• Big defeat for UC/Berkeley in CRISPR war

    The outcome was an affirmance that no interference-in-fact existed;
    UC/Berkeley loses its appeal:


    This case turns in its entirety on the substantial evidence
    standard. The Board found a person of ordinary
    skill in the art would not have had a reasonable expectation
    of success in applying the CRISPR-Cas9 system in
    eukaryotic cells. J.A. 48–49. Given the mixture of evidence
    in the record, we hold that substantial evidence
    supports the Board’s finding that there was not a reasonable
    expectation of success, and we affirm. UC argues
    that the Board: (1) improperly adopted a rigid test for
    obviousness that required the prior art contain specific
    instructions, and (2) erred in dismissing evidence of
    simultaneous invention as irrelevant. For the reasons set
    forth below, we hold the Board did not err in its analysis.

    Statements made on the UC/Berkeley side were used
    AGAINST UC/Berkeley:


    The Board was also presented evidence of statements
    by the UC inventors acknowledging doubts and frustrations
    about engineering CRISPR-Cas9 systems to function
    in eukaryotic cells and noting the significance of Broad’s
    success. One of the named inventors, Dr. Jennifer Doudna,
    acknowledged the “huge bottleneck” in making genetic
    modifications in animals and humans, J.A. 5911, and
    after the publication of the initial UC research, she stated
    “[o]ur 2012 paper was a big success, but there was a
    problem. We weren’t sure if CRISPR/Cas9 would work in
    eukaryotes,” J.A. 5880. She also explained that she had
    “many frustrations” in getting CRISPR-Cas9 to work in
    human cells, and that she thought success in doing so
    would be “a profound discovery.” J.A. 5908. Evidence in
    the record also suggested her colleagues recognized
    Broad’s development was significant. When a colleague
    contacted Dr. Doudna to inform her of Broad’s success he
    stated “I hope you’re sitting down,” “CRISPR is turning
    out to be absolutely spectacular in [Broad researcher]
    George Church’s hands.” J.A. 5908. The Board viewed
    this evidence as indicating that an ordinarily skilled
    artisan would have lacked a reasonable expectation of
    success.3

    Footnote 3:

    UC also argues the Board erred in giving “near dispositive
    weight” to statements by Dr. Doudna and Dr.
    Carroll, which it claims were misinterpreted by the
    Board. The Board considered a variety of statements
    made by both Dr. Doudna and Dr. Carroll. In doing so, it
    afforded the statements weight depending on the contexts
    in which they were made and their relevance to its analysis.
    See J.A. 14–23. To the extent UC argues the Board
    erred in its reading of these statements in the contexts in
    which they arose, we conclude substantial evidence supports
    the Board’s interpretation.

    Note text by the CAFC:


    UC expended substantial time and effort to convince
    this court that substantial evidence supports the view it
    would like us to adopt, namely, that a person of ordinary
    skill would have had a reasonable expectation of success
    in implementing the CRISPR-Cas9 system in eukaryotes.
    There is certainly evidence in the record that could support
    this position. The prior art contained a number of
    techniques that had been used for adapting prokaryotic
    systems for use in eukaryotic cells, obstacles adopting
    other prokaryotic systems had been overcome, and Dr.
    Carroll suggested using those techniques to implement
    CRISPR-Cas9 in eukaryotes. We are, however, an appellate
    body. We do not reweigh the evidence. It is not our
    role to ask whether substantial evidence supports factfindings
    not made by the Board, but instead whether such
    evidence supports the findings that were in fact made.
    Here, we conclude that it does.


    Of simultaneous invention:


    Simultaneous invention may serve as evidence of obviousness
    when considered in light of all of the circumstances.
    Lindemann Maschinenfabrik GMBH v. Am.
    Hoist & Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984).
    We have recognized that simultaneous invention may
    bear upon the obviousness analysis in two ways. Monarch
    Knitting Mach. Corp. v. Sulzer Morat GmbH, 139
    F.3d 877, 883 (Fed. Cir. 1998). First, it is evidence of the
    level of skill in the art. Id. Second, it constitutes objective
    evidence that persons of ordinary skill in the art
    understood the problem and a solution to that problem.
    Id. Inherent in the existence of interference practice is
    the principle that evidence of simultaneous invention
    cannot alone show obviousness, otherwise any claims
    involved in an interference would be unpatentable for
    obviousness. Lindemann, 730 F.2d at 1460. The weight
    of evidence of simultaneous invention must, therefore, be
    carefully considered in light of all the circumstances. See
    Monarch Knitting, 139 F.3d at 883.
    In August 2012, the Jinek 2012 paper was published
    explaining the CRISPR-Cas9 system and its use in vitro
    using isolated components. There is no dispute that this
    represented a breakthrough in the art. The fact that six
    research groups succeeded in applying this technology in
    eukaryotic cells within a short period of time after this is
    certainly strong evidence that there was a motivation to
    combine the prior art in this manner. The Board expressly
    recognized UC’s evidence of simultaneous invention in
    this context, and it concluded the evidence of simultaneous
    invention was evidence of the motivation to combine
    the prior art references but did not “necessarily” indicate
    an expectation of success prior to the completion of the
    experiments. J.A. 23.

