• China Acquires Nineteenth Century U.S. Patent Models for Traveling Innovation Museum

    In recent weeks we’ve learned that U.S. patent models are beginning to find a new audience in China’s growing inventor class. The Chinese expect the exhibits to raise awareness on innovation and patent protection among Chinese residents and to help build an innovative economy.

    The post China Acquires Nineteenth Century U.S. Patent Models for Traveling Innovation Museum appeared first on IPWatchdog.com | Patents & Patent Law.

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  • Section 101’s Absurdities

    Rant warning.

    Over on the main page, Dennis has pointed out that a cert petition including citations to my posts here about why Section 101 is not a “defense” to infringement, and to the recent CAFC cases about why 101 includes factual inquiries.  This rant is about those issues.

    Let me start there.  That 101 contains factual inquiries is the exact point Judges Rader and O’Malley made years ago, relying on Judge Lourie’s opinion from Alice five times:

    [A]s is shown more fully below, the analysis under § 101, while ultimately a legal determination, is rife with underlying factual issues. For example, while members of this court have used varying formulations for the precise test, there is no doubt the § 101 inquiry requires a search for limitations in the claims that narrow or tie the claims to specific applications of an otherwise abstract concept. CLS Bank, __ F.3d at __, 2013 WL 1920941,  at *27-30 (meaningful limitations); Id. at *10 (opinion of Lourie, J.). Further, factual issues may underlie determining whether the patent embraces a scientific principle or abstract idea. Id. (opinion of Lourie, J.) (“The underlying notion is that a scientific principle .

    Continue reading Section 101’s Absurdities at Patently-O.

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  • Use of Experts at Mediations

    I serve as an expert witness in patent suits and in legal malpractice cases/ethical issues relating to them (and general ethical matters).  Twice in the past year or so I’ve been asked to attend mediations as an expert, and sometimes to talk in the opening sessions and at another to simply talk to the mediator in the “closed” sessions.  I had thought it odd, but then read this article (hopefully here and not behind a paywall) which suggests that it’s good practice to have an expert at mediations.

    To do so competently, the article explains that ahead of time the lawyers should agree on a process that avoids creating a cross-examination proceeding, but to also allow legitimate inquiry.  The goal, as the article put it:

    First, to explore the possible weaknesses in the factual and technical underpinnings of the experts’ positions. And, second, to build a working knowledge of each expert’s strongest points in order to be able to best convey them to the other side.

    Given that most cases settle, and given the importance of experts in patent suits generally, I thought this was an interesting observation and perhaps explains why I’ve been to mediations lately.  

    Continue reading Use of Experts at Mediations at Patently-O.

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  • Mayo/Alice ‘Directed to’ Inquiry and a Split Federal Circuit: Vanda Pharma v. West-Ward Pharma

    n Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being directed to a judicial exception in step one of the Mayo/Alice test. What differences between the claims in Vanda and those in CellzDirect led Judge Prost to dissent? Can these differences shed further light on the characteristics necessary for a claim to be found not directed to a patent-ineligible concept in step one?

    The post…

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  • TC Heartland Update: Federal Circuit decides ZTE and Bigcommerce

    Of the many lingering issues left in TC Heartland’s wake for domestic corporations, a Federal Circuit panel resolved several of them recently. In In re ZTE (USA), No. 2018-113, the court addressed two of the most common issues dogging appeals over the application of § 1400(b): whose law governs burden, and where does that burden lie. In In re Bigcommerce, No. 2018-120, the court addressed the territorial bounds mapped by the phrase “judicial district” in § 1400(b). Judge Linn authored…

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  • Doudna, of CRISPR fame, shares in Kavli prize

    Berkeley.edu notes:

    The $1 million award, announced May 31, will be shared by Doudna,
    a professor of molecular and cell biology and of chemistry at the University of California, Berkeley,
    Emmanuelle Charpentier of the Max Planck Society and Virginijus Šikšnys of the Institute of Applied Enzymology in Vilnius, Lithuania.

