• NASA Tech in Your Life, From Hair Care to Coffee Makers to Baby Formula

    NASA recently launched a new version of its Home & City website featuring a redesigned, interactive interface designed to give users a sense of the scope of technologies originally developed by NASA which they encounter in their lives, sometimes on a daily basis. According to Derek Wang, NASA’s public outreach manager for the Space Technology Mission Directorate, the approximately 130 technologies included in the Home & City website is less than one percent of the thousands of…

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  • USPTO Discards Broadest Reasonable Interpretation Standard

    The USPTO has discarded the broadest reasonable interpretation standard.  This may lead to fewer patents held to be invalid during IPR, PGR, and CBM proceedings.  The announcement states: 
    The United States Patent and Trademark Office (USPTO) has published a final rule changing the claim construction standard applied during inter partes review (IPR), post-grant review (PGR), and the transitional program for covered business method patents (CBM) proceedings before the Patent Trial and Appeal Board (PTAB). 
    The final rule replaces the “broadest reasonable interpretation” standard with the federal court claim construction standard that is used to construe a claim in a civil action under 35 U.S.C. § 282(b). This is the same claim construction standard articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and its progeny. Additionally, under the final rule, when construing a claim term in an IPR, PGR, or CBM, the PTAB will take into consideration any prior claim construction determination that has been made in a civil action, or a proceeding before the International Trade Commission (ITC), if that prior claim construction is timely made of record in that IPR, PGR, or CBM.
    . . . As noted in the rule package, the change will lead, among other things, to greater consistency and harmonization with the federal courts and the ITC and lead to greater certainty and predictability in the patent system. . . .  Several comments questioned the proposed “retroactive” application of the rule. In response to these comments, the final rule will not be retroactively applied and instead will apply only to IPR, PGR, and CBM petitions filed on or after the effective date of the final rule, which is November 13, 2018.


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  • USPTO Discards Broadest Reasonable Interpretation Standard

    The USPTO has discarded the broadest reasonable interpretation standard.  This may lead to fewer patents held to be invalid during IPR, PGR, and CBM proceedings.  The announcement states: 
    The United States Patent and Trademark Office (USPTO) has published a final rule changing the claim construction standard applied during inter partes review (IPR), post-grant review (PGR), and the transitional program for covered business method patents (CBM) proceedings before the Patent Trial and Appeal Board (PTAB). 
    The final rule replaces the “broadest reasonable interpretation” standard with the federal court claim construction standard that is used to construe a claim in a civil action under 35 U.S.C. § 282(b). This is the same claim construction standard articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and its progeny. Additionally, under the final rule, when construing a claim term in an IPR, PGR, or CBM, the PTAB will take into consideration any prior claim construction determination that has been made in a civil action, or a proceeding before the International Trade Commission (ITC), if that prior claim construction is timely made of record in that IPR, PGR, or CBM.
    . . . As noted in the rule package, the change will lead, among other things, to greater consistency and harmonization with the federal courts and the ITC and lead to greater certainty and predictability in the patent system. . . .  Several comments questioned the proposed “retroactive” application of the rule. In response to these comments, the final rule will not be retroactively applied and instead will apply only to IPR, PGR, and CBM petitions filed on or after the effective date of the final rule, which is November 13, 2018.


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  • Kavanaugh, Henius, and McLean

    One thing that was not disputed in the Senate hearings on Judge Kavanaugh was that, as a young man, Kavanaugh enjoyed beer.As one bit of trivia, Max Henius (Ph.D., chemistry, University of Marburg, 1881) founded the Chicago-based American Brewing Acade…

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  • Mike Andrews on Historical Patent Data

    Mike Andrews is a postdoc at NBER, and I recently came across his PhD dissertation, Fuel of Interest and Fire of Genius: Essays on the Economic History of Innovation. He presents some interesting new results from historical patent records:

    I already described the work in chapter 1 in my post on the NBER Summer Institute; in short, he compares U.S. counties that received new colleges in the period 1839-1954 with finalist sites that were not chosen for plausibly exogenous reasons. He finds that counties that received a college had 33% more patents per year, mostly due to increases in population rather than the colleges’ graduates and faculty.

    Chapter 2 looks at the effect of statewide alcohol bans on counties that previously set their own alcohol policies. Statewide prohibition reduced patents by 15% per year in previously wet counties relative to previously dry counties, and there is a larger decline for men than for women. Andrews suggests this decline is due to a disruption of information social interactions in saloons.

