The recent announcement of the Indian Government for granting Compulsory Licenses (CL) for three more patented drugs has been outrageously cheered by health activists and patients’ across the country. The Department of Industrial Policy and Promotion (DIPP) is exploring a proposal from the Health Ministry to issue CL for three anti-cancer drugs.

The drugs which qualify the list are Roche’s Herceptin (trastuzumab), a biotech drug for the treatment of breast cancer and Bristol-Myers Squibb’s (BMS’s) Sprycel (dasatinib) for the treatment of leukemia and Ixempra (ixabepilone) for the treatment of breast cancer.

SECTIONS UNDER WHICH CL IS GRANTED IN INDIA

  1. Section 84

As per section 84(1) of the Patents (Amendment) Act, 2005 (hereinafter “the Act”), an application for the grant of CL on patent can be made to the Controller by any person interested on any of the following grounds:

  1. that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
  2. that the patented invention is not available to the public at a reasonably affordable price, or
  3. that the patented invention is not worked in the territory of India.1

However, this option can be explored only after the expiration of three years from the date of the grant of a patent. That is to say, if the Controller is satisfied that the aforesaid grounds exists, he may grant a CL upon such terms as he may deem fit.

  1. Section 92

According to Section 92 of the Act, the CL on patent shall be granted by the Central Government any time after the sealing of the patent under following situations:

a circumstance of national emergency; or

a circumstance of extreme urgency; or

a case of public non-commercial use,

According to the Indian Express, Herceptin, Ixempra and Sprycel cost around 50,000 rupees (€687), 70,000- 80,000 rupees (€961 to €1,098) and 15,000 rupees (€206) respectively for a month’s dosage2. Consequently these drugs are beyond the reach of the poor patients. As a result this situation gives rise to a case of public non-commercial use of the patent product. The Government is possibly exploring the choice of granting CL on patented drugs under the current section.

However, as per Section 92 (3) public health crises relates to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria and other epidemics. The point is, whether the uncontrolled growth of abnormal cells in the body leading to Cancer comes under the purview of the said section.

POWER OF CENTRAL GOVERNMENT TO USE INVENTIONS FOR PURPOSES OF GOVERNMENT

Section 100 of the Act confers power on the Central Government to use the invention for the purposes of government. The invention can be used by the Central Government or any person authorized in writing by it for purposes of government at any time after an application for a patent has been filed at the patent office or a patent has been granted.

For the purpose of Chapter XVII of the Act, an invention is said to be used for the purposes of Government if it is made, used, exercised or vended for the purposes of the Central Government, a State Government or a Government undertaking (Section 99)3.That is, the Government has the right to work that invention or use it or sell it using Government authorized channels.

  1. Section 92A

This section facilitates the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems by granting CL for that patented pharmaceutical products. The point to be noted is that the CL is granted solely for manufacture and the export of the concerned pharmaceutical product to such country.

SCENARIO OF RECENT ANNOUNCEMENT

Now, if the CL on patented drugs is granted in India the manufacturing of the biologically similar copies of the low cost generic versions of the drug would be another hurdle. It is easier to produce generic drugs that are pharmaceutically equivalent to innovative drugs. Whereas, manufacturing generic biologics (i.e. Biosimilars) which are complex protein molecules, biological in nature and similar to innovative biologics is comparatively difficult. It is not currently possible to demonstrate that two biologic drugs are pharmaceutically equivalent. The efficacy of biosimilar pharmaceuticals is highly dependent on the method of manufacture and formulation.

Apparently, minor and innocuous variations in manufacture and formulation can lead to unforeseen clinical consequences. For instance, in the case of biopharmaceutical ‘Recombinant human erythropoietin (rHuEPO)’ for the treatment for renal anemia the number of pure red-cell aplasia (PRCA) cases in patients treated with this medicine increased dramatically and the development of antibodies counteracting against it remained an obstacle for years to come. Therefore, the generic biologics need to be pharmaceutically and therapeutically equivalent to the innovator drug and the companies manufacturing them have to be extra cautious as the biosimilars have the potential to induce an immunogenic response, rather than a therapeutic one.

CONCLUSION

This initiative of the Government to make the high-end medicines affordable to the common man is a welcoming step. The drugs Herceptin, Sprycel and Ixempra are way too expensive for the common man. Therefore the Government has taken a wise move to grant the CL on these drugs. The provision of CL under the Patents (Amendment) Act, 2005 is available as a remedy against abuse of patent right, not working of patent and to address the public health concern in India. Introduction of generic versions of pharmaceuticals through CL into the market is a way to reduce the health care costs. The crux is not that how long it will take to fix the predatory pricing of drugs by pharmaceutical giants but that the process has begun.