TRIPS IP Waiver Could Establish Dangerous Precedent for Climate Change and Other Biotech Sectors

By Melissa Brand
May 26, 2021

“If an IP waiver is purportedly necessary to solve the COVID-19 global health crisis, can we really feel confident that this or some future Administration will not apply the same logic to the climate crisis? And, without the confidence in the underlying IP for such solutions, what does this mean for U.S. innovation and economic growth?”

https://depositphotos.com/44432073/stock-illustration-climate-change-and-global-warming.htmlWhile the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.

The biotech industry is making remarkable advances towards climate change solutions, and it is precisely for this reason that it can expect to be in the crosshairs of potential IP waiver discussions. President Biden is correct to refer to climate change as an existential crisis. Yet it does not take too much effort to connect the dots between President Biden’s focus on climate change and his Administration’s recent commitment to waive global IP rights for Covid vaccines (TRIPS IP Waiver). “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.” If an IP waiver is purportedly necessary to solve the COVID-19 global health crisis (and of course we dispute this notion), can we really feel confident that this or some future Administration will not apply the same logic to the climate crisis? And, without the confidence in the underlying IP for such solutions, what does this mean for U.S. innovation and economic growth? United States Trade Representative (USTR) Katherine Tai was subject to questioning along this very line during a recent Senate Finance Committee hearing. And while Ambassador Tai did not affirmatively state that an IP waiver would be in the future for climate change technology, she surely did not assuage the concerns of interested parties.

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International Pressure May Be Influencing Domestic IP Policy

The United States has historically supported robust IP protection. This support is one reason the United States is the center of biotechnology innovation and leading the fight against COVID-19. However, a brief review of the domestic legislation arguably most relevant to this discussion shows just how far the international campaign against IP rights has eroded our normative position. The Clean Air Act, for example, contains a provision allowing for the mandatory licensing of patents covering certain devices for reducing air pollution. Importantly, however, the patent owner is accorded due process and the statute lays out a detailed process regulating the manner in which any such license can be issued, including findings of necessity and that no reasonable alternative method to accomplish the legislated goal exists. Also of critical importance is that the statute requires compensation to the patent holder. Similarly, the Atomic Energy Act contemplates mandatory licensing of patents covering inventions of primary importance in producing or utilizing atomic energy. This statute, too, requires due process, findings of importance to the statutory goals and compensation to the rights holder.

A TRIPS IP waiver would operate outside of these types of frameworks. There would be no due process, no particularized findings, no compensation and no recourse. Indeed, the fact that the World Trade Organization (WTO) already has a process under the TRIPS agreement to address public health crises, including the compulsory licensing provisions, with necessary guardrails and compensation, makes quite clear that the waiver would operate as a free for all.

Forced Tech Transfer Could Be on The Table

When being questioned about the scope of a potential TRIPS IP waiver, Ambassador Tai invoked the proverb “Give a man a fish and you feed him for a day. Teach a man to fish and you feed him for a lifetime.” While this answer suggests primarily that, in times of famine, the Administration would rather give away other people’s fishing rods than share its own plentiful supply of fish (here: actual COVID-19 vaccine stocks), it is apparent that in Ambassador Tai’s view waiving patent rights alone would not help lower- and middle-income countries produce their own vaccines. Rather, they would need to be taught how to make the vaccines and given the biotech industry’s manufacturing know-how, sensitive cell lines, and proprietary cell culture media in order to do so.

In other words, Ambassador Tai acknowledged that the scope of the current TRIPS IP waiver discussions includes the concept of forced tech transfer. In the context of climate change, the idea would be that companies who develop successful methods for producing new seed technologies and sustainable biomass, reducing greenhouse gases in manufacturing and transportation, capturing and sequestering carbon in soil and products, and more, would be required to turn over their proprietary know-how to global competitors.

While it is unclear how this concept would work in practice and under the constitutions of certain countries, the suggestion alone could be devastating to voluntary international collaborations. Even if one could assume that the United States could not implement forced tech transfer on its own soil, what about the governments of our international development partners? It is not hard to understand that a U.S.-based company developing climate change technologies would be unenthusiastic about partnering with a company abroad knowing that the foreign country’s government is on track – with the assent of the U.S. government – to change its laws and seize proprietary materials and know-how that had been voluntarily transferred to the local company.

Necessary Investment Could Diminish

Developing climate change solutions is not an easy endeavor and bad policy positions threaten the likelihood that they will materialize. These products have long lead times from research and development to market introduction, owing not only to a high rate of failure but also rigorous regulatory oversight. Significant investment is required to sustain and drive these challenging and long-enduring endeavors. For example, synthetic biology companies critical to this area of innovation raised over $1 billion in investment in the second quarter of 2019 alone. If investors cannot be confident that IP will be in place to protect important climate change technologies after their long road from bench to market, it is unlikely they will continue to invest at the current and required levels.

Next on the Chopping Block

It is quite reasonable to be worried about the broad implications of a TRIPS IP waiver precedent. International campaigns to weaken IP rights seem to be taking hold in U.S. domestic policy. The TRIPS IP waiver discussions will not conclude in the near term and will not yield more shots in people’s arms. This is not even truly disputed, as our own administration acknowledges that the goal here is technology transfer abroad. Given the signaling that our Administration believes waiving IP rights is an appropriate measure to end global crises, it is proper to worry that facets of the biotech sector addressing climate change may be next on the chopping block.

Image Source: Deposit Photos
Vector ID:44432073
Copyright:Juric.P 

The Author

Melissa Brand

Melissa Brand is Assistant General Counsel and Director of Intellectual Property at the Biotechnology Innovation Organization (BIO), a major trade association with over 1,000 members in the biotechnology industry. In her role at BIO, Ms. Brand advocates on domestic and international intellectual property matters, with a particular emphasis on patent law and policy. Prior to joining BIO, Ms. Brand worked as a patent litigator at Latham & Watkins and Wilson Sonsini Goodrich & Rosati. Ms. Brand also served as a law clerk to the Honorable Kimberly A. Moore at the United States Court of Appeals for the Federal Circuit. She graduated magna cum laude from the University of San Diego School of Law where she was a member of the Order of the Coif and served as a Comments Editor for the San Diego Law Review. She graduated cum laude with a degree in Biomedical Engineering from Vanderbilt University.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 3 Comments comments. Join the discussion.

  1. Anon May 26, 2021 3:04 pm

    Hmmm,

    ALL of this seems familiar.

    I wonder why?

    😉

  2. xtian May 27, 2021 11:18 am

    Hey Anon – when did we say this was forced tech transfer? Oh yeah, on day one!! It isn’t polite to brag, but I think the phrase to those naysayers is “we told you so!”

  3. B May 27, 2021 12:56 pm

    Good article, and a good “we told you so” by Anon et al.

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