Introduction – IP strategy in life sciences – hints for ‘local’ strategy from Japanese IP practice

The life science industry in Japan is a dynamic and rapidly evolving sector, particularly from diverse modality point of view. Intellectual property (IP) plays a crucial role in fostering such emerging innovations and ensuring the competitive edge of companies operating in this field. An effective IP strategy is vital for protecting innovations, maximising returns on investment and navigating the complex regulatory landscape. This article explores the various aspects of IP strategy in the life science sector such as:

• pharmaceutical;
• medical device;
• regenerative medicine; and 
• other medical businesses in Japan, including: 
  • the legal framework;
  • patentability issues;
  • enforcement strategies;
  • protection extension tactics including patent term extension and the creation of life cycle management plan;
  • non-patent exclusivities including re-examination period (quasi-data/market exclusivities and healthcare insurance listing strategy);
  • launch-to-market strategies; and 
  • considerations for bringing generics to market and vice versa (ie, protection strategy for innovators).

Legal framework – basic overview of IP in the life science field in Japan

Japan’s IP legal system is governed by a comprehensive legal framework designed to protect intellectual property rights (IPRs). The primary laws relevant to the life sciences sector include the: 

• Patent Act, Utility Model Act (less relevant);
• Trademark Act;
• Design Act (for container or the like);
• Act on the Protection of the Layout of Semiconductor Integrated Circuits (some medical device, but less relevant); and
• Unfair Competition Prevention Act. 

Among others, patent strategy is most important for the life science sector. The Copyright Act also plays in an important role, especially in terms of digital health technology. Protection of some genetic resources is also important and such is achieved by the Plant Variety Protection and Seed Act and Act on Prevention of Unfair Competition in Livestock Genetic Resources (Wagyu Act). Further, other laws such as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices (the PMD Act) also provide certain (or substantive) part of IP protection in the life science sector.

The Japan Patent Office (JPO) is the primary authority responsible for examining and granting patents, utility models, trademarks and designs. The Ministry of Agriculture, Forestry and Fisheries is responsible for the PVP Act and Wagyu Act. Copyright is supervised by the Agency for Cultural Affairs. The legal framework also includes various regulations and guidelines that provide detailed procedures and criteria for the protection and enforcement of IPRs.

Protection of intellectual property rights is achieved mainly through the industrial property system including but not limited to: the Patent Act; the Utility Model Act; the Design Act; and the Trademark Act (administered by the Commissioner of the JPO). The Patent Act grants a 20-year term of exclusive protection against the manufacture, use, sale, import or export of a patented invention without the patentee’s permission. The Trademark Act provides a registration framework for brand names, three-dimensional marks, logos and, in certain cases, sounds and other types of non-classical marks. The Design Act may give some protection to a container used for delivering pharmaceutical products and grants a 25-year term of exclusive protection against the manufacture, use, sale, import or export of a registered design without the registrant’s permission. Pharmaceutical products, including regenerative medical products, are subject to a patent term extension, which is also affected by the Patent Act, under certain circumstances; the patent term may be extended by five years at most, in addition to the normal 20-year term. Further, the Patent Act has recently introduced another type of extension of patent term because of examination delay similar to the US’s Patent Term Adjustment. There is also the Orange Book, which lists information about drug approval; however, this is not a US-style patent linkage under Japanese practice but substantially speaking, the Japanese practice has an effect of patent linkage practised in the US. Such a vague system has, however, been questioned at the Intellectual Property High Court of Japan in 2023, which will be detailed in this chapter. There is no equivalent system to the ‘Purple Book’ under US practice in Japan, as there is no clear distinction between compounds and biologics in terms of approval. Additionally, the Unfair Competition Prohibition Act provides some intellectual property protection such as trade secrets, ‘data with limited access’, unfair usage of a well-known sign, misleading representation regarding the place of origin and imitation of the configuration of a third party’s product. Last but not least, there is another type of system that practically provides some exclusive effects by a regulatory system – the re-examination period. The re-examination period is similar to but not identical to data or market protection or exclusivity in the US or EU, which is explained in detail below.

IP protection strategy in detail

General

IP protection strategy in Japan is a complex of several types of exclusivities, which include (regular) patents, patent term extensions and regulatory exclusivities. Here, patent strategy is explained, followed by the other types of exclusivities.

