India Rejects Johnson & Johnson’s attempt to extend monopoly on lifesaving TB drug : Daily Current Affairs

Date: 25/03/2023

Relevance: GS-3: Issues relating to Intellectual Property Rights.

Key Phrases: anti-tuberculosis drug Bedaquiline, Johnson & Johnson’s (J&J), Evergreening of Patent, Section 3(d) of the Indian Patents Act, Section 3(e) of the Indian Patents Act, Multi-Drug Resistant TB, Assistant Controller of Patents and Designs.

Why in News?

  • In a significant victory for patients seeking wider access to the crucial anti-tuberculosis drug Bedaquiline, the Indian Patent Office rejected Johnson & Johnson’s (J&J) attempt to extend its monopoly on manufacturing the drug in India beyond July 2023.
  • This rejection paves the way for generic drug manufacturers to produce Bedaquiline, thereby ensuring cheaper and wider access to the drug.

Evergreening of Patent:

  • Evergreening is any of various legal, business, and technological strategies by which producers (often pharmaceutical companies) extend the lifetime of their patents that are about to expire in order to retain revenues from them.
  • This is done by making minor changes to the original drug, such as a new formulation or a slight modification in dosage, and then filing for a new patent.
  • This allows the company to maintain its exclusive right to manufacture and sell the drug, even if it is essentially the same as the original.
  • This can limit competition from generic manufacturers and keep drug prices high, making access to essential medicines difficult for those who cannot afford them.

What does the law say about the evergreening of patents in India?

  • Section 3(d) of the Indian Patents Act states that the mere discovery of a new form of a known substance that does not result in the enhancement of the efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process, the machine, or apparatus unless such known process results in a new product or employs at least one new reactant, is not considered to be an invention.
  • Section 3(e) of the Indian Patents Act states that a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not patentable.

What is multidrug-resistant tuberculosis (MDR TB)?

  • The bacteria that cause tuberculosis (TB) can develop resistance to the antimicrobial drugs used to cure the disease.
  • Multidrug-resistant TB (MDR-TB) is TB that does not respond to at least isoniazid and rifampicin, the 2 most powerful anti-TB drugs.

Importance of Bedaquiline in Treating Multi-Drug Resistant TB Patients:

  • Bedaquiline is a critical drug in the treatment of multi-drug resistant TB patients for whom the first-line drug treatment has stopped working.
  • Currently, Bedaquiline tablets are priced at $400 per six-month treatment course, making them unaffordable for many patients.
  • According to the latest estimates, in 2019, over 55,000 patients who had developed multi-drug resistant TB could have benefited from access to Bedaquiline, but only a little over 10,000 of these patients had accessed the drug as of March 2020.

Evergreening attempts

  • Since 2007, Johnson & Johnson had engaged in ‘evergreening’ – a strategy to extend the life of patents about to expire to retain revenues from them – by making multiple claims in its applications for patent extensions.
  • When the company filed for evergreening of its patent on fumarate salt (a formulation salt of Bedaquiline), the practice was challenged by two TB survivors.
  • Their patent challenge in 2019 aimed to ensure that the safer, oral, and efficacious drug Bedaquiline was available to all people who needed it.

Legal Basis for Rejecting J&J's Patent Extension

  • J&J had sought a patent extension on the basis of its claim that it had invented the method for making a derivative of quinoline in its salt form.
  • The Indian Patent Office rejected the patent extension, stating that the invention claimed was obvious and did not involve any inventive step and, therefore, was non-patentable.
  • The rejection was made based on Section 3(d) of the Patents Act, which states that salt forms and derivatives of known substances are not patentable.
  • The order passed by the Assistant Controller of Patents and Designs stated that the claimed compounds were mere admixtures, resulting in mere aggregation of properties and not a new invention under Section 3(e) of the Patents Act.
  • The applicant cannot claim a patent on these methods and compositions of salt forms that have been known in the scientific world for more than three decades

Conclusion:

  • The rejection of Johnson & Johnson’s attempt to extend its monopoly on manufacturing the anti-tuberculosis drug Bedaquiline in India beyond July 2023 is a significant victory for patients seeking wider access to the drug.
  • It will benefit thousands of patients who require the drug for treatment and ensure that alternate manufacturers can supply the drug at lower prices, which is critical as TB programs worldwide plan to scale up the all-oral, six-month drug-resistant TB regimen.

Source: The Hindu

Mains Question:

Q. What is the evergreening of patents, and how does it affect the availability of essential medicines like Bedaquiline in India? Discuss the legal basis for rejecting Johnson & Johnson's attempt to extend its monopoly on manufacturing Bedaquiline in India, and its potential impact on wider access to the drug for patients suffering from multidrug-resistant tuberculosis.