Patent Docs

Top Three Stories of 2021

By Donald Zuhn –-

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

IPO Webinar Provides 2021 Year-End Case Law Review

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "2021 Year-End Case Law Review" on January 21, 2022 from 12:00 pm to 1:00 pm (ET).  Paul Berghoff of McDonnell Boehnen Hulbert & Berghoff LLP, Gregory Castanias of Jones Day, and Wendy Larson of Pirkey Barber will review the most significant intellectual property decisions of 2021 and give a sneak peek at coming attractions.

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.

BIO IPCC Webinar Series

The Biotechnology Innovation Organization IP Counsels Committee will be offering the next installment in its webinar series on January 26, 2022 at 1:00 pm (ET).  In the webinar, entitled "Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Considerations," Matthew A. Pearson and Rachel J. Elsby of Akin Gump will moderate a panel consisting of Paul Golian of Bristol Myers Squibb and Paula Fritsch of Amgen.  The panel will discuss recent developments in BPCIA litigation, PTAB practice, and potential legislative and policy reforms that may be on the horizon, including strategic considerations that influence how to approach the "patent dance" and parallel PTAB proceedings, as well as the impact of Fintiv on parallel proceedings.  The panel will also provide a high-level overview of relevant case law and trends in BPCIA litigation and related PTAB proceedings, followed by a "roundtable" discussion of the factors that may influence litigation strategy, early case resolution, and market entry.

The webinar is complimentary for BIO members and $99 for non-members.  Those interested in registering for the program, can do so here.

IPO Webinar Provides 2021 PTAB Year in Review

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "2021 PTAB Year in Review" on January 27, 2022 from 2:00 pm to 3:00 pm (ET).  Tom Irving, Mark Feldstein, and Joshua Goldberg of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Jessica Marks of Unified Patents; and Nichole Valeyko of Merck & Co. will highlight important PTAB decisions from 2021, as well as impacts on PTAB practice from external sources such as the Supreme Court, Federal Circuit, and Congress, and what to watch out for in 2022.

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.

CVC Files Substantive Miscellaneous Motion No. 4 to Add Senior Party Patents and Designate Claims Corresponding to the Count

By Kevin E. Noonan --

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Miscellaneous Motion No. 4 in Interference No. 106,132 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to add Sigma-Aldrich's U.S. Patent Nos. 10,731,181 and 10,745,716 to the interference and designate claims 1-17 of the '181 patent and claims 2-4, 11, 14, and 21-22 of the '716 patent as corresponding to the Count, pursuant to 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Standing Order ("SO") 203.2.  CVC's substantive argument is that these claims would have been obvious over Count 1 and the Jinek 2012 reference (Jinek et al., 2012, "A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive Bacterial Immunity," Science 337(6096): 816-21) in light of the Krebber 2000 reference (Krebber and Silver, 2000, "Directing Proteins to Nucleus by Fusion to Nuclear Localization Signal Tags," Methods in Enzymology 327: 283-96) or the Lange 2007 reference (Lange, 2007, "Classical Nuclear Localization Signals: Definition, Function, and Interaction with Importin α," J. Biol. Chem. 282(8): 5101–05).

CVC identifies what it characterizes as "nominal differences" between the Count and the claims to be designated in these two patents as "the recitation of the well-established Cas9 protein (from S. pyogenes), a well-known nuclear localization signal (a C-terminal SV40 NLS), and the natural and previously disclosed location for the DNA-targeting region (at the 5' end of the guide RNA).  None of these differences render these claims patentably distinct from the Count, as evidenced CVC argued by "highly similar claims already being involved in this proceeding as part of Sigma's U.S. Application No. 15/456,204."  These claims satisfy the test set forth under 37 C.F.R. § 41.207(b)(2) and Standing Order ¶ 208.3.1 that claims correspond to the Count where "the subject matter of the count, if treated as prior art, would have anticipated or rendered obvious the subject matter of [each] claim."  This test is satisfied if additional references are relied upon to make out a prima facie case of obviousness CVC argues, citing Desjardins v Wax, Interference No. 105,915, Paper 125, 17-20 (P.T.A.B. Jan. 21, 2014).  The basis for CVC's argument that the distinctions set forth above do not render these clams patentably distinct is that these distinctions are found in the cited prior art or were otherwise "well known for year," the brief the setting forth reasons for the Board to reach this conclusion.  Finally, CVC argues there are no objective indicia (or secondary considerations) that would provide the missing distinctions.