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  • Patents on drugs are not the only issue in the release of generic formulations

    In a post titled The Myth of ‘Trivial’ Drug Patents , David Forman writes on IPWatchdog:

    Follow-on patents are improvements on the original drug. Well-known examples of an improved formulation
    are modified release formulations that may allow a patient to take a single pill rather than several pills a day.
    Sometimes these are made by applying what may have become well-known methods for making modified release pills,
    and as such may not be patentable. But if a new modified-release formulation would not have been obvious
    and predictable from the prior art methods of making modified-release formulations, then it can be separately patentable.
    Once the original patent expires the patent law does not prevent a generic competitor from making a generic version
    of the original drug. Some critics complain that they should have the right to make not merely
    the previously patented FDA-approved drug, but also the still-patented improvements.
    This argument ignores that the public can choose between the generic version of the older
    but effective drug and the convenient but more expensive patented version.
    There is nothing unfair about this market choice. If the generic manufacturer is dissatisfied
    it can challenge the validity of the modified-release patent in an ANDA case in district court
    or file an IPR in the USPTO. Challenging the patent in these forums is expensive
    but the costs are small compared to the amount that the generic manufacturer has saved
    in the costs of discovering, developing, and gaining FDA approval of a pharmaceutical.

    Back in September 2015, Gene Quinn at IPWatchdog wrote of an IPR petition by Kyle Bass challenging
    US Patent 8,399,514 on the multiple sclerosis [MS] drug Tecfidera in the post With dubious logic and inaccurate statements of law,
    PTAB denies another Kyle Bass IPR petition
    , which petition relied on prior art by one Dr. Ludwig Kappos, an
    expert in the field of multiple sclerosis:

    Kappos was summarily dismissed by the Board. Under the first rationale it was dismissed
    because the entirety of the study wasn’t provided, and in the second rationale it was dismissed
    because the written description constituted nothing more than prior use. Put aside for a moment
    that neither of those conclusions make any sense under any reading of U.S. patent law, which is
    indeed problematic in its own right. What is really bizarre is that under the third rationale
    Kappos is now characterized as constituting “a description.” Frankly, it seems the Board
    wanted to have their cake and eat it too. Kappos cannot merely be about prior use if the Board
    itself is relying on the description, which they have to realize is in writing as they are reading it.
    Clearly the description of the Phase II pilot study is and should have been considered to be prior art.

    this IPR institution denial decision has numerous logical and legal flaws. Clearly,
    the description of the Phase II clinical trial was a publication that can be used
    as prior art in an IPR proceeding. The petitioner submitted journals going back years
    all teaching DMF as a means to treat multiple sclerosis. Thus, I have to wonder whether
    this decision has more to do with Kyle Bass than with the law.

    Given that IPR institution decisions are not appealable there will never
    be a check on the egregious mistakes made by the Board in this situation.

    IPBiz also discussed the problematic nature of this decision by PTAB in the
    PTAB declines to institute IPR against Biogen’s US 8,399,514 related to the MS drug Tecfidera

    Kyle Bass later had a different petition on the Tecfidera patent granted, but failed in his attempt
    to invalidate the claims of the ‘514 patent.
    Kyle Bass loses challenge to MS drug Tecfidera on US Patent 8,399,514 in IPR2015-01993

    An article by R. P. Spencer [ Pharm Pat Anal. 2014 Mar;3(2):183-98 ] discloses part of the history of Tecfidera and shows that issues
    other than patent protection delay entrance of competitors:

    As a case study of patent coverage for a repurposed drug, Biogen Idec’s approach for Tecfidera(®),
    an oral formulation of dimethyl fumarate, was analyzed. While mixtures of fumarates have been used
    for over 50 years to treat psoriasis, Tecifidera is approved for the treatment of
    relapsing-remitting multiple sclerosis. Biogen pursued claims to pharmaceutical formulations
    and useful doses for treating multiple sclerosis, an approach that is relevant to pharmaceutical
    lifecycle management in general. A survey of recent US, EP, and PCT patent applications indicate
    other companies are developing competing fumarate formulations. While it is possible to pursue secondary patents
    for compounds without composition of matter coverage, regulatory data exclusivity provides additional protection to delay competitors.

    Of re-purposing, one notes that the costs of trials can far exceed the cost of drug discovery [related to Forman’s text:
    gaining FDA approval]

    As to FDA regulations, one notes that Tecfidera was one of two MS related drugs to appear on the FDA’s
    list of Reference Listed Drug (RLD) Access Inquiries.
    See The Trump FDA publishes list of Reference Listed Drug (RLD) Access Inquiries

    As to a choice “between the generic version of the older
    but effective drug and the convenient but more expensive patented version,” see some of
    the discussion surrounding the drug — tenofovir alafenamide fumarate (“TAF”)– compared with the drug –tenofovir disoproxil fumarate (“TDF”), a component of Truvada. Truvada made the recent FDA list of Reference Listed Drug (RLD) Access Inquiries (with no REMS issue). The FDA approved generic Truvada in 2017, with Teva and Gilead making a deal. Some of the lawsuits involving Gilead and TAF are over issues other than patents,
    including asserted ethics issues of delaying market entry of a drug with superior safety profiles.

