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  • Webinar on Patentability of Simulations at the EPO

    J A KempJ A Kemp will be offering a webinar entitled "Patentability of Simulations at the EPO" on June 30, 2021 at 16:00 pm BST (GMT+1).  John Leeming of J A Kemp will detail the approach of the EPO to computer-implemented inventions (including simulations) and consider what the recent G 01/19 does (and does not) tell us about the patentability of simulations and computer-implemented inventions in general, and also provide practical advice regarding the drafting and prosecution of applications directed to computer-implemented inventions in Europe in light of the decision.  The webinar will address the following topics:

    • The EPO's general approach to computer-implemented inventions
    • What G 01/19 tells us about how this approach should be applied to simulation inventions
    • Further guidance in the decision regarding how the EPO views important concepts such as technicality
    • Practical tips for drafting applications directed to computer-implemented inventions in light of G 01/19
    • Helpful arguments that can be deployed in prosecution

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

  • IPO Webinar on Waiving IP Protections to Address COVID-19

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Waiving IP Protections to Address COVID-19: The WTO Proposals and Ensuring Equitable Access to the Vaccines" on June 30, 2021 from 12:00 pm to 1:00 pm (ET).  Tanuja Garde of Raytheon Technologies; David Kappos of Cravath, Swaine & Moore LLP; James Pooley of James Pooley, PLC; and Tony Rollins of Rollins IP Strategies Ltd. will share information about the status of the waiver proposals made by India and South Africa and the European Union's proposal to increase the global supply of COVID-19 vaccines, the logistics of negotiations at the WTO, and the roles of various U.S. governmental and international agencies.  The panel will also discuss questions such as whether a waiver would actually increase access to vaccines and other technologies, the impact of a waiver on innovation, impediments to ensuring broader vaccine access, and the effectiveness of ongoing voluntary efforts to distribute the vaccine and other important technologies more widely.

    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.

  • Webinar on Discretionary Institution in PTAB Proceedings

    Fitch EvenFitch Even will be offering a webinar entitled "The Better Part of Valor? Discretionary Institution in PTAB Proceedings" on June 30, 2021 from 12:00 pm to 1:00 pm (ET).  David A. Gosse and Karen J. Wang of Fitch Even will discuss the following topics:

    • How the PTAB exercises its discretion to deny institution in the face of parallel district court proceedings, e.g., in the Western District of Texas "rocket docket"
    • Whether prior reexamination, IPR, PGR, or even prosecution will cause the PTAB to exercise its discretion and deny institution
    • Why the PTAB may or may not deny institution of multiple petitions challenging a single patent

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • ACI Advanced Summit on Life Sciences Patents Conference

    ACIAmerican Conference Institute (ACI) will be holding its 19th Advanced Summit on Life Sciences Patents conference on July 21-22, 2021 as a virtual conference.

    The conference will offer presentations on the following topics:

    • Refining global patenting strategies in the U.S., Europe, China, and Brazil
    • Gauging the continued impact of the COVID-19 pandemic, including compulsory licensing and march-in rights
    • A PTAB year in review, including latest developments at the Board, the Federal Circuit, and an update on the Arthrex case
    • Future landscape of Section 101: Will there ever be clarity?
    • An international perspective on written description and enablement standards in antibody claims
    • Examining the recent surge in doctrine of equivalents decisions
    • Developments in patent term extensions in the U.S. and Europe, including the implications of Biogen v. Banner and Europe's SVC manufacturing waiver
    • Obviousness, obviousness-type double patenting, and inherency
    • Method of treatment and second medical use claims, personalized medicine and dosage regime patents
    • Separate interactive sessions from life sciences litigators regarding what they wish the prosecutor had done, the implications on skinny labels of GSK v. Teva, and ethical dilemmas in patent prosecution

    The registration fee for the conference is $1,595 if registered and paid by July 2nd and $1,695 if registered and paid by July 20th.  There is an in-house counsel rate of $1,295 available until July 20th.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-762-762DX03.  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 19th Advanced Summit on Life Sciences Patents Conference.

