On January 20, 2025, which is the first day of the second term of President Trump, the United States formally initiated the U.S. withdrawal from the World Health Organization’s (WHO) membership through a Presidential Executive Order. Ironically, the U.S had founded the WHO in 1948 in the aftermath of World War II, and established it as a specialized agency of the United Nations to promote global health and coordinate responses to health emergencies. When the termination process completed after the required 12-month notification period in 2026, it left the rest of the world to grapple with “what does a WHO divorced by the US mean for the rest of the world to enable access to healthcare?.” The paper indulges in the question and underscores that capacity building through appropriate policies comporting with new realities is critical to achieving healthcare access. The paper presents policy options within a regional framework to promote transfer of technology and innovation with the goal of inducing more efficiency into regional and local pharmaceutical industry. Next, the paper will discuss components of innovation policy at a sub-regional/national level focusing on intellectual property policies that affect pharmaceutical research and access such as patents, licensing, know-how and transfer of technology. The study concludes by emphasizing the need for formal regional health centric instruments to promote regional cooperation in critical areas such as prosecution and regulatory approvals.

Abstract This chapter proposes an overhauling of the approach to global health vis-à-vis the trade and intellectual-property regime. Public health needs to be treated as a significant challenge, but within an independent framework that does not impede the free flow of trade. We recommend positioning global public health, not just during pandemic times but under non-energy conditions as well, as the primary focus, and implementing policies that implicate trade, intellectual property, and transfer of technology. The chapter imagines what the structure of a holistic-health-centric treaty should look like. However, while awaiting the ratification of such a treaty, we welcome any framework that promises to deliver access to health care efficiently and effectively.

Abstract This chapter looks beyond private players, often viewed as the primary players in the innovation game, to analyze the roles of actors such as the government, non-state entities such as NGOs, and lobbyists. The roles of governments as negotiators in the international arena and as multifaceted actors in domestic contexts are examined, and the underappreciated capacity of government’s ability to use or bypass traditional market-driven solutions that have otherwise been viewed as problematic for health-care access is discussed. Indicatively, the chapter presents examples of Brazil’s integration of IP norms within its constitutional rights, India’s carefully calibrated legislative approach resulting in unique provisions balancing innovation with access, and the role of the Bayh-Dole Act in contextualizing the norms of public investment in the United States by directing market-centric players toward public-oriented goals. Whereas conventional studies have tended to focus on the impact of policies on developed economies, where the search for solutions has tended toward the theoretical tenets of IP rights, this study emphasizes the role of the governments of developing countries. The fragility of public health in lower-income countries has repeatedly afflicted the health of the global community, hence the focus on the “attribution gap” by discussing research blind spots, which also aligns with the need to focus on local realities to identify causes for the fragilities. Strong government leadership is needed to address an overreliance on approaches that attempt to address health-care access through market mechanisms alone.

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best to engage in an exercise of prioritizing affordability to enable access to life-saving medications to all people as opposed to a select few. The casualty of the conundrums and conflicts that prevail between patent law and its interludes into healthcare access and trade law is unfortunate and leaves the American consumer literally unhealthy. Meanwhile, a lack of health equity has forced legislators to engage with the public health issues of their constituents to explore solutions that improve affordability and access to high-priced pharmaceuticals. One such legislative solution, the Inflation Reduction Act (IRA) of 2022, forms the backdrop for this paper. With that background, this paper engages with simple questions. How did prices get so high in the first place? What can be done to dismantle barriers to make America healthy, literally? To answer this, the paper addresses the root causes of high drug prices. It explores how established policies and practices, which Americans fund in the first place, limit affordability and access to life-saving medications. In tracing high drug prices to their source, this paper identifies burdensome legal barriers that prevent both generic and biosimilar medications from entering the market in a timely manner. It also identifies solutions. Specifically, the paper explores whether, and if so, how, agency action between the United States Patent and Trademark Office (USPTO) and the United States Food and Drug Administration (FDA) can intervene to alleviate the burdens. To do this effectively, this paper uses the insulin story and the Humira story to discuss market-entry barriers and to provide suggestions for market entry of generic and biosimilar medications.

