This is Part II of a two-part article examining the changes that we need in our domestic and international trade secret disclosure and use practices TODAY to assure that effective treatments and vaccines to combat the deadly COVID-19 pandemic are available as a practical matter to all patients who need them. In Part I, I discussed the changes that I believe we need to make to current patent disclosure obligations to shore up what promises to be an ineffective and socially unjust supply chain for COVID-19 vaccines and treatments.
As an even deadlier second wave of the COVID-19 virus sweeps the globe, the search for effective treatments, including vaccines, has grown more pressing. Recent news that several promising clinical trials have been suspended has only added to the urgency. But such discoveries will prove of little value if they are not readily and widely available to everyone who needs them.
When President Trump recently tested positive for the Coronavirus, he received a cocktail of antibiotic and other treatments that commentators admitted would not be available to many other people. That result is wholly unacceptable. Because such unavailability is not due to a lack of physical supplies. It is the terrible result of our current system that forces health care professionals to make choices among deathly ill patients in allocating scarce life-saving equipment, including ventilators and beds in intensive care units. We need to take every step possible to reduce the need for such choices. Producers of the next wave of treatments, including vaccines, must have the necessary information to ensure a rapid turn-around in production and delivery. In short, we need a system for mandatory access by authorized drug producers to confidential and trade secret vaccine production and delivery information.
Information Access Matters
There is no doubt that in the case of pharmaceutical patents, associated trade secrets represent critical knowledge about their practical application. This includes knowledge concerning best formulations, most effective dosages, and best production and delivery processes and techniques, including the identity and use of relevant cell lines. When Gilead Sciences announced its voluntary license program for third party production of Remdesivir, it included “a technology transfer of the Gilead manufacturing process to enable them to scale up production more quickly.” We need to ensure that this information “transfer” is available for all authorized producers of COVID-19 treatments, including those operating under government-imposed compulsory licenses.
We already know that production of sufficient vaccines to meet the global demand will be a herculean undertaking, requiring truly global production and distribution. No single company, no matter how large, will be able to produce the physical amount of vaccine required to combat this deadly disease. Many countries already have in place emergency legislation allowing for compulsory licenses and/or grey market imports of sufficient doses of COVID-19 related drugs to meet domestic demand. As I indicated in Part I of this article, the efficacy of those efforts will be severely undercut, if not wholly destroyed, without access to the necessary “technology” to produce those drugs. Voluntary efforts by individual companies like Gilead Science or international organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), COVAX, Medicines Patent Pool (MPP) and COVID 19 Technology Access Pool (C-TAP) are helpful in assuring access to such needed information. But, like all voluntary efforts, they are only as helpful as the interests of the individual participants allow. Mandatory disclosure of trade secret information necessary to ensure the rapid and effective dissemination of approved vaccines and treatments must be available when voluntary efforts falter.
Mandatory “Critical Information” Sharing
TRIPS does not expressly authorize limited mandatory disclosure for trade secrets. Articles 30, 31 and 31bis for patents and Article 13 for copyrights expressly recognize that in certain situations, compulsory licenses and/or “fair uses” for the intellectual property right at issue are permitted. The closest recognition of any such right for trade secrets is the right to disclose “undisclosed test or other data” granted Member countries in Article 39(3) “where necessary to protect the public.” This permissive mandatory disclosure is limited to certain clinical test and “other data” submitted to governmental authorities to secure marketing approval for pharmaceutical products “utilizing new chemical entities.”
The permissive disclosure language in Article 39(3) admittedly does not cover all of the data that may be necessary to ensure rapid production turn arounds for COVID-19 vaccines. Not all countries require submission of detailed data regarding manufacturing processes to secure marketing approval. Even more problematic, Article 39(3) only addresses data regarding drugs utilizing “new chemical entities.” Biologics, which may be a valuable source of treatment against COVID-19, are not covered.
Nevertheless, the public necessity disclosure language of Article 39(3), like the Doha Declaration on TRIPS and Public Health, provide support for a limited mandatory disclosure of relevant production-and-delivery trade secrets. In addition to recognizing that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all,” the Doha Declaration expressly recognized that Member countries have “the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.” This right is not limited to compulsory licenses for patents.
Crafting a Balanced System
Like other TRIPS flexibilities, mandatory disclosure-and-use of trade secret data, including clinical test data, should be carefully crafted and narrowly circumscribed. In countries where manufacturing data is required for the approval of new drugs, such data is generally not disclosed to the general public. For example, in the United States, the Food and Drug Administration requires disclosure of manufacturing and production data in new drug applications, including abbreviated new drug applications. That data, however, is generally prohibited from disclosure to the public under 21 CFR 314.430(g)(1). This prohibition against the disclosure of “business confidential” information submitted to the Government was recently strengthened by the U.S. Supreme Court. In Food Marketing Institute v. Argus Leader Media the Court held that “where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is ‘confidential’ within the meaning of Exemption 4 [of the FOIA Act]” and therefore not disclosable to the public. This severely limited public access to all trade secret data submitted by private companies to the U.S. Government. Such limitations indicate that efforts to mandate disclosure of submitted production data would be strongly opposed. But the pandemic is an extraordinary event that requires extraordinary measures.
