NEED FOR PATENT LINKAGE SYSTEM IN INDIA

Patent linkage is the system that links generic products and the patent status of the innovator’s product for market authorization, significantly in the pharmaceutical field. The patent gives exclusive rights to the patent holder to prevent others from selling, using, or creating any generic product for the market sale. For Individual or private interests of property or freedom of will, the monopoly lies within the owner, and he holds such rights for a term of 20 years to exclude others. However, for public interests or desires such as peace, public health, equality, it is essential to equilibrate the monopoly of the patent owner with the conflicting interests.

Patent Jun 6, 2021 0 Add to Reading List

INTRODUCTION

Patent linkage is the system that links generic products and the patent status of the innovator’s product for market authorization, significantly in the pharmaceutical field. The patent gives exclusive rights to the patent holder to prevent others from selling, using, or creating any generic product for the market sale. For Individual or private interests of property or freedom of will, the monopoly lies within the owner, and he holds such rights for a term of 20 years to exclude others. However, for public interests or desires such as peace, public health, equality, it is essential to equilibrate the monopoly of the patent owner with the conflicting interests.

However, the patent linkage is not allowed for the marketing approval of generic products unless the consent is given by the patent owner and the patent of the original reference is valid. This concept originated and was adopted in the US, which has been included under Hatch Waxman Act, 1984, to provide timely generic products in the market.

PROVISIONS OF PATENT LINKAGE UNDER TRIPS

As per the TRIPS agreement, the WTO member states do not mandate to keep this concept of patent linkage in practice. However, it provides certain obligations wherein the exclusive rights should be provided to the patent right holder for a restricted period as mentioned under domestic laws of the member country.

Article 28.1(a) of TRIPS prevents any party from using, selling, making, offering for the sake, or importing without consent of the patent right holder. While Article 39.3 deals with the marketing of pharmaceutical or agricultural chemical products, It also states that any undisclosed data concerning these shall be from any unfair commercial exploitation.

PATENT LINKAGE SYSTEM IN INDIA

In India, market approval of any pharmaceutical drug is given by the Drug Controller General of India, which has been empowered under the Drugs and Cosmetics Act, 1940 (DCA). The main duty of the drug controller is to ensure that the drug is fit, harmless to be introduced in the Indian market. The system of patent linkage is not recognized in India, and the Delhi High Court recently ruled that the patent linkage system cannot be concluded in any way from the Drugs and Cosmetic Act, 1940. Let us understand the concept with some case laws.

Bristol Myers Squibb Co. v. Hetero Drug Ltd.

Patent Linkage has been in Indian courts several times, and the debate first started in this case. The Delhi high court dealt with the validity of the Patent linkage system in India. In this case, Bristo-Myers Squibb applied for an Ex-party injunction to prevent India’s drug controller from approving the generic version of their cancer medicine ‘Dasatinib’ which the plaintiff sold in India under the brand name "Sprycel" and is used to treat ‘chronic myeloid leukemia. The Court, in this case, put a stray to the defendant’s application seeking the approval of its drug for making, selling, or exporting. However, this decision was questioned since it burdened the Drug Controller with additional patent rights obligations that should be resolved by the patent officer and the court. Further, in the case of Bayer Corporation and Anr. vs. Union of India and Ors, the court made some observations.

The Drug controller should not be accused of any violation or aiding in infringement of an existing patent while approving any generic drug.
The manufacturer of the generic drug must merely satisfy the Drug controller that the drug is bio-available and equivalent to the patent drug and nothing else for market approval.
The DCA's sole purpose is to regulate the importation, manufacturing, distribution, and sale of pharmaceuticals and cosmetics. It does not extend to enforcing a patent issued under the Patents Act and then refusing to approve a generic version of a patented drug on the market.

The court also mentioned the following disadvantages that could arise if India recognized the patent linking system.

Instead of testing the patent's validity, the Drug Controller will have to presume. Then he must either totally deny the applicant's request for marketing authorization or put the application on hold until the applicant's patent validity is resolved in a court process before a competent authority which is beyond the scope of the drug controller’s authority. Secondly, If the term of protection for the original patented drug has not ended, the Drug Controller will be obliged to reject any generic drug manufacturer's application as per DCA and the Patents Act. In addition to this, the patentee would be able to prevent all generic manufacturers from making the drug available on the market at a reasonable price. As a result, even if the patentee does not file for marketing authorization, the patented medicine will be essentially inaccessible in India until the patentee makes a different decision.

ADVANTAGES OF PATENT LINKAGE SYSTEM IN INDIA

Unnecessary Patent infringement lawsuits will be reduced.
Patent's rights will be strictly protected.
Promotion of pharmaceutical industry to be more innovative.

DISADVANTAGES OF PATENT LINKAGE SYSTEM IN INDIA

Delayed availability of affordable generic drugs on the market, which will have negative consequences for the country's public health.
The marketing approval merely determines whether the drug is safe to use and then permits it to conduct clinical trials so that it can be released onto the market as soon as the valid patent expires without any delay
In developing countries like India, Increased paperwork will contribute to delays and inefficiencies while government offices are already overburdened with work.

CONCLUSION

India is still a developing country; it is unlikely that we would be able to implement the concept of patent linkage immediately. We cannot afford to pay outrageous costs for drugs that would be less expensive if given by generic companies. Consumers and governments that fund health care bear a significant cost because of patent linkage. It may also prove advantageous if India adopts it in the future with caution and a balance between the public interest in health and the commercial interests of the pharmaceutical business.

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