Guest Post by Prof. Contreras: How the ‘Patent Eligibility Restoration Act’ Would Harm American Businesses and Endanger Global Health by Reintroducing ‘Pathogen Patents’

Guest Post by Professor Jorge L. Contreras

The Patent Eligibility Restoration Act should 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 pathogen 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 Thom Tillis (R-NC) in August 2022, is designed, among 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 methods, one piece of the eligibility puzzle that the Supreme Court got right, and which should not be changed, is Myriad’s holding 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 Who 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 variants with significant health implications (e.g., this and this) patentable again, potentially removing them from the broad competitive 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 skill). I have previously discussed these concerns here. In this post, however, I focus on a different and less-discussed issue: the risk that non-human pathogenic genomic sequences (i.e., from viruses and bacteria) will be patented by non-U.S. institutions and used to delay the development of lifesaving diagnostics, vaccines and therapeutics.

When Patents Held Up Pathogen Research

Prior to the Myriad decision, research groups around the world were able to obtain patents on newly identified pathogen genomic sequences, including those 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, however, research groups appear to have stopped seeking patents on new pathogenic agents, as shown 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 therapeutics.

SARS-CoV-2:  the Benefits of Patent-Free Pathogens

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 against COVID-19 were being tested. 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 without fear of patent infringement and without the need to negotiate complex patent licensing agreements and pay royalties to the first researchers to determine its sequence. This open and unencumbered global research environment enabled scientists to identify and trace the spread of multiple pathogenic variants around the world, to understand the biological mechanisms of the virus, and to develop vaccines, diagnostics and therapeutics, all in record time.

PERA and U.S. Competitiveness

Senator Tillis, when introducing PERA, explained that a major goal of the bill is to enhance “the economic and global competitiveness 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 again”, warning that “[e]conomic growth, job creation, global competitiveness, 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 pathogenic sequences, PERA would work largely to benefit institutions in China and elsewhere, and could have adverse consequences for U.S. businesses and global public health.

Pathogens Usually Emerge, and are Sequenced, Outside the United States

Most serious pathogenic 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, hunting 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 pathogenic outbreak has entered human populations, the locations where its variants will emerge is also unpredictable. For example, the major variants of SARS-CoV-2  were first documented 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 entities. 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 pathogenic emergence, inexpensive genome sequencing and national treatment under TRIPS suggests that if U.S. patents become available for pathogenic 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 pathogen 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 those sequences would either be excluded from the market or required to pay unpredictable prices for a license to operate under those patents.

Countries That Are Willing to Hold-Up Research

In recent years, certain foreign governments have shown themselves willing to hold-up international disease research and response efforts in order to gain 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 products. Similar tactics were adopted by other countries during the MERS, Ebola and Zika outbreaks, as documented here.

If countries are willing to hold-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 pathogen patenting will give countries where diseases emerge yet another tool to hold-up critical international research and development to the detriment of all.

Patents are not Necessary to Incentivize Pathogen Sequencing

One of the principal 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 pathogen sequences. The identification of new pathogens 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 therapeutics, 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 Pathogen Sequences

It is also unnecessary to patent underlying pathogenic sequences in order to protect novel and innovative technologies such as diagnostics, vaccines and therapeutics. A 2012 WIPO study identified more than 50,000 patents and published patent applications across 57 countries that claimed the active ingredients of pneumonia, typhoid and influenza vaccines, most without claiming the underlying pathogen. Even more opportunities for innovation exist with respect to therapeutics, 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, though the viral sequence was freely available on GenBank.

The broad availability of patents for innovation around pathogenic disease outbreaks is amply demonstrated by the COVID-19 pandemic. Despite the absence of patents claiming the SARS-CoV-2 sequence or its many variants, the research institutions and private firms that developed COVID-19 diagnostics and vaccines obtained numerous patents on the innovative aspects of their products. For example, one 2020 study found that, with respect to mRNA vaccine technology alone, 56 different entities ranging from large pharmaceutical companies to small and medium-sized entities held a total of 119 different patent families. Perhaps the most convincing evidence that sizeable numbers of patents have issued in this space is the expanding universe of patent litigation among 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 without the need for patents on naturally occurring pathogenic sequences.

