• J A KempJ A Kemp will be offering a webinar entitled "Sufficiency at the EPO" on May 21, 2020 from 16:30 to 17:30 pm GMT (Greenwich Mean Time).  Sarah Roques and Stuart Raynor of J A Kemp will consider the law surrounding sufficiency in particular in relation to the biotechnology and chemical fields, and also consider strategies that can be used by those on both sides of the sufficiency debate.  Topics to be covered will include:

    • Sufficiency and breadth of claim
    • How sufficiency is considered in respect of medical use claims
    • The relevance of sufficiency to claims defined with parameters
    • The relationship between sufficiency and clarity

    Those wishing to register can do so here.

  • IAMIPBC Talking Heads and iam will be offering a free webinar entitled "Identifying the new normal: what past downturns tell us about how the IP future will evolve" on May 20, 2020 from 11:00 am to 12:00 pm (EDT).  In IP terms, the COVID-19 crisis builds on two prior economic shocks:  the bursting of the dot-com bubble in 2000 and the 2008 financial collapse, which confirmed IP's status as a counter cyclical asset and led to market-defining events such as the growth of NPEs and the 2011 Nortel auction.  While some of the specifics of current events look very different to those of previous times, IP may once again see its status rise as a driver of value for many companies.  The webinar will explore what past downturns tell us about how the IP future will evolve.

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

  • Schwegman Lundberg WoessnerSchwegman Lundberg & Woessner will be offering a webinar entitled "Patenting Vaccines: A Look Back and the Road Ahead" on May 21, 2020 starting at 11:00 am (CT).  Warren D. Woessner, Janet E. Embretson, Monique Perdok and Robin A. Chadwick of Schwegman Lundberg & Woessner will review patenting opportunities and obstacles presented by the massive research effort to develop a vaccine against deadly viruses such as MERS, SARS, and COVID-19.

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

  • By Kevin E. Noonan

    Sigma-AldrichFor several years, Sigma Aldrich has been prosecuting several applications (including USSNs 15/188,911; 15/188,924; and 15/456,204) claiming CRISPR technology that (it alleged) would be deserving of an interference with University of California's U.S. Application Nos. 15/9547,718 and 15/981,809, and reserving the right to supplement its request to include other patents and patent applications owned by the University of California Berkeley et al. (collectively "CVC") as well as those of owned by The Broad Institute and colleagues (see "Sigma-Aldrich Wants Its Piece of CRISPR Pie" and "Sigma-Aldrich Tries Again").  Such an interference, if declared, threatened to upset the CVC/Broad apple cart regarding CRISPR-Cas-9 patent ownership, Sigma–Aldrich alleging an earlier priority date than the Broad's earliest date and 3-7 months after CVC's earliest date:

    Image
    However, the U.S. Patent Examiner had taken the position that Sigma-Aldrich was not entitled to a Declaration of Interference until it had obtained allowed claims, and that CVC's earlier patent dates prevented such an allowance unless, inter alia, Sigma-Aldrich could swear behind the earlier patent application filing dates.  With significant justification, Sigma-Aldrich characterized this situation as a Catch 22 in view of the seemingly contradictory conclusion arrived at by both Patent Trial and Appeal Board (see "PTAB Decides CRISPR Interference — No interference-in-fact" and "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning") and Federal Circuit (see "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018)").

    The logjam was recently broken for two of these Sigma-Aldrich applications, the Patent Office issuing a Notice of Allowance for 15/188,911 and 15/188,924.  The allowed claims, including Examiner's amendments, are as follows:

    U.S. Application No. 15/188911:

    1. (currently amended) A method for integrating an exogenous sequence into a chromosomal sequence of a eukaryotic cell, the method comprising:
    introducing into the eukaryotic cell:
        (i) at least one RNA-guided endonuclease or nucleic acid encoding at least one RNA-guided endonuclease, wherein the at least one RNA-guided endonuclease is a clustered regularly interspersed short palindromic repeats (CRISPR)/CRISPR associated (Cas) (CRISPR-Cas) type II system protein, wherein the nucleic acid encoding the CRISPR-Cas type II system protein is codon optimized for expression in the eukaryotic cell,
    wherein the CRISPR-Cas type II system protein is a Streptococcus pyogenes Cas9 protein including at least one nuclear localization signal consisting of comprising SEQ ID NO: 1 or SEQ ID NO:2 covalently attached to the C-terminal amino acid of the Cas9 protein sequence; and
        (ii) at least one engineered guide RNA or DNA encoding at least one engineered guide RNA, each guide RNA comprising
            (1) a first region at the 5' end that base pairs with a target site in the chromosomal sequence, and
            (2) a second region that forms a secondary structure which interacts with the at least one RNA-guided endonuclease; and
        (iii) at least one donor polynucleotide comprising the exogenous sequence;
    whereby the at least one guide RNA guides the at least one RNA-guided endonuclease to the target site in the chromosomal sequence where the RNA-guided endonuclease introduces a double-stranded break, the target site in the chromosomal sequence is immediately followed by a proto spacer adjacent motif (PAM), and repair of the double-stranded break by a DNA repair process leads to integration of the exogenous sequence into the chromosomal sequence.

    8. (original) The method of claim 1, wherein the exogenous sequence in the donor polynucleotide is flanked by sequences having substantial sequence identity to sequences on either side of the target site in the chromosomal sequence.

    9. (previously presented) The method of claim 1, wherein the exogenous sequence in the donor polynucleotide further comprises a targeted cleavage site that is recognized by the at least one RNA-guided endonuclease.

    10. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA

    11. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is DNA

    13. (previously presented) The method of claim 1, wherein the eukaryotic cell is a human cell, a nonhuman mammalian cell, or a plant cell.

    14. (original) The method of claim 1, wherein the eukaryotic cell is in vitro.

    15. (original) The method of claim 1, wherein the eukaryotic cell is in vivo.

    16. (original) The method of claim 1, wherein the at least one guide RNA is at least partially chemically synthesized.

    18. (previously presented) The method of claim [[19]] 1, wherein the Cas9 protein is from Streptococcus pyogenes strain MGAS15252 and comprises SEQ ID NO:9.

    20. (currently amended) The method of claim [[19]] 1, wherein the at least one nuclear localization signal covalently attached to the C-terminal amino acid of the Cas9 protein sequence consists of comprises SEQ ID NO:1.

    21. (currently amended) The method of claim 1, wherein the at least one RNA guided endonuclease comprising the at least one nuclear localization signal covalently attached to the C-terminal amino acid of the Cas9 protein sequence consists of comprises SEQ ID NO:2.

    22. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA and the at least one guide RNA is comprised of two non-covalently bound RNA molecules.

    23. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA and the at least one guide RNA is comprised of a single RNA molecule.

    24. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is DNA, the at least one guide RNA is encoded by DNA, and the at least one guide RNA is comprised of a single RNA molecule.

    25. (previously presented) The method of claim 1, wherein the at least one donor polynucleotide is double stranded DNA.

    26. (previously presented) The method of claim 1, wherein the at least one donor polynucleotide is single stranded DNA.

    The Notice of Allowance states that:

    The [Examiner's] amendment of the claimed method to recite, "wherein the CRISPR-Cas type II system protein is a Streptococcus pyogenes Cas9 protein including at least one nuclear localization signal consisting of SEQ ID NO: 1 or SEQ ID NO:2 covalently attached to the C-terminal amino acid of the Cas9 protein sequence" obviates the rejections of record.

    This claim has been narrowed to limit the nuclear localization sequence (NLS) to consist of the expressly recited sequence identified by SEQ ID Nos. 1 or 2, which were not disclosed in the prior art including CVC's earlier priority documents.  And it is interesting to note that while the Office has asserted dozens of CRISPR patents and applications in earlier rejections, only one patent (and a scientific reference) are noted in the Examiner's Reasons for Allowance.