    UC would have the Board read more into this evidence
    and infer that because several research teams
    pursued a particular approach, and that approach was
    ultimately successful, they must have expected that
    approach to work. It argued to the Board that absent an
    expectation of success, multiple groups “would not have
    undertaken the use of UC’s Type-II CRISPR-Cas system
    in eukaryotic cells.” J.A. 245. The Board rejected this
    bright-line rule and instead determined in this instance
    the evidence of simultaneous invention did not establish a
    reasonable expectation of success given the “specific
    context of the art at the time.” See J.A. 23–25. The Board
    explained that “[e]ach case must be decided in its particular
    context, including the characteristics of the science or
    technology, its state of advance, the nature of the known
    choices, the specificity or generality of the prior art, and
    the predictability of results in the area of interest.”
    J.A. 25 (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d
    1341, 1352 (Fed. Cir. 2008)). We do not see any error in
    this analysis. Contrary to UC’s claims, the Board recognized
    that UC’s evidence of simultaneous invention is
    relevant to the obviousness determination. We consider
    Broad’s evidence of simultaneous invention, along with
    evidence regarding the state of the art, the statements of
    the inventors, failures involving similar technologies, and
    the remainder of the record evidence, and conclude the
    Board’s finding is supported by substantial evidence.

    The conclusion:


    For the foregoing reasons, we affirm the Board’s
    judgment of no interference-in-fact. The Board performed
    a thorough analysis of the factual evidence and considered
    a variety of statements by experts for both parties and the
    inventors, past failures and successes in the field, evidence
    of simultaneous invention, and the extent to which
    the art provided instructions for applying the CRISPRCas9
    technology in a new environment. In light of this
    exhaustive analysis and on this record, we conclude that
    substantial evidence supports the Board’s finding that
    there was not a reasonable expectation of success, and the
    Board did not err in its determination that there is no
    interference-in-fact.

    We have considered UC’s remaining arguments and
    find them unpersuasive. We note that this case is about
    the scope of two sets of applied-for claims, and whether
    those claims are patentably distinct. It is not a ruling on
    the validity of either set of claims.

    ***Of relevance

    UC’s Patent Application No. 13/842,859

    Broad’s U.S. Patent No. 8,697,359

    PTAB 106,048

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  • Nine No-Nos of Patent Licensing (1970)

    I’m thinking about the USDOJ’s “Nine No-Nos” of Patent Licensing. These were the subject of an important set of remarks in 1970 by then Bruce Wilson (USDOJ) on antitrust considerations for patent and know-how license agreements.  At the time, the DOJ considered these all per-se antitrust violations.  US Antitrust Law has really relaxed since then, and for the most part these are no longer per-se violations.  That said, they still represent cautionary signs of potential antitrust trouble — especially if coupled with actual market power.

    The nine no-nos:

    1. Tying: Don’t require the purchase of unpatented materials as a condition of a patent license;
    2. Assign-Back: Don’t require the licensee to assign-back subsequently developed patents;
    3. Resale Restrictions; Don’t restrict the right of a product purchaser to re-sell the product;
    4. Using Non-Patented Products: Don’t restrict the licensee’s ability to deal in products outside the scope of the patent;
    5. Exclusive Licenses: Take care with exclusive licenses — especially if in a horizontal market relationship.
    6. Package Deals: Don’t require mandatory package licenses;
    7. Relationship with Payments: Royalty provisions should be reasonably related to the licensee’s sales;
    8. Licensee’s Use of Product: Don’t restrict a licensee’s use of a product made by a patented process; and
    9. Minimum Resale Price: Don’t include minimum resale price provisions for the licensed products.

    Continue reading Nine No-Nos of Patent Licensing (1970) at Patently-O.

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  • CAFC vacates Summary Judgment entered against Intellectual Ventures

    On Tuesday, September 4th, the Court of Appeals for the Federal Circuit issued a precedential decision in Intellectual Ventures I LLC v. T-Mobile USA, Inc., et. al., vacating and remanding a grant of summary judgment entered by the district court finding the defendants in the case didn’t infringe a patent asserted by Intellectual Ventures. The Federal Circuit panel of Chief Judge Sharon Prost and Circuit Judges Kimberly Moore and Jimmie Reyna found that the district court had erred in its claim…

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  • Acorda Therapeutics: Other Patents Covering Invention Precludes Reliance on Secondary Indicia of NonObviousness

    Acorda Therapeutics: Other Patents Covering Invention Precludes Reliance on Secondary Indicia of NonObviousness

    by Dennis Crouch

    Acorda Therapeutics v. Roxane Labs (Fed. Cir. 2018)

    In a 50+ page majority opinion, the Federal Circuit has affirmed a district court obviousness judgment.  Judge Taranto penned the majority opinion and was joined by Judge Dyk. Judge Newman wrote in dissent — arguing in 20+ additional pages that the majority improperly discounted the objective indicia of non-obviousness. On news of the invalidity decision, Acorda’s stock price dropped 25%.

    Acorda’s branded drug Ampyra is the only approved pill proven to “help improve walking [speed] in adults with multiple sclerosis (MS).”  The patents don’t cover the 4-AP drug itself — 4-AP was already publicly known — but cover particular apparently important tweaks in administration and dosage. (U.S. Patent No. 8,007,826; No. 8,663,685; No. 8,354,437; and No. 8,440,703).  Acorda also exclusively licensed an earlier patent (the Elan patent) that broadly covered use of 4-AP to treat MS (but without the tweaks).

    Secondary Indicia of Non Obviousness: Sometimes the best way to measure the extent of a contribution is by its impact.  In patent law, we certainly look to the technical specifications and consider technical differences between a claimed invention and the prior art. 

    Continue reading Acorda Therapeutics: Other Patents Covering Invention Precludes Reliance on Secondary Indicia of NonObviousness at Patently-O.