Patenting strategy 

Medical and pharmaceutical products, and the technologies related thereto, can be protected by substance patents (also known as ‘compound patents’), medical-use patents, formulation patents and manufacture method patents. Patent protection lasts for 20 years from the filing date of the application. Payment of an annual fee is required to maintain the patent registration. Methods of medical acts per se, such as methods of treatment, diagnosis and surgery, are not patent-eligible subject matters under Japanese patent practice. Note that second medical use and dosage regimen inventions are patentable under Japanese patent practice as long as a proper claim language format is used. However, this requires a special claim format and it is therefore strongly recommended that a local patent attorney with special knowledge and experience is consulted. 

Examination bars: exceptions

The invention must also be capable of industrial application, meaning it can be made or used in any kind of industry, including agriculture. Medical activities are excluded from ‘industry’ under the current patent practice in Japan; however, such exception can be waived by drafting an appropriate claim language. Ordre public is also an issue. This includes some embodiments of stem cells, such as embryonic stem cells. It is also noted that induced pluripotent stem cells are not excluded.

Most medical and pharmaceutical inventions can be protected with patents

For medical and pharmaceutical inventions, the primary concern is the potential impact on patent eligibility as well as public health and ethical considerations as mentioned above. However, this exclusion does not extend to products used in these methods, such as medical devices (including computer software) or pharmaceuticals (including cell formulations and the like), which can be patented if they meet the other requirements for patentability, but claim language needs to be specifically formatted.

Good patenting strategy may extend the life cycle of the life science innovation

Life cycle management of patents in the life science sector can be achieved by a good patenting strategy to cover an innovation of interest, which involves strategically using various types of patents (and sometimes trade secrets) to maximise the commercial lifespan and profitability of life science products and services such as a drug. This approach typically extends beyond the initial patent protection of a new chemical entity to include multiple layers of intellectual property protection, including substance/entity patents, use patents, manufacture patents, formulation patents, second medication patents, combination patents, dosage regiment patents and the combination thereof and the like.

Substance/entity patent

Usually, primary protection can be given by a substance/entity patent. In the case of a drug innovation, the initial patent filed for a new drug is often the substance (or compound or entity) patent, which covers the active ingredient of the drug, with no limitation of use and the like except for the structure thereof. In the case of a cell formulation, a novel cell may be protected as such without any other limitation than the structure thereof (this is why this category is called ‘substance/entity’ patent. The substance/entity patent protects the specific structure of the entity, preventing others from making, using or selling the entity without authorisation. Therefore, even if it is used differently than initially envisaged, it can also be covered by the subject category. Although the duration of the category lasts 20 years from the filing date as a normal course of action, many strategies can be contemplated to extend the life of the exclusivity period other than a patent term extension (PTE). 

Initially, one can think of filing a second patent application that may cover the entity even if the priority period is over but before the initial patent application is laid open. This is because, unlike the European Patent Office (EPO) practice, there is no ‘self-collision’ and the second patent application is not rejected unless there is any intervening prior art because there are no prior art effects for prior application for the same applicants or inventors.

Use patent

Even if an entity such as a substance or a cell is known, if a specific application is unknown, such an application can be protected as a use patent, which protects specific applications or methods of using a known substance for treating a particular condition. By obtaining such a patent, patentees can be allowed to differentiate their products based on new therapeutic uses or dosing regimens, even if the substance itself is off-patent.

Second medical use and dosage regimen patent

Second medical use patents are granted for discovering new therapeutic uses for known drugs in Japan. This can breathe new life into an existing drug by opening up new markets in the form of a repurposing strategy. This allows pharmaceutical companies to re-enter the market with a known drug, now protected for its new use. 

Optimised treatment may be protected by ‘dosage regimen patents’, which protect specific dosing schedules and amounts that optimise the therapeutic effect while minimising side effects. These types of patents can extend the product life by offering protection for new dosing strategies, even if the drug and its use are already known. These types of patents are particularly useful when there are some clinical benefits of a new dosage regimen, which can provide significant marketing advantages and enhance patient adherence. As such, one needs to have close contact with a pharmaceutical affairs sector.

Strategic considerations in life-cycle management

Filing different types of patents at different times can extend the overall protection period of a drug. For example, filing a process patent later in the life cycle of a substance patent.

