• USPTO SealThe U.S. Patent and Trademark Office will be holding the next installment of the 2022 Women's Entrepreneurship Symposium, entitled "Trends and Opportunities," on March 16, 2022, from 2:00 pm to 3:05 pm (ET).  Tené Dolphin of the National Women's Business Council and Adji Fatou Diagne of the U.S. Census Bureau will discuss the economic impact of women in business and how social trends are affecting their professional growth and business opportunities.

    Additional information regarding the Symposium can be found here.  Those interested in registering for the event, can do so here.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Trending Global IP Issues Through the Lens of IPO's Special 301 Comments" on March 16, 2022 from 2:00 pm to 3:00 pm (ET).  Stephen Bauer (retired, Medtronic Inc.), Dean Harts of 3M Innovative Properties Co., Sharon Reiche of Pfizer Inc., and Bill Warren of Eversheds Sutherland will provide an overview of significant IP policy concerns across different countries and regions based on IPO's comments made during the U.S. Trade Representative's Special 301 review, note issues that IP practitioners need to be aware of, and point out global trends in IP law and policy.

    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 attending the webinar should register here.

  • Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) Patent Litigation Committee will be offering a remote program entitled "Recent Developments in Pharmaceutical Patent Litigation" on March 17, 2022 from 1:00 pm to 2:00 pm (ET).  April Weisbruch of McDermott Will & Emery LLP will moderate a panel consisting of Christopher Bruno of McDermott Will & Emery LLP and Coy Stull of Carlton Fields, PA.  The webinar will cover recent developments in pharmaceutical patent litigation and in particular district court and Federal Circuit decisions involving written description, enablement, and skinny labels.

    The webinar is complimentary for FCBA members and students, $50 for government/academic/retired non-members, and $175 for private practitioner non-members.  Those interested in registering for the program, can do so here.

  • ACIThe American Conference Institute (ACI) will be holding its 17th Annual Paragraph IV Disputes Conference on April 26-27, 2022, at the Intercontinental Hotel in New York City.  The conference starts each day at 8:00 am and ends at 6:00 pm on April 26th and 5:30 pm on April 27th.  Two workshops are offered on April 25th, starting at 9:30 am and 1:30 pm.

    The conference will open with an introduction by Co-Chairs Stephanie Donahue from Sanofi-Aventis and Lars Taavola from Mallinckrodt Pharmaceuticals.  This will be followed by an opening panel featuring Andre Iancu, former Director of the USPTO and partner at Irell & Mandela LLP, Jay R. Deshmukr from Kasowitz Benson Torres, and Nicholas Groombridge from Paul, Weiss, Rifkin Wharton & Garrison LLP.  There will also be a keynote from Beckey Egeland from the Federal Trade Commission.

    ACI faculty will give presentations on:

    • Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense, featuring a discussion of Biogen Int'l GmbH v. Mylan Pharmaceuticals
    • The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing and Infringing Use and Encouraging That Use in a Label
    • The Costs and the Consequences of Determining Venue Post-Valeant v. Mylan: Coordinating Multiple ANDA Suits through MDLs
    • Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents
    • Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits
    • A Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Partes Review (IPR)
    • Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits
    • The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

    Breakout sessions will discuss several aspects on the Business and Practice of Paragraph IV Disputes involving cross-border business considerations, advanced pleadings drafting, the economics of Paragraph IV challenges, the use of expert witnesses in parallel proceedings, monitoring legal spending and budgets, seeking damages and value calculations assessments, communicating value and coordination between corporate and outside counsel, and a risk-benefit analysis of joint defense groups.

    Conferees will hear from judges from each of the relevant tribunals.  The Honorable Kathleen M. O’Malley from the Federal Circuit will be interviewed by the Honorable Mary Pat Thynge, Chief Magistrate Judge of the U.S. District Court of Delaware.  There will be a View from the Bench, featuring the Honorable Julien Xavier Neals of the U.S. District Court of New Jersey and the Honorable Mitchell S. Goldberg of the U.S. District Court of Pennsylvania, moderated by Rachel L. Pernic Waldron from Rakoczy Molino Mazzochi Siwik LLP and Gregory A. Morris from Honigman LLP.  The Honorable Jacqueline Write Bonilla, Deputy Chief Administrative Patent Judge at the PTAB will discuss Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes.  A cocktail reception will follow the Judges' remarks on April 26th.

