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  • USPTO News Briefs

    By Donald Zuhn —

    USPTO Launches Webpage on PTE Applications and Patent Terms Extended under 35 U.S.C. § 156

    USPTO SealIn a Patent Alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced the launch of a new webpage providing information regarding applications for patent term extension (PTE) that have been filed within the past five years and patent terms that have been extended under 35 U.S.C. § 156.  With regard to PTE applications, the new webpage provides access to a spreadsheet listing the application number, patent number, and trade name identified in the PTE application, and provides a link to the electronic file containing the PTE papers.  The USPTO alert indicates that the new webpage was launched in response to stakeholder feedback requesting readily available information about PTE applications.  The USPTO plans to update the information on the webpage on a quarterly basis.


    USPTO Announces Fourth Extension of Modified COVID–19 Prioritized Examination Pilot Program

    In a notice published in the Federal Register (87 Fed. Reg. 38714) in June, the U.S. Patent and Trademark Office announced that it was extending the modified COVID–19 Prioritized Examination Pilot Program, and that requests to participate in the pilot program would be accepted until December 31, 2022.  The pilot program, which was implemented in May of 2020 and has been extended three times previously, allows applicants that qualify for small or micro entity status to request prioritized examination without paying the fees typically associated with such prioritized examination (see "USPTO Announces COVID-19 Prioritized Examination Pilot Program").

    In addition to the requirement that applicants qualify for small or micro entity status, the claims of a participating application must cover a product or process related to COVID–19, and such product or process must be subject to an applicable FDA approval for COVID–19 use.  Such approvals may include, for example, an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA).  Other requirements for participating in the pilot program include making the request at the time of filing of a non-continuing original utility or plant nonprovisional application; at the time of filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. §§ 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or at the time of filing or after the filing of a Request for Continued Examination of a plant or utility application or a national stage of an international application.  However, any application that claims the benefit of the filing date of two or more prior filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. §§ 120, 121, or 365(c) is not eligible for participation in the pilot program.  In addition, requests to participate in the pilot program must include an Application Data Sheet, be made via the Office's patent electronic filing systems (EFS-Web or Patent Center), and qualifying applications cannot present more than four independent claims, more than 30 total claims, or any multiple dependent claims.

    In announcing the extension of the pilot program, the Office noted that as of May 16, 2022, 261 patents had issued from applications that had been accepted under the pilot program, and the average total pendency, from filing date to issue date, for those applications was 280 days.

    As we reported earlier this year in our "Top Patent Law Stories of 2021" webinar, of the 149 patents that recite "COVID-19" or "SARS-CoV-2" in the claims (as of January 2022), 89 issued from applications that had been accepted under the pilot program, and the average total pendency for those applications was 280 days.  This compared favorably with the 41 patents that recite "COVID-19" or "SARS-CoV-2" in the claims where examination was accelerated under the Track One Prioritized Examination Program, and where the average total pendency was 259 days.


    USPTO Announces Continuation of PPH Pilot Program with IMPI

    Mexican Patent Office - Instituto Mexicano de la Propiedad IndustrialIn a notice published in the Official Gazette (1499 OG 496) in June, the U.S. Patent and Trademark Office announced that the Mexican Institute of Industrial Property (IMPI) and USPTO had agreed to extend the Patent Prosecution Highway (PPH) pilot program between the two offices.  Under the PPH pilot program, which was extended to June 30, 2027, the USPTO will treat as timely any PPH request based on IMPI work product filed in the USPTO on or before June 30, 2027.


    USPTO Makes Electronic Filing of PTE Applications Permanent

    In May 2020, the U.S. Patent and Trademark Office announced that because it considered the effects of the COVID-19 pandemic to be an "extraordinary situation" within the meaning of 37 C.F.R. § 1.183, the Office would permit patentees to file initial Patent Term Extension applications that meet certain criteria via EFS-Web or Patent Center (see "USPTO News Briefs, June 2, 2020).  At the time, the Office noted that while the waiver would be "effective only until the USPTO provides further notice," it was making efforts to allow for electronic filing of PTE applications on a permanent basis.

