PIUG Biotech 2023 - Plenary

Contents

2023 BIOTECHNOLOGY CONFERENCE

February 28 – March 1 Kimpton Marlowe Hotel Cambridge, Massachusetts

Plenary Sessions: TUESDAY

Meeting Book prepared by BizInt Solutions Inc., a proud sponsor of the 2023 PIUG Biotechnology Conference

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PIUG 2023 Biotechnology Conference

Message from the Chair

Welcome to the PIUG 2023 Biotechnology Conference!

2023 BIOTECHNOLOGY CONFERENCE COMMITTEES PIUG Board Liaison : Victoria Smith Planning : Qin Meng Program : Greg Roland, Alison Taylor Evaluation : Christine Geluk Operations : Ken Koubek Publicity : Christine Geluk Meeting Book : Diane Webb Web Pages : Richard Williams Sponsorship : Jane Thompson, Ken Koubek Workshops : Monica Weiss-Nolan Registration : Donna Fisher Bobrick Exhibitor Liaison : Monica Weiss-Nolan

On behalf of the PIUG Board of Directors, I want to welcome you to the PIUG 2023 Biotechnology Conference. The organizing committees have worked hard to put together an outstanding program for you of presentations from information professionals in the biotech industry. I hope you take advantage of the opportunities to attend the workshops, to spend time with our sponsors, to network and to make a new friend or two! So glad you could join us! Thank you to our sponsors, our speakers, and all the volunteers who make this conference possible. Thank you, the attendees, for your support and patience with our changing formats for these meetings. We are glad for your support as we continue to look for making these meetings meaningful and valuable for all.

Enjoy the Conference! Please share your feedback with us!

Kartar Singh Arora, PIUG Chair (2022-2024)

PLEASE GIVE US YOUR FEEDBACK ON THE CONFERENCE AT: https://form.jotform.com/biotechconf/PIUG23BIO

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Thank you to our Sponsors!

Explore the Biotech Universe with BizInt Smart Charts for Patents – your solution for integrating IP sequence, patent and non-patent literature, and chemical structure data. Since 1996, IP searchers and analysts have used the BizInt Smart Charts product family to create multi-database reports and visualizations – turning search results into intelligence as a foundation for strategic decisions. Aptean GenomeQuest enables companies to search worldwide patent literature for biological sequences. Its database, GQ-Pat, is the largest repository of sequences cited in patents. IP profession

GOLD

als and law firms use GenomeQuest to perform freedom to operate, patentability, validity, and prior art searches. GenomeQuest serves 18 of the top 20 pharmaceutical companies and all five top agrochemical companies, with a customer base of nearly 200 leading life science and biotechnology organizations.

SILVER

CAS is a leader in scientific information solutions, partnering with innovators around the world to accelerate scientific breakthroughs. CAS employs over 1,400 experts who curate, connect, and analyze scientific knowl edge to reveal unseen connections. For over 100 years, scientists, patent professionals, and business leaders have relied on CAS solutions and expertise to provide the hindsight, insight, and foresight they need so they can build upon the learnings of the past to discover a better future.

CAS is a division of the American Chemical Society. Connect with us at cas.org.

Minesoft develops global patent databases & solutions, winning the prestigious Queen’s Award for Enterprise in 2009 and 2015 for outstanding growth internationally. PatBase is a sophisticated global searchable patent database offering analytics. A new NPL solution broadens searches beyond patents

whilst a new Semantic Search facility further aids patent discovery and subject searching. Chemical Explorer offers a text-mined searchable database of chemical structures and chemical terminology extracted from over 11 million full-text patents.

BRONZE

Founded in 2007, PatSnap is the company behind the world’s leading Connected Innovation Intelligence platform. PatSnap is used by more than 10,000 customers in over 50 countries around the world to access market, technology, and competitive intelligence as well as patent insights needed to take products from ideation to commercialization. Customers are innovators across multiple industry sectors, including Biotechnol ogy, Medical devices, Pharmaceuticals, Chemical, Electronics Manufacturing, Automotive, Consumer Goods,

Aviation & Aerospace, Education, Legal Firms.

