Introduction

 A concept for a Medicines Patent Pool  (MPP) And Access To Healthcare , arose in response to a problem caused by a lack of access to key medications in underdeveloped countries. Initially, two non-governmental organizations, Médecins Sans Frontières(MSF)/Doctors Without Borders and Knowledge Ecology International(KEI), provided the most support. The idea called for the development of a body that would rely on patent holders, notably private pharmaceutical corporations, to agree to licence important medications for the benefit of patients in poor nations on a voluntary basis.  Finally, UNITAID helped to establish the Medicines Patent Pool (MPP), whose goal is to facilitate the manufacturing and distribution of low-cost generic HIV/AIDS medicines. This blog gives history on patent pools as well as context for the dilemma of access to medicines. It also examines and describes how MPPs are licenced.

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What is Medicine Patent Pool and why is it required?

The Medications Patent Pool (MPP) is a United Nations-backed public health organization dedicated to improving access to life-saving medicines and facilitating their development in low- and middle-income countries. MPP collaborates with civil society, governments, international organizations, industry, patient groups, and other stakeholders to prioritize and licence needed medicines, as well as pool intellectual property to encourage generic manufacturing and the development of new formulations, through its innovative business model.MPP has agreements in place with 13 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, two long-acting technologies, two experimental COVID-19 oral antiviral treatments, and a COVID-19 serological antibody diagnostic test.

Licensing Agreements

By lowering prices, boosting supplies, or increasing capacity, the Medicines Patent Pool's licence agreements aim to help enhance access to safe, effective, and affordable vital medicines in low- and middle-income countries. MPP is a non-profit voluntary licencing method that facilitates access and promotes innovation by forming agreements between originator pharmaceutical firms and generic producers. Before patent expiration, the patent pool negotiated the majority of the licencing deals with pharmaceutical companies that allowed for competitive generic antiretroviral manufacturing in low- and middle-income nations. These licences have also aided the development of new formulations, such as fixed-dose combos and paediatric formulations, which are particularly important in resource-constrained settings. According to a biannual review conducted by a major auditing firm, the patent pool's generic partners have dispersed 22 million patient-years of treatment, resulting in global savings of 1.06 billion United States dollars (US$). The Lancet Commission on Critical Medicines Policies, the WHO, and other stakeholders urged for the patent pool's mandate to be expanded to include a larger variety of patented essential medicines in 2016.

Role of Intellectual Property rights in enabling these licensing agreements

Owning the intellectual property rights to a product or therapy motivates businesses to invest in the research and development and other costs required to develop health solutions. In many situations, new goods in the health industry require years to develop and test before reaching the market.

The COVID-19 pandemic accelerated this process, which included significant public investments as well as those made by the pharmaceutical sector and others in some circumstances. MSD's molnupiravir repurposing and Pfizer's discovery of PF-07321332 were both made possible by the IP system's incentives. The international community is now aiming for universal access, as a rising number of COVID-19 vaccinations and other goods become available. This is where organizations like the Medicines Patent Pool and others come in to help IP-owning companies connect with local partners that can help them scale up manufacturing and distribution of medical technology. The Medicines Patent Pool is an initiative that brings together interested parties to support pharmaceutical companies' voluntary licencing policies.

The international community is now aiming for universal access, as a rising number of COVID-19 vaccinations and other goods become available. This is where organizations like the Medicines Patent Pool and others come in to help IP-owning companies connect with local partners that can help them scale up manufacturing and distribution of medical technology. The Medicines Patent Pool is an initiative that brings together interested parties to support pharmaceutical companies' voluntary licencing policies.  The licence agreements for molnupiravir and PF-07321332 are significant milestones in the fight against the COVID-19 pandemic, and a prime example of how IP is a fundamental component in addressing important issues, acting as a link that enables disparate parties to collaborate with clarity.

