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By Yungjoon Kwon
Yungjoon Kwon, Korean patent/trademark attorney and managing director at law firm Kwon & Kim, introduces general practice and case laws related to medical use claim in South Korea in an Expert View piece.
General rule on drafting medical use invention
The preamble of "use" recited in claims is not acceptable due to a claim description format violation in Korea.
In detail, under Korean patent law, patentable subject matter is restricted to the categories of “a product,” “a method” and “a method of preparing a product.”
According to the KIPO examination guidelines (Korean Manual of Patent Examining Procedure, K-MPEP), since the claim format “compound X for use in treating disease Y” is considered to claim “compound X” per se, not a medical use, such a claim is only allowable when “compound X” per se is patentable. Therefore, if the medical indication of the known product is novel technical feature of invention, it is suggested that the medical use is drafted as corresponding pharmaceutical composition claim format.
Unpatentable subject matter: use of product X …
Patentable subject matter: a pharmaceutical composition comprising product X for the treatment of disease Y.
KIPO’s examination guideline for pharmaceutical composition claim description
According to the KIPO examination guideline, a claim directed to such a pharmaceutical composition should be defined by its pharmacological effect against a specific disease. That is, the claim should recite the pharmaceutical effects of diagnosing, treating, reducing, curing or preventing diseases. The names of disease should be exemplified by the disclosure of the specification.
Unpatentable subject matter: a pharmaceutical composition comprising product X.
Patentable subject matter: a pharmaceutical composition comprising product X for the treatment of disease Y. Related case law is as follows: MCW RESEARCH FOUNDATION, INC, Korean Supreme Court 2006 Hu 3564, issued on October 11, 2006: Supreme Court held that “a composition for treating nitric oxide overproduction...” is not allowed as a reason for including indefinite medical indication. On this issue, since the reasonable correlation between the certain kinds of disease and the inhibition of nitric oxide overproduction was not substantiated, the expression of “nitric oxide overproduction” was not considered to be specific names/kinds of diseases. The KIPO examination guideline exceptionally allows the case where a specific name of disease is not recited in the claim. In detail, reciting the specific name of disease in a claim is not always necessary if the pharmacological effect/mechanism is clearly understood as a concrete medical indication to those having ordinary skill in the art. For example, recitations “antibacterial” and “for inhibiting histamine release” are acceptable exemplified expressions to the KIPO examination guideline. The “angiogenesis inhibitor” has been allowed as specific medical indication by the Supreme Court (Supreme Court 2003 Hu 1550). However, the above cases are not general practices, thus it is recommended to use a concrete name of disease in the pharmaceutical composition claim. Medical treatment method claim patentable in Korea? Other than product-type claims, treatment method claims can be considered for covering medical use. However, according to the Korean Patent Act, an invention which involves the human body as one of its indispensable technical features, such as a method for a surgical operation conducted on the human body, a method for the application of a medicine to the human body for diagnosis, medical treatment or prevention of human diseases, is not regarded as being industrially applicable or useful, and thus is not patentable. However, the treatment method claim for an animal (not human being) is not rejected for lack of industrial applicability. Unpatentable subject matter: a treatment method for disease Y, comprising administering product X to patient. Patentable subject matter: a treatment method for disease Y, comprising administering product X to animal (except human being). General rule on drafting medical use invention Under Korean patent practice, if new medical uses of known medicines are found, second medical use inventions can be patentable. The second medical use is generally protected by the same category as first medical use, ie product-type claim (pharmaceutical composition claim). The KIPO clearly allows that treatment of new disease of known medicines is patentable. - New pharmacological mechanism: targeting new etiology for same disease The KIPO considers the patentability of medical use in the view of treatment of new disease, ie therapeutic/preventing effect of certain diseases or pathological condition. The discovery of pharmacological mechanism per se cannot give a distinguishable patentable weight thereto. Related case law is as follows: ALCON LABORATORIES INC, Korean Supreme Court 2012 Hu 238, issued on May 16, 2014: The subject invention is related to topical ophthalmic formulations containing doxepin derivatives for treating allergic eye diseases. The patentee applied to amend the claim by inserting a limitation of “by stabilizing human conjunctival mast cell” as follows: A topically administrable ophthalmic composition for treating allergic eye diseases by stabilizing human conjunctival mast cell, comprising a therapeutically effective amount of 11-(3-dimethyiaminopropylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid, or a pharmaceutically acceptable salt thereof.
