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  • Guest Post — Reconsidered: The Federal Circuit’s Enfish Interpretation of Mayo-Alice

    By Circuit Judge Paul R. Michel (Ret.) and John T. Battaglia —

    The esteemed authors of Patent Docs have written of the need to reconsider the Federal Circuit's approach to section 101 eligibility, given the court's latest expansion and en-banc vote on subject-matter eligibility in AAM v. Neapco (Fed. Cir. July 31, 2020).  Is It Time for Federal Circuit to Rethink Its Subject Matter Eligibility Jurisprudence? by Kevin E. Noonan, Ph.D., Patent Docs (Aug. 24, 2020).  Among other points, we agree that such a need exists and suggest that the first step should lie with correcting the Federal Circuit's decisions in Enfish and Affinity Labs—the precedents that set forth the Federal Circuit's interpretation of "directed to" in the Mayo-Alice "framework" for testing a patent claim's ineligibility.  See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1334-35 (Fed. Cir. May 12, 2016); Affinity Labs of Texas, LLC v. DirecTV, LLC, 838 F.3d 1253, 1257-58 (Fed. Cir. Sept. 23, 2016); 35 U.S.C. §101.

    To be sure, Enfish was (and largely remains) one of the rare Federal Circuit precedents that upheld the claims' eligibility.  But we are not concerned with particular outcomes; only legal reasoning and an even-handed rule of law.  And Enfish's analysis and resulting rule of law on §101 does not track even the Supreme Court's Mayo-Alice §101 framework, itself fraught with controversy.  More specifically, Mayo-Alice established the two-step "framework" to assess patent-eligibility:  step one asks whether the claim-at-issue "is directed to" an ineligible topic, such as an abstract idea or natural law; and if so, step two asks whether the claim's elements nevertheless add "something more" and demonstrate an "inventive concept" over what was "routine, conventional, or well-understood" at the time.  Alice Corp. Pty Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347, 2355 (2014); Mayo Collaborative Servs v. Prometheus Labs, Inc., 132 S.Ct. 1289, 1298 (2012) (all emphases added unless otherwise noted).

    Enfish in particular interpreted Alice's "directed to" language, as used in step one.  With that backdrop, we analyze Enfish's transformation of what was once a one-step eligibility test into a framework that, at both steps of Mayo-Alice, delves into the claim's patentability or "patentable advances."

    I.  The Enfish Focus: What Does "Directed to" in Alice Step One Mean?

    In Enfish, the Federal Circuit applied the Mayo-Alice ineligibility framework to a patent claiming an improved "self-referential database" design for computers.  822 F.3d at 1333.  Microsoft had successfully challenged these claims as "abstract," persuading the district court to grant summary judgment of ineligibility.  Id. at 1330.  The Federal Circuit panel agreed these claims were sufficiently similar to claims deemed "abstract" in other precedents.  Id. at 1334-35.  But then it turned to the issue that resulted in the Federal Circuit's unique §101 rule:  Namely, the issue of interpreting Alice's step one "directed to" language.

        A.  Enfish Misinterprets "Directed to."

    Enfish started well enough.  It rejected the notion that "directed to" meant "involved," since such a broad interpretation would sweep in and put at risk myriad patent claims.  822 F.3d at 1335 ("That formulation plainly contemplates that the first step of the inquiry is a meaningful one, i.e., that a substantial class of claims are not directed to a patent-ineligible concept.  The 'directed to' inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon") (citation omitted) (emphasis in original).

    But then Enfish ceased any effort to deconstruct "directed to."  It didn't consider, for example, its own case law, the decisions for which have been using "directed to" for decades before Alice issued.  Nor did it consider how the Supreme Court's pre-Mayo-Alice precedents had applied the eligibility exceptions for §101.  If Enfish had, it would've fairly discerned that "directed to" and variations thereof meant the claim-at-issue was "in practical effect on" or "essentially" on an ineligible topic "itself"—such as the "formula itself" for computing an "updated alarm limit," Parker v. Flook, 437 U.S. 584, 587 (1978), or an "algorithm itself," Gottschalk v. Benson, 409 U.S. 63, 67-72 (1972); accord Diamond v. Diehr, 450 U.S. 175, 182 (1981).  The Supreme Court specifically re-affirmed these precedents in its 2012 Mayo opinion.  132 S.Ct. at 1298, 1302.

        B.  Enfish Relies on Dicta in Alice Step Two to Define the Different Test in Step One.

    Enfish took a different approach when interpreting step-one's "directed to" formulation.  Primarily, it latched onto a sentence of dicta at the tail-end of Alice.  In Enfish's reading, this Alice dicta "suggested that claims 'purport[ing] to improve the functioning of the computer itself,' or 'improv[ing] an existing technological process' might not succumb" to the abstract idea exception in step one.  822 F.3d at 1335 (citing "see" Alice, 134 S.Ct. at 2358-59).  Enfish admitted, however, that it was taking this "improved computer" dicta from the Alice Court's discussion on step two (the "inventive-concept" step) in order to define step one (the "directed to" ineligibility step).  Id.  But Enfish had a reason: "While it is true that the Court discussed improvements to computer-related technology in the second step of its analysis in Alice, …, that was because the Court did not need to discuss the first step of its analysis at any considerable length, …."  Id.

