Breaking Bad Patents: Learning from HIV/AIDS to make COVID-19 treatments accessible

Abstract

The COVID-19 pandemic has brought renewed attention to the topic of challenging drug patents in the interest of public health. Pharmaceutical companies have already begun to patent existing medicines for the treatment and prevention of SARS-CoV-2, affording them exclusive manufacturing rights over vital medicines. Advocates have raised concerns regarding the pricing of COVID-19 drugs, as well as patent monopolies on the manufacture of COVID-19 treatments. The HIV/AIDS pandemic provides a useful lens through which we can analyze existing pathways for challenging pharmaceutical patents in the context of global pandemic. In this article, we review three legal pathways for overriding and seizing patents on medicines by describing cases in which they were employed to make antiretroviral drugs more accessible to people living with HIV. Last, we highlight the weaknesses inherent in these pathways and offer advocacy and policy suggestions for how to strengthen these pathways to improve access to COVID-19 treatments as they become available in the United States and globally.

INTRODUCTION

Access to essential medicines is an integral component of our human “right to health,” outlined in the Universal Declaration of Human Rights (1948). Assuring that all persons have access to medicines is particularly critical in midst of the COVID-19 global pandemic. Achieving access to the most effective prophylactic and therapeutic treatments for SARS-CoV-2 is integral to controlling the global burden of COVID-19 and minimizing fatalities. Additionally, ensuring access to medicines that treat and control diabetes, hypertension and cardiovascular disease and other morbidities have important implications for minimizing COVID-19 deaths and disease-severity related to underlying conditions that exacerbate COVID outcomes (Bajgain et al., 2020; Nandy et al., 2020). In the age of COVID-19, endeavors to overturn patents take on renewed urgency as the need for affordable and accessible medicines escalate with the ongoing global pandemic. Further, the pandemic provides new political opportunity to challenge monopoly production of medicines essential for global public health.

Achieving access to essential and emergency medicines has been complicated by an entanglement of global, multinational, international and state laws that protect intellectual property rights, including patent rights on essential medicines (Correa, 2002; Médecins Sans Frontières [MSF], 2020a). Global intellectual property laws like the World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPS), provide an overarching global framework of patent holder rights, governing the minimum standards on property rights for all member states (Correa, 2002; WTO, 2006b). Further, multi- and bi-lateral trade agreements between high-income, patent-holding countries and low and middle income countries (LMICs) often provide additional layers of complexity, creating new sets of rules in addition to TRIPS standards. Such agreements are colloquially referred to as “TRIPS-Plus” and have been a result of intense lobbying on the part of pharmaceutical companies (Make Medicines Affordable, 2020).

Notably, patents have historically created barriers to providing antiretroviral drugs (ARVs) to those living with HIV globally, particularly in LMICs, and have thus inspired the attention of HIV advocacy groups, non-governmental organizations (NGO) and governments in LMICs (t Hoen et al., 2011). Access issues resulting from patents have also been mirrored in more recent efforts to provide ARVs as Pre-Exposure Prophylaxis (PrEP) to those most vulnerable to HIV (Brachmann, 2019; Hayes et al., 2019; Carines, 2016). Historical and contemporary case studies of efforts to challenge patents on ARVS provide a useful lens through which we may glean insights into potential actions for challenging current and future patents on emergency and essential medicines (t Hoen et al., 2011).

Since the emergence of SARS-CoV-2 in 2019, pharmaceutical companies have been quick to apply for additional patents on drugs that show any promise at treating SARS-CoV-2. For example, in March 2020, Gilead Sciences was granted “orphan rights” by the U.S. Food and Drug Administration on the anti-viral drug remdesivir, a drug that showed promise for treating SARS-CoV-2 in early clinical trials and has since shown negligible effects on COVID outcomes in the SOLIDARITY trial (Dyer, 2020; Lui et al., 2020). Civil society groups and public health advocates were quick to criticize the application of additional patent protections on any potential treatment for SARS-CoV-2, inspiring Gilead to forgo their orphan drug rights just one day after receipt (Keown, 2020). However, Gilead maintains exclusive rights to manufacture remdesivir in most high-, middle- and low-income countries. In India, Pakistan and Egypt, Gilead has agreed to allow several generic manufacturers to produce the drug, while limiting the sale of generic formulation to just 127 LMICs (Gilead Scinces, 2020; Garrison, 2020). Such prohibitive parameters will restrain “economies of scale” from bringing down the cost of remdesivir, which is currently priced at $3,120 per treatment course (Garrison, 2020; Kolata, 2020). This is only one example of how patent rights have already challenged the distribution of affordable generic drugs during the ongoing COVID-19 pandemic; similar actions with regard to effective therapeutic drugs would have deleterious global health effects. Currently, there are two FDA-approved drugs for the treatment of SARS-CoV-2, remdesivir and dexamethasone. However, a study published in Nature identified 21 existing drugs with potential to block the replication of the virus, offering new promise for the treatment of SARS-CoV-2 (Riva et al., 2020). As medicines are tested and approved for treatment and prevention of SARS-CoV-2, new patents will likely recreate old barriers to life-saving medicines.

