The concept of Drug Exclusivity can be perceived as a period or duration of time when a drug of a particular brand is protected from other generic drugs competition in the market. The conceptualization of Exclusivity was majorly evolved to induce and bring about a balance between new drug production and competition of generic drugs.
Initially, the concept of “exclusivity” was attributed to the protection of undisclosed data, and information that have highly commercialised value that needs to be protected in accordance with the TRIPS Agreement. Under the common law, these types of date have been protected as Trade Secrets.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
Therefore, in specific pertinence to drugs, there arises a need to gauge and assess the existing conditions in the developing countries wherein a generic drug manufacturer might develop drugs at prices that are cheaper by manufacturing a biologically equivalent drug that is similar to the innovator company.
The concept of exclusivity acts as a conflict between the inventing company that has already availed protection under the existing patent laws and that of the public interest.
Extension of Data Exclusivity to Drugs
In India, the Indian Pharmaceutical Alliance was brought notice about a rule change that was proposed by the Central Government to provide a longer duration of protection to drugs that are newly manufactured which would bring about an impact of generic and low cost medicines for the public in India.
This change was suggested in lieu of the United States Trade Representative (USTR), which falls under the United States government that is responsible for the enforcement of intellectual property from the US around the world. The proposed change by the central government was to increase the exclusivity period from the existing four years to that of ten years.
Data Exclusivity in essence includes the exclusion of registration data, and can be established as the period of not disclosing the chemical compositions, pharmaceutical compositions and any other form of agrochemical registration or test data. This is an individual intellectual property right and cannot be included under the protection that is provided by the other rights like the patents.
For Drugs, there are many clinical trials and tests that are conducted, the results of which cannot be disclosed as it is a resultant scientific discovery and the innovating company has invested expenses as well as time. A simple molecular discovery and development generally takes about a decade and is seen to be expending millions of dollars. Within this, the generation of test results takes 50% of the cost. Therefore, the data when publically disclosed might be taken advantage of by third parties.
Data and Drug exclusivity provide the innovating company with the right to secrecy and prevents third parties from utilising the data to obtain any marketing authorization for duration of time. But this right does not prevent any third parties from producing their own data.
Subsequent manufacturers could apply for their formulations and discoveries, but they have to get it sanctioned by the innovating company and prove the equivalence of the product with that of international standards. Otherwise, by simply making reference to the originator’s submitted information, they get an unnecessary benefit, as they have not played out any of the costly and tedious tests or presented any information to show the security and viability of their item. Therefore this process helps in securing and making sure that-
- The innovating company obtains exclusivity of the drugs for a specified period which would enable the company to recover the costs that would be incurred while obtaining approvals.
- The regulatory authority is not supposed to check the innovating company’s data, without the consent, while reviewing applications put forth by the subsequent manufacturers.
The subsequent generic manufacturers could apply for marketing sanctions if they are in a position to generate their own test results.
Without a drug data exclusivity period, subsequent registrants can bring identical items into the market solely based on bioequivalence tests without leading tedious and costly preliminary tests that are needed to show the effectiveness of the discovery. This would bring about extreme detriment to the innovating company, having made significant speculation and investments to their discoveries.
An Anatomization of Drug Data Exclusivity: A Global Frame of Reference
Data protection of drugs came into effect and gathered international limelight when the issue of unfair competition was undertaken in the Paris Convention and importance was attributed to undisclosed information. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994 also advocates the exclusivity of information under Article 39(3).
Accordingly, the concept of drug exclusivity provides that there exists a predefined period where no subsequent manufacturer could demonstrate bioequivalence and stay away from a tests for adequacy, safety and different properties. A trade off is struck where the innovating company is permitted a specific timeframe to recover the costs engaged with the testing in; and the public premium objective of benefiting protected and proficient items in the commercial center, while empowering subsequent participant items to enter the market yet after a characterized period. The subsequent participant may not be permitted during this period to be absolutely or to some extent excluded from recording unique testing information by demonstrating bio-equality. This is a commitment of non-dependence, both by the authorities and that of the third parties.
A Reference to Indian Legal Framework
There has been immense tension on India from the nations like the US and the EU, as international embargoes on the issue of drug data exclusivity, obviously on the grounds that the vast majority of the drug monsters have a place with these nations.
As per The Official Secrets Act, 1923- has been enacted that binds the public servants and government official from using any information that is deemed to be confidential in an unauthorised manner which would ultimately affect the security, integrity and sovereignty of the country. An oppressed party might sue the Government in a Civil Court. Nonetheless, the extent of this enactment is exceptionally restricted as it doesn’t guarantee data protection, however is restricted to security against divulgence of the information which is just one of the components of information protection. There is no arrangement to address against unfair competition brought about by outsider to unlawfully depend on the innovative company’s exclusive information. Albeit, this resolution accurately concedes an oppressed party the option to guarantee harms in a common suit and get damages, it doesn’t proactively guarantee insurance against out of line business utilization of the information. Consequently, the Official Secrets Act, 1923 doesn’t guarantee information security according to TRIPS Article 39.3 principles.
Trade secret protection is a solution to forestall the revelation of information, yet it is a private cure that is untested against administrative experts in India. Moreover, regardless of whether such an apparatus might be utilized to limit the abuse of test information, it again doesn’t keep the regulatory authorities from depending on it themselves to allow endorsements to subsequent manufacturers.
The Indian Patents Act, 1970 is another significant enactment. In any case, the Patent Act is appropriate just to patentable developments and doesn’t secure new utilization of a known substance or definitions by blends. Further, patent security stretches out just to the creation yet not to the information produced by the originator.
Conclusion
The methodology suggested for drugs and pharmaceuticals includes a momentary period for which initial steps will be taken to carry out the process of minimum data protection for example to work on the protection information the board in the Drug Regulatory Authorities and to forestall unapproved revelation of information. This period will can be trailed by a post transition period which will involve a duration of 5 years in which the Drug Regulatory Authority would not depend on the information put together by the innovating company while giving second and ensuing marketing approvals.
Author: Haritha Dhinakaran, Symbiosis Law School, Pune
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