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  • GOP Legislators Write in Opposition to Proposed TRIPS Waiver

    By Donald Zuhn —

    House of Representatives SealEarlier this month, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."  One day prior to Ambassador Tai's announcement, a group of Republican legislators sent a letter to the Ambassador urging the Biden Administration to continue the United States' opposition to the request by India, South Africa, and other nations to waive certain portions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for all members of the World Trade Organization (WTO).  The group asserted that "[t]he requested waiver is extraordinarily broad and unnecessary to accomplish the goal of giving as many people as possible access to vaccines and treatments for COVID-19, including in developing countries," and argued that "the waiver would undermine the very innovation that has led to the record-breaking rapid development of COVID-19 vaccines already saving lives around the world, and it would not meaningfully improve vaccine availability."  Instead, the legislators suggested that the focus should be "overcoming the real obstacles faced by developing countries in accessing vaccines and treatments, which does not require waiving intellectual property (IP) rights."

    The group of Republican legislators who signed the letter, all of whom are members of the Subcommittee on Courts, Intellectual Property, and the Internet of the House Committee on the Judiciary, included Ranking Members Jim Jordan (R-OH) and Darrell Issa (R-CA), and Steve Chabot (R-OH), Louie Gohmert (R-TX), Matt Gaetz (R-FL), Mike Johnson (R-LA), Tom Tiffany (R-WI), Thomas Massie (R-KY), Dan Bishop (R-NC), Michelle Fischbach (R-MN), Scott Fitzgerald (R-WI), and Cliff Bentz (R-OR).  The group's letter presented four arguments against the proposed waiver.  First, the legislators argued that IP rights are not the bottleneck for worldwide access to COVID-19 vaccines and treatments.  Second, the group contended that worldwide access to COVID-19 treatments can be expanded without weakening IP rights.  Third, they asserted that the proposed waiver is excessively broad.  And finally, the group argues that the requested waiver would harm American innovation, technological leadership, and economic competitiveness.

    With respect to their first argument, the legislators note that the sponsors of the proposed waiver have presented no convincing evidence to support their assertion that IP rights are a significant bottleneck to the widespread availability of COVID-19 vaccines and treatments.  Instead, they suggest that factors other than IP, such as the lack of cold storage, transportation and infrastructure problems, and shortages in basic supplies like syringes, have had a far greater effect on the availability of COVID-19 vaccines and treatments, particularly in developing countries.  The group also notes that the manufacturing of COVID-19 vaccines and therapeutics is complex and requires exacting standards to ensure patient safety, stating that:

    Canceling IP rights would not improve the quality control of any manufacturing facilities.  In fact, allowing potentially any manufacturer to ignore IP rights and produce complex COVID-19 drugs on their own could instead increase the risk that defective and potentially unsafe medicines are produced, harming the patients who receive them, damaging public confidence, and ultimately undermining global vaccination efforts.

    Turning to their second argument, the legislators point out that the United States has, along with its allies, pledged billions of dollars and other resources to support the World Health Organization's COVAX program and the Access to COVID-19 Tools (ACT) Accelerator initiative, which the group states are "providing real solutions for countries that need access to COVID-19 vaccines and treatments without dismantling IP protections, even temporarily."  They also present evidence that COVID-19-related IP rights have been successfully licensed, highlighting licenses secured by the Serum Institute of India to the Astrazeneca and Novavax vaccines, by South Africa's Aspen Pharmacare to the Johnson & Johnson vaccine, and by nine generic pharmaceutical manufacturers to Gilead's therapeutic drug remdesivir.  In addition, the legislators point out that "TRIPS already allows countries to impose compulsory licenses to access vital IP rights, and no country has availed itself of that capability to date for COVID-19 vaccines or treatments."

    Regarding their third argument, the legislators argue that the proposed waiver is "excessively broad and far exceeds any reasonable measure to address the COVID-19 pandemic," noting that the waiver is not limited to patents on vaccines or treatments for COVID-19.  The group also states that it is "unclear how a waiver of TRIPS obligations would provide more access to trade secrets and proprietary technologies, which are confidential by definition and typically closely guarded."

