Denying Institution Where Displayed Posters Were Not Found to be Printed Publications IPR2015-00720, IPR2015-00817 Challenge to Acorda Drug Patents by Kyle Bass Denied

Takeaway: Petitioner must persuade the Board that an alleged “printed publication” qualifies as prior art by submitting requisite evidence that the publication was sufficiently publicly accessible in the pertinent timeframe to qualify under § 102(b). In its companion Decisions in … Continue reading

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Challenge to Acorda Drug Patents by Kyle Bass Denied

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  • Denying Institution Where the Same Prior Art and Arguments were Previously Presented CBM2015-00047

    Takeaway: The Board has the discretion to deny a petition if either (a) the same or substantially the same prior art OR (b) the same or substantially the same arguments were previously presented in an earlier Petition. In its Decision, … Continue reading

    The post Denying Institution Where the Same Prior Art and Arguments were Previously Presented CBM2015-00047 appeared first on PTAB Trial Blog.

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  • IPRs against other Teva Copaxone patents

    FiercePharma reports:


    On 25 August 2015, the U.S. Patent and Trademark Office (PTO) instituted inter partes review (IPR) proceedings against two of the patents on Copaxone 40 mg, with the third patent still pending. Next up will come a one-year review, and at that point, the office will decide whether to invalidate the IP shields, Bernstein analyst Ronny Gal wrote in a note to clients.

    link: http://www.fiercepharma.com/story/us-patent-office-puts-new-copaxones-ip-shield-under-lens/2015-08-26

    A press release on MarketWatch noted:


    Mylan N.V. announced that the U.S. Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two Copaxone® 40 mg/mL patents, U.S. Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. The patents relate to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg subcutaneous injections of glatiramer acetate over a period of seven days with at least one day between each injection. Mylan also has filed another petition for inter partes review of a related patent (U.S. Patent No. 8,969,302), which the PTO is expected to act upon shortly.

    Some background on MS from US Patent 8,906,357:

    Multiple Sclerosis (MS) is a common neurological disease affecting more than 1 million people worldwide (EMEA CHMP Guideline on MS, 2007). Its prevalence rate varies between races and geographical latitude, ranging from more than 100 per 100,000 in Northern and Central Europe to 50 per 100,000 in Southern Europe. MS is an inflammatory condition that damages the myelin of the Central Nervous System (CNS; the brain, spinal cord and optic nerves) and causes neurologic impairment and, frequently, severe disability. It is the commonest cause of neurological disability in young and middle-aged adults and has a major physical, psychological, social and financial impact on patients and bodies responsible for health care.

    The etiology of MS remains unknown. It is generally assumed that MS is mediated by some kind of autoimmune process, an abnormal response of the body’s immune system against the myelin in the CNS, possibly triggered by infection and superimposed upon a genetic predisposition. Research to date has identified the immune cells which attack the myelin, some of the factors causing them to attack, and some of the sites or receptors on the attacking cells that appear to be attracted to the myelin to begin the destructive process. However, the specific target on the myelin is yet to be identified. MS is characterized by chronic patchy inflammation of the CNS with demyelinization and gliosis (scarring). It is thought that progression of lesions in MS might have two components: an active immunological aspect and a degenerative aspect; it is unknown to what extent these are causally interrelated.

    Two principal clinical courses were classified 20 years ago by the US National Multiple Sclerosis Society; relapse remitting MS and chronic progressive MS. These were further refined in 1996 by Lublin & Reingold into four clinical courses of the disease, currently recognized as: Relapsing Remitting MS (RRMS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS) and Progressive Relapsing MS (PRMS). Each of these categories can be mild, moderate, or severe. Other very rare forms of MS also exist. More specifically, RRMS is the initial course in 80 to 85% of people diagnosed with MS and is characterized by unpredictable clearly defined relapses (flare-ups or exacerbations) of worsened neurological functioning with partial or complete recovery periods (remissions), during which no disease progression occurs. Remissions last for a period of months or years and impairments suffered during attacks may resolve or leave sequelae. Following an initial period of RRMS, many sufferers develop a secondary-progressive disease course in which the disease worsens more steadily between acute attacks, without definite periods of remission, or stable periods. Occasional relapses and minor remissions may occur. Approximately 50% of RRMS patients develop SPMS within 10 years, and after 25 to 30 years, the percentage rises to 90%. Approximately 10-15% of people diagnosed with MS have PPMS, which is characterized by slowly worsening neurologic function from the outset, with no distinct relapses or remissions.

    The rate of progression may vary over time, with occasional periods of stability and temporary minor improvements. The age of onset is later than for other clinical courses. In PRMS (approximately, 5% of people diagnosed with MS), patients experience steady neurological decline from disease onset, but with clear attacks of worsening function. They may or may not experience some recovery following these relapses, but the disease continues to progress without remissions. Finally, the term clinically isolated syndrome (CIS) applies to those patients who have suffered a single clinical event but do not comply with the diagnostic criteria for definite MS.

