• Actual Use vs Inherent Disclosure: Endo v. Custopharm
    in: Patently-O  | 

    Actual Use vs Inherent Disclosure: Endo v. Custopharm

    Endo Pharms. Sols., Inc. v. Custopharm Inc., — F.3d —, 2018 U.S. App. LEXIS 19265 (Fed. Cir. 2018).

    by Dennis Crouch

    Endo’s injectable testosterone Aveed is listed in the Orange Book as being covered by Bayer’s U.S. Patent Nos. 7,718,640 and 8,338,395.  Endo and Bayer sued Custopharm after it submitted an Abbreviated New Drug Application (ANDA) to produce a generic version. (Under 35 U.S.C. 271(e), submission of the ANDA is an act of infringement).

    On appeal, the Federal Circuit has sided with the patentee — affirming the district court judgment of validity.

    The claimed invention here requires the use of testosterone undecanoate (TU) at a concentration of 250 mg/ml in a vehicle containing a mixture of about 40% castor oil and 60% benzyl benzoate. (Claim 1 of the ‘640 patent). Three key prior art references are all research articles that report using the same concentration of TU and also the castor oil.  The articles do not, however, actually report that benzyl benzoate was used — it turns out though that the researchers (including one overlapping listed inventor here) used the same 40/60 split of castor oil and benzyl benzoate. 

    Continue reading Actual Use vs Inherent Disclosure: Endo v. Custopharm at Patently-O.

  • Pro se Appellant Burnett loses in a 12(b)(6)/101 case
    in: 未分類  | 

    Pro se Appellant Burnett loses in a 12(b)(6)/101 case

    The outcome was that pro se appellant Burnett lost:


    Carl M. Burnett (“Burnett”) appeals an order of the
    United States District Court for the District of Maryland
    dismissing Burnett’s amended complaint for failure to
    state a claim upon which relief can be granted. Burnett v.
    Panasonic Corp., No. 17-cv-0236 (D. Md. Nov. 1, 2017)
    (“District Court Decision”). Specifically, because the
    district court held that claims 1 and 9 of U.S. Patent No.
    7,107,286 (“the ’286 patent”) are invalid as directed to
    ineligible subject matter under 35 U.S.C. § 101, it concluded
    that dismissal pursuant to Rule 12(b)(6) of the
    Federal Rules of Civil Procedure was appropriate. Burnett
    argues that the asserted claims are patent-eligible,
    that the district court erred procedurally when it failed to
    construe five allegedly disputed claim terms, and that the
    district court violated Burnett’s due process rights when it
    failed to hold Rule 12(b)(6) and claim construction hearings.
    We affirm.

    As to 12(b)(6), the CAFC noted:


    The Fourth Circuit reviews de novo a dismissal under
    Rule 12(b)(6). Monroe v. City of Charlottesville, Va., 579
    F.3d 380, 385 (4th Cir. 2009). “We have held that patent
    eligibility can be determined at the Rule 12(b)(6) stage,”
    but “only when there are no factual allegations that,
    taken as true, prevent resolving the eligibility question as
    a matter of law.”
    Aatrix Software, Inc. v. Green Shades
    Software, Inc., 882 F.3d 1121, 1125 (Fed. Cir. 2018).
    Here, the district court appropriately assessed eligibility
    at the pleading stage because the asserted claims are
    patent-ineligible even when accepting as true all factual
    allegations pled in Burnett’s amended complaint

    Of abstract idea:


    Like the concept of using a formula to convert binarycoded
    decimals into pure binary numerals, which the
    Supreme Court found to be an abstract idea in Gottschalk,
    409 U.S. at 72, the concept of using a formula to convert
    geospatial coordinates into natural numbers, if found
    eligible, “would wholly pre-empt the mathematical formula
    and in practical effect would be a patent on the algorithm
    itself.” Claims 1 and 9 are both directed to a
    similarly abstract idea.

    Of Alice:

    The remainder of Burnett’s arguments related to his
    proposed claim constructions stand for the proposition
    that “the claims recite significantly more than the purported
    idea of a ‘mathematical methodology.’” Appellant
    Br. at 46. But that a claim allegedly contains more than
    an abstract idea does not mean the claim survives step
    one, because, under that inquiry, it is enough that the
    claims are directed to a mathematical methodology at all;
    rather, Burnett’s argument is more appropriately assessed
    under our inquiry in step two. Alice, 134 S. Ct. at
    2355 (assessing under step two whether additional features
    in a claim transform an otherwise a patentineligible
    concept into a patent-eligible concept).

    (…)

    As the district noted, these additional features effectively
    do no “more than simply state the [abstract idea]
    while adding the words ‘apply it.’” Mayo, 566 U.S. at 72.
    The preambles of both claims, as construed by Burnett,
    instruct a user to implement the mathematical methodology
    or instruct using a “geospatial media recorder” to do
    the same. Such “wholly generic computer implementation
    is not generally the sort of ‘additional featur[e]’ that
    provides any ‘practical assurance that the process is more
    than a drafting effort designed to monopolize the [abstract
    idea] itself.’” Alice, 134 S. Ct. at 2358 (quoting Mayo, U.S.
    at 77); accord Gottschalk, 409 U.S at 70–72.

  • Global Innovation Divide: Can Investment In Innovation Bridge The Gap?
    in: Copyright Policy, Development, English, Features, Finance, Innovation/ R&D, IP Policies, Language, Patents/Designs/Trade Secrets, Subscribers, Technical Cooperation/ Technology Transfer, Themes, Trademarks/Geographical Indications/Domains, Venues, WIPO  | 

    Global Innovation Divide: Can Investment In Innovation Bridge The Gap?

    The Global Innovation Index 2018, launched on 10 July in New York, has lauded the rise of China as a model for how other low and middle-income economies can advance on innovation. Amid this optimism, however, the global innovation divide remains in ste…