    Finally, with respect to their fourth argument, the legislators contend that "[e]ven if IP protections on the broad array of technology covered by the waiver are bypassed only temporarily, the damage could not be undone for key trade secrets and proprietary know-how if countries force the disclosure of such sensitive information."  The group argues that "the proposed waiver represents a danger to American technological leadership and economic competitiveness without any significant benefit to global public health" (emphasis in letter).  Highlighting the "ground-breaking mRNA vaccine technology that could revolutionize future vaccine development," the group argues that the waiver's sponsors "are seeking not only the COVID-19 vaccines produced using that technology but also that technology itself, which they could then use for other purposes."  And the Republican legislators assert that "[a]t a time when the Biden Administration is proposing trillions of debt-funded spending, the United States must not give away advanced technology developed with billions of Americans' tax dollars to other countries, including adversaries like China and Russia."

    The legislators conclude their letter by stating that "[w]hile considerable work can still be done to improve access to COVID-19 medicines and other innovations, that work can be done without the drastic step of suspending IP rights, and significant progress has already been made to address the real obstacles hampering the global COVID-19 response," urging Ambassador Tai and the Biden Administration to maintain U.S. opposition to the waiver, and expressing their willingness to work with the Administration on solutions to the actual problems causing shortages and supply issues with COVID-19 vaccines and treatments.

    For additional information regarding this topic, please see:

    • "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021
    • "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021
    • "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021
    • "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021
    • "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021
    • "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021
    • "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
    • "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
    • "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
    • "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
    • "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
    • "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
    • "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

  • Webinar on Crystalline/Solid Form Patents

    IPWatchdogIPWatchdog and Barash Law and will be offering a webinar entitled "Crystalline/Solid Form Patents in the Life Sciences: Issues in Prosecution and Litigation" on May 18, 2021 at 12:00 pm (ET).  Eyal Barash of Barash Law and Gene Quinn of IPWatchdog, Inc. will discuss solid-form patents in the pharmaceutical industry, including prosecution, claim drafting, novelty, obviousness, enablement, non-species claims in a crystalline-form context, claim interpretation, and proving infringement.  The webinar will also compare and contrast these issues with elements of EU law, and discuss both court decisions as well as opinions from the USPTO (PTAB) and the EPO.

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • Webinar on Patent Extensions in Brazil & Mexico

    Moeller IPMoeller IP will be offering a webinar entitled "Patent Extensions in Brazil & Mexico" on May 18, 2021 at 11:00 am (ET).  The webinar will address the Brazilian Supreme Court's final ruling on the current suspension of Article 40 of the Industrial Property Law (Law 9.279 / 1996) setting forth a minimum period of patent validity of 10 years, and the Mexican Supreme Court's decision from October 2020, which extended the period of validity of Mexican Patent No. 238942.

    While there is no cost to participate in the program, those interested in attending the webinar can register here.

  • Webinar on Patent Landscape Monitoring

    IPWatchdogIPWatchdog and Relativity and will be offering a webinar entitled "Creating a Patent Landscape Game Plan: Identifying Strategic Threats and Potential Incoming Litigation" on May 19, 2021 at 12:00 pm (ET).  David Donoghue of Holland & Knight, Evan McAlpine and Ryan Hynes of Relativity, and Gene Quinn of IPWatchdog, Inc. will discuss the proper balance between defensive monitoring and monitoring to identify white space and other specific examples of how landscaping analysis can be useful to proactively provide value-add to business development strategies, and will also address what to do when litigation is approaching.

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • Webinar on Auxiliary Requests at the EPO

    J A KempJ A Kemp will be offering a webinar entitled "Auxiliary Requests at the EPO" on May 20, 2021 from 2:30 to 3:30 pm BST (British Summer Time).  Amanda Simons and Martin Jackson of J A Kemp will examine what an auxiliary request is and when filing an auxiliary request should be considered as well as exploring tactical considerations relating to preparing and filing of auxiliary requests.  The webinar will address the following topics:

    • When can you file an auxiliary request
    • Timing of filing auxiliary requests
    • Number of auxiliary requests
    • Tactics relating to which auxiliary requests to file and when
    • Admissibility of auxiliary requests

