Data exclusivity provisions in India

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DATA EXCLUSIVITY PROVISIONS IN INDIA

P.ILANANGAI

PATENT DEPARTMENT



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INTRODUCTION

• Intellectual property rights have evolved over the years with the intention of protecting novelty and innovation of ideas while creating a competitive market.

• The strongest tools-Patents.

• In the field of pharmaceuticals, foods and agrochemicals, marketing of products requires statutory clearances from the appropriate National regulatory bodies.

• Generating such data generally involves elaborate experimentation, trials in various phases, chemical analysis, and an estimation of the impact on the environment, all of which are time-consuming and expensive processes.

• Thus the intellectual property right of data exclusivity becomes important, as it involves the question of whether these processes, once completed, can be taken advantage of by other applicants.



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DATA

• Clinical trial data and other test data are the proprietary data resulting from scientific discovery and development conducted by the originator with investment of time and cost, to demonstrate the efficacy and safety of new chemical entities, formulations and their new uses.

• Clinical trial data becomes very important at the time of obtaining marketing approval from regulatory authorities.

DATA EXCLUSIVITY (DE)



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• Data Exclusivity (DE) or marketing exclusivity, or exclusivity of registration data is the period of non-reliance and non-disclosure that is provided to new chemical entities, pharmaceutical compositions, and agrochemical registration data or test data.

• It is for a limited period of time when the Drug Regulatory Authorities [DRA] do not allow the test data of the originator to be used to register the generic version.

• Data exclusivity is an independent intellectual property right.

• The concept of protecting undisclosed data having high commercial value has gained momentum to be protected as exclusive data or information under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in recent times.

• Conventionally this data was protected as trade secrets under the Common law.

• Data exclusivity provides the originator with rights to preclude third parties from relying on the data to obtain marketing approval for a specific period of time. However, it does not prevent third parties from generating their own data.




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Data exclusivity ensures that

• - the originator obtains market exclusivity for a specified period which in turn enables him to recover the costs incurred in obtaining the marketing approval;

• - for a specified period, the regulatory agency must not access the originator's data, without his consent, when reviewing an application from a second entrant seeking approval of a copied product.

• Second entrants may apply for their formulations or products, but always must obtain authorization from the originator's data and prove bioequivalence according to international standards.

• Generic manufacturers can also apply for marketing approval provided that they conduct their own tests to prove the efficacy and safety of their product.

• Test data protection gained international attention when it was made necessary to restrict unfair competition under the Paris Convention and thus the obligation arose to protect undisclosed information.

contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



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• Data exclusivity again came into the limelight in 1994 with the Agreement on TRIPS. TRIPS advocated for such exclusivity to the registration data under Article 39(3).

WORLDWIDE SCENARIO

• Most of WTO member states have recognized and appreciated the role of data exclusivity.

• The period for which the originator can enjoy the exclusivity after the marketing approval is generally between 5 to 10 years.

UNITED STATES

• In 1984 the US became the first country to enact data exclusivity legislation.

• The Drug Price Competition and Patent Term Restoration Act, commonly known as the "Hatch-Waxman Act", actually relaxed the level of protection afforded to testing data in the US.

• Under the Hatch-Waxman Act, applications for approval of new drugs receive 5 years of data exclusivity. Applications for the approval of new indications for an existing drug receive 3 years of data exclusivity.

• contd…




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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WEBSITE

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OTHER COUNTRIES

• EU, Australia, New Zealand and the Andean Group countries have a system for providing data protection whereby the results of the invention for which a patent has been granted would not be available to public and R&D agencies for a period of five years.

• China grants data exclusivity for 6 years; Philippines 8 years; Brazil 10 years; Korea 8 years and Taiwan 6 years. Japan provides the data exclusivity from 4 to 10 years.

• However, there is a group of countries which deny the TRIPS mandate, and India is one amongst these countries.

INDIAN SCENARIO

• The Indian law has no statutory protection for the data that is submitted to regulatory authorities for testing for approval of any manner of products.

• contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



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• RELEVANT INDIAN LAWS

• The Official Secrets Act, 1923, is a legislation binding public servants from disclosing or using any confidential information in an unauthorized manner, so as to affect the security, sovereignty and integrity of the country.

• Trade secret protection is a common law remedy to prevent the disclosure of information, but it is a private remedy that is untested against regulatory authorities in India.

• The Insecticides Act, 1968 is the most relevant legislation in India, from the point of view of crop-protection chemicals.

• The Indian Patents Act, 1970




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INDIA'S STAND ON DATA EXCLUSIVITY

• Generic manufacturers in the country are gripped with the fear that granting data exclusivity right would lead to ever greening of patents.

• The Indian government has consistently taken the stand that Article 39(3) does not oblige member states to introduce data exclusivity legislation in the country.

• Article 39.3 of TRIPS says that WTO members should protect "undisclosed information and data" against "unfair commercial use" and "disclosure". Nowhere does TRIPS state that countries should provide exclusive rights to the originator of the data for a given period.

