On 14 September 2011 and 16 September 2011, the World Trade Organization (WTO) undertook a trade policy review of India. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The TPRM takes place in the “Trade Policy Review Body which is actually the WTO General Council — comprising the WTO’s full membership — operating under special rules and procedures” (Source: WTO, Trade Policy Reviews: Brief Introduction). In October 2011, the WTO released the records of the meeting including WT/TPR/M/249, WT/TPR/M/249/Add.1 (containing advance written question posed by WTO members and replies by India) and WT/TPR/M/249/Add.2 (containing additional advance written question posed by WTO members and replies provided by India).
The questions raised by WTO members relating to patents and pharmaceuticals include such topics as compulsory licensing, exhaustion, patentability criteria and the protection of test data. The following piece is a walkthrough of the trade policy review of India in the context of IPRs and health technologies. Although the activities of the WTO TRIPS Council receive much scrutiny during discussions of controversial issues such as ACTA, public health and tobacco plain packaging, the WTO’s trade policy reviews have not traditionally attracted the same level of attention. While discussions within the Trade Policy Review Mechanism are often routine in nature, this is not always the case – as this post will highlight. Perhaps a more diligent examination of the goings-on of the WTO’s Trade Policy Review Mechanism is merited, to provide more insight into how TRIPS flexibilities are treated in the WTO system. From September 2012 to December 2012, the WTO will undertake trade policy reviews of the following countries: Korea, Norway, Bangladesh, Israel, Iceland, East African Community (Kenya, Tanzania, Uganda, Burundi, Rwanda), Nicaragua and the United States of America.
According to the WTO,
The Trade Policy Review Mechanism was an early result of the Uruguay Round, being provisionally established at the Montreal Mid-Term Review of the Round in December 1988. Article III of the Marrakesh Agreement, agreed by Ministers in April 1994, placed the TPRM on a permanent footing as one of the WTO’s basic functions and, with the entry into force of the WTO in 1995, the mandate of the TPRM was broadened to cover services trade and intellectual property.
The objectives of the TPRM, as expressed in Annex 3 of the Marrakesh Agreement, include facilitating the smooth functioning of the multilateral trading system by enhancing the transparency of Members’ trade policies.
All WTO Members are subject to review under the TPRM. The Annex mandates that the four Members with the largest shares of world trade (currently the European Communities, the United States, Japan and China) be reviewed each two years, the next 16 be reviewed each four years, and others be reviewed each six years. A longer period may be fixed for least-developed country Members.
WTO members that raised questions related to India’s IPR regime in the context of pharmaceuticals include Australia, Brazil, Chile, Chinese Taipei Costa Rica, European Union, Japan, Switzerland and the United States. The following extracts are taken from WT/TPR/M/249/Add.1 unless specifically noted.
AUSTRALIAAustralia 14, 15, 16, 17:REPORT BY WTO SECRETARIAT (WT/TPR/S/249): III TRADE POLICIES AND PRACTICES BY MEASURE: (4) MEASURES AFFECTING PRODUCTION AND TRADE: (vi) Intellectual Property Rights (b) Patents
Australia notes in paragraph 250, page 114 of the Secretariat report that patent protection may be granted to any invention relating to either a product or process that is new, involves an inventive step, and is capable of industrial application (Section 2(1)(j) of the Patents Act 1970, as amended). Article 3(p) of the Act excludes ‘an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components’.14. Could India advise whether this exclusion has been applied in practice to reject patent applications?
Reply: Section 3 of the Patent Act lists out those that are not considered as inventions. Sub section (p) of Section 3 includes traditional knowledge or an aggregation or duplication of known properties of traditional known component or components. Traditional knowledge, therefore, is not patentable under the Act. This exclusion has to be applied in practice to evaluate patent applications.
15. Could India explain the policy reason for this exclusion?
Reply: Only novel inventions having inventive step and industrial applicability are patentable. Traditional knowledge which is used by the communities for generations but have not been documented comes under prior use and it is necessary to protect the knowledge of such communities is the rationale for this enactment of this section.
16. Could India explain which specific national elements are included in India’s definition of Traditional Knowledge? Do India’s criteria apply to Traditional Knowledge from a country other than India?
Reply: The Patents Act does not define the term traditional knowledge. However, any knowledge existing traditionally either with any local or indigenous community or elsewhere is taken into account. Therefore, it is not limited to the traditional knowledge existing in India.
