

The standards by type are as follows. [2]

• Natural products: the standard is prior art such as prescriptions in existing books of traditional Korean medicine and dictionaries of herbal medicine, and prescriptions derived from folk remedies. If the invention is no more than an imitation of these, it is regarded as lacking novelty. Even where the configuration and the use are publicly known from those documents, the invention is regarded as novel if a new medical use was invented (3.3.2).
• Peptides and nucleic acids: in principle, the sequence is compared with the prior art. A pharmaceutical composition containing a peptide or nucleic acid whose sequence is the same as in the prior art is determined mainly by the medical use (3.3.3).
• Antibodies: the determination is based on the amino acid sequence, the antigen or the epitope. A composition containing a publicly known antibody is determined by whether the medical use is publicly known (3.3.3).

The Practice Guidelines also deal with inventions that differ only in the form of statement (3.3.4). An invention of a medicament and an invention of a mere method of using it are regarded as inventions that are identical in substance. Inventions of a manufacturing process that differ only in the expression of the use at the end of the claims are regarded as identical inventions if the manufacturing process is the same and they are based on the same pharmacological effect. An invention of a manufacturing process to which a new step is added is regarded as novel. However, it is regarded as lacking novelty if the added step is a step of publicly known or commonly used art and is merely added, so that there is no creation of a new technical idea. [2]

Inventive step: the question is whether the therapeutic effect could be easily predicted

The inventive step of a medical use invention turns on whether the pharmacological effect could be predicted (3.4.1.1). The Practice Guidelines state two cases that involve an inventive step. One is where, in view of the state of the art at the time of filing, the pharmacological effect cannot be easily inferred from the chemical structure of the active substance or from the constituent components of the composition. The other is where there is a remarkable effect to a degree that a person skilled in the art could not easily infer from the pharmacological mechanism of the cited invention. [2]

Inventive step can be denied even if the prior art documents contain no experimental results. This is the standard of Supreme Court Decision 2016Hu502 Decided January 31, 2019. It is an invalidation case. The Supreme Court held that inventive step is denied if the invention is no more than something whose therapeutic effect a person skilled in the art could easily predict from the prior art. It held that, in such a case, the prior art cannot be regarded as required to go as far as “confirmation of the therapeutic effect by clinical trials or the like”. [8] The Supreme Court reversed the lower judgment, which had found that inventive step was not denied, and remanded the case to the Intellectual Property High Court of Korea (Patent Court of Korea) (특허법원). [8]

The Practice Guidelines also deal with conversion between medicines for humans and medicines for animals. Merely converting a substance publicly known as a medicine for humans into a medicine for the same or a similar disease of animals does not involve an inventive step. The same applies to a mere conversion in the opposite direction (3.4.1.1). [2]

For a medical use invention with several active ingredients, two things are looked at (3.4.1.2). Whether the combination of the active ingredients is easy is determined together with the medical use. Inventive step is acknowledged if the plural active ingredients selected show an effect that is different in kind or remarkably superior in comparison with the prior art. [2]

For a medical use invention that limits the administration and dosage or the target patient group, inventive step is determined with that limitation recognized as an element (3.4.1.3). There is one case that is regarded as involving an inventive step. It is the case where that limitation produces a remarkable effect that a person skilled in the art could not predict, and the invention is recognized as worth protecting by a patent. [2]

The Practice Guidelines give five examples under this item, and in all of them inventive step was denied (3.4.1.3). The examples in the Practice Guidelines, in shortened form, are as follows. [2]

• A similar administration and dosage are stated in the cited invention. The Practice Guidelines state that optimizing the unit dosage and the method of administration is a technical matter of the level ordinarily carried out in the pharmaceutical field.
• The administration and dosage can be inferred from the broad range of the amount administered in the cited invention and the content in its embodiments
• There is no objective basis for confirming a remarkable effect on the limited target patient group
• The time of administration is limited, but there is no need to distinguish the effect from that of the cited invention
• The period of administration is limited, but the specification has no statement from which the technical significance or a critical effect of that limitation can be recognized