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  • 作製する

                            目次はこちら

    作製する

    (MAKE)
    $$ FIG. 3 is a top perspective view of a rigid curved pack with hinged lid made from the blank illustrated in FIG. 2; / 【図3】図2に例示したブランクから作製したヒンジ式蓋付きパックの斜視図である。(USP8038001)

    $$ A RAID (Redundant Array of Inexpensive Disks) is a method of combining multiple hard drives for making a larger, faster data access and storage system as is well known in the art. / RAID(低価格ディスク冗長アレイ)は、当該技術分野で周知のように、より大きくより速いデータ・アクセスおよび記憶システムを作製するために多数のハード・ドライブを組み合わせる方法である。(USP7619972)

    $$ Moulded tablets may be made by moulding in a suitable machine a mixture of the powdered compound moistened with an inert liquid diluent. / 成形した錠剤は、不活性液体希釈液で湿らせた粉末状の合成物の混合物を適切な機械で成形することによって作製してもよい。(USP7615210)

    $$ The transparency support is typically made of a plastic or thermoplastic material. / 透明物支持体は、代表的に、可塑性の材料か、または、熱可塑性の材料により作製される。(USP5373373)

    $$ To provide adjustability and control of bed height and bed compression, at least the top end cell is usually made in the form of a piston slidable in the column tube interior. / 吸着床の高さ及び吸着床の圧縮荷重を調節しかつ制御するために、少なくとも上端部セルは一般に、カラムチューブの内側で摺動可能なピストンの形式で作製される。(USP7604747)

    $$ The advantages of the linear array is that it is easier to make. / 直線状アレイの利点は作製がより容易であることである。(USP6900756)

    $$ Branched polymers were made according to the invention using CoBF, a catalytic chain transfer agent. / CoBF(触媒的な連鎖移動剤)を用いて、本発明に従う分枝ポリマーを作製した。(USPA03013822)

    (FABRICATE)
    $$ For example, the metal shell 500 is optionally fabricated from silver and the layer 520 from silver chloride. / 例えば、金属殻500は任意に銀から作製され、層520は塩化銀から作製される。(USP7735379)

    $$ Where the antennae are fabricated using micromachining techniques, the retroreflectors are preferably lithographically fabricated and suspended across the antenna aperture on thin silicon strips. / 微細加工技術を使用してアンテナを作製する場合、再帰反射体は好ましくはリソグラフィにより作製され、細いシリコンストリップ上にアンテナアパーチャを跨いで懸架される。(USP7579596)

    $$ In electro-optical device fabrication, it is a first lithographic step which is critical to ensuring that delineated features are aligned to crystal planes of a wafer. / 電気光学装置の作製においては、描出される構造が確実にウェハの結晶面にアライメントされるのに重要なのは、最初のリソグラフィのステップである。(USP7072441)

    $$ Generally, fabrication of the device including a "well", is similar to that described with reference to FIGS. 2A-2I. / 一般的に、”井戸”を含むデバイスの作製は図2A~2Iに関連して述べたものと同様である。(USP5429953)

    (MANUFACTURE)
    $$ Furthermore, the present invention also relates to methods of manufacturing such sensing electrodes. / さらに、本発明はまた、そのような検知用電極を作製する方法に関する。(USP7735379)

    $$ Preferably, the tooth primordium is used in the manufacture of a medicament for generating a tooth in a subject in need of tooth replacement, preferably a human patient. / 好ましくは、歯の原基は、歯の交換が必要な対象者で、好ましくはヒト患者で、歯を作製するための薬剤の製造に使用される。(USP7588936)

    (PREPARE)
    $$ Eleven electrodes were prepared using the method described below. / 後述の方法を使用して11個の電極が作製された。(USP8273225)

    $$ In WO98/43314 methods for fabricating millimetre and sub-millimetre horn antenna are described in which a mould for the shape of half of a horn antenna is first prepared using resist on a substrate. / 国際公開第WO98/43314号(特許文献1)には、ミリメートルおよびサブミリメートルホーンアンテナを作製する方法が記載されており、そこでは、最初にホーンアンテナの半分の形状の型が、基板上にレジストを使用して作成される。(USP7579596)

    (OTHERS)
    $$ As mentioned this could find application for surveying and mapping. / 上述のように、これは、測量と地図作製に用途を見出すことができる。(USP7589825): map

    $$ Using stepper techniques with 10:1 magnification and electron beam generated master patterns, reproducabilities of better than 1% are easily achievable for the different elements of the filter. / 10:1の倍率のステッパ技術、および電子ビームで作製したマスターパターンを使用すると、フィルタの様々な素子について、1%よりも優れた再現性が容易に達成可能である。(USP6980362): generate

                            目次はこちら

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  • 作製する

                            目次はこちら

    作製する

    (MAKE)
    $$ FIG. 3 is a top perspective view of a rigid curved pack with hinged lid made from the blank illustrated in FIG. 2; / 【図3】図2に例示したブランクから作製したヒンジ式蓋付きパックの斜視図である。(USP8038001)

    $$ A RAID (Redundant Array of Inexpensive Disks) is a method of combining multiple hard drives for making a larger, faster data access and storage system as is well known in the art. / RAID(低価格ディスク冗長アレイ)は、当該技術分野で周知のように、より大きくより速いデータ・アクセスおよび記憶システムを作製するために多数のハード・ドライブを組み合わせる方法である。(USP7619972)

    $$ Moulded tablets may be made by moulding in a suitable machine a mixture of the powdered compound moistened with an inert liquid diluent. / 成形した錠剤は、不活性液体希釈液で湿らせた粉末状の合成物の混合物を適切な機械で成形することによって作製してもよい。(USP7615210)

