• By Kevin E. Noonan

    Supreme Court Building #2The Supreme Court heard oral argument last week in Minerva Surgical Inc. v. Hologic, Inc. over the issue of assignor estoppel (transcript).

    As a reminder, the case arose in an infringement suit over U.S. Patent Nos. 6,782,183 and 9,095,348.  The patents were directed to "procedures and devices for endometrial ablation."  Claim 9 of the '183 patent and claim 1 of the '348 patent were considered by the Court to be representative:

    '183 patent:

    9.  A method of detecting a perforation in a uterus, comprising the steps of:
        passing an inflation medium into the uterus;
        monitoring for the presence of a perforation in the uterus using a pressure sensor;
        if no perforation is detected during the monitoring step, permitting ablation of the uterus using an ablation device; and
        if a perforation is detected during the monitoring step, preventing ablation of the uterus.

    '348 patent:

    1.  A device for treating a uterus comprising:
    an elongate member having a proximal portion and a distal portion, the elongate member comprising
        an outer sleeve and an inner sleeve slidably and co-axially disposed within the outer sleeve;
        an applicator head coupled to the distal portion, the applicator head defining an interior volume and having a contracted state and an expanded state, the contracted state being configured for transcervical insertion and the expanded state being configured to conform to the shape of the uterus, the applicator head including one or more electrodes for ablating endometrial lining tissue of the uterus;
        a handle coupled to the proximal portion of the elongate member, wherein the handle comprises a frame, a proximal grip and a distal grip pivotally attached to one another at a pivot point and operably coupled to the applicator head so that when the proximal grip and the distal grip are moved closer together, the applicator head transitions from the contracted state to the expanded state;
        a deflecting mechanism including flexures disposed within the applicator head, the flexures including first and second internal flexures and first and second external flexures, the first and second external flexures being coupled to the outer sleeve and the first and second internal flexures being coupled to the inner sleeve, wherein the deflecting mechanism is configured so that translating the inner sleeve relative to the frame causes the applicator head to transition from the contracted state to the expanded state; and
        an indicator mechanism operably coupled to the inner sleeve, the indicator mechanism configured to indicate a dimension of the uterus [emphases added to indicate disputed claim terms not further discussed herein].

    Inventor Truckai (named on both the '183 and '489 patents) founded Novocept, which developed a system for detecting perforations in a uterus that could cause serious side effects for women undergoing endometrial ablation; the system depends on introducing carbon dioxide into the uterus and monitoring gas escape.  It was undisputed that Novocept's ablation product uses the claimed technology, and that inventor Truckai assigned his right to these patents to Novocept.  Thereafter, Novocept was acquired by co-plaintiff Cytyc Corp., which was subsequently acquired by co-plaintiff Hologic.

    Meanwhile, Inventor Truckai founded accused infringer Minerva and developed the accused infringing article, termed the Endometrial Ablation System (EAS).  Hologic sued Minerva over sales of the EAS for infringing the '183 and '349 patents.  Hologic moved for summary judgment that Minerva was estopped under the doctrine of assignor estoppel for both the '183 and '348 patents, which motion the District Court granted.

    Assignor estoppel has differences in both philosophy and patent policy than licensee estoppel, which was abolished by the Supreme Court in Lear, Inc. v. Adkins, 395 U.S. 653, 666 (1969).  Licensee estoppel, according to the Supreme Court, was against public policy because a licensee of an invalid patent, of all parties, has the most incentive to see such patents invalidated.  (Similar considerations motivated the Supreme Court in MedImmune, Inc. v. Genentech, Inc.)  Assignor estoppel, on the other hand, is a situation where a patent owner (frequently the inventor) has transferred ownership rights in their patent for consideration, and now wishes to challenge the transferred patent's validity.  This behavior smacks of "unclean hands" or at least sharp practices, and a court in applying equitable principles should avoid permitting the assignor from involving the power of the Court to support this seeming inequity.  Here, the District Court found that Inventor (and assignor) Truckai was intimately involved inter alia as founder, President, and CEO of Minerva in bringing the accused EAS product to market.

    The Federal Circuit affirmed with regard to assignor estoppel issue in an opinion by Judge Stoll joined by Judges Wallach and Clevenger.  The panel affirmed the District Court's grant of summary judgment based on assignor estoppel with regard to Minerva's invalidity defenses in this litigation regarding the '348 patent.  The opinion notes that the Federal Circuit first had occasion to consider (and "affirm the vitality of") assignor estoppel in Diamond Scientific Co. v. Ambico, Inc., 848 F.2d 1220 (Fed. Cir. 1988), which also held that the estoppel extends to those in privity with the estopped assignor (relevant here, to Minerva).  The opinion provides the following basis for the continued vitality of the assignor estoppel doctrine, citing Diamond Scientific:

    The public policy favoring allowing a licensee to contest the validity of the patent is not present in the assignment situation.  Unlike the licensee, who, without Lear might be forced to continue to pay for a potentially invalid patent, the assignor who would challenge the patent has already been fully paid for the patent rights.