The brief then explicates with particularity the disclosures in the cited references which in combination with the limitations in the Count satisfy the requirements for obviousness.  These include 1) disclosure of dual-guide (dgRNA) and single-guide (sgRNA) RNA embodiments of CRISPR in the Jinek 2012 reference; and 2) the use of the nuclear localization signal from SV40 T antigen as the "canonical NLS for targeting proteins to the nucleus" in the prior art, citing references in exhibits.  The brief then subjects each of the claims CVC asks the Board to designate as corresponding to the count to the test established by the Supreme Court in Graham v. John Deere and KSR v. Teleflex  Int'l to support its obviousness argument with regard to those claims.

In addition, the brief sets forth a comparison between the claims CVC asks the Board to designate as corresponding to the Count with Sigma-Aldrich's claims already involved in the interference the inclusion of which the Senior Party has not contested:

Finally, CVC argues that it should prevail against Sigma-Aldrich in this interference based on nothing more than the disclosures in U.S. Provisional Application No. 61/652,086, filed May 25, 2012 ("P1"), and U.S. Provisional Application No. 61/716,256, filed October 19, 2012, ("P2"), the benefit of priority to which CVC argued in its Substantive Preliminary Motion No. 1.

CVC Files Substantive Preliminary Motion No. 3 to Substiture the Count

By Kevin E. Noonan --

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 3 in Interference No. 106,132 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to substitute the Count of the interference pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1).

The present Count is set forth in the alternative either as Claim 156 on CVC's application-in-interference No. 15/981,807 (which claim also has been a portion of the Count in Interference No. 106,127 naming ToolGen as Senior Party) or Claim 31 in Sigma-Aldrich's involved Application No. 15/456,204*:

31.  (previously presented) A method for modifying a chromosomal sequence in a eukaryotic cell by integrating a donor sequence, the method comprising introducing into the eukaryotic cell:
    (i) a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)/CRISPR-associated (Cas) (CRISPR-Cas) type II protein linked to only one nuclear localization signal (NLS) or a nucleic acid encoding the CRISPR-Cas type II protein linked to only one NLS, wherein the CRISPR-Cas type II protein is a Cas9 protein, and the nucleic acid encoding the CRISPR-Cas type II protein is codon optimized for expression in the eukaryotic cell;
    (ii) a guide RNA or DNA encoding the guide RNA, wherein the guide RNA comprises a first region that is complementary to a target site in the chromosomal sequence, which target site in the chromosomal sequence is immediately followed by a protospacer adjacent motif (PAM), and a second region that interacts with the CRISPR-Cas type II protein, and wherein the guide RNA comprises a crRNA and a tracrRNA; and
    (iii) a donor polynucleotide comprising the donor sequence and upstream and downstream sequences;
    wherein the guide RNA guides the CRISPR-Cas type II protein to the target site in the chromosomal sequence, the CRISPR-Cas type II protein introduces a double stranded break at the target site, and repair of the double-stranded break by a DNA homology-directed repair (HOR) process leads to integration or exchange of the donor sequence into the chromosomal sequence.

In its motion, CVC proposes that this claim be substituted for claim 33, which has the additional limitation that "the guide RNA is a single molecule."  CVC argues that substituting this Count is more symmetrical with CVC's portion of the Count and "avoids inconsistency" with the Counts in related interferences (see "CRISPR Battle Joined Again"; "The CRISPR Chronicles: Enter Toolgen"; and "Sigma-Aldrich Joins the CRISPR Interference Fray").

This "consistency" CVC seeks is that the Count reflect the limitation that the CRISPR complex recited therein comprise a single-molecule RNA species ("sgRNA") comprising the structural tracrRNA and the sequence-specific crRNA that, in combination with Cas9 protein introduces double-stranded breaks in DNA at specific sites in a target DNA.  CVC notes that this consistent recitation of sgRNA species in Counts of the pending interferences is present whether the claims corresponding to the Count in each interference are limited to sgRNA or encompass "dual-molecule" RNA species (termed "generic-guide" claims).  CVC argues that Sigma-Aldrich's claims are "outliers" in this regard, and that the Board has discretion to substitute the Count under appropriate circumstances (like these, according to CVC), citing Hitzman v. Rutter, 243 F.3d 1345, 1359 (Fed. Cir. 2001), without abusing its discretion.

