A recent amendment to a unique feature in patent law under which patentee/licensee has to disclose information regarding the extent to which they have worked patent in India, could have several implications.

Why the changes in rules matter

• Indian patent law grants a 20-year patent monopoly to an inventor.
• In exchange for such monopoly, India’s patent law imposes a duty on the patentee to commercially work the invention in India to ensure that its benefits reach the public.
• Accordingly, section 146(2), a unique provision not found in patent laws of most other countries, requires every patentee and licensee to submit to the Patent Office an annual statement (Form 27 format) explaining the extent to which they have worked the invention in India.
• This statement is meant to help the Patent Office, potential competitors, etc. to determine whether the patentee has worked the invention in India and made it sufficiently available to the public at reasonable prices.
• A failure of this duty could trigger compulsory licensing or even subsequent revocation of the patent under the Patents Act, 1970. 
• The central government recently amended the format of a statement that patentees and licensees are required to annually submit to the Patent Office.
• The amendment has significantly watered down the disclosure format.
• This could hamper the effectiveness of India’s compulsory licensing regime.
• This in turn could hinder access to vital inventions including life-saving medicines, thereby impacting public health.
• There has been significant pressure from multinational corporations and the United States government to do away with this requirement.

What changes were made through the amendment

• The recent amendment to the form was made in response to a PIL filed by Shamnad Basheer before the Delhi High Court in 2015.
• The PIL brought to the Court’s attention the rampant non-filing and defective filing of Form 27 and sought a direction to strictly enforce the patent working disclosure rules and take action against the violators.
• The PIL also called for a reform of Form 27, arguing that the information it sought was grossly insufficient to ascertain the extent of the working of the patent.
•  However, instead of strengthening the form, the amendment has significantly weakened it further, thereby defeating the entire purpose of the amendment exercise.
• The amended form has removed the requirement of submitting a lot of important information.
• It is no longer required to provide any information in respect of the quantum of the invention manufactured/imported into India, the licenses and sub-licenses granted during the year and the meeting of public requirement at a reasonable price.
• It no longer requires quantum or the total units of the invention manufactured/imported in India.
• The deletion of this requirement of its disclosure is shocking.
• This is because,  it is the disclosure of this data by Bayer in Form 27 that played a crucial role in grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar.
• The removal of the requirement of submitting any licensing information, including the disclosure of even the existence of licenses means that the patentees/licensees can just self-certify that they’ve worked the patent.
• The omission to mandate disclosure of details makes it extremely difficult to ascertain whether the invention has been made available to the public in sufficient quantity and at an affordable price.

Conclusion

The government has significantly weakened the critical duty imposed by the law on patentees/licensees to disclose patent working information. Therefore, the government must reconsider its amendments to the form taking into account the PIL recommendations and re-amend it to restore as well as strengthen its spirit.

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