• The Art of Dealing with Uncertainty

    Do you sometimes feel unsure of yourself when speaking to a client or making a presentation?   Anyone who answered no is not being honest.   We all feel insecure at certain times; that is human.   It is impossible to know everything or anticipate every possible question.  You can be more effective with clients and colleagues if you follow a few simple rules when dealing with situations where you are not 100% certain.

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  • USPTO Patent Quality Chat Webinar Series

    The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on November 14, 2017. The latest webinar, entitled “How is an Examiner’s Work Product Reviewed?” will be hosted by Sandie Spyrou, Supervisor, Office of Patent Quality Assurance, and Christyann Pulliam, Supervisor, Technology Center 2100, who will discuss how quality fits in to a patent examiner’s performance appraisal plan and how the Office of Patent Quality Assurance (OPQA) reviews and provides feedback to examiners. Instructions for viewing the webinar can be found here. Additional information regarding…

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  • Webcast on Overcoming §103 Rejections for Biotech and Chemical Patents

    Strafford will be offering a webcast entitled “Overcoming §103 Rejections for Biotech and Chemical Patents: Recent Decisions and USPTO Guidance” on November 16, 2017 from 1:00 to 2:30 pm (EST). Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Amelia Feulner Baur of McNeill Baur, and Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel for overcoming §103 rejections for biotech and chemical patents, and review recent judicial and PTAB case law and offer insights to address §103 rejections. The webinar will review the following issues: • What evidentiary support should counsel…

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  • Webinar on CRISPR

    Technology Transfer Tactics will be offering a webinar entitled “CRISPR Confusion: A Legal and Practical Analysis for IP Professionals” on November 14, 2017 from 11:00 am to 12:00 pm (ET). Patents Docs author Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will cover the following topics: • A brief overview of the technology • A review of the patent positions of the parties • A discussion of the arguments raised in the Interference • An assessment of the PTAB’s decision and its effect on the patents and applications • Analysis of strategies for further appeal • Impact on…

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  • CAFC affirms D. Del. in Sanofi v. Watson related to generic Multaq®

    The outcome in Sanofi v. Watson:

    After a three-day bench trial, the district court ruled
    in crucial respects for Sanofi. Sanofi v. Glenmark Pharm.
    Inc., USA, 204 F. Supp. 3d 665, 704–705 (D. Del. 2016).
    As to the ’167 patent, the court made the following rulings
    of relevance here: Sanofi proved that Watson’s and
    Sandoz’s sale of their proposed generic drugs, with their
    proposed labels, would induce physicians to infringe all
    but one of the asserted claims, id. at 673–84; and Watson
    and Sandoz did not prove that any of the asserted claims
    were invalid for obviousness, id. at 685–96. As to the ’800
    patent, the district court, rejecting the non-infringement
    argument made by Watson and Sandoz, concluded that
    the asserted claims do not exclude compositions contain-
    ing polysorbate surfactants. Id. at 699–704. The district
    court then entered a final judgment rejecting the obvious-
    ness challenge to claims 1–6, 8–13, and 16 of the ’167
    patent; finding inducement of infringement, by both
    defendants, of all of those claims except claim 5; and
    finding infringement by both defendants of claims 1–3, 5-
    9, and 12–15 of the ’800 patent and by Watson of claims
    10 and 11 as well.

    Watson and Sandoz appeal. We have jurisdiction un-
    der 28 U.S.C. § 1295(a)(1). We affirm.

    The issues presented to the CAFC:

    Watson and Sandoz challenge the district court’s in-
    ducement finding as to the ’167 patent, the district court’s
    rejection of their obviousness challenge to that patent,
    and the district court’s rejection of their prosecution-
    disclaimer argument for limiting the scope of the ’800
    patent claims.