    In a notice of proposed rulemaking published in the Federal Register (87 Fed. Reg. 27043) in May, the U.S. Patent and Trademark Office announced a proposal to amend the Rules of Practice in Patent Cases to require that patent term extension (PTE) applications, interim PTE applications, and any related submissions to the USPTO be submitted electronically via the USPTO patent electronic filing system (EFS- Web or Patent Center).  According to the Office, the proposed rule changes would reduce the administrative burden on PTE applicants, as well as improve administrative efficiency by facilitating electronic file management, optimize workflow processes, and reduce processing errors.  The Office noted that it had received informal feedback with respect to the processing of electronic PTE applications under the COVID-19 pandemic waiver, and stakeholders had communicated unanimous support for electronic filing of initial PTE submissions.  The Office also noted that the USPTO and its partner agencies had successfully implemented a system by which the USPTO electronically transmits a copy of any initial submission for PTE to the relevant agency, and that the new system had not caused any processing errors.

  • Conference & CLE Calendar

    CalendarSeptember 13, 2022 – 2022 Business Methods virtual customer partnership meeting (U.S. Patent and Trademark Office) – 10:00 am to 3:00 pm (ET) on 

    September 14-15, 2022 – FDA Boot Camp conference (American Conference Institute)

    September 15, 2022 – Stakeholder Offerings and Resources (SOaR) virtual training session on Patent Center and Patent Public Search tool (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)

    September 16, 2022 – "Implications of File History Estoppel During Litigation" (National Association of Patent Practitioners) – 12:00 pm to 1:00 pm (EDT)

    September 21-22, 2022 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago, IL

    September 29, 2022 – "Computer-Implemented Inventions in the EPO" – Part II (Schwegman Lundberg & Woessner) -12:00 pm (CT)

  • ACI FDA Boot Camp

    ACIAmerican Conference Institute (ACI) will be holding its 39th Annual FDA Boot Camp conference on September 14-15, 2022 as a VIRTUAL conference.

    The conference will provide attendees with presentations on these topics:

    • Exploring New FDA Initiatives under Commissioner Robert M. Califf
    • Navigating the approval process for drugs and biologics
    • Exploring FDA's Expedited Programs with regard to applicability and eligibility
    • The Nuances of Obtaining Approval for Controlled Substances
    • Clinical Trials for Drugs and Biologics
    • Patents and Related IP Protections and Mechanisms
    • Hatch-Waxman and BPCIA Essentials, follow-on products and generic entry
    • Drugs and Biologics Labeling
    • The Role of Current Good Manufacturing Practices (cGMP) in the post-approval process
    • Advertising and Promotion for Drugs and Biologics
    • Off-label Communications: subtleties and safe zones
    • Adverse Events Monitoring, Pharmacovigilence, Risk Management, and Recalls
    • FDA Enforcement Authority and Actions

    In addition, two pre-conference workshops will be offered on September 13, 2022.  The first, entitled "FDA Law 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws," will be offered from 9:00 am to 12:00 pm EST, and the second, entitled "Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations," will be offered from 1:30 pm to 4:30 pm.  There will also be a post-conference workshop held from 2:30 pm to 5:30 pm on September 15th entitled "Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group."

    A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee for the conference and all three workshops is $2,495 for registration by September 14, 2022.  Registration for the conference alone is $1,795.  The workshops are $400 apiece.  Patent Docs readers are entitled to a 10% discount off of the registration fee using discount code D10-999-PATENTDOCS.  Those interested in registering for the conference can do so here,  by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's 39th Annual FDA Boot Camp.

  • ACI Paragraph IV Disputes Master Symposium

    ACIAmerican Conference Institute (ACI) will be holding its 8th Annual Paragraph IV Disputes Master Symposium on September 21-22, 2022 in Chicago, IL.