17. What is the policy reason for the exclusion of ‘methods of agriculture’ in Section 3(h) of the Patents Act 1970?
Reply: The policy behind the exclusion of methods of agriculture and Horticulture under section 3(h) is to promote the public interest in sectors of vital importance to India’s socio economic and technological development (Article 8. 1 of TRIPS).
Australia 20, 21, 22:
REPORT BY WTO SECRETARIAT (WT/TPR/S/249): III TRADE POLICIES AND PRACTICES BY MEASURE: (4) MEASURES AFFECTING PRODUCTION AND TRADE: (vi) Intellectual Property Rights (b) Patents
Regarding the requirements for grant of a patent, the Indian Patent Manual describes the requirement for the applicant to disclose information on biological material in the application. Section 25 of the Patents Act provides the ground of opposition that this information was not disclosed.
20. Which provision of the Patents Act requires the applicant to disclose this information?
Reply: Section 10(4)(d)(ii)(D) requires applicant to disclose the source and geographical origin of the biological material in the specification when used in an invention.
21. Which provision of the Patents Act requires the Patent Office to check for disclosure of this information?
Reply: As above.
Australia 24, 25:
REPORT BY WTO SECRETARIAT (WT/TPR/S/249): III TRADE POLICIES AND PRACTICES BY MEASURE: (4) MEASURES AFFECTING PRODUCTION AND TRADE: (vi) Intellectual Property Rights (b) Patents
Australia notes in paragraph 256 that compulsory licensing is permitted under certain circumstances.
24. Is export under compulsory licence permitted for export to any country or only to certain countries?
Reply: Under the provisions of section 84(7)(iii) the reasonable requirement of public for the purpose of grant of compulsory licence shall not be considered to have been satisfied if by reason of the refusal of the patentee to grant a license or licenses on reasonable terms, a market for export of the patented article manufactured in India is not being supplied or developed. Hence, the compulsory license will be available by virtue of this section to export of patent products to any country.
However, as per provisions of section 92(A), the compulsory licence for export of patented pharmaceutical product is available to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problem.25. Could India provide the internet link to the Department of Industrial Policy and Promotions discussion paper on compulsory licensing, if this is available online in English?
Reply: The website of DIPP is http://www.dipp.nic.in/English/default.aspx.
BRAZILIntellectual property rights
Brazil 19:In paragraph 245 (page112) of the Secretariat Report (WT/TPR/S/249) it is stated that “India has signed bilateral cooperation MOUs on IPRs with Australia, France, Japan and Switzerland; and with the European Patent Office, the German Patent Office, the US Patent and Trademarks Office; and WIPO.”
Do these agreements provide for the obligation to consult the Indian Library of Traditional Knowledge when analyzing patent applications?
Reply: There is no obligation to mandatorily search the database of the Traditional Knowledge Digital Library when analyzing patent application. However, the access is provided to facilitate prior art search where Indian TK is used.
Brazil 21:
In paragraph 256 (page 115) of the Secretariat Report (WT/TPR/S/249) it is stated that compulsory licensing is permitted if a patent is not worked in India. It is also mentioned that “compulsory licenses are also permitted for exports of patented pharmaceutical products in certain exceptional circumstances, when the Government declares an emergency”.How the term “work a patent” is defined in Indian Law and jurisprudence?
Under which circumstances are compulsory licenses permitted for exports of patented pharmaceuticals? Which Government should declare it an emergency, the Indian Government or the importing country Government? Is this provision in any sense connected with the Paragraph 6 system of the Doha Declaration on TRIPS and Public Health?
Reply: Section 83 of the Patents Act defines the general principle applicable to working of patented inventions. These are as follows:
– that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;
– that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;
– that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;
– that patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio economic and technological development of India;
– that patents granted do not in any way prohibit Central Government in taking measures to protect public health;
– that the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and
– that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.
Section 92(A) of the Patents Act gives details of circumstances when compulsory license can be issued for export of patented pharmaceutical products. Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.The Controller shall on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him.
Application for compulsory licence can be made under Form 17 of the Patents Act and Rules
Brazil 22:
In paragraph 257 (page 115) of the Secretariat Report (WT/TPR/S/249) it is stated that “parallel import are allowed when authorized under the law. The authorities noted that: “under the law” should be interpreted as the law of the country where the item is being produced”.What is India’s exhaustion regime? Would it be allowed to import from country A if in this country parallel imports where not allowed to that market?