    The opinion recites four commonly recited justifications for the doctrine:

    "(1) to prevent unfairness and injustice; (2) to prevent one [from] benefiting from his own wrong; (3) by analogy to estoppel by deed in real estate; and (4) by analogy to a landlord-tenant relationship." [Diamond Scientific] at 1224 (alteration in original) (quoting Cooper, Estoppel to Challenge Patent Validity: The Case of Private Good Faith vs. Public Policy, 18 Case W. Res. L. Rev. 1122 (1967)).

    The Court recognized that the assignor is in a unique position because of the imputed earlier representation (express or implied) that the patent had value and that it would be an injustice to permit the assignor to repudiate that earlier representation.  Thus, the Court affirmed the District Court's decision that assignor estoppel prevented Minerva from asserting invalidity defenses against the '348 patent (specifically rejecting Minerva's call for the Court to "abandon the doctrine" as being contrary to Lear (for at least the reasons discussed above).  While also recognizing that the doctrine should not be applied automatically it should be applied consistent with the facts and equities before the Court.

    On the other hand, the panel concluded that assignor estoppel did not preclude Minerva from relying on the PTAB's decision that the '183 patent was invalid.

    Minerva filed a petition for writ of certiorari, on the grounds that the Court should abrogate assignor estoppel on a number of grounds, and Hologic countered that the doctrine remains an important bulwark against the inequities that could be occasioned by permitting an inventor to assign a patent for value and then be able to argue that the patent was invalid when asserted against future infringing acts.  The Court granted the writ, and twelve amicus briefs were filed including one by the U.S. Government, which provided an alternative to abrogation or maintenance.

    The Court held oral argument last week, and as has become the custom in the absence of in-person argument, the proceedings took the form of each party having a few minutes to set out its position, and then the Justices in order of seniority have time to pose their questions to counsel.  This format provides a nice framework for considering what each Justice asked each of the parties, which can (but does not necessarily) shed light on their thinking.

    Robert Hochman, representing Petitioner Minerva, set forth the argument that the Court should strike down assignor estoppel.  The doctrine is not in the Patent Act and despite the doctrine's approval by the Court in Westinghouse Electric & Manufacturing Co. v. Formica Insulation Co., 266 U.S. 342 (1924), Counsel argued that "the world didn't stop" in 1924 (even if Petitioner was willing to concede that Formica evinced Court approval of the doctrine, which they were not willing to do).  This is shown by later cases, such as Scott Paper Co. v. Marcalus Manufacturing Co., 326 U.S. 249 (1945), where the Court permitted an assignor to challenge the validity of a patent.  The Court's "logic" requires final abrogation of the doctrine, he argued, and in addition the sound policy goal of "[e]xposing bad patents" was such "vital patent law policy" that the Court should remove impediments against assignors being able to do so.  Moreover, other doctrines (he recited "claim preclusion or issue preclusion or even equitable estoppel") were distinct from the "patent-law-specific" doctrine of assignor estoppel and did not counsel against its abrogation by the Court.  Evoking equity, he argued that "an inventor should be allowed to show that the assignee is asserting a claim broader than what the inventor adequately described and enabled."  The circumstances in this case, where the assignee and not the inventor prosecuted the claims at issue long after the assignment were also factors that he argued were contrary to patent law policy.  And, although initially having the Chief Justice inadvertently neglect to permit rebuttal, Petitioner's counsel provided the Court with a succinct synopsis of Petitioner's petition.

    Morgan Ratner, arguing for the Government, set forth the "middle path" between having the Court abrogate or uphold the doctrine.  She characterized the doctrine as it now exists as being "too broad" because it prevents an assignee from challenging a patent even if the claim at issue "looks nothing like the claims that existed at the time of the assignment."  To this extent the Government agreed with Petitioner but believe the doctrine should be saved because "lower courts have applied the doctrine for 140 years," the Court has approved it since 1924, and Congress did not disturb it since that time.

    Matthew Wolf, arguing for Respondent Hologic, made his case that precedent favors upholding assignor estoppel, relying on the Formica decision in 1924, the Court's refusal to abrogate the doctrine in prior decisions, that lower courts had followed the doctrine for the past 100 years, and Congress has not seen fit to alter or abolish it.  And it is Congress, not the Court, he argued that should address the issue should the costs and benefits of the assignor estoppel doctrine need to be reweighed.

    The Chief Justice opened the questioning of Petitioner's counsel by asking about the policy arguments of "good" versus "bad" patents and the influence of assignor estoppel on efforts to promote the former and discourage the latter.  Counsel emphasized the nature of the patent "bargain" that a patentee not be able to extend the scope of patent protection to aspects the specification does not entitle her to have.  The Chief followed up by asking Minerva's position on the Government's compromise position, which Counsel refused to endorse.  Petitioner did ask the Court not to remand back to the Federal Circuit (and hence to the District Court) based on the costs and time such an outcome would impose on Minerva.

    In quizzing the Government's counsel, the Chief Justice focused on the aspects of their brief regarding the equitable factor of there having been valuable consideration obtained by the assignor that is the basis of assignor estoppel, asking what "valuable consideration" means.  Counsel stated that when an inventor agrees to assign before an invention exists for example there can be no representation that the invention has value.  In response to the Chief Justice's query regarding instances where the inventor is an employee who is obligated to assign inventions, the Government responded by saying that such a situation does not involve valuable consideration.