    With regard to U.S. Application No. 15/188,924, the allowed claims are:

    1. (currently amended) A method for modifying a chromosomal sequence in a eukaryotic cell, the method comprising:
    introducing into the eukaryotic cell
        (i) at least one RNA-guided endonuclease or nucleic acid encoding at least one RNA-guided endonuclease, wherein the at least one RNA-guided endonuclease is a clustered regularly interspersed short palindromic repeats (CRISPR)/CRISPR associated (Cas) (CRISPR-Cas) type II system protein,
    wherein the nucleic acid encoding the CRISPR-Cas type II system protein is codon optimized for expression in the eukaryotic cell,
    wherein the CRISPR-Cas type II system protein is a Streptococcus pyogenes Cas9 protein including at least one nuclear localization signal consisting of comprising SEQ ID NO: 1 or SEQ ID NO:2 covalently attached to the C-terminal amino acid of the Cas9 protein sequence; and
        (ii) at least one engineered guide RNA or DNA encoding at least one engineered guide RNA, each guide RNA comprising
            (1) a first region at the 5' end that base pairs with a target site in the chromosomal sequence, and
            (2) a second region that forms a secondary structure which interacts with the at least one RNA-guided endonuclease; and, optionally,
        (iii) at least one donor polynucleotide; [[and]]
    whereby the at least one guide RNA guides the at least one RNA-guided endonuclease to the target site in the chromosomal sequence where the RNA-guided endonuclease introduces a double-stranded break, the target site in the chromosomal sequence is immediately followed by a proto spacer adjacent motif (PAM), and repair of the double-stranded break by a DNA repair process leads to modification of the chromosomal sequence.

    8. (previously presented) The method of claim 1, wherein the optional donor polynucleotide comprises a donor sequence that has at least one nucleotide change relative to the chromosomal sequence near the target site in the chromosomal sequence.

    9. (original) The method of claim 8, wherein the donor sequence is flanked by sequences having substantial sequence identity to sequences on either side of the target site in the chromosomal sequence.

    10. (previously presented) The method of claim 8, wherein the donor sequence further comprises a targeted cleavage site that is recognized by the at least one RNA guided endonuclease.

    11. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA

    12. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is DNA

    14. (previously presented) The method of claim 1, wherein the eukaryotic cell is a human cell, a nonhuman mammalian cell, or a plant cell.

    15. (original) The method of claim 1, wherein the eukaryotic cell is in vitro.

    16. (original) The method of claim 1, wherein the eukaryotic cell is in vivo.

    17. (original) The method of claim 1, wherein the optional donor polynucleotide is not introduced into the eukaryotic cell, and repair of the double-stranded break by a non-homologous end-joining repair process results in inactivation of the chromosomal sequence.

    18. (original) The method of claim 1, wherein the optional donor polynucleotide is introduced into the eukaryotic cell, and repair of the double-stranded break results in a change of at least one nucleotide in the chromosomal sequence.

    19. (original) The method of claim 1, wherein the at least one guide RNA is at least partially chemically synthesized.

    20. (original) The method of claim 1, wherein only (i) and (ii) are introduced into the eukaryotic cell.

    21. (original) The method of claim 1, wherein (i), (ii), and (iii) are introduced into the eukaryotic cell.

    23. (currently amended) The method of claim [[24]] 1, wherein the Cas9 protein is from Streptococcus pyogenes strain MGAS15252 and comprises SEQ 10 NO:9.

    25. (currently amended) The method of claim [[24]] 1, wherein the at least one nuclear localization signal covalently attached to the C-terminal amino acid of the Cas9 protein sequence consists of comprises SEQ 10 NO:1.

    26. (currently amended) The method of claim 1, wherein the at least one RNA guided endonuclease comprising the at least one nuclear localization signal covalently attached to the C-terminal amino acid of the Cas9 protein sequence consists of comprises SEQ ID NO:2.

    27. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA and the at least one guide RNA is comprised of two non-covalently bound RNA molecules.

    28. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is mRNA and the at least one guide RNA is comprised of a single RNA molecule.

    29. (previously presented) The method of claim 1, wherein the nucleic acid encoding the at least one RNA-guided endonuclease is DNA, the at least one guide RNA is encoded by DNA, and the at least one guide RNA is comprised of a single RNA molecule.

    30. (previously presented) The method of claim 1, wherein the optional donor polynucleotide is double stranded DNA

    31. (previously presented) The method of claim 1, wherein the optional donor polynucleotide is single stranded DNA

    As with the '911 application, the Notice of Allowance states:

    The amendment of the claimed method to recite, "wherein the CRISPR-Cas type II system protein is a Streptococcus pyogenes Cas9 protein including at least one nuclear localization signal consisting of SEQ ID NO: 1 or SEQ ID NO:2 covalently attached to the C-terminal amino acid of the Cas9 protein sequence" obviates the rejections of record.

    And the claims are equally limited to embodiments consisting of SEQ ID Nos. 1 or 2.

    Also, the claims in U.S. Application No. 15/456,204 are not yet allowed but remain as subject matter for an interference under Rule 202:

    1. 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 at least one nuclear localization signal (NLS) or a nucleic acid encoding the CRISPR-Cas type II protein linked to at least 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 that is immediately followed by a protospacer adjacent motif, and a second region that interacts with the CRISPR-Cas type II protein; and (iii) a donor polynucleotide comprising the donor sequence;
    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 repair process leads to integration or exchange of the donor sequence into the chromosomal sequence.

    (These claims have not been subject to a limiting Examiner's amendment.)  Sigma-Aldrich has withdrawn its Request under 37 C.F.R. § 41.202 for the PTAB to declare an interference with the patents and patent applications currently at issue between CVC and the Broad in Interference No. 106,115.  Sigma-Aldrich has maintained its Petition to the Director that the PTAB should declare an interference involving the claims of the '204 application without requiring an allowance ("Sigma-Aldrich does not withdraw, and specifically maintains, the portions of its Renewed Petition and its Partial Withdrawal and Supplementation directed to Sigma-Aldrich's U.S. Patent App. No. 15/456,204 ("the Sigma '204 Application")."

    That the allowed claims are exceedingly narrow is not the impediment it otherwise might be, because should the PTAB declare an interference (and Sigma-Aldrich be awarded priority of invention), the "prior art" that necessitated acceptance of these narrow claims would no longer preclude Sigma-Aldrich from obtaining claims commensurate with the scope of CRISPR-Cas9 disclosed in its applications.  The allowed claims merely overcome the procedural requirement for having allowed claims; indeed, Sigma-Aldrich affirmatively asserts in its most recent Office Action responses prior to allowance that it intends to file continuations applications having claims that interfere with CVC and Broad's patents and applications.  Interference motion practice, as has occurred between CVC and the Broad over the past nine months (and slated for culmination at Oral Hearing on May 18th) would be available to Sigma-Aldrich to craft the scope of the count and the claims corresponding thereto to its advantage.

    There is no time frame for Sigma-Aldrich's petition in the '204 application to be considered much less granted, but allowance of these claims complicates the already complicated web of determining who really owns CRISPR technology.

