• Are Today’s Social Media Tech Giants the Big Brother that Orwell Warned Us About?

    Dystopian novels and science fiction often return to the subject of the loss of personal privacy which is often encouraged by the use of technology enabling constant, omnipresent surveillance. Perhaps the most famous example of this in the science fiction canon of the 20th century is George Orwell’s Nineteen Eighty-Four. First published in 1949, Orwell’s novel conceives of a world where government surveillance is so complete that the vast majority of citizens don’t mind being watched by two-way…

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  • Fixing Facebook

    Facebook has seen better times for sure.  The reviews on Facebook’s reaction to the recent Cambridge Analytica disaster have been far from glowing.  Can Facebook address consumer concerns with privacy, particularly when a good part of its business model is based on the commodification of user data?  If its profit center is primarily selling data, what can Facebook do to better protect privacy.  Should it obtain “more” consent?  How much “consent” is enough?  One potential fix (and practically I don’t know how this would be implemented) would be to change Facebook to a B Corp—a public benefit corporation.  Facebook could become a corporation that is not primarily driven by maximizing shareholder value, but instead also by the public interest.  Here is a description of the Delaware B Corp:

    A public benefit corporation (PBC) will be formed in the same manner as any other corporation formed under the Delaware General Corporation Law. However, in order to be a PBC, the corporation’s certificate of incorporation must identify one or more specific public benefits and must have a name that clearly identifies its status as a PBC. Public benefits for which corporations may be formed include, but are not limited to, those of an artistic, charitable, cultural, economic, educational, environmental, literary, medical, religious, scientific or technical nature.

    At least once every two years, a public benefit corporation must send its stockholders a statement with respect to its promotion of the public benefit(s) identified in its charter, as well as its promotion of the best interests of those materially affected by the corporation’s conduct. 

    This is not a “perfect” fix, but maybe it is a move in the right direction. 

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  • ACI Summit on Biosimilars

    American Conference Institute (ACI) will be holding is 9th Annual Summit on Biosimilars on June 25-27, 2018 in New York, NY. Patent Docs author Kevin Noonan is a co-chair of this conference. ACI faculty will help attendees: • Explore the current initiatives to foster innovation and lower healthcare costs from the current administration; • Review current case law that will impact the biologics marketplace, such as Amgen v. Hospira and Amgen v. Sanofi; • Compare various strategies for biosimilar manufactures and reference product sponsors in view of the Supreme Court’s Sandoz v. Amgen case; • Consider strategic decisions related to…

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  • Webinar on Patent Inventorship

    Strafford will be offering a webinar entitled “Patent Inventorship: Best Practices for Determination and Correction — Distinguishing Between Inventor and Contributor; Navigating Joint Inventorship, Disclosure of Ownership, Real Party in Interest” on M…

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  • Program on Ethics in the Practice of Intellectual Property Law

    The John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be holding its 9th Annual Program on Ethics in the Practice of Intellectual Property Law from 12:30 to 5:15 pm on April 27, 2018 in Chicago, IL. The conference will consist of the following sessions: • What IP Lawyers Should Know About ARDC Proceedings and Client Complaints • Ethical Issues in Providing Pro Bono IP Representation • Trademark Scams and Unauthorized Practice of Trademark Law • Mental Health and Addiction Issues Among Lawyers: A Focus on Clinical Depression and Substance Use Disorders Additional information about the…

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  • 2018 European Practice Committee Conference

    The Intellectual Property Owners Association (IPO) European Practice Committee will be hosting a one-day conference entitled “The Very Essence of Romance is Uncertainty” on May 3, 2017 in Amsterdam, Netherlands. The conference will include sessions on the following topics: • “Shapes Of Things to Come” — Current Legislative and Juridical Trends in the US • “My Weakness is None of Your Business” — The Present and Future of Discovery and Trade Secrets • “Traummaschine” — What Future Does the UPC Hold for Us? • “Wir Sind De Roboter” — IP and Legal Tech A program for the conference, including an…

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  • Webcast on Double Patenting

    The Knowledge Group will offer a webcast entitled “Recent Developments in Double Patenting: ODP Challenges and Considerations” on May 2, 2018 from 12:00 to 1:30 pm (ET). Russell S. Timm of Womble Bond Dickinson (US) LLP, Carl A. Morales of Dechert LLP, and Bonnie Weiss McLeod of Cooley LLP will address the following topics: • ODP — Trends and Developments • Risks for Patent Owners • Challenges and Considerations • Recent Double Patenting Court Rulings • Best Practices to Protect Against ODP Issues The registration fee for the webcast is $99. Those interested in registering for the webinar can do…

