• Patent Pendency Snapshot

    The charts below provide a pendency snapshot for utility patents issued in the past month. Each chart provides two curves – one counting pendency from filing date (or 371 Date for Nat’l Stage) to issuance and the other counting pendency from the earliest priority filing date to issuance.  (Each dot represents a three-month period). Median […]

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  • Merck loses to Amneal at CAFC in mometasone furoate monohydrate [Nasonex] case

    This case, arising on appeal of a decision by Judge Robinson in D. Delaware, is strongly related to a case arising in D. New Jersey, and also appealed to the CAFC [2012 U.S. Dist. LEXIS 83414; Merck Sharp & Dohme Corp. v. Apotex Inc., 517 F. App’x 939 (Fed. Cir. 2013). ]

    There is a lot to discuss.

    For starters, there was an appeal of a discovery ruling.

    This included the text


    Following two discovery hearings on the issue, the
    district court became aware of Amneal’s discovery violation
    and acknowledged that ideally Amneal should have
    produced samples of the Day 4 and A Batches. The
    district court determined, however, that it did not have
    enough information at the time to determine whether the
    Day 4 and A Batch samples were materially different
    from the Day 1 Batch samples. The district court concluded
    that it was “not persuaded sitting right here that
    mixing [] makes a substantive difference, and if it doesn’t,
    then it doesn’t matter that Amneal didn’t give [Merck] a
    sample of both [the Day 4 and A Batches] . . . [and] only
    gave [Merck the Day 1 Batch].” J.A. 128 at 27:7–12. The
    district court did not compel Amneal to produce the
    additional samples. Nor did the court postpone trial.
    Instead, the district court gave Merck the opportunity to
    prove at trial that the Day 4 and A Batch samples were
    substantively different than the Day 1 Batch samples and
    warned Amneal that it was at risk of incurring costs if
    Merck prevailed on the issue.

    (…)

    We start our analysis with the district court’s discovery
    ruling. We review the district court’s denial of additional
    discovery under regional circuit law. Digeo, Inc. v.
    Audible, Inc., 505 F.3d 1362, 1370 (Fed. Cir. 2007). The
    Third Circuit will not disturb a denial of additional discovery
    absent an abuse of discretion and “a showing of
    actual and substantial prejudice.” Anderson v. Wachovia
    Mortg. Corp., 621 F.3d 261, 281 (3d Cir. 2010).

    The district court’s standing discovery order required
    Amneal to “immediately make available to Merck samples
    of any further representative commercial batches sent to
    the FDA.” J.A. 82 (emphasis added). Amneal, however,
    did not produce samples of its Day 4 Batch that it submitted
    to the FDA, in violation of the discovery order.

    The earlier case in D.N.J. has some interesting text about
    Dr. Matzger, who testified in the Amneal case:

    Dr. Threlfall found Dr. Matzger’s testimony troubling in four ways. Dr. Threlfall stated:

    I think he went wrong at four levels: I don’t think he applied proper scientific judgment to his testing; I think that the design of his experiments was wrong; the actual performance of experiments leads a lot to be desired; and I think that he analyzed the data incorrectly.
    (T. 909, 15-19).
    Dr. Threlfall opined that Dr. Matzger had “the mindset of an advocate rather than of a scientist. And in particular, Dr. Matzger [*13] went on the hunt for traces of material, without really applying scientific judgment, . . . .” (T. 910, 10-14). Although Dr. Matzger found that conversion begins to occur as soon as the Apotex ANDA Product is manufactured, Dr. Threlfall’s calculation was far different. According to Dr. Threlfall, the “Apotex formulation would be stable against conversion to the monohydrate for around 800 years.” (T. 922, 21-24).

    Dr. Threlfall was very critical of the shaking or vortexing procedure of Dr. Matzger. Dr. Matzger indicates that the shaking was “gentle.” Dr. Threlfall disagreed, he honed in on vortexing.

    A. Vortexing is an even more energetic process. I mean it’s like creating a mini tornado within the tube. And you can imagine that sort of — smashes all things to pieces, it grinds the nuclei together, it causes them to break and nascent surfaces to form, and nascent surfaces are much more susceptible to change than the intact one would be, because they lost their coatings basically for a moment, and therefore they can change when they wouldn’t have otherwise been subjected to change.
    (T. 925, 18 through T. 926, 1). Likewise, Threlfall was critical of the washing. He opined that Dr. Matzger [*14] “washed out some of the essential components,” (T. 926, 8-10), and that the removal of Avicel by shaking and washing was deleting its “protective coating.” (T. 926, 20). Threlfall likened the removal of Avicel to an explorer sent to the Arctic, and then his clothes are “pinched, and you leave him in his underwear.” (T. 926, 19-23). Evidently, Threlfall believes that when Dr. Matzger washed and shaked the Apotex product, he was undermining the stability of the compound. (T. 926, 23-24).
    In commenting on Dr. Matzger’s procedures, Threlfall stated “I would describe this as making scrambled eggs and then claiming you still had the eggs with the shells in the carton.” (T. 927, 17-19).

