Dr Ashwani Mahajan
Final judgment on the legal battle between a Swiss pharmaceutical company and Government of India has been finally pronounced in the Supreme Court. Not only India, the whole world was keeping a watch on this litigation. Plea of the company was that Government of India is not granting patent to its cancer medicine ‘gleevec’ and thus its right to have monopoly over the manufacture of drug is infringed. Company’s argument was that if the patent was not granted to the company, it would not be possible for the company to recover huge expenditure it has made on the research and development for developing this drug. When in 2006, Government of India had refused to grant patent for its product ‘imatinib’, company filed a case against the government in Madras High Court. While not granting the patent, government had argued that since the company has not invented any new chemical entity in making this drug and has merely made some changes in the old drug, patent cannot legitimately be granted for the same. As per Indian Patent Act 1970, Section 3(d), patent cannot be granted in case of a mere discovery of a new property or a new use for a known substance or the mere use of known process in a new product. Therefore, argument of the government was that it has committed no mistake by not granting patent to imatinib. Accepting the argument of the government, Madras High Court ruled that decision of the government is right in not granting the said patent.
Background of the case is, that a provision of Exclusive Marketing Rights was included by an amendment in Indian Patent Act 1970, according to which if a patent application was filed in the ‘mail box’, before the final amendment in patent laws are made, in pursuance of agreement with regard to TRIPS in General Agreement on Trade and Tariff (GATT); EMR would be granted to the applicant filing patent application. According to the EMR, the applicant would get an exclusive right to manufacture and market the product under question. Accordingly, an EMR was granted to Novartis for its medicine Gleevec, with brand name imatinib. On the basis of this EMR, the company filed an application to disallow other companies to manufacture and market that medicine, and Madras High Court decided in favour of the company and banned other manufacturers to produce that drug.
History of Section 3(D)
When the government was proposing amendment in the Indian Patent Act 1970, section 3(d) of the present contents, was not there. Had the original amendment bill was passed, it would have opened floodgates for companies, to obtain patents on their products on which patent had expired, by claiming a mere discovery of a new property or a new use for a known substance or the mere use of known process in a new Product. And present case would not have arisen, as patent office would have obtained patent on imatinib, in the first instance. Government, under pressure from parliamentarians and experts, had to include this provision in section 3(d), disallowing grant of patent by claiming a mere discovery of a new property or a new use for a known substance or the mere use of known process in a new Product in the ordinance issued by the President on December 27th 2004, which was later ratified by the parliament. In this way a law for the protection of the public health, not only for India but for the whole world was made.
The final amendment was effected from January 1, 2005, and the ordinance to this effect was ratified by the parliament in February 2006.. While Patent Act 1970 was under process of amendment, there was lot of opposition, in view of the looming dangers on public health and the government had to modify the amendments to incorporate the concerns of the experts and organizations. Accordingly production of generic drugs by virtue of compulsory licenses granted prior to amendments was allowed to continue. As such the provision was made that the company who holds the patent of a drug, whose term has expired is not allowed to get the same patented by mere discovery of a new property or a new use for a known substance or the mere use of known process in a new product. Section 3(d) of the Act was worded such that ever greening of patents was severely limited.
Significance of Novartis versus GOI Case
Many companies in India manufacture a drug named ‘gleevec’. This is a drug which is a very effective drug for blood cancer. Nearly 25000 new blood cancer patients get added in the country every year. Price at which Novartis sells this drug is rupees 1,20,000 per month; whereas Indian companies manufacturing this drug sell the same at rupees 6000 to 8000 per month. If monopolized, this drug would have become unaffordable to most of the end users (blood cancer patients) and will cause death for them.
This case is not merely about the intellectual property (patent) right on Gleevec. Whole world was watching this case curiously. If Novartis had succeeded in this case, then not only Novartis would have been able to establish monopoly over the production of Gleevec, many more companies would have been allowed to evergreen their patents by making small and frivolous changes in their formulation and doses. And companies who are producing generic versions of these drugs would have been disqualified and prohibited to produce those drugs and original patent holder companies would have regained their monopoly over these products. India, who is selling these generic drugs to over 200 countries and is helping developing and even developed countries to safeguarding their public health, would have no longer been in position to lead that role. As such this Novratis versus GOI was a case of profit versus affordable drugs.
In many countries of the world a campaign has been going on in the name of ‘Capture Novartis’. Campaigners have been demonstrating at the offices of Novartis in different countries. Many organizations all around the globe are pursuing Indian government, not to succumb before Novartis. They were also demanding that in no case, this litigation should be taken lightly and in view of significance of this case, the government should send its Advocate General to appear before the Supreme Court.
Absense of political will for public health
For the last two decades, it has become fashionable for government(s) to go any far to attract foreign investment, even if it is at the cost of public health. In the last one decade, nearly US$9 billion of FDI was received in pharmaceutical sector, and surprisingly US$ 4.73 came for mergers and acquisition of established Indian pharmaceutical companies. Such type of foreign investment is called ‘Brownfield Investment’. Despite the demand of Ministry of Health to change these provisions, Government has failed to change the law and lured by the ability of Indian companies to manufacture cheap generic drugs, foreign pharmaceutical companies have been fast acquiring Indian companies, and the government is not doing anything to stop these attempts. There is danger that these multinational giants would form cartel to fleece consumers. There is a sizable number of drugs which are going off-patent, with a potential market for 117 billion US$ for generic drugs. This decision may go a long way to provide relief to the consumers by way of making available cheap generic versions of these off-patent drugs.
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