But is this Threat Real?

An argument that may be made against the need to limit further pathogen patents is that the ability of patent holders to enforce their patents, especially during global health crises, is limited by law.  For example, in the United States, a patent holder cannot obtain a permanent injunction preventing an infringer from practicing a patented invention unless it demonstrates that the public interest would not be disserved by the entry of the injunction.  Likewise, the International Trade Commission, when assessing 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 injunctions 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 pathogenic sequences might not represent a significant threat to pathogen research or biomedical product development. However, the existence of patents on these basic research tools, no matter what the likelihood 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 shifting is rare.  Thus, while various litigation doctrines may tend to lessen the threat of pathogen 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 pathogen-based biomedical products.

Don’t Let PERA Potentially Hold Up Research Efforts

For the reasons outlined above, PERA should be modified to ensure that naturally occurring genomic sequences – even once isolated – remain ineligible subject matter for patent protection. Preventing the reintroduction of pathogen patents will enable international pathogen research to advance rapidly while interfering little with private incentives to develop innovative new biomedical technologies. In contrast, opening the door to pathogen patents arguably will provide opportunities for individual countries where outbreaks emerge to hold up international research efforts for their own benefit, causing delays and barriers to the development of lifesaving diagnostics, vaccines and drugs.

22 thoughts on “Guest Post by Prof. Contreras: How the ‘Patent Eligibility Restoration Act’ Would Harm American Businesses and Endanger Global Health by Reintroducing ‘Pathogen Patents’

  1. 9

    Here’s the Plan.

    1. Sequence the DNA of a pathogen.

    2. Get a patent on it.

    3. Sue the pathogen for patent infringement (and win).

    4. Get an injunction against the pathogen barring it from reproducing.

    The result will be one less pathogen in the world.

  2. 8

    Professor Emily Morris explained in a letter to Congress last October that, aside from compelling anecdotes, there is no empirical evidence that “gene patents” have held up R&D by preventing access or deterring research. I think Jorge would make a better case if he acknowledged and addressed Emily’s points in her letter to Congress in support of the Patent Eligibility Restoration Act:

    link to ipwatchdog.com

    1. 8.2

      When given multiple opportunities (and even politely), and yet still choosing to ignore the counterpoints presented, at what point does the offer become less of a helpful discourse and more of a mere propaganda attempt?

      Asking for a friend (I already full well know the answer).

    2. 8.3

      Oh, the irony of footnote 1:

      Identifying the existence, location, and sequence of the gene variants in Myriad, for example, took decades of effort.1

      1: Jorge L. Contreras, Association for Molecular Pathology v. Myriad Genetics: A Critical Reassessment, 27 MICH. TECH. L. REV. 1, 5-9 (2020)

  3. 7

    I find it interesting that someone is playing devils advocate and actually endorsing the 101 Alice v. line of cases. (I worked as an examiner in the business method section and 101 rejections were a regular issue.) Unfortunately, patent attorneys are trying to patent the known universe and sometimes a 101 rejection is the only thing preventing world commerce from coming to a screeching halt due to a death star type patent claim. I agree the CAFC has gone off the deep end using 101 to invalidate any patent in the US based on some very fuzzy logic, but the original intention of the US Supreme Court was on the right track.

    We need the CAFC to be made up of judges who have education and experience actually prosecuting or litigating patents. The CAFC is the clearing house of judges that can’t clear Senate confirmation. Better yet, make a special court just to hear patent case made up of patent practitioners just like Pres. Reagan originally intended when he signed off on the law creating the CAFC. It is not the law in Alice; it is the ham handed application of the law in Alice by the CAFC. (I am sure many will condemn me to burning in hell for supporting Alice. So be it. ) link to youtu.be

    1. 7.1

      Wrong. CAFC was created to implement the ’52 act’s goal of objective evidence based standards, abolish the forum shopping issue between the circuits and abolish the subjective hell hole created by the 2nd circuit. Gist, heart, Eureka!, spark of [ ], etc, which invalided all patents in the 2nd circuit. Which, not so ironically, SCOTUS has re-discovered in KSR, Alice, Etc. At least get your history correct.