    $$ The transparency support is typically made of a plastic or thermoplastic material. / 透明物支持体は、代表的に、可塑性の材料か、または、熱可塑性の材料により作製される。(USP5373373)

    $$ To provide adjustability and control of bed height and bed compression, at least the top end cell is usually made in the form of a piston slidable in the column tube interior. / 吸着床の高さ及び吸着床の圧縮荷重を調節しかつ制御するために、少なくとも上端部セルは一般に、カラムチューブの内側で摺動可能なピストンの形式で作製される。(USP7604747)

    $$ The advantages of the linear array is that it is easier to make. / 直線状アレイの利点は作製がより容易であることである。(USP6900756)

    $$ Branched polymers were made according to the invention using CoBF, a catalytic chain transfer agent. / CoBF(触媒的な連鎖移動剤)を用いて、本発明に従う分枝ポリマーを作製した。(USPA03013822)

    (FABRICATE)
    $$ For example, the metal shell 500 is optionally fabricated from silver and the layer 520 from silver chloride. / 例えば、金属殻500は任意に銀から作製され、層520は塩化銀から作製される。(USP7735379)

    $$ Where the antennae are fabricated using micromachining techniques, the retroreflectors are preferably lithographically fabricated and suspended across the antenna aperture on thin silicon strips. / 微細加工技術を使用してアンテナを作製する場合、再帰反射体は好ましくはリソグラフィにより作製され、細いシリコンストリップ上にアンテナアパーチャを跨いで懸架される。(USP7579596)

    $$ In electro-optical device fabrication, it is a first lithographic step which is critical to ensuring that delineated features are aligned to crystal planes of a wafer. / 電気光学装置の作製においては、描出される構造が確実にウェハの結晶面にアライメントされるのに重要なのは、最初のリソグラフィのステップである。(USP7072441)

    $$ Generally, fabrication of the device including a "well", is similar to that described with reference to FIGS. 2A-2I. / 一般的に、”井戸”を含むデバイスの作製は図2A~2Iに関連して述べたものと同様である。(USP5429953)

    (MANUFACTURE)
    $$ Furthermore, the present invention also relates to methods of manufacturing such sensing electrodes. / さらに、本発明はまた、そのような検知用電極を作製する方法に関する。(USP7735379)

    $$ Preferably, the tooth primordium is used in the manufacture of a medicament for generating a tooth in a subject in need of tooth replacement, preferably a human patient. / 好ましくは、歯の原基は、歯の交換が必要な対象者で、好ましくはヒト患者で、歯を作製するための薬剤の製造に使用される。(USP7588936)

    (PREPARE)
    $$ Eleven electrodes were prepared using the method described below. / 後述の方法を使用して11個の電極が作製された。(USP8273225)

    $$ In WO98/43314 methods for fabricating millimetre and sub-millimetre horn antenna are described in which a mould for the shape of half of a horn antenna is first prepared using resist on a substrate. / 国際公開第WO98/43314号(特許文献1)には、ミリメートルおよびサブミリメートルホーンアンテナを作製する方法が記載されており、そこでは、最初にホーンアンテナの半分の形状の型が、基板上にレジストを使用して作成される。(USP7579596)

    (OTHERS)
    $$ As mentioned this could find application for surveying and mapping. / 上述のように、これは、測量と地図作製に用途を見出すことができる。(USP7589825): map

    $$ Using stepper techniques with 10:1 magnification and electron beam generated master patterns, reproducabilities of better than 1% are easily achievable for the different elements of the filter. / 10:1の倍率のステッパ技術、および電子ビームで作製したマスターパターンを使用すると、フィルタの様々な素子について、1%よりも優れた再現性が容易に達成可能である。(USP6980362): generate

                            目次はこちら

    Continue Reading ...
  • Big news in multiple sclerosis drugs: Acorda loses appeal on patent invalidity

    The outcome in Acorda v. Roxane was that Acorda lost:


    Roxane Laboratories, Inc.; Mylan Pharmaceuticals,
    Inc.; and Teva Pharmaceuticals USA, Inc., have submitted
    Abbreviated New Drug Applications seeking FDA
    approval to market generic versions of Ampyra. In July
    2014, Acorda and Alkermes sued those entities (“defendants”)
    in the District of Delaware, alleging infringement
    of several claims in each of the Elan and Acorda patents.
    The defendants stipulated to infringement but challenged
    the validity of the asserted claims. The district court held
    that the asserted claims in the Acorda patents are invalid
    for obviousness. But the court upheld the asserted claims
    of the Elan patent against invalidity challenges and
    enjoined the defendants from activity infringing that
    patent until it expired on July 30, 2018.

    Acorda appealed the invalidity ruling regarding the
    Acorda patents. The defendants cross-appealed the
    validity ruling regarding the Elan patent and the resulting
    injunction. We now affirm the judgment that the
    asserted Acorda patent claims are invalid. We dismiss
    the cross-appeal as moot.

    Of legal matters, the discussion of “blocking patents” is
    significant.