Intellectual property rights scholar Kalyan Krankanola argued that “patent validity is a figment of legal interpretation, it can be contested, reversed and cancelled any time before expiry” (Kankanala, 2012). Such logic lends support to further inquiry into potential legal pathways for challenging patents, which should be considered legitimate opportunities to increase access to life-saving medicines, particularly in the context of a global pandemic. In this article, we review three legal pathways for overriding and seizing patents on medicines. We will also describe examples of successes and failures in the US and globally in using these pathways to make ARVs more accessible. Last, we aim to highlight the weaknesses in our existing solutions and offer suggestions for how we may strengthen these options to improve access to COVID-19 treatments as they become available in the United States and globally.

PATHWAY 1: TRIPS FLEXIBILITIES

The Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) of 1994, was an agreement orchestrated by The World Trade Organization (WTO) in an effort to strengthen and globalize intellectual property rights among member states (World Trade Organization [WTO], 2006b, 2020a, 2020b). In brief, the agreement provided a framework of policies around intellectual property rights for member states, which included the vast majority of trading states. Specifically, the global law outlined patent rights for inventors by dictating state actions on the production and trade of patented entities (WTO, 2020a). The public health implications of TRIPS are substantial, with the law providing limitations on state production and purchasing of ARVs and other drugs, as well as other patented health technologies (t Hoen, 2002; t Hoen et al., 2011). However, TRIPS includes several provisions for protecting public health. These include allowing states to produce and purchase drugs without permission from the patent owner through two pathways: compulsory licensing and parallel importation (WTO, 2006a). It is these flexibilities, outlined in TRIPS’ Articles 31 and 6, that provide opportunities for challenging COVID-19 patents, and have historically improved access to ARVs (t Hoen et al., 2018; WTO, 2006a).

Compulsory licensing allows states to manufacture patented drugs domestically to distribute to their residents without the permission from the patent holder (WTO, 2006a). Alternately, parallel purchasing and importation affords states the right to purchase drugs via another manufacturing country where perhaps the drug is off-patent or available at a differential cost, thus lowering the price for the importing nation (WTO, 2006a). These provisions are included in the original TRIPS Agreement, albeit without specific language to protect states that chose to pursue such avenues. Further, the original agreement does not provide enforcements for protecting public health, despite providing mandates on intellectual property protections (Subhan, 2006). This disparity illustrates the agreement’s core intentions, which are to globalize intellectual property rights.

Early attempts by LMICs to utilize TRIPS flexibilities by codifying compulsory licensing and parallel importation into state law faced aggressive retaliatory threats from patent holding countries, often a result of pressure from pharmaceutical companies and trade associations (Subhan, 2006). Such cases made it clear that further protections for LMICs were needed. In 2001, a convention was held in Doha, Qatar, in response to the demand for greater enforcements of TRIPS flexibilities (Correa, 2002). The Doha Ministerial Declaration did not fundamentally rewrite TRIPS flexibilities, but rather provided further protection for countries utilizing TRIPS flexibilities, and achieved this goal by outlining the language around compulsory licensing in the interest of public health (Correa, 2002). Following Doha, TRIPS was amended to allow for some countries to export compulsory licenses for the manufacture and import of needed drugs, a change that responded to implementation challenges due to limited manufacturing capacity of some member nations (WTO, 2017). Despite promising increases in use, implementation of TRIPS flexibilities has produced mixed results, with some countries experiencing success in making essential medicines more available, while others have not been able to use compulsory licensing and importation to improve access (t Hoen et al., 2018).