Reply: India follows international exhaustion of rights for Patents. Under section 107A of the Act, importation of patented products by any person from a person who is duly authorized under the law to produce and sell or distribute the product is not considered an infringement of patent rights. Therefore import from country A will be allowed from a person who is duly authorized to produce/sell or distribute the product.
Brazil 31:
With regard to competition policy, please provide information of its interface with Intellectual Property Rights. Has any case of restriction of IPR in mergers and acquisitions ever occurred?
Reply: The rights which are conferred under various IPR Acts are exempted under the anti competitive agreements under Section 3 of the Competition Act. As on date no issue on restriction of IPR is mergers and acquisition has arisen.
CHILEQuestions to India in Regards to Intellectual PropertyChile 3:
In terms of patents and that established in paragraph 251(WTO Secretariat Report) regarding the necessary prior permission to patent when the applicant does not wish to file a patent application in India prior to filling abroad, does this apply to both residents and non residents. In other words, in the case of an invention developed in India by a foreign company would this company have to request permission to be able to file a patent in the US before it files for a patent in India?Reply: If the inventor for the invention developed in India by the foreign company is a resident in India, the company is required to seek permission under Section 39 of the Patents Act, 1970 for foreign filing before filing in India.
Chile 4:
In regards to pharmaceutical patents, and the requirement of proof of efficiency in order to prove inventive step that appears in paragraph 250, we would like to inquire in the case of a pharmaceutical product, is a sanitary permit for its commercialization or circulation within the Indian market required, and if so: (i) Does this permit require evidence of efficiency and how would this differ from that required by the patent authority; and (ii) what is the link between the sanitary permit and that patent, in other words would the existence of a patent impede the granting of a sanitary permit on a generic product and to what extent.
Reply: The Member should elaborate what it means by sanitary permits in the case of patents.
Chile 5:
Regarding to that expressed in paragraph 283 in relation to the creation of Copyright Enforcement Cells within the crime section of the police, Chile would like to receive more information on the inner workings of these cells as well as if patent infractions fall under their jurisdiction.
Reply: Copyright protection has both civil and criminal enforcement. Patent infringement on the other hand is covered by civil proceedings.
COSTA RICA
85. Could India give detailed information on the discussion paper on Compulsory Licenses issued by the Department of Industrial Policy and Promotion? (Page 134, paragraph 256)
Reply: DIPP prepared a Discussion Paper on the subject of compulsory licensing and hosted the same on its website to invite the views and suggestion on certain issues for resolution. The objective of this exercise was not to invite any change/amendment to the provisions of the Patent Act 1970 but only to elicit the suggestions to take an appropriate policy decision whether the existing provisions of the Patents Act, 1970 require any amplification through issuing of guidelines by the Government. As such, the question of any change to the existing provisions of the Patents Act 1970 does not arise. Moreover, after obtaining and examining the suggestions on the said Discussion Paper, the Government has decided that there is no need to issue additional guidelines for the issue of compulsory license and issued a press release to this effect to conclude the matter. Further, the existing provisions of the Patent Act 1970 are already TRIPS compliant including Article 31 thereof. The Discussion Paper is available on DIPP’s website: www.dipp.nic.in.
EUROPEAN UNION(vi) Intellectual property rights
(a) OverviewA high level Inter Ministerial Report, “Report on Steps to be taken by the Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement” in May 2007 suggested that Indian legislation regarding data protection for pharmaceuticals may not be TRIPS compliant, and put forward a recommendation on how the problem could be solved. The EU also learned that a new legislation is being developed in India concerning plant protection products.
104) Could India inform whether it intents to follow the recommendations put forward in this report, and if so, to indicate the possible timeframe for such changes? Could India provide information on this new pending legislation?
Reply: The report is being examined and decision will be taken as per the national interest. The legislation on plant protection products is pending in the Parliament.(b) Patents
WTO’s Secretariat Report, page 114, paragraph 250
The EU is concerned about the enhanced efficacy requirement included in Section 3(d) of the new Patent Act.
105) Could India please explain its views in this regard, in particular concerning Section 3(d) TRIPS compatibility?Reply: The efficacy requirement for a new form of a known substance is to substantiate the inventive step provided novelty of the substance is already established. This provision is fully TRIPS compatible in view of Article 8 and 27 of TRIPS.
