• IPWatchdogIPWatchdog and IP.com will be offering a webinar entitled "Leveraging Artificial Intelligence in the Invention Disclosure Process" on May 3, 2022 at 12:00 pm (ET).  Joe Manico of Kodak Alaris, Jim Durkin and Tony Christopher of IP.com, and John White of the PCT Learning Center will discuss leveraging the latest AI technology to power IP workflows.

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

  • Hoffmann-EitleHoffmann Eitle will be offering four webinars providing four case studies covering the main practice areas of patent litigation, in which the advantages, risks, and strategic tweaks of the new system will be highlighted.

    The four sessions will include the following:

    Session 1: A New Era of Pharma Litigation? — Preliminary Injunction Proceedings National vs. UPC — May 5, 2022 or May 6, 2022

    • Filing of PI requests – advantages, challenges and legal uncertainty under the UPC system
    • Strategic forum shopping and scope of injunctions
    • Impact of the couleur locale – and how to strategically use it
    • Possible counter attacks by the generic applicant

    Session 2: Inspection and Evidence Proceedings/Double Protection and the Strategic Implications under the UPC System — May 17, 2022 or May 18, 2022

    • Practical case example to assess the full spectrum of evidence tools
    • Inspection procedure before the UPC compared to national procedures
    • Strategies on clearing the market / counter attacks after being served with infringement lawsuit
    • Outline of new German rules on double patent protection with practical case examples

    Session 3: The UPC Approach to Damages Actions and Compensation Claims — June 28, 2022 or June 30, 2022

    • The UPC vs. national rules on Burden of Proof
    • The use of experts
    • Claiming damages under different types of claims, e.g., second medical use claims
    • The calculation of damages under the UPC vs. the national procedure

    Session 4: The new regime on the revocation of European patents/ The “long-arm jurisdiction” of the UPC — July 8, 2022

    • An in-depth look on the procedural requirements of the UPC revocation proceedings
    • Strategic implications of parallel UPC revocation and EPO opposition proceedings
    • Advantages of EPO oppositions / national invalidity proceedings / UPC revocation proceedings
    • Considerations for opting-out
    • The “long-arm jurisdiction” of the UPC regarding infringement outside UPC territory

    Those interested in attending any of the sessions can register here.

  • By Kevin E. Noonan

    U.S. Trade RepresentativeOn April 27th, apparently without a trace of irony, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2022 Special 301 Report.  In a press release, the USTR stated that "[i]ntellectual property-intensive industries support more than 60 million jobs – from the independent inventor just starting out to the documentary filmmaker studying critical social issues.  We need robust protection and enforcement in foreign countries to protect these individuals, their livelihoods, and ensure they can fairly compete in the global marketplaces."  The press release repeats mention from last year that the review period underlying the Report took place during the COVID-19 pandemic, "the largest global health crisis in more than a century."  And getting right to the heart of the matter, this year as in every year in recent memory, the Trade Representative asserts that "the 2022 Special 301 Report identifies trading partners that are falling short" and that the "Biden-Harris Administration will continue to engage with these trading partners to level the playing field for our workers and businesses."

    The press release accompanying the release of the Report notes that its review of Ukraine, which has frequently been criticized particularly with regard to copyright infringement of music, movies, and other media IP, has been suspended due to the Russian invasion in February.  The USTR's press release reiterates the administration's support for the IP waiver being negotiated at the World Trade Organization, tying these efforts (against most informed commentary) to its "comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible."  After extolling China in last year's Report for its IP rights protections and amended laws, Ambassador Tai states that the U.S. is "closely monitoring China's progress in implementing [these] commitments" in light of "concerns about the adequacy of these measures and their effective implementation, as well as about long-standing issues like bad faith trademarks, counterfeiting, and online piracy."  Singled out for praise are Kuwait, Saudi Arabia, Romania, and Lebanon for improvements this past year.  On the other hand, the press release announces that the USTR will commence an "out-of-cycle" review of Bulgaria "to assess whether [that country] makes material progress on addressing deficiencies in its investigation and prosecution of online piracy cases, particularly its failure to adopt evidence sampling in criminal cases," and voices "concerns" with the "aggressive policies" of the EU in promoting its exclusionary geographic indications (e.g., so that a Bordeaux wine actually comes from Bordeaux), singling out relevant provisions of the EU's Common Agricultural Policy that are scheduled to come into effect next year.

    According to the Executive Summary of the Report, it is as it was last year "[a] priority of this Administration is to craft trade policy in service of America's workers, including those in innovation-driven export industries."  The Summary further asserts the exhortation that:

    The Report serves a critical function by identifying opportunities and challenges facing U.S. innovative and creative industries in foreign markets and by promoting job creation, economic development, and many other benefits that effective IP protection and enforcement support.  The Report informs the public and our trading partners and seeks to be a positive catalyst for change. In addition, given the importance of innovation and IP in developing the advances necessary for fighting the ongoing COVID-19 crisis, this Administration is committed to trade policies that seek to save lives in this pandemic and ensure preparedness for the next one.  USTR looks forward to working closely with the governments of the trading partners that are identified in this year's Report to address both emerging and continuing concerns, and to build on the positive results that many of these governments have achieved.

    The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These Watch Lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

    The Report also notes the USTR's continued efforts to enhance public engagement.  These efforts were limited to written submissions due to the COVID pandemic and the responses posted online (www.regulations.gov, docket number USTR-2021-0021).  The Report notes that the USTR received submissions from 44 non-government stakeholders and 18 foreign governments.

    The USTR reviewed "more than 100" of this country's trading partners and identified seven countries on a "Priority Watch List" (decreased by two from last year) and another 20 countries on the "Watch List" (decreased by three from last year), all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the 2022 Report includes Argentina, Chile, China, India, Indonesia, Russia, and Venezuela (Saudi Araba and Ukraine being removed from the list this year).  Countries on this list "present the most significant concerns this year regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection."  On the Watch List this year are Algeria, Barbados, Bolivia, Brazil, Canada, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Mexico, Pakistan, Paraguay, Peru, Thailand, Trinidad & Tobago, Turkey, Turkmenistan, Uzbekistan, and Vietnam (Kuwait, Lebanon, and Romania being removed from the list this year).

    The Report contains two Sections (on "Developments in Intellectual Property Rights Protection and Enforcement" and "Country Reports") and two Annexes on particular issues (the statutory bases of the Report, and government technical assistance and capacity building efforts).

