• Calendar

    June
    10, 2010 –
    "Patents
    and the Written Description
    Requirement: Meeting Section 112 Disclosure Obligations After Ariad
    v. Lilly
    " (
    Strafford) – 1:00
    – 2:30 PM (EST)

    June
    11, 2010 –
    "The
    Future
    of U.S. Patent Law: An In-Depth
    Discussion on the Congress, the Courts, and the USPTO
    " (
    Patent
    Resources
    Group) –
    Alexandria,
    VA

    June
    15, 2010 –
    Patent
    Reform 2010:
    What Shape Will It Finally Take?
    (
    Analysis
    Group, Georgetown University's Center for Business and Public Policy,
    and McKool Smith) – Washington, DC

    June
    16-18,
    2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (
    Practising
    Law
    Institute) – New York, NY

    June
    21-22,
    2010 –
    Follow-on
    Biologics
    (
    American
    Conference
    Institute) –
    New
    York, NY

    June
    20-22,
    2010 –
    IP
    Business Congress
    (
    Intellectual
    Asset
    Management (IAM) magazine) –
    Munich,
    Germany

    June
    23,
    2010 –
    Regulatory
    and Intellectual Property Opportunities and
    Challenges for Life Science Companies Entering the U.S. Market
    (
    American
    Bar Association) –
    12:00
    – 1:30 PM (EST)

    June
    23-24, 2010 –
    Maximising
    Pharmaceutical Patent Life
    Cycles
    (C5) –
    London,
    England

    June
    29, 2010 –
    Navigating
    the U.S. Biosimilar Pathway
    (
    American
    Bar Association) –
    1:00
    – 2:30 PM (EST)

    June
    30, 2009 –
    Markman
    Hearings and Claim Construction
    in Patent Litigation 2010
    (
    Practising
    Law
    Institute) –
    New
    York, NY (
    with groupcasts in Atlanta, GA;
    Mechanicsburg, PA; Philadelphia, PA; and
    Pittsburgh, PA)

    July
    7, 2010 –
    Prior
    Art &
    Obviousness 2010: Current Trends
    in Sections 102 & 103
    (
    Practising
    Law
    Institute) –
    New
    York, NY

    July
    7-9, 2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (Practising
    Law
    Institute) – San Francisco, CA

    July
    19-20,
    2010 –
    Hatch-Waxman
    Boot Camp
    *** (
    American
    Conference
    Institute) –
    Boston,
    MA

    July
    29-31, 2010 –
    Intensive
    Patent Law
    Training Workshop
    (Chisum
    Patent Academy) –
    Seattle,
    WA

    August
    18-19, 2010 –
    The
    Life Sciences
    Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions
    ***
    (American
    Conference
    Institute) –
    New
    York, NY

    September
    15, 2010
    Prior
    Art &
    Obviousness 2010: Current Trends
    in Sections 102 & 103
    (
    Practising
    Law
    Institute) –
    San
    Francisco, CA

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


  • New York #1 American Conference
    Institute (ACI) will be holding a conference entitled "The Life Sciences
    Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions" on
    August 18-19, 2010 in New York, NY. 
    ACI faculty will help attendees:

    • Understand the
    unique role of PTE and PTA in patent life cycle management for the life
    sciences industry;
    • Master the
    essentials of PTA from questions of eligibility and calculation to the
    application process to procedures for redress;
    • Decipher the
    mysteries of A, B and C-delays;
    • Learn to solve
    the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco;
    • Avoid applicant
    delays and circumvent "failure to engage" findings by the PTO;
    • Navigate the
    complexities of PTE in terms of substance and procedure;
    • Comprehend how
    the key challenges in Wyeth Holdings,
    Photcure, Lupin, and The Medicine
    Company
    will affect PTE determinations in the future;
    • Appreciate how
    second generation patents and regulatory exclusivities factor into patent term
    extensions; and
    • Examine the
    significance of Supplemental Protection Certificates (SPCs) in patent term
    restoration in the EU.


    Brochure In particular,
    ACI's faculty will offer presentations on the following topics:

    • Exploring the
    role of PTA and PTE in patent life cycle management in the life sciences
    industry;
    • PTA 101:  Mechanics, essentials and conundrums;
    • Using A-delays,
    B-delays and C-delays to your advantage;
    Wyeth v. Dudas:  Analyzing and solving the A and B delay
    overlap dilemma;
    • Japan
    Tobacco:  Remedying B-delay errors in
    national stage applications under 35 U.S.C. § 371;
    • Strategies for
    avoiding applicant PTA delays and other pitfalls;
    • PTE:  Laying the groundwork for patent term
    restoration;
    • New trends and
    challenges in PTE litigation:  Key
    cases to watch;
    • Supplementing PTE
    through the use of second generation patents;
    • Understanding the
    interplay of PTE and certain regulatory exclusivities; and
    • Exploring patent
    extensions and exclusivities in the EU.

    A complete brochure
    for this conference, including an agenda, list of speakers, and registration
    form can be obtained here.


    ACI - American Conference Institute The registration
    fee for this conference is $2,195. 
    Attendees registering by June 18, 2010 will receive a $300 discount and attendees
    registering by July 23, 2010 will receive a $200 discount.  ACI will also be offering a special rate
    of $1,795
    to all Patent Docs
    readers who reference the discount code "Patent Docs – PTA" when
    registering.  Those interested in
    registering for the conference can do so here,
    by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Patent Term Adjustment and Patent Term
    Extension conference.

