Today the judicial authority may be faced with balancing patent rights and patients' rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.———–.THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), "Our world will only be safer once everyone can benefit from the science and access a vaccine – and that is a political challenge….Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces." It is equally a judicial challenge..I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space..“In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive "Who shall live" or "Whose side are you on"? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier..Public interest is embedded in the patent statutes.Public interest is not an either-or factor in (India's) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South..By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get "canonized" as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said "(W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries)." The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare..What about the economic entitlement?.The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the "Money, money, money" in Swedish pop group ABBA's words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creator's right is a human right too and has been recognised as such, it is not bound to give way to right to health..The Tools to unravel the conundrum.“Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance..The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year..The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. "The right to life, we acknowledge, encompasses several rights … each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.".How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, "The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.".It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access..The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion..The Nagoya Protocol can be used as a tool. What has been overlooked "…in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.".Resolution of the paradox.The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions..It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access..“It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs "…will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much…. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged." What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer "…a decision that calls into consideration issues of 'economic' and 'political' viability. In other words, the problem of 'access' moves beyond the realm of the purely 'legal' into the realms of 'economics' and 'politics'..The judicial authority will have to choose life. "Forced to choose between protecting the essential right to life – an unalienable right assured by the Constitution (Art.5) – or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life." While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be "ungranted". The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right..“The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in D'Arcy v. Myriad Genetics, it is observed, "This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly."16.Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives..This has happened earlier and the South has "resisted such corporate and political hegemony" that has "facilitated the capitalization of health in various forms", and has "been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.".The judicial authority must infuse itself with a spirit of constitutionalism "that depends upon an interpretive, non-technocratic hermeneutics" and "has emerged as a democratic counter weight to logics of multinational pharmaceutical capital." It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a "commercial" or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives..There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics..Instead we may have other "innovative methods" like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS..“The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlet's question must be answered in favor of life..(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)
Today the judicial authority may be faced with balancing patent rights and patients' rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.———–.THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), "Our world will only be safer once everyone can benefit from the science and access a vaccine – and that is a political challenge….Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces." It is equally a judicial challenge..I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space..“In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive "Who shall live" or "Whose side are you on"? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier..Public interest is embedded in the patent statutes.Public interest is not an either-or factor in (India's) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South..By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get "canonized" as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said "(W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries)." The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare..What about the economic entitlement?.The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the "Money, money, money" in Swedish pop group ABBA's words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creator's right is a human right too and has been recognised as such, it is not bound to give way to right to health..The Tools to unravel the conundrum.“Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance..The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year..The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. "The right to life, we acknowledge, encompasses several rights … each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.".How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, "The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.".It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access..The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion..The Nagoya Protocol can be used as a tool. What has been overlooked "…in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.".Resolution of the paradox.The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions..It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access..“It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs "…will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much…. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged." What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer "…a decision that calls into consideration issues of 'economic' and 'political' viability. In other words, the problem of 'access' moves beyond the realm of the purely 'legal' into the realms of 'economics' and 'politics'..The judicial authority will have to choose life. "Forced to choose between protecting the essential right to life – an unalienable right assured by the Constitution (Art.5) – or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life." While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be "ungranted". The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right..“The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in D'Arcy v. Myriad Genetics, it is observed, "This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly."16.Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives..This has happened earlier and the South has "resisted such corporate and political hegemony" that has "facilitated the capitalization of health in various forms", and has "been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.".The judicial authority must infuse itself with a spirit of constitutionalism "that depends upon an interpretive, non-technocratic hermeneutics" and "has emerged as a democratic counter weight to logics of multinational pharmaceutical capital." It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a "commercial" or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives..There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics..Instead we may have other "innovative methods" like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS..“The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlet's question must be answered in favor of life..(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)