    The workshops offered on April 25th are Workshop A, Comparative Analysis of Drug Patent Linkage Systems in China and the United States, and Workshop B, Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation.  Workshop A will be presented by Jiazhong (Jason) Luo of Duane Morris LLP and Ningling Wang of Finnegan, Henderson, Farabow, Garrett & Dunner LLP.  Workshop B will be presented by Mira A. Mulvaney of Eli Lilly & Co. and Serena Farquharson-Torres of Bristol Myers Squibb.  The workshops are available as in-person events only.

    An agenda for the conference and additional information regarding the workshops 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 in-person conference is $2,395 (paid registration by April 26th), with a special in-house counsel rate of $1,895.  The livestream virtual conference fees are $2,095,and $1,595 for in-house counsel.  Workshop A is an additional $600 and Workshop B is an additional $400.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-896-896EX03.  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 17th Annual Paragraph IV Disputes Conference.

  • By Donald Zuhn

    Russia FlagIn a Resolution issued on March 6, 2022, the Russian Federation introduced an amendment to the methodology for determining the amount of compensation to be paid to certain patent holders for the use of an invention, utility model, or industrial design without the patent owner's consent.  In particular, for patent holders who are "associated with foreign states" that commit "unfriendly actions" in relation to Russian legal persons and individuals, the amount of compensation to be awarded to the patent holder for the unauthorized use an invention, utility model, or industrial design shall be "0 percent of the actual proceeds" derived from the production and sale of goods or performance of work and provision of services related to the use of the invention, utility model, or industrial design.  The Resolution, which took effect as of the date of its publication, specifies that patent holders will be considered to be associated with foreign states for the purposes of the Resolution when the patent holders have citizenship of such states or their place of registration, primary business activities, or primary profit-making activities are located in such states.

    A list of states that Russia has deemed to have committed "unfriendly actions" in relation to Russian legal persons and individuals is set forth in an Order that was issued by the Russian Federation on March 5, 2022.  In particular, the Order indicates that the following foreign states and territories committed unfriendly actions:

    Australia
    Albania
    Andorra
    Great Britain — including the island of Jersey and the territories of Anguilla, British Virgin Islands, and Gibraltar
    Member States of the European Union
    Iceland
    Canada
    Liechtenstein
    Micronesia
    Monaco
    New Zealand
    Norway
    The Republic of Korea
    San Marino
    North Macedonia
    Singapore
    United States of America
    Taiwan (China)
    Ukraine
    Montenegro
    Switzerland
    Japan

    A machine translation of the Resolution can be found here, and a machine translation of the Order can be found here.

    Hat tip to fellow MBHB partner Aaron Gin for alerting us to the Resolution and Order and for obtaining machine translations of the documents, and to the Baker McKenzie Sanctions & Export Controls Update blog for reporting on the Resolution and Order (see Denis Khabarov, Margarita Divina, and Maxim Kalinin, "Russia adopts zero compensation to patent owners from unfriendly countries," Sanctions & Export Controls Update, March 10, 2022).

  • By Donald Zuhn –-

    Over the last week, the Ukrainian Institute of Intellectual Property (Ukrpatent) has been posting letters of support that it has received from other European patent offices.  Among the offices from which Ukrpatent has received such letters are the European Patent Office (EPO), the Patent Office of the Republic of Poland, the Industrial Property Office of the Slovak Republic, the Austrian Patent Office, and the Finnish Patent and Registration Office (PRH).

    Lithuania IP OfficeToday, Ukrpatent posted a letter of support that it received from the State Patent Bureau of the Republic of Lithuania.  In the letter, Acting Director Lina Mickiene begins by "express[ing] complete solidarity with you on behalf of me and my colleagues in the Lithuanian patent office," and declaring that "[w]e are shocked and appalled by the unjustified and illegal military aggression against your nation, your institutions, and people that is carried out by Russian Federation."  The Acting Director offers the State Patent Bureau's "sincere[] hope that these unjustified military actions by Russia, grossly violating not only international law but the principles of humanity itself, that are unimaginable in our times, will be stopped as soon as possible."  The letter also notes that the State Patent Bureau will make "all efforts to take any actions that are possible in the realm of our activities including those to avoid the loss of IP rights by the Ukrainian applicants and right holders," including an offer from State Patent Bureau employees to "contribute to any help they are able to provide in this situation."  The letter concludes by stating that the "Lithuanian office firmly stands with you in these unprecedented times, and our hearts go to your colleagues and all the Ukrainian nation," closing with the message: "Слава Україні!" (Glory to Ukraine!).

