Department of Intellectual Property
Thailand
- Section 1: General
- Section 2: Private and/or non-commercial use
- Section 3: Experimental use and/or scientific research
- Section 4: Preparation of medicines
- Section 5: Prior use
- Section 6: Use of articles on foreign vessels, aircrafts and land vehicles
- Section 7: Acts for obtaining regulatory approval from authorities
- Section 8: Exhaustion of patent rights
- Section 9: Compulsory licenses and/or government use
- Section 10: Exceptions and limitations related to farmers' and/or breeders' use of patented inventions
- Section 11: Other Exceptions and Limitations
Section 1. General
1. As background for the exceptions and limitations to patents investigated in this questionnaire, what is the legal standard used to determine whether an invention is patentable? If the standard for patentability includes provisions that vary according to the technology involved, please include examples of how the standard has been interpreted, if available. Please indicate the source of law (statutory and-or case law) by providing the relevant provisions and/or a brief summary of the relevant decisions.
According to Section 5 of the Patent Act of Thailand 1979, a patent may be granted only for an invention in respect of which the following conditions are satisfied: (1) the invention is new; (2) it involves and inventive step; and (3) it is capable of industrial application.
Correspondingly, please list exclusions from patentability that exist in your law. Furthermore, please provide the source of those exclusions from patentability if different from the source of the standard of patentability, and provide any available case law or interpretive decisions specific to the exclusions.
According to Section 9, the following inventions are not protected under the Patent Act:
(1) naturally occurring microorganisms and their components, animals, plants or extracts from animals or plants;
(2) scientific or mathematical rules or theories;
(3) computer programs;
(4) methods of diagnosis, treatment or cure of human and animal diseases;
(5) inventions contrary to public order, morality, health or welfare.
2. As background for the exceptions and limitations to patents investigated in this questionnaire, what exclusive rights are granted with a patent? Please provide the relevant provision in the statutory or case law. In addition, if publication of a patent application accords exclusive rights to the patent applicant, what are those rights?
Section 36 of the Patent Act 1979 stipulates the exclusive rights of the patent owner as follows;
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
According to Section 35 bis of the Patent Act, any act in violation of Section 36 committed before the grant of a patent shall not be deemed to be an infringement of the patentee’s rights unless the act is in respect of the invention under the pending application already published under Section 28, the person so acting knowing of the filing of the patent application or having been informed in writing that a patent application has been filed for the invention, in which case the applicant shall be entitled to damages from the infringer. A compliant for such damages shall be filed with the court after the patent is granted.
3. Which exceptions and limitations does the applicable law provide in respect to patent rights (please indicate the applicable exceptions/limitations):
Experimental use and/or scientific research;
Preparation of medicines;
Prior use;
Use of articles on foreign vessels, aircrafts and land vehicles;
Acts for obtaining regulatory approval from authorities;
Exhaustion of patent rights;
Compulsory licensing and/or government use.
Section 2: Private and/or non-commercial use
4.-10.
[Note from the Secretariat: the applicable law of Thailand does not provide exceptions related to private and/or commercial use.]
Section 3: Experimental use and/or scientific research
11. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
(1) any act for the purpose of study, research, experimentation or analysis, provided that it does not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner;
…
12. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
13.(a) What are the public policy objectives for providing the exception?
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was revised twice by the Patent Act (No.2) B.E. 2535 and the Patent Act (No.3) B.E. 2542.
14. Does the applicable law make a distinction concerning the nature of the organization conducting the experimentation or research (for example, whether the organization is commercial or a not-for-profit entity)? Please explain:
No distinction
15. If the applicable law defines the concepts “experimental use” and/or “scientific research”, please provide those definitions by citing legal provision(s) and/or decision(s):
No definition
16. If the purpose of experimentation and/or research is relevant to the determination of the scope of the exception, please indicate what that purpose is:
Experimentation and/or research should aim to:
For the purpose of study, research, experimentation or analysis, provided that it does not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner
17.-19.
[Note from the Secretariat: response was not provided.]
20. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
The Patent Act provided that the experimental exception shall not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner.
21.-22.
[Note from the Secretariat: response was not provided.]
Section 4: Preparation of medicines
23. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
…
(3) the compounding of a drug specifically to fill a doctor’s prescription by a professional pharmacist or medical practitioner, including any act done to such pharmaceutical product;
…
24. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
25.(a) What are the public policy objectives for providing the exception? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was first introduced in the Patent Act (No.2) B.E. 2535.
26. Who is entitled to use the exception (for example, pharmacists, doctors, physicians, others)? Please describe:
A professional pharmacist or medical practitioner
27. Does the applicable law provide for any limitations on the amount of medicines that can be prepared under the exception?
No
28.-30.
[Note from the Secretariat: response was not provided.]
Section 5: Prior use
31. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
…..
(2) the production of the patented product or use of the patented process, provided that the producer or user, in good faith and without knowing or having no reasonable cause to know about the patent application, has engaged in the production or has acquired the equipment therefore prior to the date of filing of the patent application in Thailand, Section 19 bis not applicable hereto;
….
32. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
33.(a) What are the public policy objectives for providing the exception? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was revised twice by the Patent Act (No.2) B.E. 2535 and the Patent Act (No.3) B.E. 2542.
34.-37.
[Note from the Secretariat: response was not provided.]
38. Does this exception apply in situations where a third party has been using the patented invention or has made serious preparations for such use after the invalidation or refusal of the patent, but before the restoration or grant of the patent?
No
39. If the applicable law provides for other criteria to be applied in determining the scope of the exception, please describe those criteria. Please illustrate your answer by citing legal provision(s) and/or decision(s):
According to Section 36 Paragraph 2 (2), in order to gain the benefit of the exception, that person must produce or use in good faith and without knowing or having no reasonable cause to know about the patent application.
40.-41.
[Note from the Secretariat: response was not provided.]
Section 6: Use of articles on foreign vessels, aircrafts and land vehicles
42. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
…..
(5) the use of a device forming the subject of a patent in the body of a vessel or other accessories of a vessel of a country party to an international convention or agreement on patent protection to which Thailand is also party, when such a vessel temporarily or accidentally enters the waters of Thailand, provided that such a device is used there exclusively for the needs of the vessel;
(6) the use of a device forming the subject of a patent in the construction or other accessories of an aircraft or a land vehicle of a country party to an international convention or agreement on patent protection to which Thailand is also party, when such aircraft or land vehicle temporarily or accidentally enters Thailand;
…..
43. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
44.(a) What are the public policy objectives for providing the exception? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was introduced in the Patent Act (No.3) B.E. 2542.
45. The exception applies in relation to:
Vessels
Aircrafts
Land Vehicles
46. In determining the scope of the exception, does the applicable law apply such terms as ”temporarily” and/or “accidentally” or any other equivalent term in relation to the entry of foreign transportation means into the national territory? Please provide the definitions of those terms by citing legal provision(s) and/or decision(s):
[Note from the Secretariat: response was not provided.]
47. Does the applicable law provide for any restrictions on the use of the patented product on the body of the foreign vessels, aircrafts, land vehicles and spacecraft for the exception to apply (for example, the devices to be used exclusively for the needs of the vessel, aircraft, land vehicle and/or spacecraft)? Please explain your answer by citing legal provision(s) and/or decision(s):
According to Section 36 paragraph 2(5), a device must be used exclusively for the needs of the vessel but there is no restriction on the case of aircrafts and land vehicles.
48.-50.
[Note from the Secretariat: response was not provided.]
Section 7: Acts for obtaining regulatory approval from authorities
51. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
…..
(4) any act concerning an application for drug registration, the applicant intending to produce, distribute or import the patented pharmaceutical product after the expiration of the patent term;
…..
52. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
53.(a) What are the public policy objectives for providing the exception? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was introduced by the Patent Act (No.2) B.E. 2535.
54. Who is entitled to use the exception? Please explain:
Those who wish to produce, distribute or import the patented pharmaceutical product after the expiration of the patent term.
