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  • Genes Associated with ALS Identified

    By Kevin E. Noonan —

    Gehrg, LouOne of the promises of the Human Genome Project was that knowledge of the entirety of the human genetic complement would permit researchers to identify genetic bases for diseases that had been intractable to conventional approaches.  While these efforts have borne equivocal fruit much more slowly that expected or hoped, occasionally there are reports that validate the expectations that were the foundation for much of the support the HGP received during the time before its immediate goal of genome deciphering was achieved.

    One such report was published earlier this year in Science using exome analysis (i.e., genetic analyses that focus on the expressed portion of the genome) to identify genes associates with amyotrophic lateral sclerosis (ALS), commonly known as "Lou Gehrig's disease."  Ever since Gehrig's timeless declaration that he was "the luckiest man on the face of the earth," the specter of ALS has haunted mankind.  A progressive, degenerative motor neuron disease that results in the lost of motor control, ALS sufferers face a frightening death.  Despite this, and the impetus the disease has produced to search for a cure, there has been precious little progress since that day in 1939.

    While not producing a cure, the results reported in Science at least provide additional clues to where a cure may be found.  Specifically, the researchers studied 2869 ALS patients and 6405 (non-ALS normal) controls and "loss-of-function (LoF)" mutations in one gene in particular, TBK1 encoding TANK-binding kinase were found to be positively associated with ALS in about 1% of cases.  This gene is known to bind to and phosphorylate two genes previously "implicated" in development of the disease, optineurin (OPTN) and p62 (SQSTM1/sequestosome), as well as a number of other proteins involved in innate immunity and autophagy.  Patients having mutations in TBK1 exhibited shorter-than-usual survival times.  In addition, patients having mutations in multiple ALS-associated risk genes presented with symptoms of the disease at an earlier age.  According to the authors, these results "reveal a key role of the autophagic pathway in ALS and suggest specific targets for therapeutic intervention."  Further, "pathogenic variants in OPTN, SQSTM1, or TBK1 would be expected to lead to defects in autophagy and in key innate immunity signaling pathways.  Mutations in these genes might therefore interfere with the normal function of these pathways in maintaining normal cellular riboproteostasis."

    The authors* state that their results provide "possible directions for drug screening programs" and "a critical role of autophagy and/or inflammation in disease predisposition."  They conclude:

    Our exome sequencing study has identified variants that definitively predispose humans to a sporadic, complex human disease.  Larger exome sequencing studies may reveal identifiable roles for genes that have not yet achieved significant associations.  There is reason for optimism that such studies will begin to fill in an increasingly complete picture of the key genes implicated in ALS, providing multiple entry points for therapeutic intervention.

    In the words of an old Yiddish (and Arabic) saying, "from their lips to God's ear."

    * The international team was from the following institutions: Center for Applied Genomics and Precision Medicine and Department of Biostatistics and Bioinformatics, Duke University School of Medicine; Duke ALS Clinic and Durham VA Medical Center; HudsonAlpha Institute for Biotechnology; Institute for Genomic Medicine, Department of Neurology, Center for Motor Neuron Biology and Disease, Department of Pediatrics and Medicine, and Department of Biochemistry & Molecular Biophysics, Columbia University; Department of Neurology, University of Massachusetts Medical School; Montreal Neurological Institute, Department of Neurology and Neurosurgery, McGill University; Department of Genetics, Stanford University School of Medicine; Biogen Idec; Neurogenetics DNA Diagnostic Laboratory, Center for Human Genetics Research, Department of Neurology, Massachusetts General Hospital; Department of Neurology, Washington University School of Medicine; Department of Genome Analysis, Academic Medical Center, Amsterdam; Academic Unit of Neurology, Trinity Biomedical Sciences Institute, Trinity College Dublin; Department of Basic and Clinical Neuroscience, King's College London, Institute of Psychiatry, Psychology and Neuroscience; Department of Neurology, Brain Center Rudolf Magnus, University Medical Centre Utrecht; Department of Neurology and Laboratory of Neuroscience, IRCCS Istituto Auxologico Italiano, and Department of Pathophysiology and Transplantation, Dino Ferrari Center, Università degli Studi di Milano, Milan; Cedars Sinai Medical Center; Houston Methodist Hospital; Weill Cornell Medical College of Cornell University; Ludwig Institute for Cancer Research and Department of Neurosciences, University of California, San Diego; Department of Neurology, University of Utah School of Medicine; Department of Pathology and Laboratory Medicine and Department of Neurology, Penn ALS Center and Penn Frontotemporal Degeneration Center, Perelman School of Medicine, University of Pennsylvania; Department of Neurology, Emory University; and Department of Cell Biology, Harvard Medical School.