  • By Kevin E. Noonan

    U.S. Trade RepresentativeThe 2019 Review of Notorious Markets for Counterfeiting and Piracy provides a list of such markets (the NML), of both physical and virtual (online) varieties.  These include:

    Online markets:

    1337x, 1Fischier, Amazon Foreign Domains, BestBuyIPTV, Bukalapak, Carousell, Chomikuj, Cimaclub, DHGate, DYTT8, Flokinet, FMovies, Hosting Concepts B.V., MP3Juices, MPGH, NewAlbumReleases, PHIMMOI, Pindioduo, Private Layer-hosted sites, Propeller Ads, Rapidgator, RARBG, Rutracker, Sci-Hub, Seasonvar, Shopee, SnapDeal, TaoBao, ThePirateBay, Tokopedia, TorrentZ2, Turbobit, Uploaded, UPSOBox, VK, and Warmane

    Physical Markets:

    Argentina, Brazil, Cambodia, China, Ecuador, India, Kyrgyz Republic, Malaysia, Mexico, Paraguay, Peru, Philippines, Russia, Spain, Thailand, Turkey, Ukraine, UAE, and Vietnam

    The NML Review is provided (and needed) because "[c]ommercial-scale copyright piracy and trademark counterfeiting cause significant financial losses for U.S. right holders and legitimate businesses, undermine critical U.S. comparative advantages in innovation and creativity to the detriment of American workers, and pose significant risks to consumer health and safety."  The Review provides "prominent and illustrative examples" of markets that "engage in or facilitate substantial piracy or counterfeiting."  The goal of disclosing these markets in the Review is to "motivate appropriate action by the private sector and governments to reduce piracy and counterfeiting."  The listed countries and markets "exemplify global counterfeiting and piracy concerns and because the scale of infringing activity in these markets can cause significant harm to U.S. intellectual property (IP) owners, consumers, legitimate online platforms, and the economy."

    Some of the markets on the NML are a mixture of legitimate and illicit activities, while others are known or suspect to be engaged solely in counterfeiting and piracy.  Inclusion in the list varies from year-to-year as the markets come and go, or governments improve enforcement or other activities to limit counterfeiting and piracy, or market owners cooperate with branded product manufacturers and purveyors.

    The NML warns that the list is not exhaustive nor has the USTR made findings of lawbreaking, deferring to the Special 301 Report for more detailed assessments.

    On a positive note, the Review commends "notable efforts to address widespread availability of pirated or counterfeit goods in some online and physical markets."  Particular successful efforts in 2019 regarding virtual content providers:

    • Ukraine's cyber police launched a nationwide anti-piracy operation that resulted in the shutting down of four popular video streaming sites with a combined daily audience of over 100,000 visitors: Kinogo, UAFilm, UKRFilm, and Kino-HD.

    • In Uruguay, Interpol and the national police closed and arrested the operators of the Pelispedia websites, a popular linking service to unlicensed movies and TV shows that attracted an estimated 44 million visits a month.

    • OpenLoad, one of the largest cyberlockers that reportedly provided pirated content to 36 of the top 50 global illegal video streaming and linking sites, was also taken offline in October 2019, along with another popular cyberlocker that was nominated as a notorious market this year, Streamango.

    • In Indonesia, the Ministry of Communications and Information in conjunction with industry groups pressured the operators of the notorious movie pirate site IndoXXI to cease operations.

    • In Thailand, Movie2free.com, Thailand's most-visited pirated movie and TV content provider that was nominated as a notorious market this year, was also shut down after successful enforcement efforts, and the administrator of the site was arrested by the Thai Department of Special Investigation.

    • Brazilian law enforcement executed Operacao 404, through which they took action against approximately 210 websites and 100 Internet Protocol television (IPTV) apps that facilitated the unauthorized streaming and downloading of films, TV shows, and live sporting events.

    Particular attention is given in the NML to illegal IPTV purveyors, the Review noting that an international team of police in Bulgaria, France, Germany, Greece, Italy, and the Netherlands, coordinated by Eurojust, carried out raids in multiple locations resulting in the shutdown of more than 200 servers used by Xtream Codes, which was responsible for over 5,000 IPTV apps streaming to about 50 million viewers.  There was also a major criminal case brought in Singapore for sales of Android set top boxes "preloaded" with infringing apps.  In the Middle East, the infringing beoutQ piracy operation was also shut down.  And notorious market Mp3va was shut down when U.S. credit card processors voluntarily agreed to terminate their support.

    Turning to physical markets, officials are extolled in the Report for Argentina, Brazil, Romani, UAE, and Vietnam.

    On a more disturbing note, the Review has an "Issue Focus" on the nexus between malware and online piracy, particularly on 1Fichier, MPGH, and ThePirateBay online markets.  Malware as defined in the Review to include backdoor Trojans, cryptominers, ransomware, and botnets, which can produce mass cyberattacks including distributed denial-of-service attacks.  What drives the nexus, according to the Review, are financial incentives that permit cybercriminals to use malware to buy and sell personal and financial information, collect ransoms, and other nefarious deeds.  The cost: $3.3 million in 2015.  Also implicated in malware schemes are copyright infringement of computer games, software, movies, music, and books, which are used as vectors for introducing malware to recipients.

    The NML Review also includes detailed descriptions of physical and online markets, their characteristics, and attempts to block or restrict their infringing activities in 2019.

    The NML concludes with URLs "[t]o assist U.S. right holders and consumers who confront IP infringement online," which include https://www.stopfakes.gov, https://eallegations.cbp.gov, and https://www.iprcenter.gov/referral.

  • By Donald Zuhn –-

    Federal Circuit SealYesterday, in Idorsia Pharmaceuticals, Ltd. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting summary judgment in favor of the U.S. Patent and Trademark Office, finding that the District Court had correctly concluded that the Office properly calculated the Patent Term Adjustment for U.S. Patent No. 8,518,912.  In particular, the District Court had determined that the Examiner's issuance of the first of three restriction requirements during prosecution of the application that issued as the '912 patent satisfied the notice requirement of 35 U.S.C. § 132, and thus ended any further accumulation of "A Delay" for the '912 patent.

    Actelion Pharmaceuticals, Ltd. — Plaintiff-Appellant Idorsia Pharmaceuticals' predecessor in interest in the '912 patent — filed U.S. Patent Application No. 12/745,358.  On March 14, 2012, the Examiner issued a restriction requirement, identifying six invention groups.  Actelion notified the Examiner by telephone that the invention groups omitted subject matter from the scope of the claims (but without electing any of the invention groups).  The Examiner agreed, indicated that a new restriction requirement would be issued, and then issued a new restriction requirement on April 18, 2012 (35 days after the first restriction requirement).  In the second restriction requirement, which superseded and replaced the first restriction requirement, the Examiner identified eight invention groups.  Acetelion again notified the Examiner by telephone that the invention groups omitted subject matter from the scope of the claims (but without electing any of the invention groups).  The Examiner again agreed, indicated that a new restriction requirement would be issued, and issued a new restriction requirement on June 21, 2012 (64 days after the second restriction requirement).

    The '358 application eventually issued as the '912 patent, and the Office determined that the PTA was 314 days, which included 229 days of A delay.  Actelion requested reconsideration of that PTA determination, and the Office issued a final decision determining that the PTA for the '912 patent was 346 days, including 261 days of A Delay, with the Office determining that the Examiner's second restriction requirement stopped the accrual of A delay.  Actelion filed suit in the Eastern District of Virginia, challenging the Office's PTA determination, and the District Court remanded the case to the USPTO to reconsider its PTA determination in light of Pfizer, Inc. v. Lee.  On remand, the Office determined that Actelion was entitled to 311 days of PTA, including 226 days of A Delay, with the Office determining that the Examiner's first restriction requirement stopped the accrual of A delay.

    In Pfizer, Inc. v. Lee, the Federal Circuit affirmed the finding by the District Court for the Eastern District of Virginia that the USPTO properly calculated the PTA for Pfizer's U.S. Patent No. 8,153,768 (see "Pfizer, Inc. v. Lee (Fed. Cir. 2016)").  In calculating the PTA, the USPTO denied Pfizer 197 days between the time the Examiner issued a first restriction requirement and then, after the applicant noted that the Examiner had omitted claims 75, 76, and 103-106, issued a corrected restriction requirement.  Noting that the applicant "could have taken direction for the[] classification [of the six omitted claims] from the fact that their respective independent claims were each included in the initial restriction requirement," the panel majority sided with the District Court and USPTO.

