• Inequitable Conduct Renders ’993 Patent Unenforceable

    In Energy Heating v. Heat On-The-Fly, the court did not abuse its discretion in finding clear and convincing evidence that the inventor knew that the prior uses were material and specifically intended to deceive the PTO by not disclosing them. The court had sufficient evidence – including evidence of 61 commercial sales dating back to 2006 and no contemporaneous evidence of experimentation – to disbelieve Mr. Hefley’s testimony to the contrary.

    The post Inequitable Conduct Renders ’993 Patent…

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  • WesternGeco’s Time-Bar Argument Fails to Save its Invalidated Patents

    On appeal, WesternGeco argued 1) the Board erred as to its unpatentability determinations; and 2) the IPR proceedings were time-barred under 35 U.S.C. § 315(b) because ION acted in privity with PGS, and over a year passed between its infringement complaint against ION and the PGS IPR petition. Based on the Federal Circuit’s en banc decision known as Wi-Fi One, the time-bar issue was appealable, but WesternGeco’s argument was unpersuasive because the relationship between ION and PGS was not…

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  • Webinar on Implications of Oil States and SAS

    Strafford will be offering a webinar entitled “Oil States and SAS: Implications of the Supreme Court’s Decisions for Patent Practice” on May 31, 2018 from 1:00 to 2:30 pm (EDT). Thomas L. Irving, Amanda K. Murphy, and Barbara R. Rudolph of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on two recent Supreme Court patent decisions. The panel will provide an analysis of the Court’s Oil States and SAS decisions and discuss the impact of these decisions on daily patent practice. The webinar will review the following issues: • Has there been an increase in IPR…

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  • Webinar on Divided Infringement

    Strafford will be offering a webinar entitled “Divided Infringement after Travel Sentry v. Tropp: Direct Infringement Liability for Third-Party Conduct” on May 24, 2018 from 1:00 to 2:30 pm (EDT). Thomas L. Irving, Paul W. Browning, and Barbara R. Rudo…

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  • Plagiarism in a high school yearbook in Pensacola?

    From the Pensacola News Journal article titled Escambia High rewrites yearbook page on school’s racial history, claims student plagiarized :

    Escambia High School administrators removed and rewrote a page from this year’s student yearbook that contained information about the school’s origin and race-related issues, claiming the student who wrote the page plagiarized information from the internet.

    But the student, 18-year-old yearbook co-editor Sasha Slack, believes the school rewrote the page because they are “trying to change the history of Escambia High School because they’re too ashamed to admit that our school was founded as an all-white school.”

    In the 60th anniversary edition of the yearbook, Slack wrote about the school’s pre-segregated era and the on-campus race riots of 1976. The senior said she researched multiple websites and wrote a long paragraph titled “Escambia’s Past” in her own words, which the school claims to be false. [emphasis added]

    (…)

    Murphy said that ultimately, he did not want Slack’s original writing to reflect poorly on the school.

    “I just feel that we cannot allowed plagiarized work to be presented in a journalism class,” Murphy said. “That is the issue here. That’s the only issue here, is the plagiarism.” [emphasis added]

    There are several issues here

    was there plagiarism? [copying without attribution]

    if no plagiarism, was the motivation of the school an unfavorable portrayal in the yearbook? Was the portrayal false?

    was the plagiarism claim a pretextual makeweight argument or a reasonable response to a concern about bad journalism?

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  • Rensselaer Polytechnic Institute sues Amazon in ND NY over US Patent 7,177,798

    The co-plaintiff is the exclusive licensee Dynamic Advances, a Delaware corporation whose principal
    place of business is located at 1345 Avenue of the Americas, 46th Floor, New York, NY.

    Paragraph 41 of the complaint refers to patent citation:

    The ’798 Patent has been repeatedly cited in subsequent patent
    applications filed by leading technology companies. The ’798 Patent, its published
    application, or other patents within the same family, have been cited in patent
    applications filed by Hewlett-Packard, Microsoft, IBM, Sony, Google, and Apple.