  • FDA Releases “Final” Guidances for Industry regarding the Biosimilar Approval Pathway

        By Kevin E. Noonan —

    FDAAbout three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances (see "FDA Publishes Draft Guidelines for Biosimilar Product Development" and "More on FDA Draft Guidelines for "Follow-on" Biologic Drug Approval Pathway") were expressly "draft" in nature, and were the subject of public hearings with the Agency welcoming industry input.  This input was necessary; even a cursory review of the pathway provisions of the law would strike one with the frequency with which Congress delegated to the FDA the details of setting out the requirements for biosimilar approval.  This did not come as a shock, it being rational that Congress should recognize that Agency expertise was particularly important in developing standards for approving drugs as complex as biosimilars under circumstances where the "follow-on biologic" drugs were frankly not identical to the approved reference biologic product.

    In April the Agency released "final" Guidances that look remarkably like the originals; these Guidances are entitled:

    • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product [link]

    • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product [link]

    • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 [link]

    The FDA has released an additional, more explicit Guidance related to the requirements for establishing biosimilarity since promulgating these first three (see "FDA Releases Draft Guidance on Biosimilars: Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity") as well as a Guidance on market exclusivity (see "FDA Releases Another Prospective Guidance").  More importantly, the Agency recently approved the first biosimilar drug in the U.S. (see "FDA Approves Sandoz Filgrastim Biosimilar").  But as noted in the letter from several Senators discussed yesterday (see "Senators Send Letter on Biosimilars to FDA"), this progress has not come fast enough for some.  In addition, the Agency has made at least one no-decision decision (using an "interim" non-proprietary name for Sandoz XARZIOTM product (filgastrim–sndz)) and has not yet addressed the standards for interchangeability.  However, such carping seems unfairly critical from the institution that left it to the Agency to actually develop a biosimilars pathway and, of course, be ready to take the blame for any problems arising along the way.

  • Senators Send Letter on Biosimilars to FDA

    By Donald Zuhn —

    Senate SealA group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food and Drug Administration, "to express concern and raise questions over how the Food and Drug Administration (FDA) is implementing critical elements of the biosimilar product pathway established by the Biologics Price Competition and Innovation Act [BPCIA]."  In particular, the Senators were concerned about the FDA's failure to resolve "unsettled questions about the biosimilar approval pathway," including the failure to provide policies on nonproprietary naming of biosimilar products, interchangeability, and production of patent information.

    FDANoting that members of Congress had sought guidance on these issues in 2013 and 2014, the letter points out that "[d]espite this repeated urging, FDA did not make public its policy on the review and approval process before moving forward with the first approval of a biosimilar product" (see "The First Biosimilar Application Has Been Approved — But What About the Patent Issues?").  The Senators suggest that "FDA's failure to resolve fundamental science and policy questions prior to approving a biosimilar for the first time last month raises a number of serious concerns."  Among those concerns is the FDA's use of a "placeholder" nonproprietary name for the biosimilar it just approved.  The letter states that "[i]t is unclear to us what it means for a nonproprietary name to be a 'placeholder,'" and asks "what authority FDA has to make such a designation."  The Senators also express "concern[] that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved."

    While noting that the FDA recently released the first final guidance on the biosimilar pathway, the Senators also point out that "much of the guidance FDA has provided on the biosimilar pathway remains in draft form."  And as for the three finalized guidance documents, the Senators note that "FDA did not finalize these documents until after reviewing and approving the first biosimilar application."  The letter continues:

    FDA's failure to issue complete and final guidance before beginning to review and approve biosimilar applications raises significant questions.  In particular, it is not clear to what extent FDA staff has been following draft guidance when reviewing biosimilar applications.  And, if FDA staff has not been following draft guidance when reviewing applications, it is not clear what agency policies, if any, have been governing the process.