    While the four main courses of MS are currently defined according to clinical characteristics, there is increasing evidence of distinct pathological and pathogenic mechanisms between the different courses. Relapses are considered the clinical expression of acute inflammatory focal lesions whereas progression is considered to reflect the occurrence of demyelination, axonal loss and gliosis. These differences are important as they reflect differences in prognosis and because disease modifying drugs are currently effective only in the relapsing types of MS, i.e. patients either with a RRMS form or a SPMS form that are suffering relapses. Patients with relapsing MS constitute a common target for therapeutic treatments, indeed, RRMS and SPMS can be considered as different stages of the same disease while PPMS may imply different processes.

    There is currently no treatment proven to slow the progression of PPMS, nor curative treatment for MS. In general, current therapeutic approaches include: symptomatic treatment, corticosteroids for acute relapses, and treatment aimed to modify the course of the disease (disease modifying drugs).

    Symptomatic treatments refer to all therapies applied to improve symptoms caused by the disease: fatigue, spasticity, ataxia, weakness, bladder and bowel disturbances, sexual dysfunction, pain, tremor, paroxysmal manifestations, visual impairment, psychological problems, cognitive dysfunction and other associated conditions that can improve with non specific treatments. Disease modifying drugs are therapies aimed to decrease the relapse rate or modify relapses and to diminish the accumulation of disability in time (Table 1). While disease modifying medications may impact how quickly patients move from RRMS to SPMS and potentially the overall number of patients developing this course, long term data are not yet available. Currently approved therapies to modify the MS course target the immunological processes of the disease. Most of them are considered to act as immunomodulators but their mechanisms of action have not been completely elucidated. Immunosupressants or cytotoxic agents are also used in some patients after failure of conventional therapies. Based on the immunological nature of the disease, combination therapy targeting different parts of the immune processes may also be a possible strategy.

    AND


    FDA Approved Disease Modifying Therapies for MS FDA ap- Active agent Drug approval Approved Indication interferon Betaseron 1993 Treatment of relapsing forms of beta 1b MS and SPMS with relapses; and after a first clinical episode with MRI features consistent with MS interferon Extavia 2009 Treatment of relapsing forms of beta 1b MS and SPMS with relapses; and after a first clinical episode with MRI features consistent with MS interferon Avonex 1996 Treatment of relapsing forms of beta 1a MS, and for a first clinical episode if MRI features consistent with MS are also present glatiramer Copaxone 1996 Treatment RRMS; and for a first acetate clinical episode if MRI features consistent with MS mitoxantrone Novantrone 2000 Treatment of RRMS and progressive-relapsing or SPMS interferon Rebif 2002 Treatment of relapsing MS beta 1a natalizumab Tysabri 2004/ Treatment of relapsing forms of 2006* MS as a monotherapy (not used in combination with any other disease-modifying medication). *Voluntarily withdrawn from the market on Feb. 28, 2005; US FDA March 2006 Advisory Panel recommended for re-approval.

    Despite these approved therapies, the unmet medical need in the MS field remains substantial, even for relapsing MS patients treated early and in particular for the populations of PPMS and relapse-free SPMS (rfSPMS). Several reasons can be given for this: None of the available drugs completely stop the disease process. MS progression can be at an advanced stage before any diagnosis is made and advanced MS is not highly responsive to treatment with any of the available drugs. None of the drugs have been shown to be effective in rfSPMS or PPMS, subpopulations in which inflammation appears to be less prominent. There is a suspicion that inflammation alone cannot entirely explain the progressive neurodegeneration, particularly later in the disease. Many of the standard treatments require regular injections or infusions which, considering the chronic nature of this disease, impact negatively on the patient’s adherence to treatment, quality of life and can lead to a common side effect of injection site reactions. MS follows a highly heterogeneous disease progression, yet patient-optimized treatment, e.g. weight-adjusted dosing, is not developed in the currently available drugs. Long-term treatment regimens using corticosteroids are associated with numerous detrimental side effects, with its benefits possibly outweighed by potential complications.

    Role of c-Kit and Mast Cells in Inflammation

    Mast cells (MC) are predominantly found in tissues at the interface between the host and the external environment, such as lung, connective tissue, lymphoid tissue, gut mucosa, and skin. They develop from a common circulating CD34+/c-Kit+/CD13+/Fc.epsilon.RI- hematopoietic progenitor representing a single lineage, which gives rise to different phenotypes after migrating into peripheral tissues. Immature MC progenitors circulate in the bloodstream and differentiate in tissues. These differentiation and proliferation processes are influenced by cytokines, notably Stem Cell Factor (SCF), also termed Kit ligand (KL), Steel factor (SL) or Mast Cell Growth Factor (MCGF). The SCF receptor is encoded by the proto-oncogene c-Kit. It has been shown that SCF regulates the migration, maturation, proliferation, and activation of MCs in vivo–injection of recombinant SCF into rodents, primates, or humans, results in an increase in MC numbers at both the site of injection and at distant sites.