    Of background


    4-AP [4-aminopyridine], also called “dalfampridine” and “fampridine,”
    was first identified in 1902. Acorda Therapeutics, Inc. v.
    Roxane Labs., Inc., No. 1:14-cv-00882-LPS, 2017 WL
    1199767, at *3, *5 (Mar. 31, 2017) (Dist. Ct. Op.). Belonging
    to a class of compounds that function as potassiumchannel
    blockers, 4-AP “has been found to slow the potassium
    flow in nerve impulse transmission” and, by doing
    so, help “restor[e] conduction in blocked and demyelinated
    nerves,” ’826 patent, col. 2, lines 5–11, i.e., nerves whose
    myelin insulation has been damaged. 4-AP was first used
    in human studies in the 1970s to investigate its effect on
    neurological diseases resulting in muscle weakness. Dist.
    Ct. Op. at *5. For several decades, 4-AP has been the
    focus of research regarding the treatment of multiple
    sclerosis in particular. See, e.g., id. at *5–7 (reciting
    studies); J.A. 6697 (paper published in 1987 describing
    study of the effect of 4-AP on subjects with multiple
    sclerosis). Multiple sclerosis causes the demyelination, or
    loss of myelin, of nerves in the central nervous system
    and results in a wide variety of symptoms, including
    walking impairment, tingling or pain, brain scarring,
    cognitive changes, visual impairments, and fatigue. See
    ’826 patent, col. 1, lines 36–42; Dist. Ct. Op. at *2. Eventually,
    4-AP research led to the development, patenting,
    and FDA approval of Ampyra.

    As to the mootness issue, July 30, 2018 has passed:


    On April 25, 2017, the court entered final judgment in
    favor of the defendants as to the Acorda patents and in
    favor of Acorda as to the Elan patent. The court set the
    effective date of any final FDA approval of the defendants’
    Abbreviated New Drug Applications no earlier than the
    expiration date of the Elan patent—July 30, 2018—and
    enjoined the defendants from any infringing activity
    before that date.

    A Kyle Bass effort is mentioned in footnote 10:

    In inter partes reviews initiated by a petitioner
    not included among the defendants here, the Patent Trial
    and Appeal Board considered challenges to the Acorda
    patents that did not involve Schwid or the Goodman
    references but, instead, depended on whether a particular
    filing with the Securities and Exchange Commission was
    prior art to the patents. The Board concluded that it was
    not. Coalition for Affordable Drugs (ADROCA) LLC v.
    Acorda Therapeutics, Inc., Nos. IPR2015-01850, -01853, -
    01857, -01858, 2017 WL 950736, at *9–20 (P.T.A.B. Mar.
    9, 2017). That ruling does not change the analysis in this
    case.

    Acorda’s [unsuccessful] arguments:


    Acorda challenges the district court’s findings about
    the relevant skilled artisan’s motivations and expectations
    regarding the administration of a stable 10 mg 4-AP
    dose twice daily to improve walking. It presents two
    relatively focused arguments: that Schwid teaches away
    from the claimed invention; and that the prior art teaches
    the administration of sustained-release 4-AP in a titrateddosing
    regimen rather than a stable-dosing regimen.
    More broadly, Acorda argues that neither the Goodman
    Poster nor the prior art collectively teaches the efficacy of
    a stable 10 mg twice-daily dose or indicates that such a
    dose is among the small number of options that a skilled
    artisan would have been motivated to test with a reasonable
    expectation of success to improve walking. We reject
    these challenges.

    Of the first argument:

    And in light of Schwid’s warning that seizures may occur at higher doses,
    the district court did not clearly err in finding that a
    person of skill would look to lower doses rather than
    higher ones. See Dist. Ct. Op. at *32 (“While the prior art
    may have generally suggested that 4-AP would be more
    effective in higher doses, the art also reduced the set of
    plausible doses because it suggested that higher doses of
    4-AP were more likely to cause adverse events.”)
    .

    Of titrated dosing:


    Acorda’s second argument is that the prior art teaches
    administering sustained-release 4-AP only in a titrateddosing
    regimen to avoid the risk of seizure, and therefore
    that the district court could not properly find that a
    person of skill would have been motivated to pursue, or
    had a reasonable expectation of success concerning, a
    stable-dosing regimen. We reject this argument.
    The prior art is not limited to titrated dosing (where
    doses start low and move higher) but rather contains
    evidence of stable dosing (where the dose starts and stays
    at the claimed level). As the district court noted, Polman
    is evidence of safe and effective long-term oral administration
    of a stable dose of immediate-release 4-AP. Dist.
    Ct. Op. at *34; see J.A. 6655. Schwid also provides evidence
    of a stable-dosing regimen of 4-AP, if only for a
    week. As for the studies that used escalating doses, some
    of those studies began with 10 mg as the lowest dose
    before titrating upwards to doses that may increase the
    risk of seizure. E.g., Davis at 187 tbl.1; see also Dist. Ct.
    Op. at *8 (1994 Elan study began with 12.5 mg 4-AP twice
    daily); id. at *9 (10 mg twice daily was the lowest dose
    used in the Acorda MS-F202 study); cf. J.A. 6647 (trial in
    patients with other conditions began with dose of 10 mg 4-
    AP twice daily and titrated up to 200 mg daily); J.A. 6434
    (Acorda’s trial in patients with spinal cord injury began
    with 10 mg twice daily as the lowest dose). Significantly,
    the most important prior art, the Goodman references,
    report a start dose of 10 mg twice daily. J.A. 6370, 6372,
    6502.