55. The exception covers the regulatory approval of:
Pharmaceutical product
56. Please indicate which acts are allowed in relation to the patented invention under the exception?
Any act concerning an application for drug registration
57.-59.
[Note from the Secretariat: response was not provided.]
Section 8: Exhaustion of patent rights
60. Please indicate what type of exhaustion doctrine is applicable in your country in relation to patents:
International
If the exception is contained in statutory law, please provide the relevant provision(s):
Section 36 : No other person except the patentee shall have following rights:
(1) where the subject matter of a patent is a product, the right to produce, use, sell, have in the possession for sale, after for sale or import the patented product;
(2) where the subject matter of a patent is a process, the right to use the patented process, to produce, use, sell, have in the possession for sale, offer for sale or import the product produced by the patented process.
The preceding paragraph shall not apply to:
…
(7) the use, sale, having in possession for sale, offering for sale or importation of a patented product when it has been produced or sold with the authorization or consent of the patentee.
If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
61.(a) What are the public policy objectives for adopting the exhaustion regime specified above? Please explain:
[Note from the Secretariat: response was not provided.]
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was introduced in the Patent Act (No.3) B.E. 2542.
62. Does the applicable law permit the patentee to introduce restrictions on importation or other distribution of the patented product by means of express notice on the product that can override the exhaustion doctrine adopted in the country?
No
63.-64.
[Note from the Secretariat: response was not provided.]
Section 9: Compulsory licenses and/or government use
Compulsory licenses
65. If the exception is contained in statutory law, please provide the relevant provision(s):
PART V
LICENSES OF RIGHT COMPULSORY LICENSES AND GOVERNMENT USE
Section 45 Any patentee may, in accordance with the rules and procedures as prescribed in the Ministerial Regulations, apply to the Director-General for an entry to be made in the register to the effect that any other person may obtain a license.
At any time after an entry has been made, the Director-General shall grant a license under the patent to any person who applies for such a license on such conditions, restrictions and royalty terms as agreed upon by the patentee and the applicant. If the patentee and the applicant cannot agree within the period as prescribed by the Director-General, the Director-General shall grant a license on such conditions, restrictions and royalty terms as he deems appropriate.
Any of the parties may appeal the decision of the Director-General made under the preceding paragraph to the Board within thirty days from the receipt of the decision. The decision of the Board shall be final.
The application for and grant of a license under the second paragraph shall comply with the rules and procedures as described by the Ministerial Regulations.
Where an entry is made pursuant to the first paragraph, the annual fees in respect of the patent after the date of the entry shall be reduced as prescribed by a Ministerial Regulations, by at least one half of the annual fees which would be payable if the entry had not been made.
Section 46(1) At any time after the expiration of three years from the grant of a patent or four years from the date of application, whichever is later, any person may apply to the Director-General for a license if it appears, at the time when such application is filed, that the patentee unjustifiably fails to exercise his legitimate rights as follows:
(1) that the patented product has not been produced or the patented process has not been applied in the country, without any legitimate reason; or
(2) that no product produced under the patent is sold in any domestic market, or that such a product is sold but at unreasonably high prices or does not meet the public demand, without any legitimate reason.
Whether it is an application under (1) or (2), the applicant for a license must show that he has made an effort to obtain a license from the patentee having proposed conditions and remuneration reasonably sufficient under the circumstances but unable to reach an agreement within a reasonable period.
The application for a license shall comply with the rules and procedures prescribed in the Ministerial Regulations.
Section 47(1) If the working of any claim in a patent is likely to constitute an infringement of a claim in a patent of any other person, the patentee, desiring to exploit his own patent, may apply to the Director-General for a license under the patent of the other person under the following criteria:
(1) the invention of the applicant involves an important technical advance of considerable economic significance in relation to the invention for which the license is applied;
(2) the patentee shall be entitled to a cross-license on reasonable terms;
(3) the applicant shall not assign his right in the license to other persons except with the assignment of his patent.