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • Webinar on IP Strategy

    CPA GlobalCPA Global will hosting a webinar entitled "Maximizing IP to Drive Strategic Advantage " on May 20, 2021 beginning at 10:00 am ET.  The webinar will present two panel discussions with speakers from Alibaba, Johnson Controls, AkzoNobel, and Ferrero:

    • Panel 1: IP strategy—does one size fit all?
    • Panel 2: Combining patents and trademarks to drive innovation

    The webinar will address the following topics:

    • What IP strategy means in different industries and regions
    • How companies can protect, manage, enforce and commercialize IP
    • Ways market dynamics influence IP practices
    • Varying factors that influence IP strategies
    • How and when trademarks and designs should play a role in the innovation process
    • How IP practitioners can manage IP portfolios to drive business performance

    Those interested in registering for the webinar can do so here.

  • IPO Webinar on Inequitable Conduct & Duty of Disclosure

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inequitable Conduct and the Duty of Disclosure" on May 20, 2021 from 12:00 pm to 1:00 pm (ET).  Gordon Arnold of Arnold & Saunders, LLP; Ron Derrington of Bracewell, LLP; Justin Hendrix of Collins Aerospace; and Luke McCammon of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will focus on the state of the law after GS Cleantech, the nuanced differences between the scope of the duty of disclosure between different Patent Office forums, and best practices and tips from the patent prosecutor's perspective.

    The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Science Does Not Support the Latest COVID Hysteria

    By Kevin E. Noonan —

    SARS-CoV-2In a time of a global pandemic, with antivaxxer and anti-science sentiments running rife, and when combinations of fear, distrust, and paranoia are rampant, it is easy for important results from basic science to become fodder inaccurately supporting the doomsday memes that abound.  This is the story of a scientific paper from two eminent scientists that, properly understood, explains a puzzling aspect of SARS-CoV-2 biology in COVID-19 patients:  why can viral genetic information be detected in some patients months after they have recovered from their illness, using sensitive testing (polymerase chain reaction, or PCR; for reference see CSI).  As it turns out, it is not evidence that SARS-CoV-2 is manmade, or that the various vaccines against the disease are toxic or disease-causing, or that (as Senator Rand Paul (R-TN) is (in)famous for charging) Dr. Anthony Fauci supported "gain-of-function" research in Wuhan China and then tried to cover it up.  There are plenty of websites having that content; here we will strive to stick to the facts.

    The paper, "Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient-derived tissues," appeared in the Proceedings of the National Academy of Sciences USA this week, and was authored by Rudolf Jaenisch and Richard Young and their colleagues.  The purpose of the paper as stated therein is to resolve "[a]n issue of SARS-CoV-2 disease is that patients often remain positive for viral RNA as detected by PCR many weeks after the initial infection in the absence of evidence for viral replication," i.e., in the absence of producing live virus.  Their hypothesis:  perhaps enzymes produced in human cells, capable of converting RNA (like messenger RNA) to DNA, was introducing some portions of the SARS-CoV-2 RNA into the genome of infected cells.  This RNA would then be detected after the RNA was made as part of gene sequences surrounding the integration site.

    It should be appreciated in this regard that a great deal of human DNA, colloquially termed "junk" DNA, does not encode proteins or regulatory sequences (which is the function of the remainder of genomic DNA and was what earlier workers believed to be the totality of the genome).  This seemingly non-functional DNA is made up in significant part by the remnants of ancient retroviruses and retrotransposons, DNA elements "reverse transcribed" from RNA to DNA and inserted in the genome (perhaps randomly).  Some of these species form so-called repetitive elements; one of the most prevalent in human DNA (17%) named Long Interspersed Nuclear Element 1 (LINE1):

    Image
    These repeats, like their retrovirus and retrotransposon ancestors, can express a form of reverse transcriptase that can act on cellular RNA and result in reinsertion of the resulting DNA into the cellular chromosome (this is not an unknown phenomenon and is not necessarily associated with virus infection when it has been detected; see, Horie & Tomonaga, 2011, "Non-retroviral fossils in vertebrate genomes," Viruses 3, 1836–1848).  Importantly to this work, other RNA viruses and even cellular genes have been known to have portions of their RNA retroinserted into cellular genomic DNA after reverse transcription by endogenous cellularly encoded reverse transcriptases.

