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Pharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation

The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting…

Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP. Andrii Zastrozhnov/iStock via Getty Images Plus

Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs.

I am an economist who studies innovation and digitization in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a patent pool geared toward public health can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.

Patent pools can help increase access to expensive drugs.

Drug patents in the global landscape

Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, typically 20 years from the application filing date.

However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “evergreens” the company’s patent portfolio without requiring substantial new investments in research and development.

Furthermore, because patents are jurisdiction-specific, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.

To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.

Determining what is patentable can be complicated.

The 2001 Doha Declaration clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.

One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court denied Novartis’s patent application for Glivec for obviousness, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been patented in 40 other countries. As a result of India’s landmark ruling, the price of Glivec dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88) for one month of treatment.

Patent challenges and pools

Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain multiple patented compounds, each of which can be owned by different companies. Overlapping patent rights can create a “patent thicket” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.

One solution to these drug access issues is patent pools. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization.

Diagram of licensing markets with and without a patent pool
Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market. Lucy Xiaolu Wang, CC BY-NC-ND

Patent pools were first used in 1856 for sewing machines and were once ubiquitous across multiple industries. Patent pools gradually disappeared after a 1945 U.S. Supreme Court decision that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later revived in the 1990s in response to licensing challenges in the information and communication technology sector.

The Medicines Patent Pool

Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The Medicines Patent Pool, or MPP, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.

But how much has the MPP improved drug access?

I sought to answer this question by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.

Diagram of the Medicines Patent Pool licensing structure
The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs. Lucy Xiaolu Wang, CC BY-NC-ND

I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.

I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.

The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.

Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.

Technology licensing for COVID-19 and beyond

Since May 2020, the Medicines Patent Pool has become a key partner of the World Health Organization COVID-19 Technology Access Pool, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an mRNA vaccine technology transfer hub in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.

Licensing COVID-19-related technologies can be complicated by the large amount of trade secrets involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as manufacturing details. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to close the licensing knowledge gap.

Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug nilotinib – the first time a cancer drug has come under a public health-oriented licensing agreement.

Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.

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Public support for extending the 14-day rule on human embryo research indicated by foundational dialogue project

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded…

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The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Credit: Dr Matteo Molè (Babraham Institute)

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Headline findings include:

  • Appetite for review of the 14-day rule: Participants recognised that extending the 14-day rule could open up ways to achieve benefits in fertility and health, with participant support for reviewing this, including national discussion.
  • Confidence in regulation: There was a high level of confidence in how human embryo research is regulated, despite a low level of awareness of the regulators and statutes themselves. This included strong desire to see robust regulation governing any changes to the 14-day rule and further regulation for the use of stem cell-based embryo models.
  • Support for improved fertility and health outcomes: The strongest hopes for future human embryo research were where new knowledge would deliver improvements in understanding miscarriage, preventing health conditions such as spina bifida and raising the success rates of IVF procedures.
  • Concerns about genetically engineering humans: The public expressed concerns on the application of developments in this field to genetically alter or engineer humans.

The dialogue engaged a group of 70 people broadly reflective of the UK population in over 15 hours of activities including a series of online and face-to-face workshops with scientists, ethicists, philosophers, policy makers and people with relevant lived experience (such as embryo donors from IVF procedures).

Dr Peter Rugg-Gunn, scientific lead for the HDBI and senior group leader at the Babraham Institute, said: “Recent scientific advances bring incredible new opportunities to study and understand the earliest stages of human development. To ensure this research remains aligned with society’s values and expectations, we must listen and respond to public desires and concerns. This public dialogue is an important first step and as a scientist I am reassured by the findings but there is still a long way to go to fully understand this complex issue.” 

The report is exceedingly timely, following notable scientific advances in human developmental biology presented at conferences and in leading scientific journals in recent months. As well as generating excitement in scientific fields and with the public, announcement of these breakthroughs also prompted some concerns and criticisms, with the view that these findings raised significant ethical issues. The dialogue provides insight into public considerations following deliberation on early human embryo research. The hope is that it will act as a foundational reference point that others in the sectors can build upon, such as in any future review of the law on embryo research.