WTO’s Secretariat Report, page 115, paragraph 256
The EU has concerns regarding Sections 84 (and others). In the EU’s opinion, the range of situations in which a compulsory license can be imposed is very broad.
106) Could India explain why it considers it necessary to be able to issue compulsory license in such broad situations, and whether it considers such measures are TRIPS compliant?
Reply: The provisions are TRIPS compliant in view of 7, 8 and 31 of TRIPS.
The EU has concerns regarding Sections 83 and 146 of the new Patent Act. The EU has especially strong concerns regarding the right of the Controller to publish sensitive information regarding the extent to which the patent is commercially worked in India.
107) Could India please explain the need for a local working requirement, and the need for the possibility to publish these data? How does India consider this requirement in light of its TRIPS obligations?
Reply: Such publication is required for public knowledge and transparency which may help a prospective applicant for compulsory license. TRIPS does not exclude any such publication.
JAPAN(Question 10: Page 113, paragraph 247)
According to the Secretariat Report, “The Intellectual Property Appellate Board (IPAB) was constituted in 2003 to hear appeals against the decisions of the registrar of trademarks and geographical indications. However, as of 2007 the IPAB has also heard appeals regarding patents”. It is known that almost 75% of its judgments were reversed by the High Court last year and a writ petition challenging the legality of the IPAB has been filed with the Madras High Court. So please explain a) the measures IPAB has taken or will take in order to develop its expertise on IPR, also b) any institutional or other systemic backgrounds for the high unsuccessful rate of its judgments and c) specific issue concerning the legality of IPAB.
Reply (a) and (b): IPAB is a specialized appellate body to hear and decide appeals against the decisions of the Registrar of Trade Marks and under section 116 of the Patents Act against the decisions of the Controller of Patents. It exercises the powers and functions previously exercised by the high courts. The Board consists of a Chairman, Vice Chairman and three technical members whose qualifications are commensurate with their judicial responsibility. It is at present chaired by a retired Judge of the High Court of Madras.Reply (c): IPAB was established under Section 83 of the Trade Marks Act, 199. There are no issues about its legality.
(Question 13: Page 114, paragraph 250)
According to the Secretariat report, “Section 3(d) of the Patent Act refers to the scope of patentability of pharmaceutical and other chemicals and calls for proof of the efficacy of the substance.” Japan would like to know how ”efficacy” is measured.(1) According to the explanation of Section 3(d) in India’s “MANUAL OF PATENT OFFICE PRACTICE AND PROCEDURE” published in last March which says that “In a recent case in relation to a pharmaceutical substance, the Madras High Court held that efficacy means therapeutic efficacy”. With regard to pharmaceutical substance related inventions, please indicate whether “efficacy” means only therapeutic efficacy, or not.
(2) Please indicate whether there are any differences between the definition of efficacy for pharmaceutical substance related inventions and that for other chemical substance related inventions.
Reply: According to Section 3(d) of the Indian Patents Act, the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not an invention and hence not patentable. The explanation given under Section 3(d) of the Indian Patents Act further elaborates on application of efficacy criteria to salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance. The explanation to Section 3(d) further clarifies that these substances may be considered as patentable only if they differ significantly in properties with regard to efficacy.
The Examiner on a case to case basis applies the test as to what constitutes such salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives to differ significantly in properties with regard to efficacy from the known substance. The complete specification may bring out clearly and categorically in the description, as to how the subject matter differs significantly in properties with regard to efficacy from the known substance thereof.In a recent case (Novartis AG Vs. Union of India, W.P. No. 24760/06), the Madras High Court held that in relation to a pharmaceutical substance, the efficacy means therapeutic efficacy. It was held that:
“… what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease and having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the “therapeutic effect” of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.”
In respect of inventions related to other fields of science the Court has held that:
“Due to the advanced technology in all fields of science, it is possible to show by giving necessary comparative details based on such science that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivatives so derived will not be the same substance, since the properties of the derivatives differ significantly with regard to efficacy.”
