• PTAB Institutes CBM Review of Nasdaq Patents Challenged by MIAX
    in: 35 USC 101, Alice Analysis, CBM institution decisions, Covered Business Method, district of new jersey, Federal Circuit, Ineligible Subject Matter, IP News, IPWatchdog Articles, IPWatchdog.com Articles, NASDAQ, patent trial and appeal board, patents, PTAB Trials, Trading Technologies International v. CQG, US Supreme Court, validity  | 

    PTAB Institutes CBM Review of Nasdaq Patents Challenged by MIAX

    In early October, the Patent Trial and Appeal Board (PTAB) instituted a series of covered business method (CBM) reviews on patents owned by American stock exchange Nasdaq. The CBM reviews were petitioned by trading platform provider Miami International…

  • 次第に
    in:  | 

    次第に

                            目次はこちら

    次第に

    –>だんだん

    $$ As shown in FIG. 6, each channel 60 comprises a convergent inlet portion and a divergent outlet portion. / 図6に示されているように、各流路60は先が次第に細くなった入口部および先が次第に太くなった出口部を有している。(USP7213467): convergent/divergent

    (INCREASINGLY)
    $$ The use of carbon monoxide, smoke and fire detectors in homes has become increasingly common. / 家庭において一酸化炭素、煙、及び火災の検出器を使用することは、次第に一般的になってきている。(USP8860573)

    $$ At value greater than this thickness, nozzle resistance becomes increasingly significant, and efficiency is again reduced. / この厚さより大きな値で、ノズルの抵抗は、次第に顕著になり、そして能率は再び低下する。(USP8123337)

    $$ Thus standard techniques are becoming increasingly inadequate. / したがって、従来の構成では次第に不適当なものとなってきている。(USP8120867)

    (PROGRESSIVELY)
    $$ During this time the pink colouring became progressively stronger. / この間に、ピンクの色彩は、次第により強くなった。(USP8534133)

    $$ Clearly, as the number of levels increase then for a given number of conclusion sets at the least significant level, the number of level one conclusion sets becomes progressively diminished. / 明らかに、所定の最下位レベルの結論セットの個数に対して、レベル数が増加すると、それに伴い、レベル1の結論セットの個数は、次第に減少する。(USP7577673)

    (GRADUALLY)
    $$ The ratio decreases gradually across the rail seat region 2 from the edges 2c, 2d to the centre 2e of the rail seat region 2. / 上記の割合は、線路座部分2の縁2c、2dから中央2eまで線路座部分2に亘って次第に減少する。(USP8201751)

    $$ However, in specific tests, using apparatus similar to that of the invention, it was found that, without specific extra addition of gaseous oxygen, the fall in voltage 41 was gradually restored (FIG. 3). / しかし、本発明の装置と類似した装置を使用して行った特定の試験では、ガス状酸素を特別にさらに添加しなくしても、出力電圧の低下41が次第に回復されることが分かった(図3)。(USP5436086)

                            目次はこちら

  • Webinar on Confidentiality Agreements and Provisions

    McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on “Trust Everybody, but Cut the Cards” on October 20, 2015 from 10:00 am to 11:15 am (CT). In this presentation, MBHB attorneys Grantland G. Drutchas and James L. Lovsin will discuss confidentiality agreements and confidentiality provisions and the risks and unintended consequences of such agreements and provisions. Topics to be addressed in the webinar include: • Confidentiality Agreements — negotiation, preparation and risks • Ownership of follow-on IP • Monitoring • Enforcement — options, risks and outcomes • Derivation Actions — procedures, scope and appeals While there…

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  • Final Written Decision Finding Reference Qualified as Prior Art Based on Library Catalog IPR2014-00821 All challenged claims found unpatentable.

    Takeaway: Evidence establishing a specific date of cataloging and shelving before the critical date is desirable, but not required, in a public accessibility determination. In its Final Written Decision, the Board found all challenged claims of the ‘142 patent unpatentable … Continue reading

    The post Final Written Decision Finding Reference Qualified as Prior Art Based on Library Catalog IPR2014-00821

    All challenged claims found unpatentable.

    appeared first on PTAB Trial Blog.

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  • Plagiarism hinders scientific progress

    A post at dw titled Why painstaking detective work beats computer automation in the hunt for plagiarism concerning the copying allegations against German Defense Minister Ursula von der Leyen contains the text:


    VroniPlag was set up by Martin Heidingsfelder and is maintained by volunteers, who include, says the website, “the young and the old, men and women, scientists and non-scientists.”

    (…)
    Their motivation is simple. Plagiarism, says a detailed comment on the community website, hinders scientific progress.

    Clearly, simply copying the work of others does not advance scientific progress. Taking credit for the work of others is an additional problem. But, relevant to arguments of some patent reformers, ignoring the work of others (and re-inventing the wheel) does not advance scientific progress either.

    ** Of wheel re-invention, recall the IPBiz post Unintentional plagiarism, again with text


    In the realm of patent, of course, there is no independent creation defense. If one falls within
    the scope of a claim, one infringes, whether or not one knows about the claim.
    In theory, that encourages people to know the prior art and not waste time re-inventing the wheel.
    And recall the South Park episode relating to “the Simpsons already did it.”