    ***Separately from the May 2018 white paper of HHS as to costs to drug consumers, American Patients First :

    Consumers who have not met
    their deductible or are subject to
    coinsurance, pay based on the
    pharmacy list price, which is not
    reduced by the substantial drug
    manufacturer rebates paid to PBMs
    and health plans. As a result, the
    growth in list prices, and the widening
    gap between list and net
    prices, markedly increases consumer
    out-of-pocket spending,
    particularly for high-cost drugs
    not subject to negotiation.
    This is not only a fnancial challenge,
    but a health issue as well: One
    study found that consumers asked
    to pay $50 or more at the pharmacy
    counter are four times more likely
    to abandon the prescription than a
    consumer charged $10.

    What had been a hidden negotiation
    and wealth transfer between drug
    manufacturers and PBMs is now a
    direct increase on consumer out-ofpocket
    spending that likely decreases
    drug adherence and health outcomes.
    The Growth of High-Cost Drugs
    New challenges are emerging onto
    this landscape. A growing number of
    complex drugs account for a growing
    percentage of health care spending.
    The pharmaceutical industry
    has shifted its attention to high-cost
    drugs that face little to no competition,
    because they ofer the freedom
    to set high launch prices and increase
    them over time.
    Though these drugs ofer hope
    to the 1 percent of insured benefciaries
    who use them, they account
    for 35-40% of health plan spending,
    and will increase to over half of drug
    spending over the next 5 years.12
    Absent reform, the growth of high
    cost drugs will further compound
    the issues already described.

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  • No en banc re-hearing in BERKHEIMER v. HP INC

    From the concurring opinion of Judge Lourie (joined by Judge Newman) in Berkheimer:

    Accordingly, I concur in the decision of the court not
    to rehear this § 101 case en banc. Even if it was decided
    wrongly, which I doubt, it would not work us out of the
    current § 101 dilemma. In fact, it digs the hole deeper by
    further complicating the § 101 analysis. Resolution of
    patent-eligibility issues requires higher intervention,
    hopefully with ideas reflective of the best thinking that
    can be brought to bear on the subject.

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  • Tinnus Enterprises obtains reversal of PTAB decision at CAFC

    In Ericsson v. Intellectual Ventures, decided 29 May 2018, Judge Pauline Newman cited Homeland Housewares:

    To contradict a reference, an unsupported opinion is
    not substantial evidence. See Homeland Housewares,
    LLC v. Whirlpool Corp., 865 F.3d 1372, 1378 (Fed. Cir.
    2017) (“[W]e must disregard the testimony of an expert
    that is plainly inconsistent with the record, or based on an
    incorrect understanding of the claim[s].” (citations and
    internal quotation marks omitted) (second alteration in
    original)). Although the PTAB adopted the opinion of IV’s
    expert and stated on rehearing that it found Ericsson’s
    expert lacking in credibility, this is not a matter of credibility
    but of technological evidence.

    One day later, on 30 May 2018, Judge O’Malley in Tinnus v. Telebrands also cited Homeland Housewares:

    Regardless, we need not defer to the Board’s assessment
    of Dr. Kamrin’s testimony or of Dr. Kudrowitz’s
    testimony when it is inconsistent, as it is here, with the
    intrinsic evidence. See Homeland Housewares, LLC v.
    Whirlpool Corp., 865 F.3d 1372, 1378 (Fed. Cir. 2017)
    (“[W]e must disregard the testimony of an expert that is
    plainly inconsistent with the record, or based on an incorrect
    understanding of the claim[s]” (citations and internal
    quotation marks omitted)). Here, we find that the Board’s
    assessment that the expert testimony “highlights a second
    level of ambiguity” is inconsistent with the intrinsic
    evidence, because the intrinsic evidence sets out the
    objective boundaries for the claim term within the context
    of expandable containers. Therefore, we need not defer to
    the Board’s assessment of the expert testimony.