    The conference will offer presentations on the following topics:

    • Proposed Hatch-Waxman Reform Measures including live audience polling
    • The Fate of "Skinny Labeling" at the Supreme Court in GSK v Teva
    • The Relationship between Written Description and Enablement in view of Biogen v Mylan
    • Patent Eligible Subject Matter after the Supreme Court Denied Cert in American Axle v. Neapco
    • Venue in the Litigation War Room: Planning Attacks in view of MDL with Joint Defense Groups
    • Diversity, Including Implicit Bias in Life Sciences IP (and How to Reduce It)
    • The Role of the Magistrate Judge in Hatch-Waxman Litigation
    •     Perspectives on ANDA Litigation from District Court Judges
    • Analyzing the Impact of FDA Initiatives On Generic Drug Access and ANDA Litigation
    • The APJs Speak: Practice, Policy and Procedure
    • Interplay of Co-Pending IPR Proceedings and ANDA Litigation and Winning Strategies in Each Forum
    • Restrictions on Reverse Payment Settlement Agreements, in Non-monetary Settlements and FTC Review
    • Cross-Border Business Considerations in Hatch-Waxman Litigation: A Global Approach
    • Obviousness-type Double Patenting and Patent Term: the Effects on Ex Parte Cellect
    • Damages in At-Risk Launch Scenarios
    • Ethical Dilemmas in Paragraph IV Practice: Discovery, Privilege, and Professional Responsibility

    The agenda for the Paragraph IV Disputes master symposium can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee for the conference is $2,395 (or a special $1,895 in-house rate for pharmaceutical & biotech organizations).  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-999-PATENTDOCS.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's Paragraph IV Disputes Master Symposium.

  • USPTO and FDA Webinar on Strategies for Biotech and Medtech Startups

    USPTO SealThe U.S. Patent and Trademark Office and U.S. Food and Drug Administration will be discussing the intricacies that biotech and medtech independent inventors and startups face when securing intellectual property (IP) rights from the USPTO and when seeking regulatory approval from the FDA.  The online program will be held on September 8, 2022 from 10:00 am to 2:00 pm (PT).  Topics to be covered during the webinar will include:

    • Navigating USPTO patent and FDA regulatory processes with an emphasis on biotech and medtech industries
    • Initiatives, strategies, tips, and best practices to protect your discoveries and innovations

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

  • Webinar on National Phase Entry

    J A KempJ A Kemp will be offering a webinar entitled "National Phase Entry Strategy" on September 8, 2022 from 16:00 pm to 17:00 pm (GMT).  Lucy Barnes and Andrew Clark of J A Kemp will explore the factors and national/regional phasing strategies that can be used to optimise international examination from both the cost perspective and for maximising scope of protection.  The webinar will address the following topics:

    • Where to enter the national/regional phase
    • When to enter the national/regional phase (for example we will explore strategies involving staggering national/regional phase entry)
    • What claims to include
    • Prosecution strategies, such as acceleration

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

  • Moderna Sues Pfizer and BioNTech over mRNA Vaccine Technology

    By Kevin E. Noonan –

    ModernaOn Friday, August 26th, Moderna Tx, Inc. and Moderna US, Inc. filed a complaint for patent infringement in Federal district court for the District of Massachusetts against Pfizer, Inc., BioNTech SE, BioNTech Manufacturing GmbH, and BioNTech US, Inc.  (A parallel suit was filed in Germany asserting Moderna's corresponding German patents.)  There are several interesting aspects to this complaint, and perhaps of even greater interest has been the reaction to the filing in light of Moderna's earlier "pledge" to refrain from asserting any of its patents "during the pandemic."

    The complaint asserts three patents, identified herein in the context of the claims set forth in the complaint itself:

    U.S. Patent No. 10,898,574

    Claim 2.  A pharmaceutical composition comprising:
        a plurality of lipid nanoparticles comprising a cationic lipid, a sterol, and a PEG-lipid,
        wherein the lipid nanoparticles comprise an mRNA encoding a polypeptide,
        wherein the mRNA comprises one or more uridines, one or more cytidines, one or more adenosines, and one or more guanosines and wherein substantially all uridines are modified uridines.

    Claim 9.  The pharmaceutical composition of claim 2, wherein the modified uridine is 1-methyl-pseudouridine.

    U.S. Patent No. 10,702,600

    Claim 1.  A composition, comprising:
        a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.

    U.S. Patent No. 10,933,127

    Claim 1.  A method comprising administering to a subject
        a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle
        in an effective amount to induce in the subject an immune response to the BetaCoV S protein or S protein subunit
        wherein the lipid nanoparticle comprises 20-60 mol% ionizable cationic lipid, 5-25 mol% neutral lipid, 25-55 mol% cholesterol, and 0.5-15 mol% PEG-modified lipid.

