Medical Hub of Asia
According to the Public Health Ministry, Thailand is gaining worldwide recognition for the high quality of its healthcare services.
Although the value of domestic market for pharmaceuticals in Thailand decreased in 2021-2022 due to a drop off in hospital visits for those seeking treatment for less serious conditions during severe Covid-19 pandemic, in 2023, annual growth in the market should accelerate to 3.5% on the return of foreign patients to Thai hospitals, a rising concern among Thais over personal health and wellness and the aging of Thai society[1].
The Thai government has policies to make Thailand as “a Hub of Wellness and Medical Services”, within a ten-year time frame (2016-2025). The idea is to turn Thailand into a medical hub in four major areas: wellness, medical services, academics and products[2].
The growth of medical sector leads to high demand of pharmaceutical products. Conventional pharmaceuticals are divided into two group which are patented drugs (original drugs) and generic drugs. The patented drugs involve significant production cost and lengthy in research and development process. Therefore, Thailand and many developing countries play the role of importer of expensive patented drugs1. About 65% of all medicines sold in Thailand are imported. The hospitals account for about 75% of Thailand’s medicine market, 65% public hospitals, 10% private, and 25% for pharmacies[3].
In Thailand, the patent protection of medicine lasts for 20 years and when the patents expired, other manufacturers are then allowed to produce those drugs.
Patented drugs for chronic diseases such as diabetes and for treatment of high blood pressure are most widely used and as a result, Thailand imports many high-value pharmaceutical products, with top imports coming from Europe, the United States and Japan. Most valuable medicines imported to Thailand include antineoplastic, systemic anti-infectives, blood and blood forming organs and alimentary tract and metabolism drugs[4].
Bearing in mind these general market trends, how does the country regulate its drug market and what information can we extract from looking into the patent database of Thailand?
A close look at patented drugs in Thailand
It is possible to search the Thai patent database to look specifically at some categories of pharmaceutical patents. One tool is to perform a patent search using the International Patent Classification (IPC) system. The IPC is a system to classify patents and utility models according to the technology area of the invention.
Relevant classes of the IPC for medicines are IPC classes A61P (specific therapeutic activity of chemical compounds or medicinal preparations) and A61K (drug or other biological compositions and body treating compositions).
The search for filed, published and granted patent applications in these two IPC classes reveals what many pharmaceutical companies and intellectual property lawyers know already. Despite a high volume of patent/petty patent applications filed for medicines, only a few are published and even less are granted every year. As of July 19, 2023, a total of 1,689 patent and petty patent applications were found to have been filed to date and published in IPC class A61P and 16,623 in class A61K.
Understanding the challenge of getting pharmaceutical patents granted in Thailand
Excluding patent applications voluntarily withdrawn by their applicants, various factors can explain the challenge faced by pharmaceutical companies in getting their patent applications prosecuted and ultimately granted in Thailand.
One challenge very often highlighted is Thailand’s lack of qualified and sufficient number of patent examiners which leads to slow examination process and significant backlog issues.
Figure 1 below shows the evolution number of filling of patent of invention (A) and utility model application (B) in Thailand and number of granted patent and utility model[5].
Figure 1A- Number of filing and grant of Thai patent applications per year between 1979 and 2021
Figure 1B- Number of filing and grant of Petty patent applications per year between 1999 and 2021
In the recent years, Thailand did acknowledge this matter and initiated a large recruitment of new patent examiners. In 2015, there were only 15 patent examiners working for the patent department of the Department of Intellectual Property (DIP). The number increased to 106 patent examiners in 2022[6] and additional patent examiners are still being added – still the pendency rate for pharmaceutical patents is much higher compared to other types of patents in Thailand.
Another challenge identified is Thailand’s very strict interpretation of the patentability exclusions enshrined in its current patent law and established practice regarding acceptance of Swiss-claims. According to the Thai Patent Act B.E. 2522 as amended by the Patent Act (No.2) B.E 2535 and the Patent Act (No.3) B.E. 2542[7] , inventors may be granted absolute protection for (i) new inventions that include an (ii) inventive step, and are (iii) capable of industrial application (Section 5). The novelty requirement means that the invention must not have published elsewhere or should not have been otherwise disclosed in Thailand.
Specifically, regarding pharmaceutical patents, Section 9 of the Thai Patent Act excludes from patentability: (1) naturally occurring microorganisms and their components, animals, plants or extracts thereof; (2) scientific or mathematical rules; (3) computer programs; (4) methods of diagnosis, treatment or cure of human or animal diseases; and (5) inventions in opposition to public order, morality, health or welfare of the people. As in other countries, the exclusions are based on ethics and social policy, in order to maintain the welfare of the public.
A considerable number of pharmaceutical patent applications in Thailand are objected as early as during the formality examination (i.e. before publication of the patent application) because of Section 9(4). In fact, any patent claim referring to a “method of diagnosis, treatment or cure of human or animal disease” is strictly not permitted in Thailand.
