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  • Top Stories of 2017: #10 to #14

    By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories.  For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Yesterday, we counted down stories #19 to #15, and today we count down stories #14 to #10 as we work our way towards the top five stories of 2017.  As with our other lists (2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2017" on January 17, 2018 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.


    14.  Federal Circuit: PTAB and District Court Can Reach Different Conclusions on Same Evidence

    In April, the Federal Circuit determined in Novartis AG v. Noven Pharmaceuticals Inc. that the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) did not have to take into account a final district court determination of non-obviousness of the same claims based on the same prior art in an inter partes review proceedings.  The Federal Circuit based its decision on the different burdens of proof required in the two different types of proceedings, citing to Cuozzo Speed Techs., LLC v. Lee, wherein the Supreme Court which noted that the "different evidentiary burdens mean that the possibility of inconsistent results is inherent to Congress' regulatory design."  Cuozzo, 136 S. Ct. 2131, 2146 (2016).

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

    • "Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)," April 4, 2017


    13.  Patent Associations Propose Changes to § 101

    In the aftermath of the Supreme Court's decision in 2016 not to grant certiorari in Sequenom v. Ariosa, many voiced the opinion that only Congress could resolve the acknowledged uncertainty that recent Supreme Court decisions have created in the law of patent subject matter eligibility.  In February, the Intellectual Property Owners Association was the first of three patent associations to propose an amendment to 35 U.S.C. § 101.  In March, the Intellectual Property Law Section of the American Bar Association (ABA-IPL) sent its proposal for revising § 101 to U.S. Patent and Trademark Office Director Michelle Lee.  Finally, in May, the American Intellectual Property Lawyers Association (AIPLA) announced its proposal to amend § 101.  The three proposals can be found in the posts listed below.  Many in the patent community are hopeful that the three patent associations will be able to come together on a consensus proposal in 2018 and have a bill to change § 101 introduced in Congress.

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

    • "AIPLA Proposes Legislative Changes to 35 U.S.C. § 101," May 16, 2017
    • "ABA IP Law Section Sends Section 101 Revision Proposal to USPTO Director Lee," March 29, 2017
    • "What to Do about Section 101? IPO Provides Its Answer," February 9, 2017


    12.  Federal Circuit Narrows Enfish & McRO in Recognicorp

    Since September of 2016, when the Federal Circuit issued its decision in McRO, Inc. v. Bandai Namco Games America Inc., it had been understood that an invention that improves the operation of a computer or another technology is not abstract under § 101, and that a court should review the specification to make this determination.  While Recognicorp, LLC v. Nintendo Co. did not exactly throw that notion under the bus, it did serve to possibly narrow the holdings of Enfish, LLC v. Microsoft Corp., decided in May of 2016, and McRO.  In deciding Recognicorp, the Federal Circuit refused to acknowledge the possibility that the claimed invention resulted in such an improvement, and did not analyze the specification in detail.  As we reported shortly after Recognicorp was decided in April, the disconnect between the Federal Circuit's characterization of the claims under part one of the Alice two-part test (to determine whether claims are directed to patent-eligible subject matter) and the actual claimed invention was remarkable.  In the Court's view, there was no substantive difference between claim 1 and "Morse code, ordering food at a fast food restaurant via a numbering system, and Paul Revere's one if by land, two if by sea signaling system."  As many have noted, evaluating claims at such a high level does violence to the actual invention, which is the specific method recited by the claim.  Indeed, Enfish and McRo specifically warned against over-generalizing claims and reducing them to a subjective "gist" in part one of the Alice analysis.