    For Hologic, the Chief's questions centered around Respondent's position that the Court's precedent consistently affirmed the doctrine, noting dicta in the Court's decisions characterizing assignor estoppel as being a failure and other negative statements.  In response, Counsel noted that the Court had had an opportunity to abrogate the doctrine in Scott Paper Co. v. Marcalus Manufacturing Co., 326 U.S. 249 (1945), and had not.

    Justice Thomas asked Petitioner's counsel to distinguish assignor estoppel from other doctrines such as issue preclusion, which are not a part of statutory law but nevertheless are sound principles.  Counsel responded by noting the differences in that those other principles had a more general application than patent law and also a different posture with regard to stare decisis.  In response to the Justice's question about changes to the patent from the time it was assigned to when it was asserted, Counsel somewhat unproductively got into the weeds on patent-specific issues regarding what was disclosed and what was claimed that led the Chief Justice to more questioning along to Justice Breyer.

    Turning to the Government's counsel Justice Thomas asked about the relevant assignments at issue in the case, and Counsel (perhaps wisely) noted that this was the sort of issue for the Federal Circuit to resolve.

    Finally, in questioning Hologic's counsel Justice Thomas asked how far from the original assignment could assignor estoppel principles apply, relevant here because the patent in suit was different (although related by priority) from the one assigned.  Counsel responded that the issue isn't what the inventor thought the invention was but what was disclosed (which determined what was assigned), and also that if the Court believed that the doctrine should be changed it was up to Congress to do so (to which the Justice asked whether Hologic wanted Congress to include assignor estoppel expressly in the statute).

    In Justice Breyer's turn, he asked Petitioner's counsel about the weight of precedent and asked what limitations would be best to cabin the doctrine if the Court did not abrogate it entirely.  Counsel responded that the Government's alternative formulation, that the claim at issue be "materially identical" to what was assigned, had too much ambiguity and that the issue required what Counsel termed "textual identity," and also whether the standard should be claims as pending at the time of the assignment.

    Justice Breyer challenged the Government's position by positing what would be a recurring hypothetical:  if the original patent claimed a widget, and the accused infringing article was a "widget-prime," wouldn't the doctrine's preclusion of the inventor challenging validity lead to a situation where the assignee could "foist [an] invention on the public forever" (fortunately that is not the case in any event).  The Government responded that this is a question of claim breadth (i.e., scope) and that their formulation was intended for an arms-length transaction, not applicable to employee assignments.  Counsel also noted that this was a question of what was valuable at the time of the assignment and what is at issue in the litigation with regard to claim scope.

    When questioning Hologic's counsel, Justice Breyer challenged on the basis of the "problems" with assignor estoppel precedent, and that "employment practices, the nature of invention, [and] complexity " had changed since the Court's foundational case in 1924 (Formica).  The Justice reiterated his concern regarding the "widget versus widget-prime" hypothetical, and his understanding that under Federal Circuit application of assignor estoppel such an extension could not be argued by an assignor.  This would permit "monopolies [to be] extended improperly."  Respondent replied that the world had changed "in amount not kind," and offered the post-grant review provisions of the American Invents Act as a shield against the outcome concerning the Justice.

    Justice Alito asked Petitioner why this issue was before the Court and suggested the Federal Circuit was empowered by Congress for determine the scope of these patent-specific doctrines, and further that Petitioner can go to Congress if they believe the doctrine is contrary to the statutory regime.  Counsel responded that assignor estoppel was another patent "doctrinal dinosaur" produced by the courts and the Court's abrogation was consistent with other instances.  In response to Justice Alito's question regarding whether parties could contract around the doctrine or if that would be against public policy, Counsel stated that assignor estoppel is not "settled law" and that much of the Supreme Court's precedent "hints away" from it, for the same policy reasons enunciated in Lear, Inc. v. Adkins, 395 U.S. 653, 666 (1969), regarding licensor estoppel.

    Justice Alito asked the Government's counsel whether their brief just enunciated a policy position (which in the context of the Justice's question to Minerva's counsel suggested an extension of his "go to Congress" sentiments).  The Government's counsel argued that assignor estoppel was doctrinally related to estoppel by deed as opposed to estoppel by conduct, otherwise known as equitable estoppel.  In response to the Justice's question regarding application of the doctrine Counsel responded that proper application was more difficult regarding instances where claims were pending at the time of an assignment, but that the Court's Westinghouse decision provides the proper analysis.

    When it was Hologic's turn, Justice Alito had no questions.

    Justice Sotomayor began her questioning of Petitioner's counsel with regard to their response to the Government's suggested compromise, and asked whether it isn't close to the Court's decision in Westinghouse?  Pursuing the "things have changed" argument, the Justice asked whether the Government wasn't asking the Court to return to earlier applications of the doctrine, and why the Court should rule in Petitioner's favor in view of Congress not abrogating the doctrine when revising the Patent Act in 2011?  Counsel asserted that between Lear and the Federal Circuit's decision in Diamond Scientific Co. v. Ambico, Inc., 848 F.2d 1220 (Fed. Cir. 1988), the doctrine was believed to be dead and the Federal Circuit "revived" it.  (Somewhat provocatively, Counsel asked that the Court should not permit the Federal Circuit to overrule it on this issue.)