    In the instant case, Idorsia challenged the Office's decision on remand, arguing that A Delay continued to accrue for 99 days until the third restriction requirement was issued because the first and second restriction requirements did not meet the notice requirement of 35 U.S.C. § 132.  Idorsia and the Office each moved for summary judgment, with the District Court granting summary judgment in favor of the USPTO, finding that the first restriction requirement complied with the notice requirement of § 132 based on the standard set forth in Pfizer.  Idorsia appealed.

    On appeal, the Federal Circuit determined that under Pfizer, the Examiner's first restriction requirement stopped the accrual of A delay because the first restriction requirement met the notice requirement of § 132.  Citing 35 U.S.C. § 154(b)(1)(A)(i), the Court noted that "A Delay stops accruing when the PTO 'provide[s] at least one of the notifications under section 132,'" and citing Pfizer, the Court noted that "[a] written restriction requirement qualifies as a 'notification[] under section 132.'"  The Court explained, again citing Pfizer, that "§ 132 'is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.'"  According to the opinion, "the parties' dispute focuses on whether the first restriction requirement was 'sufficiently informative to allow [Actelion] to counter the grounds for rejection.'"  The Federal Circuit "agree[d] with the district court and the PTO that under Pfizer, the examiner's first restriction requirement for the '912 patent satisfied the notice requirement of § 132."  In particular, the Court stated that "[t]he examiner's first restriction requirement asserted that all pending claims of the '358 application were subject to the restriction requirement," noting that "Actelion was able to respond to the first restriction requirement and successfully oppose the examiner's description of the multiple invention groups, which demonstrates that Actelion was able to understand the examiner's proposed invention groups and prepare responsive arguments."

    Idorsia argued that the first and second restriction requirements violated § 132 because "Actelion plainly lacked the necessary information to determine how to proceed," and attempted to distinguish Pfizer on the ground that the restriction requirement at issue in Pfizer omitted dependent claims and not subject matter from independent claims.  The Federal Circuit, however, rejected Idorsia's "overly narrow reading of Pfizer," stating that "[a] restriction requirement need not be correct to satisfy the statutory notice requirement," and adding that "Actelion's and the examiner's 'exchanges concerning the challenged restriction requirement were part of the typical 'back and forth' process of patent prosecution,'" citing Pfizer.  The Court also stated that "[a]lthough this process 'often involves changes in both the applicant's and examiner's positions, an examiner's reissuance of an office action in response to an applicant's suggestion does not automatically mean that an application has been 'delayed' for purposes of patent term adjustment,'" again citing Pfizer.  Agreeing with the USPTO and District Court that "Idorsia's alleged delay is 'not the type of error for which the Act was intended to compensate'" (again citing Pfizer), the Federal Circuit determined that the USPTO properly calculated the PTA for the '912 patent, and concluded that the District Court did not err in granting summary judgment in favor of the USPTO.

    Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Circuit Judges Chen, Hughes, and Stoll
    Opinion by Circuit Judge Stoll

  • By Kevin E. Noonan

    Federal Circuit SealInfringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is most frequently rebutted by the doctrine of prosecution history estoppel ("Pharma Tech Solutions, Inc. v. Lifescan, Inc.").  This is not the only defense available to an accused infringer; its sister doctrine, of dedication-disclosure, can be equally effective under circumstances where a patentee has disclaimed aspects or embodiments that could fall within the scope of equivalents but was disclaimed to avoid prior art, for lack of utility, or insufficiency of disclosure under 35 U.S.C. § 112.  Last Friday, the Federal Circuit applied the dedication-disclosure doctrine to affirm the District Court's dismissal on the pleadings of plaintiff Eagle Pharmaceuticals' infringement allegations under the doctrine of equivalents in Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC.

    The case arose in ANDA litigation over Eagle's bendamustine formulation (BELRAPZO®).  Eagle asserted U.S. Patent Nos. 9,265,831; 9,572,796; 9,572,797; and 10,010,533 in the litigation; claim 1 of the '796 patent was considered representative by the parties and hence the Court:

    1.  A non-aqueous liquid composition comprising:
        bendamustine, or a pharmaceutically acceptable salt thereof;
        a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol, wherein the ratio of poly- ethylene glycol to propylene glycol in the pharmaceutically acceptable fluid is from about 95:5 to about 50:50; and
        a stabilizing amount of an antioxidant;
        wherein the composition has less than about 5% total impurities after 15 months of storage at about 5° C., as calculated on a normalized peak area response basis as determined by high performance liquid chromatography at a wavelength of 223 nm.

    The emphasized limitation was the basis of the dispute, Slayback conceding that in all other respects its competing generic formulation literally infringed Eagle's claims.  Eagle contended in its complaint that that term was infringed under the doctrine of equivalents, wherein the ethanol used in Slayback's product was equivalent to Eagle's polyethylene glycol.  Slayback countered with a motion under Fed. R. Civ. Pro. 12(c) that Eagle was barred by the dedication-disclosure doctrine from prevailing on its doctrine of equivalents allegation, because the '796 specification (and the specifications of all the other asserted patents) disclosed but did not claim ethanol-containing embodiments.

    Set forth in the Federal Circuit's opinion, as relied upon by the District Court, are almost a half dozen citations to the specification reciting ethanol as a "pharmaceutically acceptable fluid" used in the claimed formulation (including ones where ethanol is a dreaded "preferred" embodiment).  Eagle countered by asserting that ethanol was properly a component of the claimed invention only in the presence of chloride salts (which were not claimed) and not in the claimed embodiments comprising an antioxidant.  Eagle supported its assertions with a declaration from an expert witness that the skilled worker would appreciate this distinction and understand that patentee had not disclaimed ethanol-comprising embodiments, properly formulated; there was no rebuttal of this testimony by Slayback.  Refusing to consider the expert's testimony (and opining that Eagle was attempting to "manufacture a factual dispute"), the District Court held for Slayback and granted its motion to dismiss as a matter of law; this appeal followed.

    The Federal Circuit affirmed, in an opinion by Judge Reyna, joined by Judges O'Malley and Chen.  The opinion sets out the relationship between the doctrine of equivalents as defined by the Supreme Court in Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605 (1950), and Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (1997), and its limitation by the disclosure-dedication doctrine in Johnson & Johnston Assoc. v. R.E. Servs., 285 F.3d 1046 (Fed. Cir. 2002) (en banc).  The equitable principle of the doctrine recognized by the Court is that it "reinforces 'the primacy of the claims in defining the scope of the patentee's exclusive right.'"  To be properly applied, the specification must "disclose[] unclaimed subject matter with 'such specificity that one of ordinary skill in the art could identify the subject matter that had been disclosed and not claimed,'" citing PSC Comput. Prods., Inc. v. Foxconn Int'l, Inc., 355 F.3d 1353, 1360 (Fed. Cir. 2004).

    The panel appreciated Eagle's challenge to be procedural, regarding whether the District Court properly dismissed its complaint on the pleadings, as well as on the merits of whether plaintiff had disclaimed ethanol-comprising embodiments by disclosing but not claiming them.  The Court recognized that Eagle claimed its bendamustine formulations were disclosed in three alternatives:  "(i) chloride salt formulations; (ii) antioxidant formulations; and (iii) dimethyl sulfoxide ("DMSO") formulations," and that ethanol was an alternative only in the "unclaimed chloride salt formulations" (emphasis in opinion).  According to Eagle, the skilled worker would appreciate that distinction and that it had not disclaimed ethanol as an equivalent to polyethylene glycol in other formulations.  As pithily put in the opinion, the Court "disagreed."

