Report of the Panel

ANNEX 1

INDIA

The Patents Act, 1970 ¹²³

(No. 39 of 1970)

Section 2

(1) In this Act, unless the context otherwise requires, -

.....

(j) "invention" means any new and useful -

and includes any new and useful improvement of any of them, and an alleged invention;

.....

(l) "medicine or drug" includes -

.....

Chapter II - Inventions not patentable

Section 5

In the case of inventions -

no patent shall be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture shall be patentable.

Chapter III - Applications for patents

Section 6

(1) Subject to the provisions contained in section 134, an application for a patent for an invention may be made by any of the following persons, that is to say, -

(2) An application under sub-section (1) may be made by any of the persons referred to therein either alone or jointly with any other person.

Section 7

(1) Every application for a patent shall be for one invention only and shall be made in the prescribed form and filed in the patent office.

(2) Where the application is made by virtue of an assignment of the right to apply for a patent for the invention, there shall be furnished with the application, or within such period as may be prescribed after the filing of the application, proof of the right to made the application.

(3) Every application under this section shall state that the applicant is in possession of the invention and shall name the owner claiming to be the true and first inventor; and where the person so claiming is not the applicant or one of the applicants, the application shall contain a declaration that the applicant believes the person so named to be the true and first inventor.

(4) Every such application (not being a convention application) shall be accompanied by a provisional or complete specification.

Section 8

(1) Where an applicant for a patent under this Act is prosecuting either alone or jointly with any other person an application for a patent in any country outside India in respect of the same or substantially the same invention, or where to his knowledge such an application is being prosecuted by some person through whom he claims or by some person deriving title from him, he shall file along with his application -

(2) The Controller may also require the applicant to furnish, as far as may be available to the applicant, details relating to the objections, if any, taken to any such application as is referred to in sub-section (1) on the ground that the invention is lacking in novelty or patentability, the amendments effected in the specifications, the claims allowed in respect thereof and such other particulars as he may require.

Section 9

(1) Where an application for a patent (not being a convention application) is accompanied by a provisional specification, a complete specification shall be filed within twelve months from the date of filing of the application, and if the complete specification is not so filed the application shall be deemed to be abandoned:

Provided that the complete specification may be filed at any time after twelve months but within fifteen months from the date aforesaid, if a request to that effect is made to the Controller and the prescribed fee is paid on or before the date on which the complete specification is filed.

(2) Where two or more applications in the name of the same applicant are accompanied by provisional specifications in respect of inventions which are cognate or of which one is a modification of another and the Controller is of opinion that the whole of such inventions are such as to constitute a single invention and may properly be included in one patent, he may allow one complete specification to be filed in respect of all such provisional specifications.

(3) Where an application for a patent (not being convention application) is accompanied by a specification purporting to be a complete specification, the Controller may, if the applicant so requests at any time before the acceptance of the specification, direct that such specification shall be treated for the purposes of this Act as a provisional specification and proceed with the application accordingly.

(4) Where a complete specification has been filed in pursuance of an application for a patent accompanied by a provisional specification or by a specification treated by virtue of a direction under sub-section (3) as a provisional specification, the Controller may, if the applicant so requests at any time before the acceptance of the complete specification, cancel the provisional specification and post-date the application to the date of filing of the complete specification.

Section 10

(1) Every specification, whether provisional or complete, shall describe the invention and shall begin with a title sufficiently indicating the subject matter to which the invention relates.

(2) Subject to any rules that may be made in this behalf under this Act, drawings may, and shall, if the Controller so requires, be supplied for the purposes of any specification whether complete or provisional; and any drawings so supplied shall, unless the Controller otherwise directs, be deemed to form part of the specification, and references in this Act to a specification shall be construed accordingly.

(3) If, in any particular case, the Controller considers that an application should be further supplemented by a model or sample of anything illustrating the invention or alleged to constitute an invention, such model or sample as he may require shall be furnished before the acceptance of the application, but such model or sample shall not be deemed to form part of the specification.

(4) Every complete specification shall -

(5) The claim or claims of a complete specification shall relate to a single invention, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification and shall, in the case of an invention such as is referred to in section 5, relate to a single method or process of manufacture.

(6) A declaration as to the inventorship of the invention shall, in such cases as may be prescribed, be furnished in the prescribed form with the complete specification or within such period as may be prescribed after the filing of that specification.

(7) Subject to the foregoing provisions of this section, a complete specification filed after a provisional specification may include claims in respect of developments of, or additions to, the invention which was described in the provisional specification, being developments or additions in respect of which the applicant would be entitled under the provisions of section 6 to make a separate application for a patent.

Section 11

(1) There shall be a priority date for each claim of a complete specification.