That the administration and the dosage can be an element was decided by Supreme Court en banc Decision 2014Hu768 Decided May 21, 2015. The Majority Opinion stated that the administration and the dosage can be “an element that gives a new meaning” to a medicine as a product. It also stated that a new patent right can be granted to a medicine that meets the requirements for patentability, such as novelty and inventive step. [10] This decision overruled Supreme Court Decision 2007Hu2926 Decided May 28, 2009 and others, which had held that the administration interval and the unit dosage cannot be regarded as elements. There is a Concurring Opinion by 2 Justices. [10]

This decision is a decision in a case of a trial to confirm the scope of a right, and its conclusion is dismissal of the final appeal. The determination of the lower court that the Supreme Court accepted is that the accused invention is a free-to-work technology. [10] Section 3.4.1.3 of the Practice Guidelines gives this decision as a reference for the first example above and shortens it to an example in which the remarkable effect of “the claimed invention” (출원발명) was denied. [2] In the written judgment, what was found to be something that a person skilled in the art could easily practice is not a claimed invention but the accused invention. [10] This decision is covered in “Supreme Court en banc Decision 2014Hu768 Decided May 21, 2015: are administration and dosage (a dosage regimen) an element of the invention in Korea?”.

The standards for the remaining types are as follows. [2]

• Natural products: the standard is the content of the prior art, such as existing books of traditional Korean medicine, dictionaries of herbal medicine and folk prescriptions. Inventive step is not acknowledged if a person skilled in the art could easily make the invention from it. Medicines derived from plants or microorganisms of different species of the same genus can have the same use. Even then, the invention is regarded as involving an inventive step if it has a pharmacological effect that is remarkably improved in comparison with the cited invention (3.4.2).
• Biopharmaceuticals: if a peptide or nucleic acid involves an inventive step, a biopharmaceutical invention that contains it as an active ingredient is also regarded as involving an inventive step. An invention concerning a publicly known use of a variant peptide that has a backbone similar to a publicly known protein is regarded as lacking an inventive step. However, it is regarded as involving an inventive step if there is a remarkable effect in activity, side effects, bioavailability, stability or the like. Inventive step is not denied on the basis of a cited invention that contains a negative teaching about the function of a publicly known peptide. For a method of manufacturing or purifying a protein therapeutic, inventive step is not acknowledged if the elements are technical means that are generally adopted or changed and there is no substantial difference in effect (3.4.3).
• Formulations: the standards for determining the inventive step of ordinary product inventions and manufacturing process inventions are followed as they are. If the problem is the same and the compounds have a common property or are in the same category, no difficulty of the technical configuration is recognized in applying the active ingredient of the claimed invention to a formulation of the prior art. For a formulation limited by an effect or a characteristic, that effect or characteristic is considered as a factor that limits the other elements. Inventive step is not acknowledged if the manufacturing process is a mere application of commonly used art in pharmaceutics. Inventive step is not acknowledged if the difference in configuration is at the level of merely adopting well-known and commonly used art and the effect is at a level that can be predicted (3.4.4).

Amendment: pharmacological data cannot be added later

The standard for amendment is the same as the general rule. An amendment that adds a technical matter beyond the scope of the matters stated in the original specification or drawings is not allowed (4.1). [2] The basis is the former part of Art. 47(2) of the Patent Act. [1] An amendment to a patent application in a foreign language must also be made within the scope of the final Korean translation or the drawings initially attached. If the translation has been corrected, the corrected Korean translation is the reference, and the explanatory parts of the drawings are excluded (Art. 47(2), latter part). [1]

For an international patent application filed in a foreign language, the words are read differently. “The specification or drawings initially attached to the patent application” is deemed to be “the description of the invention, the claims or the drawings submitted by the international filing date” (Patent Act, Art. 208(3)). The amendment is also bound by the scope of the final Korean translation (paragraph (4) of the same Article). The description of the invention, the claims and the drawings submitted by the international filing date are deemed to be the specification and drawings initially attached (Art. 200-2(2)). [1] For an international patent application, therefore, whether the pharmacological data was in the original specification is decided by what was submitted by the international filing date.

