• BIO, Biologics, and Biosimilars

    By Andrew Williams

    BIO International Convention_shortThe 2017 BIO International Convention began earlier this week, but there are still many sessions and forums still to come.  Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention.  For example, today, we focus on sessions that will address the use of therapeutic biologics and the introduction of biosimilars.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#1728) to discuss these sessions (or whatever other topic is of interest to you).

    One topic that is of particular interest to readers of this blog is that of the BPCIA and the introduction of biosimilars in the U.S. marketplace.  To address that interest, the Intellectual Property track will include a panel entitled "Biosimilars IP Litigation: Where We've Been and Where We're Heading," on Wednesday, June 21, 2017 at 3:00 PM.  Of course, the panel did not know the outcome of the Sandoz v. Amgen Supreme Court case when the description was written.  Nevertheless, litigation strategies that are likely to be implemented as a result of this case will certainly be discussed.  The panel promises to provide general guidance, general strategies, and general lessons learned from both sides of the issue.  Importantly, the various categories of patent claims being litigated will be discussed.  The panel will include the Hon. Faith Hochberg, United States District Judge (retired), and currently of Judge Hochberg ADR; Dr. Chuck Sholtz, Ph.D., Vice President, Intellectual Property at Coherus Biosciences; and Wendy Whiteford, Esq, BS, Vice President of Law at Amgen.  The session will be moderated by Mr. Bob Ramos, JD, MS, Partner at Procopio.

    There are, of course, topics outside of the Intellectual Property track dealing with the introduction and utilization of biologics.  For example, the Oncology Track will feature a session entitled "Immune-Oncology Drugs: Ready for First Line Therapy?" on Thursday, June 22, 2017 at 10:15 AM.  As the description points out, immune checkpoint inhibitors, such a Keytruda and Opdivo, have had remarkable success in the clinic.  The panel promises to look to whether the new immune-oncology ("IO") drugs are likely to supplant tumoricidal drugs and radiation as the first-line therapy for cancers.  The panel will address other questions such as:  Are IO drugs affordable?  Do biomarkers exist to identify and monitor patients?  Can IO drugs be combined with other IO or tumoricidal drugs to achieve maximum efficacy?  And, can the side effects be minimized?  The speakers on the panel will be Dr. Kaan Certal, Ph.D., head of external innovation, oncology for Sanofi U.S.; Dr. Norman Greenberg, Ph.D., Senior Vice President and Chief Scientific Officer for Atreca, Inc.; Kinney Horn, Director of Business Development at Genentech Inc.; and Tim Reilly, Vice President and Head of Oncology Early Asset Development at Bristol-Myers Squibb Company.  The session will be moderated by Dr. Tauseef Butt, Ph.D., President and CEO of Progenra Inc.

    One of the last events to address the issue of therapeutic biologics, among other things topics, will be The Scientific American WorldVIEW Super Session: Wrapping Up and Looking Forward, on Thursday, June 22, 2017 at 1:00 PM.  This session will include explore the multiplicity of issues raised during the week at BIO, and will create a snapshot of future trends.  The panel will also tackle the latest commercial, scientific, and ethical issues facing innovation stakeholders, both today and for the year ahead.  This is the 9th year that this Super Session will examine global life science innovation.  The panel will include, Lawrence Bloch, MD, JD, President of Infinity Pharmaceuticals; Donald Jones, Chief Digital Officer at Scripps Translational Science Institute; Dr. Kenneth Kizer, MD, MPH, Director at the Institute for Population Health Improvement, UC Davis Health; John Mendlein, Ph.D., JD, CEO and Director at aTYR Pharma; and Susan Peschin, MHS, President and CEO for Alliance for Aging Research.  This session will be moderated by Andrew Marshall, Chief Editor at Nature Biotechnology.

    We hope you have been, and will continue enjoying BIO 2017 for the upcoming few days.