    The Report cites (and emphasizes) significant progress in several U.S. trading partners, including:

    • Kuwait, which was removed from the Watch List "for making continued and significant progress on concerns that stakeholders identified with intellectual property (IP) enforcement and transparency."  These include online portals for its Ministry of Commerce and Industry and it Copyright Office for streaming violation reports for trademarks and copyrighted content.  Also noted was Kuwait's "increased engagement and transparency," inter alia, with United States-Kuwait Trade and Investment Framework Agreement (TIFA) Intellectual Property Working Group;

    • Saudi Arabia, which moved from the Priority Watch List due to actions by the Saudi Authority for Intellectual Property (SAIP) to publish IP enforcement procedures; "increase enforcement against counterfeit and pirated goods and online pirated content; create specialized IP enforcement courts with trained judges and expedited timelines; conduct strong IP awareness, outreach, training, and support; set up a centralized committee to coordinate IP enforcement actions across multiple authorities; and train IP specialists in 76 different authorities to increase government compliance with IP laws."  (Although also mentioned were concerns by stakeholders regarding the Saudi Arabia Food and Drug Authority (SFDA) that preferentially grants marketing approval for domestic versions of registered products without requiring data showing equivalence to branded drugs);

    • Romania, which was removed from the Watch List for "taking significant actions to improve IP protection and enforcement" including appointment of its first ever National IP enforcement coordinator, the establishment of a new department in the economic police dedicated to online piracy, and IP group working sessions in the General Prosecutor Office's Intellectual Property Coordination Department;

    • Lebanon, which was removed from the Watch List, because apparently "[s]takeholders have not raised significant concerns about IP protection or enforcement during the Special 301 review";

    • Japan, for amending its trademark act to address a personal use exemption for imported good which had been used to send counterfeit good through the mail and by courier services from overseas;

    • United Arab Emirates, which had been removed from the Watch List last year, "continued to advance IP protection and enforcement by enacting a series of major legal reforms to its Industrial Property, Trademark, Copyright, and Cyber Crime laws;" and

    • Bahrain, for enacting a Protection of New Plants Varieties Law in December 2021, a part of its obligations under a United States-Bahrain Free Trade Agreement."

    Also noted in this section of the Report 110 member of the WIPO Performance and Phonogram Treaty and 112 parties to the WIPO Copyright Treaty.

    Another Section of the Report involves "illustrative best practices" by U.S. trading partners.  These include "cooperation and coordination among national government agencies involved in IP issues is an example of effective IP enforcement," citing Thailand, India, Saudi Arabia, Brail, Ukraine, and Indonesia for these efforts; "specialized IP enforcement units," in Malaysia; "IP awareness and educational campaigns" in India, Thailand, Trinidad and Tobago, and Saudi Arabia; and "active participation of government officials in technical assistance and capacity building" in Romania, Algeria, India, the Philippines and Brazil.  Micro-, small- and medium-sized enterprises (MSMEs) were particularly noted as "contribut[ing] widely to innovation, trade, growth, investment, and competition" and thus the Report applauds efforts in Hong Kong, the UK, Saudi Arabia, India, and Algeria to support these businesses.

    Multilateral and bilateral initiatives are discussed in the Report.  Perhaps significantly the primary multilateral initiative called out in the Report is the WTO, with regard to which the Report states that "[i]n the past year, the United States co-sponsored discussions in the TRIPS Council on the positive and mutually reinforcing relationship between the protection of IP, innovation, and business development."  U.S. efforts include an Intellectual Property and Innovation agenda in the TRIPS Council that presented on relationships between IP and investment, green technology, and women in IP. Pandemic response and preparedness relating to trade facilitation and IP protections rated a mention even without any "multilaterally agreed outcome."  Also mentioned is the failure of WTO to come to agreement in an IP waiver despite the Biden Administration's support for it.

    Bilateral agreements and regional initiatives mentioned in the Report include various Trade and Investment Framework Agreements (TIFAs) between the U.S. and several trading partners, discussing specifically such arrangements with Pakistan, Kuwait, Argentina, Indonesia, Central Asia, Taiwan, Ukraine, and India.  The Report states that the United States-Mexico-Canada Agreement (USMCA), updating and revising NAFTA, "secur[ed] strong improvements in the protection and enforcement of IP."  Regional initiatives included in the Report include the Asia-Pacific Economic Cooperation (APEC) Intellectual Property Experts Group which this year considered a U.S.-led initiative on illicit streaming and another on industrial design protection.  Other regional programs discussed in the Report include the African Growth and Opportunity Act, Caribbean Basin Economic Recovery Act, and Caribbean Basin Trade Partnership Act.

    Turning to specific issues of concern, trademark counterfeiting is said to harm "consumers, legitimate producers and governments."  The problem is one with global scale, "and involved the production, transshipment, and sale of a vast array of fake goods . . . including semiconductors and other electronics, chemicals, medicines, automotive and aircraft parts, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods."  Many of these goods arise in China, whereas India is called out as a source of counterfeit medicines and Turkey for counterfeit apparel and foodstuffs.  Such goods are transshipped according to the Report through hubs in Hong Kong, Turkey, Kazakhstan, Kyrgyzstan, and the UAE and sold in markets in Brazil, Nigeria, Russia, and Paraguay.  Citing a 2021 Organisation for Economic Co-operation and Development (OECD) and European Union Intellectual Property Office (EUIPO) study the Report states that the "global trade in counterfeit and pirated goods reached $464 billion in 2019, accounting for 2.5% of the global trade in goods for that year," with China being the largest country of origin for counterfeit and fake goods and Singapore border enforcement mentioned for weakness and "lack of coordination between Singapore's Customs authorities and the Singapore Police Force's Intellectual Property Rights Branch."

    Counterfeit pharmaceuticals remain a particular concern, having "important consequences for consumer health and safety [that are] exacerbated by the rapid growth of illegitimate online sales . . . [and] contributes to the proliferation of substandard, unsafe medicines that do not conform to established quality standards."  Most of these goods confiscated by the U.S. were transshipped through India, China, and the Dominican Republic, with China, India, the Philippines, Vietnam, Indonesia, and Pakistan being leading sources of counterfeit medicines.  These statistics include COVID-19 test kits and personal protective equipment (PPE) "such as N-95 and equivalent masks, and sanitizers, detergents, and disinfectants" from China.  These problems are exacerbated by use of legitimate delivery services and online pharmacy sites, particularly those involved in consumer-to-consumer sales, according to the Report.  And these counterfeit items are being distributed by "legitimate express mail, international courier, and postal services to ship counterfeit goods in small consignments" rather than large cargo ships, making detection and enforcement more difficult.

