India - Patent Protection for Pharmaceutical and Agricultural Chemical Products

Request for the Establishment of a Panel by the EC

The following communication, dated 9 September 1997, from the Permanent Delegation of the European Commission to the Chairman of the Dispute Settlement Body is circulated at the request of that delegation.

Annex 1

My authorities have asked me to submit the following request on behalf of the European Communities and their Member States for consideration at the next meeting of the Dispute Settlement Body.

The Agreement on Trade-Related Aspects of Intellectual Property Rights contained in Annex 1C to the Agreement Establishing the World Trade Organization (hereafter the "TRIPS Agreement") obliges all Members of the World Trade Organization (hereafter the "WTO") to grant patents for the subject matter specified in Article 27 of the TRIPS Agreement. Article 70.8 of the TRIPS Agreement provides that where a Member makes use of the transitional provisions contained in the TRIPS Agreement and does not make patent protection available for pharmaceutical and agricultural chemical inventions as of the date of entry into force of the WTO Agreement for it, that Member must implement measures to permit parties to file patent applications concerning such inventions on or after that date (hereafter referred to as the "interim filing procedure"). When product patent protection is established, these applications must be examined according to the criteria for patentability set forth in the Agreement, based on the earliest effective filing date claimed for the application. Patents granted on the basis of such applications must enjoy the term and rights provided for under the TRIPS Agreement. Article 70.9 of the TRIPS Agreement further requires that Members subject to the obligations under Article 70.8 of the TRIPS Agreement provide exclusive marketing rights to those parties that have filed an application under the interim filing procedure, insofar as the product covered by the invention has been granted marketing approval in the Member providing protection and another Member, and a patent has been granted on the invention in another Member.

The legal regime currently in force in India does not make patent protection available for inventions concerning pharmaceutical and agricultural chemical products as provided in Article 27 of the TRIPS Agreement, nor does it provide rules that conform to obligations of the TRIPS Agreement regarding the acceptance of applications and the grant of exclusive marketing rights. As a consequence, India's legal regime appears to be inconsistent with its obligations under the TRIPS agreement, including but not limited to Articles 27, 65 and 70 of the TRIPS Agreement.

In a communication dated 28 April 1997 (WT/DS79/1), the European Communities and their Member States requested consultations with India pursuant to Article 4 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (hereafter the "DSU") contained in Annex 2 of the WTO Agreement and Article 64 of the TRIPS Agreement in conjunction with Article XXII of the General Agreement on Tariffs and Trade 1994. Consultations were held on 14 May 1997, but did not result in a satisfactory solution of the dispute.

Accordingly, the European Communities and their Member States request the establishment of a panel to examine the matter in the light of the relevant provisions of the TRIPS Agreement and to find that India fails to conform to the obligations contained in Article 27, 65 and 70 of the TRIPS Agreement and thereby nullifies or impairs benefits accruing directly or indirectly to the European Communities and their Member States under the TRIPS Agreement.

The European Communities and their Member States ask that this request be placed on the agenda of the meeting of the Dispute Settlement Body scheduled to be held on 25 September 1997, and that the panel be established with standard terms of reference as provided for in Article 7 of the DSU.

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)

The Patents Act, 1970¹³⁶

(No. 39 of 1970)

Section 2

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

.....

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

.....

.....

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.

GlaxoWellcome Fax

Global Intellectual Property

To: Mr. Bernhard Janssen Fax No. 00 41 22 734 22 36

European Commission

From: Dr. Alan Hesketh Date: 28 April 1998

Ref: AH/KEE

Direct tel: 0181 966 86 40 Total pages: 1 (incl. cover sheet)

Direct fax: 0181 966 57 37

Dear Mr. Janssen,

INDIA

Although I have not had replies from all companies, I can provide some positive information. There are two companies that are likely to file applications for marketing exclusivity during 1999.

One is a Swiss Company which is likely to have two cases relating to formulations during 1999.

The second company is my own company, Glaxo Wellcome. We have a product called valaciclovir for which we have patents on a tablet formulation and a crystalline form. These applications have been filed in the mail box procedure. A marketing approval application has been filed in India and we expect launch to occur in early 1999. We will therefore be making an application for marketing exclusivity before that time.

This is certainly not a comprehensive list, but I hope it provides some evidence that the marketing exclusivity provisions will need to be in place in India this year.

Regards.

Yours sincerely,

Dr. Alan Hesketh

Manager, Global Intellectual Property

Glaxo Wellcome plc

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UK

__________

¹³⁶ The short title