    Also of interest are the following statements in the DNJ opinion:


    XRPD is the standard method for looking at solid materials and polymorphs. (T. 228, 17-23). 7 XRPD looks at arrangement and characteristic spacings of molecules by measuring the intensity of refracted X-rays at different angles. (T. 230, 10-20). According to Dr. Matzger, XRPD is relatively sensitive and excellent at being able to differentiate between different forms of the same compounds. (T. 228, 17-23). Dr. Cockcroft found that Dr. Matzger did not find peaks due to the lack of intensity; and at best, he found “bumps.” (T. 781, 13).

    (…)

    Dr. Cockcroft, 8 an expert for Apotex, noted that x-ray diffraction is covered by a very simple equation “developed by Nobel prize winner William Brack in 1913.” The Brack formula relates “to the two-theta values in a diffraction powder” in terms of intensity. (T. 780, 13-21). Based on this formula, the XRPD testing device (diffractometer) was created, and it depicts material on a graph based on the intensity of its peaks. In Dr. Matzger’s testing, he used an automatic diffractometer on which he set the scan through the two-theta angles. Once he filled a cell with the prepared sample, the diffractometer then automatically records any peaks based on the intensity on [*19] a graph. (T. 262, 21-25). A peak is produced by a clear signal or intensity. That is, the diffractometer “measures an intensity at each angle . . . so [there] is an intensity versus two-theta peak.” (T. 261, 3-6). Often the prepared sample may have some different materials commingled in it during XRPD testing, and the peak may be surrounded by noise (non-peak sound). The signal to noise factor was critical in this case for several reasons.

    (…)

    According to Dr. Cockcroft, the history of the three peaks standard is derived from the work of Mr. Hanawalt. Evidently, in the 1940’s, Hanawalt was researching numerous minerals which required him to perform XRPD tests on many minerals. Since there were so many samples, Hanawalt devised a database of XRPD patterns so he could identify each one. In developing a card system to identify each sample, he listed the three most intense peaks of the material on a separate card. This format became known as the Hanawalt Search Index. (T. 788, 4-12). Due to this practice, most scientists still use three peaks to identify a pattern. (T. 788, 4-12).

    Lastly, the use of the Brack Formula recognizes [*22] that if a peak occurs at a specific level (say 7.8 degrees) and another peak occurs at a factor of 2 (say 15.6), the second peak is a duplication of the first; and hence it is not considered a unique peak (T. 780, 19-25). Hence, duplication must be considered in analyzing XRPD results.

    All four samples were subject to XRPD analysis and recorded on a graph (PTX-451). In each of the samples, Dr. Matzger found “evidence of conversion” with peaks at 7.8 and 11.6 as recorded on figure 2 of the patent. (T. 272, 19-25). 9 On sample 012245, Dr. Matzger found that XRPD showed three peaks “consistent with conversion,” namely 7.8, 15.6 and 11.6. (T. 277, 13-19). With regard to the 15.6 peak, it is a factor of 2 of the 7.8 peak. Dr. Matzger noted it “illustrates . . . the problems you can have with overlap because there is a shoulder here that is associated with the 15.6 degree peak as opposed to a “distinct peak as it did in the previous pattern.” (T. 278, 11-18) (PTX-480). Despite the fact that it is a shoulder and not a peak, he opined that “its all consistent with conversion.” (T. 278, 20). In sample 012245, Dr. Matzger fails to consider the limitation within Brack’s formula (see above). Dr. [*23] Cockcroft had indicated that a peak at 7.8 and a peak at 15.6 were duplicative based on the application of the Brack formula. Hence, in sample 012245, there are not three peaks as Dr. Matzger finds, but only two in accordance with the Brack formula. Dr. Matzger never refuted the Brack formula, as such, the limitations within the Brack formula are credible.

    For accuracy, the Nobel Prize in Physics 1915 was awarded jointly to Sir William Henry Bragg and William Lawrence Bragg “for their services in the analysis of crystal structure by means of X-rays” The experiment is x-ray diffraction, not refraction.

    The Hanawalt method relates to identifying an unknown sample via powder x-ray diffraction. In the 1930’s, Hanawalt decided to use the d-values of the three strongest strongest lines in the
    diffraction pattern of the unknown (d1, d2, d3) along with their respective respective intensities intensities (I1,I2, I3) to search the powder diffraction diffraction file (PDF) database. There is no database search involved in the Nasonex matter.

