The sole intent driving innovations in healthcare sector is to save lives…
An assumption surely far-fetched and wishful, Pharma sector like every other business thrives on profit making. Yet in the face of deaths due to unaffordability of expensive life saving drugs, the irony exposes itself.
A recent Kerala High Court case which was filed against high priced life saving breast cancer drugs Ribociclib manufactured by Novartis, Abemaciclib by Eli Lilly and Palbociclib by Pfizer, aptly conveys the distressing ground reality. A case in which the patient suffering from breast cancer sought relief to avail alternate affordable version of these medications, came to a tragic end for her as she lost her battle against the disease. With Petitioner succumbing to the disease, the court and media were forced to seriously take notice of the dire situation in India, where many lives are lost due to unaffordability of expensive life saving drugs.
Yet again debate on the need of compulsory licensing of Patents has come alive, is it an only option to combat situations of malpractice due to patent protection and monopoly rights which are granted to inventions, specifically pharmaceuticals for the period of 20 years?
Article 21 of the Constitution of India guarantees a fundamental right to life and personal liberty and every citizen’s right to health is intrinsic to live a life with dignity .India being home to large number of patients who are extremely poor, it doesnt help when the fact remains that multinational companies import large percentage of medication here and the same are too expensive and beyond reach of the poor as well the middle income population of the nation, making affordability of healthcare a privilege rather than a necessity.
Product Patent For Drugs Under Indian Patent Act of 1970:
If we look back at newly independant india, in 1947 western multinational companies controlled the pharma sector and primarily imported drugs to india, with prices being among the highest when compared globally. The dire need of affordable medicines in a poor nation led to amendments in Indian Patent law and the first Patent law of independent India came in 1970. The Patents Act 1970 brought into force on 20 th April 1972, prohibited patents for new product innovations in the category of pharmaceuticals, chemicals and food. Patents were only granted in these field for new process and the protection granted was for a reduced period of 7 years. This regime ensured advancement of generic medicine industry and Indian citizen availed medicines at comparatively less cost.
But a change in India’s Patent protection system was demanded with India signing WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) on 15th April 1994. Before TRIPS many countries had no patents for pharmaceutical products, which later became mandatory under TRIPS and accordingly being a signatory country India too extended Patent protection to pharma products and process by 2005.
By Indian Patents (Amendment) Act, 1999 which came into force with retrospective effect from 1st January, 1995, filing of applications for patent in the field of drugs, medicines and agro-chemicals was introduced . These applications were kept pending in the mailbox to be opened on 1st January 2005. Provision of Exclusive Marketing Rights was brought in protecting pharmaceutical and agro-chemical manufacturers whose applications for product were in mailbox.
The second phase of amendment was brought in by the Patents (Amendment) Act, 2002 by which term of patent was extended from 14 to 20 years.The third amendment to the Patents Act, 1970 came by The Patent (Amendment) Act, 2005 and with the third amendment India met with the international obligations under the TRIPS by removing Exclusive Marketing Rights and opening of mailbox to grant product patents.
Compulsory License In India:
Post TRIPS, with product and process patents being granted to medicines, it was also feared that instances of abuse of monopoly may arise resulting in unfair pricing of pharmaceutical products, hence to combat any such situations, TRIPS included measures such as compulsory licences and parallel imports. Compulsory license being the main tool against negative impact of Patents by which public interest could be protected.
As per Article 31 of the TRIPS, Compulsory License can be issued by a Country to a third party for manufacturing and selling a patented product without the permission of Patentee in cases of national emergencies or situations of extreme urgency or for public non commercial use or as a measure against anti competitive practices. Under Article 31 before applying for compulsory license a prior unsuccessful attempt must have been made to obtain licence from the patentee on reasonable terms. Compulsory license also mandates paying royalty to the patentee by the Compulsory License holder.
The end of 1990s witnessed a devastated South Africa with high AIDS infections and deaths, struggle against U.S and pharmaceuticals giants to avail life saving drugs at affordable price. Medicine Act 1997 was passed by South Africa with the aim of reducing price of medicine, which resulted in the U.S govt and 39 pharmaceuticals coming together in an act of threatening to take legal recourse against South Africa. It was a clear message against implementing the safeguard of compulsory license provided under TRIPS. Eventually with worldwide condemnation, the conflict was resolved resulting in backing of the Pharma group.
On what grounds the Compulsory license can be granted in India?
In India a patentee has to at regular intervals disclose the extent of working the invention to the Controller General of Patents. 3 years post the grant of a Patent if the Patentee has failed to meet the reasonable working requirements, the Indian Patent law has provisions for granting compulsory license.
As per subsection 1 of section 84 of Indian Patent law, at any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:-
(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
(b) that the patented invention is not available to the public at a reasonably affordable price, or
(c) that the patented invention is not worked in the territory of India.
The first Patent related Compulsory license in India post TRIPS era was granted to Natco against Bayer Corp’s kidney cancer medicine Nexavar by the Indian Patent Office (IPO) order dated 9th March 2012 after a high profile legal battle. Natco was to pay 6% royalty on the net sales every quarterly to Bayer, for selling the generic version of Nexavar, alongwith supplying free medicines to 600 needy persons each year.
The Order against Bayer was based on following findings:
(a) Since Bayer could provide only 2% of Patients with Nexavar, the reasonable requirements of the public with respect to the patented invention was not satisfied,
(b) The cost came to about 2.8 lakhs per month for the medicine, being too expensive the patented invention was not available to the public at a reasonably affordable price,
(c) The patented invention was not sufficiently worked in the territory of India as working of patent does not imply mere importation.
Bayer appealed against the order but in vain, both Bombay High Court and later Supreme Court dismissed it’s appeal. United States considered this a dilution of its international patent regime and India had to face severe adverse reactions from the United States Pharma lobby and it’s government. News reports in U.S claimed India is on route to granting more drug related compulsory licenses in future and how it is going to negativity impact pharmaceuticals.
With immense pressure on India, an alleged unofficial assurance of India against any future compulsory license was speculated to probably be the root cause behind no more compulsory licenses granted by the Indian Patent Office.
LAW-IP AND MORE 