Introduction
Breast cancer is the most common type of cancer among women, and it has surpassed lung cancer to become the most common type of cancer in the globe itself. As per a 2020 report in India, Breast Cancer accounted for 13.5% (178361) of all cancer cases.
The only way to survive a disease as crippling as cancer is by undergoing expensive treatments and taking highly-priced life-saving drugs. Needless to say, in lower-income countries this high price often deters patients from having access to such life-saving drugs.
The Case So Far
The Kerala High Court took suo moto cognizance of a writ petition which had been filed by the petitioner, demanding the use of the Patent Act as means of reduction in the costs of life-saving cancer drugs.
The drug in question here is Ribociclib, which is available under the brand name Kisqali (in the USA) and Kryxana (in India) and is used to treat certain kinds of breast cancer. The patent for this drug belongs to Novartis and is valid till 2027.
The monthly cost of the drug is INR 58,140/. The petitioner had previously averred that the price of the drug will reduce substantially if the drug is manufactured in India. The drug is currently imported from Switzerland, contributing to the steep price and unaffordability.
Previously in the order dated 14th June 2022, the Court had ordered the Government to utilise Patent Act provisions to reduce the price. There was inaction on the part of the government and ultimately on 16th September 2022, the court was informed that the Petitioner had unfortunately succumbed to her illness, after which the court took suo moto cognizance of the case.
What Are the Relevant Provisions in the Patent Act?
While patents provide a monopoly to inventors, there are certain provisions in the act that put public good or need over individual monopoly rights.
Firstly, there is the Compulsory Licensing provision u/s 84 or 92 of the Patent Act. The Government on an application filed by the aggrieved applicant can issue such a license when it is satisfied that the said drug is not available at an affordable rate. The Government may also invite applicants for public non-commercial use of the drug.
Secondly, the Government may at any point under Section 100 allow the drug to be used for government means
Thirdly, under Sections 102 and 47 of the Act the Government can acquire the patent from the patentee or import it and make it available in any government-run dispensary or hospital.
Using Compulsory Licensing
An unfettered use of this provision may result in global pharmaceutical companies being hesitant to introduce new medicines in other countries. The India Patent Office granted the first Compulsory License to Natco Pharma for the production and sale of the generic version of Bayer’s Nexavar, an advanced drug used in the treatment of liver and kidney cancer. This decision brought praise from developing nations for allowing access to such life-saving drugs. However, developed nations criticised this move by claiming that such licensing deprived the patentee of commercially exploiting his invention.
Therefore, it is imperative that such cases of compulsory licensing be allowed only in rare cases and after checking that the objectives of granting such license have been met under the Indian Patent Act, 1970. Thus, despite having the legal mechanism to overcome the patent monopoly like compulsory licenses and government use, the government has rarely been keen to use it, since it may further result in other issues like lack of know-how and fear of sanctions by the developed nations.
Conclusion
In the event, that a compulsory license for the drug Ribociclib is in fact granted, it could incentivize other generics to employ this route. It would certainly be beneficial for patients who have been struggling with excessive prices of essential drugs for the longest time. Further, compulsory licensing may not necessarily be viewed as an obstacle to the invention. Instead, they may even boost invention and boost further innovations.
Author: Dipanwita Chakraborty, Legal Trainee at PA Legal.
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