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  • Lilly prevails in SD Indiana in Alimta case

    AP reported Shares of Eli Lilly rose August 26, 2015 after the drugmaker said the federal district court in SD Indiana upheld a patent protecting one of its top-selling drugs, the cancer treatment Alimta. The defendant in this Hatch-Waxman case was a subsidiary of the generic drugmaker Teva Pharmaceutical Industries Ltd.

    link: http://www.washingtontimes.com/news/2015/aug/26/federal-court-backs-patent-protecting-eli-lilly-ca/

    From DocketReport –>

    Following a second bench trial, the court found that the defendant drug manufacturers induced infringement of plaintiff’s chemotherapy drug patent because all steps of the claimed methods could be attributed to physicians. “[T]he factual circumstances are sufficiently analogous to those in [Akamai Technologies, Inc. v. Limelight Networks, Inc., No. 2009-1372, 2015 WL 4760450 (Fed. Cir. Aug. 13, 2015) (en banc) (per curiam)] to support a finding of direct infringement by physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b). . . . Although the parties present extensive arguments as to whether [the physician’s instructions] constitutes the physician ‘administering’ the folic acid, whether or not this satisfies the definition of ‘administer’ is not relevant. What is relevant is whether the physician sufficiently directs or controls the acts of the patients in such a manner as to condition participation in an activity or receipt of a benefit—in this case, treatment with pemetrexed in the manner that reduces toxicities—upon the performance of a step of the patented method and establishes the manner and timing of the performance. Defendants argue that there is no way of knowing whether the patient will or will not actually take the folic acid, thus the physician lacks ‘control or direction’ over this step of the patented process. . . . The Court cannot base a finding of non-infringement upon the mere possibility that some patients might not follow their physician’s instructions and instead must look to the ANDA Products’ labeling to determine, if all the patented steps are followed, whether it would infringe the Asserted Claims.”
    Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al, 1-10-cv-01376 (INSD August 25, 2015, Order) (Pratt, J.)

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  • The PTAB denial of the Bass IPR petitions on Acorda’s Ampyra patents: not quite as being reported in the popular press

    Further to an earlier IPBiz post, there has been discussion of PTAB’s denial of Kyle Bass’s petition on Acorda’s Ampyra.

    The reason for denial by PTAB turned on the issue of whether or not two poster presentations (that of Goodman and that of Hayes ) were printed publications suitable for mounting an IPR challenge.

    These two references were mentioned in an Information Disclosure Statement (IDS) by the patentee. So the Bass team did not identify any new “smoking guns” but rather used information they obtained from the patentee’s IDS.

    PTAB quickly disposed of any idea that the patentee “admitted” Goodman and Hayes were prior art:


    Petitioner asserts that the Goodman poster “constitutes prior art under
    35 U.S.C. § 102(b) because it was published at least as early as September
    18–21, 2002 (a fact admitted by the ’685 patent applicants in an October 1,
    2012 IDS, see Ex. 1043, at Reference No. C416).” Pet. 18. Petitioner also
    contends that the Hayes poster “constitutes prior art under 35 U.S.C.
    § 102(b) because it was published on Sept. 30–October 3, 2001, more than
    one year prior to December 11, 2003 (a fact admitted by the ’685 patent
    applicants in an October 31, 2011 IDS, see Ex. 1033, at Reference No.
    C148).” Id. at 19. Exhibits 1043 and 1033 present portions of Information
    Disclosure Statements (“IDSs”) for Application No. 13/187,158 (“the ’158
    application”), which issued as the ’685 patent.

    Patent Owner acknowledges that relevant IDSs submitted during
    prosecution of the ’158 application state that the Goodman and Hayes
    posters “were ‘presented.’” Prelim. Resp. 11–12 (citing Ex. 2033, 3,
    “C416”; Ex. 2031, 12, “C148”). Patent Owner contends, however, that
    “even if Petitioner claims that the posters were displayed at meetings, this
    does not establish that the posters are printed publications” that qualify as
    prior art under § 102. Id. at 12 (citing In re Klopfenstein, 380 F.3d 1345,
    1349 n.4 (Fed. Cir. 2004)). We agree.

    First, the submission of an IDS does not constitute an admission that a
    cited reference is material prior art.
    ResQNet.com, Inc. v. Lansa, Inc., 594
    F.3d 860, 866 (Fed. Cir. 2010); Abbott Labs. v. Baxter Pharm. Prods., Inc.,
    334 F.3d 1274, 1279 (Fed. Cir. 2003)); see also 37 C.F.R. § 1.97(h) (stating
    that the filing of an IDS “shall not be construed to be an admission that the
    information cited in the statement is, or is considered to be, material to
    patentability as defined in § 1.56(b)”). Moreover, in this case, the relevant
    IDSs themselves state expressly that “[i]dentification of the listed references
    is not meant to be construed as an admission of Applicants or Attorneys for
    Applicants that such references are available as ‘prior art’ against the subject
    application.” Prelim. Resp. 19 (quoting Ex. 2031, 2; Ex. 2033, 1).

