There have been news reports here and here of the likelihood that a compulsory license may be issued by the Government of India for three cancer drugs – Trastuzumab, Dasatinib and Ixabepilone. Out of the three cancer drugs in question, Dasatinib and Ixabepilone are small molecule drugs whereas trastuzumab is a biologic.
Provisions for issuance of Compulsory License under the Patent Act:
Under the Patent Act, a compulsory License can be issued either under section 84 or 92 of the Patent Act. Section 84 requires applicant to establish that, reasonable requirements of the public with respect to the patented invention have not been satisfied or the patented invention is not being made available at an affordable price to public in India. This is what happened in Bayer and Natco’s case. Under section 92, Government can notify a patent for issuance of compulsory license if any of the following 3 conditions are met: 1) National Emergency; 2) Cases of extreme urgency; or 3) In the case of public non-commercial use. Once the central government has issued a notification under section 92, any person interested may approach the controller for a compulsory license. The process becomes much simpler as the applicant does not have to establish that reasonable requirement of the public are not met.
Additionally, the under section 100, the Central Government can authorized any person in writing to use an invention for the purposes of the government. The right to use an invention under this section includes right to sell, on a non-commercial basis, the goods which have been made in exercise of that right. Section 99 defines used by the government to mean if it is made, used, exercised or vended for the purposes of the Central Government, a State Government or a Government undertaking.
Can Pharma Companies Oppose this Compulsory License?
Decisions, orders and directions issued by the Controller or the Central Government under section 92 of the Patent Act can be appealed before the Intellectual Property Appellate Board, whereas decision/direction under section 100 is not.
Incase of Trastuzumab generic version are already available and marketed by Roche as well Emcure, at reduced price points in the Indian market. Grant of compulsory license on grounds of public non-commercial use, atleast on this drug will be fraught with many issues in view of the lower priced generic versions. Further, Traztuzumab being a biologic and being structurally more complex in comparison to the small drug molecules, is difficult, though not impossible to reproduce as it is extracted from cell culture using modern biotech techniques. Growing conditions of the cell culture can have major impact on the function and quality of the final biologic product.
No further details regarding the terms of the compulsory license or even a gazette notification by the Government of India on the three cancer drugs is available at this stage. However, the news has generated considerable buzz and apprehensions in the pharma industry and is bound to make a few companies rethink their business strategy in India.