Are Medical Methods Patentable in Japan? Understanding the 'Industrial Applicability' Requirement

For an invention to be granted a patent in Japan, it must satisfy several core criteria, including novelty, an inventive step, and "industrial applicability." While the first two are common touchstones in global patent law, the requirement of industrial applicability (sangyō-jō no riyōkanōsei) under Article 29, Paragraph 1 of the Japanese Patent Act has served as a particular gatekeeper for certain types of inventions, most notably methods related to medical treatment of humans.

This article delves into how Japan has traditionally approached the patentability of medical methods, the rationale behind its stance, and the evolving landscape in this critical area of innovation.

The "Industrial Applicability" Threshold in Japanese Patent Law

The preamble of Article 29(1) of the Japanese Patent Act states that an inventor of an invention that is "industrially applicable" may obtain a patent therefor. The term "industry" in this context is interpreted broadly, encompassing a wide range of productive human activities including manufacturing, agriculture, mining, commerce, and services. Generally, if an invention can be used or produced "as a business" or has the potential for commercial sale or operation, it is considered to have industrial applicability.

Conversely, inventions whose utility is confined to purely personal use (such as a method of smoking, if it offers no broader application) or exclusively academic or experimental purposes without any potential for commercial transaction or industrial use, are typically deemed to lack industrial applicability. However, this line can blur; for instance, research tools used in drug discovery or genetic diagnosis, even if "experimental" in one sense, often have significant commercial value and are transacted, making them difficult to classify as lacking industrial application.

Medical Methods: The Traditional Hurdle of Industrial Applicability

Historically, and as a general rule, methods of surgery, therapy, and diagnosis practiced directly on the human body have been considered to lack industrial applicability in Japan and are therefore not patentable subject matter.

Rationales for Exclusion

Several intertwined reasons have underpinned this exclusionary stance:

1. Humanitarian and Ethical Concerns: A primary concern has been that granting exclusive patent rights over acts performed by medical professionals directly on patients could lead to situations where life-saving or health-improving treatments are unduly restricted or made prohibitively expensive. The idea of a surgeon being enjoined by a patent from performing a necessary operation, or a doctor from diagnosing a condition, has been viewed as contrary to public health, humanitarian principles, and the inherent dignity of human life. This ethical consideration has been a dominant factor.
2. Nature of Medical Practice: There has also been a traditional perception of medical acts as a form of "benevolent art" (jinjutsu), implying a non-commercial, skill-based practice rather than an "industry" in the conventional sense.
3. Patent Law Mechanism: From a purely patent law perspective, the Japan Patent Office (JPO) historically used the "lack of industrial applicability" criterion as the most suitable available ground within the Patent Act to exclude these medical methods, as other criteria like novelty or inventive step were less apt for this purpose.

The Distinction: Patentable Medical Products vs. Generally Unpatentable Medical Acts

It's crucial to distinguish between medical methods practiced on the human body and medical products such as pharmaceuticals (medicines) and medical devices. In Japan, pharmaceuticals and medical devices are, and have long been, patentable subject matter. This creates a somewhat nuanced situation: the tools of medicine (drugs, scalpels, diagnostic machines) are patentable, but the direct method of using those tools on a human patient for surgery, therapy, or diagnosis has generally not been.

This has led to what some see as an imbalance, where an invention's patentability diminishes the closer its claimed subject matter approaches a direct method of human treatment. For instance, it's sometimes possible to obtain patent protection by carefully drafting claims directed to a medical device that operates in a novel way, rather than claiming the method of using that device on a patient.

Evolution in Interpretation and JPO Examination Guidelines

The traditional stance has not been entirely static. A notable judgment from the Tokyo High Court on April 11, 2002 (in a case concerning an optical display device), observed that there is no inherent reason in the term "industry" itself that requires it to be interpreted narrowly so as to always exclude medical practice. However, the court also noted that as long as the Patent Act lacked specific measures to appropriately balance patent rights with public access for medical acts (analogous to, for example, Article 69(3), which exempts pharmacists preparing medicines according to prescriptions from patent infringement for certain types of pharmaceutical inventions), inventions concerning medical acts performed on humans would continue to be treated as lacking industrial applicability.

