Comments and Suggestions to the Draft Patent Manual March 2019

On behalf  of the accessibsa project (www.accessibsa.org), the Médecins Sans Frontières Access Campaign (https://msfaccess.org/) and the Centre for Internet and Society (www.cis-india.org) , as well as numerous endorsing organisations and individuals across Indian Civil Society, we are pleased to present our comments, feedback and suggestions on the draft Manual of Patent Office Practice and Procedure, Version 3, published on 1 March 2019, to which your office invited comment from all stakeholders.

The Indian Patent Office (IPO) on 1 March 2019, published a draft of the “Manual of Patent Office Practice and Procedure, Version 3.0” (hereafter, the “Manual”). This draft extends upon the previous Manual, Version 01.11, dated 22 March 2011, which is currently the Manual in force.

At the outset, we should note that the current draft Manual does not differ substantially from the version in force. Aside from a few updations (for instance, noting the Indian Supreme Court decision in the Novartis case of 2013, as regarding Section 3(d) of Indian patent law), the current Manual under consideration is similar in most aspects to the Manual in force. However, given that several provisions in the current Manual in force were insufficient to implement Indian patent law as it was intended even in 2011, as well as the fact that there have been numerous developments in law, scholarship and practice since the time the Manual was last updated in 2011, we urge the IPO to take this opportunity to reflect upon the developments in patent law and practice, as well as the extensive scholarship now available to us.

Preamble: Indian patent law was substantially amended in 2005, and we began the process of implementing this law a few years later. Today, in 2019, we have data and evidence from almost 14 years of practice, and we suggest that the IPO fully incorporate all learnings available to us, to bring the full force of Indian patent

law into effect, as originally intended. The Manual of the Patent Office has the potential to be a comprehensive handbook on implementing patent law for all stakeholders including patent agents, applicants and the courts. The current version, in the manner proposed, is not. Our suggestions, if adopted in entirety, would make this so: furthermore, our suggestions provide a much-needed opportunity to correct course, by understanding and correcting the failures of the system to implement the original and far-sighted provisions in the Indian patent law amendment of 2005.

Overarching themes: Several of our suggestions for the current Manual under consideration are systemic, and, as such, require broad and serious attention to completely overhaul.

Structure: The Manual under consideration is badly composed and incomplete. Tabular columns are an inappropriate format for a patent manual. Furthermore and separately, the IPO makes use of several instances of “Guidelines” when examining patents. The IPO currently consults, among others, Guidelines for pharmaceuticals, biotechnology and computer related inventions. These guidelines are randomly categorized, badly deployed, hard to locate and amended haphazardly, without notice or any attention. There is no excuse for the IPO Guidelines to not form a part of the Patent Office Manual, thus giving them stability, and subjecting them to a transparent and participative process, like the rest of the Manual. Lastly, the Guidelines should evolve to covering the examination of Biologics as a distinct category, as we should with other frontier technology, such as Artificial Intelligence and Synthetic Biology.

Coherence: We have three inter-locking layers in the patent system in India: the patents act, the patent rules and the patent manual (which should incorporate the patent examination guidelines). The IPO is currently soliciting suggestions for the draft Patent Office Manual, while it has an ongoing amendment to the Patents (Amendment) Rules, 2018. We expect the final Rules to be published shortly; however, we are also being asked to provide suggestions on the Manual, without any knowledge of what the IPO’s final version of the Rules will look like. (For instance, the Patent Rules have suggested a procedural change in how pre-grant patent oppositions will be conducted in India; however, since the Rules are not final, it is unclear how they integrate with the Manual, and how we can comment on the process, since the status of the Patent Rules remains unclear). Furthermore, the Manual makes no reference to the Rules. As such, the IPO should decide and publish a final version of the Rules, and only then solicit feedback on the Manual (which it could do in the current time by extending the date of feedback on the Manual). Regardless, the IPO must achieve coherence and cohesion between its many layers, including the patents act, the patent rules, and the patent manual. This coherence, if achieved, would allow the Manual to serve as a handbook for all stakeholders involved in the patent system, including serving as a basis for open-book exams for patent agents.

Updation: Patent law and practice are fast evolving fields. The IPO necessarily needs to keep up with the pace of technology, as well as evolving interpretations of existing patent law provisions. For instance, the Indian Supreme judgment in the Novartis case was announced in 2013; however, it has taken over 6 years for this important judgment to formally reflect in the work of the Patent Office Manual, despite being Indian law for these 6 years. The IPO, therefore, needs to update the Manual and the examination guidelines, frequently – at least as frequently as major events in technology and the law require.