    Citing Johnson, the opinion asserts that "[t]he disclosure-dedication doctrine does not require the specification to disclose the allegedly dedicated subject matter in an embodiment that exactly matches the claimed embodiment"; indeed, according to the opinion the patentee made arguments (unsuccessfully) in that case similar to Eagle's arguments here.  The issue of whether the disclosure-dedication doctrine applies is resolved "only [where] the specification disclose[s] the unclaimed matter 'as an alternative to the relevant claim limitation,'" citing Pfizer, Inc. v. Teva Pharm. USA, Inc., 429 F.3d 1364, 1378 (Fed. Cir. 2005).  The panel found no qualifications in the specification as now asserted by Eagle regarding limitations to where ethanol is or is not an alternative to polyethylene glycol.  The Court was "not persuaded" that the facts here track those in Pfizer (where the Court deigned not to apply the doctrine), on the grounds that in Pfizer the limitation in dispute was directed to a unique, specific purpose ("a suitable amount of a saccharide to inhibit hydrolysis"; emphasis in opinion) whereas in this case the alternatives all have only one purpose (i.e., to be "pharmaceutically acceptable").

    Turning to Eagle's procedural objections, the opinion sets these forth as 1) there was a factual dispute that precluded judgment; 2) the District Court did not draw all inferences in non-movant Eagle's favor; and 3) the District Court did not consider its proffered expert's testimony.  In rejecting these contentions, the opinion notes that considering evidence (like Eagle's expert's) outside the pleadings is within the District Court's discretion (and in doing so converts the motion to be one for summary judgment), citing Kulwicki v. Dawson, 969 F.2d 1454, 1462 (3d Cir. 1992), and 5C WRIGHT & MILLER, FED. PRAC. & PROC. CIV. § 1371 (3d ed.).  The standard of review is thus abuse of discretion and the panel found no such abuse in relying on the disclosure in the asserted patents themselves.  Nor was there any error in deciding the issue as a matter of law, and the opinion states that "[e]xpert testimony is not always required for a district court to determine how a skilled artisan would understand a patent's disclosure and claimed invention," citing Union Carbide Corp. v. Am. Can Co., 724 F.2d 1567, 1573 (Fed. Cir. 1984), and Amgen Inc. v. Coherus BioSciences Inc., 931 F.3d 1154, 1160 (Fed. Cir. 2019).

    Finding these and all other Eagle arguments unpersuasive, the Federal Circuit affirmed.

    Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC (Fed. Cir. 2020)
    Panel: Circuit Judges O'Malley, Reyna, and Chen
    Opinion by Circuit Judge Reyna

  • By Kevin E. Noonan

    U.S. Trade RepresentativeOn April 29th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2020 Special 301 Report.  In a press release, the USTR stated that "[t]he Trump Administration is committed to holding intellectual property rights violators accountable and to ensuring that American innovators and creators have a full and fair opportunity to use and profit from their work."  The press release also asserts that "[o]ver the last year, USTR has secured strong and enforceable obligations on intellectual property in our historic agreements with China, Canada, and Mexico.  The two reports issued today illustrate the Administration's commitment to protecting intellectual property rights and combatting counterfeiting and piracy in online and physical markets."

    According to the Executive Summary of the Report, "[a] top trade priority for the Administration is to use all possible sources of leverage to encourage other countries to open their markets to U.S. exports of goods and services, and provide adequate and effective protection and enforcement of U.S. intellectual property (IP) rights."  In tune with the more combative rhetoric on trade adopted by the Trump Administration, the Summary repeats last year's exhortation that:

    This Report provides an opportunity to call out foreign countries and expose the laws, policies, and practices that fail to provide adequate and effective IP protection and enforcement for U.S. inventors, creators, brands, manufacturers, and service providers.  The identification of the countries and IP-related market access barriers in the Report and of steps necessary to address those barriers are a critical component of the Administration's aggressive efforts to defend Americans from harmful IP-related trade barriers.

    The Report cites four countries for particular consideration upon being placed on the Priority Watch List.  Regarding China, the Report characterizes placement on the list due to "U.S. concerns with China's system of pressuring and coercing technology transfer, and the continued need for fundamental structural changes to strengthen IP protection and enforcement, including as to trade secret theft, obstacles to protecting trademarks, online piracy and counterfeiting, the high-volume manufacturing and export of counterfeit goods, and impediments to pharmaceutical innovation."  The Report states that "[o]ver the past year, the United States' engagement of China began to demonstrate key progress with the signing of the U.S.– China Economic and Trade Agreement in January 2020, which the Report maintains "requires changes in China's acts, policies, and practices, including structural reforms and other changes to China's legal and regulatory regime to address numerous longstanding concerns of a wide range of U.S. industries."

    India is cited (again) for "lack of sufficient measurable improvements to its IP framework on long-standing and new challenges that have negatively affected U.S. right holders over the past year," which include ones that "make it difficult for innovators to receive and maintain patents in India, particularly for pharmaceuticals, insufficient enforcement actions, copyright policies that do not properly incentivize the creation and commercialization of content, and an outdated and insufficient trade secrets legal framework."  The Report newly asserts that,"[i]n addition to these long-standing concerns, India also further restricted the transparency of information provided on state-issued pharmaceutical manufacturing licenses, continues to apply restrictive patentability criteria to reject pharmaceutical patents, and still has not established an effective system for protecting against the unfair commercial use, as well as the unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceuticals and certain agricultural chemical products."

    Indonesia is on the Priority Watch List, according to the Report, due to the reported lack of adequate and effective IP protection and enforcement" which continues to "raise serious concerns . . . with respect to patentability criteria and compulsory licensing."  Counterfeiting and piracy are also cited for being "pervasive" and IP enforcement as being "weak."

    The Report also notes that Chile has "not delivered on IP commitments made to the United States" and that Trinidad and Tobago has not pressed "enforcement actions against operators that broadcast unauthorized cable and satellite channels."

    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 USTR reviewed "more than 100" of this country's trading partners and identified ten countries on a "Priority Watch List" (decreased by one from last year) and another 23 countries on the "Watch List" (decreasing by two from last year), all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the 2020 Report includes Algeria, Argentina, Chile, China, India, Indonesia, Russia, Saudi Arabia, Ukraine, and Venezuela (Kuwait 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 Barbados, Bolivia, Brazil, Canada, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Kuwait, Lebanon, Mexico, Pakistan, Paraguay, Peru, Romania, Thailand, Trinidad & Tobago, Turkey, Turkmenistan, the United Arab Emirates, Uzbekistan, and Vietnam  (Costa Rica and Greece being removed from the list this year).

    The Report also notes the USTR's continued efforts to enhance public engagement.  In addition to written comments (www.regulations.gov, Docket Number is USTR 2019-0023), from 75 interested parties, including 25 trading partner governments, there was a public hearing on February 26, 2019 that heard testimony from six "representatives of foreign governments, [and 20 representatives from] industry, and non-governmental organizations" (where the comments and a transcript and video of the hearing are available on the USTR website).

    The Report states that "[i]n virtually all countries identified in this Report, IP enforcement is lacking," due to, inter alia, "[in]adequate or effective border enforcement against counterfeit and pirated goods" (including Brazil, China, Colombia, Hong Kong, India, Indonesia, Nigeria, Paraguay, Singapore, Thailand, Turkey, the UAE, and Vietnam), and that in such countries "customs officials lack authority to take ex officio action to seize and destroy such goods at the border or to take such action for goods in-transit."

    The Report also notes efforts with several countries (including Argentina, Australia, Canada, China, Colombia, Ecuador, Egypt, Indonesia, Japan, Korea, Mexico, New Zealand, Saudi Arabia, Thailand, Turkey, the United Arab Emirates (UAE), and Vietnam) "to address concerns related to IP protection, IP enforcement, and market access barriers with respect to pharmaceuticals and medical devices so that trading partners contribute their fair share to research and development of new treatments and cures."