(Question 14: Page 115, paragraph 257)
The Indian Patent Act provides that “parallel imports are allowed when authorized under the law.” The Secretariat Report says that “the authorities noted that: “under the law” should be interpreted as the law of the country where the item is being produced.” However, there is no citation supporting the Indian authorities’ view. Since Article 107a can be interpreted as Indian law instead of “the law of the country where the item is being produced,” Japan would like to make sure whether the Indian authorities’ view on the interpretation of Article 107a is that “under the law” should be interpreted as the law of the country where the item is produced or not.Reply: The words “under the law” in section 107 A(b) of the Patents Act should be interpreted as the law of the country where a person is duly authorized under the law to produce, sell or distribute the product.
(Question 22: Page 117, paragraph 270)
According to the Secretariat’s Report, “[t]he re exportation of goods infringing trade marks in an unaltered State is also prohibited.” Since “re exportation” involves importation and exportation, the definition of re exportation and transit could overlap. Japan would like India to describe the difference between re exportation and transit. Please also explain what procedures ‘in transit’ involves.Reply: It has been rightly observed that “re exportation” involves importation and exportation. Transit is different from re exportation. Transit is defined under Article V of the GATT 1994 and as per this, goods shall be deemed to be in transit across the territory of a contracting party when the passage across such territory is only a portion of a complete journey beginning and terminating beyond the frontier of the contracting party across whose territory the traffic passes. Traffic of this nature is termed “traffic in transit”. Vide Customs notification 51/2010 Customs (NT) dated 30 June 2010 India has excluded transit from the purview of IPR border enforcement.
PERU
Peru 15:15) Request that India elaborates on what consists “efficacy trials” and how these function for obtaining patents for patent pharmaceuticals and agrochemicals. Are these requirements for compliance with the requirement of ‘inventive step’ or an additional requirement? Does this require scientific proof of the functioning and efficacy of the medicine?
Reply: As per section 3(d) of the Patents Act, efficacy requirement is invoked when the subject matter involves “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance”. The efficacy requirement has been further elaborated in the explanation provided under section 3(d). Unless the requirement of the efficacy is met with, a new form of a known substance is not an invention meaning thereby that the criteria of patentability is not fulfilled. Thus, the efficacy requirement for a new form of a known substance is to substantiate the inventive step provided novelty of the substance is already established.
Peru 17:
17) Request clarification on the general doubt about the validity of the patent rights granted in India: period of 20 years is counted from the publication (as seems to be pointed out in paragraph 254 of document) or from the filing of the application (paragraph 255).
Reply: It may be noted that the term of patent starts from the date of filing of the application. In case of application filed under Patent Cooperation Treaty, the term of patent shall be reckoned from International filing date accorded under PCT.
However, Section 11A(7) provides provisional protection of the invention from the date of publication of the application. Accordingly, the patent right accrue from the date of publication of a patent application under section 11(A). However, as per Section 11A(7), the patent right can be enforced only when patent is granted i.e. the patentee can claim the damages from said date of publication only after the patent is granted and, also, the Applicant is not entitled to institute any infringement proceeding until grant of patent.
This question from Peru is taken from WT/TPR/M/249/Add.2.
PERU
Additional questions
Peru 21:
When a right holder does not live in the country, who is notified if an infringement is detected during the application of border measures under the transhipment and transit regimes?Reply: Indian Customs IPR law does not apply to goods in transit.
SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, KINMEN AND MATSU
Chinese Taipei 6:
WTO Secretariat Report (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (4) MEASURES AFFECTING PRODUCTION AND TRADE: (vi) Intellectual property rights: (a) Overview: (Page 113, paragraph 247)
The Intellectual Property Appellate Board (IPAB) was constituted in 2003 to hear appeals against the decisions of the registrar of trade marks and geographical indications. However, as of 2007 the IPAB has also heard appeals regarding patents.
i) Does this mean that all appeals regarding patents are now heard by the IPAB?
ii) What is the next resort in the process of IP litigation if an appeal is not successful before the IPAB?
iii) Is the IPAB a judicial authority or purely administrative?
Reply (i): Under Section 117A of the Patents Act, an appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government under section 15, section 16, section 17, section 18, section 19, Section 20, sub section(4) of section 25, section 28, section 51, section 54, section 57, section 60, section 61, section 63, section 66, sub section (3) of section 69, section 78, sub sections (1) to (5) of section 84, section 85, section 88, section 91, section 92 and section 94.Reply (ii): High Courts have writ jurisdiction under Art 226 of the Constitution and Special Leave Petition can be taken to appeal before the Supreme Court on a question of law/constitutional issues.Reply (iii): IPAB is a judicial tribunal.