In CVC's view, the benefits of substituting the Count as they suggest are "[e]fficiency, uniformity, and clarity" consistent with 37 C.F.R. § 41.1(b), while on the other hand "there are significant negative consequences of proceeding with this Interference if the Sigma side of the count is not conformed to the other pending interferences and continues to recite something other than a single guide system," naming two such negative consequences:

• First, proceeding with the existing count in this interference invites the parties to submit proofs that are different than those in the co-pending interferences.  The inconsistency between the count in this interference and the co-pending interferences creates the possibility of irreconcilable decisions among interferences that involve the same claims for each party.  Such inconsistency would be prejudicial to any party in CVC's position, and the public.

• Second, this uncertainty is magnified where the Sigma side of the count is subject to a disputed construction and is, as discussed in detail below, ambiguous as to whether it covers RNAs other than single-guide RNA.  To avoid this ambiguity, the Board should substitute dependent claim 33 because it clearly recites a single-guide RNA molecule.

The brief explicates the details of these benefits and negative consequences with reference to the co-pending Interferences, their subject matter as defined by their Counts and the claims-in-interference in each, noting in addition that "[t]he PTAB chose to declare multiple, co-pending two-party interferences as an alternative to managing a single, multi-party interference" which would have avoided the possibility of [unnecessary differences in scope across the various counts [that] could lead to inconsistent results and . . . create uncertainty among the parties and the public."

In addition, CVC argues that the best use of so-called "McKelvey counts" as here is to choose claims from each party's pending or granted claims that are "as balanced and similar in scope as possible" (as, CVC argues, the Board has done in the '115, 126, and 127 interferences).

CVC argues that "Sigma will suffer no prejudice" by this substitution because its first provisional application (corresponding to the earliest priority date for which the Declaration of Interference gives the benefit of priority and Senior Party status) discloses sgRNA species-comprising CRISPR complexes (as well as dual-molecule species).  Further, substituting this Count does not require the Board to de-designate any of the claims corresponding to the Count contained in the Interference Declaration, nor would substitution prevent the Board from granting (or denying) CVC's Motion No 4 to designate claims in Sigma-Aldrich's U.S. Patent Nos. 10,731,181 and 10,745,716 (arguing separately that these claims correspond to the Count).  Nor would the substitution affect limitations in certain of Sigma-Aldrich's claims (using a codon-optimized nucleic acid to encode Cas9 protein having a nuclear localization sequence, for example), according to CVC.

The brief sets forth the claims of each party corresponding to Proposed Substitute Count 2 as follows:

CVC also notes that it is entitled to priority benefit as set forth in its Preliminary Motion No. 1 setting forth a table of correspondence between the express embodiments set forth in these provisional applications (U.S. Provisional Application 61/652,086 ("P1"), filed May 25, 2012 and, in the alternative, U.S. Provisional Application 61/716,256 ("P2"), filed October 19, 2012) and the limitations recited in Proposed Count 2:

as supported by particular disclosure in the specification and drawings as they would be understood by the skilled artisan in view of the teachings of the prior art.

Finally, pursuant to 37 C.F.R. § 41.208(c)(2), CVC argues that its proposed Substitute Count 2 is patentable over the prior art, inter alia, because it "is narrower than Count 1, and therefore does not raise any issues regarding patentability over the prior art."

Top Stories of 2021: #4 to #6

By Donald Zuhn –-

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.  On Monday, we counted down stories #9 to #7, and today we count down stories #6 to #4, as we work our way towards 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.

6.  Patent Community Living with Subject Matter Eligibility Status Quo Nearly a Decade after Mayo v. Prometheus

It has been almost a decade since the Supreme Court issued its decision in Mayo v. Prometheus, and in the time that has passed since that decision, the current subject matter eligibility standard has become the status quo with little prospect for change.  Notwithstanding the subject matter status quo, subject matter eligibility once again made our top stories list -- as has been the case in seven of the past eight years.  In particular, stories involving subject matter eligibility took the #2 and #3 spots on our list last year after taking the #2 and #5 spots on our 2019 list; the #2 spot on our 2018 list; the #1, #2, and #4 spots on both our 2016 and 2015 lists; the #1 and #2 spots on our 2014 list; and the #1 spot on our 2013 list.

The year started with Patent Docs authors Kevin Noonan and Michael Borella joining two other Chicago patent attorneys in filing an amicus brief supporting Supreme Court review of the Federal Circuit's decision to invalidate claims of American Axle's U.S. Patent No. 7,774,911 under 35 U.S.C § 101 (our #3 story in 2020 was the Federal Circuit's decision in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC).  In May, the Supreme Court requested the views of the Solicitor General in its consideration of American Axle's certiorari petition, which asks the Court to reverse the Federal Circuit's decision in American Axle.