Transparency & Accountability: In the current time, stakeholders in the Indian patent system, be they multinational corporations or ordinary members of Indian society, are faced with considerable challenges when attempting to view patent information. Despite the IPO having made information

available online for some years, the information on Indian patents is needlessly limited, often inaccurate, often incomplete, and frequently unavailable. On occasion, this is due to insufficient disclosure on the part of the applicant, but overwhelmingly, it is because the IPO is not well organized and insufficiently invested in transparency or accountability. For instance, mandating pharmaceutical patent applicants to provide an INN (International non-proprietary name) on all applications where the information is available, would invaluably assist in extending the transparency and utility of the IPO’s functioning with the Indian public. Patent information in India is the right of every Indian citizen to have, and we have made several suggestions by which the IPO can move towards complying with our constitutional right to information.

Specific themes: Drawing from law, scholarship and practice over the last 14 years of Indian patent law, we strongly urge the IPO to consider these very specific suggestions on having their work comply with the spirit and letter of Indian patent law.

Focus on Biologics: Biologics are a relatively new category of therapy that have quickly become the world’s most expensive medicines emerging as critical therapies in areas like cancer. 7 out of 10 of the world’s best-selling medicines are biologics, and they will play only an increasingly important part in public health in India. Therefore, identifying, understanding and examining patent applications on biologics is of crucial importance to Indian citizens. The IPO would benefit from identifying biologics as a critical category; providing them their distinct field of invention; as well as developing guidelines and practices for evaluating biologics, along with other frontier technology that emerges.

Expedited examination: Since 2016, expedited examination of patents has been the law. More recently, there are reports that the IPO is considering PPH partnerships with some rich country economies such as Japan. This is unwise, especially since even in the extended examination currently underway, the IPO has faced several challenges. We strongly suggest that the IPO needs to evidence the ability to manage the ordinary processes in place with accuracy and compliance with Indian law, before attempting to expedite the said processes, especially since the non-functioning of the patents side of the Intellectual Property Appellate Board (IPAB)  has meant that India has not had a corrective mechanism for any incorrect grants that may have been made at the IPO since May 2016.

Check exceptions to patentability first: The law, as has evolved in the Novartis Case in the Supreme Court, and the Roche vs Cipla case before the Delhi High Court, clearly points towards applying all exceptions to patentability under Sections 3 & 4 of the Indian Patents Act, first, before applying the test of patentability under Section 2 (1)(j). Such a procedure would make the work of the IPO more efficient, as well as fair.

Making anti-evergreening provisions work: The Manual currently does not capture the guidelines explicitly laid out in the Indian Supreme Court’s judgment in the Novartis case. Specific principles relating to how to apply Section 3(d) were laid out in the judgment which have no reflection in the Manual. Like with Section 3(d), applicants also routinely circumvent other anti-evergreening provisions in Indian law, such as Section 3(e) and 3(i). Sometimes, these provisions are circumvented alone; other times, when combined, applicants take advantage of the confusion and adduce evidence on one ground, and then use that as a basis to circumvent the other grounds. To apply anti-evergreening provisions in Indian patent law efficiently and fairly, we suggest an anti-

evergreening checklist that will facilitate this process, and which we recommend be an official part of the examiner’s report, both within the process and as a reported output.

Computer related inventions: The Manual currently does not adequately regulate Computer Related Inventions (CRIs). We suggest the introduction of a 3-step test to comprehensively regulate the patentability of mathematical methods, business methods, computer programmes and algorithms as laid down in the Indian Patents Act. Furthermore, we suggest ways in which the law can be applied more carefully within the Manual to detect camouflaging of claims, with an intent to confuse the IPO and Indian patent examiners, especially when conjoined to computer technology, by noting that (1) mathematical methods may sometimes be claimed as “technological development”, (2) that business methods must be evaluated as such, regardless of their application through computers, computer programmes, computer networks or other programmable apparatus, and that (3) that the scope of algorithms needs to be extended to any invention where the function claimed to be performed can only be carried out by means of a computer programme.

Finally, while the nature of our comments and suggestions are deep and extensive, we are aware that we have also asked for the system to be evaluated in full, rather than in parts. As such, the Indian Patent ecosystem is large and complex, and the IPO has been engaged with setting the Patent Rules (under finalization), the Patent Office Manual (the subject of our commentary in this communication) as well as the Examining Guidelines (which we recommend move from being arbitrarily categorized and extended to becoming a formal part of the Patent Office Manual).

In order to comprehensively react to changes to the Indian Patent ecosystem, we require the opportunity to comment comprehensively on a range of inter-linked proposals.

In this spirit, we hope you will allow us – as civil society – to react, once more, to the Patent Rules (as connected  to the Patent Office Manual) as well as each of the Examining Guidelines (old and new, i.e. including those intended such as for biologics), in the interests of fairness and transparency. We look forward to assisting you at every step of this process.

Thank you for your time. We trust that, as civil society researchers, activists and academics, who have devoted a considerable number of years towards the research of intellectual property, and the protection of public interests and human rights in India, our submission will be considered seriously and acted upon. We remain, of course, at your disposal, should you or your office have any questions – which we will gladly answer.

Sincerely,

Achal Prabhala, Feroz Ali, Ramya Sheshadri, Roshan John and Anubha Sinha