Are Patent Waivers without the disclosure of Trade Secrets effective during Global Pandemics?

Introduction

Patents are important because they grant creators a legal monopoly on the use of their inventions for a set period (usually 20 years), allowing them to benefit financially from their creations. But patents don’t include “trade secrets”, i.e., know-how. So while the general public may have access to the product, they do not have access to the actual know-how (such as clinical trial data) required to produce it. Therefore, if you waive the patent over a drug but continue to protect the know-how required to produce it under trade secret law, then you only have access to the blueprint of the product without having the ability to manufacture it.

This was the main concern sought to be addressed when, on 24th May 2025, the World Health Organisation (WHO) voted on the WHO Pandemic Agreement, aiming to address inequalities arising from previous instances of “Vaccine Apartheid”. This became particularly clear during the COVID-19 pandemic when wealthier countries were able to acquire vaccines much faster than poorer countries. They wanted to ensure the world would be better prepared to address future pandemics and not be restricted by IP rights.

However, the real challenge with the agreement concerns its annexes. These annexes outline the conditions for technology transfers; as a result, they raise the question of whether wealthy nations will be legally required to disclose their trade secrets to developing countries. The success of the entire treaty depends on these annexes, which aim to ensure transparency regarding data sharing.

The Background: Why did the 2022 WTO “Compromise” fail?

To understand why the WHO treaty may not be effective, it is important to understand the historical background of the 2022 World Trade Organisation (WTO) Ministerial decision.

In October 2020, India and South Africa proposed a solution to the hoarding of medical supplies by wealthy nations: a total TRIPS waiver system suspending all intellectual property rights, including patents, copyrights, and trade secrets, for all COVID-19 vaccines, therapeutics, and diagnostics. Although this recommendation was a perfect solution to the health crisis, it led to an 18-month-long geopolitical standoff. As a result, the final compromise text was heavily reduced by the Western Nations and Big Pharma. The resulting WTO decision strictly limited the waiver to vaccine patents, leaving the underlying trade secrets entirely untouched.

This “compromise” reflected the existing realities based on an income divide rather than creating actual change. Legal scholars and experts have pointed out that this has set a dangerous precedent for global health equity for three major reasons:

• No Blueprint for Complex Biologics: A biologic medication is a drug derived from living organisms (such as human cells or animals) rather than synthesised from basic chemicals. Modern therapies like mRNA vaccines are biologics that comprise complex molecules and cannot be reverse-engineered solely from patent documents. Thus, a patent waiver is meaningless without the transfer of undisclosed information, such as cellular information, purification methods, etc.

• Compulsory Patent drawbacks: If countries that require the recreation of a drug rely on standard compulsory patent licensing, They can only gain access slowly, one product at a time, which is a fatally slow strategy during a rapidly moving global viral pandemic. Moreover, the compulsory licensing system was often difficult to use, particularly because they were subject to enormous pressure from pharmaceutical companies and even to sanctions from several Western countries.

• Pushback from Corporate Giants: Because the WTO decision excluded trade secrets, it allowed big corporations to retain their monopoly over products. Big Pharmaceutical companies like Pfizer went so far as to argue that their IP was a “human right” to prevent developing countries from issuing local generic licenses for life-saving therapeutics.

Thus, by excluding trade secrets from the “compromise”, the 2022 decision essentially placed corporate interests over human lives, and this is the exact failure leaders in the Global South sought to fix through the clashes over the WHO Pandemic Agreement.

The Dossier Secrecy

To understand why patent waivers fail, it is important to examine the information that is not disclosed alongside the drugs, which is crucial to modern biomanufacturing. When a pharmaceutical company develops a new vaccine, it submits a large regulatory dossier to agencies such as the FDA. This dossier contains thousands of pages of undisclosed information, including raw clinical trial protocols, toxicity data, and precise quality control metrics. Under the current legal framework, the regulators are barred from sharing this data. Thus, generic manufacturers from Global South nations cannot simply recreate the drug through a patent waiver but must undergo years of redundant, expensive clinical trials to prove that their version of the drug is safe.

While a patent usually expires in 20 years, a trade secret, on the other hand, can remain undisclosed forever, and this can serve to impede effective action, especially during a global health emergency, because modern medical technologies like mRNA platforms have molecular structures that are so complex that they cannot simply be obtained from reverse-engineering the patent blueprints. During pandemic crises, this lack of access to trade secrets is what served as the ultimate hurdle because competent facilities across the Global South who stood ready to manufacture the drugs were unable to do so, not because of patent litigation but rather because they lacked the necessary information behind the patent blueprint.

The WHO Pandemic Treaty

While the WHO Pandemic Agreement was officially adopted by the 78th World Health Assembly on May 20th, 2025, to address this issue, it will only enter into force 30 days after sixty nations have ratified it.

However, the real problems lie in dismantling the inequalities through legal mandates:

• Article 11 promotes non-exclusive licensing, transparency in agreement, reasonable royalties and technology transfer to manufacturers in low- and middle-income countries. However, a significant drawback is that such a transfer is based solely on “mutually agreed” terms, which risks preserving the status quo when the right holders decline to cooperate.

• Paragraph 4 of Article 11 (using existing TRIPS flexibilities) further provides a tool that allows a government to authorise local generic production of patented machines without the patent holder’s consent, in exchange for a modest royalty.

When such mechanisms are used, the results are revolutionary: In March 2012, India issued its first-ever compulsory license for a highly priced cancer drug, slashing the monthly cost from an impossible $5,500 to $170, a 97% reduction. However, despite the domestic legal victory being upheld by the Supreme Court of India in 2014, the geopolitical backlash was severe. Wealthy nations and pharmaceutical lobby groups mounted intense political pressure, creating a “chilling effect”. The consequences have been severe, and India has not issued a single pharmaceutical compulsory license since. This chilling effect paused global leadership during the COVID-19 pandemic, when no nation issued a compulsory license for the COVID-19 vaccine.

To overcome these issues, legal scholars have argued that the Pandemic Agreement should introduce two structural innovations:

• A Binding “Non-Challenge” Clause: This would be modelled after paragraph 7 of the 2022 WTO Ministerial Decision. This clause would legally shield LMICs from retaliatory trade disputes or claims arising from the invocation of public health waivers.

• The PABS System (Article 12): In exchange for global access to pathogen data, participating manufacturers must provide rapid, real-time access to at least 20% of their pandemic diagnostics, therapeutics and vaccines.

Conclusion

For more than two years, countries around the world worked together towards one historic and generational goal: to better prepare for future global health pandemics like COVID-19 and to ensure that IP protections for vaccines and related drugs do not impede the control of health crises. At a time when the world is overcome by politics, conflicts, and economic forces that have wrought destruction, discord, and division, several leaders found a way to work together to address such emergencies.

However, the conclusion of the 79th World Health Assembly exposed the deep, unresolved conflicts between self-interest and public survival. Despite a unified push from LMICs to introduce binding, mandatory technology transfer rules into the final PABS framework, intense lobbying by Western nations largely kept it bound to “voluntary cooperation.” Thus, if the global community wants an effective and equitable response to a future such crisis, international law must find a way to create a “knowledge commons” that balances corporate incentives with the highly incentivised sharing of trade secrets for life-saving drugs.

As the WHO Director General pointed out, “The Pandemic Agreement is a life-saving instrument, akin to a defibrillator for the world. This tool must be built and made available to benefit everyone, recognising that no one can be left behind. We all must agree on and know how to use it. And above all, it must work to protect and promote global health when it is needed, for our loved ones, young and old.”

Author: Samiksha Pai, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.