JOIN US AT THE PIUG 2023 ANNUAL CONFERENCE! 30 April - 3 May in Alexandria, VA

Registration is now open for the PIUG 2023 Annual Conference, and Early Bird Registration ends on March 26. Join us for a truly great conference to meet others with a professional interest in patent information within a block of the USPTO. This year we will have a slightly different format. There will be some speakers but there will also be some unconference sessions. Participants will vote on unconference sessions that they would like to participate in and then break into small group sessions. We are trying to facilitate as much interaction as possible. The in-person plenary sessions at the Westin Alexandria run fromMonday, May 1 to Wednesday, May 3, but you’ll have many great opportunities to learn and connect throughout the conference.

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 M O R N I N G S P E A K E R S

Standing on the Shoulders of Warring Giants: mRNA Vaccines Patents Three Years into the Pandemic Thomas H. Ehrich, Counsel at RMMS LLP 9:00 – 9:45 am  ABSTRACT One of the few bright spots of the COVID-19 pandemic has been the speed with which mRNA vaccines were developed against it. For example, Moderna developed is mRNA-1273 vaccine within days of receiving the genetic sequence of the SARS-CoV-2 virus that causes COVID-19, and was ready for human trials within two months. Pfizer/BioNTech developed its COVID-19 mRNA vaccine, BNT162b2, with similar rapidity. Now, three years into the COVID-19 pandemic, Moderna has filed patent infringement suits against Pfizer in the United States and Germany, and has itself been sued by Arbutus for alleged infringement of patents related to the nanoparticles used to convey the mRNA component to the body’s cells. This presentation will discuss technical aspects of COVID-19 mRNA vaccines, including the simultaneous convergence of technologies that made them possible, as well as explaining why this convergence complicates both current lawsuits and future patent strategies.  BIOGRAPHY Thomas Ehrich is Counsel at RMMS LLP, a Chicago-based law firm that specializes in patent litigation and counseling for clients in the pharmaceutical and biotechnology sectors. Prior to this, he worked with Cambia in Australia to develop the biological sequence analytic tools for the Lens (www.lens. org). He has a Ph.D. in molecular biology fromWashington University in St. Louis, and a law degree from Northwestern University in Chicago.

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Standing on the Shoulders of Warring Giants: mRNA Vaccines Patents Three Years into the Pandemic  Thomas H. Ehrich, Counsel at RMMS LLP

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 M O R N I N G S P E A K E R S

Understanding in Vitro Diagnostic Inventions: What Can Be Claimed andWhere? LisaMueller, Casimir Jones 9:45 – 10:30 am

 ABSTRACT The worldwide in vitro diagnostic market is expected to exceed $127 billion in 2022. Over the course of the last three years, there was a renewed understanding of the importance of diagnostic inventions in controlling and managing the spread of deadly viruses, such as COVID-19. Intellectual property protection for these inventions is critical to provide the incentive needed for companies to spend the millions of dollars needed to develop such tests, not only to protect against deadly viruses, but also to diagnose and monitor the treatment of diseases such as HIV, heart disease, Alzheimer’s disease and much more. This presentation will examine the types of patent claims available for diagnostic inventions in various jurisdictions and challenges associated with getting such claims.  BIOGRAPHY Lisa Mueller is a shareholder at Casimir Jones. For over twenty-five years, Lisa has provided strategic counsel on complex patent issues to clients in the plant, food, pharmaceutical, biopharmaceutical, biotechnology, diagnostic, and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on the global patent protection, freedom to operate and validity of the products they aim to produce and distribute. Lisa also edited and authored a chapter in the book entitled, “Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions” published by Wolters Kluwer, and the host of the podcast, AUTM in the AIR, a weekly podcast which interviews the leaders in Technology Transfer. Lisa is also involved in a number of equity, diversity and inclusion initiatives, including the creator and instructor of the Casimir Jones Life Sciences Patent Academy and the Chair Elect of the AUTM Equity, Diversity and Inclusion Committee.

