Chipping away
Why is India backing down on its strict patentability criteria on drugs and cutting access to life-saving drugs?
The Union government is bowing to pressure from western drug giants and diluting its drug patentability criteria, cutting access to livesaving drugs
PRIME MINISTER Narendra Modi recently made an interesting speech on how nations that forget their heritage lose their identity. The PM reminded us that nations cannot progress unless they valued and cherished their history and heritage, a lesson most Indians are in dire need of being told—again and again. He was not referring to the controversy over the Taj Mahal, which his party’s member of parliament, the notoriously communal Sangeet Som, had described as a blot on India’s culture. Modi was, instead, talking about ayurveda, the ancient system of medicine.
Inaugurating the All India Institute of Ayurveda (aiia) in New Delhi on October 17, he made an oblique attack on the Congress Party for not preserving India’s traditional knowledge (TK) such as Ayurveda and yoga because of which India had lost to other nation’s patents of many things that existed here for centuries. Apart from the public embarrassment of watching the PM “inaugurate” an institute that has been functional since 2010, Modi’s speech revealed a muddled understanding of patents and how TK is protected.
The most problematic of Modi’s statements was his claim that the government was focused on providing affordable healthcare by improving affordability and access to treatment. That claim doesn’t appear to hold. Since the bjp-led nda regime came to power in 2014 there has been a flurry of patent manoeuvres that have not boded well for its stated policy of providing affordable drugs. Not only did his government rush to set up a pointless intellectual property (IP) think tank to formulate a new IP policy under US pressure, it has also done little to ensure that mncs do not indulge in price gouging on new life-saving drugs as other nations have done.
More worrying is the apparent pressure on the Patent Office to be more lenient with its scrutiny of mnc patent claims, specially those from the US. These allegations have been floating around for a while now and have been given credence by recent decisions of the Patent Office. India’s laws on the patentability criteria for pharma are far stricter than in most other countries because of Section 3d of the Patent Act which lists all that is not patentable. The US, of course, abhors this section and has been doing its utmost to have the law repealed. Multinational drug firms have found it a tough barrier to evergreening their patents which is the practice of extending the life of patents by taking out fresh iprs on new forms of a known molecule. Both the Patent Office and the courts have till recently been scrupulous in upholding Section 3d.
But the approach has been changing and not subtly. In August, the Patent Office stunned the Indian generic drugs industry and public health organisations worldwide by granting a patent to Pfizer’s vaccine against pneumonia, or pcv, that it markets as Prevnar13. It was shocking because the Pfizer patent had been rejected by the European Union for failing the innovation test. All of a sudden, there has been a role reversal with India appearing keen to reward a drug giant with unmerited patents whereas the more liberal European Patent Office (epo) is appearing stricter in granting claims.
Global humanitarian organisation Médecins Sans Frontières (msf) contends that the method Pfizer has patented is too obvious to get a patent and so has rival firm Merck which argued successfully at epo against it.
On October 13, msf filed a petition before the Delhi High Court to overturn Pfizer’s pcv patent soon after generics maker Panacea Biotech filed a similar review petition with the Patent Office. This battle is important not just from the patent angle. India carries the heaviest burden of global infant pneumonia deaths and this unwarranted patent makes it more difficult to provide access to life-saving drugs. Is the government aware of this?