India: Data Exclusivity & Patents Unrelated

The seven different forms of intellectual property rights stipulated in TRIPS are patents, copyrights, trademarks, industrial designs, geographical indications, protection of IC layout design and protection of undisclosed information. Each one is independent of each other and protects different aspects of an inventive work and extends different rights to the owner. TRIPS in Article 39 dealing with the protection of undisclosed information (trade secrets), deals invariably with non-disclosure of data meaning thereby data exclusivity.

Article 39.3 of TRIPS on Protection of Undisclosed Data states: "Members, when requiring, as condition of approving the marketing of pharmaceutical or agricultural chemicals products which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use."

The scope and intent of the Article requires members to protect such data against both "disclosure" and "unfair commercial use". While the first requirement is straightforward, the second necessitates that Data have a "commercial value" as they give the originator marketing rights. Now, if another person also gets these rights without having to submit his own data, but based on the originators data and hence no effort, will give the latter an "unfair commercial advantage". This can be prevented by providing for a period of "exclusivity" to the originator of the drug or the first applicant during which a subsequent applicant cannot get market approval citing former's data. This will enable the originator to recoup his investment in generating the data. At the same time, users will have access to the original knowledge. On expiry of the "exclusivity" period, the subsequent applicants can be given market approval by demonstrating the parity of their products with that of the originator/first applicant.

Thus "Data exclusivity" refers to test and other data that a pharmaceutical company must provide to a drug regulatory authority in order to get first-time registration for any new medicine it wishes to market in a country. This test data is necessary to demonstrate the efficacy and safety of the drug to get registration or marketing approval by the drug regulatory authority of that respective country. This practice prevents, for a fixed period of time, the drug regulatory authorities to allow the registration files of an originator of a drug to be used to register a therapeutically equivalent generic version of that medicine. Practically data exclusivity prevents drug regulatory authorities from registering generic versions of a medicine during a limited period, unless the generic manufacturer independently carries out its own tests showing the safety and efficacy of the medicine.

Data exclusivity is like a complete monopoly for a set period but it must not be confused with patent. For a patent grant, an innovation has to fulfill the three criteria of novelty, inventive step and capable of industrial application. Following patent grant, the entire knowledge associated with innovation comes into public domain, unlike in the case of data exclusivity. In this case subsequent applicants can get market approval based on their own data. Patent confers monopoly to the patent holder during the patent term.

To be eligible for Data Exclusivity, a product should meet the criteria of New Chemical Entity as per patent law but the registration data and innovation are two separate intellectual properties. TRIPS agreement clearly recognises this by providing for data protection and patent protection respectively under different articles. Therefore transposing a New Chemical Entity as defined in the context of patent, to read the provisions of the Article 39 would result in a dangerous situation whereby products not patent-protected will not qualify for grant of data exclusivity.

The data exclusivity protects registration data or long-term studies resulting in clinical data in case of drugs for getting market approval for that drug whether protected by patent or not. Where there is a chance of overlap of the two forms of intellectual property rights, Patent and data exclusivity are meant to protect distinct IP rights. Hence, there is no question of double protection. DE protects efforts involved in registration data generated irrespective of whether the product is protected by patent or not whereas patents protects a novel product which is not obvious to the person having ordinary skill in the art or is non-obvious. In other terms, unlike patent, grant of data exclusivity does not give market exclusivity.

What happens if Data Exclusivity is not granted? An original applicant not meeting patentability criteria or patent term expired will be left in the lurch. Without it, even an applicant enjoying patent protection at the time of registration could be vulnerable if the residual patent term is small.

All the myth that data exclusivity is similar to patents, are the result of a mind-set that views data exclusivity through the prism of patent. Data Registration is an independent intellectual property. This must be protected by grant of Data Protection/Data Exclusivity to the original registrant.

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