An important legal reason why India can frequently impose restrictions on international pharmaceutical giants and refuse to grant them patent protection in China and other countries is the compulsory licensing system for pharmaceutical patents, that is, the system of copying their drugs without the consent of the patentee. When the Indian Patent Court rejected Bayer's lawsuit, it said that nexavar's drug is too expensive to rely on imports, but it constitutes the basic needs of many patients, so it is necessary to ensure the availability of this drug in India through compulsory licensing. This is a common reason for compulsory licensing.
Legally, after the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) passed the amendments related to compulsory licensing of patents, India immediately amended the patent law, stipulating that applicants can apply for compulsory licensing in three situations: the public's reasonable demands for patents have not been met; Patented products are not sold to the public at reasonable prices; This patent has not been applied in India. At the same time, if there is a public health crisis or serious emergency in China, or if it is for non-commercial public use, the central government can notify the patent authorities to sign a compulsory license for the public interest.
By restricting patents and compulsory licenses of international pharmaceutical companies, India has not only ensured the supply of essential drugs, but also enabled the country to better cope with epidemic crises such as malaria, bird flu and AIDS.
In addition to India, the Philippines, Thailand, Brazil and other countries have also weakened the patent protection enjoyed by large international companies, relaxed the imitation of patented drugs by domestic pharmaceutical companies, or allowed the import of generic drugs from other countries to promote the basic health protection of the poor. For example, Thailand has imposed compulsory licensing on some anti-cancer and anti-AIDS drugs.
Of course, China is not without a compulsory licensing system. China's Patent Law also stipulates that, for the purpose of public health, the State Council's patent administration department may grant compulsory licenses to countries or regions that meet the requirements of relevant international treaties to which China is a party. The revised Measures for Compulsory Licensing of Patent Implementation came into effect on May 1 last year, and it also has detailed provisions on this system. Only in practice, it is rare for the government to directly apply for compulsory licensing of drug patents. Although there are also calls for compulsory licensing of drugs for diseases such as hepatitis B, tuberculosis and AIDS, few people actively promote this action.
The patent system has many advantages, which can protect innovation, encourage pharmaceutical companies to invest in R&D expenditure and achieve technological breakthroughs. But its essence is a special protection guaranteed by government power. When this special protection conflicts with the basic health needs of citizens in developing countries, there will be a certain need for trade-off, and WTO rules allow compulsory patent licensing of drugs precisely to leave room for this trade-off.
In India and other countries, the pressure of drug consumers forces the government to bargain with multinational companies that produce imported patented drugs to limit the excessive use of their patents. At the same time, because some drugs belong to the scope of government medical insurance, the government also has the incentive to reduce their prices, thus reducing medical expenses. While consumers in China are in a fragmented state, it is difficult for the government to exert pressure on international pharmaceutical companies through applications. Therefore, compulsory patent licensing is in full swing in India, but it is silent in China, which is related to the lack of organization and discourse power of patients and drug consumers in China.
Of course, the practices of India, Brazil and other countries also have negative effects-they may provoke conflicts with international pharmaceutical companies, thus facing negotiation and litigation costs. International pharmaceutical companies are also reluctant to invest in R&D in these countries, preferring countries with strong patent protection like China. However, China is also a developing country, and the compulsory licensing of drug patents in WTO is a special treatment that developing countries generally emphasize and call for. It is also a pity not to take advantage of this and strive for low-priced drugs for domestic consumers within the legal scope allowed by international rules.
Therefore, China should learn from the positive and negative experiences of Indian countries and seek a certain balance between protecting patents and promoting innovation, protecting the legitimate rights and interests of foreign capital and meeting the basic health needs of residents.
This does not mean that international pharmaceutical companies must be forced to make too many sacrifices with a "big eater" mentality. However, for some special imported drugs for the treatment of extreme diseases such as cancer, if domestic pharmaceutical companies can be allowed to copy them at a lower price through reasonable application of international rules, it will mean saving many lives and avoiding many families from "poverty due to illness", which will bring huge social benefits, and they will only pay the cost of reasonable game between the government and some multinational pharmaceutical companies. In that way, we can also avoid the embarrassment that the poor in China have to buy medicine from India.