        C.  The Bottom Line: How Enfish Changed Alice Step One into a Test That Examines the Claim's     "Patentable Advance" Over the Prior Art.

    In sum, the Federal Circuit in Enfish took the following to answer what "directed to" means in Alice's step-one eligibility framework:  (1) a sentence of Alice dicta; (2) on a specific technology ("improvements in computer technology"); and (3) that Alice addressed only when discussing step two's "inventive-concept" test.  Based on those points, Enfish effectively extended Alice to conclude that this step-two dictum was now (1) binding; (2) on all technologies subject to a §101-ineligibility challenge; and (3) applicable to Alice's step-one "directed-to" test.  In doing all this, Enfish transformed Alice step one from a test that asked "whether the claims at issue are directed to" a patent-ineligible concept to the "inquiry [that] … look[s] at the 'focus of the claimed advance over the prior art' to determine if the claim's 'character as a whole' is directed to excluded subject matter."  Affinity Labs, 838 F.3d at 1257-58; accord Enfish, 822 F.3d at 1327, 1335; American Axle & Manufacturing LLC v. Neapco Holdings, –F.3d–, No. 18-1763, at *9 (Fed. Cir. July 31, 2020) (applying Enfish-Affinity Labs' "patentable advance" inquiry to claimed process for manufacturing auto-parts).

    II.  Enfish Couldn't Justify Its Step-One "Directed-to" Interpretation By Relying on Alice "Computer" Dicta in Step-Two's "Inventive Concept" Test.

    In our view, Enfish cannot reasonably rely on Alice step-two dicta—dicta focused on a specific technology, no less—to fashion what has become the Federal Circuit's across-the-board step-one test.  Dicta is of course non-binding.  And the terse Alice sentence on "computer" technology hardly seems like a sufficient foundation on which to substantially transform the Federal Circuit's step-one inquiry, applicable in all circumstances.

    These factors alone should've counseled against Enfish's approach.  Arguably as well, so too should have the differences between Alice's two steps, with one step focused on "ineligibility," the other on an "inventive-concept" test "analogous" to patentability.  Contrast, e.g., SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 1167 (Fed. Cir. 2018) (addressing ineligibility of claimed calculation under Alice and explaining that, no matter how "new" or even ingenious that claimed mathematical calculation might be, it was "still an [ineligible] abstract idea") (emphasis in original) with Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346-48 (Fed. Cir. 2015) (explaining how step two's "inventive-concept" search requires an analysis "analogous to those of § 102 [anticipation] and §103 [obviousness]" and comparing claims to "the prior art").

    Moreover, the lone justification Enfish offered for such cross-step borrowing—its belief that Alice simply "didn't need to discuss the first step of its analysis at any considerable length"—seems to rest on speculation.  As we read it, the proper deduction is that Alice didn't discuss this "patentable advance" test (or anything similar) in its step-one eligibility analysis precisely because the Supreme Court doesn't consider such a "patentable advance" relevant to step one.  If anything, "claimed" or "patentable advances" are the stuff of Alice step two, and certainly for the Patent Act's substantive patentability requirements, 35 U.S.C. §§102-103.  But not for Alice step one.

    III.  Affinity Labs Solidifies the "Patentable Advance" Inquiry as Part of Step One—Without Discussion or Debate.

    Given Enfish's various pressure points, as described above, one would've thought subsequent cases would've tried to limit or distinguish Enfish, whether because it was technology-focused, predicated on dicta in a different step (step two), or otherwise so unique as to be limited to its facts.  See, e.g., Miller v. U.S. Steel Corp., 902 F.2d 573, 575 (7th Cir. 1990) (the "polite formula for overruling").  Not so.  Four months later, in Affinity Labs, the court effectively sealed Enfish's transformation of step one.  838 F.3d at 1257-58.

    Conclusion

    Whether in Enfish or another imminent case, the Federal Circuit was right to interpret "directed to," as used in Alice step one.  The problem is that Enfish and its subsequent cases (such as Affinity Labs) proceeded to make its "patentable advance" interpretation not just inconsistent with Alice's "directed to" step; but nearly unrecognizable in view of it.  And it is wholly unclear that Enfish did much to stem the ineligibility tide.  After all, a recent study documenting §101 outcomes at the Federal Circuit (in published post-Alice cases) concluded that, regardless of technology or other such distinctions, some 82.1% of claims before the Federal Circuit "succumb" (in Enfish's words) to Mayo-Alice step one.  See Lessons From a Quantitative Analysis of the Federal Circuit's Section 101 Decisions Since Alice, by C. Graham Gerst & Paul Choi, IP Watchdog (Sept. 2, 2020).  Accordingly, as to the Federal Circuit's "patentable-advance" interpretation and the reasoning and process that produced it, patent lawyers should ask the court to revisit and correct this misinterpretation.