The Practice Guidelines state that matters that are evident to a person skilled in the art from the statements in the original specification or drawings can be regarded as within “the scope of the matters stated” (4.1). [2] If the claims are changed to a generic concept and a matter that is not in the original specification or drawings is thereby added, it is addition of new matter. The same applies to an amendment that changes the claims to a specific concept that is not specifically stated (4.1). [2] As seen in the section above, test examples of the pharmacological effect cannot be supplied by amendment (2.1.1.1). [2][4]

An amendment made after receipt of a notice of grounds for rejection concerning a ground for rejection that arose from an amendment, and an amendment made when requesting re-examination, are narrower (Art. 47(1), subparagraphs 2 and 3). [1] The Practice Guidelines call the former notice a notice of final rejection. [2] In these cases, the claims can be amended only in the cases set out in the subparagraphs of Art. 47(3). [1] If that amendment violates Art. 47(2) or (3), the examiner dismisses the amendment by a decision. The same applies where it is found that a new ground for rejection has arisen from that amendment (Art. 51(1), main clause). A ground for rejection that arose from an amendment deleting a claim is excluded. The proviso to the same paragraph sets out the amendments that are not dismissed. [1] The Practice Guidelines give as an example an amendment that changed the use from efficacy to an inhibitor of a mechanism. The Practice Guidelines state that the medical use in that expression is not clear, so that a new ground for rejection arose (4.2). [2]

What Chapter V does not cover, and where it is out of date

Chapter V has no section on types of compound such as crystalline forms, salts and isomers. On the specific matters of compounds, Chapter V states that the examination practice guidelines on the compound side are to be referred to (2.1.1.2, 2.2.2.1). [2] Chapter IX, “Compound Field” (제9부 화합물 분야), of the same Practice Guidelines is that place. Chapter IX explains isomers, hydrates, salts and prodrugs in its explanation of terms (1.3) and has an item on crystalline form inventions under inventive step (3.4.1). [2] Selection inventions are covered in “How are selection inventions treated in Korea?” and “Supreme Court Decision 2021Hu10022 Decided May 30, 2024: how is the inventive step of a selection invention assessed in Korea?”.

The item on crystalline form inventions in Chapter IX cites a 2011 Supreme Court decision and states the standard by reference to the effect. It states that inventive step is not denied only where there is an effect that is qualitatively different from that of the compound of the prior art or a quantitatively remarkable difference. [2] Supreme Court Decision 2018Hu10923 Decided March 31, 2022 dealt with the inventive step of a crystalline form invention again. The Supreme Court held that, merely because polymorph screening is ordinarily carried out, it cannot be concluded that “the difficulty of the technical configuration is denied” for a crystalline form invention. It also held that the effect of the invention needs to be taken into account when determining the difficulty of the technical configuration. [18] This decision also dealt with proof of the effect. It held that, where the effect is in doubt, it is allowed to assert and prove the effect by submitting additional experimental data after the filing date, to the extent that this does not go beyond the scope of the content stated in the specification. [18] This decision is a decision that reversed and remanded in a case on a decision of rejection, and the provision stated in the written judgment is Art. 29(2) of the Patent Act. [18] Here the wording of the Practice Guidelines and the wording of the decision are set side by side.

Chapter V was last revised in December 2021. When it was compared with the legislation and the decisions on 10 October 2026, the points that differed were as follows.