    As to the classic demonstration, patent law rewards people for writing down their inventions
    in timely fashion, so one does not have fuzziness of who invented what when. And, did that
    classic experiment prove the unintentional character? Does it comment on the Poshard matter?

    Of spats about inventorship, take a good look the CAFC Shukh case of 2 Oct 2015:

    Dr. Shukh’s manager also indicated that
    Dr. Shukh demonstrated “unsatisfactory” teamwork
    skills, explaining that he “is often insistent on getting
    appropriate or complete credit for his work” and that he
    “repeatedly accused” Seagate workers of “stealing his
    work.” J.A. 5223;

    **See also the post at ScienceInsider

    German defense minister accused of plagiarism

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  • Granting In Part Additional Discovery Regarding Secondary Indicia IPR2015-00841

    Takeaway: Where a patent owner has proffered deposition testimony as relevant to secondary indicia of non-obviousness, the Board may determine that such documents are discoverable and relevant. In its Decision, the Board granted Petitioner’s Motion for Additional Discovery with respect … Continue reading

    The post Granting In Part Additional Discovery Regarding Secondary Indicia IPR2015-00841 appeared first on PTAB Trial Blog.

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  • CAFC in Shukh: concrete and particularized reputational injury can give rise to Article III standing

    SHUKH v. SEAGATE contains a most interesting discussion of
    inventor-employer interactions, in the context of a
    correction of inventorship case.

    From the decision–>


    Alexander Shukh appeals from the district court’s
    dismissal of some of his claims for failure to state a claim
    and its grants of summary judgment on his remaining
    claims in favor of the defendants, Seagate Technology,
    LLC; Seagate Technology, Inc.; Seagate Technology; and
    Seagate Technology PLC (collectively, “Seagate”).
    Dr. Shukh also appeals from several of the court’s discovery
    orders and other ancillary orders. For the reasons
    discussed below, we vacate and remand the court’s grant
    of summary judgment on Dr. Shukh’s claim for correction
    of inventorship under 35 U.S.C. § 256 and affirm its
    remaining holdings.

    BACKGROUND

    Dr. Shukh, a native of Belarus, is a leading scientist
    in the field of semiconductor physics, with a Ph.D. in
    Condensed Matter Physics and a B.S. and an M.S. in
    Electronics and Electronic Engineering. In 1997, Seagate
    recruited Dr. Shukh to move to the United States and
    work for it. Dr. Shukh was employed at Seagate from
    September 1997 until his termination in early 2009.
    During his employment, Seagate sponsored Dr. Shukh for
    an H-1B work visa, a visa extension, and eventually
    permanent residency.

    (…)

    He received numerous awards for his achievement and innovation generally and
    on specific products, and was named to the Seagate
    Technology Inventor’s Hall of Fame. The district court
    found that Dr. Shukh had a reputation as “an extremely
    successful innovator in the hard disk drives engineering
    community.” Shukh v. Seagate Tech., LLC, No. CIV. 10-
    404 JRT/JJK, 2013 WL 1197403, at *3 (D. Minn. Mar. 25,
    2013) (“Summary Judgment Order”).
    When he was hired, Dr. Shukh executed Seagate’s
    standard At-Will Employment, Confidential Information,
    and Invention Assignment Agreement (“Employment
    Agreement”), in which Dr. Shukh agreed to “hereby
    assign to [Seagate] all [his] right, title, and interest in and
    to any inventions” made while at Seagate. J.A. 600.
    Seagate policy prohibited Seagate employees from filing
    patent applications themselves for their inventions.
    Instead, they were required to submit Employee Invention
    Disclosure Forms to Seagate’s Intellectual Property
    (“IP”) Department. Inventors were responsible for identifying
    co-inventors of their inventions on these forms. The
    IP Department would then forward the form to the internal
    Patent Review Board, which would determine whether,
    for example, to pursue a patent application for the
    invention or to protect it as a trade secret.
    Dr. Shukh’s time at Seagate was undisputedly tumultuous.
    His performance evaluations indicated that he did
    not work well with others due to his confrontational style.
    Moreover, Dr. Shukh’s conduct interfered with his
    productivity. For example, Dr. Shukh applied a “threestrikes”
    rule to interactions with his coworkers, under
    which he would stop communicating with coworkers who
    had engaged three times in behavior he considered dishonest.
    Dr. Shukh also frequently accused others of
    stealing his work, and his managers criticized him for his
    insistence on receiving credit for his work. To avoid
    accusations of plagiarism, some Seagate employees refused
    to attend presentations by Dr. Shukh.
    In 2009, Seagate terminated Dr. Shukh and 178 other
    employees. Although he has submitted many job applications
    to other potential employers, Dr. Shukh has not yet
    secured employment. Dr. Shukh claims that the hiring
    manager of Hitachi, a company to which he applied,
    contacted a Seagate employee to discuss rumors the
    Hitachi manager had heard about Dr. Shukh. Moreover,
    a Hitachi engineer told Dr. Shukh during his interview
    that he would never find employment at Hitachi with his
    reputation.

    This lawsuit stems, in part, from Dr. Shukh’s allegations
    that Seagate has not properly credited him for his
    inventions.

