ASIAN PATENT ATTORNEYS ASSOCIATION Recognized Group of Korea. Report to Emerging IP Rights Committee 2012, Chiang Mai

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1 ASIAN PATENT ATTORNEYS ASSOCIATION Recognized Group of Korea Report to Emerging IP Rights Committee 2012, Chiang Mai SPECIAL TOPIC REPORT ON Business Methods and the Laws of Nature, As Discussed by the US Supreme Court in Mayo v. Prometheus Korean Group Emerging IP Rights Study Committee [Hong-Gyun KIM Young Joo ROH] I. Introduction In March 2012, the US Supreme Court unanimously ruled in Mayo Collaborative Services v. Prometheus Laboratories Inc. that a method for adjusting a drug dosage after observing a patient s reaction to a drug administration was patent-ineligible subject matter under 35 U.S.C In its decision, the Supreme Court identified the claimed diagnostic method based on the correlation or relationship between specific metabolite and drug dose to be an unpatentable law of nature. Patent law has long held that laws of nature, natural phenomena, and abstract ideas are not patentable. At the same time, many patents cover applications that grow out of these fundamental concepts, and many countries have recognized that such applications are patentable. The Mayo decision serves as a strong reminder that laws of nature are excluded from patent-eligible subject matter, and leaves open to patent eligibility claims that represent a particular, useful application of a law of nature. Especially, it will affect the analysis of patentable subject matter in various inventions including diagnostic method, biomarker, personalized medicine, business method, etc. 1

2 Therefore, there is a need to consider a patent-eligibility about the unpatentable concepts including laws of nature, natural phenomena, and abstract ideas, especially, what additional feature might be sufficient to transform them into patentable application thereof. II. Mayo v. Prometheus 1. The Decision of the Supreme Court At first, the Federal Circuit found that the claimed processes in Prometheus were patent eligible because they involved transforming the human body by administering a thiopurine drug and transforming the blood by analyzing it to determine metabolite levels. in view of machine-or-transformation test from Bilski v. Kappos. However, the Supreme Court overturned the U.S. Court of Appeals for the Federal Circuit and ruled that two patents owned by Prometheus Laboratories are invalid because Prometheus' claims set forth only "laws of nature", since they merely correlated concentrations of metabolites in the blood and the likelihood that a dosage will either be effective or cause harm. The Supreme Court believed the correlation between 6-thioguanine blood levels and its dosage to be a consequence of the metabolism of thiopurine compounds in the human body, in other words, a natural occurrence. Claim 1 of the 623 patent is representative. It recites: A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immunemediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immunemediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 2

3 The court characterized the administering step as referring to the relevant audience of doctors who are already administering the drug. Likewise, the determining step merely tells the doctor to determine the level of the chemical in the patient, a step found to be well known as well as well-understood, routine, conventional activity. Furthermore, the court characterized the wherein clauses were held to simply tell a doctor about the relevant natural laws, at most adding a suggestion that one should take those laws into account when treating a patient. We can know that the Court acknowledged the conventional steps of determining and administering did not present a patentable application of the law of nature, and these limitations could not change an unpatentable concept into a patentable application. Relying on this decision, many people are concerned that this decision has the potential to affect thousands of existing patents directed to personalized medicine and other practical applications which may be construed as being impermissibly drawn to a natural law. In addition, this decision may probably give rise to other problems, for example, reevaluating many existing patents and applications or narrowing re-issues or claim amendments by adding additional features sufficiently for patentable transformation. 2. Concerns According to the Supreme Court s comments, we can summarize that the following three types of limitations do not make an unpatentable idea patent-eligible: (i) limiting an unpatentable concept to a particular audience, (ii) telling someone about the concept, or (iii) adding a conventional or obvious pre-solution activity. However, unfortunately, the Supreme Courts did not provide clear and reliable guidance as to what additional limitations can change an unpatentable concept into a patentable application. As you know, biological and pharmaceutical inventions inevitably involve natural phenomena, and many current patents involve the application of equations to a new problem using computer. 3