    Complaint available at:
    https://regmedia.co.uk/2018/05/11/alexapatentcomplaint.pdf

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  • 規模

                            目次はこちら

    規模

    (SCALE)
    $$ A single chip can thus be provided that comprises an integrated detection device with on-chip processing of the picoamp scale currents o…

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  • Altaire wins on evidentiary issues at CAFC; a split vote on standing, and injury-in-fact

    The case is nominally an appeal of a PTAB decision:


    Appellant Altaire Pharmaceuticals, Inc. (“Altaire”)
    sought post-grant review of claims 1–13 (“the Asserted
    Claims”) of Appellee Paragon Bioteck, Inc.’s (“Paragon”)
    U.S. Patent No. 8,859,623 (“the ’623 patent”). The U.S.
    Patent and Trademark Office’s Patent Trial and Appeal
    Board (“PTAB”) issued a final written decision determining
    that Altaire failed to prove that the Asserted Claims
    were unpatentable for obviousness over two production
    lots of Altaire’s phenylephrine hydrochloride ophthalmic
    solution products, Lots #11578 and #11581,

    There is much more going on here; from the dissent:


    The undisputed facts are these: In 2011, Altaire and
    Paragon entered into an agreement to pursue U.S. Food
    and Drug Administration (“FDA”) approval for Altaire’s
    phenylephrine hydrochloride products (the “Agreement”).
    By its terms, the Agreement terminates on May 30, 2021.
    See Joint Appendix (“J.A.”) 1909. Subsequently, a dispute
    arose between the parties, which apparently led Altaire to
    file two lawsuits in federal court in the Eastern District of
    New York. In the first suit, Altaire Pharmaceuticals, Inc.
    v. Paragon BioTeck, Inc., Case No. 2:15-cv-02416
    (E.D.N.Y.) (“the breach of contract suit”), Altaire alleges
    that Paragon breached the Agreement by, among other
    things, disclosing Altaire’s confidential and proprietary
    product information in its patent application and in its
    resulting U.S. Patent No. 8,859,623 (“the ’623 patent”).
    See Complaint and Jury Demand at 7 (No. 2:15-cv-02416)
    (E.D.N.Y. April 28, 2015). P

    BUT the issues decided are evidentiary in nature.

    There was an initial standing issue, which was a basis for the dissent
    opinion; the majority noted:


    We recently “established the legal standard for
    demonstrating standing in an appeal from a final agency
    action,” including “the burden of production[,] the evidence
    an appellant must produce to meet that burden[,]
    and when an appellant must produce that evidence.”
    Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172
    (Fed. Cir. 2017) (footnote omitted). We explained that
    “[a]n appellant’s obligation to establish injury in fact
    remains firm even though it need not meet all the normal
    standards for redressability and immediacy when, as
    here, a statute provides that appellant with a right to
    appeal.” Id. at 1172 n.2 (internal quotation marks and
    citation omitted); see 35 U.S.C. § 141(c).

    (…)

    While we recognize that “[a] claim is not ripe for adjudication
    if it rests upon contingent future events that may
    not occur as anticipated, or indeed may not occur at all,”
    Texas v. United States, 523 U.S. 296, 300 (1998) (internal
    quotation marks and citation omitted), we conclude that,
    under these circumstances, Altaire’s injury is inevitable.
    Therefore, Altaire has satisfied its burden of production
    by producing sufficient evidence that the threat of infringement
    litigation is an injury that is “real” and “imminent.”
    Prasco, 537 F.3d at 1339.

    Having determined that Altaire faces imminent injury,
    we next must determine whether that injury is concrete
    and particularized. See Spokeo, 136 S. Ct. at 1548
    (“Particularization is necessary to establish injury in
    fact . . . .”); id. (“Concreteness . . . is quite different from
    particularization.”).

    Graver Tank is cited:


    First, § 42.65(b) does not require that the affidavit
    corroborating the technical test or data be submitted by
    an expert. Cf. Graver Tank & Mfg. Co. v. Linde Air
    Prods. Co., 339 U.S. 605, 609 (1950) (stating that, in the
    context of the doctrine of equivalents, “[p]roof can be
    made in any form,” including “through testimony of
    experts or others versed in the technology” (emphasis
    added)).

