Synopsis: The dilution of patent working disclosure rules obstructs the success of India’s compulsory licensing regime.
According to the new Patent Rules, 2020, licensees are no longer required to annually submit to the Patent Office disclosing the degree to which they have commercially worked or made the patented inventions available to the public in the country.
What were the requirement of disclosure in Patent Rules, 2003?
The purpose of granting patents itself is to ensure that the inventions are operated in India and are made available to the public in adequate amounts at rational prices.
- The information about the degree at which these patentees are operating in India is very important to check abuse of patent monopoly. For example, excessive pricing or scare supply of the invention
- Courts have refused a temporary ban in cases charging violation of a patent which has not been operated in India.
- Section 146 (2) asks every licensee to submit to the Patent Office an annual statement explaining the extent to which they have worked the invention in India was not found in patent laws.
- The disclosure is to be made in the Form 27 format as suggested under the Patent Rules, 2003.
Irregularities and PIL filed
- The amendment to the form was made after a PIL was filed by Shamnad Basheer before the Delhi High Court in 2015. The PIL was about the non-filing and defective filing of Form 27 by licensees and wanted an action against the violators.
- The PIL also called for a reform of Form 27 because the information it sought was totally insufficient to determine the level of the working of the patent.
- Court directed the government to bring an amendment to strengthened the patent working disclosure rules.
- However, after 2 years, instead of strengthening, government introduced an amendment that dilutes the disclosure requirements.
How government changed the disclosure requirement?
The amendment in patent laws has considerably weakened it and is defeating the whole purpose of the amendment exercise. The requirement of submitting a lot of important information was removed. The form now requires the patentees to provide only for the following information:
- Firstly, whether the invention has worked or not and the revenue generated from it (manufacturing and importing). Reasons for the invention not working and the steps being taken towards it to make it work.
- Secondly, they don’t have to provide data about the amount of the invention manufactured in India and imported which is vital for proper assessment.
- Licensees can just self-certify that they’ve worked the patent without having to prove the claim with the data on how they’ve done it, including through licensing/sub-licensing the patent.
- For instance, the disclosure of this data by Bayer in Form 27 played a crucial role in grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar.
What are its impacts?
- Doing away with the condition of providing inventions for public requirement at a reasonable price, will have negative impacts on the affordability of new medicines in India.
- Doing away with the condition to disclose price and demand will make it difficult to assess the quantum of invention made available to the public in sufficient quantity and at an affordable price.
- The government must reconsider its amendments as it is going to impact public interest. Some inventions may remain inaccessible to public because of the lack of information. Such lack of accessibility in case of patented medicines could have adverse consequences for public health of the country.