State, not patients, must fight drug giants

There is predictable celebratory reporting in India of how patient networks have scored a major win against US drug multinational Johnson & Johnson (J&J)—along with its subsidiary Janssen Pharmaceutica—by stopping it from evergreening its patents on bedaquiline, a key medicine in fighting drug-resistant tuberculosis or TB. The victory against patent claims for a paediatric formulation of the drug is undoubtedly significant. Such a claim would have extended the patent term on the paediatric forms of bedaquiline till 2036 and 2038. Such a ploy, known as evergreening, is routinely used by pharma companies to extend their patent monopolies through known modifications and minor improvements that require no originality. This is strictly barred under India’s Patent Act.

The July triumph by Delhi Network of Positive People and TB survivor Ganesh Acharya of Mumbai, comes a year after an earlier pre-grant opposition by two other TB survivors, Nandita Venkatesan of Mumbai and Phumeza Tisile of South Africa, was upheld by the patent office. The 2023 decision stopped the drug giant from extending its patents on the primary compound of bedaquiline by staking claims on a modified version that used the bedaquiline fumarate salt. Pre-grant oppositions, filed in order to increase access to critical medicines through the production of inexpensive generic versions by removing patent barriers, are not easy for patients to mount. Filed four-five years before they are taken up by the patent office, these are complex applications that require knowledge of pharmacopeia and patent law regulations in the country. It is primarily because of the support of humanitarian organisation Médecins Sans Frontières (MSF), which works towards increasing supply of affordable medicines, that the two opposition petitions succeeded.

The arguments that the patient group and TB survivor raised were irrefutable. They said the J&J claim lacked inventive steps in manufacturing the drug and that at least seven things about the paediatric formulation of bedaquiline were known before the patent application itself was filed. These include its antibacterial use, the composition of the tablet form and the range of the active ingredient used along with the method of preparation of the tablet. The patent office could not disagree since the evidence was all too clear. Its order said, “the present invention is obvious to the person skilled in the art” of making such a formulation even before the application was filed. If it was such a clear-cut case, the question that arises is why the patent office did not reject the claim on its own. There is no ambiguity in the Indian law, which is one of the few to clearly state what is not patentable. Incremental and minor improvements to a known drug are a strict no-no.

But there is an important reason why individual patients or patient groups are compelled to file opposition. The unpleasant fact is that most pharma patents in India are filed for secondary claims on existing drugs. A 2018 study, "Pharmaceutical Patent Grants in India: How Our Safeguards against Evergreening Have Failed", reveals that over 70 per cent of the patents granted between 2009 and 2016 flout the law against evergreening by allowing claims for marginal improvements.

Despite the warnings of such studies, the government has done little to stem the rot. The patent office comes directly under the Department of Industrial Policy and Promotion (DIPP) of the Union Ministry of Commerce and Industry, which has not undertaken any research of its own as to why so many decisions taken by the Office of the Controller General of Patents land up in the courts. This is in part a corollary to the abolition of the Intellectual Property Appellate Board, but primarily to the poor quality of the examiners by the patent office, notably in the lack of rigorous application of the patentable criteria of pharmaceuticals.

There are other disturbing indications on the ability of patient groups or individuals to fight the system. The Narendra Modi government has ensured that all the unique safeguards in India’s Patent Act have been removed or diluted to an alarming degree (see "India’s unhealthy patent amendments", Down To Earth, 1-15 May 2024). One such is the pre-grant opposition that could be filed by anyone. This right has now been whittled down after the patent rules were amended in April this year. Heavy fees will have to be paid by individuals and organisations filing patent oppositions.

As we celebrate what could be the one of the last big victories of public health activists, let us look at what South Africa achieved with much less fanfare the same month. In one swift move it managed to bring J&J to heel by using one of the key government agencies that fight monopoly power: the anti-trust regulator. Shortly after South Africa’s Competition Commission threatened to open an investigation into the company’s anti-competitive pricing policies, J&J capitulated.

In mid-July, the Commission announced J&J and its subsidiary, Janssen Pharmaceutica, had agreed not only to withdraw a secondary patent on bedaquiline but also to cut prices for the drug to South Africa's National Department of Health by a sharp 40 per cent. This will bring the TB drug price in line with what other low- and middleincome countries are paying. As the Competition Commission underlined, the agreement opens the market in South Africa for generic suppliers to produce lower-cost versions of the drug. In return, the Competition Commission said it has decided to end its investigation into the two companies for alleged anti-competitive conduct. The Commission issued its complaint against J&J in September 2023 immediately after the company filed for a secondary patent on bedaquiline.

South Africa is a country that knows where its priorities lie and how to exercise state power. It has one of the highest TB burdens in the world, with an estimated 304,000 cases and 55,000 deaths in 2021—but still far lower than India that had estimated mortality of 320,000. Its strategy worked far better than in India, where patients have been forced to battle predatory drug giants. As for the Competition Commission of India, the less said the better. It clearly considers the pharma industry a holy cow.

This could well be the era of South Africa. On the global stage it has filed the most important humanitarian case in the International Court of Justice by seeking a halt to the genocidal and savage war unleashed by Israel on a helpless civilian population in Gaza. That was a watershed. Its suit against Big Pharma could turn out to be almost as significant.

This was first published in the 1-15 August, 2024 print edition of Down To Earth