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

    • "Recognicorp, LLC v. Nintendo Co. — Petition for En Banc Rehearing and Amicus Briefs," June 22, 2017
    • "Recognicorp — A Miscarriage of Justice Calling for En Banc Reconsideration," May 10, 2017
    • "Recognicorp, LLC v. Nintendo Co. (Fed. Cir. 2017)," May 1, 2017


    11.  Federal Circuit Eschews "Newly Characterized Antigen" Test for Antibodies

    In October, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies.  Perhaps the most significant portion of the opinion involved the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen.  The Federal Circuit determined that this instruction "is not legally sound and [] not based on any binding precedent," finding the instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  In setting forth its abrogation of the "fully characterized antigen" test more directly, the Federal Circuit declared that:

    [T]he "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

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

    • "Amgen Inc. v. Sanofi (Fed. Cir. 2017), November 19, 2017


    10.  Supreme Court to Decide Whether Board Must Address Every Claim Raised in IPR Petition

    In November, the Supreme Court heard oral argument in SAS Institute, Inc. v. Complementsoft, LLC (immediately after the Supreme Court heard oral argument in Oil States Energy Services, LLC. v. Greene's Energy Group, LLC — which, as most readers may surmise, will make a subsequent appearance on our top stories list for 2017).  As for SAS Institute, the case arose in litigation over a patent assigned to Complementsoft.  SAS filed its inter partes review petition on claims 1-16 of that patent, and the Board instituted as to claims 1 and 3-10 on obviousness grounds.  The PTAB found all instituted claims but claim 4 obvious and issued a final written decision on these claims.  SAS appealed, arguing that "the Board's final written decision is deficient for failing to address the patentability of all claims SAS included in its IPR petition, including those for which the Board did not institute IPR."  On appeal, the Federal Circuit held that the Board was not required to render a decision as to claims for which it did not institute the IPR, and that its decision in Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309 (Fed. Cir. 2016) was controlling.  At least one basis for the Federal Circuit's decision was the differences between the statutory language in 35 U.S.C. § 318(a), which recited "claims challenged by the petitioner," and the language in 35 U.S.C. § 314, in which the language "claims challenged in the petition" was used to describe the institution decision.  SAS's petition for certiorari set forth the following Question Presented:

    Whether 35 U.S.C. § 318(a), which provides that the Patent Trial and Appeal Board in an inter partes review "shall issue a final written decision with respect to the patentability of any patent claim challenged by the petitioner," requires that Board to issue a final written decision as to every claim challenged by the petitioner, or whether it allows that Board to issue a final written decision with respect to the patentability of only some of the patent claims challenged by the petitioner, as the U.S. Court of Appeals for the Federal Circuit held.

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

    • "Supreme Court Hears Argument in SAS Institute, Inc. v. Complementsoft, LLC," December 5, 2017

  • Top Stories of 2017: #15 to #19

    By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories.  For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Today, we count down stories #19 to #15, and then in the coming week, we will work our way towards the top stories of 2017.  As with our other lists (2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2017" on January 17, 2018 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.


    19.      PTAB Finds No CRISPR Interference

    CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015.  CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme.  Given the commercial potential of this method, patenting is an obvious concern and, as it turned out, more than one group of inventors filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications.  Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent had to be resolved via an interference.  In 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party.  In February of 2017, the Patent Trial and Appeal Board (PTAB) handed down its decision, finding no interference-in-fact between several patents and patent applications owned by The Broad Institute and applications owned by the Regents of the University of California, Berkeley.  The decision ended the interference without any prejudice to any of the claims corresponding to the interference count, allowing both parties to license (and assert) their patents to (or against) any third party.  The basis for the decision was that UC's claims would not anticipate the Broad's claims-in-interference because all of Broad's claims contained the affirmative limitation that the CRISPR technology be operative in eukaryotic cells, and the UC's claims were devoid of any limitation regarding the context in which CRISPR was applied.  In April, the University of California, Berkeley filed a Notice of Appeal at the Federal Circuit, challenging the decision, so the dispute could make a third straight trip to our list of top stories next year — the CRISPR patent dispute was #18 on last year's list.