• The wording of Art. 32. Section 3.2 of the Practice Guidelines writes “문란하게 할 염려” (liable to disturb) and “해할 염려” (liable to harm). [2] This is the wording that applied until 31 December 2014. From the version in force from 1 January 2015, the wording of Art. 32 is “어긋나거나” (violates) and “해칠 우려” (likely to harm). [1]
• The name of a statute. Section 3.2.1 of the Practice Guidelines gives an example in which manufacture and sale are prohibited by the “마약법” (Narcotics Act). [2] The 마약법 was repealed by Art. 2 of the Addenda to the Narcotics Control Act (마약류 관리에 관한 법률) (Act No. 6146), and that Act entered into force on 1 July 2000. [17]
• The Established Rule in the appendix. The Practice Guidelines state that a statement of a medical use shown in the classification table of MFDS Established Rule No. 148 (식품의약품안전처예규 제148호) of 25 February 2020 is allowed, and carry that table in the appendix (2.2.1.2). [2] The current Regulation on Classification Numbers of Drugs, etc. (의약품등 분류번호에 관한 규정) is MFDS Established Rule No. 223, in force from 23 February 2026. [16]

Where the wording of the Practice Guidelines and of the legislation differ, this article follows the wording of the legislation. Art. 29, 32, 42, 47, 51, 62 and 208 do not change in the amended Patent Act (Act No. 21955) that will enter into force on 16 March 2027. [1]

Supreme Court decisions handed down after December 2021 were searched for on 10 October 2026 by the case search of the Ministry of Government Legislation. The search words included 약리데이터 (pharmacological data), 의약용도발명 (medical use invention), 투여용법 (administration), 투여용량 (dosage), 약리기전 (pharmacological mechanism) and 대상 환자군 (target patient group). This search did not find a Supreme Court decision that decided the standards stated in Chapter V on the statement of the pharmacological effect, the statement of the medical use, novelty or inventive step. Four Supreme Court decisions handed down on 26 June 2025 (2023Hu11487, 2023Hu11494, 2023Hu11524 and 2023Hu11562) are cases on patents for pharmaceutical compositions. What the four decisions decided is the interpretation of claims that state an active ingredient and its dosage, the requirements for correction, and the assertion of free-to-work technology. The two decisions that dealt with correction held that the grounds for invalidation of violation of the description requirements for the specification and of denial of inventive step should have been determined on the basis of the claims before correction, and remanded the cases. The written judgments of the four decisions do not state a legal principle on the statement of the pharmacological effect or on the inventive step of a medical use invention. [19]

The decisions behind the standards

The decisions cited in the text are collected here. The provisions are as stated in the written judgments. For a decision that does not write “former” (구), which version in force it applied cannot be known from the written judgment alone.

The description requirements of the current Patent Act are in Art. 42(3), subparagraph 1 and Art. 42(4), subparagraphs 1 and 2. [1] The wording of the former Act is not the same as the current wording. Art. 42(3) of the former Patent Act, as set out in Decision 2016Hu601, required the “purpose, configuration and effect” of the invention to be stated. [9] The current Art. 42(3), subparagraph 1 does not have those words. [1] Chapter V of the Practice Guidelines cites seven of the decisions above, that is, all except 2017Hu1854 and 2018Hu10923. [2]

Decisions 2016Hu502, 2016Hu601 and 2018Hu10923 are decisions that reversed and remanded. [8][9][18] This article did not check the conclusions after the remand.

Systems in the pharmaceutical field that are covered in separate articles

Outside the examination standards, four of the systems that bear on the pharmaceutical field are covered in separate articles.

Patent term extension for approval, etc. (extension of patent terms by permission; 허가등에 따른 존속기간 연장). The term of a patent right can be extended for an invention that is prescribed by Presidential Decree and for which the tests of effectiveness, safety and the like that are necessary for the approval, etc. take a long time. The extension is for the period during which the invention could not be worked, up to 5 years, and only once (Patent Act, Art. 89(1), main clause). [1] For pharmaceuticals, what is eligible is the invention of a drug that is manufactured with a new substance as its active ingredient and is the first to receive permission by item (approval). A new substance is a substance in which the chemical structure of the active moiety that produces the medicinal effect is new (Enforcement Decree of the Patent Act (특허법 시행령), Art. 7(1), subparagraph 1). The same subparagraph provides for narcotic drugs and psychotropic substances under the same requirements. Subparagraph 2 provides for pesticides and technical ingredients. [12] An application for registration of an extension of a patent must be filed within 3 months from the date on which the approval, etc. was obtained. It cannot be filed from 6 months before the expiration of the term (Art. 90(2)). [1] The proviso that the term cannot be extended beyond 14 years from the date on which the approval, etc. was obtained was introduced by the amendment in force from 22 July 2025. The provision that, where there are two or more patent rights for one approval, etc., the application for registration of an extension must be filed for only one of those patent rights (Art. 90(7)) was introduced by the same amendment. These amended provisions apply from applications for registration of an extension for a patented invention for which the approval, etc. is obtained on or after the date on which the Act takes effect (Addenda to Act No. 20700, Art. 2). [1] The details are in “How does patent term extension work in Korea?”.