    Of these three asserted patents, the '574 patent has the broadest claims, not being limited to a particular virus or antigenic protein thereof, while the '600 and '127 patents expressly recite mRNAs encoding a b-coronavirus Spike protein; these claims would encompass vaccines to SARS-CoV-1 (the original SARS pandemic vaccine) as well as MERS and SARS-CoV-2 (COVID19).  These claims in particular form a basis for Moderna's allegations of infringement by the Pfizer/BioNTech Comirnaty® vaccine, as recited in several paragraphs in the complaint.  In particular, Moderna alleges that the Comirnaty® vaccine was a direct copy of their vaccine (a path taken over three other competing candidate vaccines), citing public statements by Pfizer CEO Albert Bourla on June 9, 2020, at Goldman Sachs Virtual 41st Annual Global Healthcare Conference (¶20 of the complaint).

    Perhaps in recognition of the post-pandemic patent zeitgeist, the complaint has two remarkable features.  The first is a long expostulatory section explaining the long antecedents of the technology Moderna was able to apply towards making its Spike mRNA SARS-CoV-2 vaccine (and the skepticism those efforts elicited pre-pandemic).  This portion of the complaint includes a history of Moderna's development of the underlying mRNA technology as well as its efforts to develop its vaccine (unnoted is that Moderna abjured participation in "Operation Warp Speed" with its attendant Federal government financial support) during the pandemic (and makes the point that their technology is not limited to vaccines against COVID infections).  The complaint also makes the case that the company's IP was both the technical foundation for its successful and rapid development of the COVID vaccine and provided protection against the significant financial and investment risk occasioned by Moderna's development of its vaccine.

    The second remarkable feature of the complaint, and Moderna's strategy in bringing suit, is in the Prayer for Relief (and certain sections explaining the limitations of the remedy Moderna asks the Court to grant).  In addition to a judgment that Pfizer and BioNTech infringe by sales of its Comirnaty® vaccine (and that such infringement was willful), Moderna seeks money damages that expressly exclude damages it would be entitled to from "sales to the U.S. government that are subject to 28 U.S.C. § 1498 or to the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC)."  And in the litany of other remedies routinely requested in patent infringement cases (a finding that this is an exceptional case, with an award of attorneys' fees, costs, and expenses under 35 U.S.C. § 285, and treble damages for willful infringement under 35 U.S.C. § 284), expressly excluded is an injunction from "such other relief the Court may deem just and proper."  Deigning to forego compensation for sales to the government under 28 U.S.C. § 1498 is likely done in an effort to avoid any attempt by Pfizer or BioNTech to have the case adjudicated under the statute in the Court of Federal Claims; disclaiming any interest in sales outside the U.S. to countries falling within the scope of the COMAX AMC avoids (or at least tries to) allegations that Moderna is putting its profits and patent rights over the health and lives of the citizens of those countries.

    The complaint also addresses Moderna's promises regarding assertion of its IP, specifically quoting its October 8, 2020 press release stating that "while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic" (italics in original) (¶22).  The complaint also provides Moderna's rationale and justification for filing this complaint at this time:

    By early 2022, however, the collective fight against COVID-19 had entered a new endemic phase and vaccine supply was no longer a barrier to access in many parts of the world, including the United States.  In view of these developments, Moderna announced on March 7, 2022, that it expected companies such as Pfizer and BioNTech to respect Moderna's intellectual property and would consider a commercially-reasonable license should they request one.  This announcement was widely publicized, including through coverage in The Wall Street Journal.  Critically, however, and to further its belief that intellectual property should never be a barrier to access, as part of this announcement, Moderna committed to never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment ("AMC").  This includes any product manufactured outside the AMC countries, such as the World Health Organization's project in South Africa, with respect to COVID-19 vaccines destined for and used in the AMC-92 countries.  Although they have continued to use Moderna's intellectual property, Pfizer and BioNTech have not reached out to Moderna to discuss a license.  (¶23)

