Software and Biotech Inventions: How Does Japan Handle Patenting in These Evolving Fields?

Japanese Attorney at Law - Bengoshi L.L.

• 7 min read

The rapid advancements in software and biotechnology continually challenge traditional notions of patent law. As these fields redefine technological frontiers, patent offices worldwide grapple with how to apply established legal principles to novel types of creations. Japan, a significant player in both the tech and life sciences sectors, has developed specific approaches and guidelines for assessing the patentability of software-related and biotechnology inventions. This article explores how Japan navigates these complex and evolving areas.

Software permeates nearly every aspect of modern technology, from complex industrial control systems to everyday consumer applications. Initially, the patentability of software faced hurdles, often being viewed as mere algorithms or abstract mental steps. However, Japanese patent practice has evolved significantly.

A. Overcoming the "Abstract Idea" Hurdle: The Importance of Technical Character

Historically, software inventions were often patented by claiming them as part of a physical apparatus or a storage medium. A pivotal change occurred with a 2002 amendment to the Japanese Patent Act, which explicitly recognized computer programs themselves as "products" (things). This legislative clarification paved the way for:

  • Software as a Product Invention: A computer program itself can be claimed as an invention of a product.
  • Software-Implemented Processes as Process Inventions: The operation of a computer as controlled by software can be claimed as an invention of a process.

Despite this, to qualify as a statutory "invention," software-related creations must still satisfy the fundamental requirement of being a "creation of a technical idea utilizing a law of nature." The Japan Patent Office (JPO) Examination Guidelines provide crucial insight here.

Key Requirement: Utilization of Natural Laws via Concrete Hardware Resources

The JPO's stance is that for software-based information processing to be patentable, it must be concretely realized using physical hardware resources (such as a CPU, memory, input/output devices, etc.) to achieve a specific technical effect. This means:

  • The software must control hardware and cause it to perform specific information processing based on the purpose of use.
  • The operation of this hardware, governed by physical laws (e.g., laws of electricity), in conjunction with the software, fulfills the "utilization of a law of nature" requirement.
  • If a software claim is not concretely linked to hardware resources and amounts to a mere presentation of information, an arbitrary arrangement, or a mathematical algorithm as such, it may be deemed to lack the utilization of a law of nature and thus not qualify as a statutory invention.

The Bit-Shortening Expression Generation Method Case (Intellectual Property High Court, February 29, 2008) illustrates this. The court denied patentability where the claims described a mathematical algorithm and a generic "apparatus" without specifying the concrete circuit configuration for performing the digital operations, finding it did not meet the requirements of a statutory invention.

B. Business Method Inventions: A Specific Application of Software Patentability

Purely abstract business methods, such as a new sales tactic or financial scheme, are generally not patentable in Japan as they are considered artificial arrangements or economic laws, lacking the necessary technical character and utilization of natural laws.

However, business methods implemented using computer technology (i.e., involving software and hardware) can be patentable if they provide a concrete technical solution that leverages these resources to achieve a business objective. The focus remains on the technical means employed, not merely the business idea itself. The JPO considers such inventions as a type of software-related invention.

  • The Two-Way Dental Treatment Network Case (Intellectual Property High Court, June 24, 2008) involved an invention for a system supporting dental treatment using computers. The court overturned the JPO's rejection, finding that the invention provided technical means for supporting dental treatment and thus qualified as a statutory invention.

Even if a business method is implemented with technology, it must still meet other patentability requirements like novelty and inventive step, which can often be significant hurdles for such inventions.

It's important for businesses to remember that software is often eligible for dual protection:

  • Patent Law: Protects the underlying technical idea, algorithm, or functionality of the software if it meets the criteria for a statutory invention and other patentability requirements.
  • Copyright Law: Protects the specific expression of the software – the source code and object code – as a "program work," which is a type of literary work.

The two rights protect different aspects: patents cover what the software does (the technical concept), while copyright covers how it is written (the literal code). A comprehensive IP strategy for software often involves leveraging both forms of protection.

D. Emerging Issues: AI and IoT Inventions

The principles for software patentability are continuously being tested and refined with the rise of Artificial Intelligence (AI) and the Internet of Things (IoT).

  • AI-Related Inventions: The JPO has issued examination guidelines specifically for AI-related inventions. Generally, if an AI technology (e.g., a machine learning model, a neural network) is used to control a device, process data in a specific way linked to a technical field, or if the AI information processing itself is concretely tied to hardware, it can be patentable subject matter. Challenges arise with inventions generated by AI, raising questions about inventorship.
  • IoT Inventions: IoT inventions often involve a combination of physical devices, sensors, networks, software, and data analytics. Their patentability is assessed by considering the technical character of the system as a whole or its individual innovative components, often involving software operating in conjunction with hardware to manage data and control devices.

II. Patenting Biotechnology Inventions in Japan

Biotechnology is another field characterized by rapid innovation and unique patenting challenges. Japan has a well-established practice for examining biotech inventions, with specific sections in the JPO Examination Guidelines (Part VII, Chapter 2 of the current guidelines, referenced as Part I, Chapter 2 in the 2014 document ).

A. General Principles and Ethical Considerations

Japan generally permits patents for a broad spectrum of biotechnological inventions, including those related to genes, microorganisms, plants, and animals, provided they meet the standard patentability criteria.