Download This Paper Open PDF in Browser Add Paper to My Library Share: Permalink Using these links will ensure access to this page indefinitely Copy URL Comment on Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights Texas A&M University School of Law Legal Studies Research Paper 14 Pages Posted: 26 Feb 2024 See all articles by Srividhya RagavanSrividhya RagavanTexas A&M University School of Law Date Written: February 6, 2024 Abstract Under 37 CFR 401.6 of the Bayh-Dole Act, the National Institutes of Health (NIH) has been granted the power to exercise march-in rights in situations where federally funded projects are not being made reasonably available to the public. The right to march-in is authorized in cases where federal funding results in patent nonuse, unreasonable pricing, and insufficient product availability. In the aftermath of the pandemic, public interest organizations have underscored the need for exercising such rights in situations where public health, safety, or security is at stake. To examine and streamline the implementation of the march-in process, the National Institute of Standards and Technology (NIST) was tasked with promulgating regulations concerning the management and licensing of federally funded inventions. In turn, the NIST requested public comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (hereinafter, guidelines). The note below responds to the call for comments on the guidelines. The note focuses on a handful of general themes: (1) the need for differentiating the use of march-in rights in the context pharmaceutical and products when public health is involved, (2) acknowledging the issues of localism versus global trade that are involved in the context of either funding or supporting technologies implicating local or global public health, (3) promoting procedural stability by instituting reasonable timelines for marching-in, implementing a uniform appeals process, and increasing transparency in information regarding a contractor’s government funding, and (4) accelerating the pace of intervention where delay in the implementation of march-in can cause potentially irreparable harm and the loss of lives. Keywords: Federal transfer of technology, march-in rights, Bayh-Dole Act, federal funding, innovation, policy paper Suggested Citation: Suggested Citation Ragavan, Srividhya, Comment on Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (February 6, 2024). Texas A&M University School of Law Legal Studies Research Paper, Available at SSRN: https://ssrn.com/abstract=4736090 Srividhya Ragavan (Contact Author) Texas A&M University School of Law ( email ) 1515 Commerce StreetFort Worth, TX Tarrant County 76102United States Download This Paper Open PDF in Browser Do you have negative results from your research you’d like to share? Submit Negative Results Paper statistics Downloads 4 Abstract Views 12 5 References PlumX Metrics Related eJournals Texas A&M University School of Law Legal Studies Research Paper Series Follow Texas A&M University School of Law Legal Studies Research Paper Series Subscribe to this free journal for more curated articles on this topic FOLLOWERS 5,260 PAPERS 1,257 This Journal is curated by: Peter K. Yu at Texas A&M University School of Law Development of Innovation eJournal Follow Development of Innovation eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 471 PAPERS 5,736 Political Institutions: Federalism & Sub-National Politics eJournal Follow Political Institutions: Federalism & Sub-National Politics eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 369 PAPERS 7,301 This Journal is curated by: Thad Kousser at University of California, San Diego (UCSD) - Department of Political Science Decision-Making in Computational Design & Technology eJournal Follow Decision-Making in Computational Design & Technology eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 65 PAPERS 2,924 Feedback Feedback to SSRN Feedback (required) Email (required) Submit If you need immediate assistance, call 877-SSRNHelp (877 777 6435) in the United States, or +1 212 448 2500 outside of the United States, 8:30AM to 6:00PM U.S. Eastern, Monday - Friday.