    EUIPOUkrpatent also posted a letter of support that it received from the European Union Intellectual Property Office (EUIPO), which is the EU agency responsible for registration of European Union trade marks (EUTM) and registered Community designs (RCD).  In the letter, Executive Director Christian Archambeau notes that "[t]he EUIPO stands with the Ukrainian people in this heart-breaking situation and supports them in their heroic efforts in fighting for democracy, their freedom and sovereignty."  In order to help safeguard Ukrainians' right to protect their IP, Executive Director Archambeau indicated that the EUIPO would grant Ukrainian applicants with a one-month extension of time, as of February 24, and will "review the need for further extensions and additional measures as we move forward."  The EUIPO also announced that it would "discontinue any international collaboration held in the framework of the Memorandum of Understanding signed on July 2017 with the Federal Service for Intellectual Property of the Ministry of Economic Development of the Russian Federation (Rospatent)," and "suspend any international collaboration held in the framework of the Memorandum of Understanding signed on March 2019 with Eurasian Patent Organization (EAPO), intergovernmental oragnisation with the participation of Russia and the Republic of Belarus."  Executive Director Archambeau closes the letter by reiterating that "the EUIPO stands with Ukrainian people and, like millions of our fellow Europeans, the desire of our staff community to do something tangible, is strong."  One tangible action taken by EUIPO staff has been to collect donations to be sent to the United Nations High Commissioner for Refugees (UNHCR) and the United Nations Children's Fund (UNICEF), which are "currently on the ground and working hard to provide help to refugees."

    The EUIPO also issued a separate statement in which it outlined the measures (discussed in its letter of support to Ukrpatent) which the EUIPO adopted "in response to the unprovoked and unjustified military aggression carried out by the Russian Federation against Ukraine, as well as to the disinformation and information manipulation actions by the Russian Federation and its associated outlets against the EU and its member states."  The EUIPO statement closed by declaring that:

    [T]he EUIPO joins the European Union in condemning, in the strongest possible terms, the Russian Federation's unprovoked and unjustified military aggression against Ukraine, and in demanding that Russia immediately ceases its military actions, unconditionally withdraws all forces and military equipment from the entire territory of Ukraine and fully respects Ukraine's territorial integrity, sovereignty and independence within its internationally recognised borders.

    For additional information regarding this and other related topics, please see:

    • "USPTO Terminates PPH with Rospatent and Terminates Engagement with NCIP," March 10, 2022
    • " Life Sciences Business Leaders Call for Immediate and Complete Economic Disengagement from Russia," March 9, 2022
    • "PRH Joins Other Patent Offices in Expressing Support for Ukraine," March 9, 2022
    • "USPTO Terminates Engagement with Rospatent and EAPO," March 7, 2022
    • "Ukrpatent Continues Normal Operations Despite Russian Aggression," March 6, 2022

  • By Donald Zuhn –-

    USPTO SealLast week, the U.S. Patent and Trademark Office announced that it was terminating engagement with officials from the Russian Federal Service for Intellectual Property (Rospatent) and Eurasian Patent Organization (EAPO), per guidance issued by the U.S. Department of State (see "USPTO Terminates Engagement with Rospatent and EAPO").

    In an email alert distributed to stakeholders earlier today, the USPTO announced that it will no longer grant requests to participate in the Global Patent Prosecution Highway (GPPH) at the USPTO when such requests are based on work performed by Rospatent as an Office of Earlier Examination under the GPPH.  The change is set to take effect on Friday, March 11, 2022.  Moreover, the USPTO noted that in pending cases in which it has already granted special status under the GPPH to applications based on work performed by Rospatent, the USPTO will remove that status and return those applications to the regular processing and examination queue.  Thus, those applications will no longer be treated as GPPH applications at the USPTO.  In its alert, the USPTO indicated that it had advised the Japan Patent Office (JPO), which serves as the Secretariat for the GPPH, of its decision.

    The USPTO also issued a news brief today in which the Office announced that it has now terminated engagement with officials from the national intellectual property office of Belarus (i.e., the National Center of Intellectual Property (NCIP)).  The news brief also addressed the termination of the GPPH with Rospatent.