    The remedy again is cooperation, cajolery, and consultation:

    The United States continues to urge trading partners to undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods.  The United States engages with its trading partners through bilateral consultations, trade agreements, and international organizations to help ensure that penalties, such as significant monetary fines and meaningful sentences of imprisonment, are available and applied to deter counterfeiting.  In addition, trading partners should ensure that competent authorities seize and destroy counterfeit goods, as well as the materials and implements used for their production, thereby removing them from the channels of commerce.  Permitting counterfeit goods and enabling materials to re-enter the channels of commerce after an enforcement action waste resources and compromise the global enforcement effort.

    The Report identifies countries such as Columbia, Indonesia, Turkey, Pakistan, Uzbekistan, and Turkmenistan as having practices that fall short of adequate efforts to stem the flow of counterfeit goods across borders.

    Online and broadcast piracy are also discussed, the Report noting that while "[t]he increased availability of broadband Internet connections around the world, combined with increasingly accessible and sophisticated mobile technology, has been a boon to the U.S. economy and trade," "technological developments have also made the Internet an extremely efficient vehicle for disseminating pirated content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content."  Sources of counterfeit optical disks mentioned in the Report include China, India, Mexico, and Pakistan, with Argentina, Bulgaria, Canada, Chile, China, Colombia, the Dominican Republic, India, Mexico, the Netherlands, Romania, Russia, Switzerland, Thailand, Ukraine, and Vietnam being identified as "hav[ing] high levels of online piracy and lack[ing] effective enforcement," estimated as costing the U.S. economy "at least $29.2 billion and as much as $71 billion in lost revenue each year."  A particular form of copyright piracy (particularly of music), termed "stream-ripping," is practiced (or ineffectively prevented) in Canada, India, Mexico, Russia, Switzerland, and Ukraine, the Report asserts.  Technology including illicit Internet Protocol Television (IPTV) services that "unlawfully retransmit telecommunications signals and channels containing copyrighted content through dedicated web portals and third-party applications that run on ISDs or legitimate devices" was used at high levels in Argentina, Brazil, Canada, Chile, China, Guatemala, Hong Kong, India, Indonesia, Iraq, Mexico, Singapore, Switzerland, Taiwan, Thailand, and Vietnam.  China, according to the Report, with Iraq is identified as being a source of satellite receivers having "preloaded" pirate IPTV applications. And signal theft is a problem in Brazil, Argentina, and Ukraine.  Also noted were the use of camcorders to produce expropriated contend, in Russia, India, and China, with impediments to counteracting such illicit activities found in Argentina, Brazil, Ecuador, India, Peru, and Russia (which don't effectively criminalize such activities), in contrast to laws now in effect in Canada, Japan, the Philippines, and Ukraine.

    The significance of the problem was synopsized in the Report as follows:

    In addition to the distribution of copies of newly released movies resulting from unauthorized camcording, other examples of online piracy that damage legitimate trade are found in virtually every country listed in the Report and include: the unauthorized retransmission of live sports programming online; the unauthorized cloning of cloud-based entertainment software, through reverse engineering or hacking, onto servers that allow users to play pirated content online, including pirated online games; and online distribution of software and devices that allow for the circumvention of technological protection measures, including game copiers and mod chips that allow users to play pirated games on physical consoles.  Piracy facilitated by online services presents unique enforcement challenges for right holders in countries where copyright laws have not been able to adapt or keep pace with these innovations in piracy.

    Difficulties in trade secret protection has its own subsection of the Report.  The problems of adequately protecting trade secrets have arisen "in a wide variety of industry sectors, including information and communications technology, services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing sectors, rely on the ability to protect and enforce their trade secrets and rights in proprietary information" and include theft of "business plans, internal market analyses, manufacturing methods, customer lists, and recipes" that "are often among a company's core business assets," according to the Report.  The Report states that trade secret protection (or lack of it) is a particular problem in Russia, China, and India.  Certain U.S. trade partners have made successful efforts in 2021 (including the EU, Chile, and Taiwan), and the USMCA also has "the most robust protection for trade secrets of any prior U.S. trade agreement" according to the Report.  The United States-China Economic and Trade Agreement (Phase One Agreement) has several trade secret commitments, according to the Report, including "expanding the scope of civil liability, covering acts such as electronic intrusions as trade secret theft, shifting the burden of producing evidence, making it easier to obtain preliminary injunctions to prevent use of stolen trade secrets, allowing criminal investigations without need to show actual losses, ensuring criminal enforcement for willful misappropriation."

    Another subsection of the Report involved "forced" technology transfer, indigenous innovation, and preferences for indigenous IP.  These include the following activities, many of which involved governmental action:

    • Requiring the transfer of technology as a condition for obtaining investment and regulatory approvals or otherwise securing access to a market or as a condition for allowing a company to continue to do business in the market;

    • Directing state-owned enterprises in innovative sectors to seek non-commercial terms from their foreign business partners, including with respect to the acquisition and use or licensing of IP;

    • Providing national firms with an unfair competitive advantage by failing to effectively enforce, or discouraging the enforcement of, U.S.-owned IP, including patents, trademarks, trade secrets, and copyright;

    • Failing to take meaningful measures to prevent or to deter cyber intrusions and other unauthorized activities;

    • Requiring use of, or providing preferences to, products or services that contain locally developed or owned IP, including with respect to government procurement;

    • Manipulating the standards development process to create unfair advantages for national firms, including with respect to participation by foreign firms and the terms on which IP is licensed; and

    • Requiring the submission of unnecessary or excessive confidential business information for regulatory approval purposes and failing to protect such information appropriately.

    China and Indonesia are recognized for such practices.