The applicant for a license must show that he has made an effort to obtain a license from the patentee having proposed conditions and remuneration reasonably sufficient under the circumstances but unable to reach an agreement within a reasonable period.
The application for a license shall comply with the rules and procedures prescribed by the Ministerial Regulations.
Section 47 bis(1) If the working of any claim in the patent having obtained a license under Section 46 is likely to constitute an infringement of a claim in a patent of any other person, the applicant for a license under Section 46 may apply to the Director-General for a license under the patent of the other person under the following criteria:
(1) the invention of the applicant involves an important technical advance of considerable economic significance in relation to the invention for which the license is applied;
(2) the applicant shall not assign his right in the license to other persons.
The applicant for a license must show that he has made an effort to obtain a license from the patentee having purposed conditions and remuneration reasonably sufficient under the circumstances but unable to reach an agreement within a reasonable period.
The application for a license shall comply with the rules and procedure prescribed by the Ministerial Regulations.
Section 48(1) Where a compulsory license is granted under Section 46, 47 or 47 bis , the patentee shall be entitled to remuneration.
The licensee under Section 38 shall be entitled to remuneration where a compulsory license is granted under 46, 47 or 47 bis, provided that he has the exclusive right to grant licenses to other persons. In such circumstances, the patentee shall not be entitled to such remuneration.
Section 49(1) In an application for a license made under Section 46, 47 or 47 bis, the applicant shall set forth the amount of remuneration, the conditions for the exploitation of the patent and the restrictions on the rights of the patentee and the exclusive licensee under paragraph 2 of Section 48, and a request for a license. In the application for a license under Section 47, the applicant shall also offer a license under his patent to the other party.
Where an application for a license is filed pursuant to Section 46, 47 or 47 bis, the competent officer shall notify the applicant the patentee and the exclusive licensee under paragraph 2 of Section 48 of the date on which the application shall be considered. The patentee and the exclusive licensee shall be furnished with a copy of the application.
In the consideration of an application for a license under the preceding paragraph, the competent officer may require the applicant, the patentee or the exclusive licensee under paragraph 2 of Section 48 to appear before him to give any statement, or to hand over to him any document or any other item. When the application has been considered by the competent officer and the Director-General has made his decision, the applicant, the patentee and the exclusive licensee shall be notified of the decision.
The decision of the Director-General made under the preceding paragraph is appealable to the Board within sixty days of receipt of the notice.
______________________
(1) as revised by the Patent Act (No. 3) B.E. 2542.
66. If the exception is provided through case law, please cite the relevant decision(s) and provide its (their) brief summary:
[Note from the Secretariat: response was not provided.]
67. What grounds for the grant of a compulsory license does the applicable law provide in respect to patents (please indicate the applicable grounds):
Non-working or insufficient working of the patented invention
Dependent patents
68. (a) What are the public policy objectives for providing compulsory licenses in your country? Please explain:
(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:
This exception was revised twice by the Patent Act (No.2) B.E. 2535 and the Patent Act (No.3) B.E. 2542.
69. If the applicable law provides for the grant of compulsory licenses on the ground of “non-working” or “insufficient working”, please provide the definitions of those terms by citing legal provision(s) and/or decision(s):
According to Section 46, the ground of “non-working” or “insufficient working” will
be granted if the patentee unjustifiably fails to exercise his legitimate rights as follows:
(1) that the patented product has not been produced or the patented process has not
been applied in the country, without any legitimate reason; or
(2) that no product produced under the patent is sold in any domestic market, or that
such a product is sold but at unreasonably high prices or does not meet the public demand, without any legitimate reason.
70. Does the importation of a patented product or a product manufactured by a patented process constitute “working” of the patent? Please explain your answer by citing legal provision(s) and/or decision(s):
[Note from the Secretariat: response was not provided.]
71. In case of the grant of compulsory licenses on the grounds of non-working or insufficient working, does the applicable law provide for a certain time period to be respected before a compulsory license can be requested?
Yes
If yes, what is the time period?