Extending term of patent protection: multiple PTEs for multiple approvals strategy

Patent term extension due to regulatory delay

For medical and pharmaceutical products, the term of a patent can be extended at the request of the patent owner under certain conditions, particularly for pharmaceutical products and regenerative medicine products, but not medical devices. It is only the patentee who can file a PTE application (equivalent to supplementary protection certificates in the EU or EPO), which may be different from the one who has received a market authorisation. Please note that unlike US or EP, multiple PTEs can be filed per market authorisation. Further, multiple PTEs can be filed per patent.

Further, it is also important that the patentee can only file such a PTE application only after a market authorisation pertinent to the patent is obtained and, more importantly, within three months of the authorisation date (it is important that the date of receipt of the market authorisation is counted). The term of the extension may not exceed five years and it is not possible to file a PTE application on or after the six months from the patent expiry date. Instead, in such a case, the patentee must file prior notice before the six-month due date. A PTE cannot, however, be filed after the expiry of the patent term.

Patent term extension or adjustment due to examination delay

The Patent Act has introduced another type of extension system of the patent term as a result of patent examination delay. The new system is similar to the Patent Term Adjustment practised in the United States.

Practical protection under the PMD Act (quasi data/market protection/exclusivity)

Japan has no explicit data or marketing exclusivity or protection system in an independent format. However, the re-examination period plays a substantially similar role to that of data exclusivity. Specifically speaking, when a novel drug is approved, the new drug is subject to a re-examination. The re-examination period is generally eight years after the initial authorisation for a regular novel drug. As a matter of practice, an applicant for a generic product cannot apply for a marketing authorisation under the PMD Act until the re-examination period for the original (innovator) drug expires (see generic drug requirements above). As such, an applicant cannot rely upon the original drug’s clinical data. As such, in substance, this re-examination system has an effect that is equivalent to that of data exclusivity. To encourage new orphan drug development, the re-examination period for an orphan drug is extended to a maximum of 10 years. For novel usage for drugs already approved for different uses, the re-examination period is shortened because some of the regulatory data are considered for the same APIs. For example, regarding novel efficacy, for novel dosage and application and other applications that are different from the original innovator’s drug, a re-examination period of four years is currently granted; and regarding new combination and novel administration, a certain re-examination period is granted. For novel formulation or similar that is deemed to be identical to the original innovator’s drug, only the remaining period of the original innovator’s drug is granted. There is no paediatric exception. However, paediatric approvals are usually categorised as novel indications and efficacies or novel regimens and dosages. As of August 2020, re-examination periods were precisely refined as stipulated below:

Summary: overall exclusivity term management

As described above, managing the exclusivity term for life science inventions involves ‘staggered’ strategic planning around several key aspects with advance insights and real time management. The standard patent term is 20 years from the filing date. However, life science patents, such as those for pharmaceuticals and biotechnology, often face lengthy development periods and regulatory approval processes, which can consume a significant portion of this term. To address this, one can consider using multiple PTE strategies and improvement patents that can be filed at a later stage of the development.

Effective management includes early filing strategies to ensure that the maximum effective patent life is available post-approval. Additionally, maintaining patents requires the payment of annual maintenance fees, necessitating careful planning, especially for inventions with long development times.

Japan also provides quasi data exclusivity periods as re-examination periods, preventing generic competitors from using clinical data for a specified time after the original product’s approval. As detailed above, orphan re-examination period provides 10 years of protection. The effective strategy may include the initial development of orphan drugs and then transit to the other type of indication including non-orphan.

Overall, a combination of PTEs, timely filings, strategic maintenance and leveraging quasi data exclusivity based on good clinical trial strategy and secondary patents is essential for effectively managing patent terms in the Japanese life sciences sector.

Conclusion

An effective IP strategy is crucial for success in the life sciences sector in Japan. Understanding the legal framework, navigating patentability issues, enforcing IP rights, extending protection, leveraging non-patent exclusivities and planning market entry are all essential components of a robust IP strategy. Additionally, considering the pathway for generics to enter the market is important for maintaining a competitive edge and ensuring long-term sustainability. By adopting comprehensive IP strategies, companies can protect their innovations, maximise their market potential and drive growth in the dynamic life sciences industry in Japan.