Drug Patent List (의약품 특허목록). A person who has obtained permission by item or permission for modification can apply for registration of a patent right in the Drug Patent List managed by the Minister of Food and Drug Safety (Pharmaceutical Affairs Act, Art. 50-2(1)). [15] The time limit for the application is 30 days. The start date is the date on which the permission by item or permission for modification was obtained, the date of registration of the grant of the patent (registration of establishment of a patent right), or the date on which a trial decision granting a correction became final (paragraph (2) of the same Article). [15] The patent right registered must relate to one of a substance, a dosage form, a composition or a medicinal use (paragraph (4), subparagraph 1 of the same Article). Paragraph (4) sets out other requirements as well. For example, the patent must have been applied for on or before the date of the permission by item or permission for modification (subparagraph 3). [15] The details are in “What is the Green List (Drug Patent List) of patents in Korea?”.

Patent linkage (허가-특허 연계). A person who has applied for permission by item on the basis of the data on the safety and effectiveness of a listed drug, or has applied for permission for modification concerning the efficacy and effects, must notify the registered patentee and the patentee, etc. of a listed drug of that fact (Pharmaceutical Affairs Act, Art. 50-4(1), main clause). The proviso to the same paragraph sets out the cases where notice is not required. [15] The patentee, etc. of a listed drug can apply for prohibition of distribution within 45 days from the date of receipt of the notice (Art. 50-5(1)). Before applying, that person must have filed an action for an injunction against, or prevention of, patent infringement, or must have requested, or be the respondent in, a trial to confirm the scope of a right (paragraph (2) of the same Article). [15] The period of prohibition of distribution is 9 months from the date of receipt of the notice (Art. 50-6(1)). The subparagraphs of the same paragraph set out the cases where distribution is not prohibited, and paragraph (3) sets out the date on which the prohibition of distribution ceases to have effect. [15] The details are in “How does the Korean patent linkage system work? Registration in the patent list, the 9-month prohibition of distribution and permission for preferential distribution of items”.

Method-of-treatment claims. As seen above, an invention of a method of treating humans is regarded as an invention that is not industrially applicable. [2][3] The details are in “Are method-of-treatment claims allowed in Korea?”.

Accelerated examination: no ground that designates pharmaceuticals alone was found

In Art. 4 of the Public Notice on Request for Accelerated Examination on Patent or Utility Model (특허·실용신안 우선심사의 신청에 관한 고시; Notification, “Public Notice” below) (MOIP Notification No. 2026-3, in force from 23 February 2026), no ground for accelerated examination that designates the pharmaceutical field as such was found. [13] Four grounds in Art. 4 were found that touch pharmaceutical applications.

