• Teva’s Imported Generic Enoxaparin Products Manufactured Using Particular Quality Control Process Are Not “Made By” Patented Process Under 35 U.S.C. § 271(g)

    Author: Hsin-Yuan (Charles) Huang, Ph.D. Editor: Aaron Gleaton Clay In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., Nos. 14-1274, 14-1277 (Fed. Cir. Nov. 10, 2015), a divided Federal Circuit affirmed a district court’s summary judgment determination that Teva’s importation of generic versions of enoxaparin, which are manufactured outside the U.S. by particular processes directed […]

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  • 2015 Supreme Court Term: Cert Petitions to Watch

    Since the start of the Supreme Court’s term in October, the Court has already agreed to hear two patent cases, Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. Both cases address the issue of willful infringement and when it is appropriate for a court to award enhanced damages under 35 U.S.C. § 284. The only question that remains is whether the Court will continue its recent trend of taking three or more patent cases a term, or whether it will revert to its…

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  • Prometheus Labs., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2015)

    By Kevin E. Noonan — The Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane. In doing so, the Court might also have given an indication of the types of claims for “personalized medicine” (in the form of methods for determining treatment of subsets of individuals suffering from a particular disease) that it would consider patentable (from one of the least patent friendly judges on the Court). The case involved ANDA litigation over alosetron, marketed by Prometheus as Lotronex®; this drug is used for treating irritable bowel syndrome (IBS). The patent-in-suit…

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  • CAFC affirms D. Del. in Cubist case

    In Cubist v. Hospira, appeals were made from
    the United States District Court for the
    District of Delaware in No. 1:12-cv-00367-GMS, Judge
    Gregory M. Sleet; the CAFC affirmed D. Del.

    Some background on the Cubist case:

    Daptomycin was developed by Eli Lilly & Co. (“Lilly”).
    The original patent to daptomycin expired in 2002. The
    five patents at issue in this case are all follow-on patents
    owned by Cubist. The first is U.S. Patent No. RE39,071
    (“the ’071 patent”), which is a reissue of U.S. Patent No.
    5,912,226 (“the ’226 patent”) and is directed to antibiotic
    compounds, compositions, formulations, and methods of
    treating bacterial infections. The next two are U.S.
    Patent Nos. 6,852,689 and 6,468,967 (“the ’689 and ’967
    patents”), which are entitled “Methods for Administration
    of Antibiotics” and are directed to dosage regimens for
    administering daptomycin. The final two are U.S. Patent
    Nos. 8,058,238 and 8,129,342 (“the ’238 and ’342 patents”),
    which are entitled “High Purity Lipopeptides” and
    are directed to the purification of daptomycin compositions.
    Cubist sells its daptomycin formulation under the
    trade name Cubicin. In 2011, Hospira filed an Abbreviated
    New Drug Application with the Food and Drug Administration
    seeking approval to manufacture and sell an
    equivalent daptomycin product prior to the expiration of
    Cubist’s patents. Pursuant to procedures set forth in the
    Hatch-Waxman Act, Cubist then filed an action in the
    United States District Court for the District of Delaware,
    alleging that Hospira had infringed all five of Cubist’s
    patents. Hospira responded by challenging the validity of
    the asserted claims of each of those patents. Two other
    related actions brought by Cubist were subsequently
    consolidated with the initial lawsuit.
    Following a bench trial, the district court held some of
    the asserted claims of four of Cubist’s patents invalid for
    anticipation and all the asserted claims of those patents
    invalid for obviousness. As for the fifth patent, the court
    held the two asserted claims not invalid and ruled that
    Hospira’s proposed products infringed those claims. Both
    parties appeal from the portions of the judgment adverse
    to them.

    Bottom line

    We affirm the judgment of the district court,
    relying heavily on the factual findings made by the court
    following the trial.

    Of the “certificate of correction” issue

    It turns out that the structural diagram of the compound
    identified as Formula 3 and depicting daptomycin
    was inaccurate in one respect. The structure in the
    diagram contained 13 amino acids, including asparagine
    (abbreviated “Asn”). While the diagram accurately identified
    the amino acids and their location in the daptomycin
    molecule, it mistakenly identified the stereoisomer of the
    asparagine amino acid as the “L” stereoisomer of asparagine,
    rather than the “D” stereoisomer.

    At the time the application for the ’226 patent was
    filed, and until well after that patent was issued, it was
    universally believed that the asparagine amino acid in
    daptomycin was the L-isomer of asparagine, as set forth
    in the structural diagram. Years after the issuance of the
    ’226 patent and after the reissue application for the ’071
    patent was filed, Lilly researchers discovered that daptomycin
    actually contains the D-isomer of asparagine, not
    the L-isomer.