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  •                         目次はこちら

    (SAID):主としてクレーム中で用いる
    $$ The propeller is preferably mounted on said at least one shaft in such a way that the plane of the propeller is substantially perpendicular to said shaft. / 上記プロペラは、好ましくは、前記少なくとも1つの軸に、プロペラの面が該軸に対して略垂直となるように取り付けられる。(USP6332818)

    $$ Said buffer is preferably a body of elastomeric material but a springloaded buffer formation could be used. / 該バッファは、エラストマー材の本体であることが好ましいが、スプリング搭載のバッファ構造体を利用することもできる。(USP5727825)

    (THAT)
    $$ In FIG. 1, in step 1, a magnetic clock pattern (the "write data track") for one track n of a magnetic disk is written to that track n. / 図1の段階1で、磁気ディスクの1つのトラックnの磁気クロックパターン(「書込みデータトラック」)が該トラックnに書き込まれる。(USP6172830)

    $$ If possible, the frame concealment apparatus 600 conceals a corrupted data element and resets the error flag associated with that element. / フレーム隠蔽装置600は、可能な場合に不良データ要素を隠蔽し、該要素に対応するエラー標識をリセットする。(USP5353059)

    (THE)
    $$ The vane member 730 is flanked by support members 760a, 760b at both major faces of the vane member 730. / 翼部材730は、該翼部材730の両主面において支持部材760a、760bにより側面処理されている。(USP6788479)

    $$ Ink deposited upon the substrate may be simply removed by washing or wiping. / 該基材上に付着されたインクは、水洗又は拭取りによって、簡単に除去され得る。(USP6267052)

    $$ Apparatus according to claim 11, wherein the transducers are resonant transducers having a resonant frequency in the range of 20 kHz and 2 MHz. / 請求項11記載の装置であって、該トランスジューサは共振トランスジューサであり、共振周波数が20kHzないし2MHzの範囲内にある装置。(USP6826982)

    (OTHERS)
    $$ The transmission in question uses two epicyclic shunt gears. / 当の変速機は2つの遊星シャント歯車を使用する。(USP8393990): in question

    $$ Received audio data is directed to the audio interface 157 which performs necessary signal conditioning before passing the signal to the speaker 95. / 受取られた音声データは、オーディオインタフェース157へ送られ、該インタフェースは、信号をスピーカ95へ送る前に必要な信号調整を行う。(USP6058304): which

                            目次はこちら

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  • Alice and the mechanical arts

    A listener/reader pointed me in the direction of the recent oral argument at the Federal Circuit in Robert Bosch v. ITC.  The case appears to concern patents of inventor/patent attorney Dr. Stephen Gass. The oral argument highlights that §101/Alice arguments are now making their way into the mechanical arts.  One of the parties was making […]

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  • From Around the Blogs

    1.  The U.S. Supreme Court’s decision to grant cert in WesternGeco LLC v. ION Geophysical Corp., No. 16-1011, a case I have discussed several times previously (see, e.g., here), has been the subject of some recent blog commentaries in addition to those I’ve already noted, including this one by Steve Brachmann on IP Watchdog and this one on Patently-O citing a paper that Professor Sapna Kamur presented at UT in 2016.   

    2.  There also have been at least three recent commentaries on the Federal Circuit’s recent decision in Exmark Mfg. Co. v. Briggs & Stratton Power , which as I noted last month arguably opens the door a bit wider to the use of the entire market value as the royalty base.  For other discussions, see this one by Cass Christenson & Rob Kramer & Carl Bretscher on IP Watchdog; this one by David Long on Essential Patents; and this one by Mark Engstrom on Kluwer.

    3.  IPKat recently published an interesting post titled Trial Sequence in SEP Litigation-Time for a Rejig?, discussing some dicta of Justice Carr in TQ Delta v. Zyxel to the effect that in FRAND/SEP cases it might make sense for the court to conduct the FRAND royalty trial before the trial on infringement and validity–what in the U.S.  is referred to as a “reverse bifurcation,” such as Judge Holderman performed in Innovatio.  Hat tip to Norman Siebrasse for bringing this to my attention.

    4.  Some other recent posts relevant to SEP/FRAND issues include Peter Picht, Standard Essential Patents, Antitrust, and Market Power on IP Watchdog; Joff Wild, The State of Mobile SEP Licensing, on the IAM Blog; and Michael Risch, What Is Essential?  Measuring the Overdeclaration of Standards Patents, on the Written Description Blog (discussing a recent paper by Sitzing, Sääskilahti, Royer, and Van Audenrode titled Over-Declaration of Standard Essential Patents and Determinants of Essentiality (I have not yet read the paper myself).

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