NEW DELHI: Indian Patent Office Rejects Johnson and Johnson’s Patent Extension for Bedaquiline: Opening Doors to Affordable Generics. On March 23, 2023, the Indian Patent Office rejected Johnson and Johnson's patent extension application for the anti-tuberculosis drug Bedaquiline. This drug, which is set to expire in July of this year, would have extended J&J's monopoly on the drug in India. However, with the rejection, generic manufacturers can now create their versions of the drug at an affordable price, ultimately allowing for better access to the medicine.
Background on Bedaquiline
Bedaquiline is a medicine that treats multi-drug-resistant tuberculosis (MDR-TB). In India, TB is a significant problem and ranks among the top ten causes of death in the country. As a result, the rejection of J&J's patent extension application has been seen as a significant win for affordable and accessible healthcare in India.
The Plea by TB Survivors
The patent office made its decision on a plea filed by two TB survivors, Nandita Venkatesan, and Phumeza Tisile. The petitioners argued that J&J's secondary patent application could block manufacturers from supplying generic versions of the drug, thus limiting people's access to the medication.
Decision Against J&J
According to the Economic Times, Latika Dawara, the assistant controller of patents and designs patent office, said, "[The] instant application [of J&J] does not meet the requirements of section 2(1)(ja) and sections 3(d) & 3(e) of the Patents Act brd on the findings from the investigation as well as from the matter presented by the opponents in the pre-grant opposition proceedings as discussed above." The decision ultimately means that the invention disclosed and claimed in the instant application has been refused to proceed further under section 15 of the Act.
Impact on Affordable Healthcare
The rejection of J&J's patent extension application means that generic manufacturers can produce the drug at an affordable price. This is expected to result in a significant reduction in the price of the drug, making it more accessible for patients in need. The Hindustan Times reports that the generic versions of the drug in the local market will likely be 80% cheaper for a six-month course. In India, the government directly procures the drug and distributes it under conditional access through state health programmes.
The Strategy of Patent Evergreening
J&J had filed a patent for Fumarate salt of Bedaquiline in 2008 to extend its patent till the end of 2027, a strategy known as patent evergreening. This strategy refers to the continuing extension of patent rights, as well as the process of obtaining many patents for the same medicine.
Impact on TB Patients
Nandita Venkatesan, one of the TB survivors who filed the plea against J&J, said, "We are thrilled to see that our attempt to break the monopoly of a pharmaceutical corporation over this lifesaving drug has been successful." She also added that the win needs to be followed by the scale-up of shorter oral TB treatment regimens by TB programmes globally to reduce unnecessary suffering caused by older toxic drugs and treatment regimens.
Conclusion
The rejection of J&J's patent extension application for Bedaquiline is a significant win for affordable healthcare in India. It allows for generic manufacturers to produce the drug at a more affordable price, ultimately improving access to the medication for patients in need. This decision could have a significant impact on the fight against TB in India, where the disease is a significant problem.
