India: Data Exclusivity – The Indian Perspective

Last Updated: 21 September 2004
Article by Manisha Singh

Under Special 301 of the U.S. Trade Act of 1974 India has been put on the ‘PRIORITY WATCH LIST’ of USTR (United States Trade Representative) for failing to provide an adequate level of protection or enforcement and market access for persons relying on Intellectual Property protection. The absence of ‘data exclusivity’ legislation inter alia forms the reason for India’s inclusion in the list. Special 301’ is a part of the U.S. Trade Law that requires the USTR to identify countries that deny adequate protection for Intellectual Property Rights or that deny fair equitable market access for the U.S. persons who rely on IP protection. PRIORITY WATCH LIST’ are the countries or trading partners that have very serious problems in terms of scope and/or impact on U.S. commerce requiring the focus of increased bilateral attention on the problem areas.

The Government of India has constituted a High level Inter-ministerial committee to consider steps to be taken in the context of the provisions of Article 39.3 of the TRIPS agreement for the protection of undisclosed information. As the Indian government caves in to the economic coercion of the U.S. government backed by the omnipotent Pharmaceutical lobby of U.S this paper attempts to analyze what India stands to lose or gain and what alternative we have to come out of this conundrum victoriously. There are several burning questions that come to the forefront with regard to the issue of data exclusivity –

  • does Article 39.3 of the TRIPS agreement mandate ‘data exclusivity’ or mere ‘data protection’?
  • should the developing countries like India adopt measure of data protection other than data exclusivity?
  • would data exclusivity sound death knell for the India pharmaceutical industry with a strong generic base?
  • what would be the ramifications of such legislation on Indian Population more than half of which lives under abject poverty?

It is imperative to find answers to these questions, as we have to reconcile the apparently opposing mandates of public health and strong IP protection. The predicament before the developing countries like India is how to strike a fine balance between public health and the demand of increased IP protection. Before attempting to analyze these issues it is important to understand the meaning of ‘data exclusivity, its genesis, impact on drugs and the reasons for conferment of this privilege.

Data exclusivity –meaning, genesis and impact

Data exclusivity is generally defined in United States as a period of exclusive marketing rights granted to a new drug application (NDA) upon obtaining marketing approval by the regulatory authority if certain statutory requirements are met.

The regulatory bodies require the pharmaceutical companies to submit extensive data establishing the safety and efficacy of a new drug before approving it for sale. This data arises out of many years of research and clinical trials and is the most expensive part of drug development. It is estimated that the total cost of drug development and marketing is approximately $500 in industrialized countries. Data exclusivity laws prevent the regulatory bodies from accessing the originators data when considering an application for a generic competitor seeking approval to sell an equivalent competing product. Thus in the countries where data exclusivity is granted the regulatory authorities can take up the applications for generic versions only after the expiry of data exclusivity period. In the alternative the competitor is required to generate his own marketing approval data. The period of data exclusivity is provided by the national legislation of a country and as such there is no uniform period.

Data Exclusivity legislation was for the first time enacted by United States of America in the year 1984.The 1984 Drug Price Competition and Patent Term Restoration Act popularly known as Waxman-Hatch Act provides for there different terms of marketing exclusivity depending on the type of drug. Each type of exclusivity has specific requirements and results in various lengths of time for which the applicant is granted the exclusive marketing rights. Three main Types of exclusivity are Orphan, Waxman-Hatch and Pediatric granted for 7years, 5years and 3 years respectively from the date of approval of the drug. Exclusivity for the first time approval of a new chemical entity in the US is for a period of 5 years.

Interestingly data exclusivity provision is seen in US as balancing the interests of innovator or pioneer drug firm that bear the research and development and the interests of the generic drug industry that can increase competition and lower the cost of the drug

The reasons for granting exclusivity in United States have been enumerated as-

  • to achieve balance between the pioneer drug industry and the generic drug industry
  • Costly clinical trials that established the safety and effectiveness of the drug would not need to be repeated in order for a generic drug to enter the market place. Once information has been established about a drug, there is no requirement for a second sponsor to prove the safety and efficacy a second time.
  • exclusivity is an incentive to a new drug development in particular in the absence of patent protection.
  • unnecessary death of and suffering to the animals due to duplication of tests could be avoided.
  • Side effects to the human subjects due to repetitive trials can be obviated.

