Top Three Stories of 2021

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After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories.  For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Last week we counted down stories #9 to #7 and stories #6 to #4 and today we count down the top three stories of 2021.  As with our other lists (2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2021" on January 19, 2022 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

3.  Supreme Court Vacates and Remands U.S. v. Arthrex

Last year, the Supreme Court's decision to review the Federal Circuit's decision in Arthrex, Inc. v. Smith & Nephew, Inc., in which the Court of Appeals determined that the manner in which administrative patent judges were appointed to the Patent Trial and Appeal Board violated the Appointments Clause of the Constitution (Art. II, sec. 2, cl. 2), made it to #4 on our Top Stories list.  We noted at the time that a decision in the case was likely to be issued by the Supreme Court in June, and that Arthrex would likely make our 2021 list.

In June, the Supreme Court determined that "the unreviewable authority wielded by APJs [Administrative Patent Judges] during inter partes review is incompatible with their appointment by the Secretary [of Commerce] to an inferior office," and the Court vacated the judgment of the Federal Circuit and remanded for further proceedings consistent with its opinion.  Chief Justice delivered the opinion of the Court and was joined with respect to Parts I and II by Justices Alito, Gorsuch, Kavanaugh, and Barrett, and with respect to Part III by Justices Alito, Kavanaugh, and Barrett.  Justice Gorsuch filed an opinion concurring in part and dissenting in part; Justice Breyer filed an opinion concurring in the judgment in part and dissenting in part, and was joined by Justices Sotomayor and Kagan; Justice Thomas filed a dissenting opinion, and was joined as to Parts I and II by Justices Breyer, Sotomayor, and Kagan.  In Part III of his opinion, which was only joined by Justices Alito, Kavanaugh, and Barrett, the Chief Justice addressed "the appropriate way to resolve this dispute given this violation of the Appointments Clause," and indicated that "the structure of the PTO and the governing constitutional principles chart a clear course: Decisions by APJs must be subject to review by the Director."  In his opinion, however, Justice Gorsuch noted that without some direction from Congress, the dispute cannot be resolved as a matter of statutory interpretation.  Although Justice Breyer did "not agree with the Court's basic constitutional determination," he wrote that:

Under the Court's new test, the current statutory scheme is defective only because the APJ's decisions are not reviewable by the Director alone.  The Court's remedy addresses that specific problem, and for that reason I agree with its remedial holding.

Following the Supreme Court's decision in Arthrex, the U.S. Patent and Trademark Office, in a series of Arthrex Q&As, outlined an interim internal process by which an advisory committee established by the Director will evaluate requests for Director review made by parties to a PTAB proceeding or reviews initiated sua sponte by the Director.

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

• "U.S. v. Arthrex: Is Historical Practice of the USPTO Relevant?" March 3, 2021
• "U.S. v. Arthrex: Supreme Court Oral Argument," March 2, 2021

2.  Increased Focus on Closing Diversity Gap in Innovation and Patent Practice

In December 2020, the Intellectual Property Owners Association wrote to then President-Elect Joe Biden and Vice President-Elect Kamala Harris "to recommend that intellectual property (IP) law and policy be priorities in your administration."  In its letter, the IPO declared that "[c]losing the diversity gap in innovation is also vitally important to our economic growth and global competitiveness," noting that women, people of color, and other minority groups are vastly underrepresented in the patent system.  The letter also pointed out that recent "scholarship indicates that increasing participation in inventing by underrepresented groups could increase U.S. GDP by as much as 4.4%," and suggested that "[i]t is imperative that the public and private sectors work together to close this gap and harness our country's potential to innovate at greater levels than ever before."  The IPO's letter at the close of 2020 led to an increased focus in the patent community last year on closing the diversity gap in innovation and patent practice.