  • BIO and the Microbiome

    By Andrew Williams

    BIO International Convention_shortThe 2017 BIO International Convention begins this week in San Diego.  This convention has become an important destination for all organizations working in the biotechnology space, but the large amount of information and opportunities available can appear daunting at first glance.  To assist our readers, we recently provided information about the convention, and listed sessions that might be of interest to Patent Docs readers (see "2017 BIO International Convention — Docs @ BIO").  In addition, with this post, we begin a more in-depth series of previews highlighting a few sessions or other opportunities, in thematic fashion, to help navigate the convention.  Of course, as we previously reported, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent.  Patent Docs readers are encouraged to stop by the MBHB booth (#1728) to discuss these sessions (or whatever other topics are of interest to you).

    The microbiome has been defined as the microorganisms in a particular environment, including the body or part of the body.  Recently, the topic of the microbiome has gained a lot of attention.  Indeed, over the past couple of years, Patent Docs has published a series of guest posts on the topic of the emergent microbiome, with one of the more recent posts appearing last February (see "The Emergent Microbiome: A Revolution for the Life Sciences — Part X, The Big Data Component").  It is no surprise, therefore, to find several educational sessions at BIO addressing the topic from various perspectives.

    The Intellectual Property track will feature a session on June 20, 2017 at 1:45 PM entitled "Innovation and the Human Microbiome: Patent Eligibility and IP Protection."  The description of the session notes that microbiome research is resulting in new diagnosis, therapies, and product development, but the related commercialization is creating IP challenges.  Because microbiomic inventions relate to microbes, microbial components, and microbial products, they could be susceptible to concerns of subject-matter eligibility stemming from recent decisions of the U.S. Supreme Court and the Federal Circuit, and guidelines from Patent Office.  Not only that, but the regulatory environment creates additional complexity as governments grapple with questions surrounding labeling and regulation of probiotics.  The session promises that attendees will hear about creative patent drafting, trademark rights, and contractual provisions that can be used to protect such innovations.  The speakers on the panel will be Amanda Barry, Associate General Counsel for Global Home Care and NA Fabric Care Innovation at The Procter & Gamble Company, Michelle Booden, Director of Intellectual Property and Licensing for Salk Institute for Biological Studies, and Simon O' Brian, Partner with D Young & Co LLP.  The session will be moderated by David Gass of Marshall Gerstein & Borun LLP.

    The microbiome focuses on the microorganisms found in the body (or parts of the body), but there is a new wave of discovery using pharmaceuticals to regulate the dialogue between microbiome and host.  The Next Generation Biotherapeutics track will feature this emerging area on June 21, 2017 at 4:15 PM in a session entitled "Microbiome 2.0: Going Beyond Bugs as Drugs."  The description notes that these new discoveries hold promise for many key areas, including insomnia, diabetes, and autism.  The panel will share insights into the following questions: what are the hottest new microbiome drug targets and why; what are the new approaches to regulate the gut-brain axis, and how does big data fit in?  The panel includes Dr. Tom Hallam, Ph.D., CEO of Leading BioSciences; Glenn Nedwin, Ph.D, President and CEP of Second Genome; Scott Peterson, Professor at Sanford Burnham Prebys Medical Discovery Institute; and Stephanie Robertson, Sr. Director, Consumer Science Innovation at Johnson & Johnson Innovation, California.  The panel will be moderated by Larry Smarr, Ph.D., Principal Investigator at the California Institute for Telecommunications and Information Technology.

    There will also be a session on June 21, 2017 at 3:00 PM entitled "Technologies for a Sustainable Future: Leveraging One Health and Engineering Synergies."  The panel for this session promises to explore emerging topics such as synthetic biology and the microbiome as examples of the important connections between challenges in the food systems and human health.  These challenges can lead to complex relationships across disciplines to enable sustainable solutions for health and wellness.  The panel will discuss ways in which "One Health and Engineering Synergies" can be leveraged to accelerate cutting edge research, created novel technologies, and develop tractable solutions.  This panel includes Joerg Bauer, Head of Scouting and Insight, Bioscience Research for BASF; David Kyle, Ph.D., CEO and Executive Director for Evolve Biosystems.  The panel will be moderated by Dushyant Pathak, Ph.D., MBA, Associate Vice Chancellor of Research for Technology Management & Corporate Relations, and Executive Director of Venture Catalyst at the University of California, Davis.

    Please be on the look-out for future preview posts, and we look forward to seeing you this week at BIO 2017.