    (…)

    In his original complaint, Dr. Shukh asserted thirteen
    claims against Seagate, including claims for correction of
    inventorship of the disputed patents pursuant to
    35 U.S.C. § 256, rescission of his Employment Agreement,
    breach of contract, fraud, breach of fiduciary duty, unjust
    enrichment, and federal and state retaliation and national
    origin discrimination claims.

    (…)

    Seagate moved to dismiss Dr. Shukh’s § 256 claim for
    lack of standing. Dr. Shukh alleged three distinct interests
    in the patents: an ownership interest, a financial
    interest, and a reputational interest. At the motion to
    dismiss stage, the district court held that Dr. Shukh had
    no ownership or financial interest in the patents because
    he automatically assigned all of his inventions to Seagate
    in his Employment Agreement. The court left open the
    possibility that Dr. Shukh had standing to sue based on
    reputational harm caused by his omission from the disputed
    patents. The district court also dismissed for
    failure to state a claim Dr. Shukh’s claims for rescission of
    his Employment Agreement, breach of contract, breach of
    fiduciary duty, unjust enrichment, and declaratory judgment.

    Two years later, Seagate moved for summary judgment
    on Dr. Shukh’s § 256 claim. The court granted
    Seagate’s motion, holding that there was no genuine
    dispute of material fact as to whether Dr. Shukh suffered
    reputational harm from not being named an inventor on
    the patents. Summary Judgment Order at *13. It also
    granted Seagate’s motion for summary judgment on Dr.
    Shukh’s fraud claim. One week later, the district court
    granted Seagate’s motion for summary judgment on Dr.
    Shukh’s federal and state retaliation and national origin
    discrimination claims.

    Of importance here –>

    Today, we hold that concrete and particularized reputational
    injury can give rise to Article III standing. As we
    noted in Chou, “being considered an inventor of important
    subject matter is a mark of success in one’s field, comparable
    to being an author of an important scientific paper.”
    254 F.3d at 1359. We reasoned that “[p]ecuniary consequences
    may well flow from being designated as an inventor.”
    Id. This is particularly true when the claimed
    inventor is employed or seeks to be employed in the field
    of his or her claimed invention. For example, if the
    claimed inventor can show that being named as an inventor
    on a patent would affect his employment, the alleged
    reputational injury likely has an economic component
    sufficient to demonstrate Article III standing.

    As to allegations about reputational injury:


    first, it harmed his reputation as an
    inventor in the field of semiconductor physics, and second,
    it contributed to his reputation for poor teamwork due in
    part to his accusations that others were stealing his work.
    Moreover, Dr. Shukh presented evidence from which a
    trier of fact could conclude that these reputational harms
    had economic consequences—namely, that Dr. Shukh was
    unable to find employment after he was terminated from
    Seagate

    Footnote 2 is of relevance to “invention disclosures” and
    “performance evaluations”:


    The district court discounted this evidence because
    the manager “clarified in his deposition testimony
    that he was concerned with the decrease in the number of
    invention disclosures that [Dr.] Shukh made to Seagate,
    and not concerned with the decrease in the total number
    of patent applications filed with the USTPO that listed
    [Dr.] Shukh as an inventor.” Summary Judgment Order
    at *12. In doing so, the district court improperly made a
    factual finding on summary judgment. Cf. Anderson, 477
    U.S. at 249–50. Moreover, this interpretation contradicts
    the plain language of the evaluation. The district court
    erred when it discounted Dr. Shukh’s performance evaluation
    at this stage.

    Of relevance to various bean-counting schemes, such as
    patent citation analysis:

    Finally, the court wrote that
    Dr. Shukh’s former co-workers testified that their impression
    of Dr. Shukh as an “excellent inventor with good
    technical skills” would not change based on the number of
    patents he was named on.

    The CAFC was critical of the way the district court
    handled summary judgment:

    In coming to this conclusion, the district court improperly
    made findings of fact on summary judgment and
    did not make all factual inferences in Dr. Shukh’s favor.
    A trier of fact could conclude that Dr. Shukh’s omission
    from the disputed patents had a concrete impact on his
    reputation in his field. There is significant evidence that
    the number of patents an inventor is named on influences
    his reputation in the field of the patents. Dr. Shukh’s
    professional reputation is based on his work in semiconductor
    physics—the same field as the disputed patents.
    Moreover, Dr. Shukh is named as an inventor on seventeen
    issued patents for work done at Seagate; he argues
    here that he should be named as an inventor on an additional
    six issued patents and four pending applications.
    The disputed patents would therefore form a significant
    portion of the patents granted to Dr. Shukh during his
    tenure at Seagate.

    True, it is undisputed that Dr. Shukh had a reputation
    as an excellent inventor, and that this reputation did
    not decrease while he was at Seagate. However, this does
    not mean that Dr. Shukh’s omission from the patents did
    not harm his reputation. The evidence supports the
    conclusion that Dr. Shukh’s reputation as an inventor
    would have been higher had he been named on the patents.