    As in other years, geographical indications (i.e., country or region of origin limitations primarily for wine and foodstuffs) are discussed, specifically in the EU.  This is particularly troubling for trademarks, the Report stating that "[t]he EU GI agenda remains highly concerning, because it significantly undermines the scope of trademarks held by U.S. producers and imposes barriers on market access for U.S.-made goods that rely on the use of common names, such as parmesan or feta."  These practices are particularly troublesome for medium-sized enterprises (MSME)s, according to the Report, because their trademarks are "among the most effective ways for producers and companies . . . to create value, to promote their goods and services, and to protect their brands."  Also a specific concern for the U.S. is that these GI practices produce a trade barrier to U.S. goods in the EU, particularly when GI protection is given to "common names" for a product.  The effects of these practices are exacerbated by the "significant deficit in food and agricultural trade" between the US and the EU (with Europe exporting $1 billion in cheese to the U.S. versus $3 million of U.S. cheese being imported by the EU).  The Report contains greater and more focused discussion of EU countries' GI practices, their "troubling aspects" and efforts to "seek to expand its harmful GI system within its territory and beyond."  While having little luck dissuading the EU from continuing and expanding its GI practices, the Report cites several bilateral agreements (with Argentina, Australia, Brazil, Canada, Chile, China, Ecuador, Indonesia, Japan, Kenya, Korea, Malaysia, Mexico, Morocco, New Zealand, Paraguay, the Philippines, Singapore, Tunisia, Uruguay, Vietnam, and others) that have a number of provisions aimed at curtailing some of the deleterious effects of GI protection.

    With regard to pharmaceuticals and medical devices and market access for U.S. products, the Report contends that "[t]he COVID-19 pandemic has highlighted the importance of pharmaceutical, medical device, and other health-related innovation, as well as a lack of widespread, equitable distribution of these innovations," including the need for fighting the current as well as future pandemics.  The Report cites tariffs and other taxes levied by countries including Brazil, India, and Pakistan, as well as "unreasonable regulatory approval delays and non-transparent reimbursement policies" that "discourage the development and marketing of new drugs and other medical products."  The Report recites successful efforts in Canada, Mexico, China, Japan, India, and Indonesia to address issues of transparency and fairness in this sector.  On the other hand, the Report also notes that stakeholders have "expressed concerns" about practices in Australia, Brazil, Canada, China, Japan, Korea, New Zealand, Russia, and Turkey, "on issues related to pharmaceutical innovation and market access."

    Trademark issues are noted in the Report for Brazil, China, Ecuador, Egypt, Spain, Turkmenistan, and Uzbekistan, for "impos[ing] unnecessary administrative and financial burdens on trademark owners and creat[ing] difficulty in the enforcement and maintenance of trademark rights," and in Algeria, China, Indonesia, Iraq, Jordan, and the United Arab Emirates, for requiring "burdensome formalities for filing documents such as intellectual property (IP) applications, registration maintenance, transfer of ownership submissions, and in opposition and cancellation proceedings."

    In copyright, the Report cites "flawed or non-operational" copyright management organizations in several countries, despite efforts in countries including India, the UAE, and Ukraine to improve matters in this regard.

    Software concerns included in the Report involve government use of unlicensed software (costing $46 billion globally in 2018 according to The Software Alliance).  This issue is particularly noted in Argentina, Brazil, China, Guatemala, Indonesia, Pakistan, Paraguay, Romania, Saudi Arabia, Tajikistan, Turkey, Turkmenistan, Uzbekistan, and Vietnam but the Report states that "[t]he United States continues to work with other governments to address government use of unlicensed software, particularly in countries that are modernizing their software systems or where there are infringement concerns."

    As in prior years, the Report sets forth subsections on IP and the environment (stating that "[s]trong IP protection and enforcement are essential to promoting investment in innovation in the environmental sector" which "not only promotes economic growth and supports jobs, but also is critical to responding to environmental challenges) and IP and health.  This latter discussion is focused (perhaps inevitably) on the COVID pandemic.  Here, the "top priority" is "saving lives and ending the pandemic in the United States and around the world" (rather than protecting IP as it is throughout the other sections of the Report).  The Report again notes the Biden Administration's support for the WTO IP waiver and the USTR's involvement in negotiating an agreement.  In this regard this portion of the Report includes an extensive discussion of the provisions of the TRIPS agreement, the Doha Declaration, and Article 31 TRIPS regarding compulsory licenses.  The USTR through this Report states that the U.S. "strongly supports the WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health" (which permits member states to issue compulsory licenses to export pharmaceuticals to countries who cannot produce these drugs themselves).  Also included in the Report is a section devoted to implementation of the TRIPS Agreement with regard to the requirement for "certain minimum standards of IP protection and enforcement."

    Finally, the Report notes that "notwithstanding provisions on the protection of undisclosed test or other data, a Party may take measures to protect public health in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, or any waiver or amendment of the TRIPS Agreement to implement the Doha Declaration on the TRIPS Agreement and Public Health."  Further, the Report asserts that "the USTR will continue its close cooperation with relevant agencies to ensure that public health challenges are addressed and IP protection and enforcement are supported as one of various mechanisms to promote research and innovation."

    The last but one subsection of Section I of the Report involve implementation of WTO agreement on TRIPS, relating to extending the "transition period" for least developed countries (LDCs) under Article 66.1 to July 1, 2034.  And the last section discusses dispute settlement and enforcement, specifically calling out "a range of unfair and harmful Chinese acts, policies, and practices related to technology transfer, intellectual property (IP), and innovation" and food-associated issues with the EU's GI regime.

    Section II of the Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.

    As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with other countries to increase protection for IP rights of U.S. IP rights holders.  While enunciating U.S. interests and policies consistent with earlier Reports, this Report is notable for addressing the trade elephant in the room, the WTO IP waiver and the Biden Administration's continued support for it.  And for those paying attention to the implications of this position (see "The Proposed WTO IP Waiver: Just What Good Can It Do? — An Analysis"), a particularly chilling section of the Report bears repeating:

    [N]otwithstanding provisions on the protection of undisclosed test or other data, a Party may take measures to protect public health in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, or any waiver or amendment of the TRIPS Agreement to implement the Doha Declaration on the TRIPS Agreement and Public Health [emphasis added].

    Taken at face value this indicates that "undisclosed test or other data" now explicitly at risk includes the type of trade secret, proprietary information disclosed to government regulatory agencies to obtain approval for drugs and vaccines.  The disclosure of this information would effectively destroy any trade secret value this information may have because, as shown for the mRNA vaccines it is the delivery vehicle and its component parts that are the IP.  While there may be sound policy or humanitarian reasons for deciding certain trade secrets must be disclosed for the greater good, it is particularly chilling to include this policy agenda in a discussion of the Doha Declaration, which is rightly seen as a successful effort to reduce if not eliminate the quid pro quo of providing IP protection in recalcitrant or at least IP hesitant states as the price of admission to the benefits of WTO membership.  In taking this position, the Biden Administration has gone much further than the "virtue signaling" some have been willing to see support for the WTO IP waiver to be, and bodes unwell for actual efforts to successfully address this pandemic and more importantly the next one.

