Patent challenge mounted against J&J’s attempt to extend monopoly on high-priced anti-TB drug

Headline : Patent challenge mounted against J&J’s attempt to extend monopoly on high-priced anti-TB drug

Details :

The News

  • Two TB patients have filed a petition challenging Johnson & Johnson’s application for extension of patent for Bedaquiline, the anti-TB drug.

Background

  • Drug-resistant TB:
    • The bacteria causing TB have developed Multi-Drug Resistance and Extreme-Drug Resistance even to the most powerful anti-TB drugs, Isoniazid and Rifampicin.
    • About 1.47 lakh people in India suffer from multi drug resistant tuberculosis (MDR-TB).
  • Bedaquiline drug for treatment is too expensive:
    • The WHO has recommended Bedaquiline as a new-generation drug for Multi-drug resistant TB patients.
    • However, Bedaquiline is extremely expensive about $400 pe patient per regimen and thus unaffordable to majority of patients in India.
    • At present, a mere 2% of over the patients suffering from MDR-TB in India are currently getting Bedaquiline.
    • India is getting about 10,000 free courses of Bedaquiline under the US-AID programme, but this number is too low.

India needs to make generics when the patent expires:

  • Thus in order to meet the ambitious goal of ending TB by 2025, India needs make new-gen drugs like Bedaquiline accessible to its vulnerable population.
  • This requires compulsory licensing of Bedaquine in order to be able to make generic version of the drug which will be more accessible and affordable.

J&J looking to extend the duration of its patent:

  • Johnson&Johnson company currently holds the patent rights over the basic molecule of Bedaquiline till 2023.
  • The company has sought an extension of patent rights or secondary patent on the fumarate salt of Bedaquiline drug for 4 more years from 2023 to 2027.

Secondary Patent and Evergreening: A brief

  • In order to protect the patent rights of a pharma company over a drug, primary patent is issued.
  • Primary patent is issued over the active pharmaceutical ingredient (API) of a drug usually of 20 years. 
  • During the 20 years, the drug is usually expensive as an incentive to the research efforts of the company holding the patent rights.
  • At the end of 20 years, generic versions of the drug are allowed to be manufactured and thus the prices of the drug come down.
  • As a strategy to continue getting profits keeping the price of the drug high, the pharma companies adopt strategies called secondary patents or evergreening.
  • Secondary patents are usually sought for derivatives and variants of the API, a new formulation, a dosage regimen, or a new method of administering the medicine.
  • This strategy of extending the patent rights beyond the 20 year period by seeking secondary patents even before the expiry of primary patent is called ‘Evergreening’.
  • Section 3(d) of the Indian Patents Act provides an effective defence against secondary patents misuse and thus evergreening in India.
  • According to Section 3(d) in order to be eligible for secondary patent, the drug must demonstrate significant improvement in therapeutic efficacy and not just change in formulation of the drug. 

Section : Science & Tech

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