Transitional arrangement under TRIPs agreement

B K Keayla delves into the intricacies of TRIPs agreement with special reference to provisions in the Indian Patents Act

B K Keayla

TRIPs Agreement under Article 65 provides for ’date of application’ of TRIPs Agreement other than Articles 3, 4 and 5 for developing countries as 1.1.2000. There are countries who do not provide patent protection for certain areas of technology as on 1.1.1995 in their national legislations. For such countries there is a provision in Article 65 (4) that they can delay the ’application of TRIPs provision’ on product patent on such areas of technologies till 1.1.2005. India falls in this category as it does not provide product patent for pharmaceuticals, food items, agrochemicals, etc. Thus for pharmaceuticals, etc date of application of TRIPs Agreement is 1.1.2005 and India is in the process of amending its patent laws to provide for this.

Article 70 (8) provides that in respect of pharmaceutical and agricultural chemical products if patent protection is not available on 1.1.1995 in any country then such a country has to provide for means by which applications for product patent for such inventions can be filed (filing of such applications is being referred to as filing in the mail box) with the patent authorities.

Article 70 (9) provides that for applications filed in the mail box, the applicant would be entitled to exclusive marketing rights for a period of five years after obtaining marketing approval in the concerned country or until the product patent is granted or rejected in that country which-ever period is shorter. The other conditions for grant of exclusive marketing rights are that the patent application has been filed and patent granted for that product in another member country of WTO and also that marketing approval has been obtained in that such other country.

In brief the criteria is as follows:

(i) Patent application has been filed in the concerned country and any other country only on 1.1.1995 or thereafter;

(ii) Patent protection has been granted in any other country on such a patent application;

(iii) Marketing approval has been granted in any other country;

(iv) Marketing approval has also been granted in the concerned country;

The term of the exclusive marketing right is five years after obtaining marketing approval in the concerned country or until the product patent is granted or rejected in that country.

Provision in India

The Patents (Amendment) Act 1999 has been enacted effective from 1.1.1995 to fulfill the above obligations. The scope of filling the product patent application in respect of pharmaceuticals and agro-chemical products is as follows:

A claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, defined as follows:

“medicine or drug” includes:

• All medicines for internal or external use of human beings or animals;
• All substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals;
• All substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals;
• Insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants.

The Patents (Amendment) Act 1999 also provides as follows:

(i) Patent applications received in the mail box shall not be referred by the Controller of Patents to an examiner for making a report till the 31st day of December, 2004.

(ii) Applications received for grant of exclusive right to sell or distribute the article or substance in India will be referred by the Controller of Patents to an examiner along with the application for patent for making a report to him as to whether the invention is not an invention within the meaning of Patents Act 1970 in terms of section 3.

(iii) If the invention is not an invention within the meaning of Patents Act in terms of section 3 the application for exclusive right shall be rejected by the Controller of Patents.

(iv) Exclusive right to sell or distribute the article or substance shall be granted if:

• an application for the same invention has been filed in any other country on or after 1.1.1995
• the patent and the approval to sell or distribute the article or substance on the basis of appropriate tests conducted on or after 1.1.1995 in that country has been granted on or after the date of making a claim for patent for pharmaceutical and agro-chemical products has received the approval to sell or distribute the article or substance from the authority specified in this behalf by the Central Government then,
• he shall have the exclusive right to sell or distribute in India the article or the substance on and from the date of approval granted by the Controller of Patents in this behalf till a period of five years or till the date of grant of patent or the date of rejection of application for grant of patent, whichever is earlier.

Comments

The following provisions of TRIPs Agreement have not been provided in the Patents (Amendment) Act 1999:

(i) The applications received in the mail box shall be granted patent protection for those applications thatmeet the criteria for protection as from the date of grant of patent and the term will be for the remainder of the patent term, counted from the filing date of the application in the mail box. This provision is as provided in Article 70 (8)(c) of the TRIPs Agreement.

(ii) TRIPs Agreement also provides in Article 70 (3) that there shall be no obligation to restore protection to subject matter which on the date of application of this Agreement (which is 1.1.2000 for all products other than such technologies which are not covered by product patent as on 1.1.1995 for which date of application of TRIPs provision is 1.1.2005) has fallen in public domain. (the dates of application of TRIPS Agreement are as provided in Article 65 (2) and (4) of TRIPs)

Other problem areas

(i) This relate to patentable subject matter of pharmaceutical patent applications. This should have been new chemical entity or new medical entity. This would have restricted patent applications only for new molecules. The provision under the Patents (Amendment) Act 1999 has complicated matters and now we have over 7,000 patent applications. These applications cannot be only for new molecules, in that case the number would have been not more than 500. Dr Mashelkar Committee on Research and Development recommended patent only for new molecules.

(ii) Section 25 of the Patents Act 1970 provides for opposition to grant of patent. According to this section and Article 70 (3) of TRIPs Agreement any subject matter which has fallen into public domain no protection need be restored. Public domain angle would extend to anywhere in the world. This angle of notifying the Controller’s intention to grant exclusive marketing right should also have been provided in the Patents (Amendment) Act 1999.

The author is Convenor, National Working Group on Patent Law and Trustee & Secretary General, Center for Study of Global Trade System & Development. E-mail: wgkeayla@del6.vsnl.net.in