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

    • "U.S. Trade Representative Releases 2021 Special 301 Report," May 23, 2021
    • "U.S. Trade Representative Releases 2020 Special 301 Report," May 10, 2020
    • "U.S. Trade Representative Releases 2019 Special 301 Report," April 29, 2019
    • "U.S. Trade Representative Releases 2018 Special 301 Report," April 29, 2018
    • "U.S. Trade Representative Issues 2017 Special 301 Report," May 4, 2017
    • "U.S. Trade Representative Issues 2016 Special 301 Report," May 19, 2016
    • "U.S. Trade Representative Issues 2015 Special 301 Report," April 30, 2015
    • "U.S. Trade Representative Issues 2014 Special 301 Report," May 19, 2014
    • "U.S. Trade Representative Issues 2013 Special 301 Report," May 30, 2013
    • "U.S. Trade Representative Issues 2012 Special 301 Report," May 1, 2012
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 4, 2011
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 19, 2010
    • "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
    • "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
    • "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008

  • By Kevin E. Noonan

    Federal Circuit SealThe consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if the agreements do not contemplate these possibilities and account (or attempt to account) for them.  Such was the case in the Federal Circuit's recent decision in BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation.

    The lawsuit involved a complicated set of licenses and co-development activities between the Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research branch of the Australian government, and BASF.  CSIRO is assignee of U.S. Patent Nos. 9,926,579; 9,951,357; 9,970,033; and 9,994,880 (termed Group A patents), as well as Nos. 9,994,792 and 9,932,541, all of which involve genetic engineering of plants to produce oils, such as canola oil, non-native to these plants.  These claims were directed generally to production of Omega-3 long chain polyunsaturated fatty acids (abbreviated LC-PUFAs in the opinion) and specifically to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both known to be beneficial to human heart health.  The commercial goal of the research was to produce oils to be used in farm-raised salmon and other fish to improve their nutritional value and flavor to be closer to free-range fish.  CSIRO and BASF (in collaboration in part and independently in part) pursued this effort beginning around the turn of the century, specifically introducing certain genes encoding enzymes in biosynthetic pathways (derived in microorganisms) for LC-PUFAs into plants including Brassica napus or rapeseed (that naturally produced canola oil).  At all relevant times, CSIRO's efforts were limited to introducing these enzymes into a laboratory strain called Arabidopsis thaliana; according to the Federal Circuit opinion CSIRO had not introduced these enzymes into commercially relevant species.  BASF, on the other hand, had introduced enzymes from the biosynthetic pathway into tobacco and linseed as well as Arabidopsis and a plant closely related to rapeseed, Brassica juncea.  Although during some of the time relevant to this lawsuit CSIRO and BASF were working together on a "focused research project," the opinion states that the parties were working on introducing different enzymes from the pathway.  Thereafter, the parties each developed collaborations with other commercialization partners; in BASF's case the partner was Cargill and their joint efforts resulted in BASF depositing recombinant seeds with the American Type Culture Collection (ATCC) in support of its own patent applications.

    Licensing negotiations aimed at BASF obtaining a license to CSRIO's patents were not fruitful and BASF sued CSIRO (and other defendants no longer in this lawsuit) for a a declaratory judgment that it did not infringe (related to patents other than the ones in this lawsuit).  BASF thereafter filed an amended complaint naming only CSIRO.  In its answer, CSIRO asserted infringement of the six patents named in this lawsuit; claims 1, 31, 32, and 33 of the '357 patent were deemed representative and reproduced in the Federal Circuit's opinion:

    1.  A recombinant plant cell which synthesizes eicosapentaenoic acid (EPA), comprising more than one heterologous polynucleotide, wherein said polynucleotides encode:
        a) a Δ6 desaturase, a Δ6 elongase and a Δ5 desaturase; or
        b) a Δ5/Δ6 bifunctional desaturase and a Δ5/Δ6 bifunctional elongase;
        wherein the more than one polynucleotides are operably linked to one or more promoters that are capable of directing expression of said polynucleotides in the cell, wherein the enzymes encoded by said polynucleotides comprise at least one desaturase which is able to act on an acyl-CoA substrate, and wherein the synthesis of EPA requires the sequential action of said enzymes.

    31.  The plant cell of claim 1 which is a Brassica napus cell or Arabidopsis thaliana cell, wherein the heterologous polynucleotides encode a Δ6 desaturase, Δ6 elongase and a Δ5 desaturase.

    32.  The cell of claim 31, comprising a heterologous polynucleotide encoding a Δ5 elongase which catalyzes the conversion of EPA to DPA [docosapentaenoic acid] in the cell.

    33.  The plant cell of claim 32, wherein said cell is capable of synthesizing DHA.

    (It was important for BASF's allegation that CSIRO's asserted claims did not satisfy the written description requirement that claim 1 was not limited to Brassica napus nor Arabidopsis thaliana cells while claims 31-33 were so limited.  Other asserted claims shared this pattern, wherein, inter alia, claim 5 of the '579 patent, claim 5 of the '033 patent, claim 1 of the '792 patent, and claims 15 and 20 of the '541 patent were limited to Brassica cells, whereas asserted claims 2 and 10 of the '880 patent were not.)

    CSIRO's complaint also named Cargill, a BASF commercialization partner, as co-defendant.  BASF countered by asserting it owned the patents-in-suit through the co-development agreement with CSIRO entered into in 2008.  Cargill moved the trial court to dismiss them from the suit for lack of personal jurisdiction; the trial court denied the motion and the case went to trial.  The parties stipulated to infringement of all but the '541 patent, which the jury found was infringed.  The jury also found that BASF had not established the patents lacked adequate written description support but did find BASF co-owned the '792 patent due to the earlier co-development agreement.  The District Court ruled CSIRO had adduced insufficient evidence of willful infringement and precluded the jury from considering enhanced damages on this basis.  In addition, the Court dismissed the jury from hearing evidence of damages but held a separate bench trial in which the District Court denied an injunction and awarded an ongoing royalty on the infringed patents but no damages for past infringement.  Somewhat predictably, the parties appealed on those grounds where they lost at trial.

