By Kevin E. Noonan —

While the details of the WTO patent waiver have not been determined (or more properly negotiated), it is important to consider the structure of the international trade regime in which the waiver will operate and the consequences of any agreement defining exactly what will be waived.

The GATT/TRIPS agreement is a treaty, which (of course) is an agreement between countries, and disputes and accommodations are between their governments.  The extent to which a private company's patent or other IP rights are protected under the terms of these agreements depends on actions of these governments in enforcing them on the company's behalf.  Thus, for protections like patents, a government can agree to "turn a blind eye" to infringement by companies in other countries (or other governments) by refusing to press the rightsholder's case before the WTO, to pressure the governments unilaterally (as in the Watch List and Special Watch List of the U.S. Trade Representative's Special 301 Report), or otherwise support a private company's private actions using an infringing country's legal system.  Such "passive" actions (i.e., refusing to enforce rights in violating or "scofflaw" countries) requires very little affirmative action by a government.  These are the types of de facto waivers that can be effective, for example, for patented drugs that can be produced by conventional drug production technology wherein description of an active pharmaceutical ingredient molecule.

The details of COVID vaccine production have been set out in various news sources (see Neuberg et al., "Exploring the Supply Chain of the Pfizer/BioNTech and Moderna COVID-19 Vaccines"; Weiss et al., "A COVID-19 Vaccine Life Cycle: From DNA to Doses," USA Today, Feb. 7, 2021; King, "Why Manufacturing Covid Vaccine to at Scale Is Hard," Chemistry World, Mar. 23, 2021; Cott et al., "How Pfizer Makes Its Covid-19 Vaccine," New York Times, April 28, 2021).  But these are certainly not disclosed in the detail necessary for commercial production, and the complexities of production are illustrated in graphics from the Times article, wherein the DNA is prepared in Chesterfield, MO and shipped to Andover, MA for mRNA production; then the mRNA shipped back to Chesterfield or Kalamazoo, MI for packaging into the vaccine nanoparticles; and then sent back to Andover for testing before release.  While some of this complexity may be company-specific, it also represents the different technological requirements for preparing an effective vaccine.  It is unlikely that most of the countries in favor of the waiver (except India and South Africa) have the technological infrastructure for producing the vaccine.  And the company in India, the Serum Institute ("the largest vaccine maker in the world"), having the greatest likelihood of being able to reproduce the vaccine if the waiver is put in place recently was forced to "hand over its vaccines to the [Indian] government," according to an article in the New York Times (Schmall et al., "India and Its Vaccine Maker Stumble over Their Pandemic Promises," May 9, 2021).

It is evident that, in the almost total absence of patents involved in COVID vaccine preparation, the disclosure needed to reproduce these vaccines (no matter how difficult that may be in practice) are protected by trade secrets.  If the WTO imposes this waiver, the question will be whether the U.S. will compel disclosure of trade secret owned by U.S. companies, or have disclosed them to the extent such secrets are part of regulatory filings.  Either action would constitute a "taking" under the Fifth Amendment ("Nor shall private property be taken for public use, without just compensation"); see Epstein et al., "The Fifth Amendment Takings Clause," Interactive Constitution: Common Interpretation.  Seemingly simple and straightforward, almost every word in the clause is open to interpretation, none perhaps as much as determining what "just compensation" entails.  It is likely that, should the government act peremptorily with regard to takings of trade secrets justified by any WTO waiver clause, the effect on trade secrets will carry the greatest consequences and be the cause of most controversy.  Indeed, the prospects arising therefrom are likely some of the biggest impediments towards effectuating any waiver in a manner that could have any chance of achieving the stated goal of facilitating COVID vaccine production.

This prospect also raises the issue of how any such waiver will be implemented in the U.S. Treaties are not necessarily "self-executing" and need to become enforceable through an Act of Congress.  The distinguishing feature of such treaties are that "provisions in international agreements that would require the United States to exercise authority that the Constitution assigns to Congress exclusively must be deemed non-self-executing, and implementing legislation is required to give such provisions domestic legal effect."  See Mulligan, "International Law and Agreements: Their Effect upon U.S. Law," Congressional Research Service 7-5700, Sep. 19, 2018.  The necessity for Congress to act, although not having the heavy weight that entails approving treaties (i.e., a two-thirds majority vote in the Senate) nonetheless could be expected to face significant opposition should it be interpreted to permit the government to exercise a form of "eminent domain" over pharmaceutical companies' trade secrets.  In this regard such an act could readily be characterized as "forced technology transfer" and even IP theft, should, for example, such trade secrets be capable of use to weaponize rather than immunize against viral infections.