  • CalendarJune 19-22, 2017 – BIO International Convention (Biotechnology Innovation Organization) – San Diego, CA

    June 22, 2017 – "Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls — Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 22, 2017 – "Who Owns the World's Patents?" (CPA Global) – beginning at 11:00 am (EST)

    June 27, 2017 – "CRISPR Confusion: A Legal and Practical Analysis for IP Professionals" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    June 29, 2017 – Judicial Conference (U.S. Patent and Trademark Office Patent Trial and Appeal Board) – 1:00 to 5:00 pm (ET) – Alexandria, VA

    June 29, 2017 – "Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" (Strafford) – 1:00 to 3:30 pm (EDT)

    June 29, 2017 – "Patent Eligibility Determination in a Post-Alice World: Significant Updates & Developments" (The Knowledge Group) – 12:00 to 1:30 pm (EST)

    August 10-11, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 14-15, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    ***Patent Docs is a media partner of this conference or CLE

  • USPTO SealThe U.S. Patent and Trademark Office Patent Trial and Appeal Board will be hosting Judicial Conference on June 29, 2017 from 1:00 to 5:00 pm (ET) in the Madison Auditorium on the USPTO campus in Alexandria, VA.  The program is intended to educate the public about aspects of Board practice and provide a forum to enhance the dialogue between the public and the Board.  The Conference will offer presentations on the following topics:

    • State of the Board
    • Behind the Scenes at PTAB: A Look at the Inner Workings
    • Perspectives from the Bench and Bar: Winning your Ex Parte Appeal
    • AIA Trial Hot Topics

    Following the Conference, an informal social gathering will be held a few blocks from the USPTO campus.

    There is no cost to attend and registration is not required.  The Conference will be webcast; instructions for viewing the webcast can be found here.  Additional information regarding the Conference can be found here.

  • Technology Transfer Tactics will be offering a webinar entitled "CRISPR Confusion: A Legal and Practical Analysis for IP Professionals" on June 27, 2017 from 1:00 to 2:00 pm (Eastern).  Patents Docs author Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will cover the following topics:

    • A brief overview of the technology
    • A review of the patent positions of the parties
    • A discussion of the arguments raised in the Interference
    • An assessment of the PTAB's decision and its effect on the patents and applications
    • Analysis of strategies for further appeal
    • Impact on patent practice — claim strategy
    • Impact on licensing
    • Predictions regarding the patent and licensing landscape if the parties do not settle
    • Likelihoods and advantages of settlement

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" on June 29, 2017 from 1:00 to 3:30 pm (EDT).  Anthony D. Del Monaco, Doris Johnson Hines, Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner will examine AIA Section 102 prior art and the AIA exceptions, and offer best practices for identifying applicable prior art when filing or challenging patent applications, and making the correct choice of law for prosecuting.  The webinar will review the following topics:

    • How did AIA expand the definition of prior art?
    • What are the Section 102 exceptions and what is the impact on Section 103 art?
    • How can counsel claim—or defend against—post-AIA patent applications asserting priority over pre-AIA applications?
    • What practices should patent counsel employ in order to utilize prior art?

    The registration fee for the webinar is $447.  Those interested in registering for the webinar, can do so here.

  • The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Patent Eligibility Determination in a Post-Alice World: Significant Updates & Developments" on June 29, 2017 from 12:00 to 1:30 pm (EST).  Orlando Lopez of Burns & Levinson LLP, James J. DeCarlo of Greenberg Traurig, and Lewis E. Hudnell, III of Hudnell Law Group PC will present and analyze the recent trends and developments surrounding patent eligibility determinations since the Supreme Court's decision in Alice v. CLS Bank, and provide practitioners practical advice in traversing Alice challenges, in both prosecution and litigation.  The panel will cover the following topics:

    • Recent Developments in Case Law and at the PTO
    • Litigation and Prosecution Perspectives
    • Practitioner Roadmaps
    • Opportunities and Challenges

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

  • CPA GlobalCPA Global will hosting a webinar entitled "Who Owns the World's Patents?" on June 22, 2017 beginning at 11:00 am (EST).  The webinar will offer a debate from Microsoft, Cravath Swaine & Moore LLP, and board members from ORoPO™ (Open Register of Patent Ownership) regarding patent ownership.  ORoPO was launched in June 2015 by organizations seeking to achieve greater transparency around patent ownership on a global scale.  ORoPO provides an open data register of patents, accessible to all at no cost.