    The second point raised by PTAB was whether or not the two posters were printed
    publications, which could be reviewed by PTAB in an IPR proceeding. PTAB did not
    determine whether they were, or were not, printed publications but rather that petitioner Bass had not
    presented evidence that they were. Thus, in theory, these Ampyra patents are still
    subject to attack based upon Goodman and Hayes (tho may be not by Bass).

    PTAB wrote:


    Second, as also noted by Patent Owner, a “determination of whether a
    reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case
    inquiry into the facts and circumstances surrounding the reference’s
    disclosure to members of the public.” Klopfenstein, 380 F.3d at 1350;
    Prelim. Resp. 12–18. Several factors “aid in resolving whether or not a
    temporarily displayed reference that was neither distributed nor indexed was
    nonetheless made sufficiently publicly accessible to count as a ‘printed
    publication’ under § 102(b).” Klopfenstein, 380 F.3d at 1350. Because
    Petitioner does not indicate that the Goodman and Hayes posters were
    distributed (rather than presented) or indexed, we consider those factors
    now, which include: “[1] the length of time the display was exhibited, [2]
    the expertise of the target audience, [3] the existence (or lack thereof) of
    reasonable expectations that the material displayed would not be copied, and
    [4] the simplicity or ease with which the material displayed could have been
    copied.” Id.
    The “duration of the display is important in determining the
    opportunity of the public in capturing, processing and retaining the
    information conveyed by the reference.” Id. Along those lines, “[t]he more
    transient the display, the less likely it is to be considered a ‘printed
    publication.’” Id. at 1350–51. Here, we agree with Patent Owner that
    Petitioner presents insufficient evidence as to how long the Goodman or
    Hayes poster was presented at any scientific meeting. Prelim. Resp. 13–14.
    The only credible evidence of record indicating that the posters were
    presented at all is in the form of IDSs stating that the posters were
    “presented.”

    Similarly, Petitioner presents insufficient evidence in relation to “the
    expertise of the target audience,” i.e., anyone who actually saw either poster.
    Id. at 14–15. Petitioner likewise presents insufficient evidence in relation to
    any reasonable expectation that one could have copied the poster material, or
    evidence regarding the ease with which the poster material could have been
    copied. Id. at 15–16. Overall, evidence of record fails to demonstrate that
    the posters nonetheless were made sufficiently publicly accessible. For
    example, evidence of record does not indicate adequately how long the
    posters were presented to anyone, or to whom exactly, or what conversations
    anyone might have had with authors about the posters.

    In addition, our review of the posters themselves indicates that they
    both present relatively dense material in a small space. Ex. 1008, 2;
    Ex. 1009, 1. As stated by the Federal Circuit, the “more complex a display,
    the more difficult it will be for members of the public to effectively capture
    its information.” Klopfenstein, 380 F.3d at 1351.

    The bottom line:


    We are not persuaded that Petitioner has made a threshold showing
    that the posters were sufficiently publicly accessible to qualify as a “printed
    publication” under § 102(b). Petitioner has not demonstrated adequately that
    the Goodman poster (relied upon in all grounds) or the Hayes poster, as
    presented in the Petition, constitute prior art to the ’685 patent.

    The Klopfenstein case involved posters, and it is worthwhile to view
    “how” the MPEP views the issue:


    MPEP 2128.01 Level of Public Accessibility Required

    (…)

    IV. PUBLICLY DISPLAYED DOCUMENTS CAN CONSTITUTE A “PRINTED PUBLICATION” EVEN IF THE DURATION OF DISPLAY IS FOR ONLY A FEW DAYS AND THE DOCUMENTS ARE NOT DISSEMINATED BY COPIES OR INDEXED IN A LIBRARY OR DATABASE