• An application to which a new patent classification related to the Fourth Industrial Revolution has been assigned (Art. 4(1), subparagraph 2, item 너). The technologies given in this item include innovative new drugs (혁신신약) and next-generation biopharmaceuticals (차세대바이오의약품). Attached Table 3 of the Public Notice states Z03M for innovative new drugs and Z05B for next-generation biopharmaceuticals. [13]
• An application directly related to medical or disease-control supplies related to infectious diseases (Art. 4(1), subparagraph 5, item 가; Enforcement Decree of the Patent Act, Art. 9(2), subparagraph 1 (a)). [12][13]
• An application related to bio (biotechnology) technology announced as an advanced technology (Art. 4(1), subparagraph 2, item 러; Enforcement Decree of the Patent Act, Art. 9(1), subparagraph 2-3). [12][13][14]
• An application filed by a resident medical research and development institution of a High-Tech Medical Complex and related to medical research and development within the complex (Art. 4(1), subparagraph 2, item 파). Medical research and development in Art. 2, subparagraph 5 of the Special Act on the Promotion of High-Tech Medical Complexes (첨단의료복합단지 육성에 관한 특별법) includes the research and development of drugs. [13][20]

The announcement for the third ground (MOIP Announcement No. 2026-21, 30 January 2026) requires both of two requirements. A patent classification (CPC) related to biotechnology must be assigned as the main classification. The classifications include A61K 38, 39, 47, 48 and others, and A61P 1 to 43. [14] In addition, the application must be one of three kinds. They are an application by a company that produces, or is preparing to produce, biotechnology-related products, devices or the like in Korea, an application for the results of a national research and development program related to biotechnology, and an application by a bio-specialized university (graduate school). [14] The period in which a request can be filed is from 1 February 2026 to 31 October 2026. The announcement states that whether to extend it is planned to be reviewed in November 2026. [14] On 10 October 2026, the titles of all the posts put up after 30 January 2026 on the MOIP notices and announcements board were read, and there was no announcement extending this announcement. [14]

The grounds for accelerated examination that do not depend on the field, and the procedure, are in “How do I get accelerated examination in Korea?“.

What applicants should do

In general, we suggest the following. Please check the assessment of an individual case with your agent.

• At the stage of the application that is the basis of the priority claim, we suggest checking whether the pharmacological data will be in the original specification of the Korean application. For an international patent application, the specification submitted by the international filing date is the reference. The reason is that test examples that were not in the original specification cannot be supplied by amendment. We suggest looking at whether the specification specifies which test was done with which active ingredient and what the result was.
• We suggest checking, for each use claimed, whether there is a statement of the pharmacological effect. The Practice Guidelines require a statement of the pharmacological effect not only for the disease but also for a limitation of the administration and dosage or of the target patient group.
• We suggest changing method-of-treatment claims and claims in the form “compound for a use” into the form of a composition before filing in Korea. The use is stated as efficacy.
• For a claim that states the active ingredient by its function, we suggest adding dependent claims that specify it by structure. For a patent application in a foreign language and an international patent application filed in a foreign language, the scope of the final Korean translation is a limit on amendment, so we suggest checking this at the translation stage.
• For administration and dosage claims, we suggest checking whether the specification has comparative data that shows the effect of that limitation. In the examples in the Practice Guidelines, inventive step was denied where there was no statement of the technical significance or the effect of the limitation.
• For crystalline forms, salts and isomers, we suggest checking separately the standards for the compound field, not Chapter V.

FAQ

Is clinical trial data required?

Not necessarily. The Practice Guidelines state that the pharmacological effect must in principle be supported by clinical trials. However, they state that, depending on the content of the invention, it may be stated by animal tests or in vitro tests (2.1.1.1). [2] A statement that clinical trials are in progress cannot by itself take the place of pharmacological data. [2]

Can pharmacological data be added to the specification after filing?

No. Supplying by amendment test examples that were not in the original specification goes beyond the scope of the matters stated in the specification. This is the standard of Supreme Court Decision 2001Hu65 and of section 2.1.1.1 of the Practice Guidelines. [2][4] Where there are special circumstances, such as where the pharmacological mechanism was clearly established before filing, that is an exception to this standard, which requires a statement of test examples. [2][4]

Can the use be stated only by a pharmacological mechanism?

The principle is to state it as efficacy. An expression stated only by a pharmacological mechanism is allowed where a person skilled in the art recognizes it as specific efficacy and the use is clear (2.2.1.2). [2] A pharmacological mechanism stated together with the efficacy is not regarded as an element that separately limits the claims. [2][6]

Can an invention that differs only in the administration and dosage also be patented?