  • PTAB Decides Parties’ Motions in CRISPR Interference

    By Kevin E. Noonan —

    USPTO SealHaving heard oral argument at a hearing held on Monday, May 18th, the Patent Trial and Appeal Board today entered its decision on these motions in Interference No 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC").

    The Broad had four substantive motions to be decided by the Board:  Broad's Substantive Motion No. 1, requesting the Board to find (as it had in the earlier, 105,048 interference between these parties) that there was no interference-in-fact; Substantive Motion No. 2 to Substitute the Count; Broad's Substantive Motion No. 3 to de-designate claims as not corresponding to Count 1; and Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.

    CVC for its part filed only two motions to be decided by the Board:  CVC's Motion No. 1 was to be accorded the benefit of priority to three earlier-filed provisional applications for Count 1 of the Interference as declared; and CVC's Responsive Contingent Motion No. 2 was to be accorded the benefit of priority to three earlier-filed provisional applications contingent on the PTAB granting the Broad's Motion No. 2 to Substitute the Count of the interference.

    CVC also filed Miscellaneous Motion No. 2 to Exclude Evidence on April 2nd to exclude four references proffered by the Broad on the grounds that four prior art references should not be considered by the Board because they were not cited in any of Broad's papers; declarations from several individuals, including some of Broad's inventors, are inadmissible as hearsay because these individuals had not been made available for deposition; and certain expert testimony fails the Supreme Court's Daubert test for expert testimony admissibility.

    In its decision today, the PTAB denied Broad's Motion No. 1 that the interference be dissolved because CVC was estopped by the decision in the earlier interference between the parties (No. 105,048).  This decision is the most significant of the decisions handed down on the parties' motions, because the interference will now proceed to the priority phase.  The Board also denied the Broad's Mo No. 2 to substitute the Count, and its Motion No. 3 to designate claims corresponding and not corresponding to the changed Count.  Finally, with regard to the Broad’s claims, the Board granted Motion No. 4 to be accorded priority benefit to U.S. Provisional Application No. 61/736,527, having a filing date of December 12, 2012.

    As for CVC's motions, the Board granted-in-part CVC's Motion No. 1, according priority benefit to USSN 61/757,640, filed January 28, 2013; because this application has a later filing date than the Broad's '527 application CVC remains the Junior Party.  The Board dismissed CVC's Motion No. 2, which was contingent on the Board granting Broad's motion to substitute the Count, and granted-in-part CVC's motion to exclude evidence as to Exhibits that were not relied upon by the parties or the Board.

    The consequences of these decisions are that the interference will proceed to the priority phase, and Broad's status as Senior Party is unchanged; accordingly, CVC has the burden of showing earlier conception of the subject matter defined in the Count as declared.  The Board redeclared the interference to reflect the benefit of priority decided in these motions.  It also issued an order establishing times for the parties to file priority motions, oppositions, replies, and other motions:

    TIME PERIOD 11 — 23 October 2020 — JUNIOR PARTY ONLY file priority motion

    TIME PERIOD 12 — 4 December 2020 — SENIOR PARTY ONLY file priority motion

    TIME PERIOD 13 — 29 January 2021 — File oppositions to all motions

    TIME PERIOD 14 — 26 February 2021 — File all replies

    TIME PERIOD 15 — 2 April 2021 — File request for oral argument, File list of issues to be considered, File motions to exclude File observations

    TIME PERIOD 16 — 23 April 2021 — File oppositions to motions to exclude, File response to observations

    TIME PERIOD 17 — 7 May 2021 — File replies to oppositions to motions to exclude

    ORAL ARGUMENT DATE (if ordered) — TBD

    More in depth analysis and discussion of these decisions and their consequences will be provided in future posts.

  • Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020)

        By Donald Zuhn —

    Federal Circuit SealEarlier today, the Federal Circuit vacated the final written decision by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in an inter partes review involving Appellant Snyders Heart Valve LLC and Appellee St. Jude Medical, LLC, and remanded for proceedings consistent with the Court's decision in Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019).  Snyders argued that the final written decision at issue on appeal violated the Constitution's Appointments Clause because it was rendered by an unconstitutionally appointed panel of Administrative Patent Judges.  Snyders also argued that the remedy in Arthrex is insufficient because it does not allow for review of the Board's decisions by a superior officer and is inconsistent with Congress' intent that Administrative Patent Judges act independently.  Snyders further argued that due to the unique circumstances of its case, it was entitled to greater relief than afforded under Arthrex.

    With respect to Snyders' first argument, the Court indicated that the issue had been decided in Arthrex, and that Snyders was entitled to vacatur and remand for a hearing before a properly appointed Board.  The Court did not address Snyders second argument, noting that it was bound by Arthrex.