    Particularly mentioned are copyright issues, including online and broadcast piracy (Argentina, Bulgaria, Canada, Chile, China, Colombia, Dominican Republic, Greece, Guatemala, India, Mexico, the Netherlands, Romania, Russia, Saudi Arabia, Switzerland, Thailand, Ukraine, Vietnam, "and elsewhere") and unlicensed government use of copyrighted software (Argentina, Brazil, China, Egypt, Indonesia, Kenya, Mexico, Nigeria, the Philippines, Romania, Russia, Thailand, Ukraine, and Vietnam).

    The Report also cites "restrictive patentability criteria that undermine opportunities for export growth" (Argentina, India, and Indonesia) and "a lack of effective protection against unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products" (Argentina, China, Egypt, India, and Saudi Arabia).

    As it did the past several years, the Report also chides India and China for inadequate trade secret protection, which puts "U.S. trade secrets at unnecessary risk" and "negative market access effects" from the European Union's geographical indications (GIs) protections.

    The Report also announces removal of certain countries from the Watch List because they have taken significant steps to address concerns in last year's Report.  Costa Rica, for example, has taken "concrete steps . . . to address unlicensed software use in the central government and to implement an online recordation system to improve border enforcement," and Greece has taken positive steps "to address the widespread use of unlicensed software in the public sector through the allocation of significant funds to purchase software licenses, progress in online enforcement, and the introduction of legislation to impose fines on those possessing counterfeit products, with the understanding that the United States will continue to monitor its enforcement effort."  Jamaica passed a new Patent and Design Act, and Kuwait has updated its copyright laws and regulations, according to the Report, and "significantly increase[ed] its in-country IP enforcement activities," albeit "ongoing concerns remain regarding the protections granted to copyright holders and the availability of counterfeit goods in the country."  Finally, Switzerland is recognized for "long-awaited" changes in its Copyright Act, specifically with regard to online protection and enforcement (although, here again the Report states that "[t]he United States will carefully monitor the implementation, interpretation, and effectiveness of the newly enacted legislation and will engage with the Swiss government on these and other IP issues").

    This portion of the Report once again ends by stating that "the Office of the U.S. Trade Representative looks forward to working closely with the trading partners identified in this year's Report to address these and other priority concerns."

    Results of 2019 "Out of Cycle" reviews discussed in the Report (which "provide an opportunity to address and remedy such issues through heightened engagement and cooperation with trading partners and other stakeholders") include Malaysia, during which the US and Malaysia "held numerous consultations with a view toward resolving outstanding issues" (as they did last year), despite which the USTR has decided to extend review in 2020, wherein the USTR will "press Malaysia to complete actions to fully resolve these concerns in the near term).  Also in 2020 the USTR plans on conducting an Out of Cycle Review of Saudi Arabia, directed to protection against unfair commercial use and unauthorized disclosure of testing and other data related to obtaining marketing approval for pharmaceutical products.

    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).  In Section I, the Report reiterates its raison d'etre, that:

    Intellectual property (IP) infringement, including patent infringement, trademark counterfeiting [(or imply "counterfeiting")], copyright piracy [("piracy")], and trade secret theft, causes significant financial losses for right holders and legitimate businesses around the world.  IP infringement undermines U.S. competitive advantages in innovation and creativity, to the detriment of American businesses and workers.  In its most pernicious forms, IP infringement endangers the public, such as through exposure to health and safety risks from counterfeit products such as semiconductors, automobile parts, apparel, footwear, toys, and medicines.  In addition, trade in counterfeit and pirated products often fuels cross-border organized criminal networks and hinders sustainable economic development in many countries.  Fostering innovation and creativity is essential to U.S. economic growth, competitiveness, and the estimated 45 million American jobs that directly or indirectly rely on IP-intensive industries.  USTR continues to work to protect American innovation and creativity in foreign markets employing all the tools of U.S. trade policy, including the annual Special 301 Report.

    It then reviews "initiatives for strengthen IP protection and enforcement," which includes "examples of initiatives to strengthen IP protection and enforcement; illustrative best practices demonstrated by the United States and our trading partners; [and] U.S.-led initiatives in multilateral organizations; and bilateral and regional developments."  It also highlights areas of continued concern, including "counterfeits, online piracy, forced technology transfer, innovative pharmaceutical products and medical devices, and geographical indications (GIs)."  As in earlier years, it mentions how important IP protection is to innovations in the environmental sector.  Finally, Section I includes a discussion relating to "the importance of full implementation of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and developments on the U.S. use of WTO dispute settlement procedures to resolve IP concerns."

    In a section entitled "IP Protection and Enforcement and Related Market Access Challenges," the Report discusses innovation in the pharmaceutical industry, medical devices and market access concerns.  In this regard, the Report states that "USTR has been engaging with trading partners to ensure that U.S. owners of IP have a full and fair opportunity to use and profit from their IP, including by promoting transparent and fair pricing and reimbursement systems."  These efforts have included "ensur[ing] robust IP systems; reduc[ing] market access barriers to pharmaceutical products and medical devices, including measures that discriminate against U.S. companies, are not adequately transparent, or do not offer sufficient opportunity for meaningful stakeholder engagement; and has pressed trading partners to appropriately recognize the value of innovative medicines and medical devices so that trading partners contribute their fair share to research and development of new treatments and cures" (echoing the "fair share" mantra recited by the President in stump speeches and tweets).  The Report calls out in this regard the following efforts in particular countries:

    • Canada and Mexico: in the context of renegotiating the North American Free Trade Agreement (NAFTA), secured strong IP provisions in the United States-Mexico-Canada Agreement (USMCA), including provisions that "ensure that national-level government processes for the listing and reimbursement of pharmaceutical products and medical devices are transparent, provide procedural fairness, are nondiscriminatory, and provide full market access for U.S. products."  The Report notes that the USMCA was signed into law in the U.S. on January 29, 2020;

    China: "[s]ecured enforceable commitments" to "(1) establish a mechanism for the early resolution of potential pharmaceutical patent disputes, including a cause of action to allow a patent holder to seek expeditious remedies before the marketing of an allegedly infringing product, so that innovative pharmaceutical companies can effectively enforce their rights in China; (2) provide patent term extensions to compensate for unreasonable patent office and marketing approval delays that cut into the effective patent term; and (3) permit the use of supplemental data to meet relevant patentability criteria for pharmaceutical patent applications";

    Korea: as part of renegotiating the U.S.-Korea Free Trade Agreement (KORUS FTA), engaged to secure "meaningful reforms on longstanding issues . . . "to ensure transparency with respect to pharmaceutical and medical device pricing and reimbursement policies and non-discriminatory treatment for U.S. pharmaceutical exports";

    Japan: engaged "to ensure transparency and fairness and address other concerns with respect to pharmaceutical and medical devices pricing and reimbursement policies";

    Indonesia: "pressed" to "fully resolve concerns regarding Indonesian patent law, including patentability criteria, local manufacturing and use requirements, and the grounds and procedures for issuing compulsory licenses";

    Argentina: "raised concerns" regarding the scope of patentable subject matter, protection against unfair commercial use and, like in many emerging countries, unauthorized disclosure of "undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products"; and

    United Arab Emirates (UAE): "encouraged" this country "o issue regulations to provide effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products."