Case Studies: TRIPS Flexibilities

Thailand

Since 1992, prior to the enforcement of TRIPS, the Thai National AIDS Program provided low-cost generic AZT to PLHIV (t Hoen, 2009). Universal ARV access was a battle hard won by AIDS activists and patient advocacy groups who created enormous pressure on the Thai government to improve access to treatment for PLHIV. With the implementation of TRIPS, the Thai government faced new challenges to providing generic versions of patented ARVs. Such challenges were not unique to ARVs, but interfered with low-cost generic production of a number of important medications, including antifungal medications (t Hoen, 2009). In 1998, generic manufactures in Thailand initiated production of fluconazole using a compulsory license (t Hoen, 2009). Fungal medications like fluconazole are life-saving for those with fungal meningitis and opportunistic fungal infections, which can threaten the health of immunocompromised PLHIV. AIDS activists, inspired by the success of generic manufacturing in bringing down the cost of fluconazole, pressured the Thai government to use compulsory licensing to again produce low-cost generic didanosine for PLHIV (Perez-Casas et al., 2000; t Hoen, 2009).

In 2000, the United States responded to these developments by pressuring the Thai government to respect U.S. patent holders who owned sole productions of didanosine (t Hoen, 2009). However, global health organizations reacted quickly, encouraging the U.S. to reverse course. The U.S. tentatively backed off, but the Thai government feared retribution in the form of trade-sections and ultimately decided to produce a generic version of only a powdered didanosine, in lieu of the U.S. patented tablet. Unfortunately, the powdered form was not as well tolerated by PLHIV. However, the generic option brought down the price of treatment dramatically, making it more accessible to PLHIV, as well as acting as a successful example of the utilization of TRIPS compulsory licensure to increase access to low-cost generic ARVs (t Hoen, 2009). This example also highlights how pre-Doha threats ultimately limited the Thai government’s decisions in seeking compulsory licenses.

Rwanda

In 2006, Rwanda utilized TRIPS flexibilities to begin the process of exporting a compulsory license to manufacture and import ARVs from Canada into Rwanda through the generic manufacturer Apotex (Kohler et al., 2010). In this case, the Rwandan government was forced to comply not only with TRIPS articles, but also with Canadian patent law. The exchange was marred by constant delays, a result of bureaucratic complexities built into TRIPS and Canadian patent law (Kohler et al., 2010). The first delay came from a missed formality wherein the Rwandan government did not complete a “formal” request to begin the importation process. The second delay, a result of Canadian law, forced Apotex to negotiate with the patent holding companies for 30 days to come to a “reasonable” royalty deal, before they were permitted to apply for a compulsory license from the World Trade Organization (Kohler et al., 2010).

After failed negations with the patent holders, Apotex was cleared to pursue a compulsory license with the World Trade Organization. This entire process took thirteen months, followed by five months to manufacture the ARVs for importation (Kohler et al., 2010). Further, Canadian law stipulated that the importation agreement was valid for two years, and could only be extended if the agreed upon number of pills were not imported during the two-year window. During the two-year license period, seven million ARVs were imported into Rwanda (Chami & Wasswa-Kintu, 2011). Due to bureaucratic and legal hurdles, Apotex was unwilling to participate in compulsory licensing and importation following this experience (Chami & Wasswa-Kintu, 2011). Additionally, the Rwanda/Canada case revealed to other generic manufacturers how difficult the process was, discouraging other firms from participating in similar efforts (Kohler et al., 2010). This case highlights some of the challenges that arise when additional patent laws are layered on top of the existing barriers inherent to TRIPS.

Challenges and Solutions: TRIPS Flexibilities

Although the TRIPS Agreement includes articles intended to protect public health, its fundamental aim was to create a global minimum standard on intellectual property rights. As the case studies illustrate, there are flaws inherent to TRIPS, as well as challenges that occur when LMICs attempt to implement its flexibilities. Such challenges will need to be considered as countries attempt to utilize TRIPS flexibilities to provide affordable generic treatment and prevention in the face of the ongoing COVID-19 pandemic. In March 2020, Israel was the first country to apply for a compulsory license for lopinavir /ritonavir for the treatment of SARS-CoV-2, a drug subsequently not shown to be efficacious (Horby et al., 2020; Medicines Law & Policy, 2020). Many other countries are likely to follow in the coming months as treatment and prevention drugs emerge.