  • ACI Annual Practitioners’ Think Tank on ITC Litigation and Enforcement

    ACIAmerican Conference Institute (ACI) will be holding its 13th Annual Practitioners' Think Tank on ITC Litigation and Enforcement conference on July 27-28, 2021 as a virtual conference.

    The conference will offer presentations on the following topics:

    • ITC State of the Union: Predictions for the future
    • ITC Year in Review, including the Top Ten developments in 2021 and forecasts for 2022
    • Evaluation of trade secret jurisprudence at the ITC
    • Public interest considerations in 337 investigations
    • Discretionary denials and developments in parallel proceedings before the ITC and PTAB
    • Satisfaction of the domestic industry requirement
    • New NPE 337 tactics and what ITC practitioners need to know in 2021
    • In-house counsel perspectives, including insights and best practices for managing ITC actions
    • Winning strategies for enforcing exclusion orders
    • ALJ insights on procedures and effective trial strategies
    • How to maneuver the 100-day early disposition program and assessing its merits
    • Keynote addresses from ITC leaders and 1:1 virtual networking

    The registration fee for the conference is $1,295 if registered and paid by June 18th and $1,895 if registered and paid by July 26th.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-868-868DX02.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    ACI is offering a limited amount of complimentary in-house passes to their 13th Annual Practitioners' Think Tank on ITC Litigation and Enforcement conference.  Apply for your complimentary pass here.

    Patent Docs is a media partner of ACI's 13th Annual Practitioners' Think Tank on ITC Litigation and Enforcement Conference.

  • ACI Women Leaders in Life Sciences Law Virtual Conference

    ACIAmerican Conference Institute (ACI) will be holding its 8th Annual Women Leaders in Life Sciences Law Virtual Conference on July 28-29, 2021 from 10:00 am to 5:45 pm EDT.  ACI faculty will give presentations on:

    • Opening remarks from the Conference co-chairs on the impact of the past year on women in the life sciences industry
    • An interactive session on working together to restore and boost female workforce momentum in the wake of the pandemic
    • Examination of key legal developments impacting life sciences
    • Getting hired and noticed in the virtual world, including tips and tools for interviewing, onboarding and moving up in the virtual environment
    • An honest discussion on what's working and what's not in diversity and inclusion efforts, including how to keep strong female talent once it's in the door
    • Empowering female conferences across generational boundaries
    • Setting boundaries and achieving personal and professional balance
    • Tacking COVID pandemic-related legal challenges faced by life sciences companies
    • Knowing your worth, and asking for it, including ways to effectively negotiate salaries
    • Advice from inspiring and influential General Counsel

    There will also be a keynote address by Dr. Julie Gerberding and opportunities for 1:1 virtual networking.

    An agenda for the conference, a brochure, and additional information regarding the workshops can be found here.  The registration fee is $1,495 with paid registration by July 29th.  An on-demand version of last November's conference is available for $895.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-684-684DX05.  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 8th Annual Women Leaders in Life Sciences Law Virtual Conference.

  • BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP

    By Donald Zuhn —

    Biotechnology Innovation OrganizationIn a message distributed to Biotechnology Innovation Organization (BIO) members, Dr. Michelle McMurry-Heath, BIO President and CEO, released a declaration signed by the corporate and organizational leaders of 209 global biotechnology companies and 41 biotech associations, in which the signatories acknowledged their "social responsibility to work with other stakeholders — healthcare providers, governments, multilateral organizations, and non-governmental donor organizations — to ensure that COVID vaccines and treatments get to the patients in the world who most need them."