Professor Robin Lovell-Badge, co-chair of the HDBI Oversight group, senior group leader and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute, said: “We have learnt a lot about human development before 14 days, but there are areas of investigation that could change how we understand development, and associated diseases, that lie beyond our current window of knowledge. Despite low awareness of current laws, members of the public quickly recognised many of the critical issues researchers are keenly aware of when it comes to growing embryos beyond the current limit. This dialogue also reinforced the fact that the public are in support of research that will yield better health outcomes, and in this case, increase the success of IVF procedures.

Other countries will be looking to the UK to see how we deal with the 14-day rule; we are not there yet with any mandate to make a change, but this does give a strong pointer. The next step will be to delve deeper into some of the topics raised through this dialogue as they apply to specific areas of research, as well as feeding into policy changes.”

The 14-day rule and the regulation of stem cell-based models

When considering the regulation of research involving human embryos, the dialogue explored participant’s views on the 14-day rule. Introduced in 1990, the 14-day rule is a limit enforced by statute in the UK. It applies to early human embryos that are donated by consent to research and embryos that are created for research from donated sperm and eggs. It limits the amount of time early human embryos can be developed in a laboratory for scientific study to 14 days after fertilisation. Due to technical advances, it is now possible to grow embryos in the lab past 14 days, but researchers are not allowed to by the law. If the law changed, it would open up this ‘black box’ of development with researchers able to investigate this crucial time in development from 14-28 days after fertilisation.

Professor Bobbie Farsides, co-chair of the HDBI Oversight group and Professor of Clinical and Biomedical Ethics at the Brighton and Sussex Medical School, said: “It has been a fascinating experience to support HDBI in the undertaking of this exercise.  I commend the participants for the care and mutual respect they have shown throughout. Their engagement and commitment to a subject few of them had previously considered allowed for a wide range of views to be expressed and considered. I hope the scientists involved will be encouraged by the high level of interest in their work, and will want to keep the public conversation going around these important subjects.”

The dialogue included participant discussion on what a change to the 14-day rule might look like, and identified points that should be considered, such as defining what the benefits of extending the rule would be and potential mis-alignment with human embryo research regulations in other countries.

Participants acknowledged the astonishing possibilities of stem cell-based embryo models. The majority of participants would like to see these models further regulated. Work in establishing potential governance mechanisms is already underway. In recognition of the need for additional guidance and regulation in this area, the Cambridge Reproduction initiative launched a project in March 2023 to develop a governance framework for research using stem cell-based embryo models and to promote responsible, transparent and accountable research.

Future steps

A key outcome from the public dialogue is the identification of areas for further exploration, with participants proposing how future national conversations might be shaped. It is hoped that the project acts as a reference base for both widening engagement with the subject and also prompting deeper exploration of areas of concern.

Dr Michael Norman, HDBI Public Dialogue coordinator and Public Engagement Manager at the Babraham Institute, said: “This dialogue shows that people want the public to work closely with scientists and the government to shape both future embryo research legislation and scientific research direction. It is crucial that others in the sector build on these high quality, two-way engagement methodologies that allow for a genuine exchange of views and information to ensure that the public’s desires and concerns are listened to and respected. Transparency and openness around science is vital for public trust and through this we, as a society, can shape UK research in way that enriches the outcomes for all.”

Public Participant (Broad public group, south) said: “I do think that an extension of this public dialogue, and educating a wider society has a benefit in itself. This is really complex and sensitive and the wider you talk about it before decisions are made, the better.”


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Public support for extending the 14-day rule on human embryo research indicated by foundational dialogue project

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded…

Published

on

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Credit: Dr Matteo Molè (Babraham Institute)

The findings of a foundational UK public dialogue on human embryo research are published today, Wednesday 25th October 2023, as part of the Wellcome-funded Human Developmental Biology Initiative (HDBI). The HDBI is an ambitious scientific endeavour to advance our understanding of human development. The dialogue project, which was co-funded by UKRI Sciencewise programme, engaged a diverse group of the public to consider how early human embryo research can be used to its fullest, the 14-day rule and the fast-paced field of stem cell-based embryo models.