    With respect to Snyders' third argument, Snyders explained that USPTO Director Andre Iancu had served as counsel for St. Jude Medical LLC in a parallel proceeding prior to his appointment as Director.  Although Director Iancu had recused himself from the instant case, Snyders argued that the Director's conflict should be imputed to all USPTO employees and that his recusal should impact the remedy available to Snyders.  The Court, however, found Snyders' argument to be without merit, noting that the Deputy Director has the authority, under 35 U.S.C. § 3(b)(1), "to act in the capacity of the Director in the event of the absence or incapacity of the Director," and that a conflict requiring recusal qualifies as an "incapacity" within the meaning of the statute.

    St. Jude's argued on appeal that because Snyders expressly waived its Arthrex-based challenge in a companion appeal, the Court should deem the argument to have been waived in the instant appeal.  The Court, however, explained that "Snyders was not obligated to press every argument available to it in a different appeal to maintain its rights in this one," noting that the companion appeal addressed inter partes reviews of a different patent than the one at issue in the instant appeal, and therefore determined that Snyders had not waived its Arthrex-based challenge in the instant appeal.

    The Court concluded that "Snyders is entitled to the same relief given to the Arthrex appellant and no more," and therefore vacated and remanded the Board's final written decision.

    Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Circuit Judges Newman, O'Malley, and Taranto
    Per curiam opinion

  • USPTO News Briefs

    By Donald Zuhn —

    USPTO Extends Cancer Immunotherapy Pilot Program

    USPTO SealIn a notice published earlier this summer in the Federal Register (85 Fed. Reg. 41570), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program.  According to the Office's notice, the Cancer Immunotherapy Pilot Program has been extended to June 30, 2022, and all parameters will remain the same as in the original pilot program.

    The Cancer Immunotherapy Pilot Program was initiated on June 29, 2016 (see "USPTO Implements Pilot Program to Support President's National Cancer Moonshot") to provide for earlier review of patent applications pertaining to cancer immunotherapy in support of the "National Cancer Moonshot," an initiative of the Obama Administration to achieve ten years' worth of cancer research from 2016 to 2021 (see "FACT SHEET: Investing in the National Cancer Moonshot").  Under the Cancer Immunotherapy Pilot Program, applications containing at least one claim reciting a method of treating a cancer using immunotherapy are advanced out of turn for examination if the applicant files a grantable petition to make special, with the goal of completing examination of the application within twelve months of special status being granted.  In order to participate in the Cancer Immunotherapy Pilot Program, an applicant must satisfy the following requirements:

    (1) File a petition to make special under 37 C.F.R. § 1.102(d) in a non-reissue, nonprovisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered national stage under 35 U.S.C. § 371.  The petition must be filed at least one day prior to the date that notice of a first Office action (which may be an Office action containing only a restriction requirement) appears on PAIR, or with a Request for Continued Examination (RCE).  For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a petition to make special may be accepted any time prior to appeal or final rejection.  The Office recommends that applicants use form PTO/SB/443 for filing the petition, as the form contains check boxes that will allow the applicant to comply with several certification requirements under the pilot program.

    (2) The application cannot contain more than three independent claims, more than twenty total claims, or any multiple dependent claims.  For applications not meeting this requirement, an applicant must file a preliminary amendment to cancel the excess claims or multiple dependent claims at the time the petition to make special is filed.

    (3) The application must include at least one claim to a method of treating a cancer using immunotherapy, and such claim must "encompass[] a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells."  Examples of acceptable claims include those directed to "the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells," "the co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery," "administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth," or "in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines."

    (4) If restriction is required, the applicant must agree to make an election without traverse in a telephonic interview, and elect an invention directed to a method of treating a cancer using immunotherapy.  The applicant will be given two working days to respond to an examiner's request for an election, and in the event that the applicant fails to respond within that period, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy as being constructively elected without traverse.

    (5) The application cannot have been previously granted special status.

    (6) The petition to make special must be filed electronically via the EFS-Web, and the document description "Petition for Cancer Immunotherapy Pilot" must be selected for the petition.

    (7) If the application has not been published, the applicant must file a request for early publication in compliance with 37 C.F.R § 1.219 with the petition to make special (or a rescission of a nonpublication request if one was filed).

    For the purposes of the pilot program, the fee for a petition to make special under 37 C.F.R. § 1.102(d) has been waived by the Office.

    In its notice extending the Cancer Immunotherapy Pilot Program, the Office noted that as of the date of the notice, more than 500 petitions requesting participation in the pilot program have been filed, and 167 patents have been granted under the pilot program.


    USPTO and IMPI Extend PPH Pilot Program

    Mexican Patent Office - Instituto Mexicano de la Propiedad IndustrialIn a notice published earlier this summer in the Official Gazette (1476 OG 56), the U.S. Patent and Trademark Office announced that the USPTO and Mexican Institute of Industrial Property (IMPI) have agreed to extend the Patent Prosecution Highway (PPH) Pilot Program between the two offices until June 30, 2022.  As a result of the extension, the USPTO will treat as timely any PPH request, based on IMPI work, filed with the USPTO on or before June 30, 2022.


