OR WAIT 15 SECS
Kevin E. Noonan, PhD, is a partner at McDonnell Boehnen Hulbert & Berghoff LLP.
Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
The current COVID-19 pandemic is the most serious worldwide infectious event since the influenza pandemic of 1918. So far, the number of infections and deaths has not reached levels seen during the “Spanish flu” pandemic. However, modern travel and global trade (and new factors such as social media, whether for good or ill) have increased risks, and awareness of those risks, throughout the world.
The economic and social consequences of the COVID-19 pandemic are also much more serious today than they were a century ago. Although some naysayers might disagree, the economy is global, and disruptions in one country or one part of the world tend to affect some or all others. Equally, the pandemic has created a need for research into better ways of detecting infections, preventing them by vaccines, and treating them more effectively. The adage that “an ounce of prevention is worth a pound of cure” applies critically to the COVID-19 pandemic.
Throughout most of the world, and particularly in the United States, patents provide incentives for the development of medicines, including vaccines, and protect the developers’ investments of time and resources. The severity of the COVID pandemic, and the concomitant need for both treatments and vaccines, has increased the need for the US patent system to respond to the disruptions created by the pandemic.
Some have voiced concerns that intellectual property (IP) protection for COVID-19 vaccines and therapies would inhibit their development or availability. Advocates for IP protection for COVID-19 vaccines and therapies counter that IP protection will be vital to the development of innovative treatments, tests and vaccines. They also point out that the federal government is empowered to prevent any inhibition of vaccine and treatment availability.
This article will examine actions taken by the US Patent and Trademark Office (USPTO) to facilitate patent procurement for IP related to COVID-19, and focus on the pros, cons, and considerations of IP protection for treatments, vaccines, tests and other technology. As with any subject of significant public interest and concern, opinions may differ, but public spiritedness should prevail, as it has so far in the face of the dangers posed by the SARS-CoV-2 virus.
Throughout spring 2020, the USPTO announced a number of programs and revisions to existing rules to reduce the negative effects of the SARS-CoV-2 virus on the US population.
In mid-March, the Office issued an announcement that the pandemic qualified as an “extraordinary situation” under PTO Rules in Parts 1 and 2 of Title 37 of the Code of Federal Regulations; Patents, Trademarks, and Copyrights (37 CFR 1.183 and 37 CFR 2.146) (1) and that the Office would waive petition fees related to delays in an applicant’s or party’s timely response that resulted in abandonment or termination of a proceeding, provided that the applicant could attest that the delay was caused by COVID. These waivers were permitted with regard to USPTO rules but did not extend to legal timeline requirements.
Two weeks later, after President Trump declared a national emergency caused by COVID-19, the Office extended deadlines for submissions that would require the payment of certain fees, moving them from March 27 to April 30, under provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. These extensions also applied to deadlines in the Patent Trial and Appeal Board (PTAB) as well as in the Examination Division. Shortly thereafter, the Office suspended requirements for an original signature in certain types of correspondence to the USPTO.
On April 28, 2020, the Office extended deadlines until May 31, 2020 or June 1, 2020 (depending on the deadline). On May 27, 2020, it extended them again, this time until July 1, 2020 for small and micro-entities only, a category that includes individual inventors, universities, and small businesses with fewer than 50 employees.Finally, on June 29, 2020, the Office pushed deadlines back yet again, giving small and micro-entities until September 30, 2020 to comply.
In May, the USPTO also launched a Prioritized Examination Pilot Program that would permit an applicant who qualified for small (or micro) entity status to apply for existing “fast track” examination programs (which reach a patentability determination within six months) without paying the increased fees usually required for such filings for COVID-related applications.
The potential for intellectual property issues or disputes to inhibit development or distribution of COVID-19 vaccines or treatment have been voiced in some quarters.A number of critics believe that IP issues or disputes would inhibit development or distribution of COVID vaccines or treatments (2). Some have called for individuals or organizations that develop COVID-19 treatments, tests, vaccines, or technology to voluntarily (or under duress) refrain from asserting IP rights. For example, in spring 2020, several universities and companies in the high-tech sector proposed the “Open COVID Pledge,” to “make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.”