In circumstances where there is an urgent need to produce an innovation at a large scale, such as public health emergency, the normal licencing model often requires additional elements to provide for possible market failures. The most common causes of market failures are a lack of mass-manufacturing capacity and the risk of concentrating distribution of the invention solely in regions where users can afford to pay a premium.

Agreements on technology transfer provide a solution to this dilemma. Technology transfer is a collaborative process that permits scientific results, information, and intellectual property (IP) to pass from producers to public and private consumers, such as research institutions and universities or company labs. The goal is to turn scientific breakthroughs and ideas into new innovative goods that benefit society. This transfer is possible because of IP ownership.

Technology transfer also encourages the expansion of manufacturing units, which can significantly boost the production of a much-needed invention, such as pharmaceuticals. The most common method of transferring IP is licencing. The licensor offers authorization to a corporation with manufacturing capacity and distribution channels to bring the idea to potential users through a licence agreement.

Challenges and opportunities

As the patent pool expands into new disease categories, issues such as inadequate health systems and diagnostic capabilities in many low- and middle-income nations, particularly in respect to specific malignancies, may occur. Another issue is the dearth of major, worldwide donors willing to help scale up therapies and contribute to the introduction of innovative goods outside of the HIV, TB, and malaria domains. This problem has already been solved in the case of hepatitis C, where the patent pool's goods were first limited to the private market because to the lack of significant viral hepatitis treatment programmes. Government treatment programmes have lately begun to be formed in a number of low- and middle-income nations as part of broader national policies to combat viral hepatitis, thanks in part to the availability of more affordable drugs. Governments and global health players are increasingly recognizing the need for increased non-communicable disease treatment programmes. Political promises made at a recent United Nations high-level summit on non-communicable diseases will need to be backed up by concrete action in order to achieve universal health coverage. Access to affordable medicines can help to develop public health initiatives, such as more active screening and diagnosis. Improved medicines with higher efficacy, quicker administration, fewer side effects, or less monitoring requirements can all help to lower health-care expenditures.

Indian Scenario

In 2009, more than 5 million patients received HIV treatment thanks to India's low-cost, high-quality generic antiretroviral medications (ARVs) and fierce competition among local manufacturers. Tenofovir/lamivudine + atazanavir + heat-stable ritonavir (by Mylan/Matrix) and tenofovir/emtricitabine/efavirenz (by Matrix, Emcure, and Cipla) merit special note among Indian FDC (or co-packaged) ARVs as a predecessor formulation and duplicate of the blockbuster brand FDC ATRIPLA® (by Bristol Myers Squibb-Gilead joint venture), respectively.However, since 2005, India has complied with World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) standards, casting doubt on the data above. Indeed, notwithstanding TRIPS-bound flexibilities (including voluntary [VL] and compulsory [CL] licencing), Indian companies are unable to produce generics for pharmaceuticals developed after 2005 due to intellectual property (IP) obligations. Pfizer, Tibotec, and Merck recently received patents in India for their HIV entry-blocking medicine maraviroc, non-nucleoside reverse transcriptase inhibitor etravirine, and integrase inhibitor raltegravir.These obligations add to the stranglehold of the US and EU's increased data exclusivity restrictions and practises. Exacerbated data exclusivity is a practise that prevents an originator's registration files from being utilised to register a generic version of a brand medicine for a certain time. Drug regulatory agencies are prohibited from registering such generic counterparts for a set length of time (5 years in the US and at least 8 years in the EU) unless the manufacturer has independently conducted the appropriate safety and effectiveness tests or has entered into VL agreements.Exacerbated data exclusivity has the effect of prohibiting CL usage until the expiration of data exclusivity, and, more importantly, of securing a monopoly term for brand corporations in countries that agree to data exclusivity, even when a drug is not patented in the stated nation. This behavior goes beyond the WTO's request for data protection from commercial use. Exacerbated data exclusivity laws impede the development of generic FDC ARVs, particularly when several companies hold patents on different chemicals. They affect not only generic versions of individual ARVs, but also FDCs that contain an unique medication. This is a concerning truth since, after first-line ARVs fail due to HIV resistance, other drugs are required (20 percent of patients within 3 years of beginning treatment)