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

    • "Berkeley Files Opening Brief in CRISPR Appeal," July 31, 2017
    • "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB," April 13, 2017
    • "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning," February 16, 2017
    • "PTAB Decides CRISPR Interference — No interference-in-fact," February 15, 2017


    18.  Unitary Patent and Unified Patent Court Timetable Revised

    After making it onto our 2012 and 2013 lists, the unitary patent and Unified Patent Court (UPC) initiatives took a three-year sabbatical from our top stories list.  In 2013, the Council of the European Union announced that twenty-four member states had signed the international agreement that would establish a Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents.  The signing of the Unified Patent Court Agreement (UPCA) initiated the process of ratification by national parliaments, with ratification requiring at least thirteen member states (including France, Germany, and the United Kingdom).  Ratification of the UPC agreement would then result in implementation of two EU regulations on the unitary patent.  Back in 2013, it was thought that ratification might not take place until 2015 or 2016, or perhaps even later in 2017 or 2018.  In January of 2017, the Preparatory Committee of the UPC released a revised timetable indicating that the Sunrise Period during which existing European Patents can be opted out of the jurisdiction of the UPC could start in September 2017 and the UPC could start accepting cases in December 2017 — provided that the UK and Germany ratified the UPCA, permitting it to come into effect.  While the UK announced its intention to proceed with ratification, the German Constitutional Court asked the German Federal President in June not to ratify the UPCA for the time being.  The Preparatory Committee confirmed at the time that the preliminary timetable set out earlier in the year was no longer achievable, and that the UPC would not begin to operate before the end of 2017.  This latest setback will likely delay the UPCA from coming into force until at least the spring of 2018.

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

    • "UK Progress on Unitary Patent (UP) and Unified Patent Court (UPC)," July 12, 2017
    • "German Constitutional Court Holds up German Ratification of Unitary Patent Court Agreement," June 13, 2017
    • "Revised Provisional Timetable for the Unitary Patent and Unified Patent Court," January 23, 2017


    17.  Federal Circuit to Hear Attorneys' Fees Case En Banc

    Patent applicants dissatisfied with final outcome of patent prosecution proceedings have long had two options for court review of a decision made by the U.S. Patent and Trademark Office's Patent and Trademark Appeal Board (PTAB):  an appeal to the Federal Circuit under 35 U.S.C. § 141 or a civil action in the Eastern District of Virginia under 35 U.S.C. § 145.  For over 175 years, applicants faced the same risk of paying the USPTO's fees in either proceeding.  But in June, a divided panel of the Federal Circuit affirmed in Nantkwest, Inc. v. Matal that the USPTO was entitled to recover attorneys' fees (and other expenses) regardless of the outcome of the case.  In August, however, the Federal Circuit issued a per curiam, sua sponte order that the question be heard en banc.  The order requested that the parties submit briefs addressing the following question:

    Did the panel in NantKwest, Inc. v. Matal, 860 F.3d 1352 (Fed. Cir. 2017) correctly determine that 35 U.S.C. § 145's "[a]ll the expenses of the proceedings" provision authorizes an award of the United States Patent and Trademark Office's attorneys' fees?

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

    • "My Health, Inc. v. ALR Technologies, Inc. (E.D. Tex. 2017)," December 26, 2017
    • "Federal Circuit Orders Rehearing En Banc in Nantkwest v. Matal," August 31, 2017
    • "Nantkwest, Inc. v. Matal (Fed. Cir. 2017)," June 27, 2017


    16.      Federal Circuit Again Limits Scope of CBM Review

    The Leahy-Smith America Invents Act (AIA) defines a covered business method (CBM) patent as "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions."  For the purpose of determining whether a CBM review is to be instituted, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) considers "whether the patent claims activities that are financial in nature, incidental to a financial activity, or complementary to a financial activity."  In 2016, in Unwired Planet, LLC v. Google Inc., the Federal Circuit resolved the issue, determining that the PTAB's "reliance on whether the patent claims activities incidental to or complementary to a financial activity as the legal standard to determine whether a patent is a CBM patent was not in accordance with law."  In February of 2017, in Secure Axcess, LLC v. PNC Bank National Association, the Federal Circuit again overturned a decision by the PTAB that a patent was eligible for CBM review.  In Secure Axcess, the Court determined that the statute requires that it is the claims, in the traditional patent law sense, properly understood in light of the written description, that identifies a CBM patent.  The Federal Circuit therefore determined that the Board had erred in deciding this case under its overly-broad statutory definition of a CBM patent, and thus vacated the Board's other determinations, including claim constructions and the Board's finding of obviousness.