    The Telebrands decision got into the issue of
    “substantial evidence”:

    Telebrands argues that we must review the Board’s
    determination that the term “filled” is indefinite for
    substantial evidence because it is based on the Board’s
    subsidiary factual finding that “the level of water in a
    ‘substantially filled’ container is not ascertainable or
    measurable by reference to any objective standard.”
    Appellee Br. at 40 (quoting J.A.32). The Board’s ultimate
    determination of indefiniteness, however, is reviewed de
    novo. Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc.,
    554 F.3d 1010, 1022 (Fed. Cir. 2009); cf. Cuozzo, 135 S.
    Ct. at 841 (“[t]he district judge, after deciding the factual
    dispute, will then interpret the patent claim in light of the
    facts as he has found them. This ultimate interpretation
    is a legal conclusion.”). Even if we find that substantial
    evidence supports the Board’s factual finding as to the
    level of water, we need not defer to the Board’s ultimate
    legal determination that this finding renders the claim
    term indefinite.

    Telebrands also addressed the issue of not reading limitations
    in the specification into the claims:

    As noted above, when read in
    the context of the surrounding claim language, “substantially
    filled” does not refer to the volume of fluid in the
    container, but rather further defines the elastic fastener
    limitation. See Hill-Rom Servs., Inc. v. Stryker Corp., 755
    F.3d 1367, 1371 (Fed. Cir. 2014) (“While we read claims in
    view of the specification, of which they are a part, we do
    not read limitations from the embodiments in the specification
    into the claims.”).

    A significant issue in Telebrands was indefiniteness.

    Related to actions by the examiner:

    The examiner’s own remarks confirm that the claim
    language informs a person of ordinary skill of the objective
    boundaries of the claim term. Additionally, we
    presume that an examiner would not introduce an indefinite
    term into a claim when he/she chooses to amend the
    claim for the very purpose of putting the application in a
    condition for allowance. See Northern Telecom, Inc. v.
    Datapoint Corp., 908 F.2d 931, 939 (“It is presumed that
    public officials do their assigned jobs”). Thus, we find
    that the ’066 patent is not indefinite under the Nautilus
    standard because the claims, viewed in light of the specification
    and prosecution history, inform a person of ordinary
    skill about the scope of the invention with
    reasonable certainty.

    Related to Nautilus:

    Here, Tinnus argues that the Board erred in applying
    Packard to assess the indefiniteness of its issued patent
    in the context of a PGR. Telebrands responds that the
    Packard standard should apply in this context because
    post-grant review proceedings share more similarities
    with examinations than with district court litigations.
    Neither party points to any binding precedent that directly
    addresses this question, and the PTO has not promulgated
    a rule addressing which standard should apply.
    Importantly, moreover, neither party explains why a
    choice between the two standards would affect our review
    of the final written decision.

    In his motion to withdraw as intervenor, the Director
    stated that the “[Board]’s approach to claim construction
    and indefiniteness during post-issuance proceedings
    under the America Invents Act is something the agency is
    actively considering[.]” No. 17-1726, ECF No. 73, slip op.
    at 1 –2. This suggests that the PTO may promulgate
    rules surrounding this issue in the future. Indeed, the
    PTO recently issued a notice of proposed rulemaking for
    claim construction that “proposes to replace the broadest
    reasonable interpretation (‘BRI’) standard for construing
    unexpired patent claims in [post-grant] proceedings with
    a standard that is the same as the standard applied in
    federal district courts[.]” Changes to Claim Construction
    Standard for Interpreting Claims In Trial Proceedings
    Before the Patent Trial and Appeal Board, 83 Fed. Reg.
    21,221 (proposed May 9, 2018) (to be codified at 37 C.F.R.
    pt. 42). While that notice does not address indefiniteness,
    it does indicate that the Director is committed to reassessing
    questions such as that presented here.

    We need not decide which standard governs PGRs
    here, because Tinnus concedes that the standard is not
    dispositive because we may resolve this case in its favor
    under Packard. See Appellant’s Br. 33 n.4 (arguing the
    Board incorrectly decided indefiniteness under the Packard
    standard “for the same reasons discussed here under
    Nautilus[.]”); see also Oral Arg. at 1:56−2:06,
    17-1726.mp3 (Q: “If we find this not indefinite, even
    under Packard, isn’t that enough for you? A: It would be,
    your honor . . . .”).