    Of evidentiary issues:


    Although the PTAB “has broad discretion to regulate
    the presentation of evidence,” Belden, 805 F.3d at 1081,
    that discretion is not without limits, see Ultratec, Inc. v.
    CaptionCall, LLC, 872 F.3d 1267, 1274 (Fed. Cir. 2017)
    (stating that “[t]he agency does not have unfettered
    discretion in [evidentiary] matters”). The PTAB’s decision
    to assign no weight to Mr. Al Sawaya’s testimony was an
    abuse of discretion. See id. at 1275 (holding that the
    PTAB “abused its discretion when it refused to admit and
    consider . . . trial testimony”); cf. Aqua Prods., Inc. v.
    Matal, 872 F.3d 1290, 1325 (Fed. Cir. 2017) (en banc)
    (plurality opinion) (“[A]n agency’s refusal to consider
    evidence bearing on the issue before it is, by definition,
    arbitrary and capricious within the meaning of 5 U.S.C.
    § 706, which governs review of agency adjudications.
    That means that the agency must take account of all the
    evidence of record, including that which detracts from the
    conclusion the agency ultimately reaches.” (citations
    omitted)).
    (…)
    On remand, the PTAB must consider Mr. Al Sawaya’s testimony when
    evaluating the reliability of the TMQC-247 and optical
    rotation test data.

    As to evidence in a reply:


    After Paragon unexpectedly challenged Altaire’s
    TMQC-247 test data for failure to comply with § 42.65(b)
    in its Patent Owner Response, see J.A. 1112–15, Altaire
    submitted its Reply, appending additional information on
    the TMQC-247 test, see J.A. 1418–25, 1505–606. This
    included Exhibits 1027 and 1028. See J.A. 1505–32.
    Similar to the Second Al Sawaya Declaration, Altaire
    properly “respond[ed] to [those] arguments raised in
    [Paragon’s Patent Owner R]esponse” by submitting additional
    evidence demonstrating the reliability of the
    TMQC-247 testing method. 37 C.F.R. § 42.23(b); see 5
    U.S.C. § 556(d); see also Belden, 805 F.3d at 1078. To the
    extent Paragon wished to contest this additional evidence,
    the PTAB could have permitted Paragon to file a surreply.
    See Belden, 805 at 1081.
    In light of Paragon’s past reliance on the TMQC-247
    test data, we conclude that the PTAB abused its discretion
    by “refus[ing] to consider evidence” regarding the
    reliability of the TMQC-247 testing method. Aqua, 872
    F.3d at 1325 (citation omitted); see Ultratec, 872 F.3d at
    1275. On remand, the PTAB shall consider all relevant
    TMQC-247 information in determining whether Altaire
    satisfied the requirements of § 42.65(b) and, if it did,
    whether the TMQC-247 test data render obvious the
    Asserted Claims.

    Some odd arguments:

    Finally, regarding the optical rotation test, the PTAB
    determined that Paragon “presented sufficient evidence to
    challenge the accuracy of estimating enantiomer purity
    based on the specific rotation,” such that it “[was] not
    persuaded that [Altaire]’s optical-rotation data amount to
    a preponderance of the evidence to show that Altaire’s
    [p]roduct[s] meet[] the chiral-purity limitations of the
    [Asserted C]laims.”
    J.A. 19, 20. As with the TMQC-247
    test data, Paragon relied upon this optical rotation test
    data before the FDA. See J.A. 783–91. Indeed, the ’623
    patent itself recognizes that the optical rotation test can
    be used to determine chiral purity.
    See ’623 patent col. 4
    ll. 33–34.

    Nevertheless, the PTAB rejected the data, stating
    that, “for the optical rotation data, as for the [TMQC-247]
    data, [Altaire] has not provided any affidavit in compliance
    with . . . § 42.65(b).” J.A. 19. However, as explained
    above, see supra Section II.B–C, the PTAB abused its
    discretion by refusing to consider Mr. Al Sawaya’s testimony
    and the additional information on the TMQC-247
    test data. To the extent the PTAB’s decision to reject as
    unpersuasive the optical rotation test data rested upon
    these erroneous determinations, the PTAB must reconsider
    the reliability of the optical rotation test data pursuant
    to § 42.65(b) on remand.