This judicial perspective, among other factors, has spurred revisions to the JPO's Examination Guidelines over the years. These revisions have generally trended towards expanding the scope of what can be considered "industrially applicable" in the broader medical field, while still largely maintaining the exclusion for methods of surgery, therapy, or diagnosis of humans performed on the human body that involve direct doctor-patient interaction. Thus, while the core exclusion remains, many other types of medical-related inventions (e.g., methods of processing biological samples ex vivo, methods of operating medical equipment not directly applied to the body in a therapeutic/surgical/diagnostic manner, new uses of existing substances for medical product manufacture) are generally found to possess industrial applicability.

Emerging Technologies and Shifting Perspectives

The rapid advancement of medical science, particularly in fields like genetics, personalized medicine, and regenerative medicine, continues to challenge traditional boundaries and perspectives on patentability.

• Personalized Medicine and Diagnostics: Inventions related to genetic diagnosis or tailoring treatments based on individual biological markers are increasingly common. Methods using induced pluripotent stem cells (iPS cells) for diagnostic purposes are also under development. These areas often involve intense R&D competition and significant investment, highlighting a need for patent incentives.
• iPS Cells as an Example: The development of iPS cells, for which Professor Shinya Yamanaka of Kyoto University was a co-recipient of the Nobel Prize, illustrates how quickly scientific discoveries can translate into technologies with vast industrial potential, including applications in drug screening, disease modeling, and regenerative medicine. Securing patent rights in such cutting-edge fields is often crucial for attracting investment and facilitating further research through licensing.

Ethical Considerations in the Background

While "lack of industrial applicability" has been the primary legal basis in Japan for excluding methods of human medical treatment from patentability, ethical considerations are never far from the surface, especially with biotechnological inventions. For example, the creation of human embryonic stem (ES) cells often involves the destruction of human embryos, which raises profound ethical concerns and can impact patentability under provisions related to "public order or morality" (Article 32 of the Patent Act).

iPS cells were developed, in part, to circumvent some of the ethical issues associated with ES cells. However, iPS cell technology itself is not without potential ethical dilemmas, such as the theoretical possibility of human cloning or the creation of human-animal chimeras. The general view reflected in expert commentary is that despite such potential for misuse, highly useful medical technologies (including those derived from iPS cells) should generally be patentable to incentivize their development for beneficial applications. Ethical concerns regarding their use are often seen as better addressed through specific regulations outside of patent law itself, rather than by denying patentability outright on ethical grounds, unless the invention's sole purpose is contrary to public order. For methods of medical treatment, however, the primary hurdle in Japan remains the "industrial applicability" requirement.

Potential Future Directions (as of 2014)

Recognizing the complexities and the evolving nature of medical innovation, discussions have occurred in Japan regarding potential future reforms. One approach considered has been to formally allow the patenting of medical methods (including those practiced on the human body), but to simultaneously introduce clear statutory exemptions from infringement for medical practitioners performing such patented methods in the course of their professional duties. This could involve, for example, provisions for non-enforceability against doctors, or a system of compulsory licenses for medical procedures. Such a system would aim to provide patent incentives for the development of new medical methods while ensuring that access to necessary medical care is not unduly hindered. This would align Japan more closely with the approaches taken in some other major jurisdictions.

Conclusion

The patentability of medical methods in Japan is a nuanced area, primarily governed by the interpretation of the "industrial applicability" requirement. While medicines and medical devices are clearly patentable, methods of surgery, therapy, and diagnosis practiced directly on the human body have traditionally been excluded on the grounds that they lack industrial applicability, a stance rooted in ethical and public health considerations.

However, the JPO's Examination Guidelines have evolved, and there is a trend towards recognizing the industrial applicability of a wider range of medical-related inventions that do not involve direct, hands-on treatment or diagnosis of human patients. The advent of groundbreaking technologies like iPS cells further underscores the significant industrial potential in the medical field. While the core exclusion for direct human medical methods largely remained as of 2014, ongoing discussions about legislative reform suggested a potential future path towards a system that might allow broader patentability of medical methods while safeguarding access to medical care through specific infringement exemptions. For now, navigating this area requires careful attention to the specific nature of the invention and the prevailing JPO guidelines.