    Chapter 3 matches 1870–1940 patents with census data and finds that patentees are consistently more likely to be older, white, male, and living in a state other than the one in which they were born. Establishment of a historically black college increased representation of black inventors, but the effect largely disappears after controlling for a county’s black population, suggesting it is driven by concentration rather than the college itself. Extension of the franchise to women did not seem to increase the representation of women among inventors.

    Finally, chapter 4 compares patent historical datasets. For those considering historical work with patent data, this is probably a good place to start. One should always be cautious about generalizing from the innovation institutions of a century ago to the ones that exist today—e.g., the effect of universities on the patent system has changed significantly in the past few decades—but it is still interesting to understand how patents worked in a particular historical context.

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  • Teva loses appeal of invalidity of patent claims of 40mg Copaxone multiple sclerosis drug

    The CAFC affirmed the decision of D. Delaware of invalidity of claims:

    Plaintiffs-Appellants Teva Pharmaceuticals USA,
    Inc., Teva Pharmaceutical Industries, Ltd., Teva Neuroscience,
    Inc., and Yeda Research and Development Co.,
    Ltd., appeal the decision of the United States District
    Court for the District of Delaware invalidating all asserted
    claims of patents directed to COPAXONE® 40mg/mL, a
    product marketed for treatment of patients with relapsing
    forms of multiple sclerosis. Because the district court
    correctly held the asserted claims invalid as obvious
    under 35 U.S.C. § 103, we affirm.

    Footnote 1 of the case


    In a companion case decided today, Yeda Research
    & Development Co., v. Mylan Pharmaceuticals Inc., Nos.
    17-1594, 17-1595, 17-1596 (Fed. Cir. Oct. 12, 2018), Yeda
    Research and Development Co. appealed from the Patent
    Trial and Appeal Board’s final written decisions finding
    all claims of U.S. Patent Nos. 8,232,250, 8,399,413, and
    8,969,302 unpatentable as obvious in three related inter
    partes review proceedings.
    [Therein: “We affirm the
    Board’s decisions.”]

    The use of the Khan (2009) reference was of interest:


    The district court admitted the Khan 2009 reference
    for the limited purpose of showing the state of the art at
    the time of the invention. In re Copaxone Consolidated
    Cases, No. 14-1171-GMS, 2017 WL 401943, at *14 (D. Del.
    Jan. 30, 2017). Khan 2009 was published three weeks
    after August 20, 2009, the priority date of the Copaxone
    patents, but the study began two years earlier. J.A.
    23904–05. The study abstract noted that “[t]here is
    considerable interest in studying a more patient friendly
    dosing regimen of GA that may be as efficacious and
    better tolerated than daily GA.” J.A. 23904. Following
    the results of Khan 2008, which showed that alternate
    day administration of GA appears to be as effective as
    daily administration, Khan 2009 compared 20mg GA
    administered twice a week to 20mg GA administered
    daily in a pilot, prospective, randomized, and raterblinded
    two-year study. J.A. 23904.

    (…)

    In light of these factual findings, the district court
    concluded that a 40mg GA 3x/week dosage would be
    obvious to try, noting that there were only two tested
    dosage amounts in the prior art—20mg and 40mg—and
    that researchers were pursuing less frequent dosing
    regimens while recognizing there are a limited number of
    days in a week on which to test frequency. See id. at *19.
    The court recognized that obvious-to-try logic is not
    always appropriate, but found that “[h]ere, there was
    market pressure to solve a known problem—the fact that
    many MS patients could not tolerate daily injections—and
    there were a finite number of predictable solutions that a
    person of ordinary skill in the art would have good reason
    to pursue.” Id. The district court cited to Khan 2009,
    Teva’s GALA study, and trial testimony as evidence of the
    motivations of POSITAs at the time of the invention, and
    noted evidence and testimony supporting the proposition
    that a dosing schedule based on three predetermined days
    each week is preferable for patients over an every other
    day schedule. Id. at *20. The district court highlighted
    testimony from Dr. Green that a regimen of injections on
    three pre-determined days of each week is more convenient
    for patients and has better patient adherence than an
    every other day regimen, in which the days on which
    patients inject differ depending on the week. Id.

