Every year, the holder of an Indian patent must file a statement declaring whether their invention is being “worked” or “not worked” in India. This is known as Form 27. If the invention is being worked, then the value of the patented product must be declared. If the invention is not being worked, then a reason for this must be given. Although, the Indian Patent Act sets out the requirement of complying with this formality and the potential consequences of not doing so, the Indian Patent Office has never established a clear practice, or issued guidelines, regarding the exact requirements of the statement, and the actual consequences of not meeting those requirements. A recent Petition filed at the Delhi High Court is seeking to make the whole situation clearer.
The requirement to file a working statement is unique to the Indian Patent Act. The failure to comply with this requirement or filing malicious/false information with Form 27 may provide a ground for obtaining a compulsory license or even revocation of the patent.
A few years ago, India witnessed its first compulsory license battle between Natco, an Indian generic company, and Bayer. Natco won the case and obtained a compulsory license for an anticancer drug “Nexavar” (a patented product of Bayer). In this case, the ground for request of a compulsory licence relied heavily upon the gaps in the working statements filed by Bayer. This was one of the first times where the importance of filing a working statement was realised and was used as an opportunity for getting a compulsory license. Bayer was selling the drug “Nexavar” at 0.28 million Indian rupees (about USD4500) per month of patient treatment. However, when the license was issued in favour of Natco, the drug then sold at around 8,800 rupees (about USD150) per month.
Since this ruling, many IP practitioners in India and across the world have been concerned with the seriousness of filing working statements, their transparency, and the consequences of failing to submit Form 27 because it is not clear what action will be taken by the Indian Patent Office for errant working statements. Meanwhile, a writ petition was filed before the Delhi High Court in 2015 by an IP professor and founder of an Indian IP blog “SpicyIP”, Mr. Shamnad Basheer, to which the Delhi High Court has given its first order this year, in January 2018
Mr. Basheer, the Petitioner, filed a writ petition pointing out serious lapses in the filing of “patent working” documents (Form 27) by various patentees. Form 27 filings should indicate how patentees have (or have not) worked the patent to the public benefit but research by Mr. Basheer and his team unveiled vast differences in the extent to which patentees are completing the form. Hundreds of patents and working statements were reviewed, mainly relating to life-saving drugs, high technology inventions and public funded research units, and it was found that many patentees failed to submit the annual statement. Of those that did submit, a number of forms were either incomplete, evasive or defective. There were also instances where patentees cited ‘confidentiality’ and refused to answer particular questions contained in Form 27.
The main motive for filing the petition was to ask that the court issue directions against the Union of India and Controller of Patents to enforce the statutory obligation under the Patents Act, force patentees to file their Form 27s correctly, and to penalise the errant ones. In addition, the petition sought a direction from the High Court to examine the current format of Form 27 and suggest improvements.
The Delhi High court made it clear in an order in January 2018 that, in the Form 27, a patentee should disclose all the necessary and relevant information relating to working of a patent in India, including licensee(s) details, and that such information cannot be treated as confidential because the information pertaining to a license of a patent is already available in the Register of patents (which is publically available). Therefore, the patent working information is not “confidential” and must be submitted by all patentees, and that all licensees (including those with compulsory licenses) have to comply with the disclosure requirement.
Furthermore, the Delhi High Court asked the Government to submit an affidavit outlining the proposed framework, a timeline for enforcing the patent working disclosure mandate, and how it proposes to put in place an enforcement mechanism against errant patentees. The court also asked the office to consider reviewing/revising the Form 27 format to make it clearer.
Meanwhile, the Indian Patent office released a circular on 8th March 2018 inviting feedback from stakeholders to which hundreds replied (including IP law firms and the in-house IP counsel of many Multi-Nationals Companies across India, China and the USA). The next step is a meeting of selected stakeholders, which is due in April 2018.
We are monitoring the matter closely and will provide an update on the outcome of the stakeholder meeting when appropriate.
if you have any queries regarding this working statement case, or any of the formal requirements for Indian patent applications, then please make an enquiry via our ‘contact us’ page and one of our attorneys will be happy to assist you.