    INAPI Transitioning to Global PPH Pilot Program

    INAPIIn a notice issued by the U.S. Patent and Trademark Office earlier this summer, the USPTO announced that it had been informed by the National Institute of Industrial Property of Chile (INAPI) that INAPI would be participating in the Global PPH pilot program effective July 6, 2020.  In November of 2018, the USPTO had commenced a Patent Prosecution Highway (PPH) pilot program in which an applicant whose claims were determined allowable/patentable in an application filed with INAPI could have the corresponding application filed with the USPTO advanced out of turn for examination.  In January of 2014, the USPTO began participating in the Global PPH pilot program, which consolidated and replaced numerous prior PPH programs, streamlining and simplifying the PPH process for both applicants and Global PPH participating offices.  INAPI's participation in the Global PPH pilot program will supersede the bilateral PPH pilot program that previously existed between the USPTO and INAPI.


    USPTO Releases Revised MPEP

    MPEP CoverThe U.S. Patent and Trademark Office announced via a Patent Alert e-mail distributed earlier this summer and a notice in the Federal Register (85 Fed. Reg. 41571) that it has released the latest version of the Manual of Patent Examining Procedure (MPEP).  The new version of the MPEP — the Ninth Edition, June 2020 Revision — incorporates updated information on patent examination policy and procedure related to a number of issues, including subject matter eligibility and examination of computer-implemented functional claim limitations.  In particular, chapters 100-1000, 1200-1500, and 1700-2800 of the MPEP have been revised.  The Office notes that updated sections are indicated by a revision indicator of [R-10.2019], which means these sections have been updated to reflect USPTO patent practice and relevant case law as of October 31, 2019.  The new version of the MPEP can be accessed here.  Suggestions for improving the form and content of the MPEP can be submitted via e-mail to mpepfeedback@uspto.gov, via the IdeaScale® tool at https://uspto-mpep.ideascale.com/a/index, or by regular mail addressed to the Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of the Editor, Manual of Patent Examining Procedure.

  • Conference & CLE Calendar

    CalendarSeptember 8, 2020 – "Compulife: Datascraping and Trade Secret Law" (Intellectual Property Owners Association) – 12:00 pm to 1:00 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – The Current State of Patent Eligibility Caselaw – 12:30 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – A Bridge of Tears for Life Sciences – 12:45 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – Hatch-Waxman and IPR Strategy – 2:15 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Keynote: Tricia Thompkins, EVP, General Counsel and Secretary, Perry Ellis International, Inc. – 12:30 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Leveraging Intellectual Property to Raise Structured Capital in Life Sciences – 12:30 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – IP as an Asset Class: Valuing Assets in Support of Monetization Strategy – 12:45 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Litigation Finance: Funding Patent Infringement Litigation – 2:15 pm (ET)

    September 10, 2020 – "Myths of Litigated Patents" (LexisNexis IP and IPWatchdog) – 12:00 pm (ET).

    September 10, 2020 – "Is Alice Pulling Manufacturing Patents Down the Rabbit Hole?" (Intellectual Property Owners Association) – 12:45 pm to 1:45 pm (ET)

    September 11, 2020 – IP, Technology & Social Justice in the Age of Coronavirus (Center for Intellectual Property, Information & Privacy Law at UIC John Marshall Law School and Institute for Intellectual Property & Social Justice) – 7:40 am to 3:00 pm (CT)

    September 14, 2020 – IPWatchdog Virtual CON2020 – Enforcing & Licensing 5G SEPs: An Innovator’s Perspective – 12:45 pm (ET)

    September 14, 2020 – IPWatchdog Virtual CON2020 – High-Tech Patent Litigation Trends: 101 and the Return of Competitor Lawsuits – 2:15 pm (ET)

    September 14, 2020 – IPWatchdog Virtual CON2020 – Preparing and Prosecuting Patents that Hold up to Challenge – 3:45 pm (ET)

    September 15, 2020 – "Traps for the Unwary Prosecutor: What Practitioners Should Know About US and European Patent Practice" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 15, 2020 – IPWatchdog Virtual CON2020 – Keynote: Rochelle Blaustein, Associate General Counsel, Technology Transfer & Intellectual Property, United States Department of Energy – 12:05 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – The Growing Importance of Trade Secret Protection – 12:30 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – Identifying, Valuing and Protecting Trade Secrets in the 21st Century – 12:45 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – The Gender Gap: Addressing STEM Education, Funding & Inventorship – 2:15 pm (ET)

    September 16, 2020 – IPWatchdog Virtual CON2020 – Ethics for IP Attorneys – 1:50 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Keynote: Alden Abbott, General Counsel, FTC – 12:05 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Efficiency in Draftsman Communications – 12:30 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Enhancing Value Throughout the Patent Life Cycle – 2:00 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Establishing a Patent Strategy for the Innovation Lifecycle – 2:15 pm (ET)

    September 23-24, 2020 – Summit on Biosimilars: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace (American Conference Institute) – virtual conference

    September 23-24, 2020 – FDA Boot Camp (American Conference Institute) – virtual conference

    September 29, 2020 – IPWatchdog Virtual CON2020 – The Future of Monetization – 12:45 pm (ET)