    (…)

    Dr. Shukh’s
    coworkers had years of experience working directly with
    Dr. Shukh, unlike potential employers, who likely lack
    that first-hand knowledge and are therefore more likely to
    rely on their knowledge of Dr. Shukh’s reputation in
    evaluating their impression of him. Considering all of the
    evidence, we find there is a genuine dispute of material
    fact as to whether Dr. Shukh’s reputation as an inventor
    was harmed by his omission from the disputed patents

    Part of a performance review of Shukh appears in the
    decision –>

    In his Fiscal Year 2007 Performance
    Evaluation, Dr. Shukh’s manager wrote:
    [Dr. Shukh’s] insistence on getting appropriate
    credit for all design ideas and implementations
    stifles open discussion and adoption of his ideas.
    Since this issue has become more important to
    [Dr. Shukh] as time goes on, and since he believes
    he has not been fairly recognized for his past contributions,
    it’s an emotional issue. Most unfortunately,
    it appears to others that [Dr. Shukh] is
    more interested in being right and in getting credit
    than in ensuring that Seagate wins.
    [Dr. Shukh] will become more effective, and his
    contributions will increase significantly, if he can
    find ways to let others see that he truly is inter-
    ested primarily in Seagate’s success, rather than
    in his own advancement or preventing theirs.
    J.A. 5222.

    Dr. Shukh’s manager also indicated that
    Dr. Shukh demonstrated “unsatisfactory” teamwork
    skills, explaining that he “is often insistent on getting
    appropriate or complete credit for his work” and that he
    “repeatedly accused” Seagate workers of “stealing his
    work.” J.A. 5223; see also Summary Judgment Order
    at *4. Dr. Shukh argues that if he is named an inventor
    on the disputed patents, it may rehabilitate his reputation
    for seeking credit for his ideas.

    Finally, Dr. Shukh presented evidence that his alleged
    reputational harm had an economic component.
    Dr. Shukh has been unemployed since 2009, and he seeks
    a job in the field of technology covered by the disputed
    patents. A trier of fact could infer that the stronger
    Dr. Shukh’s reputation as an inventor, the more likely he
    is to be hired. This is particularly true in light of his
    difficult personality. Furthermore, there is evidence tying
    Dr. Shukh’s negative reputation at Seagate—including,
    one presumes, his reputation for seeking credit for his
    own inventions—to his unemployment. Summary Judgment
    Order at *5 (writing that an engineer at a company
    Dr. Shukh interviewed with allegedly told Dr. Shukh that
    he would never get a job there because of his reputation
    at Seagate). Thus, a trier of fact could conclude that Dr.
    Shukh’s employment prospects have been harmed by the
    impact of his alleged omission from the disputed patents
    on his reputation as an inventor and his reputation for
    seeking credit for his own ideas. Moreover, a trier of fact
    could infer that Dr. Shukh’s employment prospects would
    improve if the inventorship of the disputed patents was
    corrected. Dr. Shukh’s inability to obtain employment is
    a concrete and particularized financial harm that suffices
    to create Article III standing.

    Link to case
    http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1406.Opinion.9-30-2015.1.PDF

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  • Show Me the Money: Reasonable Royalty Damages Vacated Due to Much Higher Infringer’s Total Profits

    Author: Christopher B. McKinley Editor: Lauren J. Dreyer In Nordock v. Systems, No. 14-1762 (Fed. Cir. Sept. 29, 2015), the Federal Circuit affirmed that there is no apportionment of “total profits” awards under 35 U.S.C. § 289 in design patent infringement. In this case, Nordock sued Systems for infringing its design patent covering ornamental features […]

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  • Interviews: Google Speaks On Need For Balanced IP System; EPO On “Tomato II” Case, Board Of Appeal Revamp

    COPENHAGEN – Google is “really looking for a balanced IP system,” the company’s head of litigation told the Global Patent Congress, while the European Patent Office elaborated on the “Tomato II” case, which for civil society has become the very symbol of an imbalanced IP system. Intellectual Property Watch spoke with senior officials at both Google and the EPO at the conference.

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  • Insufficient Nexus Was Found for Secondary Considerations in Final Written Decision IPR2014-00679

    Takeaway: The granting of an injunction in a related proceeding, without more, does not demonstrate a nexus between the claimed subject matter and the objective evidence of a secondary consideration of industry praise and acceptance. In its Final Written Decision, … Continue reading

    The post Insufficient Nexus Was Found for Secondary Considerations in Final Written Decision IPR2014-00679 appeared first on PTAB Trial Blog.

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  • PTAB zaps claims on on Novartis’ multiple sclerosis blockbuster Gilenya in IPR

    In IPR2014-00784 on US Patent 8,324,283, PTAB found claims 1–32 of US ‘283 unpatentable.
    MS drugs are a big deal economically; the current market for MS drugs is worth an estimated $20 billion a year.

    This oral drug for treating MS comprises a sphingosine-1
    phosphate (S1P) receptor agonist and a sugar alcohol. Ex. 1001, 1:11–14,
    1:33–35. “The sugar alcohol may act as a diluent, carrier, filler or bulking
    agent, and may suitably be mannitol.”