And then in June, a divided Federal Circuit panel affirmed a District Court determination that claims directed to a digital camera were invalid under § 101 in Yu v. Apple.  A few months earlier, Senators Thom Tillis (R-NC), Mazie K. Hirono (D-HI), Tom Cotton (R-AR), and Chris Coons (D-DE) wrote to Drew Hirschfeld, current Commissioner of Patents and Acting Director of the U.S. Patent and Trademark Office, asking the USPTO to publish a request for information on the current state of patent eligibility jurisprudence in the United States, evaluate the responses, and provide Congress with a detailed summary of the Office's findings, particularly with regard to how the current jurisprudence has adversely impacted investment and innovation in critical technologies like quantum computing, artificial intelligence, precision medicine, diagnostic methods, and pharmaceutical treatments.  The Senators asked for a response by March 2022, so subject matter eligibility is likely to keep its top stories streak going in 2022.

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

• "CardioNet, LLC v. InfoBionic, Inc. (Fed. Cir. 2021)," November 16, 2021
• "On the Nature of Prior Art in the 35 U.S.C. § 101 Inquiry," August 10, 2021
• "Yu v. Apple (Fed. Cir. 2021)," June 13, 2021
• "Supreme Court Requests View of Solicitor General in American Axle v. Neapco," May 3, 2021
• "Could Alice Be Used to Invalidate Diehr? Of Course It Could," April 20, 2021
• "In re Board of Trustees of the Leland Stanford Junior University (Fed. Cir. 2021)," March 28, 2021
• "On the Patent Eligibility of Information Processing," March 15, 2021
• "In re Board of Trustees of the Leland Stanford Junior University (Fed. Cir. 2021)," March 14, 2021
• "Senators Request USPTO to Provide Information on Subject Matter Eligibility," March 9, 2021
• "Chicago Patent Attorneys File Supreme Court Amicus Brief in American Axle," February 4, 2021

5.  Federal Circuit Continues to Develop (and Limit) Section 112

In 2017, the Federal Circuit's decision in Amgen Inc. v. Sanofi, which brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies, made it to #11 on our top stories list.  In February, the Federal Circuit took aim at the enablement requirement for antibody claims in Amgen, Inc. v. Sanofi, with similar, scope-limiting results.

The Federal Circuit followed that decision with several other decisions implicating the written description and enablement requirements, including Bayer Healthcare LLC v. Baxalta Inc. (enablement); Raytheon Technologies Corp. v. General Electric Co. (enablement); Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (enablement); Juno Therapeutics, Inc. v. Kite Pharma, Inc. (written description); Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (written description); and Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. (written description).  As a result of the Federal Circuit's decision in Juno Therapeutics, the scope of claims relating to antibodies (as well as other chemical species) will likely be limited to a "what you see (i.e., disclose expressly) is what you get (patented)" model, which will no doubt (by reducing valid claim scope) allow copyists to piggyback on others' inventions to make their own competing species of valuable therapeutic agents.

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

• "Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)," December 1, 2021
• "Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)," November 28, 2021
• "Juno Therapeutics, Inc. v. Kite Pharma, Inc. (Fed. Cir. 2021)," August 26, 2021
• "Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (Fed. Cir. 2021)," May 20, 2021
• "Raytheon Technologies Corp. v. General Electric Co. (Fed. Cir. 2021)," April 18, 2021
• "Bayer Healthcare LLC v. Baxalta Inc. (Fed. Cir. 2021)," March 8, 2021
• "Amgen Inc. v. Sanofi (Fed. Cir. 2021)," February 21, 2021

4.  Supreme Court Reaffirms (But Limits Application of) Assignor Estoppel Doctrine

In June, a five-justice majority of the Supreme Court reaffirmed the doctrine of assignor estoppel, while at the same time limiting its application, in Minerva Surgical, Inc. v. Hologic, Inc.  Assignor estoppel prohibits an inventor or other owner of rights in a patent from selling that patent to another party, then practicing the invention while attempting to avoid infringement liability by claiming the patent was invalid from the start.  The Minerva majority found that the doctrine was well-established in the law and thus was unwilling to abandon it.  However, consistent with the equitable nature of the doctrine, the Court limited the doctrine to those instances where the assignor could be fairly understood to have warranted (either expressly or implicitly) the validity of the claims that ultimately issued.  Thus, in many circumstances -- such as when an inventor assigns rights to a patent application that issues with significantly broader claims -- the doctrine will not apply.

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

• "Minerva Surgical, Inc. v. Hologic, Inc. (2021)," June 30, 2021
• "Oral Argument in Minerva Surgical Inc. v. Hologic, Inc.," April 25, 2021