    September 29, 2020 – IPWatchdog Virtual CON2020 – What Can Armor on WWII Planes & Honeybees Tell Us about Innovation Strategy? – 2:00 pm (ET)

    September 29, 2020 – IPWatchdog Virtual CON2020 – Everyone Wants to Be a Unicorn – But What About Patents? – 2:15 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – Keynote: Louis Foreman, CEO, Enventys Partners, founder of Edison Nation – 12:05 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – How China is Changing the Global Patent System – 12:45 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – Solutions for the U.S. Patent System – 2:15 pm (ET)

  • IPO Webinar on Impact of Alice on Manufacturing Patents

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Is Alice Pulling Manufacturing Patents Down the Rabbit Hole?" on September 10, 2020 from 12:45 pm to 1:45 pm (ET).  John Cheek of DRiV Inc. and Timothy McAnulty and Jeffrey Totten of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will discuss how recent decisions from the Federal Circuit in American Axle have put manufacturing, mechanical, and electrical patents at risk, and how the Alice/Mayo test for patent eligibility is not being applied to method of manufacturing patents.  The panel will discuss the following issues:

    • Do these cases push the Alice/Mayotest too far?
    • Do they further conflate patent eligibility with obviousness or enablement?
    • Do they put manufacturing, mechanical, and electrical patents more at risk for eligibility challenges (and cancellation)?

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Webinar on Myths of Litigated Patents

    LexisNexisLexisNexis IP and IPWatchdog and will be offering a webinar entitled "Myths of Litigated Patents" on September 10, 2020 at 12:00 pm (ET).  Dr. Sean Tu, Professor, WVU College of Law; Megan McLoughlin of LexisNexis® IP; and Gene Quinn of IPWatchdog will discuss whether patent examiners who issue litigated patents have common characteristics?  While intuition would argue that those examiners who issue the most patents (approximately one patent every three business days) would exhibit a higher litigation rate, surprisingly, two studies by Professor Sean Tu suggest that this is wrong.  The panel will address the following issues:

    • Which types of examiners tend to issue patents that later undergo litigation
    • Whether examiners who are "rubber stamping" patents issue litigated patents at a disproportionately higher rate
    • Whether examiners with less experience are issuing more litigated patents
    • The issues at stake during prosecution for different types of examiners
    • How this knowledge can impact your prosecution practice

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

  • IPO Webinar on Compulife v. Newman

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Compulife: Datascraping and Trade Secret Law" on September 8, 2020 from 12:00 pm to 1:00 pm (ET).  David Conrad of Fish & Richardson, PC; Kenneth Corsello of IBM; and James Pooley of James Pooley, PLC will discuss Compulife v. Newman, an Eleventh Circuit decision that appears to offer publishers of data a novel way to pursue website scrapers by using trade secret law, and thus is also an important possible threat to companies that depend on others' data as fodder for their artificial intelligence solutions.  The panel will discuss:

    • Whether this case offers website publishers a new arrow in the quiver to combat unwanted website scrapers beyond "typical" claims under the Computer Fraud and Abuse Act (CFAA) and a contract claim for breach of the underlying terms of service.
    • Other important cases involving datascraping including Van Buren v. U.S. (recently granted certoriari before the U.S. Supreme Court), HiQ v. LinkedIn (cert petition pending), and Digidrill v. Petrolink (5th Circ., July 2020).

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealToday, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma Pharmaceuticals USA Inc., Dr. Reddy's Laboratories, Inc., and Dr. Reddy's Laboratories, Ltd. were invalid for obviousness, in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.  Rule 36 decisions are rarely further discussed; this case (while not particularly remarkable) does provide an opportunity to understand the factual and legal circumstances surrounding this increasingly frequent outcome.

    The case arose in ANDA litigation over Amarin's Vascepa® drug, which is a highly purified preparation of eicosapentaenoic acid (EPA).  Specifically the formulation used in the patented methods is specified as comprising at least 96% EPA by weight and (relevant to these claims) further comprises substantially no docosahexaenoic acid (DHA) or related esters.  The drug is used to treat hypertriglyceridemia (hyperTG), a condition where blood concentrations of triglycerides (TG) can be as high as 500-1500 mg/dL (normal blood levels are less than 150 mg/dL TG).  Prior art drugs, specifically Lovaza comprised a mixture of EPA and DHA, but suffered from the side effect that patients developed increased amounts of low-density lipoprotein-associated cholesterol (LDL-C) in their blood, increasing the risk of heart attacks.  As a consequence, Lovaza was administered with a statin to counteract this negative side effect.  Amarin's Vascepa® drug did not have this side effect and did not require concomitant statin administration.

    Amarin asserted U.S. Patent Nos. 8,293,728; 8,318,715; 8,357,677; 8,367,652; 8,431,560; and 8,518,929; claims 1 and 16 of the '728 patent are representative:

    1.  A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight of all fatty acids present, ethyl eicosapentaenoate, and substantially no docosahexaenoic acid or its esters for a period of 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition and a concurrent lipid altering therapy.