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

    • "Securus Technologies, Inc. vs. Global Tel*Link Corp. (PTAB 2017)," September 5, 2017
    • "Cloud9 Technologies LLC v. IPC Systems, Inc. (PTAB 2017)," July 30, 2017
    • "Secure Axcess, LLC v. PNC Bank National Association (Fed. Cir. 2017)," February 28, 2017


    15.  Federal Circuit & PTAB "Loosen" Reins on Amendments in IPR Proceedings

    In March, the U.S. Patent and Trademark Office's Patent Trial and Appeals Board (PTAB) granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009).  As those in the patent community are well aware, this was an uncommon event.  As of 2016, the PTAB had reported in its Motion to Amend Study that only 6 motions to amend had been granted (or granted-in-part) — out of a total of 118 motions filed in 1539 instituted and completed AIA proceedings, which amounted to a positive outcome for the patent owner in 5% of the cases in which a motion was filed.  In October of 2017, in Aqua Products, Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB can no longer place the burden of establishing the patentability of amended claims on the patent owner in IPR proceedings.  There are those in the patent community that believe Aqua Products should result in more claim amendments surviving IPR proceedings, and that the decision may increase the possibility that more motions to amend will be filed.  In November, PTAB Chief Judge David P. Ruschke issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products," in which Judge Ruschke noted that patent owners must still meet the requirements for amending the claims as found in 37 C.F.R. § 42.121 (or § 42.211 for PGR proceedings), including only proposing a reasonable number of substitute claims, not enlarging the claim scope or introducing new matter, and making the claim amendments responsive to a ground of unpatentability involved in the trial.

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

    • "PTAB Motions to Amend Post-Aqua Products — Chief Judge Ruschke Issues Guidance," December 28, 2017
    • "Aqua Products, Inc. v. Matal (Fed. Cir. 2017)," October 4, 2017
    • "PTAB Update — Shire Has Rare Motion to Amend Granted," April 10, 2017

  • Conference & CLE Calendar

    CalendarJanuary 4, 2018 – "Patent Drafting for Machine Learning: Structural Claim Limitations, Avoiding 101 or 112 Rejections" (Strafford) – 1:00 to 2:30 pm (EST)

    January 9, 2018 – "After-Final Practice: Navigating PTO Options to Compact Patent Prosecution — Utilizing After-Final Consideration Pilot 2.0, Pre-Appeal Conference and More" (Strafford) – 1:00 to 2:30 pm (EST)

    January 9, 2018 – "Sequence Listings and Patent Applications" – 1:00 to 2:30 pm (ET)

    January 10, 2018 – "The Ramifications of TC Heartland and Recent Decisions About Venue in Patent Cases" (Federal Circuit Bar Association) – 1:00 pm to 2:15 pm (EST), Washington, DC

    January 11, 2018 – "Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    January 17, 2018 – "Top Patent Law Stories of 2017" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 17, 2018 – Customer Partnership Meeting of Technology Center 2600 (U.S. Patent and Trademark Office) – 8:30 am to 4:00 pm (ET)

    January 18, 2018 – "PTAB — A Year in Review" (Foley & Lardner) – 1:00 to 2:00 pm (CST)

    January 18, 2018 – "Strategic Use of Patent Reissue: Whether and When to Pursue a Reissue Application — Correcting Errors, Responding to an IPR Challenge and Mastering the Recapture Rule" (Strafford) – 1:00 to 2:30 pm (EST)

    January 18, 2018 – "IP Year in Review And Look Ahead" – Patent Research (LexisNexis) – 2:00 pm (ET)

    January 19, 2018 – "Paragraph IV Patent Certifications: Recent Legal and Regulatory Developments" (The Knowledge Group) – 12:00 to 1:30 pm (EST)

    January 25, 2018 – "IP Year in Review And Look Ahead" — Patent Prosecution (LexisNexis) – 2:00 pm (ET)