Exacerbated data exclusivity is frequently part of the TRIPS-plus policies adopted by the United States and the European Union with developing nations in terms of free-trade agreements, IP enforcement agendas, and pressures to avoid employing TRIPS flexibilities. In fact, it is believed that TRIPS-plus measures involving heightened data exclusivity would be adopted as part of an EU-India free-trade pact that is currently being negotiated. Unfortunately, this would boost ARV medicine prices, stymie the development of new formulations, and postpone access to better treatments.

This increases HIV industry concerns in India, as mentioned in a Cipla report dated June 15, 2010, which lists the third-line ARV medicine darunavir (DRV) among the company's products. While challenging the restrictions, this inclusion accords with recent Indian patent office refusals of DRV, tenofovir, and nevirapine syrup brand patent applications based on 'evergreening' grounds under Indian patent law.

Meanwhile, despite the fact that the US National Institutes of Health had licenced a DRV-related patent to the UNITAID-backed Medicines Patent Pool, this was insufficient to allow a generic low-cost version to be developed, as other large manufacturers have their own DRV patents.While the Medicines Patent Pool model expects patent holders to voluntarily offer the IP related to their inventions to the patent pool (so that generic companies wishing to use the IP to develop medicines can seek a licence from the pool against payment of royalties), some originators would still prefer to improve the affordability of their pro-poor programmes, or would rather agree VLs with generic firms, rather than giving up their IP rights via the patent pool to the advantage of competing industries in the middle-income countries.

Intriguingly, the Indian manufacturers were excluded from ViiV Healthcare's (GlaxoSmithKline–Pfizer HIV/AIDS joint venture) broadened VL policy in July 2010. The VL model's potential is limited by a number of obstacles, including the fact that the originators have complete control over the manufacturing, distribution, and pricing steps: an unbalanced mechanism. Unrestricted CL competition, on the other hand, would be a significantly better method for maximizing ARV price affordability. Unfortunately, the constraints exerted on India by wealthier countries suggest that widespread CL adoption is unlikely. Aside from national emergencies, Indian generic manufacturers are required by law to wait three years after a medicine's patent has been awarded before applying for a CL to make it.

Conclusion

Overall, the facts discussed here reinforce one other, posing a serious challenge to India's role as a provider of life-saving, inexpensive, and cutting-edge ARV formulations to resource-constrained countries. If nothing is done to reverse the trend, it will only get worse. All interested national and international actors should be included in inclusive initiatives that solve IP, policy, finance, and infrastructure challenges. The Indian government should prohibit monopolies and reject IP obligations that suffocate Indian industry's ability to provide affordable and high-quality ARV medicines. It should advocate for open competition through CLs, while also putting in place pull mechanisms to create a more competitive market and push incentives for ARV development (such as tax breaks, R&D grants, and government spending priority) far beyond what they have been. In addition, the Indian government should strengthen the national grant programme targeted at reversing the 'brain drain.'

India may be able to build an R&D business model that bypasses multinationals and industrialized countries. The costs of ARV drug development resulting from clinical studies and active pharmaceutical ingredients could be used to India's advantage. Clinical trials account for 40% of development expenditures, however due to India's cost competitiveness and vast population, these are substantially lower. Furthermore, being a significant supplier of active pharmaceutical components to both developed and developing countries (which account for 55–99 percent of direct manufacturing costs), India is well positioned to influence the evolution of ARV drug prices. On these grounds, India should seek expanding clinical trial alliances with high-tech, fast-growing developing countries in order to obtain favourable regulatory approvals, expand its market, and lower development costs.

Author: Anuja Saraswat - a student of NMIMS Kirit P. Mehta School of Law (Mumbai), in case of any queries please contact/write back us at support@globalpatentfiling.com or Global Patent Filing.