FIVE years ago the Indian Patent Act was amended to provide for patenting of medicines. Thanks to the efforts of Left Parties in parliament, supported by several movements and groups in the “access to medicines” campaign, the Indian Law incorporated several public health safeguards. While not perfect, the Indian Law is one of the best in terms of its attempt to restrict the monopoly power of patents over access to medicines.
MNCs in the pharmaceutical sector have been very unhappy with portions of the Indian Law and have tried to undermine it in different ways. Concurrently, patients groups and civil society groups have tried to use opportunities available in the Indian Patent Act to safeguard the rights and interests of patients. It is important that we take a view of the emerging legal battles that are now being fought in relation to the Patents Act.
It is important because the continued manufacture of essential medicines by Indian companies is not just a matter of interest for Indian domestic consumers. India is a key supplier of life saving drugs to many parts of the developing world. 92 per cent of patients on antiretrovirals (for treating HIV-AIDS) in low- and middle-income countries use generic drugs, mostly manufactured in India. 67 per cent of medicines exports from India go to developing countries. Further, approximately 50 per cent of the essential medicines that UNICEF distributes in developing countries come from India.
PATENTABILITY AND PRE GRANT OPPOSITIONS
A prime target of pharmaceutical MNCs has been the provision in the Indian Act that does not allow “ever greening” that is it does not allow perpetual patent monopolies by companies who make minor modifications in existing medicines and seek to extend the patent period beyond the 20 years provided for in the TRIPS agreement. The Indian Act restricts the scope for the granting of Patents on frivolous claims by clarifying in Section 3(d) of the Act that, “the mere discovery of a new form of a know substance which does not result in the enhancement of the known efficacy” is not patentable. It is further explained that: “Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
How ever greening impacts on medicines access can be seen from the example of some commonly used anti HIV-AIDS medicines. An important first line drug for treating AIDS patients, Zidovudine, was invented in the 1960s for the treatment of cancer, and its use in HIV was promoted decades later. Though many countries allowed it to be patented when its use in AIDS patients became known, the Indian law does not allow its patenting. Another essential medicine for AIDS medicines was patented in 1994 and hence cannot be patented under Indian law. However the syrup form of the medicine was again patented in 2001, but again the Indian law does not allow the patent. A formulation combining Lamivudine and Zidovudine is commonly used to treat AIDS patients. The two component medicines were patented before 1995 but the combination form was patented in 1997, but the Indian law does not recognise this patent.
Indian civil society organisations have made use of such useful provisions of the Indian Act to file pre-grant oppositions (and a few post-grant) in a number of cases, and by actually winning some of these cases. The battle however has been difficult and needs to be put in a certain perspective. Of over 10,000 patent applications on medicines; patients groups have opposed 15, though these constitute some of the main threats to access. The process of opposing patents is difficult, time consuming and requires substantial financial and human resources. What is particularly disturbing is that such opposition to frivolous patents have been done as a private initiative, without any help from the government, even though it is a valuable contribution to the safeguarding of public health.
LEGAL CHALLENGES TO THE INDIAN ACT BY MNCS
There have been several other legal battles related to the Indian Act. Unfortunately the government has been very timid in opposing such challenges, and often patient groups have taken the lead in defending the Indian law. Two such challenges to the Indian law are important as they could have far reaching consequences.
The German Multinational company, Bayer, had been granted a patent for its drug, Sorafenib tosylate (marketed as Nexavar by the company), in India a while back. The drug is used for the treatment of renal cell carcinoma (a type of cancer of the kidneys) and for treating advanced cases of hepatocellular carcinoma (a form of liver cancer). Meanwhile, an India company, Cipla, applied for approval for registration of a generic version of the drug. Bayer, responded by suing the Indian government in the Delhi High Court, on the ground that if Cipla’s request is granted, its patent right would be affected. The Delhi High Court rejected Bayer’s appeal, but Bayer appealed against the judgment to a division bench of the Court. This appeal by Bayer has also been rejected.