Challenges and recommendations introduced in Tables 1, 2 and 3 are a result of a non-exhaustive review of relevant litereature. In this article, we present case studies that exemplify common barriers to challenging patents on medical technologies. Our suggestions are based both on takeaways from scholars, activists and our own analysis of the literature and history. Table 1 displays some salient challenges for utilizing TRIPS flexibilities in the interest of manufacturing and importing low-cost generic drugs.

Table 1:

Challenges and Suggestions,, TRIPS

Challenges	Policy and Advocacy Suggestions
Emphasis on IP over public health. Compulsory licensing and parallel importations are optional, while mandating intellectual property protections for patent holders.	Mandatory implementation and default issuing of compulsory licensing for member nations, based on public health need.
Bi-lateral and multinational trade agreements and state patent laws undermine TRIPS flexibilities and create needless complexity for states seeking to utilize flexibilities.	TRIPS should be made a ceiling on patent protections for essential and emergency medicines, rather than a floor. WTO members should be restricted from enforcing policies that place additional levels of protection on essential and emergency medicines.
State governments face challenges when navigating the complexities of multi-layered intellectual property rights laws, and mistakes made during the process can create delays in implementation.	In lieu of immediate policy change, global health organizations and policy experts should be prepared to guide local governments through instances where TRIPS requirements are made increasingly complicated due to additional intellectual property laws to avoid delays in acquiring urgently needed drugs.
Power imbalances mean that LMICs are at a disadvantage compared to high-income, patent holding countries, as well as powerful pharmaceutical companies with global economic influence.	TRIPS should explicitly prohibit economic and other threats by patent holding nations and firms on those attempting to import drugs or manufacturer drugs via TRIPS flexibilities.

Table 2:

Challenges and Suggestions, March-In Rights

Challenges	Policy and Advocacy Suggestions
Disagreement about the application of the law, and no prior use of the Bayh Dole since its passage limit the likelihood of its implementation in challenging patents in the future.	Continued and frequent petitions to enact “march-in rights” could prove useful for normalizing this option as a legitimate avenue for challenging patents. Civil society should continue to push these petitions forward, and should aim to garner support from diverse public health interest groups, while learning from the strategies used by AIDS activists in the past.
U.S. government’s historical lack of willingness to challenge industry, specifically pharmaceutical companies.	Americans largely support government action to regulate pharmaceutical prices. Ubiquitous public support should be channeled toward specific solutions for bringing down drug prices, including through the utilization of march-in rights.
Opponents say use of march-in rights are an example of government overreach and an example of the “nanny state” in action.	Change the message frame; supporters of using march-in rights to challenge ARV patents should emphasize the “double payment” placed on tax-payers, who pay to fund the research and then pay again toward corporate profits from the drug they require.

Table 3:

Challenges and Suggestions, Competing Patents

Challenges	Policy and Advocacy Suggestions
Only a useful option for inventions for which the government holds a competing patent, limiting this pathway.	Creating a transparent threshold for government patent rights. For example, creating a criterion in which inventions made with government funding, in government facilities or with government staffers receive a government patent by default. In these cases, private industry can license patents for production and pay royalties to the government agency that supplied the funding.
Government has been unwilling to use this path in the past, speaking to their hesitancy to challenge corporate interests.	Strict policies around the revolving door between pharmaceutical firms and HHS/CDC etc. should be implemented to prevent infiltration of corporate executives into high level government positions. Such barriers would improve hesitancy to challenge corporate interests.
Lack of transparency regarding competing, government held patents.	Government patents rights should be made transparent, freely available and easily accessible for public search. This would offer civil society groups a tool, which can inform when to pressure government to act upon this pathway.

PATHWAY 2: MARCH-IN RIGHTS

Adopted in 1980 in the United States, the Bayh Dole Act is a bipartisan bill which gave universities, non-profit organizations and small businesses patent rights on inventions developed using government funding (Thomas, 2016). Such entities were then allowed to license the rights of commercialization to manufacturing firms to produce patented products. The bill was intended to spur the commercialization of inventions created using federal funding (Thomas, 2016). The Bayh-Dole Act includes provisions that allow the government to break industry held patents on inventions that are needed by the public: a process referred to a “march-in rights.” The bill stipulates that government funded inventions that have not been sufficiently “commercialized” by the patent holder are subject to use of march-in rights. This pathway is distinct from compulsory licensing in that it can only be used to seize patents on government funded inventions. Use of march-in rights to challenge pharmaceutical patent holders is subject to considerable debate, with academics and legal scholars falling on both sides of the argument (Arno & Davis, 2000; Hemel & L.L., 2017; Penman & Quigley, 2017; Rabitschek & Latker, 2005).