    Once again this year, the Report highlights compulsory licensing as a particular concern with regard to pharmaceuticals and medical devices, because these practices are antithetical to "promot[ing] affordable healthcare for American patients today and innovation to preserve access to the cutting-edge treatments and cures that they deserve tomorrow."  The Report states that "[s]uch actions can undermine a patent holder's IP, reduce incentives to invest in research and development for new treatments and cures, unfairly shift the burden for funding such research and development to American patients and those in other markets that properly respect IP, and discourage the introduction of important new medicines into affected markets." Compulsory licenses should be issued in "extremely limited circumstances" and only after the government (and presumably the patent rights holder) has made "every effort" to obtain the patent owners' authorization on commercially reasonable terms.  Trading partners identified by the Report as requiring U.S. involvement in this aspect of trade include Chile, Colombia, Egypt, El Salvador, India, Indonesia, Malaysia, Russia, Turkey, and Ukraine.

    More generally, the Report points to "non-transparent" and discriminatory practices and "unreasonable regulatory delay" as being of concern to the USTR and administration.  In contrast, national systems that accelerate approval based on regulatory in other countries (including Egypt and Greece) are praised in the Report.

    The Report notes that stakeholders from the pharmaceutical and medical device industries have identified industries that have expressed concerns regarding the policies of several trading partners, including Algeria, Australia, Canada, China, Japan, Korea, New Zealand, and Turkey (the same countries identified in this regard in last year's Report) with regard to "issues related to pharmaceutical innovation and market access," citing specific examples falling within these general categories for each country.

    The Report next turns to technology transfer issues, purported to be means for incentivizing innovation by indigenous peoples and "localization."  In this portion of the Report, compulsory technology transfer is emphasized as causing difficulties for American innovators.  The Report identifies the anti-innovation cycle of imposing such measures to incentivize local innovation, which leads to create market entry barriers and thus discourages foreign (i.e., U.S.) investment, which not only hurts domestic industry in those countries but also can produce "non-market distortions" which in turn can lead to "suboptimal outcomes."  The Report sets forth a litany of these practices, including requirements for technology transfer as the price for regulatory or other governmental approval; directing (an escalation of the Report's complaints from last year's "permitting") state-owned enterprises to seek "non-commercial terms" for IP licensing or otherwise; providing unfair competitive advantage to local industry (if only passively by permitting U.S. IP-rights infringement); "failing to take meaningful measures to prevent or deter" cyber-intrusions; giving preference to local products and services dependent on indigenous IP; "[m]anipulating the standards development process to create unfair advantages for national firms"; and conditioning regulatory approval or other governmental approvals on disclosure of confidential business information and then "failing to protect such information appropriately."  China, Indonesia, and Nigeria are particularly cited for these concerns (unlike last year, Turkey is not).

    Trade secret protection, or lack of it, is also a concern discussed in the Report.  It cites "growing need for trading partners to provide effective protection and enforcement of trade secrets" in "a wide variety of industry sectors, including 'ICT' [information and communications technologies], services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing" areas.  The Report cites "various sources, including the U.S. Office of the National Counterintelligence Executive" for reporting these concerns, particularly with regard to China.  Trade secret theft can arise in "a variety of circumstances," including permitting (or not stopping) departing employees from taking with them trade secret information-containing electronic storage devices, failed joint ventures, cyber intrusion and computer hacking, misuse of trade secrets disclosed to government agencies as part of a regulatory approval process.  The Report notes particular difficulties in China and India regarding "effective remedies," or that (in some countries) government regulations or policies require disclosure of trade secrets such as software source code, including Brazil, Indonesia, Malaysia, and Nigeria.  While asserting that "[t]he United States uses all trade tools available to ensure that its trading partners provide robust protection for trade secrets and enforce trade secrets laws," the Report cites on a positive note that efforts by the European Union and Taiwan to strengthen their trade secret regimes.  The USTR also "strongly supports" the work of the Organization for Economic Cooperation and Development (OECD)'s work on trade secret protection.

    The Report next addresses geographical indications (GIs) issues, saying (again) that the U.S. "is working intensively through bilateral and multilateral channels" to improve U.S. access to a variety of goods having geographic specificity, particularly with regard to the European Union.  The EU GI "agenda remains highly concerning, because it significantly undermines the scope of trademarks and other IP rights held by U.S. producers and imposes barriers on market access for American-made goods that rely on the use of common names, such as parmesan or feta."  Many of these products are protected by trademarks that predate the issuance of the GI.  Because "[t]rademarks are among the most effective ways for producers and companies, including small- and medium- sized enterprises (SMEs), to create value, to promote their goods and services, and to protect their brands," GI's "undermines trademark protection and may result in consumer confusion to the extent that it permits the registration of GIs that are confusingly similar to prior trademarks" according to the Report.

    The Report asserts that the EU "pressures trading partners to prevent all producers, other than in certain EU regions, from using certain product names" with as a consequence "American producers and traders either are effectively blocked from those markets or must adopt burdensome workarounds" (illustrated by appending "-like," "-style"," or "imitation" to the particular name).  Part of the reason for U.S. concern is frankly admitted to be that "[t]he United States runs a significant deficit in food and agricultural trade with the EU," comparing $1 billion in cheese exports from the EU to the U.S. with $3.6 million in imports into the EU from the U.S. last year.  More worrisome is the EU's extension of GI designations into other goods, including "non-agricultural products, including apparel, ceramics, glass, handicrafts, manufactured goods, minerals, salts, stones, and textiles."  The U.S. is "continu[ing] to urge the EU to not implement certain proposed changes to the EU's Common Agricultural Policy, which, if adopted, would transfer much of the GI application review process to interested EU Member States and sharply reduce the period for filing a reasoned basis in support of an opposition to register a GI."

    The Report also notes that the EU is pursuing its GI agenda in "multilateral and plurilateral bodies," including "expanding the World Intellectual Property Organization (WIPO) Lisbon Agreement for the Protection of Appellations of Origin and their International Registration to include GIs, thereby enshrining several detrimental aspects of EU law in that Agreement."  The Report characterizes these efforts as a "break with the long-standing WIPO practice of consensus-based decision-making" and consequently voted to "deny the United States and 160 other WIPO countries meaningful participation rights in the negotiations."  Those efforts have apparently been successful, the Report stating that "[i]n 2020, the EU became party to the Geneva Act of the Lisbon Agreement."

    The Report also notes that the U.S. response is to address the issue in so-called "free trade" agreements and bilateral agreements with other nations, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Indonesia, Japan, Jordan, Malaysia, Mexico, Morocco, Paraguay, the Philippines, Singapore, South Africa, Tunisia, Ukraine, Uruguay, and Vietnam.

    The Report next turns to online and broadcast piracy of copyrighted works, citing the "increased availability of broadband Internet connections around the world" as being a "boon" to the U.S economy and foreign trade.  But while advances in technology have enabled U.S. creative producers to better distribute copyrighted materials, it has also made the Internet "an extremely efficient vehicle for disseminating infringing content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content."  A variety of forms of this issue are discussed in the Report, which names Argentina, Bulgaria, Canada, Chile, China, Colombia, the Dominican Republic, Greece,  India, Mexico, the Netherlands, Romania, Russia, Switzerland, Thailand, Ukraine, and Vietnam as having "high levels of online piracy and lack effective enforcement."  A particular form of copyright piracy (particularly of music), termed "streamripping," is practiced (or ineffectively prevented) in Canada, Mexico, the Netherlands, Sweden, and Switzerland.  Illicit Internet Protocol Television and signal theft by cable operators as significant sources of copyright is identified as a problem in Argentina, Brazil, Chile, China, the Dominican Republic, Hong Kong, India, Indonesia, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, Thailand, and Vietnam, with China being called out as a source for the devices that are used for these practices.  Signal theft by cable operators continues to be a particular concern in the Report, which asserts that typically, "infringers circumvent encryption systems or otherwise unlawfully access cable or satellite signals to access content," including from "overspill" with hotels remaining a common site for this type of infringement.  Finally, the Report identifies illicit camcording as a concern, identifying Argentina, Brazil, Ecuador, Peru, Russia, and Taiwan as countries that do not have effective enforcement mechanisms to discourage the practice, and names Canada, Japan, and the Philippines as countries that have adopted effective laws and enforcement practices to prevent illicit camcording.