European Community adopted data exclusivity in the year 1987 vide the Directive 65/65 EE (amended 87/21/EEC). The period of data exclusivity in European community varies from 6 to 10 year. Data exclusivity arose in the European Community during the time when there was no patent for biotech products in order to protect the biotech industries and afforded the biotech products some form of market protection. U.K., Sweden, Netherlands, Germany, Italy, France and Belgium grant 10 years data exclusivity. More than half of the members of European union provide 6 years of data exclusivity.

In Japan, the data exclusivity period varies from 4 years (for medicinal products with new indications, formulations, dosages, or compositions with related prescriptions) to 6 years (for drugs containing a new chemical entity or medicinal composition, or requiring a new route of administration) to 10 years (for orphan drugs or new drugs requiring pharmaco-epidemiological study). In New Zealand the protection period is 5 years. There is no data exclusivity period for data relating to new uses or formulations of old active ingredients

Data exclusivity is primarily granted for pecuniary reason that is to enable the initial registrant to recover investment made by him in obtaining the marketing approval. In the absence of data exclusivity period, generic drugs could be introduced onto the market on the basis of bioequivalence tests without the having to replicate the time consuming and expensive clinical trials that are used to establish safety and efficacy of the product. The duplication of the tests would be inefficient use of the resources.

Bioequivalence means-‘the absence of a significant difference in the rate and extent to which an active ingredient or active moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions’

If bioequivalence is established, the products will have the same clinical effect and safety profile, and are considered to be therapeutically equivalent and interchangeable.

TRIPS Agreement

As a part of the Uruguay Round of the World Trade Organization (WTO) multilateral negotiations a new and rigorous treaty on intellectual property rights- the TRIPS was established in 1994. Beginning on the 1st of January 1995, the Agreement on Trade Related Aspects of Intellectual Property Rights administered by WIPO became the standard for protecting IPRs in those nations seeking to engage in international trade and enhance their prospects for economic growth. Thus the members of WTO are obliged to adhere to and provide for the minimum protection prescribed by the TRIPS.

Accordingly, member countries are required to amend their laws to bring them in conformity with the substantive standards laid down by TRIPS. Failure to do so within the conceded time would certainly lead to referral of the matter to the Dispute Settlement Body of WTO. An affirmative finding of the Body and non-compliance may culminate into trade retaliations by the member nations.

Developing countries where product patent was not being granted at the time of adoption of TRIPS were given time till 1st January 2005 to bring their patent law in line with TRIPS. India being one of them is legally bound to make the requisite amendments in its domestic patent law by the said date.

However there are certain controversial and unsettled provisions in TRIPS, which have triggered considerable deliberations and debate in the international fora. The scope, meaning and the manner of their implementation remain nebulous. Article 39.3 dealing with data protection is one such provision. Article 39.3 runs thus:

3. Members when requiring as a condition of approving marketing of pharmaceutical or of agricultural chemical product which utilize new chemical entities, the submission of undisclosed test or other data, the originator of which involves considerable efforts shall protect such data against disclosure, expect where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use"

Thus, if in respect of pharmaceutical or agricultural chemical products which utilize a ‘new chemical entity’, the regulatory authority of a country requires submission of ‘undisclosed clinical and test data’ for granting marketing approval it is under obligation –

  • protect the data against ‘unfair commercial use’
  • protect the data against ‘disclosure’ expect where it is necessary to protect the public or unless steps are taken to ensure that the data are protected against ‘unfair commercial use’.

The diclosure is permitted only in two circumstances-

  • Where it is necessary to protect the public
  • Where the data is protected from unfair commercial use

As it is evident from the language of the Article, latitude is given to the individual members to take such steps as they deem fit for protecting data against ‘unfair commercial use’. The purpose of Article 39.3 can be inferred from paragraph 1 of the same article that is to ‘ensure effective protection against unfair competition’. Article 39.1 provides-

39.1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 below with data submitted to governments or governmental agencies in accordance with paragraph below.

Unfortunately the agreement refrains from defining the practices that would constitute ‘unfair commercial use’, thus allowing the several interpretations to creep in. The term ‘unfair competition’ has been defined in article 10bis of Paris Convention but that does not aid in identifying the practices that would fall within the gamut of the ‘unfair commercial use.