The administration's public position raises the likelihood of an infringement on private property unprecedented in the U.S.  It also has implications for other aspects of foreign policy; for example, at least some of the trade secrets belong to BioNTech, a German company.  Germany has not agreed to the waiver, and should the U.S disclose BioNTech's trade secrets, no doubt Germany would have cause to seek redress against America.  This is but one of the possible legal consequences that the recent capitulation to the purported global "kumbaya" of the WTO waiver is likely to create.

More complications will likely arise as the negotiations proceed.  Provided the Administration is properly advised and the waiver properly limited (e.g., to patents) these and other deleterious consequences may be avoided.  In view of the possibility of serious liability arising by improvident acquiescence to generally uninformed calls for a broad waiver, it might not be a bad idea for all those involved in innovation (universities, technology transfer offices, pharmaceutical companies, patent lawyers, and economists) counter these opinions with the facts and make their viewpoints known and voices heard.

By Kevin E. Noonan —

Everybody knows that the dice are loaded
Everybody rolls with their fingers crossed
Everybody knows the war is over
Everybody knows the good guys lost
Everybody knows the fight was fixed
The poor stay poor, the rich get rich
That's how it goes
Everybody knows

Everybody knows that the boat is leaking
Everybody knows that the captain lied
Everybody got this broken feeling
Like their father or their dog just died
Everybody talking to their pockets
Everybody wants a box of chocolates
And a long-stem rose
Everybody knows

"Everybody Knows," Leonard Cohen

And everybody knows that suspending patent rights is necessary to provide sufficient vaccine to stem the global pandemic caused by the SARS-CoV-2 virus known as COVID-19.  It is always a sign of intellectual weakness and pack animal thinking to believe something is true because "everybody knows"; recently American pathologists reaped the consequences of their "everybody knows" campaign against "gene patenting" in AMP v. Myriad Genetics (see "Schadenfreude Is Not Always An Unpleasant Feeling"), although evidence of this eventuality was available earlier (see "The ACLU, Working for the Man").  Sadly, the true roots of the issues arising over global vaccination have been known for almost a year (see "Latest COVID Conundrum: Accessibility of Vaccines (When They Are Available)"), and the wrong-headedness of proposals for a "patent waiver" have also been recognized (see "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)").  And yet, of course, the Biden Administration, speaking though the U.S. Trade Representative Katherine Tai, issued a press release yesterday supporting the waiver (see "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines").

There is no silver lining and no Pollyanna or Professor Pangloss available to contend that this is good policy, but it may be informative to consider the possible outcomes that could arise depending on how any such waiver or suspension is effectuated.

To the extent that the suspension or waiver of rights is limited to patents, the effects could amount to no more than virtue signaling, a political exercise meant to illustrate differences between the prior administration and this one, or to placate voices like Senator Bernie Sanders who maintain that pharmaceutical companies are rapacious predators who place profits over people (with a fervor and rhetoric the prior administration and its supporters reserved for liberals and the well-educated).

But as annoying as this might be, there is a greater danger in other forms of implementation.  The terms of the press release do not say that there should be a waiver of patent protection (which was the original impetus and justification for the waiver as proposed by India and South Africa last October when it was proposed; see "Communication IP/C/W/669, "WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19, 2 October 2020").  The plain language of the press release, and the focus of the waiver that has evolved, is to include all intellectual property.  This would include trade secrets, and that raises a serious issue.  As explicated by Derek Lowe in his article "Myths of Vaccine Manufacturing," the rate-limiting step for COVID vaccine production (at least for the mRNA-based vaccines) involves proprietary machines and methods for making the vaccine that are, more than likely, not covered by patents and never will be.  The technological circumstances surrounding vaccine production involve trade secrets regarding formulation of vaccines that are what can be the bottleneck in the process.  But trade secrets are the type of property the rights to which cannot be suspended; disclosure destroys the secret and thus the property.  It is unlikely that companies will voluntarily give up their valuable trade secrets, and while there might perhaps be some stomach for forcing them to in some jurisdictions, it is unlikely that the U.S. will be one of them.