    The dissent as to standing:


    I start from the premise that the standing issue in
    this case turns entirely on the pending litigation in the
    Eastern District of New York. I say that because, although
    both Altaire and the majority point to the Agreement’s
    2021 termination date, Appellant’s Br. 47–48,
    Majority Op. at 12, I am unable to see how the fact that
    the Agreement is scheduled to terminate in 2021 supports
    standing at this point. Put most simply, what we have is
    a situation in which the parties to a contract that is due to
    terminate in approximately three years are in a dispute.
    At the same time, in view of the terms of the Agreement,
    Altaire cannot infringe the ’623 patent while the Agreement
    is in effect. These circumstances, it seems to me,
    come nowhere near providing Altaire with grounds for
    claiming that it is subject to imminent harm. Timing is
    important for a showing of imminence, or immediacy.

    The longer the time between when suit is initiated and
    when potential infringement may occur, “the more likely
    the case lacks the requisite immediacy.” Sierra Applied
    Scis., Inc. v. Advanced Energy Indus., Inc., 363 F.3d 1361,
    1379 (Fed. Cir. 2004).

    ***In passing, this is a case about enantiomers.

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  • AIDS HEALTHCARE FOUNDATION loses appeal at CAFC

    An attempt by AIDS HEALTHCARE FOUNDATION at a DJ against Gilead failed:


    Healthcare argued that in view of the lengthy time
    consumed by litigating patent validity, such litigation
    needed to start well in advance of expiration of the fiveyear
    exclusivity period. See, e.g., AHF Br. 5; Dist. Ct. Op.
    at *4–5. Healthcare filed this declaratory action in January
    2016, two months after the FDA approved Genvoya®—the
    first TAF-containing product to receive FDA
    approval.

    The outcome


    This appeal is from the dismissal of a declaratory
    judgment action filed by AIDS Healthcare Foundation,
    Inc. (“Healthcare” or “AHF”) against Gilead Sciences, Inc.
    et al. (“Defendants”) in the United States District Court
    for the Northern District of California.1 On appellate
    review, we conclude that this action does not meet the
    requirements of the Declaratory Judgment Act.

    The CAFC began its discussion:

    Exercise of the Constitution’s judicial power is limited
    to actual cases and immediate controversies. Muskrat v.
    United States, 219 U.S. 346, 356 (1911). When this constitutional
    requirement is not met, a court has no authority
    to decide the issues presented, whatever the
    “convenience and efficiency” of such judicial action.
    Hollingsworth v. Perry, 133 S. Ct. 2652, 2661 (2013)
    (quoting Raines v. Byrd, 521 U.S. 811, 820 (1997)); see
    Muskrat, 219 U.S. at 356 (“[U]nless [the exercise of the
    judicial power] is asserted in a case or controversy within
    the meaning of the Constitution, the power to exercise it
    is nowhere conferred.”).

    Some of the issues in this case


    The existence of a patent, without more, does not create
    a case of actual controversy. See Prasco, LLC v.
    Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed. Cir.
    2008) (“[J]urisdiction generally will not arise merely on
    the basis that a party learns of the existence of a patent
    owned by another or even perceives such a patent to pose
    a risk of infringement, without some affirmative act by
    the patentee.” (quoting SanDisk Corp. v. STMicroelectronics,
    Inc., 480 F.3d 1372, 1380–81 (Fed. Cir. 2007))).

    Healthcare presents several additional arguments for
    declaratory jurisdiction, including that (1) Healthcare is
    an indirect infringer of the TAF patents based on its
    requests to potential producers to provide the patented
    products; (2) Gilead’s non-response to Healthcare’s request
    for a covenant not to sue created a present controversy;
    and (3) public policy favors invalidation of invalid
    patents and thus the testing of “weak” patents. The
    district court, receiving all of Healthcare’s arguments,
    correctly held that the declaratory judgment criteria were
    not met.