Download This Paper Open PDF in Browser Add Paper to My Library Share: Permalink Using these links will ensure access to this page indefinitely Copy URL Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response Submitted to Dept of Health & Human Resources Texas A&M University School of Law Legal Studies Research Paper 11 Pages Posted: 26 Feb 2024 See all articles by Srividhya RagavanSrividhya RagavanTexas A&M University School of Law Date Written: January 31, 2024 Abstract Dealing with public health as a global issue has gained imminence because of the effect of infectious diseases on trade. In fact, lack of access to good healthcare in different parts of the world – not relegated to merely infectious diseases – has caused devastating global socio, political and economic impact including on global as well as national productivity. During the pre-COVID era, trade dictated public health such that efforts to protect public health were considered a barrier to trade.While acknowledging that the idea of the Pandemic Treaty is a step forward, the note outlines suggestions to ensure more equitable access to critical health technologies to global populations without compromising innovation focusing on the role of the World Health Organization. Keywords: Pandemic Treaty, Public Health Treaty, Global Public Health, intellectual property rights, supply chain, Bayh-Dole Act Suggested Citation: Suggested Citation Ragavan, Srividhya, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response Submitted to Dept of Health & Human Resources (January 31, 2024). Texas A&M University School of Law Legal Studies Research Paper, Available at SSRN: https://ssrn.com/abstract=4736051 Srividhya Ragavan (Contact Author) Texas A&M University School of Law ( email ) 1515 Commerce StreetFort Worth, TX Tarrant County 76102United States Download This Paper Open PDF in Browser Do you have negative results from your research you’d like to share? Submit Negative Results Paper statistics Downloads 2 Abstract Views 16 3 References PlumX Metrics Related eJournals Texas A&M University School of Law Legal Studies Research Paper Series Follow Texas A&M University School of Law Legal Studies Research Paper Series Subscribe to this free journal for more curated articles on this topic FOLLOWERS 5,260 PAPERS 1,257 This Journal is curated by: Peter K. Yu at Texas A&M University School of Law Public Health Law & Policy eJournal Follow Public Health Law & Policy eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 828 PAPERS 8,942 This Journal is curated by: Scott Burris at Center for Public Health Law Research, Temple University - James E. Beasley School of Law International Trade eJournal Follow International Trade eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 716 PAPERS 27,278 Public Health Policy eJournal Follow Public Health Policy eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 51 PAPERS 2,726 Politics & Governance of Public Health eJournal Follow Politics & Governance of Public Health eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 40 PAPERS 829 Global Health Organizations & Partnerships eJournal Follow Global Health Organizations & Partnerships eJournal Subscribe to this fee journal for more curated articles on this topic FOLLOWERS 27 PAPERS 331 Feedback Feedback to SSRN Feedback (required) Email (required) Submit If you need immediate assistance, call 877-SSRNHelp (877 777 6435) in the United States, or +1 212 448 2500 outside of the United States, 8:30AM to 6:00PM U.S. Eastern, Monday - Friday.

The paper will be based on the assertion that trade and public health can and should work in a symbiotic fashion. Thus, finding common platforms to tap into the synergies that connect trade and IP rights with public health is the way forward. It is important to foster innovation without making IP a barrier to global public health and by association, trade. The article will focus on an alternate framework - a Public Health Treaty – to work within the trade regime complex of which IP is an integral part, but in close nexus with the World Health Organization. Given the work that WTO, WIPO and the WHO has commenced together, a framework along the lines of a Public Health will be critical to strengthen the trilateral cooperation. Unlike the Pandemic Treaty being considered currently, a Public Health Treaty should be much broader. The goal should be to have competing international entities working together; the challenge is to empower sovereign nations with flexibility to institute safeguards to preserve public health locally as a means to improve global public health. In opposition to the existing rubric of harmonization, this framework, in accounting for local realities to deal with public health to sustain optimal productivity along with optimal innovation. The paper will highlight the basic constituents of a public health treaty, how it would differ from the existing rubric, how the treaty can be funded and the benefits that it is likely to yield when public health is considered as a separate subject matter working with trade and IP.

Cost of medication in the United States have historically remained one of the highest in the world. The conundrum that the US has faced in balancing innovation with accessibility to life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with health-care obligations. The result is an overflow of issues that begs to delineate the limits of innovation to balance it with the need for robust public health within the United States. This, has increasingly shifted the focus of patent law into the realm of healthcare issues, leading to an inquiry of how best to engage in an exercise of prioritizing access to life-saving medications to all people as opposed to a select few. The casualty of the conundrums and conflicts that prevail between patent law and its interludes into health care access and trade law is unfortunate but leaves the American consumer literally unhealthy!Consequently, American legislators have been forced to engage in public health issues of their constituents to explore legislative solutions that improves access to high priced medicines. The legislative solution offered by President Biden’s administration, the Inflation Reduction Act (IRA) 2022, to find solutions to lower prescription drug prices, forms the background of this paper. In that context, this paper discusses on patents and regulatory barriers within the United States which keep the cost of medications high. The discussion further focusses on addressing the challenges of involvement between the USPTO & USFDA outlining the regulatory barriers to entry for generics and biosimilars. The objective is to offer suggestions that can not only improve the quality of collaboration between the two administrative bodies, being the USPTO and USFDA but also institute important changes to the current framework of regulatory body’s involvement with patents.

The Ministry of Law and Justice in India constituted an expert committee under the Chairmanship of former Law Secretary, Mr T K. Vishwanathan to review and revise Indian Arbitration & Conciliation Act, 1996 to comport with international standards. The committee issued a notice inviting comments on the working of arbitration in India. The note is the submission made to the expert committee particularly focusing on the effects of trade and investment in India from the arbitration regime in India.