It can, if it meets the requirements for patentability, such as novelty and inventive step. The administration and the dosage can be an element. [10] The Practice Guidelines regard the invention as involving an inventive step only if that limitation produces a remarkable effect that a person skilled in the art could not predict (3.4.1.3). [2]

Are the examination standards for crystalline forms and salts also in Chapter V?

No. On the specific matters of compounds, Chapter V states that the examination practice guidelines on the compound side are to be referred to. Chapter IX, “Compound Field”, has an item on crystalline form inventions. [2]

How DEFINE IP Law Firm handles this

Before a pharmaceutical application is filed in Korea, DEFINE IP Law Firm compares each use claimed with the pharmacological data in the specification, one by one. At the translation stage, we change method-of-treatment claims and use claims in the form of a compound into the Korean form. If the comparison shows that something is missing, we tell the applicant before filing. For questions about Korean applications for pharmaceutical inventions, please write to contact@defineip.kr.

Sources

1. Patent Act (특허법), Act No. 21134, in force from 2025-11-11. Art. 29(1) and (2), Art. 32, Art. 42(3) and (4), Art. 47(1) to (3), Art. 51(1), Art. 62, Art. 89(1), Art. 90(2) and (7), Art. 200-2(2), Art. 208(3) and (4). Addenda (Act No. 20700, promulgated 2025-01-21, in force from 2025-07-22), Art. 2. The earlier wording of Art. 89 is from the version in force from 2025-05-27 (Act No. 20975), and the earlier wording of Art. 32 is from the version in force from 2014-07-01. Compared with the version scheduled to enter into force (Act No. 21955, promulgated 2026-09-15, in force from 2027-03-16). https://www.law.go.kr/법령/특허법 (verified 2026-10-10)
2. Ministry of Intellectual Property (지식재산처), Examination Practice Guidelines by Technology Field (기술분야별 심사실무가이드) (March 2026), foreword, Chapter V, Pharmaceutical Field (제5부 의약 분야) (revised December 2021), 1. to 4., appendix, and Chapter IX, Compound Field (제9부 화합물 분야), 1.3 and 3.4.1. https://www.kipo.go.kr/ko/kpoContentView.do?menuCd=SCD0200147 (verified 2026-10-10)
3. Ministry of Intellectual Property (지식재산처), Patent Examination Guidelines (특허·실용신안 심사기준), MOIP Established Rule No. 7 (지식재산처예규 제7호), in force from 2026-03-13. Part 2, Chapter 3, 2.3.2 (2); Part 3, Chapter 1, 5.1 (1). https://www.law.go.kr/행정규칙/특허·실용신안심사기준 (verified 2026-10-10)
4. Supreme Court Decision 2001Hu65 Decided November 30, 2001 (대법원 2001. 11. 30. 선고 2001후65 판결). https://www.law.go.kr/판례/(2001후65) (verified 2026-10-10)
5. Supreme Court Decision 2003Hu1550 Decided December 23, 2004 (대법원 2004. 12. 23. 선고 2003후1550 판결). https://www.law.go.kr/판례/(2003후1550) (verified 2026-10-10)
6. Supreme Court Decision 2012Hu238, 245 (intervention as co-litigant) Decided May 16, 2014 (대법원 2014. 5. 16. 선고 2012후238, 245(공동소송참가) 판결). https://www.law.go.kr/판례/(2012후238) (verified 2026-10-10)
7. Supreme Court Decision 2004Hu1120 Decided May 11, 2006 (대법원 2006. 5. 11. 선고 2004후1120 판결). https://www.law.go.kr/판례/(2004후1120) (verified 2026-10-10)