    16.  The method of claim 1, wherein no fatty acid of the pharmaceutical composition, except for ethyl-EPA, comprises more than about 0.6% by weight of all fatty acids combined.

    The District Court held that Defendants' label would induce infringement of all asserted claims of all Amarin's patents, a not uncommon outcome in ANDA litigation in view of FDA requirements for a generic drug to conform to the specifications of the corresponding branded version.  However, infringement liability of any kind was precluded by the court's further finding that all of the claims of all of Amarin's asserted patents were invalid for obviousness.

    Defendants asserted the following prior art references to support their obviousness arguments:

    1.  Lovaza as cited in the Physicians' Desk Reference (PDR), that disclosed the combination of EPA + DHA for hyperTG, administered at same dose as Amarin's patents prescribe; Lovaza was reported to have same effects as Vascepa® on LDL-C when used with a statin but had raised LDL-C when administered by itself

    2.  Mori et al., Purified Eicosapentaenoic and Docosahexaenoic Acids Have Differential Effects on Serum Lipids and Lipoproteins, LDL Particle Size, Glucose, and Insulin in Mildly Hyperlipidemic Men, 71 Am. J. Clinical Nutrition 1085- 94 (2000), which disclosed that administration of EPA alone reduced TG levels by 18.4% and DHA alone by 20%, stating these were essentially the same effects; also disclosed that serum LDL-C increased by 8% ("significantly") with DHA administration but by only 3.5% with EPA.

    3.  Hayashi et al., Decreases in Plasma Lipid Content and Thrombotic Activity by Ethyl Icosapentate Purified from Fish Oils, 56(1) Curr. Therap. Res. 24-31 (1995) disclosed that "at least one patient with hyperTG that improved with EPA treatment"; no disclosure of effects on LDL-C except that EPA did not increase LDL-C.

    4.  Kurabayashi et al., Eicosapentaenoic Acid Effect on Hyperlipidemia in Menopausal Japanese Women. Obstet. Gynecol. 96:521-8 (2000), which disclosed that EPA administration at ½ dosage with estrogen (which was known to increase TG); reported 27% reduction in serum TG levels.

    The Lovaza reference was the principal reference relied upon by the District Court in making its obviousness determination, for teaching that this formulation was effective at reducing TG levels in patients with hyperTG, but with the risk of pathological increases in LDL-C levels.  The Court considered the knowledge in the art regarding Lovaza in combination with the Mori reference for its teachings that the LDL-C raising effect was due to DHA in the Lovaza formulation.  The other cited art was relied upon for teaching that EPA alone could reduce TG levels, albeit on hyperTG patients as well as patients with elevated TG but not above 500 mg/dL.  Based on this art, the District Court found the person of skill in the art would have been motivated to combine the teachings of the Lovaza reference and the Mori reference because there would be a benefit in being able to administer one drug (EPA) rather than Lovaza plus a statin (for, inter alia, improved patient compliance reasons).  The District Court also perceived Plaintiff's expert as conceding this point, and that the prior art taken as a whole showed the desired effect known in the art to be associated with EPA administration alone.  The Court found that the skilled worker would have had a reasonable expectation of success in this combination, based on expert testimony and the District Court's understanding of what was disclosed in the prior art.

    The District Court then turned to the objective indicia of non-obviousness (termed the "secondary considerations in Graham v. John Deere & Co.).  In rendering its decision, the District Court characterized the procedural status of her deliberations by saying that Defendants had established a prima facie case of obviousness and she would then consider whether Plaintiffs had rebutted that case with evidence of secondary considerations; this analytical framework would be one of Plaintiff's arguments for errors of law on appeal.  Plaintiffs asserted the secondary considerations of unexpected benefits, satisfaction of long-felt but unmet need, skepticism, praise, and commercial success; after considering Plaintiff's evidence the Court found that certain of these secondary considerations (satisfaction of long-felt need, commercial success) provided evidence contrary to an obviousness determination but on balance Plaintiff's evidence of secondary considerations did not rebut the prima facie case.  (In an interesting twist recognized by the District Court, these patents were granted after the Examiner deemed the secondary considerations rebutted the Examiner's prima facie case.)

    On appeal, Amarin argued that the District Court erred by establishing the prima facie case before considering the secondary considerations, which Amarin argued was improper, citing In re Cyclobenzaprine, 676 F.3d 1063 (Fed. Cir. 2012).  Amarin also accused the District Court of engaging in hindsight bias, and for shifting the burden from Defendants in how it performed its obviousness analysis (again, but establishing the prima facie case and then placing the burden on Amarin to rebut it).  For their part, Defendants countered Amarin's Cyclobenzaprine citation with the Federal Circuit's later-decided Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346 (Fed. Cir. 2013) case, and further opposed Amarin's other grounds of appeal.