    The Justice asked the Government's counsel whether she accepted Petitioner's suggestions regarding the "materially identical" aspects of their formulation, noting that the Government's proposal did not reach overbroad claims but was limited to the claims at the time of the assignment.  Counsel responded that the Government takes no issue with what is assigned being "rock solid" but that the Government does not agree "that [the] claim should exist both at the time of the assignment from the assignor and at the time of the assignment to the person ultimately bringing the challenge."  This colloquy included the Justice's supposition that perhaps the doctrine has "outlived its usefulness," and also considered the changes in concepts such as "practicing the prior art" as a counter to infringement and the primacy of claim construction in modern patent jurisprudence around the issue of exactly what was estopped.

    With regard to Hologic, Justice Sotomayor raised a fairness issue to the extent that what was estopped was not tethered to what was assigned, and whether it was fair to prevent the assignor from challenging aspects of the invention that the assignor had not agreed to assign?  (In this, the Justice followed other Justices in focusing on what was claimed rather than what was disclosed as the basis for the estoppel.)  Respondent's counsel focused on the assignment comprising what was disclosed and not limited to what was claimed at the time of the assignment, and that in this case the assignor's invalidity case was incorrect.

    Justice Kagen asked Petitioner to assume precedent was sufficiently sound that the Court was not willing to abrogate it absent "special factors" as enunciated in her opinion in Kimble v. Marvel Entertainment, LLCThe Justice did not permit counsel to take recourse in the Court's Scott Paper decision, who responded with their argument that "the law has moved" from the situation in which these earlier decisions were handed down, where "practicing the prior art" was a non-infringement position rather than an invalidity argument.  The Justice asked about the fairness question from the assignee's perspective, terming the behavior the doctrine precludes as "a total bait-and-switch," and Counsel responded that equitable estoppel was available as a remedy (the Justice termed this response "semantics").  When pressed by the Justice about the vitality of having the estoppel reach "exactly what was assigned" Counsel desisted from pushing back on the Justice's argument.

    The Justice's questions to the Government involved distinguishing assignor and equitable estoppel, and asked whether the instances where assignor estoppel would not apply under the Government's formulation — pre-invention assignments, continuation applications, and changes in the law — was exhaustive.  Counsel responded that she was not "hiding something" from the Court but that the principle underlying the Government's formulation was "the basic notion that what someone is saying at time two was inconsistent with what they're saying at time one."  When asked about Petitioner's argument that equitable estoppel would satisfy the policy aims of assignor estoppel, Counsel responded that equitable estoppel required reliance and knowing misrepresentation.  The issue here from the Government's position was "not necessarily about one party misleading another as much as confidence and conclusiveness in a particular type of formal transaction."

    For Hologic's counsel, Justice Kagen asserted the hypothetical of an assignor assigning and the assignee broadening the scope of the patent; what then?  Counsel reverted to the argument that Congress had provided post-grant review provisions in the AIA to police any such instances of overbroad claiming.  The Justice did not acquiesce to a discussion of the Section 112 aspects of this case, and Counsel responded that the claims can be construed more narrowly when appropriate.  Also, to the extent the Court perceived a need on fairness grounds for changing the practice Counsel argued it should be changed by statute by Congress.

    Justice Gorsuch asked Petitioner's counsel whether equitable estoppel (which would survive should the Court abrogate assignor estoppel) be sufficient as a defense?  And what if the Court adopts the Government's suggestion — can the Justices "save the day"?  Counsel noted there were disputed meanings over the claims here, and that the Government's position risks inconsistent application.  The Justice then asked why equitable estoppel solves those problems and Counsel answered that equitable estoppel is based on actual representations (and requires evidence thereof, as well as reliance).  The Justice then asked whether the Government's position wouldn't always favor the "big guys" (i.e., corporations) who have the resources to understand the scope of what was being assigned and would not depend on reliance, in comparison to the usual sole inventor assignor?

    The Justice asked Government's counsel why there wasn't a stare decisis issue with adopting their proposal?  Further, with regard to the estoppel by deed analogy, wouldn't the Government's test permit liability even in the absence of misrepresentation, particularly in instances involving a [big corporate] buyer better positioned to assess (accurately) patent scope?  Government counsel argued that their proposal respected stare decisis but the issue is not reliance (which isn't a factor in assignor estoppel), saying the Government was not suggesting the Court "get rid of reliance" (the Justice disagreed).  And yet further, the Justice asked why use estoppel by deed as the analogy when patents are more like personal property than real property?  The Justice asked if the Government is asking the Court to modify the doctrine, "why not try to get it right"?

    The Justice challenged Hologic's counsel on precedent, asserting that both Scott Paper ("a logical embarrassment") and Lear suggest assignor estoppel is defective and Westinghouse did not address the issue.  The Justice also picked up on the post-grant review argument by noting that assignor estoppel applies only in district court litigation and "isn't that strange"?  Respondent's counsel disagreed with the Justice's characterization of precedent, and the Justice reiterated the idea that equitable estoppel is a better "fit" than estoppel by deed due to the similarities between patents and personal property.