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

  • By Kevin E. Noonan –

    NAIThe National Academy of Inventors and the Intellectual Property Owners Association released a report last week on the top 100 universities worldwide granted patents in 2016.  Overall, universities were granted 6,768 patents; the Top 10 (9 in the U.S. and one from China) accounted for about one-third of these patents and were granted to these universities:

    TableIn the U.S., 39 public universities were granted 2,794 patents (an average of ~72/university), while 30 private universities garnered 2,339 patents (78/university).  Thirty-two ex-U.S. universities were awarded 1,635 patents, with Korean universities having the most (403), followed by China (370), Japan (230), Taiwan (179), Saudi Arabia (173), and Israel (127).

    IPO #1According to the Report, the National Academy of Inventors is a 501(c)(3) non-profit member organization comprising U.S. and international universities, and governmental and non-profit research institutes, with over 4,000 individual inventor members and Fellows spanning more than 250 institutions.  It was founded in 2010 to recognize and encourage inventors with patents issued from the U.S. Patent and Trademark Office, enhance the visibility of academic technology and innovation, encourage the disclosure of intellectual property, educate and mentor innovative students, and translate the inventions of its members to benefit society.  More information can be found on the organization's website.  The report further states that the Intellectual Property Owners Association (IPO), established in 1972, is a trade association for owners of patents, trademarks, copyrights, and trade secrets.  IPO is the only association in the U.S. that serves all intellectual property owners in all industries and all fields of technology.  IPO advocates for effective and affordable IP ownership rights and provides a wide array of services to members, including:  supporting member interests relating to legislative and international issues; analyzing current IP issues; information and educational services; and disseminating information to the general public on the importance of intellectual property rights.  More information can be found on the organization's website.

  • Life Sciences Top 55

    By Donald Zuhn

    IPO #2Last week, the Intellectual Property Owners Association (IPO) announced the release of its 34th annual list of the top 300 organizations receiving U.S. patents (see "Top 300 Organizations Granted U.S. Patents in 2016").  Patent Docs Readers may recall that the U.S. Patent and Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."

    The IPO compiled its list by counting the number of utility patents granted during 2016 that listed an organization or a subsidiary as the owner on the printed patent.  The IPO notes that if an assignment to an organization or its subsidiary was recorded after the patent was printed, the patent was not counted, and further, that patents that were granted to two or more organizations jointly were attributed to the organization listed first on the patent.  The IPO also noted that 303,051 patents were issued in 2016, which was an increase from the 298,407 patents that issued in 2015.  The top fifteen companies on the IPO Top 300 are listed below (click on table to expand):

    Top 15
    Hitachi, Ltd. was the only company to fall out of the Top 15 in 2016.  Hitachi, Ltd., which dropped to 78th in 2016, was replaced in the Top 15 by Amazon Technologies, Inc., which ranked 29th in 2015.

    As in past years, Patent Docs used the IPO's list of top patent holders to compile a list of the top "life sciences" companies and organizations receiving U.S. patents in 2016.  Each organization's IPO top 300 ranking for 2016 is indicated in the "2016 IPO Rank" column; the IPO top 300 ranking for 2015 (if available) is indicated in the "2015 IPO Rank" column; and the change in number of patents from 2015 is indicated in "% Change from 2015."  The Life Sciences Top 55 is listed below (click on table to expand):
      Top 55 LS
    Please note that some of the companies and organizations listed above may be involved in work outside the life sciences sector, and therefore, a portion of the patents granted to these companies and organizations may be directed to other than life sciences-related inventions.  In addition, our list includes medical device companies.

    For additional information regarding this topic, please see:

    • "IPO Releases List of Top 300 Patent Holders for 2014," July 1, 2015
    • "IPO Releases List of Top 300 Patent Holders for 2013," July 7, 2014
    • "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
    • "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
    • "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
    • "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
    • "IPO Releases List of Top 300 Patent Holders," May 22, 2008
    • "IPO Posts List of Top 300 Patent Holders," April 20, 2007