    The final extensive discussion in the Report regards border control and criminal enforcement against counterfeiting.  Counterfeit goods (including "semiconductors and other electronics, chemicals, automotive and aircraft parts, medicines, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods") "make their way from China" and other countries, particularly those having an "ineffective or inadequate IP enforcement system."  Citing a March 2019 OECD study entitled "Trends in Trade in Counterfeit and Pirated Goods," the cost of such counterfeiting was $509 billion in 2016, which is equivalent to 3.3% of 2016 total global trade (with China accounting for 57%, $239 billion, of that trade).

    The Report states that such counterfeit goods harm "consumers, legitimate producers, and governments," particularly with regard to medicines, automotive and airplane parts, and food and beverages" because the counterfeit products do not meet the "rigorous good manufacturing practices used for legitimate products."  The Report enunciates difficulties that arise due to the use of legitimate sources of trade ("legitimate express mail, international courier, and postal services") for transporting counterfeit goods in small consignments or shop unmarked goods to which a counterfeit trademark are affixed at their final destination.  These practices inhibit trademark enforcement efforts, particularly in countries that require a counterfeit to be "completed" at the time of importation and inspection at national borders.

    The Report states that the U.S. continues to "urge" its trading partners to "undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods" and states that the Office engages trading partners bilaterally, through trade agreement and international organizations on this issue.  Another problem is the reentry into channels of commerce of counterfeit goods after they have been seized at national borders and transshipment through 'free trade zones"; the Report uses the UAE, particularly Dubai, as an example of this practice that accounted for $16 billion in counterfeit goods in 2016.  Particular instances of trade in counterfeit medicines and global patterns of such drugs (e.g., India being a major supplier of counterfeit drugs to African countries) are also discussed in the Report.

    Copyright administration and royalty payments, particularly with regard to collective management organizations (BMI, ASCAP) are next discussed, with concern arising that "CMO systems in several countries are reportedly flawed or nonoperational," citing India, the UAE, and Ukraine as examples.

    Trademarks and impediments to obtaining and enforcing them in some countries make up the next topic in the Report, with Brazil, China, India, Malaysia, and the Philippines, having "slow" opposition proceedings and Russia and Panama having no administrative opposition proceedings.  Even registering (i.e., making a record of) trademarks is problematic in some countries, with "unnecessary administrative and financial burdens" imposed on owners and there being unnecessary difficulties in maintaining and enforcing trademarks (albeit without naming any countries where these and other difficulties contained in the Report have arisen).  There are also issues with cybersquatting and particularly with country code top-level domain names (ccTLDs) for U.S. rights holders.

    Government use of unlicensed software is also discussed, with Argentina, Brazil, China, Egypt, Greece, Guatemala, Indonesia, Kenya, Mexico, Nigeria, Paraguay, the Philippines, Romania, Russia, Thailand, Turkey, Ukraine, and Vietnam being identified as countries where "further work on this issue remains" to be done.

    The Report sets forth efforts related to initiatives for improving IP protection resulting in countries not being put on the Watch List (Costa Rica, Greece, Jamaica Switzerland), and Kuwait being removed from the Priority Watch List for "taking further steps to reform its system of copyright protection and enforcement by passing the 2019 Copyright and Related Rights Law and the Implementing Regulations."  A particular irritant noted in last year's Report, BeoutQ, "the notorious online and satellite piracy service reportedly operating out of Saudi Arabia" and states it was taken offline in 2019.

    Also noted is participation by 59 member states in the 1991 Act of the International Union for the Protection of New Varieties of Plants Convention (UPOV 91), which member states to "grant IP protection to breeders of new plant varieties, known as breeder's rights," and 104 member states of the WIPO Performances and Phonograms Treaty and the WIPO Copyright Treaty, which have "raised the standard of copyright protection around the world, particularly with regard to online delivery of copyrighted content."

    Section I of the Report also has a section of "Illustrative Best IP Practices by [U.S.] Trading Partners, which expressly recites Thailand and India for "[c]ooperation and coordination among national government agencies involved in IP issues"; Spain, India, Thailand, and Vietnam for IP awareness and educational campaigns; Brazil, Malaysia, and Jamaica for "[s]pecialized IP enforcement units"; and several governments (Romania, Singapore) for active participation of government officials in technical assistance and capacity building."

    The Report discusses multilateral (WTO) and regional (APEC) and bilateral (TIFA) agreements and specific instances where such agreements are being pursued in furtherance of U.S. trade objectives.  Also included is a discussion of implementation of the WTO TRIPS Agreement.

    Section I of the Report ends by mentioning the role of intellectual property and the environment and intellectual property and health as areas of concern raised by stakeholders in their comments.  The Report contains an affirmation of the provisions regarding IP and public health set forth in the Doha Declaration and states that "[t]he United States is firmly of the view that international obligations such as those in the TRIPS Agreement have sufficient flexibility to allow trading partners to address the serious public health problems that they may face."  And the final portion of this section of the Report discusses efforts at dispute resolution of IP matters under the GATT/TRIPS provisions as they are implemented by the WTO.

    Finally, the last portion of Section I of the Report relates to dispute settlement and enforcement.  It states that while the U.S. will use all available means to resolve concerns, including bilateral dialogue and enforcement tools such as those provided under U.S. law, the WTO, and other dispute settlement procedures, as appropriate."  Efforts between the U.S. and China are specifically mentioned with regard to "a range of unfair and harmful Chinese acts, policies, and practices related to technology transfer, IP, and innovation."  Other enforcement actions, mostly of historical significance, are also discussed.

    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, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  For anyone paying adequate attention to these Reports year-to-year, the complaints, and even the language enunciating these complaints, remains dispiritingly the same, suggesting that despite pronouncements of small victories efforts to reduce unfair trade practices globally have fallen far short.  Nevertheless, as with last year's Report, the tone and tenor of this Report is robustly assertive regarding IP rights and America's intention to negotiate international agreements and confront its trading partners in ways that protect American innovation and commercial interests first and foremost regardless of consequences.

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

    • "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

  • CalendarMay 12, 2020 – "Mental Health & Well-Being During A Time of Crisis" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    May 12, 2020 – "Coordinating litigation and prosecution in complex patent disputes" (Potter Clarkson and iam) – 11:00 am to 12:00 pm (EDT)

    May 13, 2020 – "Primed for AI – the basics of artificial intelligence and machine learning" (Bereskin & Parr) – 12:00 to 1:00 pm (EDT)

    May 13, 2020 – "How in-house IP leaders are managing during the covid-19 pandemic" (IPBC Talking Heads and iam) – 11:00 am to 12:00 pm (EDT)

    May 14, 2020 – "Perspectives on the Federal Circuit's Modified Procedures During the COVID-19 Crisis" (Federal Circuit Bar Association) – 11:00 am to 12:00 pm (EST)

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Mental Health & Well-Being During A Time of Crisis" as part of the IPO's COVID-19 Webinar Series on May 12, 2020, from 2:00 to 3:00 pm (ET).  Dahlia George of the USPTO's Office of Enrollment and Discipline and Mercedes K. Meyer of Faegre Drinker Biddle & Reath, LLP will review the intersection of mental health challenges and attorneys' ethical obligation to provide clients with competent representation; provide a brief overview of the eye-opening pre-epidemic statistics around depression, substance abuse, and mental health in the bar; discuss potential impacts on productivity and work quality, the responsibilities of managers and supervisors, and wellness focused solutions as well as how the USPTO's Diversion Pilot Program and employers can help affected practitioners.

    There is no registration fee for IPO members for this webcast (the fee for non-members is $150).  Additional information regarding the webcast can be found here.