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Evergreening of bedaquiline patent: India must refuse!

GP Mohanta & R. Kumaravel Rajan
Wednesday, February 22, 2023, 08:00 Hrs  [IST]

Press has reported that India has made its stand clear that it does not want to offer any flexibility in the Intellectual Property Rights regime that will allow evergreening of patents by drug companies. This is perhaps the biggest challenge for India-UK Free Trade Agreement (FTA) and FTA is likely to be closed by March 2023. India and UK have been negotiating for about one and a half year to boost trade and investment between two countries. One of the contentious issues for India is to securing patent regime against evergreening by the pharma companies. Despite the change in internal politics in UK, they have completed the majority of the sections of FTA with India. While the India’s stand on evergreening of patents is a welcome step for the country but how long the country can withstand the international pressure is always a concern.

The current focus on evergreening of patent is Bedaquiline (BDQ). BDQ is the backbone of injection free regimen for the treatment of TB. In 2018, World Health Organization introduced Bedaquiline as a core drug in the standard treatment regimens for the treatment of multidrug and rifampicin-resistant TB (MDR/RR-TB). WHO emphasized that the immediate steps to be taken to ensure that MDR/RR-TB patients receive treatment in accordance with the latest evidence on effectiveness and safety. The new treatment guidelines prioritised the use of Bedaquiline as a drug with the lowest risk of serious side effects. This has also advocated limited use of injectable aminoglycosides. In India, Bedaquiline has been introduced as a conditional access through Revised National Tuberculosis Control Programme (RNTCP) under Programme Management of Drug Resistant Tuberculosis (PMDRT).  A subsidiary of pharmaceutical corporation J&J, Janssen Pharmaceutica N.V. (Janssen), has filed
multiple patents on Bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claims on routine improvements and formulations. Currently, Janssen exerts control over the market until 2023. At this point of time, the patent for Bedaquiline is set to expire. The company has applied for a secondary patent on the Fumarate salt of Bedaquiline and this will further delay the entry of alternative suppliers to the market until the end of 2027. The original patent of Bedaquiline base compound, its salts, isomers and enantiomers are set to expire on 18th July 2023. If the subsequent patent for Bedaquiline Fumarate with a wetting agent is granted, it will have the patent right till 3rd December 2027. The granting of patent to Bedaquiline Fumarate would further delay the entry of competition from other companies. Advocator of patents argue that denial of patents would decrease innovation though it is not true.

The secondary patent claim is currently pending at Controller of Patents. Section 25 (1) of the Indian Patents Act allows pre-grant opposition by anyone and can be filed at any time until the grant of the patent. In addition to mere modification claim, there are other logics too which urge the company not to go for patent of its salts. Bedaquiline’s development is not a single industry’s effort but a collective effort of many organizations. Many organizations/programmes like some National TB programmes, US National Institutes of Health/National Institute of Allergy and Infectious Diseases and the TB Alliance and MSF have contributed hugely establishing its safety and efficacy. MSF claims “J&J’s secondary patent application blatantly disregards public contributions to the development of the drug, and thus the secondary patent claim should be unequivocally rejected”.

Though initially it was the case of patent of Bedaquiline Fumarate, the application was revised by the Jansen and the new claim is for ‘Bedaquiline Fumarate and wetting agent’ combination. The combination can be treated as mere mixture of two substances - let us look into the merits of the admixture in terms of patenting qualities:
    • Novelty - The earlier patent granted to Janssen has already disclosed Bedaquiline free-base compound and its additional salts, including Fumarate salts and surfactant (wetting agent). Thus, there is no invention as invention claimed is already disclosed;
    • Inventive step - Patents are not granted on compounds that would have been obvious to make or arrive at based on existing knowledge or well-known techniques. Base compound, Janssen’s earlier patent on Rilpivirine, and other literature have already demonstrated that making a salt form of a known compound – in this case Bedaquiline – is obvious and cannot be termed as inventive. The patent application on Rilpivirine, which was rejected earlier based on the ground that the salt is obvious;
    • Efficacy - The new forms of known substances have to demonstrate that they have enhanced therapeutic efficacy of the known product in order to get patent. Section 3 (d) of patent act stipulates that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not patentable. The salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.  The company has not demonstrated enhanced therapeutic efficacy of the allegedly new formulation of Bedaquiline over its previously known form. The Section 3(d) is the clause which prevent evergreening of patents. The Supreme Court of India has already validated the provision of the Act during battle of patent against Novatis’ anti-cancer drug, Glivec, in 2013; and
    • Mere Admixture - Section 3(e) of India’s Patents Act requires the patent applicant to show that the combination being claimed as an invention has additional or synergistic results and that the combination is not just a mere aggregation of qualities of the substances forming the combination.

The case of Bedaquiline Fumarate and wetting agent is a classic example of evergreening of patent. A recent study on the Indian Patent Office has highlighted that a significant proportion of patents – over 70 per cent of those granted from 2009 to 2016 – are for marginal improvements, many of which have been granted despite the anti-evergreening provisions in the Indian Patents Act, which restricts the patentability of a host of secondary claims. That is reason for concern.

Granting patent to the inventor is a reward for the hard work, time and resource spent. All innovations are given protection under patent act. However, patent protection is the hinderance to accessibility of innovations. The patent period is for 20 years and is a reasonable time for the inventor to realise the investment made. The inventor or the pharmaceutical company should be generous enough to allow the patent to lapse so that others can make use of the invention. They should not go after evergreening of patent just for monopolizing the treatment and affecting adversely the public health. India has check and balance for patenting new molecule: allowing patent for real innovation and not permitting the mere changes in the known molecule for patent. Patent office should look into the India’s interest first than the profit of the pharmaceutical companies. Bedaquiline patent is particularly important for India as it proposes to eradicate the TB by 2025 well ahead of sustainable goal, 2030. Hope the good sense will prevail in the greater interest of the nation!

(Authors are professors, C. L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai  600 097)


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