    (…)

    Expert testimony supports the district court’s finding
    that a person of ordinary skill in the art would have been
    motivated to pursue, and had a reasonable expectation of
    success in pursuing, a stable-dosing regimen of 10 mg 4-
    AP twice daily. According to Dr. Peroutka, “the general
    goal of drug development [is] to provide a stable dosing
    regimen.” J.A. 414. He testified that stable dosing was
    particularly desirable for treating multiple sclerosis
    because, as a chronic disease that requires long-term
    treatment, a stable oral dose is much easier to administer.
    See Sept. 19, 2016 Trial Tr. 110 (“Obviously, it’s a lot
    easier simply to take one pill, the same pill twice a day
    than to have to figure out, well, this morning I need this
    much, that much. But with pills, it is almost impossible
    to titrate easily.”). Even Dr. Goodman conceded that “it
    would be desirable” to have a stable-dosing regimen
    where “the patient would be prescribed [some dose] to
    take on a regular basis.” J.A. 868. And titration was not
    required given such a low starting dose: Acorda founder
    Dr. Cohen testified that, upon recognizing the efficacy of
    the 10 mg twice-daily dose, “we realized we didn’t have to
    titrate anymore.” J.A. 614. Finally, Dr. Peroutka explained
    that nothing in the prior art suggested that 4-AP
    could not be used for long-term treatment for a chronic
    condition. Sept. 19, 2016 Trial Tr. 104.

    Also


    Acorda’s core argument appears not to be that the evidence
    fails to support the finding of a motivation to
    combine. Rather, it appears to be that the evidence
    cannot support a finding of a reasonable expectation of
    success (in 2004) in the absence of publications showing a
    statistically significant difference in walking tests between
    the specific dose of 10 mg 4-AP taken twice daily
    versus placebo. See Acorda Br. 41–42; Acorda Reply Br.
    20–21; Oral Arg. at 6:10–30. We reject this contention.

    (…)

    In some cases, of course, the evidentiary basis for an
    inference of reasonable expectation of success may be
    inadequate. See, e.g., In re Cyclobenzaprine, 676 F.3d at
    1070–71. Here, though, as we have discussed, expert and
    other evidence indicates that a person of skill in the
    present context can draw reasonable inferences about the
    likelihood of success even without a perfectly designed
    clinical trial showing a statistically significant difference
    in efficacy between a specific dose and placebo. See also
    J.A. 6657 (Polman: “Although a placebo effect cannot be
    excluded, the dynamics of the response in relation to the
    intake of the medication and the deterioration and subsequent
    improvement in functioning during a drug-free
    interval and subsequent restarting of the therapy are, in
    our view, highly suggestive of a real effect being induced
    by the 4-[AP]. Improvements in fatigue and ambulation
    were mentioned quite often by the patients as being
    responsible for the favorable overall effect.”). We see no
    clear error in the district court’s finding to that effect.

    Of relevance to MS patients


    Similarly, the “inconclusiveness of the exploratory
    studies of 4-AP, a 102-year old drug,” Acorda Reply
    Br. 28, does not speak to the more recent research relied
    on by the district court—namely, Schwid and the Goodman
    references. And “the rigorous 2003 Solari review of
    the field dispelling any confidence in using
    am[ino]pyridines to treat [multiple sclerosis],” id. at 29,
    does not dispel confidence in a walking improvement;
    rather, Solari, a prior-art literature review, reports a
    statistically significant improvement in walking,
    J.A. 7208 (reviewing three studies that “assessed the
    efficacy of aminopyridines on ambulation” and reporting
    that patients who received 4-AP showed a statistically
    significant improvement in ambulation compared to
    placebo (p

    Of relevance to patent academics, as to the concept of
    “blocking patents”:


    A patent has been called a “blocking patent” where
    practice of a later invention would infringe the earlier
    patent. The existence of such a blocking patent may deter
    non-owners and non-licensees from investing the resources
    needed to make, develop, and market such a later,
    “blocked” invention, because of the risk of infringement
    liability and associated monetary or injunctive remedies.
    If the later invention is eventually patented by an owner
    or licensee of the blocking patent, that potential deterrent
    effect is relevant to understanding why others had not
    made, developed, or marketed that “blocked” invention
    and, hence, to evaluating objective indicia of the obviousness
    of the later patent. See Note, Subtests of “Nonobviousness”:
    A Nontechnical Approach to Patent Validity, 112
    U. Pa. L. Rev. 1169, 1177 (1964) (Regarding commercial
    success, “a court must be assured that the patentee’s
    market domination is not attributable to monopoly power
    or other economic coercion, or to other factors unrelated to
    patent validity.”) (cited in Graham v. John Deere Co. of
    Kansas City, 383 U.S. 1, 18, 36 (1966)).