    PTAB noted


    We disagree, however, with Patent Owners’ argument that the
    inventors’ mere discovery of a new reason to combine fingolimod and
    mannitol renders nonobvious an invention that was known in the prior art.
    Where the prior art teaches the claimed invention, a claim is not rendered
    patentable by virtue of being motivated in the inventors’ minds by a newlydiscovered
    advantage of the prior-art combination; allowing such a claim to
    stand “would remove from the public that which is in the public domain.” In
    re Wiseman, 596 F.2d 1019, 1022 (CCPA 1979); see also Cross Med.
    Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed.
    Cir. 2005) (“One of ordinary skill in the art need not see the identical
    problem addressed in a prior art reference to be motivated to apply its
    teachings.”)

    As explained
    above, though, it does not matter that the prior art failed to recognize this
    advantage of a fingolimod-mannitol combination. “[T]he motivation in the
    prior art to combine the references does not have to be identical to that of the
    [patentee] to establish obviousness.” In re Kemps, 97 F.3d 1427, 1430 (Fed.
    Cir. 1996)

    Of long-felt need:


    Next, Patent Owners argue that the invention claimed in claim 19
    satisfied the long-felt but previously unmet need “for a solid oral [multiple
    sclerosis] treatment.” PO Resp. 55 (citing Ex. 2044 ¶¶ 25–27). The
    supporting evidence is a declaration stating that “some patients are resistant,
    afraid, or even unwilling to use needles,” which caused some patients to
    “drop[] the [multiple sclerosis] treatment”; that “parenteral medications were
    universally inconvenient,” making patients less likely to take their
    medication; and that “there were a number of side effects commonly
    associated with parenteral [multiple sclerosis] treatments” that “discouraged
    patients from continuing with their prescribed course[s] of treatment.”
    Ex. 2044 ¶¶ 25–27. Although no other evidence is cited in Patent Owners’
    briefing,21 additional record evidence shows that patients asked about the
    availability of an oral medication as early as 1993, id. ¶ 34, and that the
    introduction of the first oral medication in 2010 caused a “‘major shift in the
    treatment landscape,’” with “‘many patients . . . switching to oral therapy,’”
    id. ¶ 37 (quoting Ex. 2012, 1).
    Petitioners argue, Reply 18–19, that there is no evidence that the longfelt
    need was for claim 19’s combination of fingolimod and mannitol;
    instead, as Patent Owners acknowledge, PO Resp. 55, the need was merely
    “for a solid oral [multiple sclerosis] treatment.” According to Petitioners,
    any need for a solid oral dosage form of a multiple sclerosis treatment was
    satisfied by treatments that were known in the prior art but did not receive
    FDA approval until after Patent Owners’ Gilenya product did. Reply 18–19.
    Therefore, argue Petitioners, there was no longer any long-felt need by the
    time of the invention claimed in the ’283 patent. Id

    AND

    In 1999, Chiba itself suggested treating multiple
    sclerosis using a solid oral form of fingolimod. Ex. 1006, 6:26–49, 8:19–26.
    In addition, teriflunomide, marketed in solid tablet form as Aubagio®, was
    known in the prior art at least by April 1, 2002, when it was disclosed to be
    useful for treating multiple sclerosis when administered in tablets or
    capsules. Ex. 1037, at [22], 1:19–30, 2:60–3:2, 5:1–21; Ex. 2045 ¶ 63.22
    Similarly, a capsule form of dimethyl fumarate for the treatment of multiple
    sclerosis, marketed as Tecfidera™, Ex. 1070, 2, was disclosed in U.S. Patent
    No. 6,509,376 B1, issued January 21, 2003. Ex. 1097, at [45], 2:64–67,
    4:25–27, 4:31–33.

    (…)

    Industry praise must be linked to the patented invention. Power-One,
    Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1352 (Fed. Cir. 2010). Again, if
    objective indicia of nonobviousness are “due to an element in the prior art,
    no nexus exists.” Tokai Corp., 632 F.3d at 1369. Here, the evidence shows
    that what was praised about Gilenya was not the specific formulation recited
    in claim 19, but rather the general fact that Gilenya was a solid oral multiple
    sclerosis medication. As discussed above, however, a solid oral multiple
    sclerosis formulation was known in the prior art, so there is no nexus
    between the claimed invention and the industry praise.

    Tysabri (natalizumab ) is mentioned


    In either case, Dr. Blackburn excluded
    from his analysis any data regarding sales of Tysabri, id. ¶ 20 n.24,24
    a
    multiple sclerosis drug that generates more than $1 billion in annual sales,
    Ex. 1041 ¶ 38; Ex. 1057, 5–6; Ex. 1058, 37. Dr. Blackburn’s evidence of
    Gilenya’s market share is biased towards more significant sales of Gilenya
    by this exclusion and, thus, is unreliable as evidence that Gilenya’s sales are
    significant in relation to the relevant market as a whole.