The paper examines the evolution of WIPO as an organization from the perspective of international laws on economic integration. Thus, the paper first explores the WIPO treaties and how it enabled new innovations and ideas and examines how best WIPO’s role in trilateral cooperation with WTO and WHO can be active to the benefit global economic development, particularly public health. Then, it discusses WIPO’s role in Trilateral Cooperation to determine future challenges to the organization and examines initiatives and strategies of WIPO. Last, the paper focusses on WIPO’s future plans to discuss its effectiveness as a member of the Trilateral cooperation agreement. The paper explores how WIPO can adapt measures to combat the challenges and opportunities given the current challenges of the post-pandemic world. The paper concludes that future stature of WIPO would depend on its ability to enable development through promoting access to digital technology, to medication in a manner that promotes global economic development.

The Ministry of Law and Justice in India constituted an expert committee under the Chairmanship of former Law Secretary, Mr T K. Vishwanathan to review and revise Indian Arbitration & Conciliation Act, 1996 to comport with international standards. The committee issued a notice inviting comments on the working of arbitration in India. The note is the submission made to the expert committee particularly focusing on the issue of institutionalizing arbitration in India.

With around 47 million pending cases at various stages of Indian judiciary and one of the lowest levels of judges per million of population in the world, India’s arbitration regime presents a ray of hope for millions of Indians who face the prospect of justice being denied to them due to inordinate delays caused by the clogged judicial pipeline. The enactment of the Arbitration and Conciliation Act, 1996 was presented as a viable alternative to resolve commercial disputes in a timely manner. This paper uses a case study to discuss how arbitration in India has not fulfilled the timeliness promise and in turn, has detrimentally affect trade and investments making the system an inefficient alternative to the contentious and long drawn litigations. The study of the DMRC dispute is distinguished because it involves a public-private partnership and is exceptional for two reasons. First, being one of the first public-private partnership projects in metro rail infrastructure in the country, the extraordinary delay in execution of the arbitral award alone highlights the need to create a level playing field when government is involved as a party. Second, the case showcases glaring loopholes in India’s existing arbitration regime which has allowed courts to unduly intrude and cause inordinate delays at every stage of the process, as a result of which the amount of interest accumulated eventually outstripped the principal sum initially claimed by DMRC’s private partner in the project. For instance, it took 10 months to constitute an arbitration panel, 68 hearings to pass an arbitral award which culminated 4.5 years from the date of invocation of arbitration clause by DMRC and several layers of appeal, most of which favored one party, execution of the award is still pending!!The paper concludes by recommending plausible solutions to strengthen India’s arbitration laws so that the DMRC fiasco doesn’t get repeated in the future at perilous costs borne by foreign and Indian private investors.

which in turn contributed towards a top-down assertion of increasingly expansive IP norms in the name of global harmonization leading to more patents and less innovation impacting global public health.Such a reframing, this Article asserts, has resulted in two distinct consequences.The first is an outsourcing of policy positions with scant regard to the ability of local realities to accommodate the outsourced position; the second is the limiting of IP norm discourses to the boundaries imposed by the trade lens.In both instances, this Article argues, true innovation that can positively affect public health is a significant casualty by virtue of the simultaneous perception of health care by international trade norms both as an "exception" as well as a "priority" dictated by the power dynamics that drive international trade.In other words, although public health is impacted by IP norms, the reframing through a trade lens by and large sidelines the issues leaving them underappreciated in the limited contexts when it does arise.The ultimate result are IP policies completely divorced from the local realities of member states.The Inflation Reduction Act of the United States, the Article asserts, is a great example of why we need a reframing of IP issues to better fit the needs of public health.An examination of the genesis of the historical alliance, the Article asserts, does not support the needs of public health especially in the context of being governed by the trade and IP accord of the WTO.This Article concludes by outlining the need for an alternative framework that posits public health in the front and center with a view to create a workable mechanism to result in global health care equity.