    January 29, 2018 – "IP Year in Review And Look Ahead" — Patent Drafting (LexisNexis) – 2:00 pm (ET)

    March 5-6, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Houston, TX

    March 8-9, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

  • FCBA Program on Ramifications of TC Heartland

    Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a program on "The Ramifications of TC Heartland and Recent Decisions About Venue in Patent Cases" on January 10, 2018 from 1:00 pm to 2:15 pm (EST) at the FCBA office in Washington, DC.  Andew R. Sommer of Winston & Strawn LLP will moderate a panel consisting of Gregory A. Castanias of Jones Day, Douglas A. Cawley of McKool Smith, Tara D. Elliot of WilmerHale, Richard Rainey of Covington, and Jen Yokoyama, Senior Counsel, Apple Inc.  The panel will explore the Supreme Court's decision in TC Heartland LLC v. Kraft Foods Group Brands and the Federal Circuit's decisions in In re Cray and In re Micron and how these decisions are shifting the patent litigation landscape.  The panel will also discuss the shift of cases out of Texas and the increase in filings in Delaware, and explore how practice before the district courts has changed in light of TC Heartland.

    The webinar is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members.  Those interested in registering for the webcast, can do so here.

  • Webinar on PTAB Developments

    Foley & LardnerFoley & Lardner will be offering a webinar entitled "PTAB — A Year in Review" on January 18, 2018 from 1:00 to 2:00 pm (CST).  George Beck, Andrew Cheslock, and Steve Maebius of Foley & Lardner LLP will discuss the year's major developments and how they may impact practice before the PTAB going forward, and address specific topics:

    • 2017 Trends and Statistics
    • SCOTUS on IPRs — including SAS Institute Inc. v. Joseph Matal and Oil States Energy Services LLC v. Greene's Energy Group, LLC
    •     PTAB Amendment Process — via Aqua Products v. Matal
    •     Trends in Pharmaceutical IPRs Filed by Generic Petitioners
    • PTAB Grants Rare Request for Additional Discovery in Mylan v. Allergan IPR
    • Sovereign Immunity

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • Webinar on Patent Reissue

    Strafford #1Strafford will be offering a webinar entitled "Strategic Use of Patent Reissue: Whether and When to Pursue a Reissue Application — Correcting Errors, Responding to an IPR Challenge and Mastering the Recapture Rule" on January 18, 2018 from 1:00 to 2:30 pm (EST).  Amelia Feulner Baur of McNeill Baur, and Thomas L. Irving and Jill K. MacAlpine of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with an in-depth review of the pros and cons of using reissue, offer their experiences, perspectives and best practices on the strategic use of patent reissue to correct errors.  The webinar will review the following issues:

    • When should counsel be considering the possibility of reissue?
    • How have the AIA changes impacted patent reissue?
    • What are the risks and limitations of using reissue proceedings to proactively resolve patent validity/unpatentability issues?
    • How should counsel try to factor the doctrine of reissue recapture into the decision to file a reissue application?

    The registration fee for the webcast is $297.  Those registering by January 5, 2018 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Webcast on Paragraph IV Patent Certifications

    The Knowledge GroupThe Knowledge Group will offer a webcast entitled "Paragraph IV Patent Certifications: Recent Legal and Regulatory Developments" on January 19, 2018 from 12:00 to 1:30 pm (EST).  Robyn Ast-Gmoser of Polsinelli and Jason A. Lief of Cooley LLP will provide an in-depth discussion of recent Paragraph IV patent certification developments and trends, and also offer best practices while ensuring compliance with applicable laws.  Key topics to be addressed by the webcast include:

    • Use of Citizen Petition by brands
    • Blocking patents and impact on commercial success findings
    • Recent disputes regarding 180-day exclusivity
    • TC Heartland and patent venue in Hatch Waxman cases
    • IPRs and Hatch Waxman cases — based upon a personal experience
    • General discussion of the role of experts in Hatch Waxman cases and several war stories related thereto

    The registration fee for the webcast is $99.  Those interested in registering for the webinar can do so here.  Additional information regarding the webinar can be found here.

