IPO Rejects J&J’s Bid to Extend TB Drug Patent

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In a significant decision favouring tuberculosis (TB) patients, the Indian Patent Office (IPO) has rejected Johnson & Johnson’s (J&J) application to extend the patent on its life-saving TB drug, bedaquiline.

The ruling opens the door for more affordable generic versions of the drug, potentially improving access for millions of patients in India and across the globe.

Affordable Treatment Options Now Within Reach

The injectable, long-acting version of Bedaquiline currently costs hundreds of dollars per therapy. This makes it unaffordable for many in developing countries, such as India.

Despite the government providing TB drugs free of charge under its health programs, the steep cost of treatment remains a major barrier for patients.

The patent rejection could alleviate the financial challenges and ensure broader access to effective TB care.

Johnson & Johnson’s Patent Applications Denied

The IPO has denied all three patent applications for bedaquiline. Johnson & Johnson’s pharmaceutical division, Janssen has filled these application

In July, the company’s bid for a pediatric version of the drug was similarly rejected. Last year, the primary patent for bedaquiline also lost protection, further paving the way for affordable alternatives.

They filed the latest patent application in 2020. It sought protection for a long-acting injectable version of bedaquiline. TB preventive therapy is designed for this version.

Grounds for Rejection

The Indian Patent Office based its rejection on the lack of inventive step and novelty in J&J’s application. These criteria are critical for securing a patent, ensuring that only genuinely innovative advancements receive protection.

A Game-Changer in Tuberculosis Treatment

Bedaquiline, the first TB drug approved in over forty years, is often regarded as a ‘wonder drug’. It is more effective and less toxic than traditional TB treatments, which have dominated the landscape for decades.

The recent patent ruling ensures the revolutionary drug becomes accessible to a broader patient base. This could potentially transform the fight against TB in India and beyond.

As reported by timesofindia.indiatimes.com, the decision marks a pivotal moment in global health. It demonstrates how policy can drive equitable access to life-saving medications.