    As to amendment:


    Because we find each of claims 1–32 unpatentable, we next address
    Patent Owners’ motion to amend, in which claims 33–64 are proposed.
    Motions to amend are permitted by 35 U.S.C. § 316(d) and 37 C.F.R.
    § 42.121. In moving to amend their claims, as the moving the party, Patent
    Owners have the burden to show entitlement to the relief requested. 37
    C.F.R. § 42.20(c). “The burden is not on the petitioner to show [the]
    unpatentability [of the proposed claims], but on the patent owner to show
    patentable distinction over the prior art of record and also [the] prior art
    known to the patent owner.” Idle Free Sys., Inc. v. Bergstrom, Inc., Case
    IPR2012-00027, slip op. at 7 (PTAB June 11, 2013) (Paper 26)
    (representative). The “prior art of record” includes “any material in the
    prosecution history of the patent,” “any material art of record in the current
    proceeding, including art asserted in grounds on which the Board did not
    institute review,” and “any material art of record in any other proceeding
    before the Office involving the patent.” MasterImage 3D, Inc. v. RealD
    Inc., Case IPR2015-00040, slip op. at 2 (PTAB July 15, 2015) (Paper 42)

    ***Gilyena is for relapsing remitting MS [“RRMS”]. Forbes noted a possible
    game changer as to primary progressive MS, with new results on ocrelizumab [by Roche / Biogen], which
    is a humanized anti-CD20 monoclonal antibody, which targets mature B lymphocytes:


    On Monday [28 Sept 2015], the company disclosed that its experimental multiple sclerosis treatment ocrelizumab has become the first therapy to hit the main endpoint in a large Phase III study for primary progressive MS. This form of the disease accounts for between 10% and 15% of all MS patients, but is devoid of effective therapies.

    As such, ocrelizumab is looking like an increasingly significant future sales growth driver for Roche, capable of generating multi-billion dollar sales on a global basis. In June, the company announced that two Phase III studies in the more common form of relapsing remitting MS had hit their primary and key secondary endpoints. Full data from each of the late-stage trials will be presented at next month’s annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

    CD-20 immune cells are thought to be a key contributor to myelin and axonal damage in MS.

    Forbes noted that ocrelizumab might compete against Tysabri in the RRMS market :


    In the larger RRMS market, there is a growing consensus that ocrelizumab will gain an initial foothold in second-line patients and compete primarily with Biogen’s Tysabri. Roche’s drug offers comparable efficacy, but what appears to be a notably superior safety profile. Furthermore, while Tysabri is dosed once a month, ocrelizumab is administered twice a year.

    Another monoclonal antibody for MS is alemtuzumab (Lemtrada) which binds to CD52, a protein present on the surface of mature lymphocytes,

    See the story from 14 Nov. 2014 Sanofi’s Lemtrada Wins U.S. Approval to Treat MS which includes the text:

    There are about 10 treatments for relapsing-remitting MS, in a market estimated at $16 billion, including Avonex made by Biogen Idec Inc. and Copaxone from Teva Pharmaceutical Industries Ltd. Multiple sclerosis, a neurological disease that can cause severe disability, affects as many as 350,000 people in the U.S. and is twice as likely to occur in women, according to the National Institute of Neurological Disorders and Stroke.
    Patients receive five infusions of Lemtrada in the first year, followed by three more a year later. Data presented at a meeting in September showed that 70 percent of those involved in the key clinical trials of the drug didn’t require any additional treatment after the first two years. The drug will cost $158,000 over the two years, compared with about $135,000 for Merck KGaA’s Rebif, Sibold said.

    “We could see that this would become the most cost-effective, least-expensive, highest-value product over time,” he said.

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  • The CAFC affirms D. Nev. in Spectrum case on Leucovorin

    From SPECTRUM PHARMACEUTICALS, INC. v. Sandoz, concerning the
    drug Leucovorin, which is used to ameliorate the toxic effects
    of methotrexate.

    –>
    Spectrum Pharmaceuticals, Inc. (“Spectrum”) appeals
    from the decisions of the United States District Court for
    the District of Nevada holding claims 1–2 of U.S. Patent
    6,500,829 (“the ’829 patent”) invalid as obvious, and
    finding claims 5–9 of the ’829 patent not infringed by the
    submission of an Abbreviated New Drug Application
    (“ANDA”) by Sandoz Inc. (“Sandoz”). Spectrum Pharm.,
    Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2015 WL 794674
    (D. Nev. Feb. 25, 2015) (“Trial Order”); Spectrum Pharm.,
    Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2014 WL 7368845
    (D. Nev. Dec. 29, 2014) (“Summary Judgment Order”).
    Because the district court did not err in concluding that
    claims 1–2 are invalid, and additionally did not clearly err
    in finding claims 5–9 not infringed by Sandoz’s ANDA
    product, we affirm.
    B

    During prosecution of the application that became the ’829 patent, the examiner rejected the application’s claims as anticipated by or obvious over an article disclosing an enzymatic synthesis technique by which 0.91 grams of lleucovorin had been synthesized.

    At trial:


    Sandoz stipulated to infringement of claims 1 and 2, and the district court subsequently conducted a bench trial only on the validity of those claims. The court found that the prior art disclosed: (i) leucovorin as a mixture of (6R) and (6S) diastereoisomers; (ii) that the therapeutic usefulness of leucovorin derives wholly from the (6S) isomer; and (iii) a rationale for investigating a purified (6S) isomer product for use in 5-FU combination therapy. Trial Order at *6–8, *13–14. The court also found that preparations of purified (6S) isomer by an enzymatic synthesis method and by separation methods had been publicly reported before the ’829 patent’s priority date. Id. at *6–7. In particular, the court analyzed two related prior art references that disclosed a process for separating the diastereoisomers using the solubility differential of the (6S) and (6R) isomer salts, i.e., fractional crystallization. See id. at *11–13 (findings relating to Donna B. Cosulich, Diastereoisomers of Leucovorin, 74 J. Am. Chemical Soc’y 4215–16 (1952) and U.S. Patent 2,688,018 (collectively, “Cosulich” or “the Cosulich references”)).