  • IP Year in Review Webinar Series

    LexisNexisLexisNexis will be offering a webinar series entitled "IP Year in Review And Look Ahead" on January 18, 25, and 29, 2018 at 2:00 pm (ET).  The series provide highlights over the past year, trends emerging for 2018, and use cases for success on the following topics:

    • Patent Research — January 18
    • Patent Prosecution — January 25
    • Patent Drafting — January 29

    Those interested in registering for any of the webinars in the series, can do so here.

  • PTAB Motions to Amend Post-Aqua Products — Chief Judge Ruschke Issues Guidance

    By Andrew Williams —

    USPTO SealOn November 21, 2017, PTAB Chief Judge Ruschke issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products."  As we reported at the time, the Federal Circuit in Aqua Products determined that the PTAB can no longer place the burden of establishing the patentability of amended claims on the patent owner in IPR proceedings.  However, that en banc Court was highly fractured, with five separate opinions joined by differing collections of judges.  Therefore, most of the opinion could be described as "cogitations," as Judge O'Malley had put it.  In fact, the Aqua Products decision only contained two legal conclusions:

    • "[T]he PTO has not adopted a rule placing the burden of persuasion with respect to the patentability of amended claims on the patent owner that is entitled to deference"; and

    • "[I]n the absence of anything that might be entitled to deference, the PTO may not place that burden on the patentee."

    Correspondingly, Chief Judge Ruschke's guidance flowing from these conclusions was that "the Board will not place the burden of persuasion on a patent owner with respect to the patentability of substitute claims presented in a motion to amend."

    Of course, the more important question was how this change would be implemented by the Board.  Interestingly, the guidance suggests that, other than the fact that motions to amend will now be granted when the "entirety of the evidence of record before the Board in in equipoise as to the unpatentability of one or more substitute claims," "practice and procedure before the Board will not change."  Therefore, a patent owner must still meet the requirements for amending the claims as found in 37 C.F.R. § 42.121 (or § 42.211 for PGR proceedings), including only proposing a reasonable number of substitute claims, not enlarging the claim scope or introducing new matter, and making the claim amendments responsive to a ground of unpatentability involved in the trial.  Moreover, the Chief Judge reminded patent owners (as well as petitioners) that they have a duty of candor and good faith to the Office during the proceedings, pursuant to 37 C.F.R. § 42.11.  Correspondingly, patent owners have a duty to disclose information of which they are aware that would be material to the patentability of any substitute claims.

    With regard to how motions to amend will be handled procedurally, Chief Judge Ruschke also indicated that nothing will change.  Therefore, the rules regarding types, timing, and page limits for briefs will not change.  In addition, the standard Scheduling Order will continue to provide that patent owners may file motions to amend on Due Date 1.  And not surprisingly, patent owners are still required to confer with the Board before filing a motion to amend as provided by 37 C.F.R. §§ 42.121(a), 42.221(a).

    So what about situations in which trial has already been instituted?  If the proceeding is still before Due Date 1, nothing will really change, although patent owners are advised to contact the Board if they have any questions on briefing.  If Due Date 1 has past and a patent owner wishes to introduce new or substitute claims, they are urged to "contact the Board to arrange a conference call as soon as reasonable possible."  Of course, it is unclear how successful a patent owner will be in such situations, but certainly the closer the date is to Due Date 1, the better the chances will most likely be.  Finally, in cases in which a motion to amend is pending, Chief Judge Ruschke advises parties to contact the Board to arrange a conference call should they have any need to discuss the impact of the Aqua Products decision.  In fact, he indicated that the Board has already contacted such parties, and will continue to do so, to let them know that a request for conference call if desired is appropriate.  During this call, the parties are permitted to request changes to the briefing schedule, and the Board will generally permit supplemental briefing to address patentability of substitute claims if requested.

    We will continue to monitor the PTAB for how the Aqua Products case has impacted motion-to-amend practice, and whether that decision resulted in any significant change for patent owners, and we will provide updates as warranted.