    No immediacy here:


    Healthcare argues that it meets this requirement because
    of the lengthy time required for patent litigation,
    such that an immediate start is needed. However, the
    time consumed by litigation of a speculative future controversy
    does not provide the “immediacy and reality”
    required for declaratory judgment actions
    ; nor is a declaratory
    tribunal precluded from providing expedited relief
    when such is warranted. In this case, where there is no
    present infringement, no threat of or possibility of infringement
    litigation, and no meaningful preparation to
    infringe, the “immediacy and reality” criteria are not met.
    See, e.g., Prasco, 537 F.3d at 1338–39

    (…)

    The district court observed the absence of evidence of
    preparation to produce a product covered by any of the
    TAF patents, and found “significant uncertainty about the
    nature of any hypothetical product.” Dist. Ct. Op. at *5.
    The uncertainty of whether future infringement might
    occur at all weighs against the immediacy and reality
    requirement of declaratory action. Matthews, 695 F.3d at
    1328–29. In addition, precedent illustrates that the mere
    possibility of future infringement does not meet the
    immediacy and reality criteria, for “[a] party may not
    obtain a declaratory judgment merely because it would
    like an advisory opinion,” id. at 1329 (quoting Cat Tech,
    528 F.3d at 881). For example, in Benitec Australia, Ltd.
    v. Nucleonics, Inc., 495 F.3d 1340, 1349 (Fed. Cir. 2007),
    this court held that a representation that the declaratory
    plaintiff “expects to begin work shortly” on “potentially
    infringing” activities was of insufficient immediacy to
    support a declaratory action.

    Also


    Liability for induced infringement requires that some
    other entity is directly infringing the patent. Power
    Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
    843 F.3d 1315, 1331 (Fed. Cir. 2016).

    Fina was distinguished


    In Fina Research, the declaratory plaintiff was a foreign
    entity that was manufacturing and selling an ingredient
    of drilling mud abroad; the holder of United States
    patents on compositions containing the drilling mud had
    sent letters to the foreign producer, stating that the
    patentee would sue for infringement if the ingredient
    were introduced in the United States. The court held that
    such a direct threat of suit against an existing product
    and its producer established declaratory jurisdiction.
    Fina Research, 141 F.3d at 1482–84; see also SanDisk,
    480 F.3d at 1382 (describing how the presentation of “a
    thorough infringement analysis” and “element-byelement”
    product analyses created a case or controversy
    supporting declaratory judgment jurisdiction). In contrast,
    here the record does not refer to threats of litigation
    on importation of existing product, or even an identification
    of any product whose importation may violate Gilead’s
    patent rights. No such TAF-containing products are
    reported to exist.

    As to policy arguments:


    Healthcare argues that public policy is served by invalidation
    of invalid patents, and thus supports immediate
    challenge to the “weak” TAF patents. Yet the HatchWaxman
    Act is already a balance of several policy interests,
    seeking to preserve the patent incentive to invent
    new drugs, while enabling validity challenge by ANDA
    filers before actual infringement occurs. Andrx Pharm.,
    Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002).
    The present policy reflects a balance of several factors
    and public interests; any policy change would require reexploration
    of all aspects. Healthcare’s proposal of a
    change in policy to facilitate challenge to drug patents
    would warrant legislative consideration, not departure
    from precedent. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348,
    1358 (2018) (“Policy arguments are properly addressed to
    Congress, not this Court.”)

    UPDATE. Post to Patent Docs:

    As to the drug — tenofovir alafenamide fumarate (“TAF”)–, note that Truvada with –tenofovir disoproxil fumarate (“TDF”) — made the recent FDA list of Reference Listed Drug (RLD) Access Inquiries (with no REMS issue). The FDA approved generic Truvada in 2017, with Teva and Gilead making a deal. Some of the lawsuits involving Gilead and TAF are over issues other than patents. If, hypothetically, there were an obviousness issue it might be that TAF is obvious over TDF.

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