    The Federal Circuit, in an opinion by Judge Taranto joined by Judge Chen and (in part) by Judge Newman ruled as follows:

    First, we affirm the district court's determination that venue as to Cargill was proper in the Eastern District of Virginia.  Second, regarding the jury's verdict rejecting the written-description challenge to the asserted Group A patent claims, we affirm as to the claims that are limited to canola plants (the only ones either side meaningfully discusses), but we reverse as to the broader genus claims.  Third, we affirm the jury's verdict that five patents were not co-owned by BASF but reverse the contrary verdict as to the sixth, with the result that infringement of all valid claims of the six patents at issue is now settled.  Finally, on the remedy issues, we affirm the district court's refusal to submit willfulness to the jury and its decision on the evidentiary issue concerning past damages.  But we remand for reconsideration of the remedy, while leaving the current remedy in place pending such reconsideration.

    On Cargill's venue challenge, the Federal Circuit agreed with the District Court that there was proper assertion of personal jurisdiction (which Cargill did not appeal) and venue.  Factors favoring venue included a "partnership" between BASF and Cargill, BASF's deposit of seed with the ATCC (which was within the trial court's jurisdiction and was deemed an infringing "use"), and it filing its declaratory judgment action in the District (these activities being "central to the partnership").  The panel rejected Cargill's reliance on Home Depot U.S.A., Inc. v. Jackson, 139 S. Ct. 1743 (2019), which related to the removal statute (28 U.S.C. § 1441(a)) based on "textual similarity" to 28 U.S.C. § 1400(b).  The issue in Home Depot involved removal rights to third party defendants, the position Cargill was in here.  While there was some force to Cargill's argument by analogy, the Federal Circuit held that Cargill had not provided "sufficient justification for departing from the ordinary meaning of the term 'defendant'" and thus venue was proper ("[i]n short, to hold that § 1400(b) covers third-party counterclaim defendants would require us to determine that, for patent suits only, two civil actions can exist in one lawsuit, with the counterclaim qualifying as a 'civil action for patent infringement' that triggers the protections of § 1400(b) for counterclaim defendants—except for the original plaintiffs who under General Electric [Co. v. Marvel Rare Metals Co., 287 U.S. 430 (1932)] would be held to have forfeited venue protection.").  And on the facts here upon which the District Court made its decision, the Federal Circuit found no basis for disturbing it.

    Turning to the merits, the panel considered and affirmed the District Court's distinction that the asserted claims satisfied the written description requirement when limited to canola oil-producing species and related plants, but not satisfied more broadly for all plants.  Not required were "commercially desirable or other specific levels of production," however.  But the panel asserts that the evidence from the specification is focused on canola oil-producing plants and related species, as well as being supported by expert testimony from both parties, and provides working examples in Arabidopsis which "a very reliable model for Brassica napus" wherein "LCPUFA production in Arabidopsis was highly predictive of positive results in canola."

    In this way the panel distinguished as being "materially different" the factual circumstances here with Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc., 923 F.3d 1368 (Fed. Cir. 2019).  BASF's expert testimony to the contrary, that the skilled worker would not accept the Arabidopsis results as being predictive provided "no sound reason" in support of BASF's position that the patents-in-suit all failed to satisfy the written description requirement.  Moreover, the panel found CSIRO's "failure" to produce LCPUFA's in Brassica napus occurred due to focus on optimizing production in Arabidopsis thaliana rather than lack of possession of the claimed invention when limited to canola oil-producing species.

    The genus claims presented a different story to the panel, which held that these claims were invalid for failure to satisfy the written description requirement.  The parties had "not given [the Court] much to work with" on this question according to the opinion, with disclosure and testimony being "focused" on canola oil-producing species.  The panel understood that "BASF has argued for the inadequacy of the written description as to all the asserted Group A claims on a common ground—that the magnitude of the leap from success in producing LC-PUFA in Arabidopsis to success in any other plant is too great for the written description to support claims to any other plant" (emphasis in opinion).  The panel agreed that CSIRO's disclosure was insufficient to show description beyond the narrow limitations of canola oil-producing plants.  (While the Court's reasons for coming to this conclusion are couched in whether CSIRO had possession of the invention outside the scope of canola oil-producing plants, the rationale blends here somewhat into the question of whether the disclosure enabled production in other plant species, bolstered by reference to experts' testimony regarding whether the skilled worker would have believed disclosure of the former would indicate possession of the latter.)

    Regarding the patent ownership question, the Federal Circuit's opinion notes that BASF did not base its ownership claim on co-inventorship or sole inventorship by an inventor obliged to assign her rights to BASF.  The argument was limited to co-ownership and, according to the opinion, was based "entirely" on the prior co-development agreement between the parties.  The Court found this inadequate because, as a matter of contract interpretation BASF's ownership's claims were not supported.  The opinion cites to specific sections of the agreement, the Court finding three categories of ownership:  "(1) constructs that were developed under the Evaluation if they contained both CSIRO and BASF genes; (2) results, data, or information derived from the Evaluation respecting the CSIRO-BASF-gene-combination constructs developed under the Evaluation; and (3) Intellectual Property subsisting in the first two categories."  The panel appreciated BASF's co-ownership claims to rest solely on the third category, but the Court rejected this argument, saying that a reasonable jury could only find no co-ownership for any of the patents-in-suit.  But even though "none of the six patents claim the BASF-CSIRO-gene-combination constructs or properties of them or uses of them" BASF contended that CSIRO obtained the claims of these patents "by drawing on the lessons it learned from the experiments involving both BASF and CSIRO's materials" (emphasis in opinion).  This argument makes no legal sense to the panel because CSIRO's inventions would need to be considered inherent in the "results, data, or information" from the joint work for which BASF was not (and did not claim to be) a joint inventor.  Nor did it make commercial sense, because interpreting the agreement in this way would "create an ever-threatening cloud over independent post-[agreement] work and the investments in such work."  The opinion then dissected the claims of the patents-in-suit and affirmed the jury's verdict for all but one of them that BASF is not a co-owner.  And for the one patent where the jury found to the contrary (the '792 patent) the Court finds BASF's evidence for co-ownership equivalently lacking and relying on "an impermissible level of speculation."