But this "moveable feast" of policy rationales illustrates the political fact that the aim and goal of this and other proposals by India, South Africa, and other countries is to escape the TRIPS requirement for recognizing and enforcing IP protections, imposed as part of the requirements for WTO membership.  When these facts are considered, the call by these governments (and others) should be understood for what it is:  an attempt to use the pandemic to achieve a goal of status quo ante (prior to the establishment of the GATT/TRIPS/WTO global trade and patent regime), which was imposed upon these and other countries a generation ago.  The COVID pandemic provides the humanitarian reason for a solution that isn't a solution but that resonates with uninformed (albeit generally well-meaning) politicians, humanitarians, and religious and non-governmental organizations.

It is undeniable that there are significant issues regarding availability of drugs in low- and middle-income countries that need to be addressed.  But there are ways to achieve the lofty goals that are at the root of calls for an IP waiver.  This includes cooperation between pharmaceutical companies, as Merck as done with Johnson & Johnson, that can increase the number of doses of the vaccine necessary for global vaccination.  Groups like Gavi, the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), can be involved in a concerted effort obtain vaccine supplies for the rest of the world.  Western governments with "excess" vaccine reserves can use the auspices of these groups to send doses to low- and middle-income countries and economies (LMICS) and even some "wealthier" countries having the economic capacity to defray some or all of the costs.  Indeed, the Biden Administration announced it would make available "excess" vaccine doses to countries in need (amounting to 60 million doses).

The motivations for such efforts need not rely exclusively on altruism, either; as has become evident recently the virus has the capacity to mutate in ways that variants of unknown resistance to current vaccines can arise.  Vaccines, particularly the mRNA-base vaccines, may not be effective against these variants (see "Do mRNA-based COVID Vaccines Have an Achilles Heel?").  Thus, it is in everyone's interest to extend vaccination globally (regardless of how daunting that challenge may be) to reduce the probability of such variants arising.

The efforts being applied globally to develop vaccines, treatments, and better tests and technology in response to COVID-19 have been impressive.  We can hope that, ultimately, these efforts will prove to be successful.  Intellectual property protection has an important role to play in these efforts.  Past experience and recent developments suggest that protecting IP for vaccines, therapies, and technologies to fight COVID-19 will have a positive impact, and advance the cause of eradicating, or at least treating, and preventing this disease.  Support for the proposed IP waiver is a foolish and tragic mistake.

By Donald Zuhn —

Yesterday, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines" (see "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines").  The waiver was proposed last fall by India and South Africa, which asked the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) to recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO.  In March, the Biotechnology Innovation Organization (BIO), a group of fifteen industry and trade organizations (including BIO), and a group of intellectual property organizations (including the IPO), sent letters to the Biden Administration, members of Congress, and officials at the Patent and Copyright Offices asking the recipients to oppose the waiver proposal.

In response to Ambassador Kai's statement on Wednesday, BIO and IPO released their own statements.  BIO's statement, which was issued by BIO's president and CEO, Dr. Michelle McMurry-Heath, noted that the organization was "extremely disappointed that the Administration has chosen to support waiving critical protections for American ingenuity and to delay the equitable delivery of needed COVID vaccines to people around the globe."  Dr. McMurry-Heath explained that:

Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.  Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants.  The better alternative would have been to follow through on the President's pledge just last week to make the United States the world's "arsenal of vaccines".  This policy leads in the opposite direction.

BIO pointed to the COVID Global Strategy for Harnessing Access Reaching Everyone (SHARE) Program as a better alternative to "ensure sufficient global supply of vaccines, ensure safe and expeditious global access to vaccines and therapeutics, and bolster ongoing efforts to strengthen and support healthcare systems in low-and middle-income countries in addressing COVID."  BIO also contended that the Administration's "decision will disadvantage patients by undermining existing incentives to develop vaccines and therapeutics for future pandemics."  BIO concluded by stating that:

The United States has unfortunately chosen to set a dangerous precedent with these actions.  But how we negotiate with the WTO moving forward will be critical in mitigating this myopic decision and its effects on patients around the world.