    As to inducement:

    The dispute in this case involves an aspect of the con-
    nection between the marketing and the medical providers’
    infringement that is different from the two knowledge
    requirements and is inherent in the word “induce” as it
    has been understood in this area. The Supreme Court
    stated the following in Global-Tech:
    The term “induce” means “[t]o lead on; to influ-
    ence; to prevail on; to move by persuasion or in-
    fluence.” Webster’s New International Dictionary
    1269 (2d ed. 1945). The addition of the adverb ‘ac-
    tively’ suggests that the inducement must involve
    the taking of affirmative steps to bring about the
    desired result, see id., at 27.
    563 U.S. at 760 (brackets in original). The purposeful-
    causation connotation of that language is reinforced by
    the Court’s statement: “When a person actively induces
    another to take some action, the inducer obviously knows
    the action that he or she wishes to bring about.” Id.


    When proof of intent to encourage de-
    pends on the label accompanying the marketing of a drug,
    “[t]he label must encourage, recommend, or promote
    infringement.” Takeda Pharm. USA, Inc. v. West-Ward
    Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015) (cita-
    tions omitted).


    We review the district court’s finding of inducement
    based on encouragement and inferred intent for clear
    error. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042,
    1056 (Fed. Cir. 2010). We find no such error. The label
    itself has a short “Indications and Usage” section, one
    sentence long. It states what dronedarone is indicated
    for: it “is indicated to reduce the risk of hospitalization for
    atrial fibrillation.” J.A. 7609; see J.A. 7784.


    Watson and Sandoz contend that, because Multaq®
    has substantial noninfringing uses not forbidden by the
    proposed labels, Sanofi, 204 F. Supp. 3d at 684, the dis-
    trict court could not permissibly find intent to encourage
    an infringing use. But there is no legal or logical basis for
    the suggested limitation on inducement. Section 271(b),
    on inducement, does not contain the “substantial nonin-
    fringing use” restriction of section 271(c), on contributory
    infringement. And the core holding of Grokster, a copy-
    right decision that drew expressly on patent and other
    inducement law, is precisely that a person can be liable
    for inducing an infringing use of a product even if the
    product has substantial noninfringing uses (like the peer-
    to-peer software product at issue there, which was capa-
    ble of infringing and non-infringing uses). 545 U.S. at
    934–37. There is no basis for a different inducement rule
    for drug labels.

    As to obviousness:

    Watson and Sandoz accept the legal framework under
    which they had to establish that, as of February 2008, a
    person of ordinary skill in the art would have had a
    reasonable expectation that the processes claimed would
    succeed in their (claimed) aims, a factual issue. Cumber-
    land Pharm. Inc. v. Mylan Institutional LLC, 846 F.3d
    1213, 1221–23 (Fed. Cir. 2017); PharmaStem Therapeu-
    tics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed. Cir.
    2007). On appeal, Watson and Sandoz make no argument
    as to obviousness independent of their challenge to the
    district court’s finding of no such expectation. We reject
    the contention that the district court adopted an incorrect
    legal standard on the issue, and we are unpersuaded that
    the district court was clearly erroneous in determining
    that Watson and Sandoz failed to prove the required
    reasonable expectation. Based on those conclusions, we
    affirm the nonobviousness judgment.


    Watson and Sandoz’s appeal on obviousness thus ul-
    timately rests on the contention that the district court’s
    finding under the standard was clearly erroneous. We
    conclude that it was not. Although the evidence might
    well have supported the opposite finding, we cannot
    conclude that the district court clearly erred in its finding
    that Watson and Sandoz did not carry their burden of
    showing that a person of ordinary skill in the art in
    February 2008 would have had a reasonable expectation
    that dronedarone would succeed in reducing cardiovascu-
    lar hospitalization in the ATHENA patient population.


    district court credited Dr. Reiffel’s testimony, explaining
    why. Sanofi, 204 F. Supp. 3d at 692–95. We have been
    furnished no basis on which to say, in light of the other
    evidence in the case, that the district court clearly erred
    in doing so. See Senju Pharm. Co. v. Lupin Ltd., 780 F.3d
    1337, 1351 (Fed. Cir. 2015) (stressing need for exceptional
    evidentiary reasons for appellate court not to defer to trial
    court’s determination to credit expert testimony about
    what prior art taught). This is not a case like Phar-
    maStem, in which the expert testimony about prior-art
    references was rejected because the testimony could not
    “be reconciled with statements made by the inventors in
    the [patent] specification and with the prior art references
    491 F.3d at 1361; id. at 1361–63.

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