    The arguments in this case are a bit unusual:

    Sandoz responds that the district court correctly found that one of skill would have been motivated to make substantially pure (6S) leucovorin starting with the 50/50 mixture to have a more effective pharmaceutical treatment, and would have reasonably expected to succeed in doing so. Sandoz contends that it had no burden to show a motivation to contaminate the prior art pure (6S) isomer compound, because the court’s analysis began with the 50/50 mixture and rejected Spectrum’s arguments on the inoperability of the prior art. Moreover, Sandoz argues, the court found no patentable difference between the claimed substantially pure compound and the prior art pure compound, which presented a prima facie case of obviousness that Spectrum failed to rebut.

    Most issues relating to purified diastereoisomers or enantiomers involve the question whether a pure, resolved compound would have been obvious over the corresponding mixture. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301–03 (Fed. Cir. 2007);

    (…)

    This case is unusual in involving a slightly different question, namely, whether a substantially pure compound would have been obvious when both the 50/50 mixture and the pure compound were known in the art. We agree with the district court that the claimed substantially pure compound would have been obvious over both the 50/50 mixture and the pure (6S) isomer compound in the prior art. First


    Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material—that position, despite its superficial appeal, is not persuasive.

    (…)

    In the face of that evidence of obviousness, Spectrum did not provide any evidence of unexpected results for the substantially pure compound as compared to the 50/50 mixture or the 100% pure compound.

    Note:

    We owe the district court’s factual findings considerable deference on appeal, and we see no clear error based on the record before us. Based on those findings, we affirm the district court’s conclusion that Sandoz proved by clear and convincing evidence that claims 1 and 2 of the ’829 patent are invalid as obvious.

    link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1407.Opinion.9-30-2015.1.PDF

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  • Coca cola in the cloud?

    Within an article on trade secrets in the cloud, one finds the text:


    If Coca-Cola were to disclose its secret formula to an outsider, it may no longer be able to protect it as a trade secret in a suit for misappropriation, for example. Generally, unless subject to a confidentiality agreement, the disclosure of a trade secret to a third party can render the information no longer protectable.

    The Coca-Cola story reveals an interesting problem. Some have alleged that the Coca Cola formula was disclosed in the
    Atlanta Constitution in the February 28, 1979 issue. Now in the presence of an asserted disclosure is the trade secret holder going to say “you got me” or instead, “no, that isn’t it”?

    As to the cloud issue, JDSupra wrote:


    So the question becomes: is a cloud service provider a third party? When a trade secret owner stores a trade secret in the cloud, and effectively “discloses” the information to the cloud service provider, has secrecy been lost? Courts have not had a chance to answer this definitively. The outcome may hinge on the often boilerplate Terms of Use agreements associated with cloud service providers. Unfortunately, such agreements often disclaim any liability on the cloud service provider for loss of confidential information. This may render it difficult for trade secret owners to argue that secrecy was not lost and that reasonable efforts to maintain secrecy were exercised for trade secrets that are or were at any time stored in the cloud.

    link: https://www.blogger.com/blogger.g?blogID=7478238#editor/target=post;postID=8723613377859812953

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  • Final Written Decision Finding All Challenged Claims Unpatentable CBM2014-00060

    Takeaway: A declaration submitted to the PTO by or on behalf of a patent owner is not hearsay because the submission evidences the patent owner’s belief that the statements contained within the declaration were true. In its Final Written Decision, … Continue reading

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  • Innovation in Latin America: the tunnel may still be there, but the light is still burning

    The following report was provided by Felix Rozanski, based in Buenos Aires, who is the Coordinator at the Study Center CEDIQUIFA and Secretary of ASDIN (Intellectual Rights Association).

    The Sixth Annual Latin America Seminar on “The Value of Intellectual Property for Innovation and Health” was recently held at Cayetano Heredia University in Lima, Peru. A varied group of public officials, judges and experts from throughout Latin America gathered to discuss the promotion of innovation, particularly from the perspective of the legal tools offered by patents and other rights available under the intellectual property regime. The process of awareness about the value of innovation and intellectual property can be said to have started in Latin America with the conclusion of the negotiations over the establishment of the World Trade Organization and TRIPs Agreement in 1995, this despite the fact that portions of these arrangements were (and to some extent still are) strongly resisted by many emerging economies. The bilateral trade agreements concluded with the United States after TRIPs, the educational campaign implemented by WIPO, the support provided by the lines of credit made available by the World Bank and the Inter-American Development Bank, as well as lessons learnt from the success of such countries as Israel, South Korea and Singapore, have been key contributory factors.