    With regard to the remedies decided by the District Court, the Court affirmed the District Court's decision that CSIRO could not submit its assertion of willful infringement to the jury nor that CSIRO was entitled to damages for past infringement.  Otherwise, the Court remanded based on the changes in the substantive determinations regarding infringement, invalidity, and ownership (albeit including in the opinion extensive assessments of the allegations by CSIRO of error, or lack of it, for consideration on remand).

    Judge Newman's dissent was based solely on the co-inventorship issue for the '792 patent, the Judge being persuaded that the jury had substantial evidence with which to come to its conclusion that BASF was a co-owner of this patent.

    BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)
    Panel: Circuit Judges Newman, Taranto, and Chen
    Opinion by Circuit Judge Taranto; opinion dissenting in part by Circuit Judge Newman

  • By Donald Zuhn

    U.S. Chamber of CommerceEarlier this month, the U.S. Chamber of Commerce sent a letter to members of Congress indicating that the Chamber "strongly supports" recent House and Senate legislation that the Chamber noted "would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress."  The Chamber contended that "[i]nternational negotiations on IP, focused on undermining the WTO TRIPS agreement, are fundamentally misguided," suggesting that "[a]ny agreement that undermines IP would limit the ability of innovative companies to develop the cure for the next pandemic or global health threat and bargain away US competitiveness."  According to the Chamber, the global community should instead "focus on the overwhelming problem of vaccine distribution," as well as "the real issues preventing more shots in arms, such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy."

    The House and Senate bills that have garnered the support of the Chamber are the "Protecting American Innovation Act" (H.R. 7430) and the "No Free TRIPS Act" (S. 4063), which were introduced on April 6, 2022 and April 7, 2022, respectively.  H.R. 7430 was introduced by Rep. Adrian Smith (R-NE) and co-sponsored by Rep. Vern Buchanan (R-FL), Rep. Drew A. Ferguson, IV (R-GA), Rep. Jackie Walorski (R-IN), Rep. Darin LaHood (R-IL), Rep. Brad R. Wenstrup, Brad (R-OH), Rep. Gregory Murphy (R-NC), Rep. Ron Estes (R-KS), Rep. Carol D. Miller (R-WV), Rep. Lloyd Smucker (R-PA), and Rep. Kevin Hern (R-OK).  S. 4063 was introduced by Sen. Marsha Blackburn (R-TN) and co-sponsored by Sen. Thomas Tillis (R-NC), Sen. Tommy Tuberville (R-AL), Sen. Kevin Cramer (R-ND), Sen. Bill Hagerty (R-TN), Sen. Cynthia M. Lummis (R-WY), Sen. Marco Rubio (R-FL), and Sen. Mike Lee (R-UT).

    House of Representatives SealThe longer of the two bills, H.R. 7430, which is intended "[t]o establish limitations on modifications to trade agreements," would prevent the President from "enter[ing] into any suspension of or modification to a trade agreement," unless the President complied with all of the consultation requirements set forth in the Act and Congress either enacted legislation or adopted a resolution approving of the suspension or modification.  The House bill sets forth several findings of Congress, including the following:

    • "Section 8 of article I of the United States Constitution provides Congress with authority over international trade. Congress has used that authority to approve a number of trade agreements, including the WTO Agreement."

    • "Section 8 of article I of the United States Constitution provides Congress with authority to provide intellectual property protections in order to 'promote the progress of science and useful arts'."

    • "The United States may not withdraw or otherwise alter the rights and obligations for the United States arising from a congressionally approved trade agreement without the consent of Congress."

    • "Innovators in the United States successfully and rapidly brought to fruition vaccines that provide highly effective protection against COVID–19."

    • "Longstanding intellectual property protections are critical to efforts by the United States and the biopharmaceutical industry to develop and manufacture vaccines for both people in the United States and around the world."

    • "Many experts on vaccine production and distribution are warning that waiving intellectual property protections will undermine the global response to the COVID–19 pandemic and compromise vaccine safety, including by disrupting the distribution of scarce raw materials for vaccines that existing vaccine makers with proven track records for delivering high-quality, safe, and effective vaccines need to continue their own production."

    • "The United States Trade Representative announced without any consultation with Congress that the United States will support a waiver of intellectual property protections under the TRIPS Agreement for COVID–19 vaccines."

    • "The Trade Representative has not explained how a waiver of the TRIPS Agreement will expand vaccine production and access . . . ."

    • "Waiving intellectual property protections . . . raises serious economic and national security concerns."

    The House bill also indicates the sense of Congress as including the following:

    • "intellectual property protections for COVID–19 vaccines have not impeded vaccination efforts for COVID–19;"

    • "intellectual property protections in fact help ensure the safe and efficient manufacturing of COVID–19 vaccines;"

    • "waiving intellectual property protections could lead to the production of substandard, ineffective, and potentially unsafe COVID–19 vaccines;"

    • "the Trade Representative must consult with Congress before taking a position on the current TRIPS Agreement waiver proposal before the WTO and any further proposals to waive or weaken intellectual property obligations under the TRIPS Agreement;" and

    • "the United States must oppose any waiver to intellectual property obligations under the TRIPS Agreement for the response to the COVID–19 pandemic until those implications are fully analyzed."

    Among the "consultation requirements" set forth in the House bill are two reports to be submitted to Congress.  One report would be prepared by the Secretary of Commerce, in consultation with the Trade Representative, the Secretary of Health and Human Services, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control and Prevention, and would assess the impact of a TRIPS waiver on the following:

    (i) access to vaccines in the United States;
    (ii) access to vaccines globally;
    (iii) global supply chains of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies;
    (iv) the gross domestic product of the United States;
    (v) exports and imports by the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies;
    (vi) manufacturing in the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies; and
    (vii) investment in vaccine production in the United States and in research and development for future vaccines[.]

    The other report would be prepared by the Secretary of Defense, in consultation with the Secretary of Commerce, the Secretary of Health and Human Services, and the Trade Representative, and would determine the effects of a TRIPS waiver with respect to addressing the COVID–19 pandemic on U.S. national security.

    The House bill would also require the U.S. Trade Representative to publish a notice in the Federal Register identifying the objectives of any trade agreement negotiation, the rationale for why the trade agreement does not allow the U.S. to meet those objectives, and the provisions of the trade agreement that would be suspended or modified.  In addition, the bill would require the U.S. Trade Representative to:

    [C]onsult closely and on a timely basis with the appropriate congressional committees, keeping those committees fully apprised of those negotiations, and provide to those committees, including staff with appropriate security clearance, access to the text of any negotiating proposal or any other document presented by the United States that presents concepts or considerations for the negotiations . . . .