    A publicly displayed document where persons of ordinary skill in the art could see it and are not precluded from copying it can constitute a “printed publication,” even if it is not disseminated by the distribution of reproductions or copies and/or indexed in a library or database. As stated in In re Klopfenstein, 380 F.3d 1345, 1348, 72 USPQ2d 1117, 1119 (Fed. Cir. 2004), “the key inquiry is whether or not a reference has been made ‘publicly accessible.’” Prior to the critical date, a fourteen-slide presentation disclosing the invention was printed and pasted onto poster boards. The printed slide presentation was displayed with no confidentiality restrictions for approximately three cumulative days at two different industry events. Id. at 1347, 72 USPQ2d at 1118. The court noted that “an entirely oral presentation that includes neither slides nor copies of the presentation is a ‘printed publication’ for the purposes of [pre-AIA] 35 U.S.C. § 102(b). However, an oral presentation at a scientific meeting or a demonstration at a trade show may be prior art under 35 U.S.C. 102(a)(1)’s provision: “otherwise available to the public.” See MPEP § 2152.02(e). Furthermore, a presentation that includes a transient display of slides is likewise not necessarily a ‘printed publication.’” Id. at 1349 n.4, 72 USPQ2d at 1122 n.4. In resolving whether or not a temporarily displayed reference that was neither distributed nor indexed was nonetheless made sufficiently publicly accessible to count as a “printed publication” under pre-AIA 35 U.S.C. 102(b), the court considered the following factors: “the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.” Id. at 1350, 72 USPQ2d at 1120. Upon reviewing the above factors, the court concluded that the display “was sufficiently publicly accessible to count as a ‘printed publication.’” Id. at 1352, 72 USPQ2d at 1121.

    (…)

    II. ORALLY PRESENTED PAPER CAN CONSTITUTE A “PRINTED PUBLICATION” IF WRITTEN COPIES ARE AVAILABLE WITHOUT RESTRICTION
    A paper which is orally presented in a forum open to all interested persons constitutes a “printed publication” if written copies are disseminated without restriction. Massachusetts Institute of Technology v. AB Fortia, 774 F.2d 1104, 1109, 227 USPQ 428, 432 (Fed. Cir. 1985) (Paper orally presented to between 50 and 500 persons at a scientific meeting open to all persons interested in the subject matter, with written copies distributed without restriction to all who requested, is a printed publication. Six persons requested and obtained copies.). An oral presentation at a scientific meeting or a demonstration at a trade show may be prior art under 35 U.S.C. 102(a)(1)’s provision: “otherwise available to the public.” See MPEP § 2152.02(e).

    **As to Klopfenstein, the PTAB text


    In addition, our review of the posters themselves indicates that they
    both present relatively dense material in a small space. Ex. 1008, 2;
    Ex. 1009, 1. As stated by the Federal Circuit, the “more complex a display,
    the more difficult it will be for members of the public to effectively capture
    its information.” Klopfenstein, 380 F.3d at 1351.

    is a bit of a stretch, because Klopfenstain was considering ease of copying.

    From Klopfenstein:


    Finally, the ease or simplicity with which a display could be copied gives further guidance to our § 102(b) inquiry. The more complex a display, the more difficult it will be for members of the public to effectively capture its information. The simpler a display is, the more likely members of the public could learn it by rote or take notes adequate enough for later reproduction. The Liu reference was made up of 14 separate slides. One slide was a title slide; one was an acknowledgement slide; and four others represented graphs and charts of experiment results. The other eight slides contained information presented in bullet point format, with no more than three bullet points to a slide. Further, no bullet point was longer than two concise sentences. Finally, as noted earlier, the fact that extrusion lowers cholesterol levels was already known by those who worked with SCF. The discovery disclosed in the Liu reference was that double extrusion increases this effect. As a result, most of the eight substantive slides only recited what had already been known in the field, and only a few slides presented would have needed to have been copied by an observer to capture the novel information presented by the slides.

    There is no appeal from a denial of petition. Here, the denial of the petition was based on a failure of evidence that the documents were printed publications. There was no determination whether the posters were or were not “printed publications,” and
    no determination that if they were printed publications, whether there was a reasonable likelihood that petitioner could have prevailed on at least one claim.

    Relevant links:

    Paper 15 in IPR2015-00720 related to US 8,663,685, entered August 24, 2015

    MPEP 2128 “Printed Publications” as Prior Art

    In re Klopfenstein, 380 F.3d 1345 in which the CAFC concluded


    Upon reviewing the above factors, it becomes clear that the Liu reference was sufficiently publicly accessible to count as a “printed publication” for the purposes of 35 U.S.C. § 102(b). The reference itself was shown for an extended period of time to members of the public having ordinary skill in the art of the invention behind the ‘950 patent application. Those members of the public were not precluded from taking notes or even photographs of the reference. And the reference itself was presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed — particularly given the amount of time they had to copy the information and the lack of any restrictions on their copying of the information. For these reasons, we conclude that the Liu reference was made sufficiently publicly accessible to count as a “printed publication” under § 102(b).

    Reuters: Hedge fund manager Kyle Bass loses challenges to pharma patents which includes text


    On Monday, the patent office disagreed with Bass that the Ampyra patents were not new or were obvious when compared with previously known ones, and therefore should never have been granted in the first place.

    The decision means the patents will not be further scrutinized, which could have led to cancellation.

    which, as noted above, is an inaccurate report by Reuters.

    **The Wall Street Journal noted:


    Use of IPR challenges against drug patents has raised concerns in the pharmaceutical industry, which has lobbied Congress for changes to the IPR process. The patent board’s ruling Monday against Mr. Bass, however, may signal that challenging pharmaceutical patents through IPR won’t be as easy as some industry officials have feared, said Gerald Flattmann, lead outside counsel for Acorda in its IPR proceedings with Mr. Bass.