  • By Donald Zuhn –-

    LS LetterIn an open letter posted on February 26, six life sciences business leaders called on other members of their industry "to cease all business involvement in Russia."  The authors of the open letter included Meg Alexander, Chief Corporate Affairs Officer, Ovid Therapeutics; Paul Hastings, President and CEO, Nkarta Therapeutics; Peter Kolchinsky, Managing Partner, RA Capital Management, LP; Jeremy Levin, Chairman and CEO, Ovid Therapeutics; Ted Love, President and CEO, Global Blood Therapeutics; and John Maraganore, Founding CEO, Alnylam Pharmaceuticals.

    The authors of the letter encouraged "employees at all levels of all industries in all countries" to add their names to letter, and urged them to share the letter with their colleagues, noting that "[e]ven if the executives who lead your company have not signed this pledge yet, your signature signals your support of them to do so."  As of 11:00 am ET today, the letter had collected 860 signatories (a full list of the signatories can be found here).

    The authors begin their letter by stating that they "are appalled by the unprovoked war started by Russia against its neighbor Ukraine," adding that "[t]his barbaric act will lead to substantial loss of life, trauma to millions of people, and the dislocation of civil society in a nation that has repeatedly expressed its peaceful intentions."  The authors conclude that "this is a criminal act deliberately committed by Russia," which will have ramifications that "touch the entire globe."

    Declaring that they "reject the actions ordered by President Putin and the failure of those who enable and embolden him," including "the captains of Russia's industries" who support him and stand by him, the authors urge those Russian business leaders "to collectively steer Russia towards peace."  However, noting that "[w]e must take action to make clear our abhorrence of Russia's actions," and arguing that "[i]mmediate and complete economic disengagement is required," they "call on all members of our industry, and others, to cease all business involvement in Russia" (including "other countries and their elites should they join Russia in its invasion of Ukraine").  In particular, the authors pledge to:

    • Cease investment in Russian companies and new investment within the borders of Russia
    • Reject investment from Russian funds
    • Halt collaboration or service agreements with Russian companies
    • Except for food and medicines, halt trade in goods with Russian companies

    The authors note that the above actions would be reversed "upon the restoration of peace and democracy in a sovereign Ukraine."

    The authors also ask their colleagues "in all the industries in the United States, including software, social media, IT, agriculture, legal and financial services, medical devices, medical instruments, and minerals, to take the same steps and withhold assistance to oligarchs who enable this war."

    The authors conclude their letter by commending "the brave Russians opposing their government at home" and expressing admiration for their courage, and declaring that:

    We stand with our colleagues, friends, and families in Ukraine bravely fighting the invading army.  We support you, and you are not alone.

  • By Donald Zuhn –-

    Last week, the Ukrainian Institute of Intellectual Property (Ukrpatent) began posting letters of support that it had received from other European patent offices.  Among the offices from which Ukrpatent has received such letters are the European Patent Office (EPO), the Patent Office of the Republic of Poland, the Industrial Property Office of the Slovak Republic, and the Austrian Patent Office (see "Ukrpatent Continues Normal Operations Despite Russian Aggression").

    PRH (Finnish Patent Office)Earlier today, Ukrpatent posted a message of solidarity it received from the Finnish Patent and Registration Office (PRH).  In the letter, PRH Director General Antti Riivari expresses PRH's "strong solidarity with the Ukrainian people and particularly with our colleagues and their families in the Ukrainian Patent and Trademark Office," and indicates that PRH "stand[s] together with the international community in support of Ukraine and its people."  The Director General declares that:

    During the past two weeks, we have witnessed in disbelief Ukraine and its people being subject to military aggression causing loss of life and suffering.  In addition to the humanitarian tragedy, we feel that the vision of an open Europe that fosters economic and social progress through collaboration, sharing of information, and knowledge has been shaken to the core.  The prospect of creating a safer, more peaceful environment both now and for future generations has been severely damaged.  We sincerely hope that peace is restored immediately.

  • USPTO SealBy Donald Zuhn –-

    On Friday, the U.S. Patent and Trademark Office issued a statement in which the Office indicated that it "has terminated engagement with officials from Russia's agency in charge of intellectual property, the Federal Service for Intellectual Property (commonly known as Rospatent), and with the Eurasian Patent Organization [EAPO]."  The Office noted that the termination of engagement with Rospatent and EAPO was in keeping with guidance issued by the U.S. Department of State.  The Office's statement concluded that "[l]ike so many, we are deeply saddened by the events unfolding in Ukraine.  We hope for the restoration of peace and human dignity."