    The letter closes by listing a series of questions and requesting that the FDA provide answers to those questions by May 22.  Among the questions posed by the Senators are the following:

    • What is a "placeholder" nonproprietary name, and what is FDA's legal authority to issue and/or to change such a name?

    • What guidelines have FDA staff members been following in reviewing biosimilar applications?

    • What guidance documents regarding biosimilar or interchangeable products does FDA currently intend to publish, and on what schedule?

    • Why has FDA declined to provide guidance regarding whether the information exchange provisions of Section 351(l) of the PHSA are mandatory?

    In addition to providing several questions for the FDA to answer, the Senators "urge FDA to prioritize the publication of final guidance on the issues identified [in the letter], and to improve the transparency of its biosimilar review and approval process going forward."

    The text of the letter was made available by the FDANews (see "GOP Senators Request FDA Clarification of Biosimilars Policy").

  • Conference & CLE Calendar

    CalendarMay 12, 2015 – "Patent Prosecution: Leveraging Declarations to Strengthen Patents Against Post-Grant Proceedings" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 12, 2015 – 31st Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    May 12-14, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

    May 13, 2015 – "Protecting University IP against PTAB Challenges" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    May 14, 2015 – "Drafting Patents with an Eye to the PTAB" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    May 19, 2015 – "Best Practices for Cost-Effective Filing of PCT and EPO Patent Applications" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    May 19-21, 2015 – EU Pharmaceutical Law Forum*** (Informa Life Sciences) – Brussels, Belgium

    May 20, 2015 – "Never Been a Better Time (For IP) Than Right Now?" (Intellectual Property Owners Association (IPO) European Practice Committee) – London, UK

    May 28, 2015 – "Patent Exhaustion and Its Impact on Patent Licensing" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    May 28, 2015 – "Hedge Fund IPR Challenges to Pharma Patents: Strategies to Strengthen Patents to Withstand Attack" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 1-2, 2015 – Biosimilars*** (American Conference Institute) – New York, NY

    June 4, 2015 – "Navigating Section 112(a) Enablement and Written Description — Withstanding 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 9-10, 2015 – Due Diligence Summit for Life Sciences*** (ExL Events) – Boston, MA

    June 15-17, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

    June 15-18, 2015 – BIO International Convention (Biotechnology Industry Organization) – Philadelphia, PA

    July 8-10, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    ***Patent Docs is a media partner of this conference or CLE

  • 2015 BIO International Convention

    BIO International Convention_shortThe Biotechnology Industry Organization (BIO) will be holding its annual BIO International Convention June 15-18, 2015 in Philadelphia, PA.  Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  The BIO International Convention serves to educate the public and policymakers about biotechnology, while fostering partnering meetings and other business development activities to keep the biotech industry growing.

    Descriptions of the Convention's 125+ Breakout Sessions and six Super Sessions can be obtained here.  Among the sessions that may be of interest to Patent Docs readers are:

    Independence HallTuesday, June 16

    Intellectual Property Opening Plenary (Intellectual Property Track) — 9:00 to 10:00 am (Room 109AB)

    Antibody Therapeutics: May I Have Them All? (Intellectual Property Track) — 10:15 to 11:30 am (Room 109AB)

    The Impact of USPTO Inter Partes Review Proceedings on (Bio)Pharma (Intellectual Property Track) — 2:00 to 3:15 pm (Room 109AB)

    Quantifying the Value of Intellectual Property to Society (Food & Agriculture Track) — 2:00 to 3:15 pm (Room 104AB)

    Moneyball: Strategies for Structuring Deals Between Small Biotechs and Big Pharma (Business Development & Finance Track) — 2:00 to 3:15 pm (Room 103AB)

    Celebrating Innovation – Retelling the IP Story of Crixivan, an Award-Winning Life Saver & Reception (Intellectual Property Track) — 3:30 to 4:45 pm (Room 109AB)

    Wednesday, June 17

    The Evolving Landscape of Patentable Subject Matter (Intellectual Property Track) — 9:00 to 10:00 am (Room 109AB)

    "Inventions Patentable": Evaluating Proposed Amendments to Section 101 (Intellectual Property Track) — 10:15 to 11:30 am (Room 109AB)

    Global Regulatory Trends for Biosimilars and Biotherapeutics (Regulatory Science Track) — 10:15 to 11:30 am (Room 106AB)