    But, Acorda was saved only by a failure of evidence by Bass, not by a substantive ruling on validity. The pharma industry is right to worry about IPRs.

    **As one small footnote, Ampyra is not a disease-modifying treatment for MS, in contrast to Copaxone or Tecfidera.

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  • CAFC affirms PTAB in covered business method case of Progressive v. Liberty; Liberty Mutual loses

    The CAFC affirmed the PTAB on its decisions on covered business methods:


    For the foregoing reasons, the judgments of the Board
    are affirmed.

    Of details:


    Liberty Mutual Insurance Company initiated seven
    overlapping proceedings against Progressive Casualty
    Insurance Company in the Patent and Trademark Office,
    challenging many claims of several of Progressive’s insurance-related
    patents under the statutory program for
    review of “covered business method” patents. See GTNX,
    Inc. v. INTTRA, Inc., 789 F.3d 1309, 1310 (Fed. Cir. 2015)
    (describing transitional program for review of such patents
    under 35 U.S.C. §§ 321–329, pursuant to the LeahySmith
    America Invents Act, Pub. L. No. 112–29,
    § 18(a)(1), 125 Stat. 284, 329–31 (2011)). We now have
    before us Progressive’s appeals from the Patent Trial and
    Appeal Board’s final written decisions that many claims
    are invalid over prior art. See 35 U.S.C. §§ 328, 329. We
    affirm. We need not address Liberty’s cross-appeal in one
    proceeding, because that cross-appeal concerns claims
    held invalid in another proceeding whose result we affirm.

    link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1466.Opinion.8-20-2015.1.PDF

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  • The Value of the Trump Brand: “What is the Brand’s Message”

    In the United States, the race for the presidency is heating up.  Donald Trump, the upstart candidate with very little to no political experience, is the front runner for the Republican Party nomination.  Trump has been well known for his real estate holdings and his appearances on the television show The Apprentice, but now is also known for his divisive views concerning immigration in the United States.  In June, Trump made numerous comments concerning immigrants from Mexico, including stating that some of them were “rapists.”  The backlash was fast and severe (rightly so).  In a July 2, 2015 article in The Atlantic, titled, “Is Running for President Donald Trump’s Worst Business Decision,” the author, David A. Graham, reviews some of the response from the business community as does the blog, The Gawker.  Univision quickly refused to show Trump’s Miss USA Pageant.  NBC Universal made the same decision and noted that Trump would not appear on its show The Apprentice.  Macy’s decided to end a line of Trump clothing.  Serta similarly decided to end a Trump branded mattress.  NASCAR, ESPN and the PGA will not hold events at Trump branded golf courses/hotels.  The League of United Latin American Citizens (LULAC) issued a press release condemning Trump and applauding Univision and NBC Universal’s actions. 

    In The Atlantic article, Mr. Graham notes that Trump is supposedly worth around $9 billion—according to Trump.  According to a Slate article authored by Jordan Weissmann, about $3.3 billion of that $9 billion is supposed to be the value of the “Trump brand.”  Wow!  That is quite a valuation.  I wonder what it was based on.  Mr. Weissmann notes that some hotels will pay Trump to use the Trump name on the hotel—Trump actually doesn’t own the hotel itself.  Forbesputs the brand closer to around $125 million.  That is still quite a high valuation.  And, it is not entirely clear how Forbes arrived at that number.  (The branding deals with Serta, Macy’s and hotels?)

    In recent weeks, Trump has maintained his lead as the Republican front runner.  Notably, The New York Times, in Why Donald Trump Won’t Fold: Polls and People Speak, recently examined polling data and concluded:

    A review of public polling, extensive interviews with a host of his supporters in two states and a new private survey that tracks voting records all point to the conclusion that Mr. Trump has built a broad, demographically and ideologically diverse coalition, constructed around personality, not substance, that bridges demographic and political divides. In doing so, he has effectively insulated himself from the consequences of startling statements that might instantly doom rival candidates.

    In poll after poll of Republicans, Mr. Trump leads among women, despite having used terms like “fat pigs” and “disgusting animals” to denigrate some of them. He leads among evangelical Christians, despite saying he had never had a reason to ask God for forgiveness. He leads among moderates and college-educated voters, despite a populist and anti-immigrant message thought to resonate most with conservatives and less-affluent voters. He leads among the most frequent, likely voters, even though his appeal is greatest among those with little history of voting.  . . .

    His support is not tethered to a single issue or sentiment: immigration, economic anxiety or an anti-establishment mood. Those factors may have created conditions for his candidacy to thrive, but his personality, celebrity and boldness, not merely his populism and policy stances, have let him take advantage of them.

