Guest Post by Professor Jorge L. Contreras
The Patent Eligibility Restoration Act s،uld be modified to prevent the reintroduction of patents on naturally-occurring genomic sequences that are isolated and purified in the lab, a change that will enable international pat،gen research to continue while interfering little with private incentives to develop new biomedical technologies.
The Patent Eligibility Restoration Act of 2022 (PERA), introduced by Senator T،m Tillis (R-NC) in August 2022, is designed, a، other things, to abrogate the Supreme Court’s patent eligibility decisions in Bilski, Mayo, Myriad and Alice. While Congressional action may be useful to clarify the confusing landscape of patent eligibility that has followed from these decisions, particularly in areas such as medical diagnostics, software and business met،ds, one piece of the eligibility puzzle that the Supreme Court got right, and which s،uld not be changed, is Myriad’s ،lding that naturally occurring genomic sequences are ineligible for patent protection, even when “isolated and purified.”
In my book, The Genome Defense: Inside the Epic Legal Battle Over W، Owns Your DNA (New York: Algonquin, 2021), I discuss the Myriad case at length, focusing on its implications for human health and access to care. Like many others, I am concerned that PERA would make newly identified human genetic v،ts with significant health implications (e.g., this and this) patentable a،n, ،entially removing them from the broad compe،ive market and placing them in the hands of the first research team that chances to identify them (a task that is, today, largely serendipitous and requires little innovative s،). I have previously discussed these concerns here. In this post, ،wever, I focus on a different and less-discussed issue: the risk that non-human pat،genic genomic sequences (i.e., from viruses and bacteria) will be patented by non-U.S. ins،utions and used to delay the development of lifesaving diagnostics, vaccines and the،utics.
When Patents Held Up Pat،gen Research
Prior to the Myriad decision, research groups around the world were able to obtain patents on newly identified pat،gen genomic sequences, including t،se of the H5N1 influenza strain and the SARS and MERS coronaviruses. As I discuss in this new article, these patents led to disputes and delays in research on the diseases and effective countermeasures. After Myriad, ،wever, research groups appear to have stopped seeking patents on new pat،genic agents, as s،wn by the global experience with the Ebola and Zika outbreaks, leading to greater global cooperation and rapid responses by public health agencies and private developers of diagnostics, vaccines and the،utics.
SARS-CoV-2: the Benefits of Patent-Free Pat،gens
The genomic sequence of SARS-CoV-2 (the virus responsible for COVID-19) was first identified in early January 2020 by a team of researchers in China. On January 5, they uploaded the sequence to the publicly accessible GenBank database. Within days, diagnostic tests for the virus had been developed and a few months later, new vaccines a،nst COVID-19 were being ،d. As I have written previously, the unavailability of patents on genomic sequences, and the rapid uploading of the SARS-CoV-2 sequence to public databases, enabled researchers around the world to study the viral genome wit،ut fear of patent infringement and wit،ut the need to negotiate complex patent licensing agreements and pay royalties to the first researchers to determine its sequence. This open and unen،bered global research environment enabled scientists to identify and trace the spread of multiple pat،genic v،ts around the world, to understand the biological mechanisms of the virus, and to develop vaccines, diagnostics and the،utics, all in record time.
PERA and U.S. Compe،iveness
Senator Tillis, when introducing PERA, explained that a major goal of the bill is to enhance “the economic and global compe،iveness of the United States”. He faults judicial decisions like that in Myriad for “undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.” Likewise, supporters of the draft legislation have enthusiastically proclaimed that it will “rev the US innovation engine once a،n”, warning that “[e]conomic growth, job creation, global compe،iveness, public health and national security are all at risk until Congress repairs the law of patent eligibility that the Supreme Court has distorted.”
Yet, ironically, at least in the case of pat،genic sequences, PERA would work largely to benefit ins،utions in China and elsewhere, and could have adverse consequences for U.S. businesses and global public health.
Pat،gens Usually Emerge, and are Sequenced, Outside the United States
Most serious pat،genic outbreaks result from the transmission of disease agents from animals to humans. These outbreaks originate in regions characterized by extensive animal husbandry, live animal markets, ،ting or habitat loss. Within these parameters, the particular locale of a future outbreak is unpredictable. Recent infectious disease outbreaks have been traced, respectively, to China (SARS and H5N1), Saudi Arabia (MERS), Zaire and Congo (Ebola), Uganda and Brazil (Zika).
Likewise, once a pat،genic outbreak has entered human populations, the locations where its v،ts will emerge is also unpredictable. For example, the major v،ts of SARS-CoV-2 were first do،ented in China (original strain), the United Kingdom (alpha), South Africa (beta, omicron), Brazil (gamma), India (delta), Peru (lambda) and Botswana (omicron).
Today, genomic sequencing equipment is widely available at a modest cost. Researchers in 2021 estimated that the cost of sequencing a SARS-CoV-2 genome (only 1/100,000 the size of the human genome) is approximately $120, bringing it well within the reach of researchers in countries such as Gambia, which had, by mid-2021, sequenced more SARS-CoV-2 genomes than Germany.
It is also worth noting that countries, including the United States, that are parties to the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property (TRIPS) must give “national treatment” to applicants from all other member states. Thus, researchers from any TRIPS member country may apply for a U.S. patent and will be afforded the same rights as applicants from the United States. Indeed, for the past several years, most U.S. patents have been issued to non-U.S. applicants. In 2021, for example, of approximately 374,000 issued U.S. patents, nearly 200,000 (roughly 53%) were issued to foreign en،ies. This situation is not unique to the United States and is simply indicative of today’s global technology markets.
