Evergreening of Patent and Johnson and Johnson

Evergreening of Patent

The United States pharmaceutical company Johnson & Johnson (J&J) has had their request for the Evergreening of Patent on the production of the anti-tuberculosis medicine Bedaquiline in India beyond July 2023 denied by the Indian Patent Office.

Bedaquiline is an essential medication for the treatment of multidrug-resistant tuberculosis patients who have not responded to the standard first-line pharmacological therapy, which consists of the antibiotics isoniazid, rifampicin, pyrazinamide, and ethambutol.

The application for the patent was turned down for what reason.

• The substance used to make bedaquiline tablets was the subject of J&J’s patent application, which was for a fumarate salt of the compound.
• It was asserted that J&J’s approach did not need a “inventive step” in order to manufacture a “solid pharmaceutical composition” of bedaquiline
• The Indian Patent Act of 1970, Section 2(1)(ja), defines an invention as having an “inventive step” if it is one that “is not evident to a person knowledgeable in the art.”
• The new application took a large amount of inspiration from an older patent that mentioned a comparable molecule to bedaquiline, which is the basis for the drug.
• As a result of the Patents Act of 1970, some “restrictions” have been put on patentability.
• The’mere use of a known process, machine, or equipment’ is not eligible for patent protection under the law because “such known method must either result in a novel product or utilise at least one new reactant” for this to be the case.

To prevent innovator pharmaceutical companies from extending the patent beyond the stipulated period of 20 years and to ensure that the monopoly does not continue indefinitely, Section 3(d) of the Act does not permit the “evergreening” of patents. This provision was added to ensure that the monopoly does not continue indefinitely.

As of right now, it is still protected by a patent, and there is no equivalent product available in generic form. But, after the Bedaquiline patent has run its course and expired, the legislation will let pharma manufacturers produce generic copies of the medication.

Why Should We Take Notice of the Rejection?

• Because of the rejection, it is anticipated that the price of bedaquiline would drop by up to 80 percent.
• The number of persons living with tuberculosis who are resistant to treatment is highest in India. Due to J&J’s patent on bedaquiline, the price of the medicine was set at USD 400 (reduced to USD 340 in 2020) per individual. This was in addition to the cost of any additional medications.
• Up until this point, the medicine has been directly acquired by the Indian government and supplied by way of TB programmes run at the state level. Bedaquiline will become available in generic form in India from July 2023, when it would then be manufactured by generic medicine producers there.
• Evergreening is a term that is used in reference to patents.
• Evergreening patents refers to the process of making little changes to existing medications in order to lengthen the duration of their protection under a certain patent and, therefore, its potential earnings.
• The “evergreening” of patents is a sneaky and potentially harmful activity that was targeted by a number of prohibitions included in the Indian Patents Act of 1970.
• The purpose of this is to assist the millions of people who are unable to buy the pricey customised pharmaceuticals, as well as to foster the growth of the home market for generic drugs.

Concerns:

• There is no discernible improvement in the drug’s capacity to treat patients as a result of the procedure. In many jurisdictions, very slight alterations to an existing recipe may be patented and protected.
•  As a consequence of this, there is less opportunity for competition in the market, which is negative for both the market and the customers.
• Companies extend the term of protection and charge more for drugs while defending the costs that they incurred in research and development.
• However, no costs have been incurred for such compositions because it is only a minor combination or modification of existing drugs, so companies argue that there have been no costs incurred for such compositions.
• While there is a shortage of generic pharmaceuticals, the diversity of options available to customers results in a rise in the overall cost of healthcare.
• Consumers in impoverished and developing nations are the ones who suffer the most from the continuation of patents since they are unable to buy the brand name pharmaceuticals that may rescue them from potentially fatal ailments.