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Understanding in Vitro Diagnostic Inventions: What Can Be Claimed andWhere?  LisaMueller, Casimir Jones

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Product Reviews (Gold & Silver Sponsors)

10:30 am: BizInt Smart Charts (Gold Sponsor)

11:45 am: Aptean GenomeQuest (Silver Sponsor)

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Product Reviews: BizInt Smart Charts, Aptean Genome Quest

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The journey continues...

Explore the Biotech Universe

BizInt Smart Charts for Patents is your solution for integrating IP sequence, patent and non-patent literature, and chemical structure data into multi-database reports & visualizations. • Import IP search results from STN, Orbit, GenomeQuest, PatBase and other leading databases.

• Create integrated reports with the improved Reference Rows workflow. • Export reports to Word and Excel — with new enhanced templates!

Learn more! • Talk with us in the exhibit room on Tuesday &Wednesday • Come to our workshop on Wednesday, 1:00 -2:00 pm

www.bizint.com

Join the GenomeQuest Team at PIUG!

Aptean GenomeQuest

Comprehensive IP Sequence Search At Your Fingertips Aptean GenomeQuest is the industry standard in intellectual property (IP) sequence search. Offering the world’s largest IP sequence database and state-of-the-art sequence comparison algorithms, GenomeQuest combines the most comprehensive view of the patent landscape with powerful search, analysis and reporting tools. Download the datasheet here

Product Overview Video

Are you Ready to Learn More? Contact Us at info@aptean.com or visit www.aptean.com.

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 M O R N I N G S P E A K E R S

Sustainably Feeding Eight Billion People: What Technologies Can Help Enable It? Matthew L. Madsen, Bayer 11:00 – 11:45 am

 ABSTRACT The technology and information needed to enable the production of nutritious food for our expanding global population is growing exponentially. Tools from DNA/genome sequencing to Transgenics have improved our ability to produce more food in a smaller area. Based on this presentation you will understand the fundamentals of plant breeding and some of the technologies currently driving an era of incredible innovation in food production. You will further understand the basic strategies for the claiming and searching these technologies.  BIOGRAPHY Matthew was raised on a small dairy farm in Idaho, where he learned a love for nature and sciences. This led him first to complete a Ph.D. in biochemistry and then to a, so far, 24-year career as an intellectual property professional. For the past 17 years he has been with Bayer (via Monsanto) where his work has focused on protecting and licensing intellectual property for agriculture-related inventions.

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Sustainably Feeding Eight Billion People: What Technologies Can Help Enable It?  Matthew L. Madsen, Bayer

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 A F T E R N O O N S P E A K E R S

Prior Art Searching in Cellular and Peptide Therapy Julie Wu, United States Patent and Trademark Office (USPTO) 1:30 – 2:00 pm

 ABSTRACT Prior art searching is a critical part of patent examination to ensure that the best available prior art is considered during examination. Applying the best available prior art leads to high quality patents with claims that clearly define the prior art and promote innovation. Searching in cellular and peptide vaccines and cellular therapy areas is similar to searching in other patent areas. Based on the broadest reasonable interpretation of the claims, patent examiners design search strategies, including text and classification, to search multiple non-patent and patent literature databases for prior art. Sequence searches using an internal United States Patent and Trademark Office (USPTO) sequence database are performed when needed. Overall, every application is thoroughly searched to find the best available prior art and to determine the level of skill in the art so that the examiner can make informed patentability determinations.  BIOGRAPHY Julie Wu received her B.S. in Pharmacology from SUNY Stony Brook in 1999, Ph.D. in Pharmacology from Yale University in 2004, and completed her postdoctoral training at the National Institutes of Health (NIH). She joined the USPTO in 2012 as a patent examiner, where she examined patent applications on immunotherapy for cancer, recombinant antibody, and CRISPR gene editing. In 2019, she was promoted to Supervisory Patent Examiner in the technology area of immunotherapy for cancer and recombinant antibody.

