On December 24th, 2019, the Delhi High Court had granted an ad-interim injunction in favour of Bristol Myers Squibb Holdings Ireland (BMS) for the infringement of patent number 247381 associated with the drug ‘Apixaban’ by Indoco Remedies Ltd.’s (Indoco) ‘APIXABID’. Recently, Indoco had approached the Delhi Court on ‘public interest’ grounds, requesting permission for the sale of 58,000 strips of Apixabid, manufactured by them prior to the passing of the 2019 order. Indoco’s public interest defence was based on the prevailing pandemic conditions in the country, and it placed literature before the court for establishing that Apixaban is necessary for Covid-19 treatment. The court refused to lift the injunction and stated that Indoco had not put forth any evidence for demonstrating that there was a shortage of Apixaban or that it was not reasonably affordable. It found that the material placed before it did not show any overwhelming public interest that would justify the relief claimed. The court upheld the single-judge bench’s order, finding that since Indoco had manufactured the impugned strips in anticipation of the injunction order, the relief could not be allowed. This is perhaps the first judicial look at ‘public interest’ in the context of patents and Covid-19, and is worth further examination from that lens.
In Bayer v. Union of India, the IPAB emphasised the importance of ‘public interest’ while upholding the grant of India’s only compulsory license(CL) under Section 84 of the Patents Act, 1970. In this case, Natco proved all the three conditions under Section 84(1) – first, reasonable requirements of the public are not satisfied; second, the invention is not available at a reasonably affordable price and third, the patent is not being worked in India. In Bayer v. Union of India, the Bombay High Court stated that it is a matter of public interest that the Cancer medicine, ‘Nexavar’, ‘is made available to the society in adequate numbers and at a reasonable price.’
In Novartis v. Cipla (Novartis), the Delhi High Court discussed at length the applicability of public interest doctrine in patent infringement cases. The court relied on Roche v. Cipla (Roche) and distinguishing between the cases stated that – in Roche, the patent in question was under cloud and the defendants had raised a credible defence, and in Novartis, the patent was valid and no credible defence was raised. In Novartis, the court ruled that Cipla was guilty of infringement of Novartis’ patents and had raised public interest grounds in order to avoid the injunction. It was held that merely providing articles and publications that demonstrate the requirement of a drug is not adequate, the defendant needs to establish that there is a shortage of the products in question.
Justice Prabha Sridevan’s recent article “Is the right to exclusivity a Hamlet question?” published in South Centre speaks directly to the issue at hand and is a wonderful read on her thoughts on how courts should be looking at this ‘hamlet’ question. She ends her piece with these lines:
“The relationship between the private rights and the public health rights should be spatially expanded in tune with the Constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlet’s question must be answered in favour of life.”
Whenever new COVID-related treatments and vaccines are invented, invocation of Section 92 would be favourable vis-à-vis invocation of Section 66. In the long term, utilisation of Section 92 would perhaps be wiser as it may not alienate big pharmaceutical companies to the extent Section 66 would. The Section 92 approach is sustainable, in the sense that licenses could be given with a sunset clause, resulting in them being withdrawn as soon as the pandemic is over.
This is of course assuming that a generic company is willing to manufacture the drug. However, let us also recognise that our legislators have ensured we are not at the mercy of business choices of domestic firms either. If generics don’t step up to the role of applying for CLs or otherwise manufacturing the drugs, the government also has the option of exercising Section 47(4) of the Patents Act – which stipulates that as a condition of the grant of the patent – the government can, without any pre-conditions or procedural requirements – import any medicine or drug for the purpose of distribution (i.e., not sale) through its own hospitals/dispensaries or any hospital/dispensary notified to do so on its behalf. So, in the situation where there is a dire need of wide spread medicines or drugs, this is an available option.
The present pandemic is the priority, but with epidemics expected to become more common, it is essential to think about the future implications of the measures taken today. It should be ensured that whatever measures are adopted, they are not undertaken in such a manner that disregards future complications.
Unlike many other countries in the global South, India has production capabilities in order to successfully manufacture the quantum of vaccines required for overcoming the pandemic in India. Unfortunately though, India hasn’t started entering into any advance purchasing agreements, at least as of Sept 18, 2020, when this was acknowledged in the Lok Sabha. There are already signs that there will need to be significant private spending when the Covid vaccine does come out eventually. Dealing with ‘drug nationalism’ and corporate profits also forms a part of the struggle against COVID-19 and to prevent the prolonging of the crisis in India – domestic manufacturing as well as active government action and forethought will become vital.s