At any time after the expiration of three years from the grant of a patent or four years from the date of application, whichever is later.
72. In case of the grant of compulsory licenses on the grounds of non-working or insufficient working, does the applicable law provide that a compulsory license shall be refused if the patentee justifies his inaction by legitimate reasons?
No
73.-74.
[Note from the Secretariat: response was not provided.]
75. If the applicable law provides for the grant of compulsory licenses on the ground of dependent patents, please indicate the conditions that dependent patents must meet for a compulsory license to be granted:
According to Section 47, the conditions that dependent patents must meet are as follow;
(1) the invention of the applicant involves an important technical advance of considerable economic significance in relation to the invention for which the license is applied;
(2) the patentee shall be entitled to a cross-license on reasonable terms;
(3) the applicant shall not assign his right in the license to other persons except with the assignment of his patent.
The applicant for a license must show that he has made an effort to obtain a license from the patentee having proposed conditions and remuneration reasonably sufficient under the circumstances but unable to reach an agreement within a reasonable period.
76.-77.
[Note from the Secretariat: response was not provided.]
78. Please indicate how many times and in which technological areas compulsory licenses have been issued in your country:
Never
79.-80.
[Note from the Secretariat: response was not provided.]
Government use
81. If the exception is contained in statutory law, please provide the relevant provision(s):
Section 51(2) In order to carry out any service for public consumption or which is of vital importance to the defense of the country or for the preservation or realization of natural resources or the environment or to prevent or relieve a severe shortage of food, drugs or other consumption items or for any other public service, any ministry, bureau or department of the Government may, by themselves or through others, exercise any right under Section 36 by paying a royalty to the patentee or his exclusive licensee under paragraph 2 of Section 48 and shall notify the patentee in writing without delay, notwithstanding the provisions of Section 46, 46 bis and 47.
In the circumstances under the above paragraph, the ministry or bureau or department shall submit its offer setting forth the amount of remuneration and conditions for the exploitation to the Director-General. The royalty rate shall be as agreed upon by the ministry or bureau or department and the patentee or his licensee, and the provisions of Section 50 shall apply mutatis mutandis.
Section 52(2) During a state of war or emergency, the Prime Minister, with the approval of the Cabinet, shall have the power to issue an order to exercise any right under any patent necessary for the defense and security of the country by paying a fair remuneration to the patentee and shall notify the patentee in writing without delay.
The patentee may appeal the order or the amount of remuneration to the court within sixty days from the receipt of the order.
______________________
(2) as revised by the Patent Act (No. 3) B.E. 2542.
82. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:
[Note from the Secretariat: response was not provided.]
83. What grounds for the grant of government use does the applicable law provide in respect to patents (please indicate the applicable grounds):
Public health
National security
National emergency and/or extreme urgency
For the preservation or realization of natural resources or the environment, any other public service
84.-85.
[Note from the Secretariat: response was not provided.]
86. Please indicate how many times and in which technological areas government use has been issued in your country:
Since 2006, the Ministry of Public Health of Thailand announced the use of Compulsory Licensing (CL) under the government use provisions on 9 patented drugs; 2 antiretroviral drugs (Efavirenza and Lopinavir+Ritonavir), an antiplatelet drug (Clopidigrel), a lung cancer drug with generic name Erlotinib and trade name Tarceva®, a breast cancer drug with generic name Letrozole and trade name Femara®, a lung and breast cancer drug with generic name
Docetaxel and trade name Taxotere®, a medication for chronic leukemia with generic name
Imatinib and trade name Glivec®.
87.-88.
[Note from the Secretariat: response was not provided.]
Section 10: Exceptions and limitations related to farmers' and/or breeders' use of patented inventions
89.-100.
[Note from the Secretariat: the applicable law of Thailand does not provide exceptions related to exceptions and limitations related to farmers’ and/or breeders’ use of patented inventions.]
Section 11: Other Exceptions and Limitations
101.-103.
[Note from the Secretariat: the applicable law of Thailand does not provide other exceptions and limitations.]
[End of Questionnaire]
May 2012