    Justice Kavanaugh asked Petitioner's counsel why the Court should abrogate settled law since 1924, and Counsel responded that the law isn't settled, citing Scott Paper.  In response to the Justice's assertion that assignees have had a reliance interest in the existence of assignor estoppel, Counsel reasserted the argument that in the 30 years between Lear and Diamond assignor estoppel was thought to be defunct.

    To the Government Justice Kavanaugh cited three examples in their brief and followed Justice Kagen's argument regarding employee to employer assignments.  The Government responded by saying in these instances there were not implicit allegations of value.  And with regard to "materially identical" and Petitioner's objection to the phrase, Counsel stated the Government was comfortable with "rock solid" but not trivial differences between claim scope when assigned and as issued.

    In response to the Justice's question to Respondent regarding the distinctions between their position and the Government's, Counsel responded that the Government's position was more stringent than invalidity, which has no "materially identical" requirement.  Counsel also noted that the Government's position would present a "Hobson's choice" to an assignee during prosecution between changing pending claims by amendment for patentability reasons and then losing recourse to assignor estoppel under the Government's proposal.

    Finally, Justice Barrett asked Petitioner how things would work out under an equitable estoppel regime with regard to allegations, as here, that the inventor lied?  Counsel responded that equitable estoppel would not be available under the circumstances in this case.  Turning to the fairness question with regard to the "turncoat inventor," the Justice asked whether there was no reliance interests to be protected because purchasers (such as large corporations) would typically not be "led down the primrose path" by assigning inventors.  Counsel asserted that there would be no reliance (required for equitable estoppel) because prosecution is a "give and take" proposition (any further elaboration on this point being cut off by the Chief Justice).

    The Justice noted in her questioning of the Government that while Blonder Tongue (issue preclusion) made litigation more efficient, the Government's proposal (regarding the "materially identical" requirement) would complicate matters.  Government counsel responded that the issue would be straightforward, and that the estoppel shouldn't be a bright line, "on off" switch as it has been applied by the Federal Circuit.  Indeed, Counsel asserted that "to the extent there are some factual questions here, we think that that's a benefit of our theory."

    For Respondents, the Justice asked whether the argument implicated the re-enactment canon or settled common law argument, and if it mattered?  Counsel responded that it could be either and doesn't matter, and that there is no ambiguity in the Court's precedent.  The Justice challenged this assertion on the basis that the language in Scott Paper and Lear did not completely embrace the assignor estoppel doctrine and that just because the Federal Circuit had not abolished the doctrine the Court was in a position to do so.

    While there are some common threads in the Justices' questioning, the current argument format has quelled to a large extent the ability for the Justices to interact during argument in a way that illustrates their inclinations.  And because the Justices frequently pose questions contrary to their thinking on the issues before them it is foolhardy to attempt to discern from their questions how they are leaning.  It is clear that the Justices do not see the Government's suggestion as a panacea, but other than that we must wait until the end of this Term at the latest for the Court's decision.

  • CalendarApril 26, 2021 – "World IP Day — IP & SMEs: Taking Your Ideas to Market" (Intellectual Property Owners Association Education Foundation) – 5:00 pm to 6:00 pm (ET)

    April 26-27, 2021 – Paragraph IV Disputes Conference (American Conference Institute)

    April 27, 2021 – European Biotech Patent Law Webinar (D Young & Co) – 9:00 am, noon, and 5:00 pm (BST)

    April 27, 2021 – "Exploring the Continuum Between Human- and AI-Generated Inventions: How Should Patents & Ownership be Allocated?" (IPWatchdog and Kilpatrick Townsend & Stockton LLP) – 12:00 pm (ET)

    April 28, 2021 – "Expanding the Eligibility Requirements to Foster Inclusion and Innovation in the U.S. Patent System" (Intellectual Property Owners Association) – 2:00 pm to 3:00 pm (ET)

    April 29, 2021 – "Facilitating and Augmenting Innovation with Artificial Intelligence" (IPWatchdog and IP.com) – 12:00 pm (ET)

    April 29, 2021 – "Comparison of EPO Oppositions and USPTO PTAB Proceedings" (Intellectual Property Owners Association) – 12:00 pm to 1:00 pm (ET)

  • IPO #2The Intellectual Property Owners Association (IPO) Education Foundation will offer a webinar in the Behind the IDEA series, entitled "World IP Day — IP & SMEs: Taking Your Ideas to Market," on April 26, 2021 from 5:00 pm to 6:00 pm (ET).  Moderator Louis Foreman of Enventys will speak with three inventors regarding the theme of "bringing your ideas to market."  Sue Carr of CarrTech LLC, Gary Michelson of Michelson Medical Foundation, and Grant Striemer of Procter & Gamble Co. will share their different experiences of bringing an idea to market:  creating a business or licensing an invention.

    There is no registration fee for the webinar.  However, those interested in attending the webinar should register here.