    We briefly discussed blocking patents in Merck & Co.
    v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364 (Fed.
    Cir. 2005) (Merck I). The Merck patent at issue, applied
    for in 1998, was for the weekly administration of alendronate
    monosodium trihydrate (Fosamax). Id. at 1366–67.
    That patent was preceded by Merck’s earlier patent
    (issued in 1986) covering a method of administering an
    effective amount of Fosamax to treat osteoporosis, as well
    as Merck’s statutory right, since obtaining FDA approval
    in 1995, to the exclusive marketing of any dosage strength
    of Fosamax for the next five years. 395 F.3d at 1367,
    1377; Br. for Def.-Appellant Teva Pharm. USA, Inc.,
    Merck I, No. 04-1005, 2003 WL 24307848, at *62–63 (Fed.
    Cir. Dec. 17, 2003). We ruled that the district court had
    erred in its analysis of commercial success because the
    earlier patent and FDA regulatory approval depressed
    incentives for others to invent the weekly-dosing scheme.
    395 F.3d at 1377 (“Because market entry by others was
    precluded on those bases, the inference of nonobviousness
    of weekly-dosing, from evidence of commercial
    success, is weak.”). In that context, we said, the
    evidence of commercial success was “not enough to show
    the claims at bar are patentably distinct from the weeklydosing
    ideas in the [invalidating prior art].” Id.
    In Galderma Laboratories, L.P. v. Tolmar, Inc., 737
    F.3d 731 (Fed. Cir. 2013), we considered the district
    court’s finding, in support of commercial success, that the
    FDA-approved product “quickly gained and maintained
    market share.” Id. at 740. Because earlier patents owned
    by Galderma may have “blocked” competition to market
    the FDA-approved product by any entity other than
    Galderma, we reasoned that the commercial success of the
    product was “of ‘minimal probative value’” and not sufficient
    to justify a conclusion of nonobviousness in light of
    the other evidence supporting obviousness. Id. at 741
    (quoting Merck I, 395 F.3d at 1376).
    Recently, in Merck Sharp & Dohme Corp. v. Hospira,
    Inc., 874 F.3d 724 (Fed. Cir. 2017) (Merck II), we concluded
    that Merck’s exclusive license to a blocking patent did
    not, all by itself, justify discounting evidence of commercial
    success. Id. at 730–31. We explained that commercial
    success is “a fact-specific inquiry” that may involve
    considering the operation of specific blocking patents on
    possible competition. Id. at 731. But the mere existence
    or sheer number of blocking patents does not, without
    more, “necessarily detract from evidence of commercial
    success of a product or process.” Id. Nevertheless, “even
    giving the evidence of commercial success its full and
    proper weight,” we affirmed the judgment invalidating
    the claims at issue for obviousness in light of “the evidence
    that the claimed process was substantially described
    in the prior art” and that “merely ordinary
    experimentation was required to arrive at the [patent at
    issue].” Id.
    Merck II’s reasoning reflects a common-sense recognition
    that, as a theoretical matter, a blocking patent may
    or may not deter innovation in the blocked space by
    commercially motivated potential innovators other than
    the owners or licensees of the blocking patent.15 Where
    the owner of the blocking patent or exclusive licensee is
    different from the owner of the patent in suit, the granting
    of a license may be a realistic possibility. Even where,
    as here, the owner of the patent in suit and the exclusive
    licensee of the blocking patent are the same, such a
    potential innovator might or might not think it could
    successfully challenge the blocking patent. And such a
    potential innovator might or might not be willing to
    research in the blocked space without a license to a blocking
    patent—even if the research itself is within the safe
    harbor provided by 35 U.S.C. § 271(e)(1)—and wait until
    it has already developed and patented its aimed-at im-
    provement to negotiate for a cross-license with the blocking
    patent’s owner to share the profits from the improvement.
    Besides the assessment of whether the blocking
    patent can be successfully challenged, a number of variables
    appear generally relevant to the calculus, including:
    the costliness of the project; the risk of research failure;
    the nature of improvements that might arise from the
    project, and whether such improvements will be entirely
    covered by the blocking patent; the size of the market
    opportunities anticipated for such improvements; the
    costs of arriving at the improvements and getting them to
    market; the risk of losing the invention race to a blockingpatent
    owner or licensee; the risk that the blocking-patent
    owner (making its own economic calculations, perhaps in
    light of its own other products or research activities) will
    altogether refuse to grant a license to the improvement or
    will demand so large a share of profits that the whole
    project is not worthwhile for the potential innovator—all
    evaluated in light of other investment opportunities.
    For such reasons, it is clear that, if all other variables
    are held constant, a blocking patent diminishes possible
    rewards from a non-owner’s or non-licensee’s investment
    activity aimed at an invention whose commercial exploitation
    would be infringing, therefore reducing incentives for
    innovations in the blocked space by non-owners and nonlicensees
    of the blocking patent. Such a blocking patent
    therefore can be evidence that can discount the significance
    of evidence that nobody but the blocking patent’s
    owners or licensees arrived at, developed, and marketed
    the invention covered by the later patent at issue in
    litigation. But the magnitude of the diminution in incentive
    in any context—in particular, whether it was great
    enough to have actually deterred activity that otherwise
    would have occurred—is “a fact-specific inquiry.” Merck
    II, 874 F.3d at 731. That inquiry, conducted within the
    framework under which the challengers always retain the
    burden of persuasion on obviousness, may be a difficult
    one as a practical matter. In a particular case, a court
    may ultimately be left, for its evaluation, with the solid
    premise of diminished incentives, plus some evidence
    (possibly weak or ambiguous) about the significance of the
    deterrence, together with a background sense of the
    general realities in the area at issue that can affect the
    weight to be given to the evidence in the specific case.
    2
    Against this background, we review the district
    court’s consideration of objective indicia of nonobviousness
    in light of the Elan patent. Acorda licensed the Elan
    patent in the late 1990s, before the period of commercial
    success alleged by Acorda and found by the district court.
    Here, Acorda bore the burden of producing evidence of
    objective indicia, but the “ultimate burden of proving
    obviousness” at all times remained with the defendants.
    Galderma, 737 F.3d at 736–38. We conclude that the
    district court did not err in viewing the Elan patent,
    among other evidence, as evidence that discounted the
    weight of Acorda’s evidence of commercial success, failure
    of others, and long-felt but unmet need so that “the evidence
    as a whole” in the case “prove[d] clearly and convincingly
    that the Acorda Patents are invalid due to
    obviousness.” Dist. Ct. Op. at *41.
    The parties presented evidence on the objective indicia
    of commercial success, failure of others, and long-felt
    but unmet need.16 In particular, the defendants presented
    evidence of blocking by the Elan patent. See Dist. Ct.
    Op. at *38 & n.43 (undisputed that invention of Acorda
    patents practice the Elan patent).

    Judge Newman dissented.