IPO Executive Director Jessica Landacre stated that the organization was "extremely disappointed by the U.S. government's statement yesterday that it will support 'waiving intellectual property protections for COVID-19 vaccines.'"  She noted that the IPO "supports equitable, widespread, and successful distribution of vaccines to meet the challenges of COVID-19, but waiving IP rights would not further this goal," adding that "should a waiver of IP rights be implemented, it would have an immediate chilling effect on the research and collaborations that are needed to continue to combat COVID-19 and that will be needed to tackle any future crisis."  The IPO believes that the Administration's decision "sets a dangerous precedent," and contends that the "misinformed approach" will "not solve the problem it seeks to address."

The Biden Administration's decision to support a waiver of IP protections for COVID-19 vaccines, and the response to that decision, raises the question of how the ongoing humanitarian crisis in India can be most quickly addressed.  In a May 1 article in MIT Technology Review, Krishna Udayakumar and Andrea Taylor of the Duke Global Health Innovation Center write that "immediate and aggressive measures are needed to stabilize the situation and buy time for vaccine production to ramp up" (see "What India Needs to Get Through Its Covid Crisis").  They note that the crisis "will require coordinated global action."  In particular, India requires medical oxygen, medications, hospital beds, ventilators, personal protective equipment, COVID testing supplies, and more health workers "to augment India's own, who are currently working under immense pressure."  While the authors note that the first aid shipments from the UK and the U.S. arrived on April 27 and 30, respectively, they indicate that "[e]ven this global aid response will not avert a historic tragedy."  The authors conclude the article by stating that:

The heartbreaking tragedy in India will unfortunately continue for many weeks.  But by mobilizing global resources more quickly, adopting public health measures that will keep the virus in check, and ramping up vaccine manufacturing, India and the global community can at least offer some hope of better days ahead.

For additional information regarding this topic, please see:

• "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
• "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
• "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
• "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

By Donald Zuhn —

In a statement issued earlier today, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."

As we reported earlier this year, India and South Africa proposed last fall that the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO.  The two countries also recommended that "[t]he waiver should continue until widespread vaccination is in place globally."

In March and April, the Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA), a group of fifteen industry and trade organizations (including BIO and PhRMA), four intellectual property organizations, and Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property, sent separate letters to the Biden Administration, members of Congress, and officials at the Patent and Copyright Offices, asking the recipients to oppose the waiver proposal.

Ambassador Kai's statement regarding the waiver proposal was concise:

This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.  The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.  We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.  Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.

The Administration's aim is to get as many safe and effective vaccines to as many people as fast as possible.  As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts — working with the private sector and all possible partners — to expand vaccine manufacturing and distribution.  It will also work to increase the raw materials needed to produce those vaccines.

Several media outlets reported on the Ambassador's statement this afternoon before it became publicly available on the Office of the United States Trade Representative website.  The New York Times reported that the WTO had held further discussions about waiving intellectual property protections earlier in the day, and that more discussions were expected in the coming weeks, as India and South Africa were preparing a revised waiver proposal (see "The Biden administration says it will support lifting patent protections to help produce more vaccines globally").  CNN reported that prior to the Ambassador's statement, "[t]here had been divisions within the administration over whether to ease some patent restrictions on vaccines, according to people familiar with the matter" (see "US supports vaccine patent waiver proposal at World Trade Organization").

Responding to the Ambassador's announcement, the U.S. Chamber of Commerce released the following statement from Executive Vice President and Chief Policy Officer Neil Bradley:

The administration has gotten this issue wrong; undermining intellectual property rights for complex, hard to manufacture vaccines will not accelerate global production, instead it will take us off track in the ongoing and successful efforts to license and scale global production of vaccines that individuals can be confident are safe and effective.  Make no mistake, this move will undermine the global fight against COVID and it will diminish our ability to prepare for and respond to the next pandemic.  We urge the administration to reverse course and work with the business community to deliver on the President's recent promise to make America the 'arsenal of vaccines.'

For additional information regarding this topic, please see:

• "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
• "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
• "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021