Here are some examples of claims that are absolutely not admissible in Thailand:
(i) “(Compound/ substance X) for use in the treatment of (disease Y/ disorder Y)”;
(ii) “(Compound/ substance X) for use as a (Y treating agent)”; or
(iii) “(Compound/ substance X) for use in therapy (or for use as a medicament)”.
As well-known by the pharmaceutical industry, patent applications containing claims related to a method of treatment especially those related to a secondary use of a known compound to treat a new disease, are usually modified into so-called “Swiss- type” claim format. A Swiss-type claim format that would be acceptable for publication of an otherwise “method of treatment” patent application in Thailand would be: “(Use of) (compound X) in the manufacturing of a medicament for the treatment of (disease Y/ disorder Y).”
Swiss-type claims are still very widely used for pharmaceutical patents filed in Thailand because such claims are thought to help circumvent the prohibition of methods of treatment stated in Section 9 of the Act (4). However, such claims only succeed if they meet the strict requirements of novelty, inventive step and industrial application capability. For example, a new secondary use for a chemical compound previously published or widely used in Thailand may be found to lack novelty (although use of such compound might be for the treatment of a new disease or disorder). Another issue is likelihood of requalification of Swiss-type claim (or use/process claims) into methods of treatment claims. As stated in 2013 patent examiner guidelines related to Section 9(4) of the Thai Patent Act:
“A use claim indicating a process or method which results in an actual/concrete outcome is considered a process according to Section 3. To consider said use claim, it shall be determined whether the use is a method of treatment of human or animal disease pursuant to Section 9(4), which is not patentable. Provided that the use is not prohibited under Section 9(4), general criteria under Section 5 shall be taken into consideration, i.e., whether the use is new, involves an inventive step, and is capable of industrial application. In this regard, in considering whether the use is prohibited under Section 9(4), the Examiner shall mainly determine the specification and claims of the subject patent application. If the Examiner views that the main details thereof relate to a method of diagnosis, treatment, or cure of a human or animal disease, then the Examiner shall instruct deletion of such claims or reject the patent application, as the case may be”.
Decision 1/2533 of Thailand Board of Patents made in 2010, exemplifies the difficulty of obtaining grant for Swiss-type claims in Thailand. The decision was about Thai of Patent Application No. 0201003643 entitled “Method for treating hepatitis C virus infection in treatment failure patients” and claiming priority of US application number US20050031586A1. The applicant adopted Swiss type claims by using “Use” instead of “Method for treating”. An opposition was made against the grant of such patent application by the Thai Government Pharmaceutical Organization (GPO). The Thailand Board of Patents ruled on January 26, 2010 that the invention lacked of novelty and was contrary to Section 9(4) as it was perceived as a method of treatment.
Since such decision, it has been a heated debate whether or not Swiss-type claims should be allowed in Thailand. For now, it appears that Swiss-type claims generally pass the formality examination stage but the uncertainty remains high on whether patents containing Swiss-type claims would finally be granted.
The draft new Thai Patent Act is unlikely to change current situation. In fact, it is anticipated that current Section 9(4) of the Thai Patent Act will be amended to further exclude from patentability “surgical methods”. New Section 9(4) is expected to read as follows: “The following inventions shall be excluded from patent protection under this Act: (4) methods of diagnosis, treatment, surgical or cure of human diseases or animal diseases.”
Furthermore, the wording can be interpreted such that cosmetic surgery, or plastic surgery for aesthetic purposes, does not fall within this exclusion. However, the examination according to the Thai Patent Office practice usually taken together with the implementing Regulations, Notifications, and Examination Guidelines the features of methods of diagnosis, treatment or cure of human diseases or animal diseases are strictly interpreted under this regime. It will be interesting to see how the method of surgery will be interpreted in the future.
Last but not least, the draft new Thai Patent Act will introduce a new fee structure for official fees, including an excess claim fee for each claim in excess of 10 claims. Normally, the drug patent application usually contains more than 10 claims. Therefore, the new official fee will dramatically increase the cost for filing and prosecuting a patent application for drug/ pharmaceutical inventions in Thailand. The draft Patent Act will be scrutinized by the Office of the Council of State and will be subject to other further legislative procedures. It is expected to come into force in the near future.
Author: Dr. Monnat Theerachat
Footnote
[1] Industry Outlook 2021-2023 : Pharmaceuticals
https://www.krungsri.com/en/research/industry/industry-outlook/chemicals/phamaceuticals/IO/io-pharmaceuticals-21
[2] Thailand : Medical Hub Of Asia https://www.boi.go.th/index.php?page=business_opportunities_detail&topic_id=117526
[3] The Nation, July 19, 2023
https://www.nationthailand.com/thailand/general/40028909
[4] https://www.fda.moph.go.th
[5] https://www.ipthailand.go.th/th/patent-012.html
[6] DIP annual report (https://www.ipthailand.go.th/th/%E0%B8%A3%E0%B8%B2%E0%B8%A2%E0%B8%87%E0%B8%B2%E0%B8%99%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%88%E0%B8%B3%E0%B8%9B%E0%B8%B5/item/ar_dip_2021.html)
[7] Thai Patent Act (http://www.ipthailand.go.th/th/dip-law-2/category/acts.html)