In a recent development that could have major ramifications on intellectual property cases in pharmaceutical and technology sectors, the Delhi High Court issued a notice to the government in a PIL (Public Interest Litigation) filed by Mr. Shamnad Basheer in regard to the "working statement" of patented inventions in India.
MANDATORY REQUIREMENT TO FURNISH
DETAILS OF WORKINGOF PATENTS
According to Section 146(2) of the Patents Act, 1970 read with Rule 131 of the Patent Rules, 2003, every patentee and every licensee has to make an annual disclosure (Form-27) as to how far and to what extent he patent has worked on a commercial scale in India.
A statement of working is a yearly declaration to be made by the patent-holder and/or the licensees attesting the fact that the invention has indeed been commercially worked for the benefit of the public.
DETAILS REQUIRED IN FORM 27
To determine whether a patented invention has been "worked" (i.e. made accessible to the public for its benefit), the Form 27 seeks the following information:
1. Whether or not the patented invention was worked in India.
2. If not worked, the reasons for not working and steps taken for working of the invention
3. If worked, the following details need to be provided:
- Quantum and monetary values of the patent products (which includes products made through patented processes) manufactured in India and imported from other countries.
- Licenses or sub-licenses if any that were granted in respect of the patented invention
- If the reasonable requirements of the public had been met either partly, adequately or to the fullest extent possible
BACKGROUND AND IMPORTANCE
Furnishing such information is crucial in compulsory licensing cases in order to establish whether the patented invention has fulfilled the reasonable requirements of the public by interalia selling the patented product at an affordable price.
Patent working data is critical for triggering compulsory licensing and revocation provisions. This information played a pivotal role in the compulsory licensing dispute between Bayer Corporation v. Natco Pharma Ltd. Natco used this data to stake their claim to launch a more affordable version of a life-saving cancer drug, showing MNC firm Bayer's Form 27 patent filings where it was supplying the drug to only 2% of the patient population.
In the matter of Shamnad Basheer v Union of India, the petitioner(Mr. Basheer) prayed that the Hon'ble Court may, in public interest, be pleased to issue a Writ of Mandamus, or any other appropriate writ or order directing the authorities:
i. To strictly enforce compliance with Section 146(2) read with Rule 131(1) of the Patents Act, 1970 and Rules thereunder in relation to disclosure of information on commercial working of patent by every patentee and licensee;
ii. To initiate proceedings under Section 122(1) of the Patents Act, 1970 against errant patentees and licensees who have failed to comply with the mandatory requirement of Section 146(2) read with Rule 131(1) of the Patents Act, 1970 and Rules;
iii. To issue notices under Section 146(1) of the Patents Act, 1970 to patentees and licensees to furnish true and complete information in relation to incomplete disclosure of information on commercial working of the patent;
iv. To immediately rectify the 'comprehensive online filing services for patents' to enable patentees and licensees to submit full and complete working information;
v. To publish and upload the entire information relating to commercial working of all patents for all years of operation of the patent on their website as per Section 146(3) of the Patents Act, 1970 and Rules thereunder;
vi. To declare that the present format of Form-27 as contained in Schedule II of the Patents Rules, 2003 is insufficient to sub-serve the purpose of the Patents Act, 1970;
vii. To constitute a committee of experts to suggest reforms to improve the public disclosure norms around the of patents;
viii. Grant such other reliefs, including the costs of this writ petition, in the interests of justice.
Petitioner conducted survey in three critical areas: pharmaceutical drugs (lifesaving drugs for fatal diseases such as cancer, AIDS, diabetes and hepatitis); telecommunications; and publicly funded research and development and submitted data before the Court in regard to non-compliance and defective declarations of working of patented inventions along with other relevant supporting documents in the PIL, reproduced here:
According to the petitioner, approximately 35% of patentees did not disclose any working information for the years 2009 to 2012. Also a significant number of defective declarations were submitted which were incomplete, incomprehensible or inaccurate.
The government has now accepted notice and has been given 4 weeks to file a reply. The next date of hearing in the matter is November 17, 2015.
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