8. Supreme Court Decision 2016Hu502 Decided January 31, 2019 (대법원 2019. 1. 31. 선고 2016후502 판결). https://www.law.go.kr/판례/(2016후502) (verified 2026-10-10)
9. Supreme Court Decision 2016Hu601 Decided October 25, 2018 (대법원 2018. 10. 25. 선고 2016후601 판결). https://www.law.go.kr/판례/(2016후601) (verified 2026-10-10)
10. Supreme Court en banc Decision 2014Hu768 Decided May 21, 2015 (대법원 2015. 5. 21. 선고 2014후768 전원합의체 판결). https://www.law.go.kr/판례/(2014후768) (verified 2026-10-10)
11. Supreme Court Decision 2017Hu1854 Decided April 29, 2021 (대법원 2021. 4. 29. 선고 2017후1854 판결). https://www.law.go.kr/판례/(2017후1854) (verified 2026-10-10)
12. Enforcement Decree of the Patent Act (특허법 시행령), Presidential Decree No. 35809, in force from 2025-10-01. Art. 7(1), Art. 9(1), subparagraph 2-3, Art. 9(2), subparagraph 1 (a). https://www.law.go.kr/법령/특허법시행령 (verified 2026-10-10)
13. Ministry of Intellectual Property (지식재산처), Public Notice on Request for Accelerated Examination on Patent or Utility Model (특허·실용신안 우선심사의 신청에 관한 고시), MOIP Notification No. 2026-3 (지식재산처고시 제2026-3호), in force from 2026-02-23. Art. 4, attached Table 3. https://www.law.go.kr/행정규칙/특허·실용신안우선심사의신청에관한고시 (verified 2026-10-10)
14. Ministry of Intellectual Property (지식재산처), MOIP Announcement No. 2026-21 “첨단기술 관련 출원(바이오(생명공학) 기술)의 우선심사 대상 재공고” (re-announcement of advanced technology applications (bio (biotechnology) technology) eligible for accelerated examination), 2026-01-30. Titles of the posts put up on the notices and announcements board from 2026-01-28 to 2026-10-08. https://www.kipo.go.kr/ko/kpoBultnDetail.do?menuCd=SCD0200610&ntatcSeq=20048&sysCd=SCD02&aprchId=BUT0000021 (verified 2026-10-10)
15. Pharmaceutical Affairs Act (약사법), Act No. 21525, in force from 2026-10-08. Art. 50-2(1), (2) and (4), Art. 50-4(1), Art. 50-5(1) and (2), Art. 50-6(1) and (3). https://www.law.go.kr/법령/약사법 (verified 2026-10-10)
16. Ministry of Food and Drug Safety (식품의약품안전처), Regulation on Classification Numbers of Drugs, etc. (의약품등 분류번호에 관한 규정), MFDS Established Rule No. 223 (식품의약품안전처예규 제223호), in force from 2026-02-23. https://www.law.go.kr/행정규칙/의약품등분류번호에관한규정 (verified 2026-10-10)
17. Narcotics Control Act (마약류 관리에 관한 법률), Addenda (Act No. 6146, promulgated 2000-01-12, in force from 2000-07-01), Art. 1 and 2, and the history of the 마약법 (Narcotics Act) in the Korean Law Information Center (국가법령정보센터) of the Ministry of Government Legislation (법제처). https://www.law.go.kr/법령/마약류관리에관한법률 (verified 2026-10-10)
18. Supreme Court Decision 2018Hu10923 Decided March 31, 2022 (대법원 2022. 3. 31. 선고 2018후10923 판결). https://www.law.go.kr/판례/(2018후10923) (verified 2026-10-10)
19. Supreme Court Decisions 2023Hu11487, 2023Hu11494, 2023Hu11524 and 2023Hu11562 Decided June 26, 2025 (대법원 2025. 6. 26. 선고 2023후11487 판결, 2023후11494 판결, 2023후11524 판결, 2023후11562 판결). https://www.law.go.kr/판례/(2023후11487) (verified 2026-10-10)
20. Special Act on the Promotion of High-Tech Medical Complexes (첨단의료복합단지 육성에 관한 특별법), in force from 2025-10-01. Art. 2, subparagraph 5. https://www.law.go.kr/법령/첨단의료복합단지육성에관한특별법 (verified 2026-10-10)