While the primary focus here is on what constitutes an "invention," it's worth noting that inventions contrary to public order or morality are excluded from patentability under Article 32 of the Patent Act. This can be particularly relevant for certain sensitive biotechnologies, although the threshold for such an exclusion is high. The main debate usually centers on whether the subject matter qualifies as a "creation" rather than a mere "discovery."

B. Genetic Inventions (Genes, DNA sequences, etc.)

The patentability of genetic material has been a subject of global discussion. Japan's approach has clarified over time:

  • Discoveries vs. Inventions: Merely discovering a DNA sequence as it exists in nature (e.g., identifying a gene within the human body) is considered a discovery and not a patentable invention.
  • Patentability of Isolated Genetic Material: However, if a DNA sequence (such as a gene, cDNA, EST, or SNP) is isolated and purified from its natural environment, and a specific, credible, and substantial utility (function) for it is identified and disclosed, it is generally treated as a patentable chemical substance. The JPO Examination Guidelines require a clear description of the gene's function and its industrial applicability. Simply isolating a gene without knowing its function or a credible use is insufficient.

C. Living Organisms

The patentability of living organisms themselves has also evolved:

  1. Microorganisms (e.g., bacteria, yeasts, viruses, unicellular algae):
    • Newly created or isolated microorganisms that possess specific, useful characteristics (e.g., for producing antibiotics, enzymes, or for use in fermentation processes) are patentable in Japan.
    • Deposit System: Because microorganisms are often difficult to describe in a patent application in a way that enables others to reproduce them, Japan, as a signatory to the Budapest Treaty, has a mandatory deposit system. If a microorganism used in an invention is not readily available to the public, a sample must be deposited with a recognized international depositary authority before filing the application. The patent specification must then refer to this deposit.
  2. Plants:
    • New plant varieties can be patented under the Patent Act if they meet all patentability requirements, including being a technical creation and enabling reproducibility.
    • Relationship with Plant Variety Protection (PVP) Law (種苗法 - Shubyōhō): Japan also provides a sui generis system for protecting new plant varieties under its PVP Law, which is harmonized with the UPOV Convention. It's possible for inventions relating to plants (e.g., a new method for genetically modifying plants, or a transgenic plant defined by a general trait rather than a specific variety) to be protected by a patent, while a specific new plant variety itself can be protected under the PVP Law. These two systems can offer overlapping or complementary protection.
  3. Animals:
    • Genetically modified animals or animals produced by specific, repeatable technical processes can, in principle, be patented in Japan.
    • Ethical considerations and concerns about public order (Article 32) are carefully weighed, particularly for inventions involving higher animals or modifications with potentially harmful consequences. Methods of surgery, therapy, or diagnosis practiced on the human body are generally excluded for lacking industrial applicability, but this does not prevent patents on animals themselves if they are products of technical creation.
  4. Enablement and Reproducibility for Living Organisms:
    A key challenge for inventions involving living organisms is satisfying the enablement requirement—that is, describing the invention in sufficient detail to allow a person skilled in the art to reproduce and use it. Natural variability can make this difficult.
    • The Yellow Peach Breeding and Propagation Method Case (Supreme Court, February 29, 2000) addressed this for a plant breeding method. The Court held that if the method is scientifically reproducible by a person skilled in the art, it can qualify as an invention even if the probability of success in each attempt is not 100%. The focus is on the technical feasibility of reproduction, not guaranteed success in every instance.

The field continues to push patent law boundaries with technologies like:

  • Stem Cells (e.g., ES cells, iPS cells): Inventions related to the creation, cultivation, and application of stem cells, including for regenerative medicine, are generally patentable in Japan, provided they are specific, useful, and meet other criteria. Ethical aspects are considered, but the technical creations themselves are eligible.
  • Antibodies, Proteins, and Other Biologics: These complex molecules are patentable if, for example, they are newly identified, produced by novel methods, or have new therapeutic uses. Claims often require precise structural and/or functional definitions.
  • Diagnostic and Therapeutic Methods:
    • Methods of medical practice on the human body (surgery, therapy, and in vivo diagnosis) are generally not considered industrially applicable in Japan and are thus not patentable. This is a policy decision to ensure medical practitioners are not hindered by patents when treating patients.
    • However, this exclusion is narrowly construed. Pharmaceuticals, medical devices, diagnostic agents (for in vitro use), and methods of analyzing samples taken from the human body are generally patentable. The distinction between an unpatentable medical method and a patentable product/apparatus/in vitro method for medical use is critical.

Conclusion

Japan has established a nuanced framework for handling patent applications in the rapidly evolving fields of software and biotechnology. For software-related inventions, the key is demonstrating a concrete technical implementation that utilizes hardware resources, moving beyond mere abstract ideas or business schemes. For biotechnology inventions, the line between unpatentable discoveries of nature and patentable human-made creations is carefully drawn, with specific requirements for utility and enablement, including the deposit of microorganisms.

Businesses operating in these sectors and seeking patent protection in Japan must stay abreast of the JPO's detailed Examination Guidelines and relevant case law. Crafting patent applications that clearly articulate the technical character, utility, and reproducibility of their inventions, while being mindful of specific exclusions and requirements, is essential for navigating the Japanese patent system successfully.