So far, this pledge and other efforts to prevent IP protection for COVID technology have failed to gain traction. In fact, Pfizer CEO Albert Bourla called the pledge and similar proposals “nonsense” and “dangerous,” tantamount to saying ‘If you have a discovery, we are going to take your [intellectual property].’ (3)
Bouria’s response has been echoed widely by pharmaceutical industry executives, government leaders, and politicians who understand the cost and challenge entailed by drug development. As Jon Soderstrom, managing director of Yale University’s Office of Cooperative Research noted, “The system is working. Dozens of companies and universities are now investigating COVID-19 vaccines, and many more are researching treatments. If we strip away intellectual property rights, the system will break down, and we’ll find ourselves farther from ending our global health crisis…” (4).
Experts questioned the idea that IP would pose a barrier to vaccine development.In fact, Francis Gurry, former director general of the World Intellectual Property Organization(WIPO) noted that the main barriers to a vaccine were scientific and technical, that no vaccine has been identified, and that there was no evidence that IP protection was a barrier to vaccine development (5).
In fact, those in favor of IP protection for COVID-19 vaccines, treatments, tests and technologies argue that IP protection laws should be strengthened to provide incentives for innovation and investment in products such as vaccines which are, by definition, unpredictable, risky, and expensive to develop. Jan Fischer, former Prime Minister of the Czech Republic stated that, if a COVID-19 vaccine is produced, “robust IP laws” should be given some credit (6). Leaders from the International Chamber of Commerce (ICC) also voiced support for strong IP protection, which, they noted, already protects the public from counterfeit and adulterated drugs and from stockpiling medicines in developing countries (7).
Fueling concerns about vulnerabilities for IP protection for COVID-19 technology is the fact that the federal government is empowered to either “march-in” to license any patents or intellectual property by universities under the Bayh-Dole Act (8), or to invoke compulsory licensing provisions enacted during the Second World War (9).
There is a some recent precedent for these worries. The government took the latter course shortly after the September 11, 2001 attacks, when it was feared that weaponized anthrax had been sent members of Congress. Once it received signals that Bayer might not be able or willing to provide adequate supplies of the anthrax treatment, ciproflaxin (10), the government threatened the company with just this type of intervention.
In a move that may have been intended to forestall government intervention by march-in rights or otherwise, several universities—including Stanford, Harvard, and Massachusetts Institute of Technology, and 14 other research institutions—introduced the COVID-19 Technology Development Framework, which permits “nonexclusive, royalty-free licensing of intellectual property rights for available COVID-19 related technologies during the pandemic and for a short time after it ends” (11).
The group’s concerns may have been premature, but legitimate concerns remain. Attorneys General from more than 30 states (Alaska, Arizona, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, Virginia, and Washington, as well as the District of Columbia and Guam) have petitioned the federal government to exercise its Bayh-Dole “march-in” rights to permit third party manufacturers to make Gilead Sciences’ COVID therapeutic drug, remdesivir (approved by FDA on Oct. 22, 2020 ), arguing that the cost is too high and supplies inadequate.
Spearheaded by California Attorney General XavIer Becerra and Louisiana Attorney General Jeff Landry, the letter,sent to Health and Human Services Secretary Alex M. Azar, National Institutes of Health Director Francis S. Collins, and FDA Commissioner Stephen Hahn, cites news sources to support its claims of high prices and short supplies of the therapy (13).
As an alternative to federal exercise of march-in rights, the letter proposes that the government delegate this authority to the states (while not providing any statutory authority for this move). Its allegations of exorbitant pricing were based on news reports about an academic economic study (14) and supported by allegations regarding government funding (again, limited to news reports [15,16]).