    The complaint has nonetheless raised the issue of the status of Moderna's promise in the context of patent pledges in other industries, notably for standard-essential patents (SEP) and FRAND ("fair, reasonable, and non-discriminatory") agreements.  Academics (in particular, Jacob Sherkow from the University of Illinois Law School and Jorge Contreras, S.J. Quinney College of Law, University of Utah Law School) have raised the specter of successful suit by Moderna in the face of its earlier promise as creating a challenge threatening the substantial edifice of patent pledges used in these other contexts.  Some distinctions immediately come to mind, however.  One is that the patent pledges in the SEP/FRAND context are associated with consideration for the pledging party, that consideration consisting of, inter alia, compliance by companies licensing SEPs owned by the pledging patentee that provide stability and consistency in licensing regimes and create impediments against non-compliant companies.  Moderna received no such consideration for its pledge (and the effects of any "good will" it might have hoped to gain was ephemeral; after all, all the pledges in the world did not deter the WTO from adopting a patent waiver agreement at the behest of India, South Africa, and other countries who could expect to benefit and did benefit from agreements like the one in Moderna's complaint exempting sales to the COVAX AMC countries from any damages claims sought by Moderna).  Another distinction is that a fair reading of Moderna's promise-by-press-release was its essentially contingent nature; forgoing (or postponing exercise of) its patent rights was always limited to during the pandemic (although it is a fair question to ask who decides when the pandemic is over).  Finally it is not unfair to say that the SEP/FRAND situation is vastly different from patenting vaccines against a pandemic virus; there is, after all, no analogous risk to global health and welfare arising from patent pledges relating to such patents.

    On the other hand, if a court does hold Moderna's patent promise to be enforceable (under the doctrine of promissory estoppel, for example), it most likely will be the last time any biotechnology or pharmaceutical company makes such a promise.

    There is one other consideration here that may explain Moderna's willingness to file suit at this time that abjures the lion's share of any damages it could reasonably have expected to receive.  Moderna has achieved something of a Holy Grail of patenting:  true platform patents that can be and will be used for the next vaccine, and the one after that, etc.  Bringing a successful suit might result in a healthy damages award but these may pale compared with what could happen during the ~10 -15 years of patent life remaining.  Of course, any suit brings risks and it is not unlikely that Pfizer/BioNTech will petition for inter partes review; indeed, at least one patent owned by the University of Pennsylvania, U.S. Patent No. 8,691,966 (naming BioNTech principal Katalin Kariko as an inventor), discloses and claims mRNA modifications comprising 1-methylpseudouridine (albeit outside the SARS context); this patent has an earliest priority date about 4 years prior to Moderna's patents asserted in the litigation.

    All these considerations make for a compelling story that will almost certainly be the subject of future posts.

  • Guest Post — AI and Inventorship — Will Next Blockbuster Drug Be Denied Patent Protection?

    By Brian A. Pattengale* and Anthony D. Sabatelli** —

    Decades after the science-fiction visions of Stanley Kubrick’s 2001: A Space Odyssey and Isaac Asimov’s I, Robot, artificial intelligence ("AI") is finally moving to the mainstream.  Many of us use digital assistants like Apple's Siri or Google's Alexa every day, and we gape, with a mixture of awe and terror, over videos of the feats of robotic animals and stories over whether AI being developed at Google is displaying signs of sentience.  Along with this, we have finally reached the point in the development of AI where we must confront the legal and policy questions of whether AI can (or should) be able to be an inventor on a patent.

    That very question was recently addressed by the Court of Appeals for the Federal Circuit ("CAFC") in Thaler v. Vidal.1  The patent applicant in the Thaler case argued that he did not invent the subject matter of his patent applications; rather, he asserted they were invented solely by an AI system.2  In its decision, the CAFC swiftly came to the conclusion that the answer to this question is clear from the statute.  U.S. Patent Law clearly and unambiguously states that only natural persons can be named as inventors on patents.  The Court stated ". . . .it might seem that resolving this issue would involve an abstract inquiry . . . however we need not ponder these aphysical matters . . . [i]nstead, our task begins — and ends — with consideration of the . . . statute."  The Court reiterated that the Patent Act requires that inventors are "individuals" and therefore limited to human beings.  End of story.

    In this article we consider what this very clear pronouncement by the CAFC means for drug discovery:  Will the next blockbuster drug potentially be denied patent protection if it is discovered solely through highly sophisticated AI methods?