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  • Lisa Rein publishes email of Michelle Lee to USPTO employees: " time and attendance abuse is absolutely unacceptable and will not be tolerated"

    Lisa Rein of the Washington Post published an email of Director Michelle Lee to all USPTO employees which related to the August 19 report of the U.S. Department of Commerce Office of Inspector General (OIG) which detailed significant time and attendance abuse of a USPTO employee.

    The text of the August 25 email included:


    So, along with the agency’s entire Executive Committee, it is important to reiterate that time and attendance abuse is absolutely unacceptable and will not be tolerated. [sic]

    We are inspired by so many of our hardworking and dedicated employees. And importantly, I know that together we will remain vigilant in our focus on fulfilling the vital mission of our agency in the service of the American public.

    Link to Rein article: http://www.washingtonpost.com/blogs/federal-eye/wp/2015/08/26/patent-office-chief-to-employees-time-and-attendance-abuse-is-absolutely-unacceptable/

    Rein noted that the supervisor of the examiner in question worked from homw (telecommuted), so this is the inverse of the previously alleged issue of abuse by telecommuting examiners.

    Rein: An examiner with a history of poor performance who was never disciplined racked up more than 18 weeks of pay last year for not working. But his manager, who worked from home, only noticed when he received an anonymous letter calling out the employee.

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  • Laches as a defense to Ph.D. thesis plagiarism?

    An interesting argument about “Ph.D. thesis plagiarism” appears at the end of the post Delays plague Chris Spence plagiarism hearing. Chris Spence is accused of plagiarizing portions of his UToronto Ph.D. thesis and Selwyn Pieters is the lawyer for Spence.

    Pieters also argues it has been so long — 19 years — since Spence wrote his thesis, that the U of T has lost its right to rule on whether he plagiarized some of its passages. The proceedings will resume in November.

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  • IP rights in Europe: a follow-up study

    Intellectual Property Rights and Firm Performance in Europe: An Economic Analysis is the title of the 100-page report produced by the Office for Harmonisation in the Internal Market (OHIM). According to the Foreword:

    The study on the contribution made by IPR-intensive industries to the EU economy carried out in 2013, in partnership with the European Patent Office, demonstrated the importance of those industries. It showed they support directly or indirectly 35% of jobs, almost 39% of the EU’s GDP and 90% of external trade. 

    OHIM, through the European Observatory on Infringements of Intellectual Property Rights, has now carried out a follow-up study delving deeper into the influence of these rights at the firm or company level. This study, based on official public financial data from more than 2.3 million EU firms, covers companies which own patents, trade marks and designs at both national and at EU level. 

    The study shows that large companies are four times more likely to own IP rights than smaller companies – 40% of larger firms have registered rights, compared with 9% of SMEs [this raises a popular debating point: do companies have more IP rights because they’re bigger — or are they bigger because they have more IP rights? Neither, probably …]. It also shows that companies that own IP rights perform better than those that do not [again, there is a correlation v causation issue here]. This is a particularly significant finding for the 1.8 million SMEs that have registered IP rights, since they represent such an important part of the EU economy. 

    The results demonstrate that businesses that own Intellectual Property Rights generate more revenue per employee than those that do not, have more employees and pay higher salaries to their workers and that this relationship is particularly strong for SMEs.

    These conclusions are interesting and entertaining, but they are only a snapshot of a very large picture and it is still necessary to look beyond them. For example, some of the businesses that have the largest concentration of low-paid workers, such those in the fishing, agricultural and distribution sectors, and in security, construction and healthcare, are likely to have a lower concentration of IP rights too. 

    Thanks to Chris Torrero for the link!

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  • USPTO flexing its muscles as to changes in IPR proceedings?

    A Washington Post story suggests the USPTO wants to control “how” the IPR process
    might be changed:

    The USPTO’s latest data show that the IPR process is tremendously successful at getting patents invalidated: Of all patent claims to be challenged so far under IPR, nearly a quarter have been ruled unpatentable by the patent office. What you make of this figure depends on whose interests you represent: The manufacturing, biotech and pharmaceutical industries find it alarmingly high and a potential risk to future technological advances. By contrast, many in Silicon Valley view it as evidence that the patent office approved way too many “bad” patents in the past that should never have made it out the door. And now, these patent claims are being swept off the table, reducing ammunition for patent trolls.

    In a blog post proposing changes to the IPR process, the USPTO last week said its review decisions have been upheld by a federal appeals court at “a very high rate” — suggesting that they’ve made the right calls in each IPR case.

    Biotech and pharmaceutical patents also account for a tiny share — about 9 percent — of all the petitions made under IPR and similar mechanisms. The vast majority are in the “electrical/computer technology” sector, about 63 percent.

    “We recognize that, while we believe the proceedings are working well, there are improvements that could be made based on our and the public’s experiences with the proceedings,” USPTO Director Michelle Lee wrote in a blog post last week.

    The proposed changes give patent holders some new benefits (such as the ability to respond to a request for review with their own evidence arguing against an investigation).