  • D Young & CoD Young & Co will be offering its next European biotech patent law update on April 27, 2021.  The webinar will be offered at three times: 9:00 am, noon, and 5:00 pm (BST).  D Young & Co European Patent Attorneys Simon O'Brien and Jennifer O'Farrell will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • IPWatchdogIPWatchdog and Kilpatrick Townsend & Stockton LLP and will be offering a webinar entitled "Exploring the Continuum Between Human- and AI-Generated Inventions: How Should Patents & Ownership be Allocated?" on April 27, 2021 at 12:00 pm (ET).  Gene Quinn of IPWatchdog, Inc. will moderate a panel consisting of Kate Gaudry of Kilpatrick Townsend & Stockton LLP; Ryan Abbott, Professor of Law and Health Sciences at the University of Surrey School of Law, and Adjunct Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA; and Richard Frank of Siemens Healthineers.  The panel will discuss the patenting of artificial intelligence, and the patenting of innovations generated by AI.  The panel will also discuss the following topics:

    • The current status of the Artificial Inventor Project appeals and patent applications;
    • Policy and legislative initiatives on AI and intellectual property; and
    • Practical solutions for obtaining protection on AI-assisted innovations.

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Expanding the Eligibility Requirements to Foster Inclusion and Innovation in the U.S. Patent System" on April 28, 2021 from 2:00 pm to 3:00 pm (ET).  Michelle Bugbee of Eastman Chemical Co.; Andrea Lynn Evensen of Siemens Corp.; Gracie Mills of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Margaret O'Boyle of O'Melveny & Myers LLP; Jenna Saunders of Faegre, Drinker, Biddle & Reath LLP; and Kristine Yates of Setter Roche Smith & Shellenberger, LLC will examine the gender gap in the patent bar and its correlation to the STEM degree requirement; discuss the qualifications for prosecuting design patents; review the letter from Senators Hirono, Coons, and Tillis to the USPTO and the USPTO's response, and explore ways to increase diversity among patent agents.

    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 registering for the webinar can do so here.

  • IPWatchdogIPWatchdog and IP.com and will be offering a webinar entitled "Facilitating and Augmenting Innovation with Artificial Intelligence" on April 29, 2021 at 12:00 pm (ET).  Gene Quinn of IPWatchdog, Inc. will moderate a panel consisting of Carlo Cotrone of Techtronic Industries North America (TTI) and Jim Durkin of IP.com.  The panel will discuss facilitating and augmenting invention disclosures using artificial intelligence.  The panel will also discuss the following topics:

    • The budgetary impact of cryptic invention disclosures;
    • Accelerating innovation and product lifecycles; and
    • Artificial Intelligence tools for assisting and augmenting invention disclosures.

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Comparison of EPO Oppositions and USPTO PTAB Proceedings" on April 29, 2021 from 12:00 pm to 1:00 pm (ET).  Chris Comiskey of Collins Aerospace, Robert Furr of Koch Industries Inc., and Maeve O'Flynn of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will compare and contrast proceedings before the USPTO's Patent Trial and Appeal Board and opposition proceedings before the European Patent Office, and address potential synergies and conflicts when proceedings are pending or anticipated in both jurisdictions.

    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 registering for the webinar can do so here.

  • By Kevin E. Noonan

    Autumn Red PeachThe humble peach has been the inspiration for pies, album titles, independent movies, and a fictional woman's baseball team, but is also an important food species, yielding 24.5 million tons globally in 2018.  Like all plant species, their sessile nature makes them a good target for environmental studies because, unlike most animals, they must respond to changes in their environment by adaptation rather than flight.  They have a diverse temperate host range from their origins in southwestern China, being found in temperate and subtropical regions, wet and dry climates, and in harsh environments (high altitudes, severe cold, and drought conditions).  This range suggests that the peach is a good species for studying climate effects on their evolution as illustrated by genetic changes, particularly in view of the climate change the globe has been experiencing for the past ~40 years that is expected to continue.

    An international group of researchers* recently reported the results of their taking this suggestion, in a paper entitled "Genomic analyses provide insights into peach local adaptation and responses to climate change" in the journal Genome Research.  The basis for the study was 263 diverse accessions that consisted of 52 wild relatives and 211 landraces ("a domesticated, locally adapted, traditional variety of a species of animal or plant that has developed over time, through adaptation to its natural and cultural environment of agriculture and pastoralism, and due to isolation from other populations of the species").  The 263 peach accessions could be divided into seven major groups:  YG (Yun-gui plateau), NW (Northwest China), NP (North Plain China), YT (Yangtze River Middle and Backward), NE (Northeast China), TB (Tibet plateau), and ST (South China Subtropical) groups.  Placing their genome assay results in context, these researchers reported on the effects of glaciation, which had caused a sharp decline of effective population size during the two largest Pleistocene glaciations:  the Xixiabangma glaciation (that occurred 1.17–0.8 million years ago, mya) and the Naynayxungla glaciation (occurring 0.78–0.50 mya); there was also a smaller decline in population size during the "last glacial maximum" (LGM) about 20,000 years ago.  Also reported was a slight expansion of peach populations from the Tibetan plateau (TB) after the Naynayxungla glaciation about 300,000 years ago.