Critics of instituting march-in rights as a method for challenging pharmaceutical prices purport that the law cannot be used to overturn patents simply because the public is unhappy with drug prices (Treasure et al., 2015; Wilbur, 2019). They point to the clause that explains that march-in rights are a solution for inventions that have not been properly commercialized and thus need to be reclaimed by the original patent holder in order to make the product commercially available. Critics claim, as long as the license holder has provided the drug on the market, they can set the price and the government has no legal basis for “marching-in” (Treasure et al., 2015). Proponents of march-in rights disagree, claiming that impeded access to commercial drugs as a result of price-gouging justifies using march-in rights to the benefit of public health (Arno & Davis, 2000; Penman & Quigley, 2017; Whalen, 2014). Specifically, proponents of using march-in rights point to the Bayh Dole statement that specifies that if patented products are not commercially available on “reasonable terms,” then use of march-in rights is warranted. The “reasonable terms” argument has not been fully tested yet, but some experts do not believe it extends to “reasonable prices” (Rabitschek & Latker, 2005).

The debate over the use of march-in rights is ongoing. Activists, public health workers and patient advocacy groups continue to call for use of march-in rights to improve access to ARVs (Break the Patent Campaign, 2019; Love, 2016). In 2019, NYC City Council Speaker Corey Johnson called for using this approach to bring down the cost of PrEP (New York City Council, 2019). Johnson’s endorsement of using march-in rights was a response to the #breakthepatent campaign, a coalition of advocacy groups working to bring down the cost of PrEP by targeting its U.S. patents (Break the Patent Campaign, 2019). Ongoing efforts to utilize march-in rights make this a strategy worth investigating more closely by looking at prior cases, in order to better understand this pathway’s potential to bring down the cost of medicines in the United States.

Case Study: March-in Rights

Abbott Laboratories and ritonavir

In 2004, Essential Inventions, an organization committed to making essential medical inventions accessible, released a petition calling for the use of march-in rights to overturn Abbott Laboratories’ patent on ritonavir (Essential Inventions, 2004a). Ritonavir is an ARV that was developed under U.S. federal funding through the “National Cooperative Drug Discovery Group for AIDS” grant. The drug is an HIV protease inhibitor that blocks the replication of HIV, but its primary value comes from its ability to efficiently boost other protease inhibitors (Essential Inventions, 2004a). This boosting effect allows HIV patients to take lower doses of other ARVs, leading to fewer side-effects, improved drug safety, greater quality of life and even lower cost treatment (Hill et al., 2009). Thus, ritonavir is routinely prescribed as part of combination antiretroviral therapy along with other ARVs.

In 2004, Abbott announced a 400% price increase for ritonavir (commercially branded as Norvir), leaving their own fixed-dose combination product that included ritonavir, Keletra, at original cost (Roehr, 2007). This move forced many HIV patients to switch to Abbott’s Keletra, regardless of whether the product best suited their clinical needs, due to many patients requiring the boosting agent for their HIV therapy (Roehr, 2007). In response, Essential Inventions, a non-profit organization, petitioned the government to employ march-in rights, claiming the move made stand-alone ritonavir inaccessible and forced patients onto their combination pill. Over 100 HIV/AIDS groups and doctors, along with eight Senators wrote formal letters of support for the move (Essential Inventions, 2004b).

