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Intellectual Property Rights (IPR)

Drugs Price Control Order (DPCO) Intellectual Property Rights (IPR) Pharmaceutical Policy 2002

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for minimum norms and standards in respect of the following categories of intellectual property rights: -

  1. Copyrights and related rights
  2. Trademarks
  3. Geographical Indications
  4. Industrial Designs
  5. Patents
  6. Lay out designs of integrated circuits
  7. Protection of undisclosed information (trade secrets)

The Agreement sets out minimum standards to be adopted by the parties, though they are free to provide higher standards of protection. A transition period of five years is available to all developing countries to give effect to the provisions of the TRIPS Agreement. This period ended on 1.1.2000. No transitional period is available, however, for grant of national treatment and most-favoured-nation treatment. Countries that did not provide product patents in certain areas of technology as on 1.1.1995, can delay the grant of product patents in those areas for another five years i.e. upto 1.1.2005.

Where a country does not make available patent protection for pharmaceutical and agricultural chemical products as on 1.1.1995, they have to provide a means for accepting applications for such inventions (mailbox), apply applicable priority rights and provide exclusive marketing rights (EMRs) for such products. The EMRs have to be provided in India only if a set of conditions have been met, i.e. where a patent application has been filed after 1.1.1995 in any WTO Member, patent and marketing approval granted in that Member country, an application has been filed in the mailbox in India and marketing approval obtained in India. The EMR is available for five years from grant or till the patent is granted or rejected, whichever is earlier. The Patent (Amendment) Act, 1999 was passed in March 1999 to provide for mailbox and EMR facility.

The state of play of India’s obligations under TRIPS arising as on 1.1.2000 in respect of the seven IPRs covered under TRIPS is briefly given below.


(a) Copyrights and related rights

In the area of copyright and related rights (i.e. rights of performers, producers of phonograms and broadcasting organizations), the Agreement requires compliance with the substantive provisions of the Berne Convention. Computer programmes are to be protected as literary works, the term of protection for copyrights and right of performers and producers of phonograms is to be no less than 50 years. In case of broadcasting organisations, however, the term of protection is to be at least 20 years. India is already a signatory to the Berne Convention and our laws conform to the provisions of the Convention. India’s copyright law has been amended and in some ways exceeds the requirements of the TRIPS Agreement, for example, on the period for copyright protection (which is 60 years in India). The law was amended in December 1999 to grant 25-year term of protection for neighbouring rights.

(b) Trademarks

The Trade and Merchandise Marks Act. 1958 was in its essential features in accordance with TRIPS, except that it did not cover service marks in its scope. This has been done by replacing it with the Trademarks Act 1999. We are now fully compliant with our TRIPS obligations.

(c) Geographical Indication

The Agreement contains a general obligation that parties shall provide the legal means for interested parties to prevent the use of any means in the designation or presentation of a good that indicates or suggests that the good in question originates in a geographical area other that the true place of origin of the good. We currently provide protection to geographical indications through passing off action in courts or through certification marks. However, to provide better protection to geographical indications a new law "The Geographical Indication of Goods (Registration & Protection) Act, 1999 has since been enacted.

(d) Industrial Designs

Obligations envisaged in respect of industrial designs are that independently created designs that are new or original shall be protected. There in an option to exclude from protection, designs dictated by technical or functional consideration, as against aesthetic consideration, which constitutes the coverage of industrial designs. The Bill to amend Industrial Design Act was passed early this year.

(e) Patents

The basic obligation in the area of patents is that, inventions in all fields of technology whether products or processes shall be patentable if they meet the three tests of being novel, involving an inventive step and being capable of industrial application. In addition to the general security exception, which applies to the entire TRIPS Agreement, specific exclusions are permissible from the scope of patentability. These are available in the areas of inventions whose commercial exploitation is to be prevented to protect public order or morality, human, animal plant life or health or to avoid serious prejudice to the environment. In addition, we can exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of human and animals, plants and animals other than microorganisms, and essentially biological process for the production of plants and animals other than non-biological and micro biological processes.

To meet our TRIPS obligations as on 1.1.2000, the Patents (Second Amendment) Bill, 1999 has been introduced in the Parliament in December 1999 and is before the Joint Committee of the Houses.

In respect of plant varieties, there is an obligation to provide for protection either by patents or by an effective sui generis system or by any combination thereof. The Agreement does not spell out the elements of an effective sui generis system and it is left to each Government to determine the elements, which could be deemed to be providing effective protection. A decision has been taken to put in place a sui generis system as it is perceived to be in our national interest. A Bill in this regard is before the Joint Committee of the Houses of the Parliament. (f) Layout Designs of Integrated Circuits

India is a signatory to the international agreement administered by WIPO on this subject known as the Washington Treaty. The main obligations of the Washington Treaty are also incorporated in the TRIPS Agreement with some enhancement and cover the protection of the intellectual property in respect of lay-out designs that are original in the sense of being the result of their creator's own intellectual efforts. The obligations include national treatment to foreign right holders and a term of protection for 10 years. A Bill in this regard was introduced in the Parliament in December 1999 and is awaiting passage.

(g) Protection of undisclosed information

The Agreement provides in this area that natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by or used by others without their consent in a manner contrary to honest commercial practices. Further, parties are required to protect against unfair commercial uses, undisclosed or other data obtained as a condition of approving the marketing of pharmaceutical or of agricultural chemical products.

In India we do not have a separate legislation dealing with trade secrets. Common law on the subject is evolving and the courts have provided relief where allegations of wrongful disclosure have been proven. It is not felt necessary to have a separate legislation on the subject.


Drugs Price Control Order (DPCO) Intellectual Property Rights (IPR) Pharmaceutical Policy 2002