    Patentable Subject Matter Around the World: Life Science Inventions in Canada, Europe, China, Australia and New Zealand (Intellectual Property Track) — 2:00 to 3:15 pm (Room 109AB)

    Accelerating Innovation in the 21st Century (Super Session) — 2:00 to 3:30 pm (Room 114)

    Trends in Early Therapeutic Research and Funding – Project Initiation, Patent Filing, Licensing, and Venture Capital (Business Development & Finance Track) — 3:30 to 4:45 pm (Room 103AB)

    FDA Takes Charge: The Changing Regulatory Landscape for Molecular Diagnostics (Personalized Medicine & Diagnostics Track) — 3:30 to 4:45 pm (Room 105AB)

    Thursday, June 18

    Who Has the Keys to Your IP? Protecting Against Intellectual Property Theft (Intellectual Property Track) — 9:00 to 10:15 am (Room 109AB)

    TTIP: Transatlantic Trade Negotiations and Opportunities for Setting New Regulatory, IP, and Other Standards for the Biopharma Industry (Emerging Opportunities in Global Markets Track) — 9:00 to 10:15 am (Room 119A)

    I-Corps™ at NIH: How to go from idea to IP to IPO (Business Development & Finance Track) — 10:30 to 11:45 am (Room 103AB)

    Trans-Pacific Partnership (TPP): Reaching the Finish Line of a Groundbreaking Global Agreement (Emerging Opportunities in Global Markets Track) — 10:30 to 10:45 am (Room 119A)

    Get Your WorldView On: 2015 Scientific American Biotech Scorecard (Emerging Opportunities in Global Markets Track) — 12:30 to 1:45 pm (Room 119B)

    Scientific American Worldview – Biotech: The Many Spheres of Influence (Super Session) — 2:00 to 3:30 pm (Room 114)

    As part of the Convention, more than 1,800 biotech companies, organizations, and institutions will participate in the BIO Exhibition.  A searchable list of exhibitors can be found here.  Information regarding registration and pricing can be obtained here.  Patent Docs Donald Zuhn, Kevin Noonan, Andrew Williams, Sherri Oslick, Josh Bosman, Josh Rich, and James DeGiulio will be attending BIO as part of the MBHB contingent, and will be reporting on a few of the sessions listed above.  Patent Docs readers who may be attending BIO are encouraged to stop by the MBHB booth (#3226).

    BIO - Good Times on Tap 2011In addition, the Docs will be attending the MBHB reception at Fado Irish Pub (1500 Locust Street, Philadelphia) on Tuesday, June 16 from 8:00 pm to 1:00 am.  Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth on Monday or Tuesday.

    Photograph of Independence Hall (above) by Dan Smith, from the  Wikipedia Commons under the Creative Commons license.

  • Webinar on Protecting University IP against PTAB Challenges

    Technology Transfer Tactics will be offering a webinar entitled "Protecting University IP against PTAB Challenges" on May 13, 2015 from 1:00 to 2:00 pm (Eastern).  Jessica N. Morton, Vice President of Intellectual Property at IP Shakti, LLC will moderate a panel consisting of Dipanjan "DJ" Nag, CEO and President, IP Shakti LLC and Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP.  The webinar will cover the following topics:

    • A solid understanding of the mechanics of the PTAB
    • Best practices to help avoid PTAB challenges including:
        – Invention disclosure review
        – Provisional filings
        – Continuation Practices & Preserving Priority Chain
        – Claim Practices
        – Robust patent families
        – Post-grant Reissue Practices
    • Guidance on which technologies in your patent portfolio are most likely to be targeted
    • Numbers and trends: Filings in 2014 and forecast for 2015
    • Cost comparisons of post-grant reviews versus post-grant reissues: using your budget wisely
    • How to keep your TTO’s legal and patent budget in check despite higher hurdles presented by PTAB

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Webinar on Patent Exhaustion and Its Impact on Patent Licensing

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on "Patent Exhaustion and Its Impact on Patent Licensing" on May 28, 2015 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorney Patrick G. Gattari will provide an in depth review of several recent decisions on patent exhaustion, to outline their differences, and to provide guidance regarding how to address the impact of the decisions in license agreements.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO Webinar on Drafting Patents with an Eye to the PTAB

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Drafting Patents with an Eye to the PTAB" on May 14, 2015 beginning at 2:00 pm (ET).  Courtenay Brinckerhoff of Foley & Lardner, Michelle Macartney of Intellectual Ventures, and Thomas Rozylowicz of Fish & Richardson will give tips for patent claim and specification drafting that can go a long way to bullet-proofing a patent, as well as advice on savvy prosecution strategy using declarations, continuation applications, reexamination, and reissue.

