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The Indian Patent Office denied Johnson & Johnson’s (J&J) petition for extending its monopoly in India on tuberculosis (TB) medicine bedaquiline beyond the original patent’s expiration in July.
Bedaquiline Drug:
- Bedaquiline is an important medicine in the treatment of multi-drug-resistant tuberculosis patients for whom first-line drug treatment with isoniazid, rifampicin, pyrazinamide, and ethambutol has failed.
- Bedaquiline has been the foundation of all drug-resistant tuberculosis (DR-TB) treatments since 2020.
Grounds for rejection:
- J&J requested a patent extension based on its claims that it devised the process for producing quinoline derivatives in salt form.
- However, Latika Dawara, Assistant Controller of Patents and Designs, indicated in her ruling that the claimed invention was apparent and did not entail any inventive step, making it non-patentable.
- Inventive step:
- a characteristic of an invention that includes a technological advance above existing knowledge or has economic importance, or both, and makes the invention not obvious to a person proficient in the art.
- Section 3(d) of the Patents Act
- According to Section 3(d) of the Patents Act, salt forms and derivatives of known substances are not patentable. The Patent Office order states that “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.”
- Section 3(e) of the Patents Act:
- According to the order, the claims of J&J’s current application are liable to be denied because the claimed compounds are simply admixtures resulting in a mere aggregation of attributes and not a novel invention under Section 3(e) of the Patents Act.
Issue of evergreening of patents:
- Since 2007, J&J has engaged in ‘evergreening by making numerous claims in patent extension applications.
- Evergreening:
- a method of extending the life of patents set to expire in order to keep revenue from them.
- When the business applied for the evergreening of its patent on fumarate salt (a formulation salt of bedaquiline), two TB survivors, Nandita Venkatesan and Phumeza Tisile, contested the practice.
- “In 2019, a patent challenge was filed to ensure that the safer, oral, and efficacious drug Bedaquiline was available to all people who needed it.” This attempt to break a pharmaceutical company’s monopoly on this life-saving medicine was successful.
Significance of rejection:
- J&J’s key patents on Bedaquiline will expire in July, allowing generic medicine producers such as Lupin and Macleods, among others, to supply the drug, providing cheaper (around 80%) and more widespread access to the treatment.
- Bedaquiline pills are currently $400 for a six-month treatment course.
- According to the most recent projections, in 2019, nearly 55,000 individuals with multi-drug-resistant TB may have benefited from access to Bedaquiline. Only a bit more than 10,000 of these patients had received the medication as of March 2020.
Way forward:
- It is high time for alternative manufacturers to begin delivering Bedaquiline at reduced rates, especially since TB programs throughout the world intend to build up the all-oral, six-month drug-resistant TB regimen.
- However, J&J retains the Bedaquiline patent in other large countries, such as South Africa, preventing Indian generic producers from exporting the medicine there.
Tuberculosis:
- Mycobacterium tuberculosis is the bacteria that causes tuberculosis (TB). TB germs often attack the lungs, but they can affect any region of the body, including the kidney, spine, and brain.
- Transmission:
- Tuberculosis spreads through the air from person to person. When people with lung tuberculosis cough, sneeze, or spit, the TB germs are released into the air.
- Every age group is at risk. More than 80% of illnesses and fatalities occur in low- and middle-income nations.
- Symptoms:
- A cough with mucus and blood at times, chest pains, weakness, weight loss, fever, and night sweats are all common signs of active lung TB.
- Treatment:
- Tuberculosis is a treatable and curable illness. Drug-susceptible tuberculosis is treated with a normal 4-month or 6-month course of four antimicrobial medicines, with patient assistance given by a health worker or certified treatment supporter.
- Two of the most effective first-line drugs are isoniazid and rifampicin.
- For drug-resistant tuberculosis (DR-TB): bedaquiline