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  • 関係代名詞 THAT…WHICH


    関係代名詞 THAT…WHICH

    $$ The mirror 70 is bounded by and merges smoothly into a pair of convex cylindrical ears 74 that connect the walls 28, 30 an…

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  • Vanda v. West-Ward. Hatch-Waxman issues AND inducement AND 101

    D. Delaware was affirmed:

    West-Ward Pharmaceuticals International Limited
    and West-Ward Pharmaceuticals Corp. (collectively,
    “West-Ward”) appeal from the decision of the United
    States District Court for the District of Delaware holding,
    after a bench trial, claims 1–9, 11–13, and 16 (“the asserted
    claims”) of U.S. Patent 8,586,610 (“the ’610 patent”)
    infringed and not invalid. See Vanda Pharm. Inc. v.
    Roxane Labs., Inc., 203 F. Supp. 3d 412 (D. Del. 2016)
    (“Opinion”). For the following reasons, we affirm.

    We first address whether, beyond the jurisdictional
    question, a claim for infringement of the ’610 patent
    under 35 U.S.C. § 271(e)(2)(A) can lie where the ’610
    patent issued after the original ANDA was submitted and
    Vanda sued West-Ward for infringement of the asserted
    claims prior to West-Ward submitting a Paragraph IV
    certification. The district court held that West-Ward’s
    submission of the Paragraph IV certification for the ’610
    patent was an act of infringement. See Opinion, 203 F.
    Supp. 3d at 433. We review the district court’s statutory
    interpretation without deference. Warner–Lambert, 316
    F.3d at 1355.

    Vanda argues that it proved an act of infringement
    under 35 U.S.C. § 271(e)(2). According to Vanda, “[w]here
    a patent issues after an ANDA is filed but before FDA
    approval, and where—as here—the applicant submits a
    Paragraph IV certification directed at the new patent,
    that amendment of the ANDA is an act of infringement
    under Section 271(e)(2).” Appellee Br. 60

    West-Ward responds that there can be no infringement
    under § 271(e)(2) because the ANDA was filed
    before the ’610 patent issued. West-Ward contends that
    the statutorily defined act of infringement excludes
    amendments to an ANDA and “only reaches ANDAs
    submitted ‘for a drug claimed in a patent or the use of
    which is claimed in a patent’—not a drug that might or
    might not later be claimed in a patent or one that has
    been claimed in a provisional patent application or a
    patent-pending.” Reply Br. 33 (emphases in original)
    (quoting 35 U.S.C. § 271(e)(2)(A)) (other internal quotation
    marks omitted).

    The CAFC observed:

    Although we agree with West-Ward that only an issued
    patent can give rise to a valid infringement claim
    under § 271(e)(2)(A), we disagree that that conclusion
    precludes Vanda’s infringement claim in this case. The
    ’610 patent is a patent “for a drug . . . the use of which is
    claimed in a patent,” 35 U.S.C. § 271(e)(2)(A), as contemplated
    in the Act even though it issued after West-Ward
    filed its ANDA. West-Ward subsequently amended its
    ANDA to include a Paragraph IV certification for the ’610
    patent after it issued. The infringement analysis under
    § 271(e)(2)(A) “require[s] consideration of the amended
    ANDA.” Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d
    1382, 1390 (Fed. Cir. 2014). “There is no support for the
    proposition that the question of infringement must be
    addressed solely based on the initial ANDA filing, given
    that the statute contemplates that the ANDA will be
    amended as a matter of course.”


    Here, it is undisputed that West-Ward amended the
    ANDA by submitting a Paragraph IV certification regarding
    the ’610 patent after that patent issued. J.A. 19696;
    J.A. 6414–15; Appellant Br. 10; Appellee Br. 59. Such an
    act is a qualifying act of infringement under
    § 271(e)(2)(A).6 A filer of an ANDA is therefore subject to
    a § 271(e)(2)(A) infringement claim on a patent that
    issues after the filing of the ANDA, but before FDA approval.
    The resolution of infringement claims under
    § 271(e)(2)(A) for patents that issue after an ANDA is
    submitted, but before it is approved, “facilitates the early
    resolution of patent disputes between generic and pioneering
    drug companies” in accordance with the purpose
    of § 271(e)(2)(A). Caraco I, 527 F.3d at 1283.
    The FDA regulatory framework and the legislative
    history further demonstrate that West-Ward is incorrect
    in asserting that “application” in § 271(e)(2)(A) excludes
    amendments to the ANDA.