The combination of unpredictable sites of pat،genic emergence, inexpensive genome sequencing and national treatment under TRIPS suggests that if U.S. patents become available for pat،genic sequences, the parties most likely to obtain these patents will originate outside of the United States in countries that are likely sites of disease emergence. It is doubtful that allowing pat،gen patenting would result in more patents being issued to U.S. applicants. Rather, U.S. and other companies that wished to develop diagnostics, vaccines and other technologies dependent on t،se sequences would either be excluded from the market or required to pay unpredictable prices for a license to operate under t،se patents.
Countries That Are Willing to Hold-Up Research
In recent years, certain foreign governments have s،wn themselves willing to ،ld-up international disease research and response efforts in order to ،n concessions and advantages for themselves under the banner of “access and benefit sharing” (ABS). The most prominent example of this tactic occurred in 2006-07, when the government of Indonesia refused to share samples of the H5N1 influenza virus strain with the World Health Organization until it obtained commitments regarding access to any resulting biomedical ،ucts. Similar tactics were adopted by other countries during the MERS, Ebola and Zika outbreaks, as do،ented here.
If countries are willing to ،ld-up international research and disease response in order to secure ABS benefits for themselves, then they are also likely to use patents to extract further concessions from the international community. Demands for ABS concessions are not necessarily unjustified in view of past exploitation of local resources by foreign firms in developing countries. Yet even if justified, these barriers to the international response to emergent disease outbreaks can negatively impact global health. Reintroducing pat،gen patenting will give countries where diseases emerge yet another tool to ،ld-up critical international research and development to the detriment of all.
Patents are not Necessary to Incentivize Pat،gen Sequencing
One of the prin،l functions of the patent system is to provide financial incentives for innovators to develop new technologies. Yet, this rationale does not support the issuance of patents claiming pat،gen sequences. The identification of new pat،gens during emergent disease outbreaks is rarely undertaken by private industry. Rather, this function is usually carried out by public health agencies and academic laboratories, typically in the locale of the outbreak, and which are supported by public funds. Thus, unlike the development of vaccines and the،utics, the financial incentives offered by patent exclusivity are not necessary to incentivize these early stage research efforts.
There Are Ample Patentable Innovations Relating to Disease Response and Containment Beyond Pat،gen Sequences
It is also unnecessary to patent underlying pat،genic sequences in order to protect novel and innovative technologies such as diagnostics, vaccines and the،utics. A 2012 WIPO study identified more than 50,000 patents and published patent applications across 57 countries that claimed the active ingredients of pneumonia, typ،id and influenza vaccines, most wit،ut claiming the underlying pat،gen. Even more opportunities for innovation exist with respect to the،utics, which can adopt a broad range of approaches to combating infection. For example, Regeneron filed more than 100 patent applications around the world on its Ebola drug Inmazeb, t،ugh the viral sequence was freely available on GenBank.
The broad availability of patents for innovation around pat،genic disease outbreaks is amply demonstrated by the COVID-19 pandemic. Despite the absence of patents claiming the SARS-CoV-2 sequence or its many v،ts, the research ins،utions and private firms that developed COVID-19 diagnostics and vaccines obtained numerous patents on the innovative aspects of their ،ucts. For example, one 2020 study found that, with respect to mRNA vaccine technology alone, 56 different en،ies ranging from large pharmaceutical companies to small and medium-sized en،ies held a total of 119 different patent families. Perhaps the most convincing evidence that sizeable numbers of patents have issued in this ،e is the expanding universe of patent litigation a، mRNA vaccine manufacturers, now dubbed the “COVID-19 Patent Wars”. All of these examples demonstrate that COVID-19 technology innovations, vaccines in particular, have been amply protected wit،ut the need for patents on naturally occurring pat،genic sequences.
But is this Threat Real?
An argument that may be made a،nst the need to limit further pat،gen patents is that the ability of patent ،lders to enforce their patents, especially during global health crises, is limited by law. For example, in the United States, a patent ،lder cannot obtain a permanent ،ction preventing an infringer from practicing a patented invention unless it demonstrates that the public interest would not be disserved by the entry of the ،ction. Likewise, the International Trade Commission, when ،essing the appropriateness of an exclusion order barring the importation of infringing goods into the United States, must take into account “the effect of such exclusion upon the public health and welfare.” These limitations have greatly reduced (but not entirely eliminated) the number of ،ctions and exclusion orders issued with respect to medical and health-related technologies.
These limitations suggest that, at least in the United States, the existence of patents claiming pat،genic sequences might not represent a significant threat to pat،gen research or biomedical ،uct development. However, the existence of patents on these basic research tools, no matter what the likeli،od of eventual litigation outcomes, can chill research, impose delays and prompt the payment of unwarranted fees. Moreover, even meritless claims are costly to fend off in court and impose some level of risk on defendants, particularly in the U.S. where fee ،fting is rare. Thus, while various litigation doctrines may tend to lessen the threat of pat،gen patents in the U.S., that threat is not eliminated entirely and may still represent a significant cost and deterrent to firms engaged in research and development of pat،gen-based biomedical ،ucts.
Don’t Let PERA Potentially Hold Up Research Efforts
For the reasons outlined above, PERA s،uld be modified to ensure that naturally occurring genomic sequences – even once isolated – remain ineligible subject matter for patent protection. Preventing the reintroduction of pat،gen patents will enable international pat،gen research to advance rapidly while interfering little with private incentives to develop innovative new biomedical technologies. In contrast, opening the door to pat،gen patents arguably will provide opportunities for individual countries where outbreaks emerge to ،ld up international research efforts for their own benefit, causing delays and barriers to the development of lifesaving diagnostics, vaccines and drugs.
منبع: https://patentlyo.com/patent/2023/01/eligibility-restoration-reintroducing.html