Introduction
Thailand's intellectual property landscape, particularly for biopharmaceutical patents, is governed by a set of stringent rules and regulations. Understanding these guidelines is crucial for pharmaceutical companies seeking to protect their innovations in the Thai market.
Patentability of Biopharmaceutical Inventions
Exclusions Under the Thai Patent Act
The Thai Patent Act excludes several types of inventions from patentability, which are particularly relevant to biopharmaceuticals. These include:
- Naturally occurring microorganisms and their components, animals, plants, or extracts thereof[5].
- Scientific or mathematical rules.
- Computer programs.
- Methods of diagnosis, treatment, or cure of human or animal diseases[5].
- Inventions in opposition to public order, morality, health, or welfare of the people.
New Use Claims
Thailand's Supreme Court has clarified that new use claims for known drugs are not patentable if they relate to a new use of a known product. However, new use claims directed to a process can be patentable. This means that pharmaceutical companies cannot extend the patent term of a known drug by filing new use claims; instead, they must focus on process-related innovations[3].
Swiss-Type Claims
To circumvent the prohibition on method of treatment claims, pharmaceutical companies often use Swiss-type claims. These claims are formatted as "Use of (compound X) in the manufacturing of a medicament for the treatment of (disease Y/disorder Y)." However, these claims must meet strict requirements of novelty, inventive step, and industrial application capability. The Thai Patent Board and courts have been strict in evaluating these claims, often rejecting them if they are perceived as methods of treatment[5].
Accelerated Patent Examination Processes
Target Patent Fast-Track Program
The Thai Department of Intellectual Property (DIP) has introduced the Target Patent Fast-Track Program to accelerate the patent examination process for specific areas, including "Future Food" innovations starting from January 1, 2024. This program aims to expedite the examination of patent applications related to new foods, health supplements, organic foods, or medical foods with significant commercial potential. To qualify, applicants must meet specific criteria, such as filing the application in Thailand as the first jurisdiction and submitting comprehensive commercialization plans[1].
Enforceability of Biopharmaceutical Patents
Compulsory Licensing
In cases where public health is at risk, the Thai Patent Act allows for compulsory licensing. This mechanism enables the Public Health Ministry to issue a compulsory license to prevent a drug shortage, ensuring that the drug is available to the public while providing some royalty to the patent holder. The rejection of the Favipiravir patent application due to lack of inventive step is a notable example where compulsory licensing could have been a balanced solution[2].
Patent Infringement Actions
Even if a patent application is pending, any production of the patented product in Thailand could be subject to patent infringement actions if the patent is eventually granted. This highlights the importance of careful navigation of the patent landscape to avoid potential legal disputes[2].
Scope of Claims
Claim Limitations
The Thai Patent Act and upcoming amendments impose strict limitations on the number of claims in a patent application. The draft new Thai Patent Act introduces an excess claim fee for each claim in excess of 10 claims, which can significantly increase the cost of filing and prosecuting a patent application for drug or pharmaceutical inventions[5].
International Patent Classification (IPC)
Pharmaceutical patents in Thailand can be searched using the International Patent Classification (IPC) system, particularly classes A61P and A61K. This helps in identifying the scope of existing patents and potential areas for innovation[5].
Challenges in Getting Patents Granted
High Pendency Rate
Thailand faces a high pendency rate for pharmaceutical patents compared to other types of patents. Despite an increase in the number of patent examiners from 15 in 2015 to 106 in 2022, the backlog remains significant. This delay can hinder the timely protection of biopharmaceutical innovations[5].
Formality Examination
Many pharmaceutical patent applications are objected to during the formality examination stage due to Section 9(4) of the Thai Patent Act, which excludes methods of diagnosis, treatment, or cure of human or animal diseases. Applicants must ensure their claims comply with these exclusions to avoid early rejection[5].
Key Takeaways
- Exclusions and Limitations: Understand the exclusions under the Thai Patent Act, particularly those related to methods of treatment and new use claims.
- Accelerated Processes: Leverage programs like the Target Patent Fast-Track to expedite the examination process for biopharmaceutical innovations.
- Compulsory Licensing: Be aware of the possibility of compulsory licensing to ensure public health needs are met.
- Claim Management: Manage claims carefully to avoid excess fees and ensure compliance with the Thai Patent Act.
- IPC Classification: Use the IPC system to navigate existing patents and identify innovation opportunities.
FAQs
Q: What types of inventions are excluded from patentability under the Thai Patent Act?
A: The Thai Patent Act excludes naturally occurring microorganisms, scientific or mathematical rules, computer programs, methods of diagnosis, treatment, or cure of human or animal diseases, and inventions in opposition to public order, morality, health, or welfare of the people[5].
Q: Can new use claims for known drugs be patented in Thailand?
A: No, new use claims for known drugs are not patentable if they relate to a new use of a known product. However, new use claims directed to a process can be patentable[3].
Q: What is the purpose of the Target Patent Fast-Track Program?
A: The Target Patent Fast-Track Program aims to accelerate the patent examination process for specific areas, including "Future Food" innovations, to help drive Thailand's economy through innovation[1].
Q: How does compulsory licensing work in Thailand?
A: Compulsory licensing allows the Public Health Ministry to issue a license to prevent a drug shortage, enabling local production while providing some royalty to the patent holder[2].
Q: What is the impact of the upcoming amendments to the Thai Patent Act on claim fees?
A: The draft new Thai Patent Act introduces an excess claim fee for each claim in excess of 10 claims, significantly increasing the cost of filing and prosecuting a patent application for drug or pharmaceutical inventions[5].
Sources
- The Thai Department of Intellectual Property has announced its new Target Patent Fast-Track: Future Food - Nishimura & Asahi.
- Rejection of Favipiravir patent in Thailand - was there a better way? - Rouse.
- Thailand Supreme Court Limits Patent Protection for New Use Claims - Miranda Law.
- Practical Law Life Sciences Global Guide 2020: Pharmaceutical IP and competition law in Thailand - Tilleke & Gibbins.
- Patent protection for drugs in Thailand - Legal 500.