    Drs. Jaenisch and Moore first studied whether SARS-CoV-2 RNA could be reverse transcribed and reinserted into the genomic DNA from cultured human cells in a Petri dish; the cells they used are an established, immortal cell line known as HEK293T.  These cells arose from human embryonic kidney and differ from normal cells by not experiencing aging, senescence, and cell death after a limited lifespan.  They also contain DNA from a transforming adenovirus, having been made in 1973 and continuously grown (or "passaged") since then.  Their chromosomal complement is abnormal, having on average 64 chromosomes and multiple copies of some of them (e.g., 3 copies of the X chromosome and 4 copies of chromosomes 17 and 22).  In short, these are not normal cells but nevertheless have proven to be very useful for a variety of purposes in cell biology studies and biotechnology.

    In the COVID-19 studies reported in this recent paper, these scientists increased the likelihood of observing what they expected to be extremely rare events by introducing into recipient HEK293T cells a cloned copy of human LINE1 genetically engineered to express the endogenous reverse transcriptase (it will be appreciated that such cells do not occur naturally).  When assayed, using PCR detection or by genomic DNA sequencing methods, the largest SARS-CoV-2 derived DNA sequence was 1,632 basepairs (bp) encoding the protein (the nucleocapsid, NC) that acts as a "shell" for the viral RNA, in a genetic milieu that validated the hypothesis for LINE1-mediated reverse transcription and integration into the genome.  These studies also showed that portions of human genes called exons were preferential (76%) targets for integration, providing an explanation for why PCR treatment of cellular RNA could detect portions of SARS-CoV-2 RNA in otherwise virus-free individuals post-infection.  Similar results at lower frequencies were detected in HEK293T cells not having artificial LINE1-associated reverse transcriptase encoded by a genetically engineered LINE1 element.

    When the presence of chimeric human/SARS-CoV-2 RNAs were assessed in samples from infected individuals they were found at very low frequency — 0.004–0.14% of the total detected virus-related species, although they were found in multiple tissue types including lung, heart, and brain tissues.  Most of these detected sequences were from NC-encoding RNA, consistent with the HEK293T cell experiments.  That the SARS-CoV-2 RNA detected in human samples had been produced from integrated fragments of this RNA was supported by further findings that about 50% of these sample fragments had been produced by "negative-strand" (i.e., the complement in a double-stranded DNA) species that could only have come from such DNA (because the virus RNA is "positive stranded," i.e. the strand that contains the transcript in a form that can be directly translated into protein in the cell).

    These results explain the scientific conundrum of finding evidence of SARS-CoV-2 RNAs in individuals who had recovered from COVID-19 and showed neither symptoms nor the presence of SARS-CoV-2 virus in clinical samples.  It also suggested that continued expression of SARS-CoV-2 chimeric RNAs (and the proteins encoded thereby) might result in a persistence of immunity because the individual's immune system would continue to recognize them as antigenic and produce an immune response against the virus in the absence of later re-infection.

    These results show the ability of scientific inquiry to resolve unknown and unsuspected aspects of SARS-CoV-2 biology, unsurprising for a virus only recently identified and (if current etiological explanations hold) only recently having humans as a host (see "Evolution of SARS-CoV-2 from Bat to Human Pathogen").  But it is clear that what these results do not support is a conclusion that the mRNA vaccines (from Pfizer/BioNTech or Moderna) are in any way unsafe; after all, besides being the consequence of natural processes existing through geological time the exceedingly small frequency of these events is inconsistent with realistic worries about vaccination (considering the much more severe and frequent alternative outcome for those infected with the virus).  The advent of the first pandemic in over a century,  particularly coming after a little more than a century of medical and scientific achievements that "conquered" infectious diseases, is disquieting if not frightening.  But it is a mistake to let that fear inhibit use of the product of over a century of medical and scientific inquiry and successful intervention against infectious disease.  As Dan Rather was known to say, "Courage."