(2) Where a complete specification is filed in pursuance of a single application accompanied by -

and the claim is fairly based on the matter disclosed in the specification referred to in clause (a) or clause (b), the priority date of that claim shall be the date of the filing of the relevant specification.

(3) Where the complete specification is filed or proceeded with in pursuance of two or more applications accompanied by such specifications as are mentioned in sub-section (2) and the claim is fairly based on the matter disclosed -

(4) Where the complete specification has been filed in pursuance of a further application made by virtue of sub-section (1) of section 16 and the claim is fairly based on the matter disclosed in any of the earlier specifications, provisional or complete, as the case may be, the priority date of that claim shall be the date of the filing of that specification in which the matter was first disclosed.

(5) Where, under the foregoing provisions of this section, any claim of a complete specification would, but for the provisions of this sub-section, have two or more priority dates, the priority date of that claim shall be the earlier or earliest of those dates.

(6) In any case to which sub-sections (2), (3), (4) and (5) do not apply, the priority date of a claim shall, subject to the provisions of section 137, be the date of filing of the complete specification.

(7) The reference to the date of the filing of the application or of the complete specification in this section shall, in cases where there has been a post-dating under section 9 or section 17 or, as the case may be, an ante-dating under section 16, be a reference to the date as so post-dated or ante-dated.

(8) A claim in a complete specification of a patent shall not be invalid by reason only of -

Chapter IV - Examination of applications

Section 12

(1) When the complete specification has been filed in respect of an application for a patent, the application and the specification relating thereto shall be referred by the Controller to an examiner for making a report to him in respect of the following matters, namely: -

(2) The examiner to whom the application and the specification relating thereto are referred under sub-section (1) shall ordinarily make the report to the Controller within a period of eighteen months from the date of such reference.

Section 15

(1) Where the Controller is satisfied that the application or any specification filed in pursuance thereof does not comply with the requirements of this Act or of any rules made thereunder, the Controller may either -

(2) If it appears to the Controller that the invention claimed in the specification is not an invention within the meaning of, or is not patentable under, this Act, he shall refuse the application.

ANNEX 2

LOK SABHA

UNSTARRED QUESTION NO. 2601

To be answered on 2 August 1996

Amendment in Indian Patents Act, 1970

2601. SHRI ANAND RATNA MAURYA

Will the Minister of INDUSTRY be pleased to state:

ANSWER

THE MINISTER OF INDUSTRY (SHRI MURASOLI MARAN)

ANNEX 3

May 2, 1997

The Honorable Charlene Barshefsky
United States Trade Representative
600 17th Street, N.W.
Washington, D.C. 20508

Dear Ambassador Barshefsky:

I am writing to you regarding India's failure to implement "mailbox" provisions under the WTO TRIPS Agreement on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country's leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to lead longer and more productive lives. Investing nearly $19 billion a year in discovering and developing new medicines, PhRMA companies are leading the way in the search for cures.

As Senior Vice President in charge of PhRMA's international matters, I am in contact with each of the PhRMA member companies with regard to their international operations. I have discussed with them in some detail whether they believe India has mailbox and exclusive marketing rights systems in place, and whether they would use such systems if they were in place. Based on these discussions, I can state the following.

PhRMA member companies do not believe that India has established a mailbox application system or a system for the grant of exclusive marketing rights. Few PhRMA companies have filed applications for pharmaceutical product patents in India, knowing that because a "mailbox" system was not in place, there is a considerable risk that those applications would not receive the legal status required by the TRIPS Agreement. These companies were willing to expend the resources and time necessary to file such applications in the hope that India may ultimately implement its TRIPS Article 70.8 obligations in a way that minimizes the damages created by the delay.

Other companies did not file applications for patent protection of pharmaceutical products because India has failed to establish such a system. I know of at least half-a-dozen such PhRMA member companies. These companies are prepared to file mailbox applications when a system is established, with the filing dates they should have been able to specify had a system been in place since 1 January 1995. These filing dates would, presumably, be based on their United States or other foreign filing date.

With respect to requests for exclusive marketing rights, not all companies are in a position to request such rights at this time. However, at least one PhRMA company is in a position to do so. It has received a patent and marketing approval for a drug in the United States and Europe and is ready to request the grant of exclusive marketing rights from the Indian health authorities. This company will in the very near future have another drug that meets these characteristics.

As you know, PhRMA companies are experiencing great losses in India because of its failure to provide patent protection for pharmaceutical products. Unless India establishes a mechanism to ensure that mailbox applications can be filed and given the legal status required by the TRIPS Agreement (i.e., all applications that would have been filed after 1 January 1995, had a system been in place), they will continue to face enormous losses for decades to come. Furthermore, without a system for the grant of exclusive marketing rights in place, at least one company and perhaps many others will incur significant additional losses.

Thank you for your attention to this matter.