In one such example, Sen. Thom Tillis (R-NC), the Ranking Member of the Senate Subcommittee on Intellectual Property, wrote to President Biden in March regarding the selection of the next Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.  Sen. Tillis declared that the nominee "must be committed to increasing diversity in our nation's intellectual property system," stating that "[f]or too long, too many women and people of color have been underrepresented in our innovation ecosystem," and noting that "[t]hese individuals often face unique barriers to engaging in the intellectual property system and their lack of access costs our economy billions of dollars every year." On October 26, 2021, President Biden announced the nomination of Kathi Vidal, managing partner of Winston & Strawn’s Silicon Valley Office, for Under Secretary for Intellectual Property and Director of the USPTO.  The White House announcement stated that:

Kathi is a recognized leader in diversity and women's issues.  She is one of four law firm advisory board members for ChIPs, a non-profit organization committed to advancing women at the intersection of law, technology, and regulatory policy.  She founded the Next Gen initiative and actively advocates for training and opportunities for junior lawyers.  She is also a member of Winston & Strawn's Executive Committee and Diversity.  At her prior firm, Fish & Richardson, Kathi was the Litigation Chair and sat on the firm's management committee.  She has a strong technical background, having practiced in industry for five years at General Electric and Lockheed Martin in circuit, systems, software and artificial intelligence.

Ms. Vidal's nomination was placed on the Senate Executive Calendar on January 13.

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

• "USPTO News Briefs," November 22, 2021
• "USPTO to Host Event Celebrating LGBTQ+ Innovators," June 26, 2021
• "Sen. Tillis Sends Letter to President Regarding Next USPTO Director," March 7, 2021
• "USPTO Responds to Congressional Request for Information Regarding Criteria for Registration Examination for Admission to Patent Bar," January 21, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

1.  Pandemic Continues to Impact Patent Practice & Ongoing Discussions Regarding WTO Waiver Proposal

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  By January 12, 2021, the WHO indicated that there had been 88,387,352 cases globally.  And in its latest report, issued on January 11, 2022, the WHO indicates that there have been 304,350,207 cases globally.

As it has for nearly every single industry, the COVID-19 pandemic continues to have a profound impact on patent practice.  In the more than two years since the SARS-CoV-2 virus was first detected in a patient sample, the pandemic has changed how most of us work, where most of us work, and what many of us work on.  However, as the Pharmaceutical Research and Manufacturers of America (PhRMA) noted in a letter the organization sent to the Biden Administration in March, over that same two year period "[p]erhaps more than any other time in history, society is seeing and benefiting from the innovation supported by intellectual property."  For example, the U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for Gilead Sciences' remdesivir 123 days after the virus was first detected in a patient sample, granted an EUA for convalescent plasma 237 days after the virus was first detected, granted an EUA for Eli Lilly's antibody treatment 315 days after the virus was first detected, granted an EUA for the Pfizer-BioNTech vaccine 347 days after the virus was first detected (and then followed with two more EUAs for Moderna's vaccine and Johnson & Johnson's vaccine), and approved Pfizer's antiviral PAXLOVID 723 days after the virus was first detected.

Last year also saw an ongoing debate over a proposal by India and South Africa to waive implementation, application, and enforcement of Sections 1, 4, 5, and 7 of Part II of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in relation to the prevention, containment, or treatment of COVID-19.  Despite receiving letters opposing the proposed waiver from the Biotechnology Innovation Organization (BIO), PhRMA, other industry and trade organizations, IP organizations, and members of Congress, U.S. Trade Representative Katherine Tai announced In May that the Biden Administration supported the proposed TRIPS waiver, noting that "the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures."  While a revised version of the waiver proposal was to be discussed during the 12th Ministerial Conference (MC12) of the WTO in Geneva beginning November 30, the MC12 was postponed due to the omicron outbreak.  That postponement marked the second time the pandemic had forced postponement of the Ministerial Conference, and no new date has been set for the MC12.  The hope is that the coming spring will see the pandemic finally recede such that we can all return to something very close to "normal".

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

• "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
• "Science Does Not Support the Latest COVID Hysteria," May 13, 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
• "Evolution of SARS-CoV-2 from Bat to Human Pathogen," March 31, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "Neanderthal Ancestors Can Be Human Guardian Angels for COVID Infection, Too," March 18, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "Do mRNA-based COVID Vaccines Have an Achilles Heel?" January 26, 2021
• "Going from Bad to Worse: Evidence for Neuro-COVID Infections," January 17, 2021
• "USPTO Provides Update on COVID-19 Prioritized Examination Pilot Program," January 3, 2021

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