Patentability and inventorship
What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?
Software may be protected by a patent as either a product or a process if:
- the software controls an apparatus or processes information based on the technical properties of an object; or
- the software uses hardware resources to construct a specific information processing system or an operational method for the system.
Mathematical algorithms, databases and AI-generated content are not patentable. Additionally, methods of surgery, therapy or diagnosis are not patentable.
The right to obtain a patent may be assigned from an employee to an employer, or may be acquired by the employer in the first instance in accordance with rules established by the employer. In those cases, the employer must compensate the employee in accordance with the employer’s rules. If a court finds that the compensation was unreasonable based on a lack of due process in the establishment and circulation of the rules or in the compensation process, it may determine the amount of the compensation after considering various factors, including the profits arising from the exclusive right to the invention and the employer’s own contribution to the invention.
What is the patent application and registration procedure for digital health technologies in your jurisdiction?
There is no special patent application and registration process for digital health technologies. To obtain a patent, an applicant must first file an application with the Japan Patent Office. Within three years of the application date, the applicant must file a request for examination to initiate the substantive examination of the application. Then, an examiner will render a decision to grant a patent or will notify the applicant of the reasons for refusal of a patent. The applicant will be given an opportunity to amend the claims to overcome the reasons for refusal, and to submit a written document arguing that a patent should be granted. If the examiner finds that the reasons for refusal have not been overcome, the examiner will decide upon refusal. This decision may be appealed to the board of patent appeals. An unfavourable decision by the board is appealable to the Intellectual Property High Court (IPHC), and judgments rendered by the IPHC are appealable to the Supreme Court.
The Japan Patent Office’s website discloses a schedule of official fees.
Other IP rights
Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?
Computer programs that are incorporated into digital healthcare products are copyrightable. An author of a computer program may obtain a copyright without any formal process. An employer may originally obtain, as an author, the copyright for a computer program invented by its employee in the course of his or her duty and at the initiative of the employer, unless otherwise agreed to, or stipulated in, the employer’s rules. An author also retains moral rights, which consist of a right to make a work public, a right of attribution and a right to integrity. Moral rights are not transferrable by agreement. Thus, when obtaining a copyright from an author, an assignee should ask for a written agreement from the author not to exercise his or her moral rights.
A database may be protected as a trade secret if it is useful for business, controlled as confidential and not publicly known. Further, a database may be protected as ‘shared data with limited access’ even when it is open to the public if the data constitutes technical or business information that is managed and accumulated to a reasonable degree by electronic or magnetic means and is provided to specific people on a regular basis.
What practical considerations are relevant when licensing IP rights in digital health technologies?
Digital health products commonly generate a significant amount of data. Therefore, parties to an agreement should decide how to handle generated data, including whether a licensor or licensee may use or modify such data, whether they may disclose data, and what IP rights, if any, the licensor or licensee may obtain.
Further, data generated by digital health products may include personal or medical information. A licensor and licensee must acknowledge that such information must be processed or stored in accordance with the Act on the Protection of Personal Information.
Additionally, digital health products, including computer programs, may be classified as medical devices. If a licensor provides those products directly to a licensee, or if the licensee plans to sell those products, the licensor or licensee must obtain the licences required by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?
IP rights are generally enforced through infringement lawsuits filed by IP owners seeking damages or injunctive relief. Damages are typically lost profits, profits of accused infringers or a reasonable royalty. A court may issue an injunction if it finds that the defendant has committed, or is likely to commit, infringing activities. The Japanese court system has three levels: district courts, high courts and the Supreme Court.
IP owners may also seek a preliminary injunction. A court may issue a preliminary injunction if it finds a prima facie case of infringement and the likelihood of irreparable harm to the petitioner. When issuing a preliminary injunction order, a court will require the petitioner to post a bond that could compensate the accused infringer for damages if the court finds that the preliminary injunction should not have been granted.
Further, IP owners may request border enforcement of IP rights by filing a complaint with a customs office. Finally, the Japanese penal system provides that an infringer may be subject to imprisonment or a fine, but the imposition of a criminal punishment is rare.
We are unaware of any notable enforcement actions involving digital health technologies.