Chinese Taipei 12:
A. WTO Secretariat Report (WT/TPR/S/249)
III. TRADE POLICES AND PRACTICES BY MEASURES
(4) MEASURES AFFECTING PRODUCTION AND TRADE
(vi) Intellectual property rights(Page 115, paragraph 256)
As indicated in the Report, in the situation where the patented invention is not available at a reasonably affordable price, anyone interested in working a patent may, after the expiry of three years from the date of grant of the patent, apply for grant of a compulsory licence.
Could India please explain if this is only a condition or is it a prerequisite, and also whether it will cause disadvantage to the patent holder.
Reply: In fact, in order to apply for the grant of compulsory licence, it is prerequisite for any applicant to ensure that a period of three years from the date of grant has expired failing which the application for compulsory licence can be rejected ab initio. This period of three years is to ensure that the patentee or licensee is provided sufficient period to take necessary measures for commercialisation of the patented inventions in order to secure that inventions are worked in India on a commercial scale without undue delay. Moreover, the reasonable royalty is also payable to the patentee. Therefore, it will not cause any disadvantage to the right holder.
SINGAPORESingapore 11:
On the WTO Secretariat report (WT/TPR/S/249, page 113, para 248 260) that focuses on patents, we would like to seek clarification on whether there is a need for approval of marketing plans for (i) patented and generic drugs; and (ii) medical devices in India. If there is a need, we seek India’s elaboration on the procedures for seeking approval.
Reply: There is a mandatory provision of registration of imported products before they are sold in the country. However Singapore should elaborate what do they mean by marketing plans for giving further clarifications.
Singapore 12:
We would like to seek clarification with regard to the registration procedure for pharmaceutical products in India.
a) With regards to the registration of western medicinal products (pharmaceutical drugs), are such registrations done at the central government level, i.e. by Central Drugs Standard Control Organisation (CDSCO) or by the respective health authorities within each district in India?
Reply: Registration is done by Central Drugs Standard Control Organisation (CDSCO).
b) When a pharmaceutical product is registered in India, is there a certificate or registration/licence number that is issued to signify that the drug is registered in India? If there is, what is the format of the certificate/licence number? Who issues the certificate/licence number?Reply: A registration certificate (Form 41) is issued with a registration number. Form is available on the website of Central Drugs Standard Control Organisation (CDSCO).
SWITZERLAND
Report by the Secretariat: III. Trade policies and practices by measure: (4) Measures affecting production and trade: (vi) Intellectual property rights: (b) Patents: Para. 256:
Paragraph 256 of the Report by the Secretariat refers to Section 84, Chapter XVI of the Patents Act 1970 (hereafter: Patents Act) and indicates the conditions for the grant of a compulsory licence in India (the reasonable requirements of the public with respect to the patented invention have not been satisfied; the patented invention is not available at a reasonably affordable price; or it is not worked in India). Switzerland would like to submit the following questions concerning this issue:
– Article 27.1 of the TRIPS Agreement requires that patents shall be available and patent rights enjoyable without discrimination as to whether products are imported or locally produced. Please confirm that importation of a patented invention is considered as working a patent/a patented invention under Section 84 of the Patents Act.
– Further, Paragraph 256 of the Report of the Secretariat states that the Department of Industrial Policy and Promotions issued a discussion paper on compulsory licensing with a view to developing a predictable environment to use such measure. What is its legal status? Please describe shortly its contents and any possible recommendations or measures the Indian Government envisages under it. Could the Indian authorities indicate where this discussion paper can be obtained?Reply: Working of patent includes importation. However, under Section 83 (b) of the Patents Act, mere importation cannot be considered as working. This has been introduced to prevent abuse of monopoly rights and is in keeping with Article 5 of the Paris Convention and Article 2, 7 and 8 of TRIPS.
The Department of Industrial Policy and Promotion prepared a Discussion Paper on the subject of Compulsory Licensing and hosted the same on its website to invite the views and suggestion on certain issues for resolution. The objective of this exercise was not to invite any change/amendment to the provisions of the Patent Act 1970 but only to elicit the suggestions to take an appropriate policy decision whether the existing provisions of the Patents Act, 1970 require any amplification through issuing of guidelines by the Government. After obtaining and examining the suggestions on the said Discussion Paper, the Government has decided that there is no need to issue additional guidelines for the issue of Compulsory License and issued a press release to this effect to conclude the matter. The said Discussion Paper is available on the official website of this Department i.e. www.dipp.nic.in.