    On Tuesday, the USPTO also announced a request for public comments on a proposal to switch up how IPR proceedings are initiated. The current system has a three-judge panel at the agency decide whether to start a review, then uses the same judges to conduct it. Under the proposed change, only one judge would be responsible for launching the process. That judge would then be joined by two fresh judges who weren’t involved in the initial decision.

    These changes, if approved, could alter how the IPR process works. But more importantly, some tech industry officials say, it sends the message that the USPTO is capable of making decisions to improve the IPR process on its own, and that it doesn’t need Congress to write new rules laying out how IPR should work.

    link: https://www.washingtonpost.com/news/the-switch/wp/2015/08/25/shorter-patent-office-to-congress-dont-touch-the-patent-appeals-system/

    **To understand the high rate of affirmance by the CAFC of PTAB decisions, one should note the standards of review.
    The Finnegan website notes:

    the Federal Circuit applies the deferential “substantial evidence” test to the PTAB’s anticipation and written-description determinations, which are both questions of fact. In contrast, the Federal Circuit reviews questions of law—including enablement, obviousness, indefiniteness, and patentable subject matter—under a de novo standard, without deference. At the same time, the PTAB’s underlying factual findings with respect to obviousness and enablement are reviewed under the more deferential “substantial evidence” standard.

    link: http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=6d481cea-b457-43af-a5c3-3d7a69e14679

    Evidence is substantial “if a reasonable mind might accept it as adequate to support the finding.” The reviewing court might not agree with the determination, but will affirm it if there is substantial evidence. Further, as to error by PTAB, the appellant must show the error was harmful: “appellant must not only show
    the existence of error, but also show that the error was
    in fact harmful because it affected the decision
    below.”

    A petitioner may not appeal a decision not to institute an IPR proceeding (as happened in the Kyle Bass/Acorda matter over patent claims to the MS drug Ampyra). See In re Dominion Dealer Solutions, LLC., 2014 WL 1673823, *1 (Fed. Cir. Apr. 24, 2014).

    link: http://www.ipo.org/wp-content/uploads/2014/07/CAFC_Rev_of_PTAB.pdf

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  • The IPR petitions of Kyle Bass on Acorda/Ampyra denied by PTAB

    Susan Decker of Bloomberg wrote of Kyle Bass’s loss at PTAB on Acorda/Ampyra:


    The U.S. Patent and Trademark Office said Monday the hedge-fund manager hadn’t come up with enough evidence to challenge two Acorda Therapeutics Inc. patents for the multiple sclerosis drug Ampyra. The information he was using wasn’t publicly available so couldn’t be used to invalidate the patents, the patent board decided. The decision to reject the petition cannot be appealed.

    (…)

    Bass relied on information that had been presented at scientific meetings, but the board said there wasn’t enough evidence that the information was publicly available. The three-judge panel had total discretion to decide whether to institute a review, based only on the arguments presented in the two sides’ filings.

    (…)

    The cases are Coalition for Affordable Drugs v. Acorda Therapeutics, IPR2015-00720 and IPR2015-00817, U.S. Patent and Trademark Office (Alexandria, Virginia).

    Within the initial petition, one finds the text:


    Moreover, as discussed extensively below,
    Dr. Pleasure testifies that “it would
    have been obvious to one of ordinary skill
    in the art without undue experimentation
    to treat such patients for a period of at
    least two weeks (or longer) with agents shown
    to alleviate symptoms associated with MS. (Ex. 1013, ¶ 22.)
    See also In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed.
    Cir. 2012) (“‘[W]here the general conditions
    of a claim are disclosed in the prior art, it
    is not inventive to discover the optimum or
    workable ranges by routine experimentation.’”) (quoting
    In re Aller, 220 F.2d 454, 456 (CCPA 1955)). It would have
    been obvious to a POSA to extend the dosing regimen,
    for chronic diseases like MS, from a time period of 1 week
    to two weeks or more. (Ex. 1013 ¶ 41.) In fact, administering at least
    2 weeks of 10 mg 4-AP BID to a person
    with MS in need of improved walking is not
    just one of a long list of things a POSA
    would have been motivated to do in view of the prior art—it is the
    first thing a POSA was motivated to do: i.e., select the lowest
    known efficacious dose (10 mg BID) for
    use over an extended treatment peri
    od (measured in weeks not days).

    **See also: http://www.patentdocs.org/2015/08/ptab-denies-inter-partes-review-petitions-against-two-acorda-patents.html, which includes the text:


    One of the statistics gleaned from Director Michelle Lee’s recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three years. There is no statistic in the Director’s link to a more detailed description of the data regarding the correlation between petitions being denied and the patentee exercising its right to challenge the petition by filing a Preliminary Response (see “Patent Trial and Appeal Board Statistics,” July 31, 2015). But logic suggests that the Board might be less likely to grant a petition if the patentee gave them reasons not to do so.

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