    Dr. McMurry-Heath began her message to BIO members by recognizing "the ongoing effort by some political leaders to strip our scientific intellectual property rights pertaining to vaccines and treatments for COVID-19," and noting that "[t]his proprietary science and technology was developed by our scientists working day and night at great financial risk to our companies."  The BIO CEO also highlighted BIO's efforts to establish a COVID-19 global Strategy for Harnessing Access Reaching Everyone (SHARE) program, which seeks to ensure a sufficient global supply of COVID-19 vaccines, to ensure safe and expeditious global access to COVID-19 vaccines and therapeutics, and to strengthen and support healthcare systems in low-and middle-income countries in addressing COVID-19.  Dr. McMurry-Heath also pointed out that biotech companies "ARE sharing our IP and know-how through almost 300 voluntary global agreements to increase vaccine manufacturing and distribution capacity."  Yet, the BIO CEO notes that these efforts have "not changed the minds of those who believe we should simply turn over all of our science to countries around the world," an idea Dr. McMurry-Heath asserts "is misguided, and most importantly, won't solve the problem."

    The declaration sets forth five statements or goals.  First, the signatories state that the biotech sector "must continue to play a constructive, proactive part in developing COVID solutions and the global manufacturing capacity to produce them."  The declaration notes that in the past year, more than 950 global R&D projects have been launched on COVID-19 vaccines, treatments, and biologics, and more than 250 global partnerships have been formed to build manufacturing capacity.

    The declaration next states that intellectual property is the foundation of the biotech sector, explaining that:

    [Intellectual property] is responsible for creating the global biotech network that responded so quickly to the COVID crisis in the first place.  It is what gives investors the confidence to fund companies with long time horizons and high risks.  It gave companies the assurance that they could quickly pivot during the early days of the pandemic into COVID projects.  And it helped ensure the type of global cooperation and partnerships that are driving companies, countries, and manufacturers to quickly scale up the production.

    The signatories also express their support for strong, collaborative efforts like those endorsed by the G-20 to address the global imbalances in access to COVID vaccines and treatments.

    Turning to the proposed World Trade Organization (WTO) waiver of intellectual property rights, the signatories declare that the proposed waiver "will be ineffective and counterproductive in addressing this crisis," arguing that:

    Intellectual property rights are not responsible for the imbalance in COVID vaccine supplies between higher and lower income countries.  It will create a long contentious global negotiation that will not urgently address the crisis, and foster more "vaccine nationalism," exacerbating shortages in an already strained global supply chain.  It would divert limited resources from companies that are focused on maximizing current global partnerships while maintaining quality and patient safety.  Lastly, it would send a powerful signal to the biotech sector and investors to avoid taking the risks to develop solutions in future public health emergencies.

    The declaration concludes with the goal of producing more than 11 billion doses of COVID-19 vaccines in 2021, and significantly more in the first part of 2022, and a commitment by the signatories to work with other global stakeholders "to see that these doses get to those that most need them, wherever they may be."

    A list of the corporate and organizational signatories to the declaration can be found here.

  • Meanwhile . . . ToolGen Files Substantive Motion No. 1 in Interference with CVC

    By Kevin E. Noonan —

    ToolGenLest we forget, there are two other interferences proceeding before the Patent Trial and Appeal Board, one of which (Interference No. 106,127) names ToolGen as Senior Party and as Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC").  In March, the PTAB granted leave for the parties to file Preliminary Motions and on May 20th, ToolGen filed its Substantive Motion No. 1 for benefit of priority.

    As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. provisional application, Serial No. 61/717,324, filed October 23, 2012 ("P1"), resulting in ToolGen having an earlier priority date than either CVC or Junior Party in related Interference No 106,126, the Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad").  ToolGen submitted this motion to be accorded benefit of priority to two later-filed, related applications:  U.S. Provisional Appl. No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Appl. No. PCT/KR2013/009488, filed Oct. 23, 6 2013 ("PCT").  ToolGen in its motion explains that it is submitting this motion contingent on the Board granting CVC Substantive Motion No. 2, which attacks ToolGen's entitlement to priority to the P1 priority document (said motion being the subject of a later post).  The brief sets out graphically the relationship of these priority documents:

    Image 1
    The brief then sets out the basis for ToolGen's claim of priority, setting forth its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) with regard to two embodiments falling within the scope of the Interference Count.  ToolGen specifically illustrates satisfaction of that alternative language of the Count that recites claim 18 (dependent on claim 15) of Broad's U.S. Patent No. 8,697,359, the brief annotating the limitation recited therein to facilitate identification of ToolGen's disclosure corresponding thereto:

    [1] An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising
    [2] a Cas9 protein and
    [3] at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell,
    [4] wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and
    [5] the Cas9 protein cleaves the DNA molecules,
    [6] whereby expression of the at least one gene product is altered; and,
    [7] wherein the Cas9 protein and the guide RNA do not naturally occur together;
    [8] wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

    The brief takes pains to recite satisfaction of each element with reference to Examples 3 and 4 of the P3 (PCT) priority document, noting that one such embodiment (designated 3-1) comprise a Foxn1-specific sgRNA and a Cas9 mRNA, while embodiment 3-2 comprises the same sgRNA and recombinant Cas9 protein.  And in each case, the Examples illustrate CRISPR-mediated cleavage and editing of the target Foxn1 DNA in mouse embryos expressed in the resultant genetically engineered mice.  The CRISPR-Cas9 complex is illustrated in the brief by this drawing:

    Image 2
    wherein "target DNA [is] in the green box, DNA-targeting sequence of crRNA [is] in the blue box, crRNA:tracrRNA duplex linked together by a -GAAA- loop [is] in the red box, remaining tracrRNA portion shown with brown underline, Cas9 protein with label shown with purple underline depicted as a shaded oval, which is in complex with sgRNA and cleaves the target sequence in the target DNA."

    The brief also notes the portions of the P3 priority document showing such CRISPR-Cas9 complexes successfully cleaved and edited the target Foxn1 DNA.

    The brief argues that this extensive disclosure in the P3 priority document "provides abundant working examples and considerable guidance to a [person of ordinary skill in the art] to make and use CRISPR/Cas9 in eukaryotic cells."

    ToolGen also notes that the P3 priority document shares the same specification with U.S. Application No. 14/685,510, to which the Board has recognized ToolGen's entitlement to priority.  Accordingly, ToolGen argues that the skilled worker would recognize that the PCT application enables at least one embodiment falling within the Count and that as a result this disclosure constitutes a constructive reduction to practice of the Count.  While the brief focuses in most detail on the disclosure of Example 3 (if only because disclosure of only one embodiment falling within the scope of the Count is needed), the brief also sets forth an assessment of how what is disclosed in Example 4 also satisfies the requirement as a constructive reduction to practice of embodiments falling within the scope of the Count.

    The brief concludes by noting that "PCT provides additional disclosures, such as examples of Cas9 sequences that are codon optimized and contain an NLS tag, to further illustrate various embodiments of the Count" and thus provides ToolGen's constructive reduction to practice for yet additional embodiments falling within the scope of the Count.

    ToolGen has filed an identical motion as its Substantive Motion No. 1 in related interference No. 106,126 naming Broad as Junior Party.

  • Senate Passes the Endless Frontier Act

    By Michael Borella and Carlton Hemphill —

    Senate SealIn a rare showing of bipartisanship, the U.S. Senate has passed Senate Bill S.1260, the "Endless Frontier Act."  Co-sponsored by senators Schumer, Young, Hassan, Collins, Coons, Portman, Baldwin, Graham, Peters, Blunt, Daines, Van Hollen, Romney, and Kelly, the bill most notably seeks to establish "a new Directorate for Technology and Innovation in the National Science Foundation [and] to establish a regional technology hub program."

    The goal of these efforts is to increase U.S. capabilities in key technology areas that are believed to be able to provide the country with a competitive advantage in the global economy.  The bill outlines doing so in a way that increases diversity and inclusion in STEM fields while reducing the geographic concentration of R&D and the STEM workforce.  If signed into law in its current form, Congress will be able to authorize just short of $250 billion in funding for R&D, education, technology transfer, and intellectual property over the course of five years.

    The key technologies listed are:

    (A) Artificial intelligence, machine learning, autonomy, and related advances.