Switzerland 23:
Report by the Secretariat: III. Trade policies and practices by measure: (4) Measures affecting production and trade: (vi) Intellectual property rights: General question:
The Report of the Secretariat does not explicitly mention the protection of undisclosed information as provided for in Article 39.3 of the TRIPS Agreement. We would like to ask the following question related to the marketing approval of pharmaceutical or of agricultural chemical products, which utilize new chemical entities:– If a private party submits its undisclosed test data to the marketing approval authorities of India, under what legal regime and how are these test data protected against unfair commercial use as required by Article 39.3 of the TRIPS Agreement? Could the Indian authorities indicate the relevant national legislation and how it implements Article 39.3 of the TRIPS Agreement.
Reply: India implements Article 39.3 of the TRIPS Agreement through the existing legal mechanisms which are the common law, principles of equity and the law of breach of confidence developed through case law. Protection is also provided through the provisions of Law of Torts and the Indian Contract Act, 1872 where remedies are available. Section 5 of the Official Secrets Act provides that unauthorized disclosure of official secrets is a punishable offence. This provision is also applicable to government employees.
UNITED STATES
US 84:
Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (3) Measures Directly Affecting Exports: (4) Measures Affecting Production and Trade: (vi) Intellectual property rights: Page 114, paragraph 250
The Secretariat discusses the proof of efficacy requirement in Section 3(d) of India’s Patent Act. Under Section 3(d), if an applicant demonstrates the novelty, non obviousness, and industrial use of a product, can it still be denied a patent on the grounds that it fails to also demonstrate a significant improvement in efficacy? Does the Government of India consider this requirement to be in line with TRIPS Article 27(1) which states that patents shall be available for inventions in all fields of technology provided they are new, involve an inventive step, and are capable of industrial application? Please explain.
Reply:
– Patents are available to any invention that meets the criteria of patentability, that is, novelty, inventiveness and industrial application.
– Section 3(d) prevents the grant of patent for merely new forms or new usages of known substances and thus averts grant of frivolous patents, which may be obtained by minor modifications, particularly in the pharmaceutical sector.
– The provisions for requirement of enhancement of the known efficacy under section 3(d) of the Patents Act, 1970 are only for the mere discovery of a new form of a known substance. This provision has been made only to prevent the ever greening of product patents.
– Section 3(d) is also intended to ensure availability of medicines by preventing ever greening of existing patents and thus is in consonance with Member States’ rights of ensuring availability of medicines at reasonable prices for meeting public health requirements.
– This is one of the recognized flexibilities available under Article 8 of the TRIPS Agreement that countries are free to adopt in their legislation as per Doha Declaration.
– The Declaration states that TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
– As such the said provisions of section 3(d) of the Patents Act, 1970 are fully compliant with Article 27(1) of the TRIPS Agreement read with Article 8 of the said Agreement.US 85:
Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (3) Measures Directly Affecting Exports: (4) Measures Affecting Production and Trade: (vi) Intellectual property rights: Page 115, paragraph 256:
The Secretariat indicates that DIPP has issued a discussion paper on patent compulsory licensing with a view to developing a predictable environment to use such measures. How will the Government of India ensure that any suggested changes to current implementation of compulsory licensing complies with all of the conditions in TRIPS Article 31? Does India plan to seek public comments regarding any changes it is considering? How does the Government of India satisfy the undisclosed information obligations of TRIPS Article 39(3), including protection of data against unfair commercial use?Reply: The Department of Industrial Policy and Promotion (DIPP) prepared a Discussion Paper on the subject of Compulsory Licensing and hosted the same on its website to invite the views and suggestion on certain issues for resolution. The objective of this exercise was not to invite any change/amendment to the provisions of the Patent Act 1970 but only to elicit the suggestions to take an appropriate policy decision whether the existing provisions of the Patents Act, 1970 require any amplification through issuing of guidelines by the Government. As such, the question of any change to the existing provisions of the Patents Act 1970 does not arise. Moreover, after obtaining and examining the suggestions on the said Discussion Paper, the Government has decided that there is no need to issue additional guidelines for the issue of Compulsory License and issued a press release to this effect to conclude the matter. Further, the existing provisions of the Patent Act 1970 are already TRIPS compliant including Article 31 thereof.