Democratic Senator at the time, Evan Bayh (a sponsor of the 1980 Bayh – Dole Act) gave the opening speech at the NIH meeting, which evaluated the petition against Abbott. In short, Bayh claimed the medication was available on the market and that an increase in price did not justify using an extreme measure like march-in rights (National Institutes of Health [NIH], 2004b). In July 2004, the NIH formally responded to the request from Essential Inventions, denying the use of march-in rights for this case (NIH, 2004a). Elias A. Zerhouni, Director of the NIH at the time, cited the drug’s availability on the market and the integral partnerships between the NIH and industry in their statement. The NIH also stated that given the global implications of drug pricing, the issue should be handled legislatively (NIH, 2004a). March-in rights were never implemented in this case, despite continued calls from additional organizations for the government to march-in and challenge Abbott’s patent in the interest of HIV patients. However, in response to backlash over price-hikes, Abbott Laboratories agreed to waive the price increase for government insured patients. Since Essential Inventions’ request to institute march-in rights in 2004, there have been numerous petitions of the NIH to use march-in rights, several of which focused on reclaiming the patent on ritonavir (Knowledge Ecology International [KEI], 2017).

Challenges and Solutions: March-in Rights

To date, march-in rights have never been instituted in the United States to challenge pharmaceutical price-gouging, despite ongoing calls for the U.S. government to use this strategy. Barriers to using this pathway largely revolve around the U.S. government’s unwillingness to challenge industry, particularly the pharmaceutical industry. Additionally, opponents have criticized using march-in rights as an example of government overreach and evidence of the “nanny state.” Such political tropes can be powerful framing tools and may require rights-based and other counter-messaging to gain public support for government marching-in to reclaim patents.

The U.S. government has committed substantial funding for coronavirus research. Following the 2003 SARS outbreak, the NIH spent 700 million on coronavirus research. In response to the COVID-19 pandemic, the Biomedical Advanced Research and Development Authority (BARDA) has already committed close to one billion dollars in vaccine research through Johnson & Johnson and Moderna (Lui et al., 2020). In addition, Congress has granted the NIH $3.6 billion in funding for SARS-CoV-2-related research (Kaiser, 2020). Thus, many medicines and devices emerging from federally funded coronavirus research will be subject to the use of march-in rights (NIH, 2020). Should the cost of federally funded inventions that treat or prevent SARS-CoV-2 prove prohibitive, advocates may consider calling on march-in rights to increase accessibility to vital drugs and medical devices. For example, advocacy groups have already raised concerns about Gilead’s redemsivir price tag, which it set at $3,120 for those with private insurance and $2,340 for those with government-sponsored insurance per treatment in the United States. A consumer group, Public Citizen, highlights that the drug was developed with $70 million in federal funding (Kolata, 2020). Public health advocates and civil society groups should be prepared to call on the NIH to utilize march-in rights to make medicines accessible for the treatment and prevention of SARS-CoV-2, as this avenue will likely take on renewed relevance during the COVID-19 pandemic.

Table 2 lists some of the most salient challenges to utilizing “march-in” rights to challenge pharmaceutical patents, as well as suggestions for how we may overcome them.

PATHWAY 3: GOVERNMENT PATENTS

In addition to using march-in rights, the United States government can pursue alternate avenues for overturning or seizing pharmaceutical patents (U.S. Patent and Trademark Office, 2008). For example, pharmaceutical advances funded by tax-payer money can lead to duplicate patents. In some instances there may be a patent held by the pharmaceutical company who is commercializing the drug, as well as a competing patent held by a government department, such as the Centers for Disease Control and Prevention (CDC) or other government institution (Morten, 2019). In these cases, the United States government can file a patent infringement suit in federal district courts. There have been several cases of duplicate patents existing, but the U.S. government has rarely chosen to act on such competing patents (Shah & Gorgan, 2020).

The U.S. government has historically underutilized strategies to overturn or seize pharmaceutical patents in an effort to make drugs more affordable in the United States (Shah & Gorgan, 2020). Patient advocates argue that governments should challenge industry held patents in the event that a pharmaceutical company has price-gouged patients, effectively making medications inaccessible to patients (Break the Patent Campaign, 2019; Essential Inventions, 2004a; MSF, 2020a). Although little is known about government held patents on pharmaceutical drugs, this pathway is worth investigating given recent, unprecedented utilization by the U.S. government. In 2019, The United Stated Department of Health and Human Services filed a patent infringement suit against Gilead Sciences, the pharmaceutical manufacturer of Truvada and Descovy for PrEP (The United States of America, v. Gilead Sciences, Inc., 2020) This case opens the door to a new pathway for challenging pharmaceutical patents on ARVS and other medicines that may be useful for treating and preventing SARS-CoV-2.