    Thus, the district court properly conducted its
    infringement analysis for the ’610 patent pursuant to 35
    U.S.C. § 271(e)(2)(A).

    As to 101:

    We next address whether the asserted claims are directed
    to patent-eligible subject matter. West-Ward
    argues that the asserted claims are ineligible under § 101
    because they are directed to a natural relationship between
    iloperidone, CYP2D6 metabolism, and QT prolongation,
    and add nothing inventive to those natural laws
    and phenomena. West-Ward contends that the asserted
    claims are indistinguishable from those held invalid in
    Association for Molecular Pathology v. Myriad Genetics,
    Inc., 569 U.S. 576 (2013) and Mayo Collaborative Services
    v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
    Vanda responds that the asserted claims are patenteligible
    under § 101 at both steps of Mayo/Alice. Vanda
    contends that the district court erred in holding that the
    asserted claims are directed to a law of nature.

    CJ Prost dissenting:

    I would find the asserted patent claims to be directed
    to a law of nature. The majority finds the claims herein
    are not directed to a natural law at step one of the § 101
    analysis, but its efforts to distinguish Mayo cannot withstand
    scrutiny. The majority relies on the claims’ recitation
    of specific applications of the discovery underpinning
    the patent to find no natural law is claimed. But it conflates
    the inquiry at step one with the search for an

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  • Risch on Declaratory Judgments Post-MedImmune

    Michael Risch has posted an interesting empirical paper on ssrn titled Sue First, Negotiate LaterHere is a link, and here is the abstract:
    One of the more curious features of patent law is that patents can be challenged by anyone worried about being sued. This challenge right allows potential defendants to file a declaratory relief lawsuit in their local federal district court, seeking a judgment that a patent is invalid or noninfringed. To avoid this home-court advantage, patent owners may file a patent infringement lawsuit first and, by doing so, retain the case in the patent owner’s venue of choice. But there is an unfortunate side effect to such preemptive lawsuits: they escalate the dispute when the parties may want to instead settle for a license. Thus, policies that allow challenges are favored, but they are tempered by escalation caused by preemptive lawsuits. To the extent a particular challenge rule leads to more preemptive lawsuits, it might be disfavored.

    This article tests one such important challenge rule. In MedImmune v. Genentech, the U.S. Supreme Court made it easier for a potential defendant to sue first. Whereas the prior rule required threat of immediate injury, the Supreme Court made clear that any case or controversy would allow a challenger to file a declaratory relief action. This ruling had a real practical effect, allowing recipients of letters that boiled down to, “Let’s discuss my patent,” to file a lawsuit when they could not before.

    This was supposed to help the accused potential defendants, but not everyone was convinced. Many observers at the time predicted that the new rule would lead to more preemptive infringement lawsuits filed by patent holders. They would sue first and negotiate later rather than open themselves up to a challenge by sending a demand letter. Further, most who predicted this behavior—including parties to lawsuits themselves—thought that non-practicing entities would lead the charge. Indeed, as time passed, most reports were that this is what happened: that patent trolls uniquely were suing first and negotiating later. But to date, no study has empirically considered the effect of the MedImmune ruling to determine who filed preemptive lawsuits. This Article tests MedImmune’s unintended consequences. The answer matters: lawsuits are costly, and increased incentive to file challenges and preemptive infringement suits can lead to entrenchment instead of settlement.

    Using a novel longitudinal dataset, this article considers whether MedImmune led to more preemptive infringement lawsuits by NPEs. It does so in three ways. First, it performs a differences-in-differences analysis to test whether case duration for the most active NPEs grew shorter after MedImmune. One would expect that preemptive suits would settle more quickly because they are proxies for quick settlement cases rather than signals of drawn out litigation. Second, it considers whether, other factors equal, the rate of short lived case filings increased after MedImmune. That is, even if cases grew longer on average, the share of shorter cases should grow if there are more placeholders. Third, it considers whether plaintiffs themselves disclosed sending a demand letter prior to suing.

    It turns out that the conventional wisdom is wrong. Not only did cases not grow shorter – cases with similar characteristics grew longer after MedImmune. Furthermore, NPEs were not the only ones who sued first and negotiated later. Instead, every type of plaintiff sent fewer demand letters, NPEs and product companies alike. If anything, the MedImmune experience shows that everyone likes to sue in their preferred venue. 
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