    The district court observed that the objective indicia,
    viz. commercial success, long-felt but unmet need, failure
    of others, and copying, could change the result, yet discounted
    its weight on the theory that the patentee had a
    “blocking” patent. Adopting this flawed reasoning, my
    colleagues hold that this new treatment for multiple
    sclerosis was obvious. However, it is apparent that there
    is not clear and convincing evidence of obviousness.

    The consequences of this new legal theory are large,
    as the amici curiae advise. Had the court’s approach to
    the law of obviousness been in effect when Acorda took up
    the study of 4-aminopyridine after decades of failures by
    others, it is questionable whether this new treatment for
    multiple sclerosis would have been discovered and pursued.
    The loser is the afflicted public.1

    link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2078.Opinion.9-10-2018.pdf

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  • Dissecting Dissents for Ex Parte Appeals

    Dissent is not the highest form of judgment for judges on the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO).  As discussed in further detail below, our own analysis indicates that dissents for ex parte appeals are found in about .5% of decisions issued by the PTAB.  A PTAB judge deciding an ex parte appeal is more than ten times less likely to dissent than a Federal Circuit (CAFC) judge. Relying on internal USPTO policies and former PTAB judges’…

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  • Federal Circuit Affirms Award of All Litigation Fees and Costs

    The nonprecedential opinion in Large Audience Display Systems, LLC v. Tennman Productions, LLC, authored by Judge Linn and joined by Chief Judge O’Malley and Judge Hughes, was handed down on August 20.  The court finds no abuse of discretion in the finding of exceptionality and the award of $755,000 in fees and costs.  The principal bases for the finding of exceptionality were (1) the plaintiff’s opposition to a motion to transfer venue from the Eastern District of Texas to the Central District of California; (2) arguments relating to claim construction, made to the USPTO in the context of a reexamination; and (3) the plaintiff’s use of a privileged email.  The court concludes that “While we may have reached a different conclusion regarding exceptionality if we were evaluating the  parties’ arguments in the first instance, our review is limited to whether the district court, in considering the totality of circumstances, abused its discretion in reaching the conclusion that LADS’s conduct was exceptional under § 285. See Octane Fitness, 134 S. Ct. at 1756″ (p.6).  The court then goes on to find no abuse of discretion in the amount of the award:
    LADS next argues that the district court erred in awarding Tennman all of its requested fees, rather than those directly caused by LADS’s exceptional conduct. To support this proposition, LADS relies on Kilopass Tech., Inc. v. Sidense Corp., 738 F.3d 1302, 1313 (Fed. Cir. 2013), in which we explained that fees should “compensate a defendant for attorneys’ fees it should not have been forced to incur.” Tennman responds that nothing in § 285 requires a direct nexus between the exceptional litigation misconduct and the award, and that full fees are unavailable only where particular litigation misconduct forms the basis of the exceptional case determination and where the moving party only prevails on some of its patent claims, but that neither of these situations applies here. . . . 

    The district court applied a Lodestar analysis, which provides a presumptively reasonable fee award. . .  .  In addition to this presumption, we note that the district court has “considerable discretion” to determine the amount of fees under § 285, owing to its “superior understanding of the litigation and the desirability of avoiding frequent appellate review of what essentially are factual matters.” Bywaters v. UnitedStates, 670 F.3d 1221, 1228 (Fed.Cir.2012) (internal quotations omitted).

    The district court did not abuse its considerable discretion in awarding fees for the entire litigation. To begin, nothing in § 285 or our case law precludes such an award. . . .  The district court concluded that the factual bases for the exceptionality finding—from the venue fight, to the unreasonable claim constructoins [sic], to the use of the privileged email—“permeated” the entire litigation. As we have recognized, full fees may be awarded in such circumstances. . . . As discussed above, none of these findings were clearly erroneous (pp. 7-8).

    One thing the court notes in passing that I wasn’t aware of:  in discussing (and ultimately rejecting) the plaintiff’s arguments against the amount of the award, the court writes:

    Finally, LADS argues that the district court’s Lodestar analysis was flawed because . . . Tennman failed to prove its hourly rates, because the rates of timekeepers other than Langsam were supported solely by inadmissible hearsay from attorney website bios and the 2013 AIPLA Survey previously found unreliable by the Central District of California in Perfect 10, Inc. v. Giganews, Inc., No. 11-07098, 2015 WL 1746484 (C.D. Cal. March 24, 2015) . . . (p.9).

    The AIPLA Report of the Economic Survey, for those of you who aren’t aware of it, is an annual publication that provides survey evidence of the mean and median costs of various types of IP proceedings.  I cite it myself all the time as it relates to nationwide medians and means.  I looked at the district court opinion cited above, and while it does express some reluctance to use the survey to determine typical rates in a specific location, it doesn’t say that the AIPLA survey is unreliable as it applies to nationwide medians and means:
    iii. The AIPLA Economic Survey
    Perfect 10’s reliance on the AIPLA Economic Survey comes slightly closer to the mark in that it indicates average and median rates for intellectual property lawyers practicing in the Los Angeles area. (See Dkt. No. 650–2, Exh. 7.) However, in Los Angeles, the AIPLA survey only differentiates between partners and associates, without any differentiation based on years of experience. (Id.) And even in those two categories, the survey’s results are based on the reported rates of only 13 partners and 13 associates, hardly a representative sample of “prevailing market rates” in the Central District. (Id.)
    iv. Other Evidence of Prevailing Market Rates

    Because Mr. Mausner’s rates, the Laffey Matrix, and the AIPLA survey offer little to no insight on the actual prevailing market rates in the Central district of California for attorneys of equal experience, skill, and reputation, the Court looks to other evidence and concludes Defendants rates are reasonable. . . .

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