    According to a 2020 study, it generally takes on the order of 10 years and over a billion dollars to bring a new drug to market, from initial discovery in the lab through preclinical and clinical testing, to eventual approval of the new drug application ("NDA"), and then to marketing and sales.3  Furthermore, the success rate is very low — only approximately 10% of drug candidates make it all the way through the process to approval for marketing.  The drug discovery process is still very empirical, often involving medicinal chemists and their teams synthesizing and evaluating thousands of compounds.  The process also typically relies upon numerous structure activity relationship ("SAR") decisions by those involved to direct the process.  Computer-aided drug discovery ("CADD") technologies have significantly improved this very empirical process, allowing for more efficient utilization of bio- and chemoinformatic information to propose, screen, and perform target-based analyses on drug candidates.  AI-based technologies represent the next forefront of drug discovery, offering the potential to identify optimized drug molecules based on training data without further human input during the identification process.4  To be clear, scenarios such as this are not science fiction — the German biotechnology company Evotec recently partnered with UK-based Exscientia to use AI to identify a new anticancer drug candidate that is currently in Phase I clinical trials.5  Pharma giant Merck is also highly invested in utilizing AI platforms for drug discovery.6

    Experts in the field generally utilize AI systems to perform machine learning or what is known as "deep learning" to make decisions and predictions based upon correlations in training data provided to the system.  For example, in the field of drug discovery, one could start with a general core structure for a drug compound and add to it a large set of chemical substituents for altering the properties of the compound.  With appropriate training data, AI can be used to predict and sift through several tens of thousands, if not millions, of theoretical substituent combinations to identify a limited set of compounds– or even a single specific compound — having selected  target properties.  In this scenario, would AI then be the rightful "inventor" of the target compound, which otherwise might never have been identified but for the use of AI?

    Inventorship in the U.S. is based upon conception of an invention.  Activities undertaken simply to reduce an invention to practice are not sufficient to confer inventorship.  The Manual of Patent Examination Procedures ("MPEP"), provides unambiguous guidance for inventorship, even specifically for chemical compounds.  MPEP § 2109 II states:  "General knowledge regarding the anticipated biological properties of groups of complex chemical compounds is insufficient to confer inventorship status with respect to specifically claimed compounds".7  Therefore, in a simplified scenario, a medicinal chemist having expert knowledge of a broad genus of compounds would not necessarily be the inventor of a specific chemical compound falling under that genus, if that compound was discovered by another chemist on the team.  That other chemist would most likely be the inventor.  Suppose now, instead of that compound having been identified by another chemist, it is identified by AI.  Following the same logic, would not AI now likely be the rightful inventor?

    For the sake of discussion, let's assume that AI fully predicts a previously unknown compound as a particular drug target.  That target compound is tested for efficacy, safety, etc. and becomes a candidate that is eventually approved for use and reaches blockbuster sales status.  Even though humans were involved in the synthesis, testing, clinical trials, and approval process, none of those activities would constitute conception (i.e., invention) of this drug compound.  The humans were "told" by AI exactly which compound to make and would only be reducers to practice, having therefore not contributed to the original conception of that particular drug compound.

    Taking this scenario to its seemingly perverse conclusion, under current U.S. Patent Law as recently pronounced by the CAFC, the AI-discovered target compound would be unpatentable because AI cannot be an inventor on the patent and no human could specifically be identified as the discoverer of that compound.  In the absence of patent protection, this AI-identified compound could then likely end up in the public domain.  This result is at odds with the public policy standpoint of our patent system which rewards innovation by placing patented inventions before the public to encourage further innovation, while providing the patentee with an exclusivity for the term of the patent, which is generally twenty years.8

    The above thought exercise, to our knowledge, has not yet played out.  But it soon could.  There may, however, be a solution to this apparent dilemma, albeit not one that is completely satisfying or sufficiently tested through litigation.  Because U.S. inventorship is based upon the patent claims, and a co-inventor need only contribute to the conception of a single patent claim to be listed as an inventor on a patent, it is entirely possible that a human inventor could conceive of a single claim or claim limitation, or even an alternative claimed embodiment, in order to be rightfully included on a patent otherwise directed to an AI-generated compound.  For example, the chemists on the AI project may conceive of or discover salts or solvates of the compound, functional limitations related to the compound, closely related compounds, methods of using the compound, methods of synthesizing the compound, etc., which could likely be sufficient for establishing human inventorship — at least to those claims reciting these limitations.

    In Thaler, the Federal Circuit intentionally left certain questions unresolved by stating that the Court was " . . . not confronted today with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection".  It seems that there are arguments that a human being would have contributed to the inventions (i.e., claims) thereby meeting the inventorship threshold of the Patent Act.  Time will only tell how this scenario plays out.  Perhaps the more important million-dollar question (or, rather, multi-billion dollar question with respect to drug discovery) is whether or not a patent claim directed to a drug compound identified solely through AI, and having no human inventor, would be valid in view of Thaler.

    1 Thaler v. Vidal, U.S. Court of Appeals for the Federal Circuit, 2022, case number 21-2347

    2 Mr. Thaler was issued a patent in South Africa with his AI system DABUS listed as the inventor, a world first, and Europe and Australia both rejected the applications.  An Australian judge initially ruled that AI can be an inventor, and that decision was overturned earlier this year by a higher court.

    3 https://www.biospace.com/article/median-cost-of-bringing-a-new-drug-to-market-985-million/

    4 Paul, D. et al. "Artificial intelligence in drug discovery and development", 2021, Drug Discov. Today, 26:1, pp. 80–93

    5 https://www.fiercebiotech.com/medtech/merck-selects-saama-add-machine-learning-tech-drug-development-process; https://www.emdgroup.com/en/research/science-space/envisioning-tomorrow/precision-medicine/generativeai.html

    6 https://www.nature.com/articles/d43747-021-00045-7

    7 Ex parte Smernoff, 215 U.S.P.Q. 545, 547 (Bd. App. 1982)

    8 In Thaler v. Vidal, Mr. Thaler did include related policy arguments, which the Federal Circuit dismissed in view of its reliance on the statutory language that Congress chose.

    * Dr. Pattengale is a patent agent at Wiggin and Dana.  Dr. Pattengale received his Ph.D., Physical and Materials Chemistry from Marquette University, and his B.S., Biochemistry from Carroll University.
    ** Dr. Sabatelli is Patent Counsel at Wiggin and Dana.  Dr. Sabatelli received his J.D., cum laude, from the Salmon P. Chase College of Law.  He received his Ph.D., with Honors, in Organic Chemistry from Yale University, and his B.S., summa cum laude, in Chemistry from Fairfield University.

    This article was originally published on the Wiggin and Dana website on August 17, 2022.

  • Oral Arguments Rescheduled in CRISPR Interferences

    By Kevin E. Noonan –

    USPTO SealOn August 16th, the Patent Trial and Appeal Board rescheduled back-to-back oral hearings for interferences between ToolGen Inc. (Senior Party) and Junior Party The Broad Institute, Massachusetts Institute of Technology, and The President and Fellows of Harvard College (collectively, "Broad," Interference No. 106,126) and Junior Party The Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, "CVC," Interference No. 106,127).  In the '126 Interference, the hearing will commence at 1:00 pm EDT on September 12th, and for the '127 interference, the hearing will start at 3:00 pm EDT that day.  The hearings will be conducted by telephone.  In the Notices in each interference, the Board’s Order stated that postponement was at Senior Party ToolGen’s request.

    Interested members of the public may be granted access by request sent to PTABHearings@uspto.gov at least five business days prior to the hearing date.

    The issues to be discussed can be found on the PTAB website and in several prior Patent Docs posts.

  • Conference & CLE Calendar

    CalendarAugust 30, 2022 – "Litigating Inventorship — When and How to Change Named Inventors on an Issued Patent" (IPWatchdog and Ludwig, APC) – 12:00 pm (ET)

    September 1, 2022 – "Computer-Implemented Inventions in the EPO" – Part I (Schwegman Lundberg & Woessner) -12:00 pm (CT)

    September 1, 2022 – "Telling Stories to Clients with IP Intelligence" (IPWatchdog and PatSnap) – 12:00 pm (ET)

    September 29, 2022 – "Computer-Implemented Inventions in the EPO" – Part II (Schwegman Lundberg & Woessner) -12:00 pm (CT)