    In 2007, Cubist sought to correct the error by requesting
    a certificate of correction from the Patent and Trademark
    Office (“PTO”) pursuant to 35 U.S.C. § 255. Cubist
    explained that the mistake in the patent as to the identity
    of the stereoisomer of asparagine was “the result of the
    mischaracterization of one of the A-21978C factors described
    by Formula 3.” Specifically, Cubist explained,
    “the patentees erred in describing one amino acid’s stereochemistry
    as ‘L-Asn’ in the tail of the compound illustrated
    in Formula 3, when the correct stereochemistry of
    the disclosed and claimed amino acid is ‘D-Asn.’” Cubist
    further explained that the true nature of the stereochemistry
    of daptomycin was disclosed in a 2005 journal article
    by Vivian Miao et al. The Miao article, Cubist stated,
    “demonstrates that the A-21978C factors of Formula 3
    inherently contain the ‘D-Asn’ in the tail portion illustrated
    in Formula 3 when isolated from their native source,
    not an ‘L-Asn.’”

    The examiner concluded that it was appropriate to
    use a certificate of correction to correct the error identified
    by Cubist. Accordingly, the examiner issued the certificate,
    correcting the diagram of Formula 3 in the specification
    and four of the claims of the ’071 patent by
    substituting “D-Asn” for “L-Asn” in the diagram.

    Of the relevant law

    On appeal, Hospira argues that the change in the ’071
    patent made by way of the certificate of correction was not
    a change “of minor character,” as provided for in section
    255, because the change broadened the scope of the asserted
    claims. See Superior Fireplace Co. v. Majestic
    Prods. Co., 270 F.3d 1358, 1375 (Fed. Cir. 2001) (“A
    mistake that, if corrected, would broaden the scope of a
    claim must thus be viewed as highly important and thus
    cannot be a mistake of ‘minor character.’”). In Hospira’s
    view, because the change from L-Asn to D-Asn in the
    structural diagram broadened the scope of the claims to
    read on daptomycin rather than the L-Asn variant of
    daptomycin, the certificate of correction was invalid.
    Once the PTO has issued a certificate of correction, a
    court may invalidate the certificate only upon a showing
    of clear and convincing evidence that it was improperly
    issued. Superior Fireplace Co., 270 F.3d at 1367. In this
    case, no such showing has been made.


    As this court has noted, a chemical structure is
    “simply a means of describing a compound; it is not the
    invention itself.” Regents of Univ. of N.M. v. Knight, 321
    F.3d 1111, 1122 (Fed. Cir. 2003).

    One notes that claim 1 of US ‘226 incorporated the
    formula as a claim element:

    1. A compound of the formula ##STR12## in which R is C.sub.5 -C.sub.14 -alkanoyl;
    R.sup.1, R.sup.2, R.sup.3, R.sup.4 and R.sup.5 are hydrogen; or
    a pharmaceutically acceptable salt thereof.

    The problem is that “what was claimed” was not “what was possessed.”

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  • Will SCOTUS Provide Guidance on Judicial Review and Claim Construction for IPR Proceedings?

    The NYIPLA asks the Court to grant the petition in order to make clear that judicial review is available when the PTO institutes an IPR proceeding and invalidates patent claims in violation of its statutory authority, and to determine the claim construction standard that the PTO should apply to determine patent validity. The NYIPLA explains that the Supreme Court’s review of both questions is critical at this juncture since to a large and increasing extent, IPRs are supplanting district court…

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  • China’s state-led innovation model: does it really work?

    From our friends at Oxfirst comes another free webinar. This one is entitled “How China’s state-led model is harming innovation and growth”. The basic proposition behind it is that China wants leading technology industries, driving Beijing’s strategy to escape the ‘middle income trap’. However, Radomir Tylecote’s PhD research on Chinese solar photovoltaic (PV) patenting suggests that (i) the Chinese system is not be producing the innovation required, that (ii) and Beijing’s attempts to drive innovation are actually hindering it. As the webinar-blurb explains:

    Beijing’s strategy involves investing in tech firms through shareholding and R&D funding. By comparing patenting output and quality among Chinese solar firms, Radomir’s research establishes that firms with more state backing – in shareholding and funding – see innovative capabilities fall.

    Meanwhile, firms with central government ownership are especially likely to waste R&D funding. But private entrepreneurs often cannot protect their IP from infringement by state firms, and take on state shareholding to do so. Radomir will discuss how majority state-ownership leads to the registration of ‘junk’ patents in less ambitious technological fields, as employees respond to the government’s incentives to patent. But private entrepreneurs face challenges protecting their innovations in court from infringement by state-owned competitors, and in obtaining funding.

    The webinar takes place on Friday 27 November 2015 3:00 PM – 4:00 PM GMT.  To sign up for participation, click here.

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  • USPTO Proposes New IDS Framework

    Tucked into the USPTO’s proposed patent fee changes is a proposal to change the Information Disclosure Statement (IDS) framework. While applicants may welcome the simplified procedures for obtaining consideration of an IDS, they may have to adjust their patent budgets to account for new IDS fees, especially if they pursue corresponding foreign applications that might generate … Continue reading this entry

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