    In total, 342.7 Gb of paired-end sequences were assayed, with a median depth of 5.3-fold corresponding to 91.7% of a reference peach genome ("Lovell"); the peach genome is relatively small (227.4 Mb) compared with other fruit species (e.g., apple, 650 Mb; and strawberry, 805 Mb).  These sequencing studies resulted in the identification of 4,611,842 single-nucleotide polymorphisms (SNPs), with 1,931,310 residing in introns (∼11.33%) and another 848,638 (∼4.98%) in protein-coding exons.  These researches also identified 1,049,266 small insertions and deletions (indels) (< 6 bp) and 106,388 larger structural variations (>30 bp).  These variations were used as genetic markers for mapping through time genomic changes and crossbreeding between the different geographically defined groups.  The results of these genetic analyses showed a pattern of extensive admixture and possible gene flow among landrace groups.

    Genetic analyses identified specific loci involved in adaptation to local conditions.  These include a total of 2092 genomic regions found for all seven groups (comprising 19.1 Mb, ∼8.4%) and "189, 387, 301, 235, 280, 339, and 378 regions for the YG, NW, NP, YT, NE, TB, and ST groups, respectively."  These loci were termed candidate selection regions (CSRs) by these researchers, and together harbored 3742 genes, corresponding to 396, 966, 635, 403, 573, 743, and 680 genes for the YG, NW, NP, YT, NE, TB, and ST groups.  In addition, some of these genes were shared among different groups, "suggesting the unique adaptive patterns for each group and that different climates may shape distinct genomic regions" according to the authors.  Assessment of these genes identified several related to response to different types of stimuli and stress that were overrepresented; included were temperature, radiation, salt, DNA damage, osmotic, toxin, and biotic stimulus.  These results suggested to these researchers that these genes were involved in adaptive evolution in response to these stresses.

    Turning to specific forms of environmental stress, the researchers found that peach specimens from high-salt soils in northwestern China were enriched for two cation/H+ exchanger family genes.  Additional genes found from to be enriched in these specimens were genes encoding proteins having a leucine-rich repeat (LRR) domain, comprising 121 of 612 members (∼19.8%).  These researchers noted that such genes were "considered to be one of the most important domains involved in plant resistance."  Pattern recognition receptor (PPR) proteins, which "form one of the largest protein families in land plants that are related to environmental responses" and are present with 286 members in the peach genome, were found in 79 (∼27.6%) of the identified candidate selection regions (CSRs).

    Specific genetic characteristics were reported for certain groups.  For the YG group (which is found on the Yun-gui plateau (Southwest China), a low-latitude (∼23.3–26.6° N) and high-altitude (∼2000 m) region with acidic soil (pH 4.5∼5.5)), genes (107) related to "metal ion (including potassium, iron, and zinc) binding and transport, cell membrane function, and response to toxins" were found to be overrepresented.  These scientists found that expression of a phenotype encoded by these genes would be "consistent with functions in overcoming cation deficiency and aluminum toxicity that are common in acidic soils."  For the YT group, characterized by high temperature and high humidity areas in middle and lower regions of the Yangtze river, the researchers found "high enrichments of the LRR domain (24) genes," as well as other genes related to stress responses (40 genes), in comparison to other groups.

    The paper also reported on genes correlated with altitude and adaptations to altitude.

    These include 2755 association SNPs, involving 2408 genes, of which 1670 association SNPs were unique, and ∼51.9% of the associations were shared across different types of environmental variable (EVs), which suggested to them that different EVs may shape the same genomic regions.  These "hotspots" were located at "the top and bottom of Chromosome 2," wherein the top was enriched with genes encoding NBS-LRR proteins and the bottom was highly enriched with genes associated with responses to a series of stresses, as well as at the top of Chromosome 4, which was "highly enriched with genes associated encoding LRR domain-containing proteins."  Overall, a "total of 75 genomic loci associated with more than five EVs were identified and these loci were highly enriched with genes in stress-related pathways, such as plant–pathogen interaction, MAPK signaling pathway, response to stress, and defense response."

    Related to specific stresses, the researchers found that "genes involved in ion transport were highly enriched in those associated with soil pH . . ., as soil pH affects absorption of metal ions in plants."  Also enriched were genes associated with "programmed cell death (PCD), innate immune response, plant–pathogen interaction, and DNA repair," as well as "secondary metabolism, including flavonoid metabolic process, jasmonic acid (JA) biosynthesis, and plant hormone signal transduction."  These researchers also identified "temperature-associated SNPs [including] 10 association hotspots on Chromosomes 1, 2, 3, 4, 5, 6, and 7 for more than eight EVs related to temperature and altitude."  These findings were significant, according to the authors, because "[t]olerance to low temperature in winter is a major factor that restricts the spread of peach to extremely cold regions."  One particular SNP identified in this way was "located in the gene PpAHP5" which is part of a gene cluster encoding six histidine phosphotransfer proteins (AHP); these have been "reported to be involved in mediating cold signaling" and was found to be "up-regulated by cold," and cold-resistant cultivars expressed the gene at higher levels than cold-sensitive ones.  Similarly, the researchers reported precipitation-related "hotspots"; one of these showed enrichment of several stress response related genes.