  • Population of Patents at Risk from Proposed WTO Patent Waiver

    By Kevin E. Noonan —

    Dennis Crouch, our colleague at Patently-O, tweeted last week that there have been 148 U.S. patents granted having disclosure related to (COVID-19 or SARS-CoV-2); see Search of U.S Patent and Trademark Office Patent Full-Text and Image Database and

    Histogram 1
    With regard to issues involving the proposed WTO IP waiver (see "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?"), it may be instructive to inspect the relatively few (4) of these patents directed to COVID-19 specific vaccines (another 4 were directed to therapeutic antibodies).  These are set forth in this table:

    Table 1
    Of these, the only assignee associated with an actual, in-development SARS-CoV-2 vaccine is Novavax; however, the company has delayed its application for Emergency Use Authorization (EUA) from this month to sometime in the third quarter of this year (although maintaining that there is nothing troubling about the delay).

    In addition to these granted patents, there are 420 published applications that are found on the USPTO website when queried with (COVID-19 or SARS-CoV-2); the same pattern persists here, with only a small fraction being directed to vaccines or immunization methods:

    Table 2
    As with granted patents, the remainder of these pending applications are directed to detection methods, personal protective equipment, disease monitoring, and disinfectant preparations, as well as various pharmaceuticals and methods of treatment (not all of which are COVID-19 specific).

    This raises the question of whether the uproar over the proposed WTO waiver is "much ado about nothing" in view of the small number of granted patents and pending applications directed to COVID-19 vaccines.  A proper understanding of what is at stake involves considerations much more broadly shaped than these small number of patent properties.  For example, there are many other patented technologies involved in making any of the vaccines now available:

    Chart 1
    Table 3
    U.S. Food and Drug Administration EUA Information

    In addition, these vaccines are also produced using trade secrets that are undoubtedly not disclosed in these patents (see "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals").

    Most importantly, the cure is worse than the disease; as has been enunciated heretofore, the proposed IP waiver will do little if anything to solve the accessibility problem (see "Latest COVID Conundrum: Accessibility of Vaccines (When They Are Available)") but will almost certainly damage the very innovation system whose existence permitted these vaccines and others now in development to be produced on an accelerated timescale (see "The Road to Hell Is Paved with What Everybody Knows").

    The Biden administration has had the benefit of learned, reasoned calls (see "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver"; "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver"; "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal"; "IP Organizations Support Continued Opposition to Waiver Proposal") not to scramble willy-nilly down the rabbit hole enticingly proposed by those who may have good hearts but other with less than clear motives.  One of the nascent hallmarks of this administration (as compared with the last one) is an ability to recognize a blunder and correct it; after all, that is what political professionals who aspire to be statesmen are supposed to be able to do.  The negotiation period for any proposed WTO IP waiver gives this administration the opportunity to achieve the desired goal (global COVID-19 vaccination) without harming the global innovation system.  It is an opportunity the President and his administration should take.

  • Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver

    By Donald Zuhn —

    Daines SteveYesterday, Sen. Steve Daines (R-MT) wrote to President Joseph Biden to share his concerns regarding the Biden Administration's support for waiving intellectual property protections for COVID-19 vaccines and urge the President to reconsider his position on the proposed waiver.  In his letter, Sen. Daines (at right) asserted that "[s]uspending World Trade Organization (WTO) obligations to protect IP on COVID-19 vaccines would not only fail to significantly speed up vaccine distribution to the rest of the world, but it would set a dangerous precedent on IP protection at the international level and undermine American innovation."  Sen. Daines also argued that the proposed waiver would "provide[] for a technological windfall for adversaries such as China and Russia by giving away IP that has taken years of hard work and ingenuity by American scientists, not to mention billions in American investment, to perfect."

    Instead of a waiver, Sen. Daines suggested that the Administration should "prioritize fighting COVID-19 internationally by getting more shots in arms in countries who need them without transferring critical technologies and undermining our global leadership position."  He noted that as states decline additional doses of COVID-19 vaccines, "the U.S. should focus on increasing production and capacity to provide support for global vaccine supply and leading the world in vaccine manufacturing and distribution."  Sen. Daines concluded his letter by urging the Biden Administration to withdraw its support for waiving IP protections for COVID-19 vaccines and "terminate any plans to participate in negotiations at the WTO necessary to move this dangerous proposal forward."