    We, thus, await an appropriate case to resolve any
    apparent inconsistency between the two indefiniteness
    standards—one where the result actually turns on such a
    resolution and any views we express would not be dicta.
    At that time, we will consider any rulemaking from the
    Director on the matter.

    MORGAN CHU, Irell & Manella LLP, Los Angeles, CA,
    argued for the appellee Telebrands, who lost.

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  • Civil Society Issues Call For Action On Draft WIPO Copyright Exceptions

    This week the World Intellectual Property Organization copyright committee is looking at exceptions and limitations to copyright. A range of stakeholders with opposing views delivered long statements explaining their positions. Some proponents of mandatory international limitations and exceptions for certain actors cited the United Nations Sustainable Development Goals inscribing equitable quality education as a right. Others, like publishers’ associations, said the current international system provides ample possibilities to devise national exceptions and limitations.

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  • Patently-O Bits and Bytes by Juvan Bonni

    Patently-O Bits and Bytes by Juvan Bonni

    Recent Headlines in the IP World:

    • Joel Rosenblatt and Mark Gurman: Apple Awarded $539 Million in Samsung Patent Retrial (Source: The Mercury News)
    •  Erika Kinetz: China Approves 13 new Ivanka Trump Trademarks in 3 months (Source: The Associated Press)
    • Andrew J. Maas and David Winwood: Letters: Country Needs Stronger Patents (Source: The Advocate)
    • Trevor Mogg: Amazon Delivery Drone May Use Lights and Music when it Shows Up at Your Home (Souce: Digital Trends)

    Commentary and Journal Articles:

    • Dr. Heidi Ledford: Rush to Protect Lucrative Antibody Patents Kicks into Gear (Source: Nature)
    • Prof. Matthew Rimmer: Intellectual Property and Clean Energy: The Paris Agreement and Climate Justice (Source: SSRN)
    • Prof. Tabrez Ahmad: Future of IP and the Commons: Friends or Foes (Source: SSRN)
    • Ross A. Marchand: New NAFTA Needs Intellectual Property Protections (Source: Economics 21)
    • Prof. Yuan Qiong Hu: Resistance and Consistent: Access to Medicines and Patent Law Reform in India and China (Source: SSRN)

    New Job Postings on Patently-O:

    • Armstrong Teasdale, LLP
    • Medley, Behrens & Lewis, LLC
    • Daly, Crowley, Mofford & Durkee, LLP
    • The University of Southern California Gould School of Law
    • Schwegman Lundberg & Woessner, P.A.

    Continue reading Patently-O Bits and Bytes by Juvan Bonni at Patently-O.

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  • Inside Views: Draft Broadcast Treaty Takes Restrictive Approach To Limitations And Exceptions

    Sean Flynn writes: At this week’s meeting of the World Intellectual Property Organization Standing Committee on Copyright and Related Rights, there was renewed attention to the limitations and exceptions provisions of a proposed treaty for broadcast organizations. Unfortunately, the result of that attention was to make the current draft more restrictive for the adoption of exceptions than prior drafts, and more restrictive than are present copyright treaties or the than the Rome Convention the broadcast treaty seeks to update.

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  • Factual Underpinnings of Eligibility: Federal Circuit Denies Rehearing in Berkheimer / Aatrix

    By Dennis Crouch

    In Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018), Judge Moore explained that, although “patent eligibility is ultimately a question of law,” it may require an analysis of “underlying factual questions.” In particular, the court in that case ruled that “[w]hether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.”  In its petition for en banc rehearing, HP asked two questions: (1) whether eligibility has factual underpinnings; and (2) the role of the “well-understood” conclusion in the eligibility analysis:

    1. Is the threshold inquiry of patent eligibility under 35 U.S.C. § 101 a
      question of law without underlying factual issues that might prevent summary
    2. Is the appropriate inquiry under Alice’s step 2 whether the claims
      transform an abstract idea into a patent-eligible application, or merely
      “whether the invention describes well-understood, routine, and conventional

    Similarly, in the parallel en banc request following Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018), the patent challenger asked the following question:

    1. Is the threshold inquiry of patent-eligibility under 35 U.S.C.

    Continue reading Factual Underpinnings of Eligibility: Federal Circuit Denies Rehearing in Berkheimer / Aatrix at Patently-O.

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