    The bill also calls for the International Trade Commission to publish a report on the suspension or modification of any provisions of the trade agreement being proposed by the U.S. Trade Representative and to conduct a public hearing on the proposal.

    Senate SealS. 4063, by comparison, is far more concise.  In particular, the bill states that:

    The President, and any official, employee, or agent of the United States, may not negotiate or conclude any withdrawal, suspension, waiver, or modification to the TRIPS Agreement without obtaining explicit authorization from Congress before beginning negotiations with respect to that withdrawal, suspension, or modification.

    H.R. 7430 has been referred to the House Ways and Means and House Rules committees.  S. 4063 has been referred to the Senate Finance committee.

    For additional information regarding this topic, please see:

    • "Senators Send Letter to Commerce Secretary Regarding WTO Waiver Compromise," March 28, 2022
    • "The Proposed WTO IP Waiver: Just What Good Can It Do? — An Analysis," March 24, 2022
    • "IP Associations 'Concerned' by Reports of TRIPS Waiver Compromise," March 24, 2022
    • "More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise," March 21, 2022
    • "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver," March 16, 2022
    • "Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver," December 12, 2021
    • "U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver," November 14, 2021
    • "U.S. Chamber of Commerce Urges Administration to 'Double Down' on Global Vaccine Distribution," November 3, 2021
    • "Is This the WTO Waiver End Game?" July 25, 2021
    • "BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP," June 24, 2021
    • "GOP Legislators Write in Opposition to Proposed TRIPS Waiver," May 16, 2021
    • "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021
    • "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021
    • "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021
    • "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021
    • "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021
    • "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021
    • "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
    • "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
    • "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
    • "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
    • "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
    • "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
    • "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

  • CalendarApril 26, 2020 – 2022 Global Series Spring Session (Federal Circuit Bar Association and European Patent Lawyers Association) – 8:30 am to 6:00 pm (ET), Washington, DC

    April 26, 2022 – "Trending Topic in Brazil: Discussion on the Possibility of Patent Term Adjustment (PTA) in View of the Delay of the BPTO (Brazilian Patent Office)" (Dannemann Siemsen) – 12:00 pm (BRT)

    April 26-27, 2022 – Paragraph IV Disputes Conference (American Conference Institute) – New York City

    April 28, 2022 – "The Influence of Women in IP: Women and the Unified Patent Court" (OxFirst Limited) – 15:00 to 16:00 (GMT)

    April 28, 2022 – "Patenting and Litigating Pharmaceutical Salts" (IPWatchdog and Barash Law) – 12:30 pm (ET)

    April 28, 2022 – "The Power of Corporate Pledges" (Intellectual Property Owners Association) – 2:00 pm to 3:00 pm (ET)

    May 24, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 9:00 am to 11:00 am (ET)

    May 25, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)

    May 26, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 5:00 pm to 7:00 pm (ET)

  • FCBA & EPLAWThe Federal Circuit Bar Association (FCBA) and European Patent Lawyers Association (EPLAW) will be offering their 2022 Global Series Spring Session on April 26, 2020 from 8:30 am to 6:00 pm (ET) at the Army and Navy Club in Washington, DC.  The program will include presentations on the following topics:

    • International Trends in SEP/FRAND
    • The Intersection of Data and IP
    • Standard Setting – How Do Standards Impact Innovation and Trade?
    • Section 101 – What If?
    • Trade Secrets – From Enforcement to Unique Issues in the Virtual Setting
    • Pros and Cons of Waivers
    • USMCA and IP
    • Experts – A Comparison of Different Jurisdictions and What Works Best

    The registration fee for the program is $100 for private practitioners who are FCBA or EPLAW members and $50 for government/academic/retired FCBA or EPLAW members, and $400 for non-members.  An agenda for the program, including detailed descriptions of the program's sessions, a list of speakers, and registration information can be found here.

  • Dannemann SiemsenDannemann Siemsen will be offering a webinar entitled "Trending Topic in Brazil: Discussion on the Possibility of Patent Term Adjustment (PTA) in View of the Delay of the BPTO (Brazilian Patent Office)" on April 26, 2022 at 12:00 pm (BRT).  José Eduardo Cardozo of Martins Cardozo Advogados Associados, Justin Pine of the Biotechnology Innovation Organization (BIO), and Luiz Augusto Lopes Paulino of Dannemann Siemsen will address the ongoing debate regarding the possibility of PTA (Patent Term Adjustment) in view of the delay of the BPTO (Brazilian Patent and Trademark Office) in examining patent applications, a topic that surfaced after the Supreme Court revoked the right for applicants to have an automatic 10-year-term from grant, and which has resulted in patentees seeking PTA before the Brazilian courts.

    Those wishing to register for the webinar can do so here.

  • OxFirstOxFirst Limited will be offering a webinar entitled "The Influence of Women in IP: Women and the Unified Patent Court" on April 28, 2022 from 15:00 to 16:00 (GMT).  Marina Tavassi of BonelliErede, and formerly the President of the Court of Appeal; Julia Dias of Huawei; and Katie Colart of Kirkland & Ellis will address the following questions relating to women in IP and ask what can be done to remove gender barriers in intellectual property:

    • Under the Unified Patent Court (UPC), should the opportunities for women be stronger established?
    • Should women judges, given equal qualification and competence, be given priority in the selection process?
    • Should there be adjustments made to allow judges who are also parents to participate in the UPC?
    • Is there a need to come to grips with more gender-neutral language under the UPC?

    While there is no cost to participate in the program, those interested in attending the webinar should register here.

  • IPWatchdogIPWatchdog and Barash Law will be offering a webinar entitled "Patenting and Litigating Pharmaceutical Salts" on April 28, 2022 at 12:30 pm (ET).  Gene Quinn of IPWatchdog, Inc.; Stephen Byrn of Purdue University and Improved Pharma; Steven Zeman of Grünecker Patent Attorneys and Attorneys at Law; and Eyal Barash of Barash Law, LLC will focus on questions related to obviousness and inventive step, enablement and written description sufficiency, and scientific aspects of pharmaceutical salts, and address issues related to litigation of patents directed to such salts from both a legal and expert witness point of view.

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