Article 39(3) provides useful guidance for developing the scope of an appropriately circumscribed mandatory disclosure obligation. Such disclosures must be “necessary to protect the public in response to a public health emergency,” in this case the COVID-19 pandemic. They must also be limited to prevent their “unfair commercial use” in accordance with Article 39(3) requirements. Consequently, mandatory disclosure and use of trade secret data regarding manufacturing processes should be limited to critical data required to promote more rapid and effective distribution and delivery of COVID-19 related treatments and vaccines. Not every trade secret owned by a pharmaceutical company is related to the production or delivery of COVID-related treatments.
The access and use of such disclosures should also be limited to entities that are capable of rapidly gearing up to produce the treatments at issue, at least to fill the needs of the domestic market. Furthermore, those authorized entities should only be allowed to use the disclosed data for the production of the drug at issue. If entities want to access this data for purposes of further innovation, they should be required to secure access through other lawful means, by a license from the trade secret owner, for example. The limited nature of the grant should facilitate quicker adoption of these disclosure mandates at the national level. Adoption as an international standard will undeniably take longer. It should also help maintain the balance between patent rights and the public interest by assuring these mandatory procedures do not have the opposite effect of suppressing innovation.
Protecting the Innovation-Production Balance
Compulsory licenses should be limited-use licenses, granted for the sole purpose of securing production and distribution of the vaccine. Any discoveries of potential improvements to the licensed information should be subject to automatic mandatory disclosure to the trade secret owner and all other authorized producers. The license should last only so long as the present crisis. It should mandate non-disclosure to unauthorized third parties and require licensees to take all necessary steps necessary to prevent it.
Adequate compensation for use of the trade secrets should be required to help ensure that private companies are willing to undertake the time, money and effort required to innovate in the pharmaceutical field while maintaining the public interest in reasonably available access to support rapid and efficient distribution efforts. The best place to locate relevant factors for establishing adequate compensation for the disclosure of trade secrets is the 1990 Brussels Draft of the TRIPS Agreement.
The Brussels Draft set out an early version of what evolved into TRIPS Article 39l. It proposed a term of protection for data exclusivities of “generally no less than five years, commensurate with the efforts involved in the origination of the data, their nature, and the expenditure involved in their preparation.” This focus on “expenditures involved in the preparation” of the data properly includes consideration of the recoupment of research costs in creating the licensed trade secrets. Given the compulsory nature of the license, however, such costs should not include those provided by the Government or any charitable institutions, absent a binding repayment obligation. I also believe these costs should be excluded from any ROI factors that might be included in determining an adequate licensing fee.
Whatever royalty amount is established, it should not impede the production and distribution of life-saving vaccines and treatments. There is no doubt that these drugs are truly lifesaving. Contrary those who disagree, the value of a human life for such purposes is incalculable. The price for the drugs that save us from COVID-19 should not be.
Creating an Ethical Framework for Delivery
I realize that the creation of a mandatory disclosure-and-limited-use system for critical trade secret information related to COVID-19 treatments and vaccines will not solve all supply chain problems impeding their effective and rapid roll-out on a global basis. In addition to sufficient physical versions of the vaccine, we will also need access to supplemental materials, including syringes, needles and other equipment required to deliver the vaccine to patients.
I also realize that the creation of a mandatory disclosure and licensing system today will not eliminate all future delays and shortages. Physics alone would prevent everyone who needs the vaccine from receiving it on the first day of delivery. But in addition to the mandatory disclosure system described in this article, an ethical framework for rolling out vaccine delivery that does not repeat the failings of the global health care system to deal with the initial outbreak is critical.
There is undeniable evidence of the uneven morbidity rate in the U.S. among various populations. Those morbidity rates underscore the continuing role that non-health related factors play in determining treatment availability. We cannot allow discriminatory factors of social inequality based on race, class, ethnic or socioeconomic status to determine the timing of vaccine availability. We cannot pretend we cannot identify which communities will be at risk of delayed delivery. We already know from tragic experience who they are. TRIPS Article 9 recognizes: “The protection and enforcement of intellectual property rights should contribute to … the transfer and dissemination of technology… in a manner conducive to social and economic welfare.” But beyond the rights enshrined in international treaties, humanity itself demands it. As we work to overcome distributional inequalities in the health care delivery system, we must not exacerbate supply chain problems by failing to ensure that we have taken every step we can to improve the physical supply of medicines to be delivered.
In this extraordinary time, we need to take previously unimagined measures to combat the deadly COVID-19 virus. Those measures must include access to proprietary production information to prevent the supply chain of life from breaking any further.