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Prior Art Searching in Cellular and Peptide Therapy  Julie Wu, United States Patent and Trademark Office (USPTO)

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 A F T E R N O O N S P E A K E R S

Searching Chemically Modified siRNA – Mission Impossible? Anne Marie Clark, CAS IP Services and BarbaraMiller, Amgen 2:00 – 2:30 pm

 ABSTRACT Short, inhibitory RNAs (siRNA) can be challenging to search due to their size and chemical modifications. While procedures have been developed to maximize siRNA sequence searching based on the sequence length, processes for searching siRNA by chemical modifications are still being developed. Chemically modified siRNAs are increasingly important and can be claimed by sequence and/or chemical modification patterns, without mention of the siRNA target. Due to the various ways siRNAs can be claimed and the different search procedures involved, performing FTO searches can be complex and time-consuming. This talk will cover the general considerations for siRNA searches, but will focus on the new searching techniques being developed for siRNA and other short sequences with chemical modifications. Utilizing the unique data on chemically modified siRNAs available in CAS REGISTRY, methods for searching and analyzing siRNA chemical modification patterns using KNIME and Microsoft Excel will be described.  BIOGRAPHIES Anne Marie Clark is a Senior Scientist with CAS IP Services, part of CAS, a division of the American Chemical Society. Prior to joining CAS in 2016, she was an independent searcher, a Manager of Intellectual Property with Bausch & Lomb, an Associate Director-Information Science at Pfizer, and an Information Scientist with CAS. She has a Ph.D. in biophysical chemistry from University of Louisville, a Drug Development certificate from Temple University and a B.S. in chemistry from Rochester Institute of Technology. In her free time, she mentors FIRST Robotics teams, gardens and explores the Pacific Northwest. Barbara Miller is currently a Patent and Scientific Analyst in the Amgen IP Law group. Prior to joining Amgen in 2017, she was a Patent and Scientific Analyst at the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA, and an Information Scientist at Pfizer in Groton, CT. She has a Ph.D. in Biological Sciences from Emory University in Atlanta, GA, a M.S. in Regulatory Affairs and Quality Assurance from Temple University, and a B.S. in Chemistry from Rhodes College in Memphis, TN. In her free time, she enjoys reading, traveling, cycling, yoga, and finding unusual restaurants and shops.

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Searching Chemically Modified siRNA – Mission Impossible?  Anne Marie Clark, CAS IP Services and BarbaraMiller, Amgen

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Minesoft, CAS STNext ads (Bronze Sponsors)

STN IP PROTECTION SUITE TM CONFIDENTLY POWER YOUR SCIENTIFIC IP RESEARCH Analyze the patent landscape and curate comprehensive insights with innovative search solutions from CAS.

Learn more at cas.org

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PIUG 2023 Biotechnology Conference

Driving strategic IP decisions with PatSnap Bio

Bridge the gap between Biological and Patent intelligence by searching the world’s most comprehensive and intuitive biological sequence (proteins, nucleotides and antibodies) database. Understand novelty or FTO of biological sequences by combing over: • 1.8 Billion Biological sequences + 80 Patents Jurisdictions + 2M Scientific and Non-Patent Literature sources to mitigate the risk of missing key data • Monitor new biological entrants and threats through automated alerts • Go beyond Blast searching, by utilizing our dedicated short sequence algorithm, fragment searching and our next generation motif searching algorithmwhilst being able to search by Genes or Targets. • Collaborate with IP and R&D professionals by being able to share your sequences

Want to learn more? Visit our booth at PIUG Biotech to speak with one of our experts. www.patsnap.com/lifesciences