Case Study: Government Patents

United States v. Gilead

In early 2019, HIV activists discovered that the CDC held legally enforceable patents on PrEP (Morten, 2019). The discovery came from the PrEP4All Campaign, who commissioned Christopher Morten, a patent expert with the Global Health Justice Partnership at Yale Law School and the Yale School of Public Health, to do a careful review of the U.S. government’s PrEP patents (Morten, 2019). This groundbreaking finding was quickly released to the public to engender public pressure on the CDC to use its competing patents as a means to bring down the cost of PrEP. The PrEP4All Campaign was successful in generating considerable media attention on the issue of PrEP pricing and resulting access issues (GHJP Joins PrEP4All in Calling on CDC To Use Its Patents for PrEP, 2019). Heightened attention led to a Congressional House Oversight Committee hearing, during which Congresswoman Alexandra Ocasio-Cortez challenged Gilead CEO Daniel O’Day on the price of PrEP (House Committee on Oversight and Reform, 2019). The high cost of PrEP was also raised by Senator Bernie Sanders as well as Senator Elizabeth Warren. Heightened scrutiny of PrEP pricing, along with the White House’s State of the Union pledge to end HIV transmission by 2030 may have created the policy window for what came next (C-SPAN, 2019).

In 2019, the Department of Health and Human Services (HHS), on behalf of the CDC, filed a patent infringement suit against Gilead Sciences, claiming the company infringed on four patents issued by the United States Patent and Trademark Office for PrEP. The CDC claims that on numerous occasions they have offered Gilead the opportunity to license PrEP for a royalty payment to the CDC, but have never received an acceptance to those offers (The United States of America, v. Gilead Sciences, Inc., 2020). Instead, Gilead has been selling Truvada and Descovy as PrEP at ~$2,000 per month to users in the U.S. Gilead has made approximately $3 billion per year from the sale of Truvada as PrEP. Experts believe the high cost of PrEP is a primary barrier to uptake, which continues to lag need among Americans vulnerable to HIV.

The case against Gilead is still pending, however in February 2020, the Patent Trial and Appeal Board denied two of Gilead’s requests for inter partes review (IPR) of HHS’s PrEP patents, a move which sought to invalidate the government’s patents on PrEP (Sagonowsky, 2020). Although this development does not necessarily mean HHS patents are valid, it is a promising step in that direction. HIV activists and patient advocates are watching carefully to see how this case evolves in the coming year, as it has the potential to create new precedent for overturning patents on ARVs and other government funded medicines.

Challenges and Solutions: Government Patents

This potential pathway for challenging patents remains to be fully evaluated for its successes and failures. However, several barriers to its implementation are apparent and mirror those of march-in rights. Government hesitancy to challenge the pharmaceutical industry will be a primary challenge for using this pathway. Additionally, its implementation will depend on the existence- and knowledge of competing government patents. Public health advocates, civil society groups and NGOs should be prepared to identify and call on the U.S. government to use competing patents on drugs that may be effective for the treatment or prevention of the SARS-CoV-2.

Table 3 lists some of the most salient challenges to using this pathway to challenge pharmaceutical patents, as well as suggestions for how we can overcome them.

DISCUSSION

Legal pathways for challenging patents differ by country and can be impacted by a myriad of multi- and bilateral trade-agreements, as well as domestic patent laws. However, the TRIPS Agreement acts as a global base for patent protections with several flexibilities built into it. LMICs have utilized TRIPS flexibilities with varying degrees of success, but further changes to TRIPS could improve the feasibility of implementing compulsory licensing and importation. The Doha Declaration, which emphasized the rights of LMICs to utilize TRIPS flexibilities, occurred as a result of discontent from LMIC governments, NGOs, and activists in response to threats made by patent holding countries to prevent the use of compulsory licensing and importation. Further improvements on TRIPS may require similar pressures to come to fruition. Finally, recent calls from activists, global health organizations, and LMICs for specific TRIPS waivers, provide an additional strategy for making COVID-19 medicines, medical devices and knowledge easily accessible, overcoming many of the challenges to TRIPS flexibilities outlined in this article (MSF, 2020b).

