Patents over modern drugs that cure tuberculosis are one of the major hindrances towards access to acute
treatment. With TB being a leader in worldwide deaths caused by infectious diseases, especially in countries like India and South Africa, patents often lead to monopolization of drugs by big pharmaceutical companies. This, in turn, leads to highly priced medicines that are often unaffordable to those affected by the disease.
Older TB treatment regimens have often resulted in terrible side effects, including loss of hearing and vision impairment. These drugs are known to have compromised the quality of life of the patient during treatment and after. New TB drugs have proven to be much safer and are easier to administer. The biggest problem, however, is their accessibility, which occurs due to the monopoly of pharmaceutical companies that do not allow for increased production of the drug due to patents on the formula/molecules. This keeps the prices exorbitantly high, at times reaching thousands of dollars.
To discuss the methods to engage in patent opposition and to share their experiences in the field of patent activism, members from several non-profits engaged in a panel discussion organized by the People’s Health Movement and Third World Network.
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Leena Menghaney, Medecins Sans Frontieres Access Campaign, said that historically, patents have led to high prices for drugs that cure TB. “Moxifloxacin was patented in South Africa a long time ago, and it blocked alternate suppliers from entering the South African markets. Linezolid, another TB drug, was patented in South Africa and led to it being sold for USD 7000 in the country,” she said. Menghaney and her team has actively been involved in patent opposition in India as well. In the case of Lenocylid, the team wrote a letter to patent authorities once they realized that Johnson and Johnson, the main manufacturer, had not paid the patent fees. “It took time but the patent was removed. However, it was too expensive for patients to access. In the time we got rid of the patent, a large number of patients passed away,” she added.
She further stated that there was a lot of excitement about Bedaquiline, a new TB drug that had the potential to remove toxic medicines from the treatment process, but it came down soon after they realized that Johnson and Johnson, the manufacturer, had patented it. This caused problems for patients in India, South Africa, Ukraine, and Thailand.
“This is when we started to realized that the problem of intellectual property was deep rooted. Bedaquiline is the backbone of TB treatment, and contains regimen required in India and other TB affected countries. However, people cannot find it easily. The price of the drug remains around USD 1700. We have noticed a pattern here…if anything expensive comes to India, the government starts rationing it,” Menghaney added.
A number of medicines to treat drug-sensitive TB (DS-TB) are currently in the pipeline. These drugs are focused on shortening treatment to 2-4 months by optimizing dosage accurately, and introducing new and repurposed drugs to first-line regimens.
The development of these drugs often takes place via public-private funding partnerships. For instance, a number of drugs are developed by the government of EU in collaboration with private pharmaceutical players. “Understanding how drugs move through timeline of development and how they are funded can be used to challenge patents. Some drugs currently in the pipeline can change the form of TB treatment as we know it,” Treatment Action Group’s Lindsay McKenna said.
The panelists further suggested that patent opposition should begin as soon as a molecule enters phase 1 trials. This, they said, can reduce patent timelines, and can avoid specific combinations of the formula being patented. “The TB drug market is monopolistic in nature. No single company is willing to make the drug formula public. We have to challenge this early on to avoid deaths among TB patients,” Menghaney added.
Third World Network’s Pratibha Siva. elaborated on the landscape of TB drug patents from a recent survey conducted by the team, titled, ‘TB Drug Patent Landscape Project.’ The study was done to gain knowledge about the patents on particular drug to understand international discourse and the extent of monopoly on the drug. The team conducted studies in 13 regions, including several African countries, India, Bangladesh, China, Malaysia, Philippines, and Vietnam, among others.
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“We studied drugs that are both modern and relatively older. We chose them because we wanted to see the combination of these drugs and find out if any patent applications had been filed on those,” Pratibha said.
The team studied 16 drugs and found that 7 had secondary patent applications that covered rights over their markush formations (chemical structure) and compounds. They also found that while companies received philanthropic/public funding in different stages of drug development, it did not result in increased access or affordability of the medicine. Eight of the 16 drugs analysed by TNW were funded with public money or philanthropy, including Bedaquiline, Sutezolid, etc.
“We also understood that it is important to have Pre-Grant Opposition mechanism in Patent Law. Third Party Observation with limited time to file TPO makes it difficult to oppose, and early identification of patent applications can help in filing opposition,” Pratibha added. She further suggested that a greater number of patent oppositions should be filed in India, Philippines, and Indonesia, and transparency in research funding, especially with public funds, should be increased.
Anand Grover, the founder of Lawyers Collective, commented on the Indian scenario for TB drug patents. “India has a disproportionate burden of TB cases, 23% are MDR TB cases, while 6% are XDR-TB cases. We have drugs that are produced in India but cannot be accessed by those who need it the most,” he said.
Grover further added that the Indian government has been seeking drugs on donation from manufacturers (Ex: Bedaquiline from J&J) but has not made attempts to make it available for large populations. He added,” The Indian government has not been acting to grant compulsory production license to drug manufacturing companies. This is despite them favoring a TRIPS waiver to Covid-19 vaccines on an international level. There is dissonance between the government’s local ideas and its decision at the TRIPS council.” He further detailed the attempts that had been taken to seek transparency from the government, which included petitioners writing letters, former TB survivors coming to the fore, or activists filing RTIs to seek the number of patients who needed Bedaquiline.
“Indian generic industry is headed for a transformation. It does not provide drugs on altruistic reasons anymore. Once, CIPLA led the provision of low-cost anti-viral drugs in the AIDS crisis of South Africa. This week, it has decided to shake hands with Moderna and import its vaccine to India. Unless we file patent oppositions and get generic companies to produce these drugs at low cost, we will be in a very poor position,” he added.