In response to this letter, Gilead maintained that supplies of remdesivir are adequate, and that the company is investing more than $1 billion to increase manufacturing capacity for the treatment. The company also argued that following the attorneys generals’ proposals would have no impact on either supplies or prices, since it would take six to 12 months for generic competitors to produce more doses than Gilead is proposing to be able to market.(17)
Nothing has come of the attorneys generals’ proposals so far, and indications are that nothing is likely to come of it. At this point, several companies are actively developing vaccines (including Moderna, Pfizer, and BioNTech) or treatments (Regeneron). Vaccine costs of $20 to $40 per dose have been proposed, at least during the pandemic.
In addition to the successful development of a safe vaccine, much bigger barriers to widespread (if not universal) vaccination are the manufacturing, distribution, financing, and infrastructure required to support these efforts. While it seems the world has been consumed by this virus forever, the pandemic has been raging for only nine months in the US so far, and for less than a year globally.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 a 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.
1. CFR 37, Parts 1 and 2 (Government Printing Office, Washington, DC), pp.93, 323.
2. C. Koons, “The Vaccine Scramble is Also a Scramble for Patents: Intellectual property disputes throughout the drug supply chain could hold back a Covid-19 shot,” Bloomberg Business Week, August 12, 2020.
3. E. Silverman, “Pharma Leaders Shoot Down WHO Voluntary Pool for Patent Rights on Covid-19 Products,” statnews.com, May 28, 2020.
4. J. Soderstrom, “Intellectual property makes sure drug makers deliver,” Hartford Courant, June 28, 2020.
5. F. Gurry, “Intellectual Property, Innovation, Access and COVID-19,” www.wipo.int/wipo_magazine, June 2020.
6. J. Fischer, “When Researchers Discover A COVID-19 Cure, Credit Should Go To Robust IP Laws, Says Former Czech PM,” International Business Times, Aug. 15, 2020.
7. ICC, “How Intellectual Property Can Strengthen Our Response to Climate Change and COVID-19,” Press Release, April 24, 2020.
8. GPO 35 U.S.C. 203, “United States Code, 2012 Edition, Supplement 4, Title 35—PATENTS,” (United States Code, 2016).
9. GPO 28 U.S.C. §1498, “United States Code, 2018 Edition, Title 28—JUDICIARY AND JUDICIAL PROCEDURE,” (United States Code, 2018).
10. K. Bradsher and E. Andrews, “A Nation Challenged: CIPRO; U.S. Says Bayer Will Cut Cost of Its Anthrax Drug,” New York Times, Oct. 24, 2001.
11. Stanford University, “COVID-19 Technology Access Framework,” otl.stanford.edu, accessed Sept. 14, 2020.
12. FDA, “FDA Approves First Treatment for COVID-19,” Press Release, Oct. 22, 2020.
13. State of California Department of Justice, “Attorneys General Becerra and Landry Lead Bipartisan Coalition Urging Federal Government Action to Increase Access and Affordability for Remdesivir,” Press Release, Aug. 4, 2020.
14. A. Hill, et al., “Minimum Costs to Manufacture New Treatments for COVID-19,” Journal of Virus Eradication 6 (2) 61–69 (2020).
15. C. Rowland, “Taxpayers Paid to Develop Remdesivir but Will Have No Say When Gilead Sets the Price,” www.washingtonpost.com, March 26, 2020.
16. S. Koplon, “Investigational Compound Remdesivir, Developed by UAB and NIH Researchers, Being Used for Treatment of Novel Coronavirus,” www.uab.edu/news, Feb. 07, 2020.
17. Gilead Sciences, “Gilead Sciences Statement on State Attorneys General Letter on Remdesivir,” Company Statement, Aug. 5, 2020.
Kevin E. Noonan*, PhD, email@example.com, is partner at McDonnell Boehnen Hulbert & Berghoff LLP and chair of the firm’s Biotechnology & Pharmaceuticals Practice Group.
*To whom correspondence should be addressed.