• TRIPS refer generally to the need for "data protection". Data protection against unfair commercial misuse as mentioned in TRIPS is totally different from data exclusivity.

contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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INDIA'S STAND ON DATA EXCLUSIVITY

• As per current practice in India, generic manufacturers have to apply for marketing approval of the generic version of a medicine to the DRA of India. They are only required to provide simple and straight forward studies to prove that their generic version of the medicine is the therapeutic equivalent to the original and thus they do not need to re-submit test data regarding safety and efficacy, which is already with the DRA. For this, the DRA is entitled to rely on test data submitted by the pharmaceutical company who first sought marketing approval for the medicine.

• The government of India is considering amendments to the Drugs and Cosmetics Act, under pressure from the US, European countries and multinational pharmaceutical companies to amend the act to include data exclusivity protection provisions.

contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

EMAIL

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WEBSITE

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WHY SAY NO TO DATA EXCLUSIVITY?

• Most drug manufacturers in India work only on generic drugs.

• If data exclusivity is approved, domestic enterprises would be prevented from obtaining marketing approvals on the basis of the data submitted by the first enterprise that had generated and submitted the data.

• REASONS WHY DATA EXCLUSIVITY RIGHTS SHOULD NOT BE GRANTED IN INDIA

• Firstly, there seems to be no clear economic justification as to why data exclusivity should be granted to firms that already avail a patent protection term of twenty years globally for their products.

• If the generic industry in India is curbed further, a large amount of cheap supply of medicines at very competitive prices will be seriously affected.

• contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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• India is a major supplier of the world’s generic medicines and exports two-

thirds of its generic drugs to developing countries. The excellent capability

of Indian pharmaceutical industry to produce generic drugs at affordable

cost is a well-established fact.

• In order to enter even small and marginally profitable markets, generic

competitors would be required to duplicate expensive and time-consuming

clinical trials in order to establish safety, quality, and efficacy.

• Another concern is that animals and other research subjects are dangerously

exploited if the second applicant has to replicate studies already performed

by the pioneer company.

• So, If the data exclusivity law is enacted as mandatory for all ‘new drugs’

as presently defined under the Drug Control Authority (DCA), drug

companies will be able to enjoy de facto monopoly rights over trivial

changes that may not even be patentable under patent laws for lack of

inventiveness, but still qualify as new drug under the DCA.

• contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

IMPLICATIONS OF DATA EXCLUSIVITY

• Data Exclusivity measures extend the period of patent protection for drugs beyond the stipulated 20 years, adversely affecting access to affordable generic drugs.

• In Guatemala in February 2004, Atazanavir, an anti-retroviral (ARV) drug (priced at US$ 10, 000 per person per year) received data exclusivity protection for five years under the law passed by the Government. With generic competition the price can be expected to fall by approximately 95 per cent. However, even if a more affordable generic version of Atazanavir is developed, it cannot enter the Guatemalan market until 2009 as drug regulatory authorities have to provide DE protection to test data related to Atazanavir. As a consequence, DRA in Guatemala is barred from relying on it to approve subsequent generic versions.

• contd….




Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

IMPLICATIONS OF DATA EXCLUSIVITY

• Even when a medicine is not protected by any patent, multinational pharmaceutical companies are assured a minimum period of monopoly in countries that provide data exclusivity. This is clearly going beyond the TRIPS Agreement.

• Where a medicine is protected by patents, data exclusivity may constitute a barrier to the use of compulsory licenses. If a generic manufacturer is granted a compulsory license to overcome the patent, it will not be able to make effective use of the license if it has to wait for the expiry of data exclusivity before it can get its generic version approved by DRA and put on the market.

• Data exclusivity is a means of impeding generic competition, and maintaining artificially high prices, thereby restricting access to medicines.




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Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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• In Ruckelshaus v. Monsanto Co., the U.S. Supreme Court described the extensive practice of relying on data submitted by the first applicant in the U.S. and recognised that the relevant authority could use the data submitted by the originator to assess second-entrant applications. According to the law applicable at the time of the complaint, the applicant was entitled to compensation, but not to exclusive use of the data.

CASE LAW



Chennai - 600 004.Tel: +91 - 44 - 2498 4821



Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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• The government of India is considering amendments to the Drugs and Cosmetics Act, under pressure from the US, European countries and multinational pharmaceutical companies to amend the act to include DE protection provisions.

• If such DE provisions are introduced in the Drugs and Cosmetics Act, generic drug manufacturers will not be allowed to get the drug data testing information for a definite period of time thus seriously affecting the production of affordable generic medicines in the country.

• There will be no competition.

• Provide absolute monopoly to the multinational drug companies.

• The grant or refusal of Data Exclusivity protection has to be considered keeping in mind the Nation's interest and provisions of Doha Declaration and TRIPS Agreement.

• The Government must inculcate confidence in the mind of these pharmaceutical companies that their interest and data will not be misused as stipulated in the TRIPS Agreement and beyond that it need not to enter into the controversy of data exclusivity.

CONCLUSION



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Bangalore - 560 001.Tel: +91 - 80 - 6546 2400



Tel: +91 - 422 – 6552921

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THANK YOU!!!!

Law

Data exclusivity provisions in India