  • PTAB Life Sciences Report

    By John Cravero —

    USPTO SealAbout the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

    Visionsense Corp. v. Novadaq Technologies, Inc.

    PTAB Petition:  IPR2017-01426; filed May 11, 2017.

    Institution of Inter Partes Review; entered November 16, 2017.

    Patent at Issue:  U.S. Patent No. 8,892,190 ("Method and apparatus for performing intra-operative angiography," issued November 18, 2014) claims a method for assessing blood flow moving through a vessel graft anastomosed in fluid communication with an interconnected group of blood vessels in an animal, the vessel graft and at least a portion of the blood vessels being exposed during a surgical procedure on the animal, the method comprising the steps of: (a) administering a fluorescent dye to the animal such that the dye enters the vessel graft and the interconnected group of blood vessels; (b) exciting the fluorescent dye within the vessel graft and said exposed portion of the interconnected group of blood vessels with a source of illumination, thus causing the dye to emit radiation; (c) capturing the radiation emitted by the fluorescent dye with a camera capable of imaging a series of angiographic images within the vessel graft and said exposed portion of the interconnected group of blood vessels, the images including at least an image of a fluorescent wavefront corresponding to an interface between the flowing blood that first contains the fluorescent dye introduced, such image being captured by the camera as the fluorescent wavefront transitions through the exposed vessel graft and interconnected croup of blood vessels; and (d) evaluating the angiographic images to assess blood flow through the vessel graft relative to blood flow through the interconnected group of blood vessels.

    Petitioner Visionsense Corp. is challenging the '190 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2, 3, and 4).  View the petition here.  Administrative Patent Judges Hyun J. Jung (author), Michael L. Woods, and Amanda F. Wieker issued a decision instituting inter partes review of whether claims 1–3 are unpatentable under 35 U.S.C. § 103(a) over Little, Flower I, and Flower II; whether claims 1–3 are unpatentable under 35 U.S.C. § 103(a) over Flower I, Flower II, and Little or Goldstein; and whether claims 1–3 are unpatentable under 35 U.S.C. § 103(a) over Jibu, Flower I, and Little or Goldstein.

    Related Matters:  According to the petition, the '190 patent is not involved in any litigation matters.


    FlatWing Pharmaceuticals, LLC. v. Anacor Pharmaceuticals, Inc.

    PTAB Petition:  IPR2018-00168; filed November 21, 2017.

    Patent at Issue:  U.S. Patent No. 9,549,938 ("Boron-containing small molecules," issued January 24, 2017) claims a method of treating a Tinea unguium infection of a toenail of a human, the method comprising: topically administering to the toenail of the human a pharmaceutical composition comprising 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof in an amount sufficient to treat the infection.

    Petitioners FlatWing Pharmaceuticals, LLC, Ragneesh Ahuja, and Wicker Pharmaceuticals, LLC are challenging the '938 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed several other inter partes review petitions on related patents, including:  IPR2018-00169 (U.S. Patent No. 9,566,289; filed 11/21/2017; pending), IPR2018-00170 (U.S. Patent No. 9,566,290; filed 11/21/2017; pending), and IPR2018j-00171 (U.S. Patent No. 9,572,823; filed 11/21/2017; pending).


    FlatWing Pharmaceuticals, LLC. v. Anacor Pharmaceuticals, Inc.

    PTAB Petition:  IPR2018-00169; filed November 21, 2017.

    Patent at Issue:  U.S. Patent No. 9,566,289 ("Boron-containing small molecules," issued February 14, 2017) claims a pharmaceutical formulation, comprising: 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable topical carrier.

    Petitioners FlatWing Pharmaceuticals, LLC, Ragneesh Ahuja, and Wicker Pharmaceuticals, LLC are challenging the '289 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed several other inter partes review petitions on related patents, including:  IPR2018-00168 (U.S. Patent No. 9,549,938; filed 11/21/2017; pending), IPR2018-00170 (U.S. Patent No. 9,566,290; filed 11/21/2017; pending), and IPR2018j-00171 (U.S. Patent No. 9,572,823; filed 11/21/2017; pending).