Headline findings include:

  • Appetite for review of the 14-day rule: Participants recognised that extending the 14-day rule could open up ways to achieve benefits in fertility and health, with participant support for reviewing this, including national discussion.
  • Confidence in regulation: There was a high level of confidence in how human embryo research is regulated, despite a low level of awareness of the regulators and statutes themselves. This included strong desire to see robust regulation governing any changes to the 14-day rule and further regulation for the use of stem cell-based embryo models.
  • Support for improved fertility and health outcomes: The strongest hopes for future human embryo research were where new knowledge would deliver improvements in understanding miscarriage, preventing health conditions such as spina bifida and raising the success rates of IVF procedures.
  • Concerns about genetically engineering humans: The public expressed concerns on the application of developments in this field to genetically alter or engineer humans.

The dialogue engaged a group of 70 people broadly reflective of the UK population in over 15 hours of activities including a series of online and face-to-face workshops with scientists, ethicists, philosophers, policy makers and people with relevant lived experience (such as embryo donors from IVF procedures).

Dr Peter Rugg-Gunn, scientific lead for the HDBI and senior group leader at the Babraham Institute, said: “Recent scientific advances bring incredible new opportunities to study and understand the earliest stages of human development. To ensure this research remains aligned with society’s values and expectations, we must listen and respond to public desires and concerns. This public dialogue is an important first step and as a scientist I am reassured by the findings but there is still a long way to go to fully understand this complex issue.” 

The report is exceedingly timely, following notable scientific advances in human developmental biology presented at conferences and in leading scientific journals in recent months. As well as generating excitement in scientific fields and with the public, announcement of these breakthroughs also prompted some concerns and criticisms, with the view that these findings raised significant ethical issues. The dialogue provides insight into public considerations following deliberation on early human embryo research. The hope is that it will act as a foundational reference point that others in the sectors can build upon, such as in any future review of the law on embryo research.

Professor Robin Lovell-Badge, co-chair of the HDBI Oversight group, senior group leader and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute, said: “We have learnt a lot about human development before 14 days, but there are areas of investigation that could change how we understand development, and associated diseases, that lie beyond our current window of knowledge. Despite low awareness of current laws, members of the public quickly recognised many of the critical issues researchers are keenly aware of when it comes to growing embryos beyond the current limit. This dialogue also reinforced the fact that the public are in support of research that will yield better health outcomes, and in this case, increase the success of IVF procedures.

Other countries will be looking to the UK to see how we deal with the 14-day rule; we are not there yet with any mandate to make a change, but this does give a strong pointer. The next step will be to delve deeper into some of the topics raised through this dialogue as they apply to specific areas of research, as well as feeding into policy changes.”

The 14-day rule and the regulation of stem cell-based models

When considering the regulation of research involving human embryos, the dialogue explored participant’s views on the 14-day rule. Introduced in 1990, the 14-day rule is a limit enforced by statute in the UK. It applies to early human embryos that are donated by consent to research and embryos that are created for research from donated sperm and eggs. It limits the amount of time early human embryos can be developed in a laboratory for scientific study to 14 days after fertilisation. Due to technical advances, it is now possible to grow embryos in the lab past 14 days, but researchers are not allowed to by the law. If the law changed, it would open up this ‘black box’ of development with researchers able to investigate this crucial time in development from 14-28 days after fertilisation.

Professor Bobbie Farsides, co-chair of the HDBI Oversight group and Professor of Clinical and Biomedical Ethics at the Brighton and Sussex Medical School, said: “It has been a fascinating experience to support HDBI in the undertaking of this exercise.  I commend the participants for the care and mutual respect they have shown throughout. Their engagement and commitment to a subject few of them had previously considered allowed for a wide range of views to be expressed and considered. I hope the scientists involved will be encouraged by the high level of interest in their work, and will want to keep the public conversation going around these important subjects.”

The dialogue included participant discussion on what a change to the 14-day rule might look like, and identified points that should be considered, such as defining what the benefits of extending the rule would be and potential mis-alignment with human embryo research regulations in other countries.

Participants acknowledged the astonishing possibilities of stem cell-based embryo models. The majority of participants would like to see these models further regulated. Work in establishing potential governance mechanisms is already underway. In recognition of the need for additional guidance and regulation in this area, the Cambridge Reproduction initiative launched a project in March 2023 to develop a governance framework for research using stem cell-based embryo models and to promote responsible, transparent and accountable research.

Future steps

A key outcome from the public dialogue is the identification of areas for further exploration, with participants proposing how future national conversations might be shaped. It is hoped that the project acts as a reference base for both widening engagement with the subject and also prompting deeper exploration of areas of concern.