4 Therefore, we still have the question of what additional features are sufficient to transform an unpatentable concept into a patent-eligible subject matter. III. Korean Patent Law 1. Patent Act Article 29 (1) main paragraph According to Korean Patent Act Article 29 (1) main paragraph, all patentable inventions should be industrially applicable since the purpose of the Patent Act is to contribute to the development of industry (Patent Act Article 1). It requires an invention to be statutory and industrially applicable. Therefore, these examination guidelines describe the requirement of statutory invention and of subjects that involve industrial applicability There are some examples of the types of non-statuary inventions in Korean Patent Examination Guideline as follows: (i) Laws of nature as such; (ii) Mere discoveries and not creations: A mere discovery is not deemed to be a creation because a discovery means to find out laws which exist in nature. However, the method for artificially isolating substances from things in nature, not a mere discovery, is considered to be a statutory invention. So are the isolated chemical substances and microorganisms (iii) Those in which a law of nature is not utilized : If a claimed invention utilizes any laws other than a law of nature (e.g., economic laws, mathematical methods, logics, cartography, etc.), arbitrary arrangements (e.g., a rule for playing a game as such) or mental activities (e.g., method for doing business as such, teaching skills as such, financial insurance scheme as such, tax code as such, etc.), the claimed invention is not considered to be statutory. (iv) Computer programming language or computer program: However, in the case of an invention where a data processing process by a computer program is specifically executed using a hardware, a data processing unit (machine) operating in association with the computer program, its operating method, and a computer readable medium carrying the computer program thereon are viewed 4

5 as statutory inventions. As well as the above non-statuary inventions, some cases are also non-patentable since they are industrially inapplicable. A typical example is the invention related to medical activity, which is not patentable for ethical reasons in Korea. In particular, a diagnostic method s patentability would be described based on the Korean Patent Examination Guideline hereinafter, which is relevant to the Mayo decision. 2. Diagnostic method s patentability With respect to medical activities including diagnostic methods, it is described as the methods for treatment of the human body by surgery, therapy or diagnosis, which are referred to as medical activities, are considered industrially inapplicable in the Korean Patent Examination Guideline. Especially, in the case of Diagnostic method, it can be patent-eligible for industrial application unless it involves any clinical judgment or step directly and non-temporarily affecting a human body based on the guideline revised in Additionally, the guideline exemplifies a specific patentable form as a method of detecting cancer marker by using antigen-antibody response with patient s sample for diagnosing colonal cancer. Therefore, the Prometheus s claims may also be difficult to be considered as patent eligible under Korean patent practice, since it involves any clinical judgment. However, there may be a room for modification so as to transform into patentable form in Korea by limiting in vitro treatment and obtaining of a sample from the subject in addition to the determination feature (like in European s). IV. Application of Mayo to Business-Method Patents Mayo decision also can bring us the question of how we should determine the patentability of the business-method. In view of the Mayo decision, we should consider whether the business method invention comprises the steps which are obvious, already in use, or purely conventional 5

6 in the field. Applicants should draft business method claims so as to identify the steps of application of the used concepts (e.g. abstract, part of a mental process, or a mathematical algorithm) as clearly as possible, and explain how those steps integrate (or apply) to each other in a way that demonstrates a measurable improvement over existing technology. Furthermore, we should use specific languages so that the invention can be interpreted as improved process having a novelty and non-obviousness to solve a practical problem which has arisen in the field of the invention. One strategy can be refraining from broad claim-draft and adding more specific steps in independent claims. In Korea, the business method (BM) invention itself is not patent-eligible since it does not utilizes a law of nature. However, we can claim the BM invention using computer program, and thus it should be specifically executed using hardware for data processing by software on computers (2007Hu265 case by Korean Supreme Court). Namely, BM invention itself (concept) is little likely to be admitted as a patentable subject matter under the current Korean Patent law, unless it integrates to computerrelated device. V. Conclusion The Mayo v. Prometheus decision reminds us that patent-eligible subject matters in certain field, e.g. software, business method, biotechnology etc., are considered to be the balance between proper patent protection for patentees and subsequent innovation related to the underlying discovery. 6