    The Federal Circuit heard oral argument on September 2nd, before a panel of Judges Dyk, Reyna, and Hughes (a recording of the oral argument can be obtained here).  Judge Dyk raised with Amarin's counsel the effect of the Novo decision regarding the prima facie case approach, stating by question that the panel was bound by earlier cases and Novo had affirmed the legal correctness of the District Court's approach.  Amarin's counsel argued that the District Court further erred by balancing the various species of secondary indicia but Judge Dyk appeared to believe that the one sentence Amarin pointed to in the District Court's opinion was insufficient evidence of analytical impropriety.  Judge Dyk asserted that merely weighing the secondary considerations versus the prima facie case seemed to satisfy the law in his view.  Judge Reyna's less extensive questioning focused on Amarin's argument that the District Court reached its conclusion before looking to secondary considerations, asking where in the record that would be.  Judge Hughes did not pose any questions to Amarin's counsel, and none of the judges questioned Defendants' counsel.  The Court's Rule 36 affirmance followed the next day.

    It is clear that the Court was not convinced the District Court had committed any legal error in how it performed its obviousness analysis and that Amarin did not show clear error in any of the District Court's factual findings.  Thus, the Rule 36 affirmance followed.

    Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Reyna, and Hughes
    Per curiam

  • Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit recently applied well-established principles of obviousness in affirming the Patent Trial and Appeals Board's invalidation of several patents related to antifungal formulations in Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC.

    The subject matter of the claimed invention was a topical formulation of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole (known as tavaborole):

    Structure
    and sold as KERYDIN® for treatment of a fungal infection (onychomycosis) caused by Trichophyton rubrum or T. mentagrophytes.  Flatwing Pharmaceuticals successfully initiated inter partes review of all claims of U.S. Patent Nos. 9,549,938 (the "'938 patent"), 9,566,289 (the "'289 patent"), 9,566,290 (the "'290 patent"), and 9,572,823 (the "'823 patent") for being as unpatentable for obviousness; the opinion characterizes dependent claim 2 of the '823 patent as being representative:

    1.  A method of delivering a compound, in a human, from a dorsal layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising: contacting the dorsal layer of the nail plate with a pharmaceutical composition comprising a compound that penetrates the nail plate, the compound being [tavaborole] or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.

    2.  The method of claim 1, wherein the pharmaceutical composition is in the form of a topical solution comprising 5% w/w of [tavaborole], and wherein the pharmaceutical composition further comprises ethanol and propylene glycol [emphasis added].

    (Although other claims in the related patents in inter partes review recite ranges from 1-15%.)

    The PTAB had earlier found claims in two related patents to be invalid for obviousness (see "Anacor Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2018)").  Here, the PTAB applied some of the same art and arrived at the same conclusion of obviousness.  The Board decided that the prior art taught the use of antiifungal compounds (albeit not tavaborole) at concentrations overlapping the 5% recited in claim 2 of the '823 patent for treating fungal infections and thus the combination taught all the elements of the claimed invention.  The Board held that routine optimization by the skilled worker would have produced the claimed formulations which would have been reasonably expected to be effective against onchomycosis.  The Board also rejected Anacor's arguments regarding challenges posed by using organoboron compounds that would have precluded the existence of a reasonable expectation of success, based on expert testimony, and further rejected that the prior art (which taught 10% antifungal concentrations in prior art formulations) taught away from obviousness of the claimed invention teaching 5% tavaborole formulations.

    The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges O'Malley and Chen.  Using the substantial evidence standard for factual questions arising before the PTAB, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000), and de novo review of questions of law, the panel agreed with the Board's conclusion that the choice of 5% tavaborole concentrations in the claimed in formulation was a matter of routine optimization.  The Federal Circuit recognized that tavaborole concentration was "a result-effective variable[] such that one could optimize nail penetration by routine experimentation within a predictable range of concentrations" in support of its opinion.  The evidence showed that screening techniques existed in the art for testing for efficacy.  The art also taught a relationship between nail penetration and antifungal effectiveness, for example, wherein the art taught that 5% econazole concentrations were effective for penetrating nails.  According to the opinion, because tavaborole is a smaller molecule than econazole the skilled worker would have expected it to be effective in penetrating nails and thus being effective as an antifungal agent in that milieu.

    The panel also rejected Anacor's teaching away argument, because the art showed that any diminution of effectiveness caused by lowering econazole concentration from 10% to 5% was modest and depended on other factors such as excipients used in the formulation.  The opinion characterized the attitude exhibited by the art as not amounting to discouragement against using 5% econazole formulations and thus concluded that the art did not teach away from them.

    Finally, with regard to Anacor's argument that the skilled worker would have recognized that using organoborane compounds posed some difficulties in formulation, the opinion states that "[prior art] describing in vivo inhibition of a common fungus with organoboron compositions—formulated in either mineral oil or petroleum jelly—is especially damaging to Anacor's arguments."  Moreover, the Federal Circuit found that any purported challenge was not reflected in the specification, wherein "the specification does not offer any guidance beyond citation of well-known guides to pharmaceutical formulation" for making the claimed organoborane formulations.

    Finding no error by the PTAB, the Federal Circuit affirmed its judgment of obviousness for all challenged claims.

    Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, O'Malley, and Chen
    Opinion by Circuit Judge Lourie