Dr Michael Norman, HDBI Public Dialogue coordinator and Public Engagement Manager at the Babraham Institute, said: “This dialogue shows that people want the public to work closely with scientists and the government to shape both future embryo research legislation and scientific research direction. It is crucial that others in the sector build on these high quality, two-way engagement methodologies that allow for a genuine exchange of views and information to ensure that the public’s desires and concerns are listened to and respected. Transparency and openness around science is vital for public trust and through this we, as a society, can shape UK research in way that enriches the outcomes for all.”

Public Participant (Broad public group, south) said: “I do think that an extension of this public dialogue, and educating a wider society has a benefit in itself. This is really complex and sensitive and the wider you talk about it before decisions are made, the better.”


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UC Riverside physicist awarded National Medal of Science

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal…

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RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

Credit: Stan Lim, UC Riverside.

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

The President’s National Medal of Science is given to individuals “deserving of special recognition by reason of their outstanding contributions in biology, computer sciences, education sciences, engineering, geosciences, mathematical and physical sciences, and social, behavioral, and economic sciences, in service to the Nation.” It is administered by National Science Foundation.

Barish was recognized for “exemplary service to science, including groundbreaking research on sub-atomic particles. His leadership of the Laser Interferometer Gravitational-Wave Observatory led to the first detection of gravitational waves from merging black holes, confirming a key part of Einstein’s Theory of Relativity. He has broadened our understanding of the universe and our Nation’s sense of wonder and discovery.”

“UCR congratulates Prof. Barish on receiving the National Medal of Science,” said UCR Chancellor Kim A. Wilcox. “The distinguished names of previous winners make this recognition very exceptional. Prof. Barish is a strong inspiration for our students, researchers, and faculty. UCR continues to benefit from his extraordinary achievements.”

Barish won the 2017 Nobel Prize in physics for the discovery of gravitational waves. He joined the UCR faculty in 2018. He earned his bachelor’s degree in physics in 1957 and his doctorate in experimental particle physics in 1962, both from from UC Berkeley. He joined Caltech as a postdoc in 1963, became a professor in 1966, and was appointed Linde Professor of Physics in 1991. He led the Laser Interferometer Gravitational-wave Observatory, or LIGO, effort from its inception through the final design stages, and in subsequent discoveries. In 1997, he created the LIGO Scientific Collaboration, which enables more than 1,000 collaborators worldwide to participate in LIGO.

Barish has served on many committees, including co-chairing the subpanel of the High Energy Physics Advisory Panel that developed a long-range plan for U.S. high-energy physics in 2001. He chaired the Commission of Particles and Fields and the U.S. Liaison Committee to the International Union of Pure and Applied Physics.

He is the recipient of the Fudan-Zhongzhi Science Award (China), Princess of Asturias Prize for Science and Technology (Spain), Giuseppe and Vanna Cocconi Prize from the European Physical Society, the Enrico Fermi Prize from the Italian Physical Society, and the Klopsteg Award from the American Association of Physics Teachers. He is a member of the National Academy of Sciences, which awarded him the Henry Draper Medal. From 2003 to 2010, he served as a presidential appointee to the National Science Board.

He is an elected member of the American Academy of Arts and Sciences and a fellow of both the American Association for the Advancement of Science and of the American Physical Society, where he also served as president. He has received honorary doctorates from the University of Bologna, University of Florida, University of Glasgow, and Universitat de València in Spain. He has been inducted as honorary academician into the Royal Academy of European Doctors, based in Spain. He was elected a foreign member of the Royal Society in 2019. Last year, he won the Copernicus Prize, bestowed by the government of Poland. Earlier this year, he was elected a corresponding member of the Royal Academy of Sciences and Arts of Barcelona. 

The University of California, Riverside is a doctoral research university, a living laboratory for groundbreaking exploration of issues critical to Inland Southern California, the state and communities around the world. Reflecting California’s diverse culture, UCR’s enrollment is more than 26,000 students. The campus opened a medical school in 2013 and has reached the heart of the Coachella Valley by way of the UCR Palm Desert Center. The campus has an annual impact of more than $2.7 billion on the U.S. economy. To learn more, visit www.ucr.edu.


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