    It is encouraging to note that a number of Latin American governments are giving explicit recognition to the crucial importance of innovation for increasing competitiveness and promoting growth at the national level. Therefore, although the proportion of investments directed to promoting innovation is still relatively low, the trajectory is positive and at an increasingly higher rate. Thus, it is currently estimated that investment in innovation in the region as a whole is 0.68% of the growth domestic product (GDP) (versus between 2% to 4% in more developed innovative economies). Only Brazil has reached a level of investment of more than 1% of GDP (albeit before its current economic crisis). In particular, the pharmaceutical sector continues being a major actor in private R&D investment. For example, in Chile, R&D in pharma and biotech is at the top of private investment in innovation (14.38%), followed by software (9.86%).

    Still, Latin America continues to wrestle with the problem of how to attract private investment for R&D activities in the region. It is officially estimated that two-thirds of investments in innovation are made by the public sector, while informal estimates suggest that private investment is only about 20% of the total R&D. Regarding how innovation is promoted, each country in the region continues to set its own policies. For example, Peru has approved new tax incentives for R&D investments, effective as of January 1, 2016. Argentina also developed a scheme of providing tax benefits to promote biotech projects, but the law was not implemented. In Chile, research by the public agency CORFO has revealed that R&D-subsidized projects tend to cease as soon as the subsidies come to an end. In Ecuador, an innovative government scheme to hire retired senior experienced researchers to train and help design projects is facing strong headwinds in the face of plummeting international oil prices.

    At the intra-country level, there is little coordination among the relevant national agencies in designing and implementing innovation promotion policies, and often such agencies work at cross purposes. There is even less collaboration among countries in the region; mistakes made in one country may be simply repeated in another. An independent Observer monitoring the processes of innovation in the region may be helpful. Such a proposal was made during the Seminar to the Peruvian representative of the Pacific Alliance Free Trade Agreement, comprising Colombia, Chile, Mexico and Peru. Indeed, the Pacific Alliance may be a good opportunity for more extensive collaborations, but to bring it to fruition both the academic and private sectors will need to be more actively engaged. At the enterprise level, only a few firms with activities across Latin America are involved in innovation. On the whole, private companies in the region still must still work on how to develop an innovation culture. Designing realistic long-term innovation strategies is necessary as is better training of staff to support such efforts. As mentioned, finance for innovation projects continues being scarce and while there are many startups in the region, few can be described as engaged in technology. Still, the forecast is that more Latin American companies will be investing in R&D in the future. 

    As for IP, the biggest challenges are fragmentation at both the intra-national and transnational levels within the region as well inconsistent treatment of IP rights. For instance, regarding incremental inventions, such as new uses, there are substantial differences in the way that Mexico and Brazil deal with them, on the one hand, as compared with Argentina on the other, which provides thin patent protection for pharmaceutical and biotech inventions. Moreover, studies point to the fact that IP rights and the advantages that they offer for innovation and development are still poorly appreciated by public and private researchers in the region. 

    At the most basic level, empirical data indicate that better IP effective protection means more foreign direct investment, which is essential for the region, even more so when growth is slowing. In this vein, the myth that patents work against access to medicines is strongly entrenched. In addition, confusion reigns between the process of patent grant and health-marketing authorization. The result is that there are far too few patents being issued. It is estimated that Latin America registers annually a total of 1,400 national patents. In contrast, a country such as South Korea, with less than 10% of the total Latin American population, registers more than 20 times the number of patents. Against this backdrop, the promotional and educational efforts made by the various national IP agencies should be expanded.

    A particularly interesting panel at the Seminar dealt with compulsory licenses. The panel discussed the regime currently applied in Ecuador, where 33 applications for compulsory licenses of pharmaceutical products have been filed, out of which eight have been withdrawn by the applicants, five refer to patents that have ready already expired, ten have already been granted by the Patent Office, while the rest are in the grant process. In contrast, in other Latin American countries, such as Peru and Colombia, applications for compulsory licenses have been far less successful due to the failure by the applicants to provide sufficient supporting the request. Moreover, the regulatory regime for the compulsory licenses in place in Ecuador (Instruction 10-04 issued by IEPI, the I.P. Agency) is not consistent with international and national legislation, with the result that the granting of compulsory licenses under this provision has the perverse effect of de facto abrogating rights in pharmaceutical patents. In doing so, the end result is to send a negative message to foreign investors as to their property rights in Ecuador.

    As for the protection of test data, the regulations in force in those Latin American countries that do accept test data protection for the registration of pharmaceuticals by the health authorities restrict such protection to new molecules. Here again, there is a contradiction between government efforts to promote innovation while, at the same time, not providing data protection for incremental innovations, which may well make more sense for developing countries than the invention of an entirely new molecule. In this regard, it is noted that Argentina and Brazil do not grant any type of test data protection for pharmaceuticals.

    Overall, the principal take-away from this year’s seminar is that there is much work to do in the region to meet the challenge of attracting more private R&DS investments for innovation.

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  • Board Uses Discretion to Deny Institution of Petition That is Redundant to Prior Petition CBM2015-00039

    Takeaway: The Board may exercise its discretion to deny institution of covered business method patent review where the petitioner cites different prior art references from another proceeding in which it is also a party, but the different prior art references … Continue reading

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  • Institution Denied With Insufficient Evidence of Public Accessibility of Printed Publications IPR2015-00329

    Takeaway: At the institution phase of a proceeding, the Board may accept the presence of a copyright notice, together with the listing of the reference in an IDS, as some evidence of public accessibility as of a particular date. In … Continue reading

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