The Supreme Court noted that “by stabilizing human conjunctival mast cell” was an intrinsic property for treatment allergic eye disease and thus, the technical feature of “by stabilizing human conjunctival mast cell” of claimed invention was not considered as an element constituting the presently claimed composition but rather corresponded to pharmacological mechanism per se. The Supreme Court held that such amendment was not considered to be a limitation of scope of claim. BOEHRINGER INGELHEIM INTERNATIONAL, Korean Supreme Court 2012 Hu 3664, issued on May 16, 2014 : The subject invention is related to use of angiotensin II receptor antagonists, especially telemisartan, in order to increase insulin sensitivity. The Supreme Court held that a patent lacked inventiveness, citing the prior art disclosure of the treatment/prevention of diabetes. On the inventiveness issue, the Court noted that the technical feature of “induction of transcription of peroxisome proliferator-activated receptor PPARgamma-regulated gene” was an intrinsic property which telemisartan had for treating/preventing diabetes, and thus such pharmacological mechanism was not considered as novel medical use. NIKKEN CHEMICALS CO, LTD, Korean Intellectual Property Tribunal 2012 Won 6749, issued on June 13, 2013 : The subject invention is directed to pharmaceutical composition for the prevention of malignant alteration of hepatic stem cell by inhibiting TGFalpha expression in a hepatic stem cell comprising polyprenyl carboxylic acid as an active ingredient. The Korean Intellectual Property Tribunal held that a patent lacked inventiveness since polyprenyl carboxylic acid was known for being useful for inhibition of TGF-alpha expression in the hepatoma cell line and known for being useful for prevention of primary hepatoma. The Korean Intellectual Property Tribunal noted that the “inhibition of malignant alteration of hepatic stem cell by inhibition TGF-alpha expression” was pharmacological mechanism per se which was not an element constituting the claimed pharmaceutical composition. The tribunal's view was that the medical use for subject invention was the prevention of hepatoma, which was obvious from the disclosure of the prior art. Product defined by medical use KIPO Examination guidelines stipulate that, since the claim format “compound X for use in treating disease Y” is considered to claim “compound X” per se, not a medical use, such a claim is only allowable when “compound X” per se is patentable. Related case law is as follows: Korean Institute of Science and Technology, Korean Patent Court 2001 Huh 1501, issued on April 4, 2002 : The subject invention is directed to chamigrenal compound having antagonistic activity to binding of platelet active factor receptor isolated from Schisandrae Fructus. Claim 1 is as below: Chamigrenal compound having antagonistic activity to binding of platelet active factor receptor isolated from Schisandrae Fructus, and having chemical formula as below:
The Patent Court held that a patent lacked novelty since the method for such chamigrenal compound, betterment for liver damages including the chamigrenal compound as an active ingredient, and the method for isolating the chamigrenal compound from Schisandrae Fructus, were known in the prior art. The court noted that the subject invention was considered for drafting of chamigrenal compound per se which was specified by function of antagonistic activity to binding of platelet active factor receptor, not the new use of chamigrenal compound. The court concluded that the subject invention lacks novelty since the chamigrenal compound was disclosed in the prior art.
Summary
Even though such medical use claim is allowed in Korea, the KIPO standard is stricter than in the other major jurisdictions of Europe, Japan and the USA. The Korean examination guideline has a relatively narrow window for allowance of second medical use, thus an extra effort of applicant to mitigate rejections is necessary, and the second medical use accompanying constitutional change in medicament/composition may avoid the heightened examination of KIPO.
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