    FlatWing Pharmaceuticals, LLC. v. Anacor Pharmaceuticals, Inc.

    PTAB Petition:  IPR2018-00170; filed November 21, 2017.

    Patent at Issue:  U.S. Patent No. 9,566,290 ("Boron-containing small molecules," issued February 14, 2017) claims a method of treating a human having onychomycosis of a toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising: topically administering to the toenail a pharmaceutical composition comprising an amount of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the Trichophyton rubrum or Trichophyton mentagrophytes.

    Petitioners FlatWing Pharmaceuticals, LLC, Ragneesh Ahuja, and Wicker Pharmaceuticals, LLC are challenging the '290 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed several other inter partes review petitions on related patents, including:  IPR2018-00168 (U.S. Patent No. 9,549,938; filed 11/21/2017; pending), IPR2018-00169 (U.S. Patent No. 9,566,289; filed 11/21/2017; pending), and IPR2018j-00171 (U.S. Patent No. 9,572,823; filed 11/21/2017; pending).


    FlatWing Pharmaceuticals, LLC. v. Anacor Pharmaceuticals, Inc.

    PTAB Petition:  IPR2018-00171; filed November 21, 2017.

    Patent at Issue:  U.S. Patent No. 9,572,823 ("Boron-containing small molecules," issued February 21, 2017) claims 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 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, thereby treating onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.

    Petitioners FlatWing Pharmaceuticals, LLC, Ragneesh Ahuja, and Wicker Pharmaceuticals, LLC are challenging the '823 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed several other inter partes review petitions on related patents, including:  IPR2018-00168 (U.S. Patent No. 9,549,938; filed 11/21/2017; pending), IPR2018-00169 (U.S. Patent No. 9,566,289; filed 11/21/2017; pending), and IPR2018-00170 (U.S. Patent No. 9,566,290; filed 11/21/2017; pending).


    Taro Pharmaceuticals USA, Inc. v. ApoPharma, Inc.

    PTAB Petition:  IPR2017-01446; filed May 17, 2017.

    Instituted of Inter Partes Review; entered November 28, 2017.

    Patent at Issue:  U.S. Patent No. 7,049,328 ("Use for deferiprone," issued May 23, 2006) claims a method of treating iron induced cardiac disease in a blood transfusion dependent patient experiencing an iron overload condition of the heart, said method comprising administering to the patient a therapeutically effective amount of deferiprone or a physiologically acceptable salt thereof sufficient to stabilize/reduce iron accumulation in the heart resulting from being transfusion dependent.

    Petitioners Taro Pharmaceuticals and Sun Pharmaceuticals are challenging the '328 patent on ten grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1-5) or as obvious under 35 U.S.C. § 103(a) (grounds 6-10).  View the petition here.  Administrative Patent Judges Lora M. Green, Jeffrey N. Fredman (author), and Zhenyu Yangs issued a decision instituting inter partes review of whether claims 1, 2, 4-11, 13-17, and 19 are unpatentable under 35 U.S.C. § 102(b) over Hoffbrand; whether claims 1, 2, 4-11, 13-17, and 19 are unpatentable under 35 U.S.C. § 102(b) over the Olivieri Abstract; whether claims 1, 2, 4-11, 13-17, and 19 are unpatentable under 35 U.S.C. § 102(b) over Olivieri; whether claims 1, 2, 4-17, and 19 are unpatentable under 35 U.S.C. § 103(a) over Hoffbrand; whether claims 1, 2, 4-17, and 19 are unpatentable under 35 U.S.C. § 103(a) over the Olivieri abstract; and whether claims 1, 2, 4-17, and 19 are unpatentable under 35 U.S.C. § 103(a) over Olivieri.

    Related Matters:  According to the petition, the '328 patent is the subject of the following civil litigation:  ApoPharma Inc. v. Taro Pharmaceutical Industries, Ltd., No. 2:16-cv-00528 (E.D. Texas).