Reference may also be made here of the WIPO model provision on protection against unfair competition (1996). Article 6 of the model provisions lays down the acts that would amount to unfair competition in respect of Secret Information. It reads as follows:

Article6 (1) -Any act or practice, in the course of industrial or commercial activities, that results in the disclosure, acquisition or use by others of secret information without the consent of the person lawfully in control of that information (hereinafter referred to as "the rightful holder") and in a manner contrary to honest commercial practices shall constitute an act of unfair competition.

Two points emerge from this general principle:

  • Firstly the disclosure, acquisition or use of the secret information must be without the consent of person lawfully in control of that information.
  • Secondly it must be in a manner contrary to the ‘honest commercial practices’.

Applying it to pharmaceutical products utilizing new chemical entity, when the undisclosed data is submitted to the drug Regulatory authority, it becomes the trustee of that data and the originator remains the person lawfully in control of the data or ‘the rightful holder’. The authority thus not being the ‘rightful holder’ cannot use the data for any purpose other than for which it is submitted without the consent of the ‘rightful holder’. The sole purpose for which the data is submitted by the originator is to enable the authority to evaluate the data for ascertaining the safety and efficacy of the drug before granting marketing approval. Therefore the regulatory authority should not be allowed to rely on that data without the consent of the originator for testing the safety and efficacy of the subsequent applications.

Further where considerable cost is incurred by the originator in order to earn reward for his investment, it would be unjust to deprive him of the legitimate and reasonable profits by allowing the other persons to avoid the cost of undertaking the similar procedure and rolling out the same drug at much lower price. Thus compelling a person to suffer loss would tantamount to acting in a manner contrary to honest commercial practices.

The model also provides some examples of unfair competition in respect of secret information. It provides that disclosure, acquisition or use of secret information by others without the consent of the rightful holder may, in particular, result from

(i) industrial or commercial espionage;

(ii) breach of contract;

(iii) breach of confidence;

(iv) inducement to commit any of the acts referred to in items (i) to (iii);

(v) Acquisition of secret information by a third party who knew, or was grossly negligent in failing to know, that an act referred to in items (i) to (iv) was involved in the acquisition. [Article 6(2)]

This list is however inclusive and not exhaustive in nature and can very well include use of data to grant approval for those drugs for which it was not meant. Information is regarded as secret if -

(i) It is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;

(ii) It has commercial value because it is secret; and

(iii) It has been subject to reasonable steps under the circumstances by the rightful holder to keep it secret.

Article 6(4) of the said model correspond with Article 39.3 of the TRIPS agreement and is full of the same ambiguities as the latter. The model also deliberately refrains to define unfair commercial use.

Article 39.3 of TRIPS has bifurcated member nations into two camps viz: - One consisting of developed countries reading ‘data exclusivity’ into Article 39.3.The most vociferous advocates include United States of America and European Union. The second Group consisting of Developing countries who subscribe to the view that data protection does not extend to granting ‘data exclusivity’ as data exclusivity invariably leads to market exclusivity, which is not envisaged by Article 39.3.

Opponents of data exclusivity rely on the negotiating history of TRIPS to refute the contention that TRIPS mandates ‘data exclusivity’. The United States and European Union had made the proposal to the GATT signatories to adopt explicit language that would obligate members to Guarantee data secrecy and exclusivity for "a reasonable period" except upon compensating the initial registrant for the "reasonable value" of any use that offered a "commercial or competitive benefit" to any other person, including the government. However the proposal was rejected by the negotiators who finally adopted the present provision. An insight into the background of the Article 39.3 would make it amply clear that the interpretation forwarded by the developed countries does not withstand scrutiny. Moreover, an author argues that if the intention had been to have such exclusive marketing rights, this term, which is used in Article 70.9 of TRIPS, would have been used here too. Therefore, she avers, that a reasonable interpretation would be that the obligation on the authorities would be to keep the test data secret and to prohibit others from accessing this test data for unfair commercial use, such as sale to rival firms and this substantive obligation would exclude use by the authorities without disclosure of the data (Jayashree Watal, 2000).

It is evident from bare reading, that Article 39.3 does not per se mandate data exclusivity.

