“Victory for TB Response: J&J Evergreening Rejected”
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…Access to Affordable Medicines Secured
CATHERINE MUROMBEDZI
HEALTH CORRESPONDENT
TUBERCULOSIS survivors, rights groups, organisations championing access and equity of health tools and therapeutics, advocates, activists, and experts in patent laws welcomed the rejection to evergreening by Johnson & Johnson, a giant pharmaceutical concern.
On the 5th of July, 2024, the Indian Patent Office rejected Johnson & Johnson’s (J&J) application for a further patent on the pediatric version of bedaquiline, which is a crucial drug for treating drug-resistant tuberculosis (TB) in children.
The decision was made due to the application being deemed obvious and lacking any new inventive step.
This outcome followed a challenge to the patent application by civil society groups and tuberculosis survivors in 2020.
Johnson & Johnson did not contest the application.
As a result, generic versions of the drug can now be produced and made available in India and other countries, increasing accessibility and affordability for patients.
In a similar decision, the Indian Patent Office previously rejected Johnson & Johnson’s attempt to extend its exclusive rights to the adult version of bedaquiline two years ago.
Indian patent law, particularly Section 3(d), stands out by explicitly prohibiting the practice of evergreening. The practice involves extending patent life by making obvious forms, improvements, and modifications to existing drugs.This provision ensures that generic forms of essential medicines remain accessible through generic competition once the primary patent expires.
A patent is an exclusive right that is given to an inventor to prevent unauthorized exploitation of their invention for 20 years.
The justification for the patent system is that it encourages technological development in that the monopoly it gives allows the inventor to recoup the investment made in developing the invention and to make a profit as the patent right creates a barrier to entrance of competitors.
Pharmaceutical companies are particularly fond of the patent system as it takes substantial resources and time to develop drugs, do clinical trials, and obtain regulatory approval.
Big Pharma therefore do everything they can to extend the period of exclusivity given by the patent system.
One way they do this is filing new patent applications for new uses of known substances.
A famous example is aspirin, which was initially patented as a pain killer; then, towards the end of the twenty year patent term, a new application was filed for its blood thinning characteristics.
If a patent is granted for the new use, it means the exclusivity is extended by a further twenty years, even in respect of the pain killer. This is called evergreening.
Mr Moses Nkomo, a prominent intellectual property lawyer in Zimbabwe, with expertise in patent law, trademarks, copyrights, and intellectual property litigation, spoke against evergreening.
“Evergreening is unfair in that it extends the monopoly of the patentee and delays the entry of the invention into the public domain. As long as the patentee has exclusivity, the prices of the invention/ medicine remain high. Expiry of the patent allows generic manufacturers to enter the market, and because generic manufacturers do not have huge research and development costs, they can produce and avail medicine at much lower costs.
“The rejection means other pharmaceutical companies, after following due diligence processes, can now manufacture the drug as a generic. They simply reverse-engineer the drugs and apply for regulatory approval. They do not have steep research and development costs (R&D), so they can sell the drugs at affordable prices. With affordable prices, many countries in need can access the drugs,” explained Mr Nkomo.
India is referred to as the “Pharmacy of the Third World” or “Pharmacy to the World” due to its significant role in producing and supplying affordable medicines, particularly generic drugs.
Countries with limited resources can access quality generic drugs manufactured at a lower cost.
Indian companies have developed expertise in reverse-engineering and manufacturing generic versions of patented drugs, making them more affordable for developing countries.
India produces a wide range of medicines, including essential drugs, vaccines, and medicines for chronic diseases, catering to various healthcare needs.
Meanwhile, South Africa’s Anti-Trust Regulator announced that J&J and its subsidiary, Janssen Pharmaceutica, have agreed to withdraw a secondary patent on the tuberculosis (TB) drug bedaquiline.
The move opens the market in South Africa for generic suppliers to produce lower-cost versions of the drug, South Africa’s Competition Commission said in a statement. The companies also agreed to lower the price charged for bedaquiline to South Africa’s National Department of Health by 40%, which will bring it in line with what other low- and middle-income countries (LMICs) are paying.
Munyaradzi Eton Saruchera, a TB survivor from Dzivarasekwa in Harare, celebrated the power of advocacy and the effect of speaking with one voice.
“Following criticism from TB patient advocacy groups and non-governmental organizations like Medecins Sans Frontieres (MSF), it is good news that J&J has climbed down,” celebrated Saruchera.
The Harare Chapter Chairman, National TB Survivors Network, Stanley Sibanda was happy that their is power in unity of purpose.
“Unity of purpose is a winning formula. It is our duty as Survivors to demand assess, equity and fair prices of therapeutics. It’s not over until TB is no longer a threat. We can not have big pharmaceuticals posing barriers by forever changing goal posts,” said Sibanda.
Candice Sehoma, Advocacy Advisor, MSF Access Campaign, in South Africa was over the moon. Speaking in a press statement, she said:
“We welcome today’s news that following the Competition Commission’s investigation initiation into anti-competitive practice, J&J has officially withdrawn its secondary patents in South Africa on the lifesaving TB drug bedaquiline, opening up generic competition in South Africa.
“In particular, we welcome the Competition Commission’s efforts in recognising J&J’s tactic of patent evergreening as a blatant attempt by a pharmaceutical corporation to extend its monopoly and put its profits before people. We applaud the Competition Commission, prioritising the tackling of similar issues.y
“We hope that this significant step will increase access to affordable bedaquiline for people living with TB in South Africa, as the country will now be able to purchase more affordable, generic versions of bedaquiline and could see more generic producers enter the market to bring the price even lower, and ultimately, save more lives from TB.”
The WHO Global TB Report of 2023 states that 10.6 million people suffered from TB disease. A total of 1.3 million people were newly infected with HIV and 630 000 died of AIDS related illness. A total of 1.3 million people died of TB. With 167 000 people succumbing to TB/HIV co-infection.
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