      1. 7.1.1

        +1 iwasthere

  4. 6

    Interesting article.

    However, aren’t the isolated genes and naturally occurring genes chemically different?

    If they are, but the difference is just “small,” how are we to define small differences without creating a chaos of ambiguity in the law as to what is a small enough difference in other chemical compouds and technologies?

    If it is so easy and routine to isolate a gene sequence of virus, bacteria, or disease once you know of its existence, then wouldn’t that make the gene seqeunce obvious, once the disease is identified, and thereofore unpatentable under 35 USC 103?

    Don’t we want to encourage the identification of diseases, so we know to make vaccines and cures for them?

    If so, then perhaps we should let 35 USC 103 do its job instead of introducing ambiguities in the law as to what is patent eligible?

    Regarding the low cost of isolating and sequencing genes, should those with little money be shut out of patenting their contribution to solutions to problems?

    It seems to me that the counter-argument to article is relatively simple and which side you take on this issue may be highly dependent on your source of income.

    1. 6.1

      +1

  5. 5

    “Make everything eligible for patenting except the things I specifically don’t want to be patentable,” is a take for sure. Come back when you have a generally applicable rule of eligibility that has the correct result in most cases, and then we can talk.

    1. 5.1

      “Make everything eligible for patenting except the things I specifically don’t want to be patentable” [as you note] is why this proposed legislation on 101 unpatentable subject matter seems unlikely to obtain enactment given such wide differences in the views of the different “I’s.”

      1. 5.2.1

        That tripe is still tripe.

  6. 4

    The fact that this author has a job as law professor reminds me of the scene in Annie Hall when Woody Allen pulls Marshall Macluhan from the wings to berate a loudmouth for his ignorance with respect to Macluhan’s works. “You know nothing of my work…How you ever got to teach a course in anything is totally amazing.” link to youtube.com

    If what’s written in this piece is what the author is teaching in his classes, then I feel sorry for his students.

    1. 4.1

      The Wokeness in the author is strong. Just the way they feel they are right and have some twisty little set of rules that are all about the ends justify the means.

    2. 4.2

      Thanks AM — truly a classic.

  7. 3

    “It is doubtful that allowing pathogen 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 those sequences would either be excluded from the market or required to pay unpredictable prices for a license to operate under those patents.”

    The US government has march in rights over any US patent, if required for some emergency the government by government contract or EO can order US private industry to infringe a patent and produce a product, and the only remedy is claims court against the US government, for maybe someday winning a judgment and getting congress to authorize the payment of the claim. Obviously, not the case when the IP is kept a trade secret because there is your proposed categorical subject matter ban on such patent ergo – hard lock down trade secrets.

    In recent years, certain foreign governments have shown themselves willing to hold-up international disease research and response efforts in order to gain 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 products. Similar tactics were adopted by other countries during the MERS, Ebola and Zika outbreaks, as documented here. <— So they were keeping the information a trade secret until they cut some deal? Isn't this an argument for the disclosure in exchange for the patent protection?

    1. 3.1

      Yes I was wondering about that too. Many developing country governments and NGOs are working really hard to take pathogen samples and genetic sequence data OUT of the public domain. They are proposing to restrict global access to pathogens and related genetic data, and to condition access on payments and preferential treatment for the countries from where the pathogen first spread. These are the same actors that are stridently calling for open access, free sharing, and patenting bans on pathogen research.

      1. 3.1.1

        Yes, this is the theft of bio property of the third world argument advanced by Banzhaf back in the day. Back in the bad old days, oh 10 years ago – LOL – you were to go into the rain forest and discover the naturally occurring molecule that cured cancer – and you could get a patent for the discovery. Then along comes SCOTUS and they ban patents on all naturally occurring molecules (even discovered after the fact – right?), hence no incentive to disclose your discovery – and every incentive to keep it a secret. Banzhaf has some other – pay them (the third world) anyways – because that was the cure for cancer was discovered in the their jungle.

  8. 1

    very informative

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