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Source- The post is based on the article “Laud the failure of J&J’s shot at patent evergreening” published in the “mint” on 30th March 2023.
Syllabus: GS3- Science and Technology
Relevance– Issues related to patents
News– Last week, when the Indian Patent Office rejected an application by Johnson & Johnson (J&J) to extend its patent on its TB drug Bedaquiline beyond its primary patent’s expiry this July.
Why is there a need for proactive action against TB?
TB is an ancient airborne disease. It is one of the deadliest infectious killers. According to the WHO, 10.6 million were infected by the disease in 2021 and an estimated 1.6 million people died.
India bears the world’s largest burden of TB as well as its multi-drug resistant version
Due to resistance to existing medications, strains have emerged that could evade the effects of various drugs. It means fewer treatment options, lower survival rates and a much longer duration of treatment.
The drugs have harrowing side effects ranging from kidney and liver disorders to permanent deafness.
What are some facts about the Bedaquiline drug?
It is used against advanced TB. It has improved cure rates. It is also observed to be a safer alternative to injectables such as Kanamycin and Amikacin.
WHO has advised the countries to scale up its use, with certain caveats.
What are provisions in the Indian patent act to safeguard the interests of citizens?
The Indian patent act has special provisions to prevent evergreening. These were introduced
through an amendment to the Indian Patents Act in 2005.
It ensures that a patent is not granted to a new form or use of a known substance, unless the modification shows enhanced efficacy.
These provisions have acted as important public-health safeguards. It has allowed the timely entry of generics and helped to bring down the cost of life-saving drugs. It makes them more accessible.
What will be the future implications of the order?
The failure of J&J’s evergreening attempt will let other drug-makers manufacture and sell this life-saving drug after July 2023. Competition will ensure its price drop.
The national TB programme currently relies on J&J supplies for its Bedaquiline requirement. It will be able to procure the drug from other players expected to enter the market.
India exports generic drugs to several low-income countries where TB prevalence is high. So, patients elsewhere will also be able to access this drug at reasonable cost.