Recently I came across a news article on a pharma – Patent Challenge case filed by two TB survivors against Johnson & Johnson (J&J) to quash its monopoly.
I had always wondered about patents and the fuzz surrounding it. So, let’s understand the basics,
What is a Patent?
It is a legal document granted by the government giving its inventors exclusive rights to produce, utilize and merchandise their inventions for a specific period.
Why are patents awarded?
The concept of patent was first introduced in the city of Venice in 1474 which laid foundation for the patent law. The primary motto of patent law is to induce the inventors to improve the current state of technology and grant them exclusive rights for their inventions so that they get benefited by them for the expenditure they incur.
What can be patented?
To be patentable it must fulfill three basic criteria’s.,
- Novelty
- Inventive (Non-Obvious)
- Useful
Coming back to the context, the case was filed objecting a patent extension for J&J for its anti TB drug Bedaquiline which is used for treating Multi Drug Resistant Tuberculosis (MDR-TB). In India about 1.47 lakh patients are suffering from MDR-TB of which only 2% of the patients are able to afford the Bedaquiline medicine due to its high cost. In such a scenario J&J has filed for a patent extension from 2023 to 2027 to maintain its monopoly on the drug. This act of extending a patent to maintain monopoly over an invention is termed as “Patent Evergreening”.
In our case here the secondary patent application fails in all the aspects required for a patent to be granted viz.,
Novelty– Since the new formulation is not something different from the earlier formulation which was already patented (IN236811) it lacks novelty.
Inventive – The company’s claims on the Inventive step is a verbatim copy of their earlier patent application on Rilpivirine.
Efficacy – The knowledge of the efficacy and existence of the Bedaquiline base compound predates the date of filing of the patent application, which covers a formulation of its fumarate salt, and a wetting agent is invalid.
Mere Admixture – Current Patent filing does not disclose any data on a synergistic effect resulting from the combination of known compounds.
To prevent such incidents the Patent Act was amended in 2005 to include sections 3d (Enhanced Efficacy) and 3e (Mere Admixture) which clearly spells out the limitations of a patent applicability. However, despite such restrictions almost 72% of the patents granted between 2009 and 2016 were secondary patents which were given for marginal improvements on a previously secured patent. Which brings back to our question “Are Indian patent law resilient?”
Conclusion:
It is high time for the Department of Industrial Policy and Promotion (DIPP) to take serious measures to enforce a resilient IP Regime in India at the earliest. Additionally, the government must also intervene and introduce price ceilings on the patented lifesaving drugs to increase its reach among all sections of the society.
References:
Business Management 
Good information
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