Research Exemption in Japanese Patent Law: When Can You Use a Patented Invention for R&D Without Infringement?

Patent rights grant the patentee an exclusive right to commercially work their invention, preventing others from making, using, selling, or importing it without permission. However, this exclusivity is not absolute. Most patent systems, including Japan's, recognize certain limitations on patent rights to balance the interests of the patentee with broader societal goals, such as the advancement of science and technology. One of the most significant of these limitations is the "research exemption" or "experimental use exemption."

This article explores the scope and application of the research exemption under Japanese patent law, primarily as defined in Article 69, Paragraph 1 of the Patent Act.

The Statutory Basis and Rationale: Article 69(1)

Article 69, Paragraph 1 of the Japanese Patent Act stipulates: "The effects of the patent right shall not extend to the working of the patented invention for experimental or research purposes."

The fundamental rationale behind this provision is the understanding that technological progress often builds upon prior innovations. Allowing the use of patented inventions for further experimentation and research is considered essential for continued innovation, the creation of new inventions, and ultimately, the "development of industry"—the overarching objective of the Japanese patent system. The law presumes that any potential economic disadvantage to the patentee from such limited, non-commercial use for research is generally outweighed by the broader societal benefits of scientific advancement.

Defining "Experiment or Research" in the Japanese Context

The critical question, then, is what kinds of activities fall under the umbrella of "experimental or research purposes." Japanese law and practice have developed interpretations to delineate this scope:

Activities Generally Covered by the Exemption:

The exemption typically covers activities directly aimed at technological advancement or a deeper understanding of the patented technology itself. Examples include:

• Verification and Understanding: Working a patented invention to understand its technical features, confirm its asserted effects, or analyze its mode of operation.
• Improvement Inventions: Using a patented invention as a basis for developing improvements upon it. For instance, experimenting with a patented chemical compound to find more effective derivatives.
• "Design-Around" or Alternative Inventions: Researching a patented invention to find alternative ways of achieving a similar technical result, potentially leading to non-infringing substitute technologies.
• Validity Assessment: Conducting experiments or research to determine if a patent is valid, for example, by trying to reproduce prior art or uncover grounds for an invalidity challenge. Such activities are seen as indirectly contributing to a healthier patent system by helping to eliminate patents that should not have been granted.

Activities Generally Not Covered by the Exemption:

The exemption is not a blanket permission to use a patented invention for any purpose that might be loosely termed "research." Activities with an underlying commercial purpose, rather than a genuine scientific or technical inquiry, are typically excluded:

• Market Research: Using a patented product for market surveys or to gauge consumer interest does not qualify as "experiment or research" for the purposes of Article 69(1).
• Sales Demonstrations or Commercial Promotion: Using a patented invention in tests conducted solely to demonstrate its efficacy or features to potential customers, licensees, or investors is generally considered a commercial activity outside the scope of the exemption.
• Routine Quality Control: Standard quality control testing during commercial production, while involving technical procedures, is usually not considered to be for "experimental or research purposes" in the sense intended by the exemption.

The Crucial Distinction: Research On vs. Research With an Invention

A key distinction often made in the context of research exemptions globally, and relevant in Japan, is between research on a patented invention and research with a patented invention.

• Research On an Invention (Generally Exempt): This involves using the patented invention as the direct subject of the research. The aim is to study, understand, analyze, or improve the patented invention itself. The examples of verification, improvement, and design-around research mentioned above largely fall into this category.
• Research With an Invention (Generally Not Exempt): This involves using a patented invention as a tool, instrument, or means in the course of conducting research on something else. For example, if a company uses a patented laboratory instrument (the tool) to conduct research and development for a new, unrelated product (the research subject), such use of the patented instrument would typically constitute infringement and would not be covered by the research exemption. The reasoning is that if the use of patented research tools were broadly exempted, the patents covering such tools—which are often specifically developed and marketed for research purposes—would be significantly devalued, thereby discouraging innovation in the creation of new research tools.

The Special Case: Generic Drugs and Regulatory Approval Trials

One of the most significant and litigated areas concerning the research exemption relates to activities undertaken to obtain regulatory approval for pharmaceutical products, particularly generic drugs.

The issue arises because generic drug manufacturers need to conduct various tests (e.g., bioequivalence studies) to demonstrate to regulatory authorities that their product is equivalent to an already-approved originator drug, which is often still under patent protection. If these tests could only begin after the originator's patent expires, there would be a substantial delay between patent expiry and the actual market entry of the generic drug. This delay would effectively extend the market exclusivity of the originator drug beyond the statutory patent term, which is contrary to the public interest in timely access to more affordable generic medicines once patent protection has legitimately ended.

The Supreme Court of Japan addressed this critical issue in a landmark decision on April 16, 1999 (often referred to as the "Pancreatic Disease Treatment Agent" case). The Court held that the working of a patented pharmaceutical invention during the patent term for the purpose of conducting tests necessary to obtain marketing approval for a generic drug does fall within the scope of "experiment or research" under Article 69(1), provided that the intention is to market the generic drug only after the patent on the originator drug has expired.

This ruling effectively established a "Bolar-type" exemption in Japan through judicial interpretation, allowing generic manufacturers to undertake necessary preparatory work during the patent term so they can launch their products soon after patent expiry. This decision was seen as crucial for balancing the rights of pioneer drug companies with the public health objective of promoting access to generic medicines.

Challenges with "Research Tool" Patents

While the generic drug scenario found a resolution through the Supreme Court, the use of patented "research tools" remains a more complex area. Research tools can encompass a wide range of inventions primarily used in the conduct of research itself, such as patented cell lines, monoclonal antibodies, screening methods, genomic databases, or specialized laboratory equipment. This is particularly prominent in the life sciences sector.

The dilemma is that these tools are often invented and patented specifically for their utility in research. If their routine use by other researchers were broadly permitted under the research exemption, the commercial value of research tool patents could be severely undermined, potentially discouraging investment and innovation in the development of new and better research tools. On the other hand, if the use of such tools is heavily restricted by patent rights, it could create bottlenecks and impede downstream research and development that relies on access to these fundamental tools.

This tension is a recognized challenge in Japan, as in other countries. Efforts have been made to address this, not necessarily by expanding the statutory research exemption to cover all uses of research tools, but through other means such as promoting smoother licensing practices for research tool patents and creating publicly accessible databases of such patents to facilitate licensing negotiations and collaborations.

Conclusion

The research exemption enshrined in Article 69(1) of the Japanese Patent Act provides an important, though not unlimited, safe harbor for working patented inventions for genuine experimental or research purposes without committing patent infringement. It plays a vital role in fostering scientific and technological advancement by allowing researchers to study, verify, and build upon existing patented technologies.

Key takeaways include the distinction between research on an invention (generally exempt) and research with an invention (where using a patented tool in research is often not exempt), and the landmark Supreme Court interpretation extending the exemption to cover tests for generic drug regulatory approval. While this framework provides significant clarity, the application of the exemption, particularly concerning patented research tools, continues to involve careful balancing of competing interests to ensure that the patent system as a whole continues to promote innovation effectively.