    Teva’s position:


    Teva contends that the district court erred in finding
    the claimed 40mg GA 3x/week dosing regimen obvious.
    Specifically, Teva argues that the district court impermissibly
    relied on hindsight and an improper “obvious to try”
    analysis, and analyzed the obviousness of individual
    claim elements, rather than the invention as a whole.
    Teva further maintains that the district court’s decision is
    at odds with this court’s decision in In re Cyclobenzaprine
    Hydrochloride Extended-Release Capsule Patent Litigation,
    676 F.3d 1063 (Fed. Cir. 2012).

    Of obvious to try


    We have previously identified two categories of impermissible
    “obvious to try” analyses that run afoul of
    KSR and § 103: when what was “obvious to try” was (a) to
    vary all parameters or try every available option until one
    succeeds, where the prior art gave no indication of critical
    parameters and no direction as to which of many possibil-
    ities is likely to be successful; or (b) to explore a new
    technology or general approach in a seemingly promising
    field of experimentation, where the prior art gave only
    general guidance as to the particular form or method of
    achieving the claimed invention. See In re Kubin, 561
    F.3d 1351, 1359 (Fed. Cir. 2009) (quoting In re O’Farrell,
    853 F.2d 894, 903 (Fed. Cir. 1988)).
    This case falls into neither of the two impermissible
    categories. Here, the prior art focused on two critical
    variables, dose size and injection frequency, and provided
    clear direction as to choices likely to be successful in
    reducing adverse side effects and increasing patient
    adherence. As of the priority date, only two GA dose sizes
    had been shown to be effective, safe, and well-tolerated:
    20mg and 40mg. Concerning frequency, the 1996 FDA
    SBOA, Flechter, and Khan 2008 all encouraged POSITAs
    to pursue a less frequent than daily dosing regimen; these
    references indicated that less frequent injections of GA
    were just as effective as daily injections, and less frequent
    injections improved patient adherence and reduced adverse
    reactions.

    (…)

    Given this motivation, a POSITA had only a limited
    number of permutations of dose and frequency to explore
    that were not already disclosed in the prior art. Because
    a thrice-weekly 40mg injection would result in a total
    weekly dose very close to that in the already-approved
    daily 20mg injection—120mg/week versus 140mg/week—
    the district court found a POSITA would have had a
    reasonable expectation of success in pursuing the thriceweekly
    dose frequency in terms of effectiveness, patient
    adherence, and FDA approval.

    (…)

    Although the universe of potential GA doses is
    theoretically unlimited
    , the universe of dosages in the
    prior art that had clinical support for being effective and
    safe consisted of only two doses: 20mg and 40mg. Even if
    there were multiple injection frequencies not yet tested in
    the prior art—1x, 2x, 3x a week etc.—these still represent
    a limited number of discrete permutations.

    This is not a situation where the prior art gave no direction
    in how to reach a successful result; the prior art
    clearly indicated that less frequent doses should be explored
    (i.e., moving away from the daily, “7x/week” dose
    towards less frequent doses) and that higher doses, while
    maintaining the same weekly dose (i.e., moving from
    20mg daily to 40mg every other day), could increase
    efficacy while not affecting adverse reactions.

    (…)

    Nor do we find merit in Teva’s argument that the district
    court separately analyzed the 40mg dose limitation
    and the 3x/week limitation, without considering them
    together “except to conclude that the mash-up would be
    obvious to try.” Appellants’ Opening Br. 55. We note that
    the district court spent considerable time discussing why
    the combination of a 40mg dose administered 3x/week
    would be obvious to try. See In re Copaxone, 2017 WL
    401943, at *19. And while “[t]he determination of obviousness
    is made with respect to the subject matter as a
    whole, not separate pieces of the claim,” SanofiSynthelabo
    v. Apotex, Inc., 550 F.3d 1075, 1086 (Fed. Cir.
    2008), this court has previously employed the same frequency-and-dosage-amount
    approach to obviousness used
    by the district court here. In Hoffmann-La Roche, 748
    F.3d at 1329, the court considered whether it would have
    been obvious at the time of invention to select a once a
    month oral dosing regimen of 150mg of ibandronate to
    treat osteoporosis. The court first discussed how the prior
    art taught that infrequent dosing, such as monthly dosing,
    was preferred. Id. at 1329–31. The court then separately
    discussed why a POSITA would have selected a
    150mg dose, before considering the limitations together
    and concluding that “[a]t the very least, the 150mg dose
    was obvious to try.” Id. at 1331–33. Teva makes no
    convincing argument why a similar approach is inappropriate
    here.