    Of economic importance, the level of fruit produced by cultivars adapted to different environmental conditions was determined, and the researchers reported finding differential expression of genes resulting in higher soluble sugar content.  Environmental factors associated with this phenotype include aridity, high diurnal temperature variation, and long sunshine duration, according to these scientists, leading them to conclude that "higher soluble sugar content in accessions from northwestern China represents an adaptive trait driven by the local drought environment."

    Other phenotypes include fruit flesh color, which the researchers found "strong geographic patterns, with ∼80% of yellow-fleshed peach landraces originating from northwestern China" and to be related to carotenoid metabolism (particularly overexpression of genes associated with carotenoid synthesis and loss-of-function mutations leading to carotenoid accumulation).  Studies of genetic variants associated with high altitude (Tibet) adapted cultivars were also reported, including specific patterns of gene expression, enrichment and loss (339 genomic regions, harboring 743 genes for high altitude cultivars, including ones involved in flavonoid production and UVB protection, and morphological changes in stomata thought to be involved in resistance to high-altitude hypoxia).

    The depth of genetic information and environmental factor correlations (much more extensive than set forth in this synopsis) led these researcher to conclude:

    In summary, this study provides new insights into peach adaptation to its habitat and how climate has shaped the genome of a perennial tree through natural selection.  These results also provide a new resource for studies of peach evolutionary biology and breeding, especially with regard to enhancing stress resistance.

    * Zhengzhou Fruit Research Institute, Chinese Academy of Agricultural Sciences; National Horticulture Germplasm Resources Center, Zhengzhou Fruit Research Institute, Chinese Academy of Agricultural Sciences; Key Laboratory of Horticultural Plant Biology (Ministry of Education), College of Horticulture & Forestry Sciences, Huazhong Agricultural University;  Agricultural Genome Institute at Shenzhen, Chinese Academy of Agricultural Sciences;  IRTA–Centre de Recerca en Agrigenòmica (CSIC-IRTA-UAB-UB); Boyce Thompson Institute for Plant Research, Cornell University; U.S. Department of Agriculture– Agricultural Research Service, Robert W. Holley Center for Agriculture and Health

  • By Donald Zuhn

    Tillis  ThomLast month, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) sent separate letters urging the Biden Administration to join the European Union, United Kingdom, Japan, Canada, Switzerland, Brazil, and Norway in opposing a proposal made by India and South Africa to have the World Trade Organization (WTO) waive the implementation, application and enforcement of certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with respect to the prevention, containment, or treatment of COVID-19.  A group of fifteen industry and trade organizations (including BIO and PhRMA) followed with their own letter to several members of the Biden Administration, opposing what the coalition called "a problematic proposal" to waive global IP protections.  And then, a group of intellectual property organizations sent a letter to several members of Congress and officials at the Patent and Copyright Offices to express their support for the United States' continued opposition to the TRIPS waiver proposal.  One of the recipients of that last letter was Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property.

    Last week, Sen, Tillis (at right) sent his own letter to members of the Biden Administration, asking that the Administration "oppose any and all efforts aimed at waiving intellectual property rights."  Calling the waiver a "disastrous" proposal (not once, but three times), Sen. Tillis expressed his concern that "the Biden Administration is being urged to support this broad and open-ended waiver in the mistaken belief that it will promote broader access to vaccines needed to halt the spread of this terrible pandemic," while arguing that the proposed waiver "would do nothing of the sort."  Instead, Sen. Tillis contends that the waiver "would undermine the extraordinary global response that has achieved historically remarkable results in record time and undermine our nation's global leadership in the technologies, medicines, and treatments of the future."

    In his letter, which was addressed to Gina M. Raimondo, Secretary of Commerce, and Katherine C. Tai, U.S. Trade Representative (both of whom received the industry and trade organizations' letter), Sen. Tillis argued that the "disastrous TRIPS waiver can do nothing to speed the development of new capacity, which requires the active cooperative involvement of the vaccine originator companies, which need to transfer not just patents but specific know-how."  The letter states that such a complex technical and logistical process "is best coordinated collectively," and asserts that the waiver would not be an efficient means of creating new global manufacturing capacity.

    The Senator also noted that the proposed waiver contains no time or technology limits, and therefore is not limited to vaccines.  According to Sen. Tillis, "[t]his means that foreign nations — nations which did not invest in the research and development of revolutionary vaccines and treatments — can demand any technology with the loosest connection to COVID without recourse."  As a result, Sen. Tillis contends that the waiver's main impact would be to legitimatize the transfer of American technologies to foreign competitors, which in turn "would allow for the creation of entire industries in these countries that will compete with American companies in the development of cutting-edge health care technologies."

    The Senator concludes his letter by declaring that "it makes no sense for the Biden Administration to support the disastrous waiver of all intellectual property rules that would allow our foreign competitors to gain free and unfettered access to our most advanced technologies," adding that it would be "virtually impossible to undo [the broad transfer of technologies] in any future trade negotiations over intellectual property rights."

    For additional information regarding this topic, please see:

    • "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
    • "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
    • "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021