The Bayh Dole Act’s march-in rights have been routinely underutilized as a strategy for challenging patents on medicines in the United States. Further, competing government held patents present another possibility for overturning patents on medicines in the U.S. Although these avenues have yet to produce successes, advocates should continue to call on the U.S. government to use all available legal pathways to challenge patents. As made evident by the ritonavir case, public pressure and the threat of march-in rights has the potential to reduce drug prices on needed medicines. American voters should be made aware of such options in an effort to pressure political representatives to endorse using available pathways for bringing down pharmaceutical costs. In the 2020 Democratic Primary, several candidates, including Senator Bernie Sanders and then Senator Kamala Harris, endorsed using march-in rights to seize pharmaceutical patents on high-cost, federally-funded drugs (Davis, 2019). Such endorsements represent a promising shift in the interpretation of the Bayh Dole Act in the interest of public health.

As mentioned, the strategies and pathways outlined in this paper are non-exhaustive and other options for challenging patents exist. For example, Title 28 USC §1498 codified compulsory licensing into U.S. law, allowing the government to purchase a license on any invention without the permission of the patent holder. This section of U.S. law has increasingly been cited as an option for seizing pharmaceutical patents, particularly for medicines that were not government funded but remain inaccessible to the public (KEI, n.d.). Additionally, in many countries, advocates may directly oppose new patents, an option that is typically time-bound and must fulfill certain TRIPS criteria that vary by member-state interpretation. This strategy has been successful in Brazil, where advocates have used opposition procedures to successfully oppose patents on ARVs for use as treatment and prevention of HIV (MSF, 2012; Saez, 2018). Notably, this strategy may be used by civil society groups without the participation of governments. Médecins Sans Frontières provides a useful online tool for guiding activists through patent opposition procedures (https://www.patentoppositions.org/en/about).

It is also worth noting that strategies to reduce the cost of medicines are not limited to existing policy and legal avenues. In the context of COVID-19, legislative proposals may see increased congressional and parliamentary support as countries grapple with cost as a barrier to making SARS-CoV-2 medicines quickly and broadly accessible. For example, several countries have already passed legislation/resolutions challenging patents in the interest of achieving broad access to essential and emergency medicines during COVID-19 (Wong, 2020). In Canada, The COVID-19 Emergency Response Act expedites the compulsory licensing process by allowing for payment negotiation between government and patent holder to occur at a later date; note that similar negations caused significant delays in the Rwanda/Canada case discussed earlier (Wong, 2020). In March 2020 in Ecuador, a committee of the National Assembly passed a resolution that calls on the National Government to utilize compulsory licensing procedures for medicines that treat or prevent SARS-CoV-2 (Wong, 2020; KEI, 2020a). In Chile, a similar resolution was passed by the Chamber of Deputies (Wong, 2020; KEI, 2020b). Notably, these resolutions are not binding legislation. Still, these cases exemplify growing political will to overturn monopoly rights on the manufacture of medicines in the context of a global public health crisis.

Legislators, civil society groups and patent law experts have long called for regulation of existing patent systems across nations, particularly in high-income, patent holding states that impact the global distribution of medicines. For example in the recent past, U.S. lawmakers have proposed legislation to increase patent challenges, create mechanisms for compulsory licensing, increase patent standards and limit abuses of the patent system, none of which have become law (Barlas, 2019; Conti & Kleutghen, 2020; Richards et al., 2020). However, COVID-19 may provide new opportunity to amend existing laws (i.e. Bayh-Dole Act, §1498), and pass new legislation that would explicitly allow the U.S. government to overturn patents on high-cost emergency and essential medicines. All told, utilizing existing legal pathways, and creating new ones, will require considerable political will to challenge pharmaceutical industry interests and thus will may rely on pressure from the general public, civil society groups and other allied stakeholders to come to fruition.

Conclusions

Over the last four decades, the relationship between governments and corporations have changed in a number of ways. These developments have given more power to corporations and reduced the power of government to protect public health (Harvey, 2007). The increased patent protections that global pharmaceutical companies now enjoy have diminished the capacity of governments to ensure the fundamental human right of access to essential and emergency medicines. Monopolies on drug production lead to high-prices for many medicines, and complex patent extension schemes only exacerbate the problem. In this article, we have explored three paths by which governments, sometimes in partnership with civil society groups, can utilize their existing powers to make essential medicines more available. Although the current article focused only on case studies of ARV access, such pathways should be useful for increasing access to all medicines, including those that treat and prevent SARS-CoV-2. In the absence of political leadership willing to tackle this problem, activists and public health advocates should be prepared to raise the issue of drug pricing and create political pressure on governments to act in the interest of public health.