    (B) High performance computing, semiconductors, and advanced computer hardware and software.

    (C) Quantum information science and technology.

    (D) Robotics, automation, and advanced manufacturing.

    (E) Natural and anthropogenic disaster prevention or mitigation.

    (F) Advanced communications technology and immersive technology.

    (G) Biotechnology, medical technology, genomics, and synthetic biology.

    (H) Data storage, data management, distributed ledger technologies, and cybersecurity, including biometrics.

    (I) Advanced energy, batteries, and industrial efficiency, including advanced nuclear technologies for the purposes of electric generation.

    (J) Advanced materials science, including composites and 2D materials.

    One significant focus of the bill is to ramp up domestic semiconductor development and manufacturing.  Due to the COVID-19 crisis, multiple industries are being impacted by a chip shortage, and the bill allocates approximately $52 billion in assistance to semiconductor manufacturing companies.

    Specifically regarding patents, the bill permits entities engaged in academic technology transfer to use awarded funding to offset the cost of patenting and licensing their research efforts.  Further, granted patents may be used as a metric in determining the effectiveness of funding allocated to regional technology hubs.  For the manufacturing and industrial sectors, the bill states that:

    Federal patent policies should be developed, based on uniform principles, which have as their objective to preserve incentives for industrial technological innovation and the application of procedures that will continue to assure the full use of beneficial technology to serve the public.

    Notably, the bill in its current form places no additional requirements on the USPTO.  Further, the bill does not address the current judicial assault on the patent-eligibility of certain types of software and devices.  Inventions in a number of the listed key technology areas have an above-average chance of being viewed as ineligible for patenting under current Supreme Court and Federal Circuit jurisprudence.

    In addition to its apparent (though somewhat tepid) support of patenting, the bill requires that intellectual property developed through its funding cannot be transferred to any foreign entity of concern, any U.S. subsidiary of a foreign entity of concern, and any for-profit, or non-profit, partnership that includes a foreign entity of concern.  Foreign entities of concern include foreign terrorist organizations, any "specially designated nationals and blocked persons" as listed by the Department of Treasury, governments engaged in certain types of espionage against the U.S., governments to which export of arms is controlled, and certain other types of entities.

    Specific provisions restrict funding or consortium membership to companies or organizations of the People's Republic of China or companies over which the People's Republic of China is deemed to have an undue amount of control.  These and other provisions have already caused the bill to be criticized by that country's foreign ministry.

    The bill has its domestic detractors on both the left and the right.  Liberals, such as Senator Bernie Sanders, have complained that the bill hands over billions of dollars to already-wealthy high-tech companies without giving the American people a piece of that pie.  On the other hand, conservatives, such as Senator Rand Paul, criticized the National Science Foundation as engaging in "wasteful spending" and appear to prefer a private-sector, free-market response.

    Nonetheless, the bill passed the Senate 68-32, and has the support of President Biden.  The bill still has to clear the hurdle of the House of Representatives, where the Democrats have a slim majority but also a very vocal progressive caucus that might push for an approach that mitigates the concerns of Senator Sanders.

    Large government spending programs like the one set forth in the Endless Frontier Act have historically been drivers of U.S. innovation, including the Apollo moon missions and the development of the Internet.  In 2020, U.S. government funding of R&D slid to 0.7% of GDP, whereas such spending peaked at 2.2% in 1964.  In contrast, China's R&D was 2.4% of its GDP in 2020.

  • USPTO Webinar on China IP

    China_WebinarThe U.S. Patent and Trademark Office will offer a webinar entitled "China IP: Quarterly Legislation and Case Law Update" on June 24, 2021 from 1:00 to 2:30 pm (ET).  The webinar, which is the first of a planned series of quarterly updates, will cover the latest developments in intellectual property (IP) law in China.  The program will provide timely, up-to-date information on the latest IP legislative and case law developments in China during 2020 and the first half of 2021, during which China passed and implemented a myriad of IP-related measures.

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