Compulsory licensing (CL) is an where a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibility on patent protection included in the WTO’s agreement on intellectual property – the TRIPS Agreement.
- An application for grant of a compulsory license may be made under the provisions (Section 84, 91, 92, 92A) of Indian Patent act, 1970.
CL is provided for following reasons:
- If the patented product is not satisfying the public needs effectively
- If patented invention is not available to the public at reasonably affordable price.
- In situation of Public health emergencies
- Patented invention is not worked in the territory of India
History of use of CL in India:
- In the first four decades since the introduction of the Patents Act 1970, no Cl application was filed in India.
- In 2007 Natco tried to seek CL for Pfizer’s Sunitinib but later it withdrew.
- It was only in 2011 that Natco successfully filed a CL application over Bayer’s anti-cancer drug (Sorafenib), Nexavar and was granted the same in 2012.
- In 2013 an application for grant of CL for Bristol Mayer’s Dastanib was filed by BDR pharmaceuticals. It was
- Lee Pharma Ltd. filed a application in 2015 for CL over Astra Zeneca’s patented diabetes drug, Saxagliptin. It was rejected as it doesn’t qualify CL considerations.
Effectiveness of CL in checking monopoly of pharmaceutical companies:
- India joining the TRIPS has led to granting of product patents, which grants the patent a larger hold on accessibility, availability, price value of drug. Thus in order to check abuse, monopoly of patent rights Indian patent act included comprehensive provisions for CL.
- In India only one CL was granted on the for manufacture of sorafenibtosylate, taking into consideration the high cost of the medicine, poor availability and on the ground that the invention wasn’t made within India.
- Though there has been complaints by U.S. the use of CL provision has been carefully done only in public interest.
- A case of Trastuzumab sold under brand name Herceptin by Roche, used in treatment of breast cancer proves the effectiveness of CL. As the drug was very costly, govt started the process of granting CL; the company decided not to pursue the case in India as there was no bio-similars for it at that time and patients has to buy its product. But the threat of CL opened the market for generic version of it. Thus checking the monopoly of pharmaceutical companies.
Though the issue of CL is a concern for most of pharmaceutical companies it serves to strike balance between rewarding patents for their invention and making the patented products available to large population at affordable cost.