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Organ-on-a-Chip Technology: Patent Landscape to Promote Innovation Christoph Schweitzer Milewski, Director ICTB- Fiocruz andWainse Barroso, Fiocruz 3:00 – 3:30 pm  ABSTRACT The use of animals in science is a subject of controversy, it contributes to R&D new drugs and vaccines. There are methods to seek the use of alternatives and less cruel methods to increasingly reduce the use of animals in projects. Among these alternative methods, there is a device known as organ-on-a-chip, consisting of a microchip containing layers of cells from a particular organ that are exposed to other cells, substances in general, or as drugs: even pathogens, such as fungi, to study and explore how they can occur between them. This is a newer technology which currently offers the possibility of simulating the functioning of various human or animal organs such as the heart, lungs, liver, kidneys, intestines, bone marrow, etc. The present study was carried out in October 2022, using the Clarivate Analytics’ Derwent Innovation Index (DII) database, applying the term “organ-on-a-chip”. We found 51 patent documents where the first patent specification was filed with the USPTO in 2008 by inventor Uwe Marx, seeking protection for the following claim categories: “self-contained organ-on-a chip device” (claims 1 to 32), “method of manufacturing a self-contained organ-on-a-chip device” (claim 33), “supply unit for receiving the self-contained organ-on-a-chip device” (claims 34 to 37), “method of manufacturing” (claims 38 to 42), “method of testing the effect” (claim 43), and “use of the self-contained organ-on-a-chip device” (claim 44). The most recent organ-on-a-chip patent application was filed Feb. 12, 2021, by Univ California and claims, “A multilayer organ-on-a-chip system” (1 to 17) and “A method of screening drugs or agents” (18 to 20). We conclude that the main applicants are universities, that Brazil may have a competitive advantage in this field since few patent applications have been filed in this field, and that the main feature of the claims includes devices and methods for drug discovery.  BIOGRAPHIES Christoph Milewski holds a degree in Law from the Federal University of Rio de Janeiro (UFRJ) (Brazil) and in Biology from the Baptist University of Minas Gerais (FBMG) (Brazil). He has experience in law and management. He has a specialization in Public Law, Management of Organizations in Health Care Science and Technology, Clinical Immunology and Innovation and Entrepreneurship from Harvard University. He holds a Master’s degree in Administrative Law from the Faculty of Law of the Fluminense Federal University (UFF) and is a Doctorate Student in Management, Research and Development in the Pharmaceutical Industry from the Professional Graduate Program of the Institute of Technology in Pharmaceuticals, Oswaldo Cruz Foundation (Fiocruz). He is currently the Director of the Institute of Science and Technology of Biomodels of Fiocruz.

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Organ-on-a-Chip Technology: Patent Landscape to Promote Innovation  Christoph Schweitzer Milewski, Director ICTB- Fiocruz andWainse Barroso, Fiocruz

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Wanise Barroso holds a Ph.D. in Information and Communication Sciences by Université de Toulon et du Var (France). Head Researcher in Health at Fundação Oswaldo Cruz (Fiocruz). She has been working for more than 40 years in Competitive Intelligence, Industrial Property and Management of Technological Innovation, mainly in the areas: patent, database, public domain, technological surveillance and patent oppositions. Vice director of the Institute of Science and Technology of Biomodels of Fiocruz. Coordinator of the Professional Postgraduate Program in Management, Research and Development in the Pharmaceutical Industry of Farmanguinhos/Fiocruz.

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Develop a Product Dashboard that Tracks Relevant Literature (Patent and Non-Patent) to the Product Christine Marie Geluk, Librarian at Your Service LLC 3:30 – 4:00 pm  ABSTRACT The session will focus on the mechanics of building a “product dashboard” with Microsoft Power BI. While the example used will be a drug product, the principles and techniques described in the session can be applicable to building any product dashboard for any other industry. Free and open resources to build the dashboard like from National Center of Biotechnology Information (NCBI), World Intellectual Property Organization (WIPO), European Patent Office and more.  BIOGRAPHY Christine (Chrissy) Geluk is the Principal, and Founder of Librarian At Your Service LLC. With over twenty (20) years experience in information science and libraries especially in the pharmaceutical industry, Chrissy has demonstrated excellence in computer programming skills like XHTML/HTML5, CSS, WordPress, SharePoint, Power BI , JavaScript and still learning more in the use of different search systems like STN, Questel Orbit, Dialog, LexisNexis, TotalPatent, and Crunchbase. She has successfully negotiated advantageous contracts with vendors and arranged end-user training to support adoption of services and systems.

Chrissy earned her undergraduate degree in mathematics from Fordham University (#AlwaysaRAM) and her graduate degree from Simmons.

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Develop a Product Dashboard that Tracks Relevant Literature (Patent and Non-Patent) to the Product  Christine Marie Geluk, Librarian at Your Service LLC

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