At long last, the final draft of the Trans-Pacific Partnership Agreement (TPPA) has been officially published, with Chapter 18 of the draft dealing with Intellectual Property (IP) Rights. This article will examine the provisions relating to patents, though the chapter also deals with other IP Rights such as Trademark, Industrial Design, Copyright, etc.

Does Chapter 18 require Malaysia to provide more than, or different from, what is already provided for in our Patents Act?

At present, although patent rights are available for any product or process in all fields of technology, it was not clear whether patent rights were available for new uses of a known product. This has now been made clear. The TPPA stipulates that a country shall make available patents claiming at least one of the following:

  1. New uses of a known product;
  2. New methods of using a known product;
  3. New processes of using a known product; subject to the limitation that a country may limit those new processes to those that do not claim the use of the products as such.

This stipulation is very relevant in the chemical and pharmaceutical area, where it was doubtful as to whether a second medical use of a known drug was patentable. Now it is clear that countries need to provide patents for inventions that claim new use of a known drug. Similar protection would also be available in the field of agricultural chemicals. If a product was used as a weedicide against a particular species of weed and if the product has now been found to act against another species of weeds, then a patent can be claimed for such new use (provided the legal requirements of novelty and inventive step are satisfied).

In the current legislation, diagnostic, therapeutic and surgical methods for the treatment of humans or animals are non-patentable subject matter in many countries including Malaysia. The TPPA does not demand changes to this exclusion. So such methods are likely to remain as excluded subject matter when our Patents Act is amended to meet the TPPA requirements.

Biotechnology

Member countries have the freedom to exclude plants and animals other than microorganisms from being patented. In the field of biotechnology, microorganisms, microbiological processes and non-biological processes need to be eligible for patent rights under the TPPA.

Exclusion on moral grounds, impact on environment

Certain inventions, the commercial exploitation of which are likely to effect ordre public or morality, can be excluded from patent rights at the option of a member country. Member countries may also exclude from patentability inventions which may cause serious prejudice to nature or the environment. Would genetically modified organisms or plants fall within such exclusions based on the current public concerns on genetically modified organisms and plants?

Each TPPA member country is obliged to make patents available for inventions that are derived from plants. Chemicals (phytochemicals) extracted from plants should now qualify for patents.

Grace Period

It is heartening to note the 12 month grace period given to applicants to file a patent application (even after disclosing details of the invention to the public by the inventor/applicant) is retained in the TPPA.

Reasonable time to process patent applications

The TPPA requires that each member country make best efforts to process patent applications in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays. However, member countries are also required to adjust the term of the patent (from the present term of 20 years from the filing date) at the request of the patent applicant if there is unreasonable delay in processing the application. The TPPA stipulates that an unreasonable delay at least shall include a delay in the issuance of a patent of more than five (5) years from the date of filing of the application in the country, or three (3) years after a request for examination has been made, whichever is later.

A country may exclude from the determination of such delays periods of time that are not attributable to the patent office, as well as periods of time that are attributable to the patent applicant. In Malaysia, the question arises: Can the Intellectual Property Corporation of Malaysia (MyIPO) process a patent application to grant within 5 years? An analysis of 51 patents published in the 27th August 2015 Patent Gazette reveal an average processing period of 7.1 years from the date of filing to date of grant of patent (Malaysian Patent Nos. 154359 to 154409)*. More structural and procedural changes need to be introduced at MyIPO in order to process the increasing number of patent applications in Malaysia.

Apart from an extension of the patent term for unreasonable delays in the processing of a patent application at the patent office of a member country, the TPPA now also requires an extension of the patent term with respect to a pharmaceutical product that is subject to a patent to compensate the patent owner for unreasonable delays in processing the application for market approval of a pharmaceutical drug at the Drug Control Bureau of the Ministry of Health.

Would those two possible patent term extensions lead to longer protection for pharmaceutical products due to the inefficiencies of the Patent Office and the Drug Control Bureau in duly processing the patent applications and marketing approval processing applications respectively?

The Drug Control Bureau of a member country may require as a condition for granting marketing approval of a pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the products. In such case the member country shall not permit any other third person, without the consent of the person that previously submitted the data or information, to market the same or similar product on the basis of:

  1. The information previously submitted by another person;
  2. The marketing approval granted to the person who submitted the data or information;

for at least five (5) years from the date of marketing approval of the new product in the country.

The restriction on the use of a third party’s data by a manufacturer of generic drugs would in practice delay the marketing approval of the generic drug, therefore indirectly extending the period of exclusivity of the patent holder of the patented drug if the latter drug is patented in the country. In addition, if a manufacturer of a generic drug is required to provide the requisite data for receiving marketing approval, it may also increase the costs of the generic drug.

These are some of the significant issues that need to be addressed when Malaysia amends the Patents Act in accordance with the terms of Chapter 18 of the TPPA. It is by no means an exhaustive discussion on all the issues raised in Chapter 18 of the TPPA.