In a matter that will bring significant changes in patent working norms in India, the Delhi High Court has sought the government’s response on a PIL seeking strict compliance of patent laws, including disclosure of information on commercial working of patent by every patentee and licensee, and action against errant patentees.
A group of lawyers led by Shamnad Basheer, patent expert and former IP chair at the National University of Juridical Sciences in Kolkata and founder of intellectual property blog SpicyIP, want the authorities to direct patentees and licensees to comply with the statutory mandate to declare information on the working of their patents as per the Patents Act, 1970, and Rules thereunder.
According to them, the current format of Form-27 disclosure specified under the Rules is wholly insufficient to fulfil the objectives of the Act. Basheer contends that Form-27 lacks precision and fails to ask for several critical particulars, like how far and to what extent they have commercially worked their patent, which are necessary for an effective assessment of patented inventions.
The petition highlights massive discrepancies by big MNCs including Allergan, Bayer, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis and Samsung Electronics in this regard.
“The inaction by the authorities enables patentees to escape public scrutiny of their efforts in working their patents, thereby causing prejudice to the social bargain underlying the patent system and undermining its very objective. And making it more difficult to trigger the compulsory licensing and revocation provisions, consequently impacting the public at large by denying them potentially cheaper and more accessible products and services, particularly affordable medications,” the patent expert says.
Besides wanting a committee of experts to suggest reforms to improve public disclosure norms, the PIL seeks a direction to the patent authorities to rectify the ‘comprehensive online filing services for patents’ to enable patentees and licensees to submit full and complete working information. In addition, it has requested for a direction 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.
“It has been eight years since the Right to Information (RTI) Act came into being but the country’s activists are clueless about what happens when India’s most potent information weapon clashes with other information dispensation mechanisms coded in a host of other pre-existing laws—such as Patents Act and Companies Act,” Basheer says in SpicyIP.
The survey of patent working, conducted by Basheer, 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—revealed a blatant disregard for an important statutory mandate, with close to 35% of the patentees failing to disclose their patent working status during 2009-12. Even among those patentees that purported to make this disclosure, the same were defective, incomplete, negligent or incomprehensible, he says.
Basheer had under RTI sought information on the level at which pharma companies are commercialising the patents they hold, particularly in critical and chronic diseases. While all patent holders are mandated to file this information with the patent office annually in a prescribed format, the patent office had uploaded part of such information on its website, which Basheer alleges is only for 2012 and 2013.
Says senior IPR lawyer Prathiba M Singh, “Patent working norms are extremely important. I feel they should be rationalised and made simpler so that it becomes easier for patentees to comply and also understand how the country is benefiting from the patent. Working norms should also take into consideration modern concepts of licensing and franchising of IP.”
Patent working information played a critical role in the Bayer versus Natco compulsory licensing (CL) dispute, with Natco using the various Form-27 (patent working data) submissions of Bayer to help demonstrate that its super-expensive patented drug for kidney/liver cancer was reaching just about 2% of the patient population. Natco, the beneficiary of the CL order, failed to comply with the controller’s order in the CL decision to submit timely information on its own sales etc of the generic version of Nexavar.
India and its IP laws have been the subject of sharp criticism. Our patent litigation has been contentious with domestic generic companies locking horns with big western pharma companies. The Indian patent regime has also been criticised, particularly by the US.
Singh feels that India is emerging as a jurisdiction where customised patent prosecution strategies will need to be followed. “We are not blindly following what is happening in other parts of the world but we are evolving a patent jurisprudence which is unique, balancing various interests including innovation, dissemination of technology and the interests of the country and economy as a whole.”
The senior advocate, who appeared for Indian drugmaker Cipla in Swiss pharmaceutical company Novartis’s patent case on its cancer drug Glivec, says that India in the last 10 years has streamlined patent law. “Almost every procedure where there was an issue, the courts have streamlined it. In the next 10-20 years, patent law will grow in a major way in India and it is not far off from becoming equivalent to other developed jurisdictions like the US, the EU and Canada.”
Even in the process of wooing foreign investment through alignment of Indian IP laws with global standards, Prime Minister Narendra Modi has called for aligning India’s patent law with “global standards” to boost trade. There are also talks of putting in place “IPR Guidelines” to match global standards.
“Make in India needs technology transfer and the same should also be reflected while structuring the working requirements in law,” says Singh.
We hope the government is able to have a more nuanced approach in terms of balancing and holding the rights and consumers interest, besides boosting trade and investment in India.
indu.bhan@expressindia.com