Biotechnology Law ReportVol. 41, No. 1 Original ArticlesAI (Re)Defining Pharmaceutical Exclusivitiesis corrected byCorrection to: AI (Re)Defining Pharmaceutical Exclusivities, by Jonathan Kimball and Srividhya Ragavan, Biotechnol Law Rep 2022;41(1):23–29; doi: 10.1089/blr.2021.29257.srBy Jonathan Kimball and Srividhya RagavanBy Jonathan KimballJonathan Kimball has worked for 15 years on pharmaceutical policy issues impacting both the brand and generic industries. Srividhya Ragavan is a Professor of Law and Faculty Director of the India Program at Texas A&M School of Law in Fort Worth, Texas, USA. A version of this argument was presented at the University of the Pacific Law School and a part of that published with Sofia Vegas as Reconsidering the Rationale for the Duration of Data Exclusivity, 51 U. Pac. L. Rev. 525 (2020). The views expressed in this article are those of the authors and do not necessarily represent the organizations for which they work.Search for more papers by this author and Srividhya RagavanE-mail Address: ragavan.sri@law.tamu.eduJonathan Kimball has worked for 15 years on pharmaceutical policy issues impacting both the brand and generic industries. Srividhya Ragavan is a Professor of Law and Faculty Director of the India Program at Texas A&M School of Law in Fort Worth, Texas, USA. A version of this argument was presented at the University of the Pacific Law School and a part of that published with Sofia Vegas as Reconsidering the Rationale for the Duration of Data Exclusivity, 51 U. Pac. L. Rev. 525 (2020). The views expressed in this article are those of the authors and do not necessarily represent the organizations for which they work.Search for more papers by this authorPublished Online:11 Feb 2022https://doi.org/10.1089/blr.2021.29257.srAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsRelated articlesCorrection to: AI (Re)Defining Pharmaceutical Exclusivities, by Jonathan Kimball and Srividhya Ragavan, Biotechnol Law Rep 2022;41(1):23–29; doi: 10.1089/blr.2021.29257.sr12 Apr 2022Biotechnology Law Report Volume 41Issue 1Feb 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:By Jonathan Kimball and Srividhya Ragavan.AI (Re)Defining Pharmaceutical Exclusivities.Biotechnology Law Report.Feb 2022.23-29.http://doi.org/10.1089/blr.2021.29257.srPublished in Volume: 41 Issue 1: February 11, 2022Online Ahead of Print:February 1, 2022Keywordsartificial intelligencedata exclusivitypharmaceuticalsperiod of exclusivityFDAbiologicsPDF download

Mindful of the current trend within the United States to revive the focus on the use of trademark to determine a mark’s ability to act as a source indicator, in this paper I highlight how focusing on use can create disparate results by examining the role of use when dealing with well-known marks. Hence, this paper implicates the prescriptions from the harmonized trade regime, especially trademark law. In doing so, the paper outlines larger public policy concerns that will ensue especially considering the role of the use doctrine in the context of international harmonization of protection of well-known trademarks. In order to do so, this paper examines protection of foreign marks in two jurisdictions, India and the United States, to identify global public policy concerns which has national implications. The study debunks the myth that harmonization would result in trading partners extending reciprocal treatment. That is, inapposite to the touted position, this paper uses the well-known marks example to outline disparate outcomes that ensue when focusing on use as source indicator. In highlighting how harmonization has not resulted in uniformity or predictability internationally to identify and recognize well-known trademarks, this paper discusses how the lack of predictability under a harmonized system has raised strong public policy concerns as well as economic outcomes that may be detrimental to some markets but beneficial to others. Overall, this paper asserts that a coherent approach will have to necessarily involve some level of flexibilities in the trade regime to determine constituents of fame for a well-known trademark in each jurisdiction.

The tumultuous tradescape, which references the landscape of the trade regime, provides the background for this chapter and hopes to outline a historiographic mapping of the struggles of diverse actors for access to medicine rupturing established global structures over three generations. The historiographic mapping traces the changes in the patent discourse terrain by analyzing the metamorphosis of IP ideology, particularly patents. In doing so, this larger book captures the different sets of actors such as states, transnational business corporations, civil society groups, and the (re)framing of patent discourses within and among these actors. Our intergenerational analyses of the legal issues surrounding the access to medicine question provides an insight into the structures within which the actors have operated along with the dynamic relationship between structures and actors. The term structure refers to the economic system within which various actors operate. The influence of structures over the behavior of actors and in turn, the influence exerted by actors over structures eventually caused generational shifts in the debate on the role of patents, trade, and access to medication. The book examines the influences over established global protocols, national and international agreements, and state and non-state entities. In doing so, we acknowledge that the history of patent harmonization discourse is a story of dynamic actors, whose interactions with established structures continue to shape the global patent regime.

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries although the waiver, in enabling vaccination of populations across the globe, would be critical to normalize global trade. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The paper hopes to capture the benefits of the waiver and compares it with the existing flexibilities, being compulsory licensing.