KUALA LUMPUR, Nov 6 – Following is the latest list of Frequently Asked Questions pertaining to the Trans-Pacific Partnership Agreement (TPPA) made available on the Ministry of International Trade and Industry (MITI) website. There are seven main topics, one of which is on patent and price of drugs. Under the patent and price of drugs discussion, four questions are answered relating to how TPPA could benefit the country.
1. What is a patent?
A patent is a time-limited exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.
WTO members have to provide patent protection for any invention, whether a product (such as a medicine) or a process (such as a method of producing the chemical ingredients for a medicine). Patent protection is given for 20 years from the date the patent application was filed.
Patents are territorial rights, and patent laws generally provide a protection term of at least 20 years, in accordance with the WTO TRIPS agreement. Once a patent expires, the protection ends, and an invention enters the public domain; that is, anyone can commercially exploit the invention without infringing the patent.
2. Will the TPP change the patent period?
The patent protection for pharmaceutical drugs remains at 20 years, consistent with the WTO TRIPS agreement. Only in the event there is an unreasonable delay would the patent period be extended. Malaysia’s current processes in granting marketing approval and patent are effective and diligent, hence the likelihood of extending a patent period should not arise.
It is important to note that ‘early working exception’ is permissible, which permit the testing of a drug for establishing the bio-equivalency of generic products before the expiration of the relevant patent. In other words, this ‘exception’ permits an early introduction of generic drugs as soon as the patent expires and thereby allows consumers to gain access to drugs at lower prices.
3. What is test data protection?
Apart from patent, another concern always raised by the public is on test data protection (or commonly referred to as data exclusivity – DE). Test data protection is the protection of pharmaceutical test data concerning the safety and efficacy of an innovator product.
In Malaysia, test data protection has been introduced since 2011, which allows the protection of pharmaceutical test data of innovator products for a period of five years. In the TPP, Malaysia will be able to continue to provide test data protection for five years. This protection will also be extended to biologics, for the same period of time.
The test data protection in Malaysia has sufficient safeguard mechanisms to ensure that any negative impact could be minimized. As a condition for test data protection, the innovator has to apply for registration of pharmaceuticals in Malaysia within 18 months from the date the product obtained its first marketing approval in any other country.
The purpose of this ‘window’ is to encourage pharmaceutical companies to market their new drugs early to Malaysia, and subsequently creating a pathway for affordable generic drugs to market it later. The ‘window’ would also prevent any test data protection to overhang any patent term, therefore, avoiding delays in the introduction of affordable generic drugs.
4. How about national emergency or circumstances of extreme urgency?
The TPP does not prevent the Government from taking any measures to protect public health and in particular, to promote access to medicines for all by using the flexibilities in accordance with The Declaration on the TRIPS Agreement and Public Health, also known as the Doha Declaration.
In fact, every country in the TPP have already affirmed their shared commitment to the Doha Declaration on TRIPS and Public Health, which helps least developed and developing countries address public health problems through the WTO TRIPS flexibilities.