    Footnote 14 gets into “needle fatigue”


    See, e.g., J.A. 4676–77 (Kolodny deposition, describing
    needle fatigue associated with Copaxone
    20mg/day); J.A. 4869 (Dr. Green, describing Khan 2008:
    “It reveals clear and obvious patient preference for an
    every-other-day dosing regimen when compared to a daily
    dosing regimen given the option.”); J.A. 4857 (Dr. Green:
    “As we discussed, most of the adverse events associated
    with the use of glatiramer acetate, and in fact the most
    troubling set of adverse events had to do with injection
    site reactions or immediate post-injection reactions. Both
    of those are tied to injections. So if you reduce the frequency
    of injections, well, it’s clearly obvious that you
    would reduce the frequency of those injection site reactions
    or immediate post-injection reactions.”).

    As to unknown mechanisms


    Finally, this court’s decision in In re Cyclobenzaprine,
    676 F.3d at 1063, does not warrant a different outcome.
    Teva argues that prior to the invention, higher doses of
    GA were not necessarily known to be more effective, GA’s
    pharmacokinetic and pharmacodynamic (“pk/pd”) profile
    was and remains unknown, GA’s mechanism of action is
    still unknown, and the cause of patient’s reactions to
    injections of GA is unknown. Teva contends that the
    unpredictable nature of GA categorically precludes the
    obvious-to-try analysis employed by the district court.
    Appellants’ Opening Br. 50.
    In Cyclobenzaprine, we held that bioequivalence alone
    could not establish obviousness because “skilled artisans
    could not predict whether any particular PK profile,
    including a bioequivalent one, would produce a therapeutically
    effective formulation.” 676 F.3d at 1070. The court
    applied traditional motivation and reasonableexpectation-of-success
    analysis, reasoning that “[w]hile it
    may have been obvious to experiment with the use of the
    same PK profile [from an immediate-release formulation]
    when contemplating an extended-release formulation,
    there [wa]s nothing to indicate that a skilled artisan
    would have had a reasonable expectation that such an
    experiment would succeed in being therapeutically effective.”
    Id. In Cyclobenzaprine, there were no prior art
    clinical studies to suggest what would be a therapeutically
    effective formulation.

    We do not read Cyclobenzaprine as establishing a rigid
    rule categorically precluding obviousness findings
    without pk/pd data.

    (…)
    In this case, the evidence shows that pk/pd data
    was largely irrelevant to the invention.
    Numerous clinical
    studies in the prior art describe GA and its effects on
    the human body. Although the precise mechanism of GA
    is not known, it is known to be immunomodulating—i.e.,
    it changes the immune system—and is not necessarily
    measurable in the bloodstream and its levels are not
    indicative of efficacy. See In re Copaxone, 2017 WL
    401943, at *21–22; J.A. 3998–99, 4886–87. Testimony
    was given at trial that pharmacokinetic studies for drugs
    like GA are less appropriate than for small molecule
    drugs, such as those at issue in Cyclobenzaprine. J.A.
    4886–87. GA was also known to be “forgiving,” in that
    occasional missed doses would not reduce efficacy, and
    that fact gave POSITAs further confidence in eliminating
    one dose every two weeks. J.A. 4848–49; 4884–85; 4732.
    Higher doses were clinically shown to be at least as
    effective as lower doses; Cohen shows, at the very least,
    that 40mg is as effective and well-tolerated as 20mg, but
    with a more rapid onset of action. Finally, Teva itself, in
    its 1996 application to FDA, indicated that pharmacokinetic
    studies “would be of limited value.” J.A. 20689.

    Is invocation of “common sense” camouflage for conclusory assertions?


    Teva finds fault with the district court’s reference to
    “common sense” in its reliance on Dr. Green’s testimony.
    During trial, Appellees’ expert Dr. Green testified that a
    POSITA would expect reducing the frequency of injections
    to be associated with enhanced overall tolerability of the
    regimen. J.A. 4911. In its post-trial briefing, Teva argued
    that Dr. Green’s testimony was conclusory and
    unsupported by the prior art. The district court rejected

    The bottom line for the CAFC:


    In light of the foregoing, we conclude that the district
    court did not err in invalidating all asserted claims of the
    Copaxone patents as obvious.

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