The case filed by Bayer in India has several implications and we are likely to see other challenges of this kind soon. The most important implication is that it 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 (or rejecting) patent applications is distinct from the one that grants approval for marketing. Patent applications are decided by Patent offices which have a certain kind of expertise which helps them to decide whether a patent application should be granted. On the other hand, drug regulatory agencies, have expertise in checking the safety and efficacy of a medicine. To ask the latter to do the job of the patent office is incorrect because it does not have the expertise to decide on patent related issues. That is why the functions of the two are kept separate. Further, patent rights are private rights and infringements of these cannot be fought on behalf of the companies by government institutions – i.e. the Government’s Drug Regulatory body cannot be asked to act as a “patent police” to safeguard private interests.
Here it must be understood that the mere grant of marketing approval does not mean that the drug would be marketed. Both the TRIPS agreement and the Indian law allow medicines to be legally registered (i.e. obtain approval from the drug regulatory agency) even when the drug is under patent protection. It is 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 the generic company even while the patent of the innovator company is still valid. It also covers for situations where the medicine is used for research purposes.
Challenge to Section 3d. of Indian patents Act by Novartis: The Gleevec Case
We have discussed in this column, earlier, the challenge mounted by Novartis on Section 3(d) of the Indian Act. To briefly recollect, the patent application for Novartis’ leukemia drug, Gleevec, was rejected by the Indian Patent office on the grounds that it was just a different form of a drug that had been patented way back in 1993. In 2006, Novartis challenged this order in the Chennai High Court and also challenged the legal validity of Section 3(d), based on which the company’s application had been rejected. The two-judge bench while dismissing the writ petition ruled that Section 3(d) was not in violation of the Indian Constitutional and also said that Indian courts cannot rule on whether its law violates an international treaty. However, Novartis continues to persist in its challenge to the Indian Act and has now filed for a fresh review in the Supreme Court.
ISSUES RELATED TO THE INDIAN PATENT OFFICE
In the changed situation since 2005, the India Patent Office has an important role in interpreting the Indian law. Responding to the needs of an enhanced role for the patent offices in India, several measures have been set in motion. These involve steps to modernise the patent offices (patent offices are located in Delhi, Mumbai, Kolkata and Chennai) including digitalisation of patent related information (grants, applications, etc.) and online publication of patent journals with this information; creation of searchable databases of patent applications and grants; preparation of a patent manual for examiners; training of patent examiners; and capacity building of patent examiners and patent office modernisation.
The patent manual has remained a “draft manual” for almost three years. The patent office had invited comments about the draft, but since then there have been no forward movement. While a well drafted patent manual can be a useful tool for patent examiners given that they need to pass judgment on a large diversity of subject matter that might be out of the scope of their initial training, the present draft manual leaves a lot to be desired. A majority of case laws cited in the manual are from the US or EU, both regions with patent laws that differ from that in India and with distinctly different objectives. Further there are instances where the manual misinterprets the Indian Patent Act.
In an extensive programme to train patent examiners has been undertaken, over a 100 IP officials have been trained in the US (a majority of them being patent examiners). Further MOUs for capacity building have been signed, all with developed countries such as the US, EU, Netherlands, and France. These measures taken together create a situation in the patent office where the letter and spirit of the country’s patent act run contrary to the orientation provided to patent examiners, as patent acts in developed countries are designed to promote very different objectives from those in India.
Finally the patent office continues to be non-transparent in provision of information related to applications and grants. Details of patent specifications, patent examination reports, pre and post-grant opposition board decisions, etc. are not made available.
GOVERNMENT IS ABDICATING ITS ROLE
Clearly, pharmaceutical MNCs are starting to aggressively challenge the Indian law on patents. There are also other legal issues that require intervention by the government – such as procedures for patent oppositions, the transparency and capability of the patent office, etc. The government has chosen to take a back seat in this process and as a result there are serious concerns that it might thereby be providing tacit support to the undermining of its own law. This is not surprising given that the government is actually not in agreement withy its own law and was forced to move amendments to safeguard public health at the behest of Left parties, in 2005, as it depended on them for survival in government. It is imperative that continued pressure be maintained on the government to defend its own law, that is designed to serve the interests of the people.