However many countries recognize marketing approval data as ‘trade secret’ of the drug developer and hence justify the data exclusivity laws. Proponents of this view give cogent reasons for regarding ‘clinical and test data’ as trade secret. The reasons forwarded are-

  • Protection in form of confidentiality obligation, granted to the data is consistent with the treatment of the data as trade secret.
  • Article, 39 falls in section 7 of the Part II of the TRIPS Agreement, which is concerned with Trade secrets and the Drug Marketing approval provided in Paragraph 3 is just a subset of the trade secret.
  • Article 1.2 of the TRIPS Agreement labels the subject matter protected by Section 7 as a category of ‘intellectual property

Article 1.2 reads thus:

For the purposes of this agreement, the term "Intellectual Property" refers to all the categories of intellectual property that are subject to Sections 1 to 7 of Part II

Therefore it is argued that prohibition on unfair commercial use when considered in the backdrop of trade secret principles does require data exclusivity (Aaron Xavier Felmeth, 2004).

Should India adopt measure of data protection other than data exclusivity?

Developed countries traditionally take the view that strengthening IPR protection fosters economic growth in developing countries by facilitating international investment while simultaneously rewarding domestic innovation. By contrast developing countries see IPR protection as impeding the flow of knowledge by increasing cost and decreasing access to new technology. Developed countries argue that IPRs therefore slows economic development and decrease social welfare, at least in short term (Gary Smith, 1999).

This argument against IPRs becomes all the more vehement in respect of Pharmaceutical products, as patented drugs are costly and unaffordable for the poor population. Moreover developing countries do not have the economic resources to provide health insurance cover to the people.

Data exclusivity protection is often charged of being a superfluous or sui generis form of protection. Many arguments are advanced against data exclusivity, which can be summed as follows-

  • Undermines genuine innovation as it encourages originator companies to focus their activities in changes in the product rather than focus on developing new innovative and beneficial product.
  • All the TRIPS members to 20 years have uniformly extended the product patent period.
  • Patents are increasingly being granted for new uses, indications, dosages and change in formulations.
  • Data exclusivity period is granted without originator having to demonstrate any of the basic principles of novelty or inventiveness.
  • Data exclusivity leads to ever greening of patents. Hypothetical example is often cited-suppose X Company applies for marketing approval of its drug in 17th year of patent, assuming data exclusivity period to be of 5 years, the total period of protection will increase to 22 years. Thus it could keep the generic drug producers out of the market for longer duration.
  • Poor consumers of medicines would suffer as a result of lack of competition in the market.

The battle lines over data exclusivity are predictably drawn between net exporters and net importers of intellectual property. The developing countries including India are reluctant in granting exclusive marketing privileges to affluent foreign drug companies for the fear that it would escalate the prices of drugs. On the other hand the developed countries fail to see any incentive to market such drugs in India in the without adequate recompense in form of data exclusivity.

Many sections of Indian Society fear that the data exclusivity will cause slew of problems for the consumers in India, would give excessive benefits and protection to the MNC pharmaceutical companies, deprive people of the generic equivalents, prices of the drugs would become exorbitant as a result a large chunk of the population will have to go without even the essential drugs.

Before we consider the ill effects of data exclusivity we must bear in mind that India is different from the other developing countries in various aspects. India has a well-developed Pharmaceutical industry, which has already notched up a large share in US generic market. Unlike other countries India has excellent outsourcing opportunities for clinical trials, R&D and technical services. In addition, fleet of highly trained scientists makes India an attractive destination for research projects. More than 15 percent of the scientists engaged in pharmaceutical R & D in US are of Indian origin.

Empirical evidence suggests that a stronger intellectual property protection would facilitate the flow of FDI in the developing countries. A study conducted by Mansfield indicated that effective intellectual property rights protection could be an important factor in securing foreign direct investment and technology transfer, especially in high technology industries. The findings indicate that, in relatively high-technology industries like chemicals, pharmaceuticals, machinery, and electrical equipment, a country's system of intellectual property protection often has a significant effect on the amount and kinds of technology transfer and direct investment to that country by Japanese and German, as well as U.S. firms (Edwin Mansfield, 1995).

Some of the international researches clearly indicate that a close relationship exists between level of Intellectual property protection and R & D expenditures. It was found that foreign R & D expenditures by Research based pharmaceutical firms was concentrated in Western Europe where patents are adequately protected and the R &D expenditures decreased by 6.6 percent over a period 1977 to 1987 in Latin America where the protection is relatively very poor (Rapp and Rozek, 1990)

According to a US representative protection of test data is key to company decisions on location of clinical trials. According to the U.S. National Institutes of Health (NIH), lack of data exclusivity in India is the primary reason why India only ranks 9th (compared to China which ranks 2nd), in funding given by the NIH outside of the U.S. U.S. pharmaceutical companies spent $30 billion on R&D in2001.

