Patent Linkage in Intellectual Property law is usually understood as the link between the market approval process of a generic drug and the patent status of the originator/innovators product. The process of market approval is very essential as it helps ensure that a certain pharmaceutical product is safe, is of good quality and is efficient. The link with the original product essentially allows the patent holder to restrict others from making, selling, showing or importing the patent product. Market approval is never given a higher status than patent rights as a patent gives the patent holder exclusive rights over the original product and no generic can be sold in the market without the patent holder’s approval.
In practice, the patent linkage is the communication between the National Regulatory Authorities and the Patent Office to ensure that there is no market approval of a generic drug till the patent of the original drug or approved use expires. Therefore, pharmaceutical companies that produce generic drugs will have to then prove that their drug is not protected by an active patent. The regulatory authorities oversee this process and ensure that no generic drug is sent for market approval if it is covered by a valid patent. The main aim of this process is to ensure that there is no unnecessary or wasteful litigation over the fact that one company sues the other on the grounds of patent infringement. This is to provide additional protection to the patent monopoly.
The United States of America was the first country to adopt the practice of patent linkage under the Hatch-Waxman Act (1984). This practice has brought about a new wave of innovation in the pharmaceutical industry. In the US, the publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book identifies drugs which have been FDA approved based upon their safety and efficacy profiles.
The European Union, on the other hand, does not approve of patent linkage. This is because the patent linkage is contradictory to the EU regulations and undermines the ‘Bolar Provision.’ The Bolar provision was put in place to provide people with low-cost drugs and also so that pharmaceuticals could experiment with patented drugs and submit the data to the drug control authority.
INDIAN SCENARIO
There is no fixed mechanism put in place for patent linkage in India yet. There has been legal jurisprudence on pharmaceutical patent infringement, however, a system has not been put in place. The Indian patent office which grants patents for generic drugs and the Central Drugs Standard Control Organization (CDSCO) are two completely independent authorities which do not work in tandem with one another. The Drug Comptroller General of India (DCG) provides marketing approval in accordance with the Drug and Cosmetic Act 1940. However, the case of Bristol-Myers Squibb Company v. Hetero drugs Ltd. was a direct push to establish a system of patent linkage in India. In this case, there was a patent infringement and the Delhi High Court granted an ex-parte injunction to BMS against hetero to stop the sale and production of their drug “dasatinib.” In its injunction, the court said that the Drug Comptroller General, in his statutory duties must ensure that they do not grant market approval to any drug that infringes upon the patent of another company.
In the case of Bayer v Cipla and Union of India, the court offered some clarity about the status of patent linkage in India. Cipla received a patent to market a drug called Sorafenib tosylate, however, Bayer, the assignee of the patent filed a writ petition restricting the DCGI from granting Cipla this patent to market this drug. The burden was on Cipla to prove that the drug they wanted to produce was not the same as Bayer’s patented drug and was not an infringement. Bayer contended that the DCGI should not have the authority to grant market approvals for generic drugs of patented products. Bayers claimed that as per the Drugs and Cosmetics Act the DCGI cannot give market approvals for generic versions of patented drugs. They also contended that the above would be a violation of the Patents Act. The court, however, rejected Bayers arguments and clearly said that there is no system of patent linkage in India. The court said that it was not the intention of the legislature to have such a system and that such a system requires an exclusive piece of legislation. The court further said that according to their interpretation the DCGI can grant patents for generic versions of patented drugs under the Drugs and Cosmetics Act.
The reasons given for not having patent linkage was that the DISCO and the Patent office are towed independent bodies with different objectives. The Drug and Cosmetic Act has no statute which denies the approval of generic drugs when the patent is in force. Moreover, the DCGI is only responsible for the safety and efficacy of the generic drug and the ensuring of other necessary infrastructural facilities required forth manufacturing of the drug. Furthermore, the market approval of the drug is only liked to the conditions given in the Drug and Cosmetic Act. Furthermore, decisions on patent infringement fall under the exclusive jurisdiction of the courts and it is beyond the adjudication powers of the DCGI.
CONCLUSION
Patent linkage is a highly debated matter in India and since there exists no exclusive legislation on it, various other alternatives have been suggested. One such solution for filling this gap was a “notification system” wherein the DCGI could put a list of all assignees and aggrieved parties could file for patent infringements with the help of this database. If a system of patent linkage is put in place in India, it should be a balanced system that promotes innovation, transparency and safety.
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