Health groups: Defend affordable drug treatment in India
Bayer sues Indian Government to retain monopoly rights / International coalition demands protection of generic pharmaceuticals
Health groups call on German drugmaker Bayer to cancel the suit against the Indian government and domestic drug company Cipla in order to protect affordable drug treatment. The organizations fear that the fate of generics in India may hinge on this case and that thousands of Indians will die without affordable pharmaceuticals.
Last year Bayer sued the Indian government in the Delhi High Court for giving marketing approval to Cipla for Bayer's patented cancer drug Sorafenib. At present, the Indian drug regulator DCGI can give a marketing approval to a generic drug even if the medicine is patented in India. Public health experts point out that marketing approval for a drug is not an infringement of a patent, and the generic company can be challenged once it launches the drug.
Amit Sen Gupta from the Indian Peoples Health Movement says: "The Bayer case has implications for drug access, not just for patients in India, but for poor people in large parts of the world. It would mean giving sanctity to higher standards of patent protection than what is required even by the TRIPS agreement. Bayer not only seeks to safeguard its own monopoly right, the company also wants to set a precedent that other corporations can benefit from. In essence it would mean that the entry of generic versions of life saving drugs would be delayed."
Philipp Mimkes from the Coalition against Bayer Dangers, an international network based in Germany, adds: "The interest of patients is at risk if marketing approvals are linked with patents. Countries like India must have the possibility to issue compulsory licenses to generic companies or to impose price controls in order to make available affordable drugs. We demand that Bayer quits this suit! Safeguarding public health must take precedence over patents and monopoly profits of drug companies!"
The case seeks to link the patent status of a drug with the procedures related to the drug's marketing approval. Across the globe, such linkage is the exception rather than the rule. That is so because the body responsible for granting patent applications is distinct from the one that grants approval for marketing. To ask drug regulators to do the job of the Patent office is incorrect because they don´t have the expertise to decide on patent related issues.
The Indian law has a provision for post-grant opposition, i.e. the grant of a patent can be challenged on several grounds after it is granted. A blanket bar on granting marketing approval to drugs which have been granted patents would mean that this provision becomes ineffective- the generic company would not be able to make use of this provision immediately even if a patent grant is overturned.
Moreover, both the TRIPS agreement and the Indian law allow medicines to be legally registered even when the drug is under patent protection. It can be allowed so that the generic version of the medicine can be made immediately available as soon as the patent term of a medicine expires or as soon as a compulsory license is issued to a generic company. It can also be allowed in situations where the medicine is used for research purposes. This provision is an important health safeguard because it allows generic manufacturers to conduct tests on its generic version, so that it is ready for marketing as soon as it is legally possible. In the case of life saving drugs, even a delay of a few months in the introduction of cheaper generics can mean hundreds or thousands of deaths among patients who would die, not because there is no treatment, but because the treatment with a patented medicine is too expensive.
If Bayer's plea is upheld, it would be in violation of the Indian Patent Act. This would be extremely unfortunate, as it would mean overturning some of the health safeguards that the Indian Parliament had put in place when the Indian Act was amended in 2005 to make it TRIPS compliant. It may be recalled that the Indian Parliament, while putting in place these safeguards had taken into account the very large mobilisation of people - in India as well as across the globe - demanding that India continue to function as a source for affordable generic medicines.