Pharmaceutical industry is a research and development intensive industry. Indian Pharmaceutical companies on an average allocate only 2 percent of their sales for R&D activities (only some allocate 6 percent). The growth of this highly competitive, technology-based industry is not possible without substantial investment. Most of the Indian companies do not have the requisite financial resources to conduct extensive researches for bringing out novel drugs.

If data exclusivity legislation is enacted in India it would provide the necessary incentive to the originators to market their drugs in India without the fear of generic manufacturers and other multinational drug manufacturers free riding on their data. The benefits that would flow would be numerous. The Data Exclusivity laws would set the environment that would

  • Afford the opportunity to the Indian Research based pharmaceutical companies to bag important research projects form top pharmaceutical companies of US and European countries.
  • Increase the diffusion of knowledge and technology. Indian pharmaceutical industry needs to be aware and in possession of latest technologies used in developed countries in order to acquire a cutting edge in this sector. India is lagging behind in developing technology for the latest drug delivery system.
  • Create demand for Indian scientists in the domestic research organizations and thus would be effective in checking brain drain from India. Most of the talented Indian scientist migrate to the greener pastures in US, UK and other European countries. These scientists would have less incentive to emigrate if their creative work was adequately protected in India.
  • The research organizations once equipped with the structural resources can conduct researches that are specific to the diseases prevalent in India. Diseases such as tuberculosis, malaria, leprosy, plague and dengue fever continue to pose serious problems in India and take millions of lives each year. It is unlikely that such researches would be undertaken by the research firms located in developed countries.
  • Facilitate the entry of new drugs in the market particularly those that are not protected by patent.
  • Employment opportunity in the pharmaceutical sector would increase manifold.
  • Bring about scientific and technological integration.

More over if the Indian Pharmaceutical Industry has to give strong competition to countries like China and Israel we must create an environment, which allures the foreign firms to invest in India rather than to these countries. In china, the period of data exclusivity is 6 years and a data exclusivity law is already in the offing in Israel. China in September 2002 PRC Drug Administration Implementing Regulations introduced a new data exclusivity right. Under this law, the government (that is the SFDA) has an obligation to "protect against [the] unfair commercial use by any other person the undisclosed clinical data and other data … submitted by a manufacturer or marketer in obtaining the approval of manufacturing or marketing a drug containing new ingredients. During this six year period, any person who relies on data which is subject to the exclusive right shall be refused marketing approval unless the data relied upon is generated by himself or on his behalf.

Data Exclusivity and pharmaceutical industry in India

The Indian pharmaceutical industry is one of the most advanced among those of the developing countries. The ranking of the industry in the global market is fourth in volume (eight percent share in world market) and thirteenth in terms of value (1 percent share in the world market). The industry exports products worth rupees 141 billion to over 65 countries. The annual turn over is rupees 226 billion. Besides all the above, India has the largest number of US Food and Drug Administration (FDA) approved manufacturing facilities outside US. The number of Drug Master Files (DMFs) filed with the US FDA is twenty six percent higher then Spain, Italy, China and Israel.

The Indian pharmaceutical industry has availed tremendous advantage of the absence of product patent regime in the past. By using the copycat technique of reverse engineering, it has succeeded in bringing out generic versions of almost every new drug developed in the other parts of the globe within 5 to 6 years of its introduction in the market. At present there are over 60,000 generic brands in 60 therapeutic categories in the market.

The generic pharmaceutical companies of India offer cheap alternative for expensive branded drugs. Bristol-Myers Squibb (BMS) an American firm sells stavudin treatments for $3,400/year in US and $55/year in Africa, Cipla an Indian firm can sell the same drug for $40/year. Similarly Cipla and Ranbaxy laboratories can provide a daily dose of three antiretroviral for $244 and $292 per patient per year. A similar treatment from major US Pharmaceutical costs at least $562 per year.

National Sector units like Ranbaxy, Dr. Reddy’s laboratories, CIPLA, Sun Pharmaceuticals, Wokhardt, Zydus Cadila and others have come out with original research on development of new drugs, delivery system and even new molecules, acquiring patents in countries US and others. The products of Indian manufactures are accepted on the WHO list of essential drugs and also approved by the regulatory authorities in EU and US.