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • USPTO Places Limits on PAIR Downloads

    By Donald Zuhn —

    EBCA colleague pointed out today that the U.S. Patent and Trademark Office has apparently begun to restrict the ability of users to make bulk downloads from Public PAIR.  While we have not noticed any recent download restrictions in our own use of PAIR, our colleague indicated that attempts to download an entire file history (sans non-patent literature (NLP) documents) via Public PAIR had failed, and that subsequent attempts to download only portions of the file history had also failed.

    Our colleague also indicated that the Office's Patent Application Information Retrieval (PAIR) system appears to throttle users down progressively.  For example, our colleague noted that at first he could download twenty documents at a time, but the system reduced that number to ten documents and then reduced the number again to five documents.  Contacting the Office's Patent Electronic Business Center (EBC), our colleague was informed that the Office does "limit bandwidth and will shut groups down completely if they exceed the data download limits for our system."  The EBC agent also noted that "Public/Private PAIR was never designed to be used to download bulk data," and that the EBC had a service for bulk downloads.  Most disconcerting was the agent's warning that if a user exceeded the Office's data download limits (whatever those might be), the system would "give[] you a specific error and you would not be able to download anything at that point" (to which our colleague suggested that this might pose a real problem if a user was precluded from downloading anything at all from PAIR).

    The bulk download service to which the EBC agent was referring is described on the Office's Electronic Bulk Data Products webpage.  There, the Office notes that it entered into a no-cost agreement with Reed Technology Information Services (RTIS) in June 2013 "to make patent and trademark public bulk data more readily available to the public free of charge."  The Office also notes that "Reed Tech is also continuing work on a special data product consisting of Public PAIR (Patent Application Information Retrieval) data, which is not currently available from the USPTO in bulk form."  Reed Tech's Public PAIR bulk patent data can be accessed here.

    Our colleague pointed out two issues with Reed Tech's service.  First, not all applications are available for download, and second, the slow-downloading .zip file provided by Reed Tech contains a separate .pdf file for every document in the file history.

    While the download restrictions were news to Patent Docs, a check of the Office's PAIR FAQs webpage suggests that the limits may not be an entirely new development.  In particular, that webpage includes one FAQ on point:

    Does PAIR limit Image File Wrapper (IFW) downloads?
    To maintain general availability of USPTO information and services provided on the Internet, any activity or operation by a third party that has the potential to cause a denial or diminution (decrease) of services to other customers, whether generated automatically or manually, will result in the Office's denying access to the Office Internet resources to that third party.

    Patent Docs is interested in hearing from readers as to whether they have experienced problems making bulk downloads from either Private or Public PAIR.

  • Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until [the] Court resolves the appeal."  The Order also sets a date of no later than seven days from today for Sandoz to propose an amount of the bond (for damages accruing daily) the Court should order, with Amgen being given seven days thereafter for responding.

    AmgenThe Court’s Order thus maintains the status quo ante between the parties, who are involved in a declaratory judgment action brought by Amgen in the Northern District of California before Judge Seeborg.  Last month, the District Court denied Amgen’s motion for an injunction (see "Gotta Dance? Apparently Not — A Biosimilar Update"), based in part on the court’s opinion that Sandoz correctly interpreted the "patent dance" provisions of Biologics Price Competition and Innovation Act of 2009 (BPCIA) to permit Sandoz to refuse to disclose to Amgen its biosimilar application and "such other information that describes the process or processes used to manufacture the biological product that is the subject of such application" as apparently mandated by the Act ("Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant—(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application") (see "The Tyranny of the Judiciary").  Thus, the first biosimilar product approved by the FDA (see "FDA Approves Sandoz Filgrastim Biosimilar") will remain off the market in the U.S. at least until the Federal Circuit decides whether Sandoz’s creative construction of the statutory language comports with Congressional intent in enacting this portion of the omnibus health care reform legislation.

    Oral argument is scheduled for June 3rd.