As regards the protection of undisclosed information against unfair commercial use as per Article 39(3) of TRIPS Agreement, adequate safeguard provisions are there in the existing Acts
These questions from the United States are taken from WT/TPR/M/249/Add.2.
UNITED STATES
Follow-up questions
US FQ 29:
(on US 84)Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (3) Measures Directly Affecting Exports: (4) Measures Affecting Production and Trade: (vi) Intellectual property rights: Page 114, paragraph 250
The Secretariat discusses the proof of efficacy requirement in Section 3(d) of India’s Patent Act. Under Section 3(d), if an applicant demonstrates the novelty, non-obviousness, and industrial use of a product, can it still be denied a patent on the grounds that it fails to also demonstrate a significant improvement in efficacy? Does the Government of India consider this requirement to be in line with TRIPS Article 27(1) which states that patents shall be available for inventions in all fields of technology provided they are new, involve an inventive step, and are capable of industrial application? Please explain.
Reply:
• Patents are available to any invention that meets the criteria of patentability, that is, novelty, inventiveness and industrial application.
• Section 3(d) prevents the grant of patent for merely new forms or new usages of known substances and thus averts grant of frivolous patents, which may be obtained by minor modifications, particularly in the pharmaceutical sector.
• The provisions for requirement of enhancement of the known efficacy under section 3(d) of the Patents Act, 1970 are only for the mere discovery of a new form of a known substance. This provision has been made only to prevent the ever greening of product patents.
• Section 3(d) is also intended to ensure availability of medicines by preventing ever greening of existing patents and thus is in consonance with Member States’ rights of ensuring availability of medicines at reasonable prices for meeting public health requirements.
• This is one of the recognized flexibilities available under Article 8 of the TRIPS Agreement that countries are free to adopt in their legislation as per Doha Declaration.
• The Declaration states that TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.
• As such the said provisions of section 3(d) of the Patents Act, 1970 are fully compliant with Article 27(1) of the TRIPS Agreement read with Article 8 of the said Agreement.U.S. Follow-Up Question: We understand from India’s response that an invention that meets the three criteria of patentability could not separately be denied a patent on the grounds specified in Section 3(d). Is this correct? If not, please explain the interaction between the patentability criteria and Section 3(d).
Reply: Patents are available to an invention that meets the three criteria of patentability. However, the provisions for requirement of enhancement of the known efficacy under section 3(d) of the Patents Act, 1970 are only for the mere discovery of a new form of a known substance, as like salts, esters, ethers, polymorphs, isomers, etc. which may be obtained by minor modifications, particularly in the pharmaceutical sector. This provision has been made only to prevent the ever greening of product patents.US FQ 30:
(on US 85)
Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (3) Measures Directly Affecting Exports: (4) Measures Affecting Production and Trade: (vi) Intellectual property rights: Page 115, paragraph 256:
The Secretariat indicates that DIPP has issued a discussion paper on patent compulsory licensing with a view to developing a predictable environment to use such measures. How will the Government of India ensure that any suggested changes to current implementation of compulsory licensing complies with all of the conditions in TRIPS Article 31? Does India plan to seek public comments regarding any changes it is considering? How does the Government of India satisfy the undisclosed information obligations of TRIPS Article 39(3), including protection of data against unfair commercial use?
Reply: The Department of Industrial Policy and Promotion (DIPP) prepared a Discussion Paper on the subject of Compulsory Licensing and hosted the same on its website to invite the views and suggestion on certain issues for resolution. The objective of this exercise was not to invite any change/amendment to the provisions of the Patent Act 1970 but only to elicit the suggestions to take an appropriate policy decision whether the existing provisions of the Patents Act 1970 require any amplification through issuing of guidelines by the Government. As such, the question of any change to the existing provisions of the Patents Act 1970 does not arise. Moreover, after obtaining and examining the suggestions on the said Discussion Paper, the Government has decided that there is no need to issue additional guidelines for the issue of Compulsory License and issued a press release to this effect to conclude the matter. Further, the existing provisions of the Patent Act 1970 are already TRIPS compliant including Article 31 thereof.As regards the protection of undisclosed information against unfair commercial use as per Article 39(3) of TRIPS Agreement, adequate safeguard provisions are there in the existing Acts.