The pharmaceutical industry is not unanimous on the issue of grant of data exclusivity in India. There are two Trade associations representing the Pharmaceutical industry - Organization of Pharmaceutical Producers of India (OPPI) and the Indian Drug Manufacturers’ Association (IDMA). OPPI has requested the government to amend Schedule Y of the Drug and Cosmetic Act to include provisions for Data Exclusivity for period of 4 or 6 years from the date of marketing approval whereas IDMA opposes data exclusivity legislation in India. IDMA attributes the growth of the Indian pharmaceutical industry to the Indian Patent Act of 1970 or in the other words to the absence of product patent regime. OPPI is of the view that the discovery, development and bringing to market a new drug the originator requires to conduct extensive chemical, pharmacological and clinical research and testing and generate data for submission to the Drug Regulatory Authority for marketing approval of the new drug. This activity takes 8-10 years of painstaking efforts. The data generated in such work is proprietary to the originator and needs to be protected

OPPI is composed of both the national as well as multinational firms. Most of the leading pharmaceutical companies are its members.foreg- Aventis Pharma ltd, Novartis India ltd, Pfizer ltd, Eli Lily &Co. (Ind) Pvt., Workhardt ltd, Johnson &Johnson ltd, Merck Ltd, Glaxo Smith Kline etc. IDMA represents the national sectors of the of the Indian Manufacturers. It has a membership of 500 Indian large, medium and small companies. Members include: Ajanta Pharma Ltd, Cadila Health Care Ltd, Cadila Pharmaceuticals Ltd, Dabur India Ltd, Dr. Reddy’s Laboratories, Lupin laboratories, Merrill Pharmaceuticals etc.

Unlike Indian Pharmaceutical industry, generic industry of US strongly advocates strengthening of the Intellectual property regime by accepting the data exclusivity laws.

Once the period of exclusivity is over the generic drug producers can prove bioequivalence on the basis of the clinical and test data submitted to the regulatory body. Thus the interest of consumers can be balanced with that of the intellectual property holders.

Impact of data exclusivity on access to health care

"The Hatch –Waxman period of data exclusivity works in this country because the people in US have Health insurance that pays for essential drugs and because we have a safety care net to assure that the poorest in our society are not left without medical care and treatment. But to impose such a system on a country without a safety net, depriving millions of people of life of life saving drugs is irresponsible and even unethical. In developing countries we must do every thing in our power to make affordable drugs for the life threatening diseases available now"- Henry Waxman

In India, however the drugs, which are put in the Indian essential drug list, are not patented and the prices of these drugs will not be affected by strong patent protection. Moreover the product patent would only apply to new drugs, which would make a very insignificant percentage of the total market.

The empirical data is not clear whether data exclusivity definitely has adverse impact on the prices of drugs. The multinational Pharmaceutical companies practice the policy of differential pricing that is to say that the prices of the drugs vary from country to country depending on the purchasing capacities of the consumers. Differential pricing policy provides a mechanism, which ensures that the consumers in the developing countries are not excessively burdened with the high prices of the drugs.

The flexibilities, which are inherent in Trips like compulsory licensing under Article under Article 31 or the parallel importing from other countries can always be used as a tool for making the drugs more affordable in cases of emergencies and on the grounds permitted by the TRIPS agreement. Compulsory Licensing is "an authorization given by a National authority to a person, without or against the consent of the title-holder, for the exploitation of a subject matter protected by a patent or other intellectual property rights": (Correa, 1999)

An author divides the middle income countries like China, Argentina, India etc the consumers of medicines can very well be bifurcated into two groups viz: - rich and the poor. On humanitarian and social grounds the poor people can be exempted from paying the additional cost of a patented product but the rich, must contribute to the cost of research and development that goes towards creating a patented product. So he is opines the Rich cannot be allowed to reap unjust advantage by free riding on the clinical and test data produced by the originator (Arvind Subramanian, 2001).

Benefits of granting data exclusivity to the Pharmaceutical products utilizing new chemical entities would certainly outnumber the drawbacks Intellectual Property protection encourages innovation, which is a key factor that contributes to improved health care, through promoting both development of new medicines and economic growth generally. (Nozek and Tully, 1999)

Therefore the Indian Government must expedite the enactment of the data exclusivity legislation in India.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions