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Shardha Rajam & Mihika Poddar

Shardha Rajam and Mihika Poddar are 4th year BA LLB students at the West Bengal National University of Juridical Sciences (NUJS), Kolkata, India

At present, only two companies—Pfizer and GlaxoSmithKline (GSK)—make highly effective pneumonia vaccines, keeping competition in the pneumonia vaccine market at a bare minimum. In August 2017, the Indian Patent Office delivered a death blow to disease mitigation by granting Pfizer a patent on Prevenar 13—the company’s 13-valent pneumococcal vaccine (PCV13). Médecins Sans Frontières (MSF) has challenged the patentability of Prevenar 13 on the grounds of anticipation, novelty and inventive step and has now approached the Delhi High Court to revoke the patent. MSF has also challenged the patent granted to the vaccine in South Korea, the USA, and Japan, and the patent has already been revoked by the European Patent Office as well as China’s State Intellectual Property Office. 

The skyrocketing cost of medicines is a consequence of the patent system, which is justified as incentivising medical innovation. A patent holder is granted exclusive rights of manufacture, sale, import, and use, thereby creating an artificial monopoly. The contradiction between the right to access affordable health care and the rights of a patent holder is a recurring theme in global health policy. The patent litigation over PCV13 in India revisits this debate and could have serious repercussions on access to the drug globally, as well as on similar battles in other jurisdictions.

According to the Indian Supreme Court, a patent is granted only if the invention involves a non-obvious inventive step that is more than a workshop improvement. In order to accomodate India’s socioeconomic realities, Section 3(d) of Indian Patents Act, 1970 (‘the Act’), provides for a higher threshold of ‘non-obviousness’. Therefore, when patents are sought for new versions of pharmaceutical products, there must be some enhancement in their efficacy.

In its landmark Novartis judgment, the Indian Supreme Court used this cautionary approach to decide the patentability of the drug Gleevec (imatinib). The Court held that although the new version of Gleevec had increased bioavailability, beneficial flow properties, improved thermodynamic stability, and lower hygroscopicity, these characteristics merely allowed ‘better preservation of the product’, rather than ‘increase its therapeutic efficacy’. Therefore, it did not meet the threshold put forth in Section 3(d). Additionally it was held that the product was already anticipated in a prior patent application and therefore did not meet the threshold of ‘invention’ according to the Act.

It is in this context that pharmaceutical patents are adjudged in India. In the case of PCV13, Pfizer produced a vaccine against 13 serotypes of Streptococcus pneumoniae conjugated to the protein CRM197. The aluminium-based adjuvant allowed these 13 serotypes to act together. Pfizer applied for a patent based on the vaccine’s novelty, capability of industrial application, and considering the research involved in increasing its therapeutic efficacy.

However, use of protein conjugates to increase the efficiency of vaccines has been known about since the 1980s and GSK vaccines use a similar aluminium-based adjuvant. Furthermore, several companies such as Sanofi, Aventis, and GSK have adopted strategies to increase the serotypes to be attacked per vaccine. Lastly, MSF argues that the patent also falls foul of Section 3(e) of the Act, according to which individual ingredients must yield synergistic results to be patentable. In the present situation, the 13-valent vaccine simply targets 13 different serotypes without yielding a new result based on synergy. Thus, the grant of patent can be questioned based on Indian law itself.

Further, India’s international obligations also allow for it to refuse the patent to PCV13. According to Article 27 of the TRIPS agreement, India can deny patents to any product or process when such denial is done to protect human life. Therefore, even if it is held that PCV13 is patentable, the patent can be denied solely on the basis of the impact its commercial exploitation has on human life. Alternatively, Article 31 of TRIPS provides for compulsory licensing, whereby the Government can allow others to manufacture the drug even without the patent holder’s consent.

Aside from international law, domestic provisions can also be resorted to. As mentioned, MSF’s contentions provide substantial grounds to revoke the patent. The Act also provides for Government use of patents under Section 100, according to which the Government or its agencies can use the patented invention for its purposes. On a similar note, Section 47(4) of the Act allows the Government to use any patented invention for its own use. It need not even pay royalties to the patent holder when resorting to this provision, thus enabling production of affordable medicines, despite patent protection.

At present, India is able to provide PCV13 to only three out of its 29 states under its Universal Immunization Programme, since one dose of the vaccine costs approximately INR 10,000 per child. Other countries too have been crippled by the prohibitive costs—more than 30% of the budget of South Africa’s national immunisation programme is spent on procuring PCV13 alone. The sheer proportion of the budget allotted to PCV13 makes it unviable for most governments to include in their domestic immunisation programmes. Considering India’s reputation as the pharmacy of the world, domestic decisions can have a substantive impact on not just affordable medicines within the country, but in other countries too. It is imperative that PCV13 is not granted a patent, especially given that India’s patent regime has a high threshold of patentability in cases of incremental inventions. At the least, the Government ought to make use of the regime’s flexibilities, both under TRIPS and its domestic laws, in order to make the drug accessible. The access debate needs to be sensitive to humanitarian needs and the patent regime adjusted accordingly. The outcome of the Indian dispute could create ripples that affect the patent-accessibility balance worldwide.

Source: Globalhealth