  •     By Kevin E. Noonan


    Kappos, David #1 Undersecretary of Commerce and U.S. Patent and
    Trademark Office Director David Kappos today announced a three tiered patent
    prosecution regime, termed "Three Track" to be instituted in the
    Office.  The scheme will be implemented
    as rulemaking pursuant to 35 U.S.C. § 2 and after a Notice and Comment period
    under the Administrative Procedures Act, although the Director noted
    that Congress would (under current law) need to set fees for the different
    prosecution options (or enact legislation providing the Office with fee-setting authority; see "New USPTO Fee-Setting Bill Introduced in House"
    ).  The Director's
    announcement was made to a group of about a dozen reporters on a conference
    call this afternoon, as well as a press release published on the Patent and
    Trademark Office website.


    USPTO Seal The Directed explained the three tiers as
    follows.  The first tier, "Fast
    Track" or "Track One," constituting an accelerated examination
    procedure, is aimed at having a first Office Action issue within four months
    after filing, with final disposition (defined as allowance or Final Rejection)
    in no more than twelve months.  Notably, there will be no requirement for an Examination Support
    Document (ESD), due to the "resistance of the patenting community" over
    this requirement in current accelerated examination procedures and the response
    to this requirement in earlier-proposed patent "reform" bills and the
    infamous "claims and continuations" rules finally rescinded by the
    Director last fall (see "'New Rules' Officially Rescinded")
    .  In response
    to a question, the Director explained that this first tier examination was not
    intended to replace existing accelerated examination (which does contain an ESD requirement).  The Director said the Office did not want to take away
    applicant options, but did say that if applicants abandoned existing
    accelerated examination procedures in favor of the "Fast Track"
    approach, he could see the Office eliminating these other existing
    protocols.  He also said that the
    Office would take advantage of its experience and infrastructure with these other
    accelerated examination schemes.  In response to another question, the Director said that there had been 3,714
    applications that have used existing accelerated examination procedures since
    2005.  Answering yet another
    question, the Director predicted that the time required to examine applications
    in certain arts (making these arts less amenable to accelerated examination),
    and the costs would be an impediment to large corporations requesting this
    accelerated "Fast Track" examination.  The Director said that the fee would not be trivial, but
    that in the absence of independent fee-setting authority (something which the
    Director took the time to mention was in a presently-pending bill in the House
    of Representatives introduced by Rep. Conyers and Smith (H.R. 5322) and that was supported by the Obama administration), fees to be imposed
    for first tier Fast Track examination would need to be set by Congress.  The Director also noted that any
    reduction in fees for traditional small entities (50%) or (even smaller) "microentities"
    (75%), constituting individual inventors and others (as defined in the current
    Senate patent "reform" bill, S. 515) would likewise require
    Congressional implementation.  The
    Director cited small entities and microentities as components of the economy that
    create the most innovation and new jobs, saying the Office "really wants
    to help them."  The Director also commented on the Patent Prosecution
    Highway (PPH) as a way to accelerate examination, conserve Office resources, and
    reduce the backlog.

    The second tier ("Track Two") constitutes
    the status quo, and would be the "default" mode for examination,
    according to the Director.  Applicants would need to do nothing to elect this examination mode
    different from what is done currently.  The Director also noted his hope that the pendency under this track will
    be reduced to 10 months to first action and 20 months to final disposition.

    The "Track Three" third tier is an
    extended or delayed examination, which would permit an applicant to defer
    examination for up to 30 months from the earliest priority date.  Analogizing this tier to the current
    Patent Cooperation Treaty timetable, the Director asserted that discussions
    with many constituencies ("small entities, large entities, pharma,
    information technology, and everybody in between") tell him "regularly"
    that applicants wanted a way to defer examination as a way to reduce costs.  The
    Director also noted that he envisions a system where the Office's actions were
    tied to payment of the fee for that action, and to provide a way to "exit"
    the process when an application is no longer desired (such as when a search
    shows anticipating prior art).  The
    Director conceded that this tier was expected to address, in part, the current
    application backlog.  The Director's
    hope is that by deferring examination some applications would be abandoned and
    thus not contribute to the backlog or consume Office resources.  (This behavior is observed in foreign
    patent offices, albeit where application pendency requires a yearly annuity
    payment.)  This is particularly important in view of reductions in the examiner
    corps occasioned by attrition not counterbalanced by new hiring.  Unaddressed was the effect (if any) of
    electing this third tier on patent term adjustment; in view of the current
    statutory provisions and Office rules that reduce such adjustments for
    applicant "failure to diligent prosecution" it is likely that deferring
    examination will incur such costs.  This can be expected to make the third tier much less attractive for
    arts, such as biotechnology and pharmaceuticals, where reduced term has
    real-world economic consequences.  As with first-tier examination, the costs for deferring
    examination, including delayed payment of search fees or examination fees, will
    depend on Congressional authorization unless the Office is granted independent
    fee-setting authority.

    In another Office initiative, the Office will delay
    examination until a first Office Action is issued by a foreign patent office
    (including for example the Japan Patent Office) for applications arising
    from a first foreign filing.  The
    USPTO will treat this Action as a "first office action" on the
    merits and require an applicant to file a paper addressing the rejections
    contained in such a foreign action.  The Director hypothesized that in some instances this will be a
    perfunctory response, such as those occasions where the basis of the rejection
    does not have a counterpart in the U.S. ("absolute novelty"-based
    rejections are one example).  For
    other grounds of rejection in common between the U.S. and the foreign patent
    office (such as § 102(b) rejections, for example), the applicant would be
    required to address the rejection in the form of a preliminary amendment, which
    the Director contended would thus advance prosecution of the U.S. application
    by overcoming rejections before substantive examination by a U.S. examiner, as
    well as avoiding RCE practice and get the application in condition for final
    disposition.  While this proposal
    certainly has benefits for the Office, the requirement that an applicant with a
    first foreign-filed application wait until the applicant receives an action from a
    foreign patent office can be expected to delay U.S. examination (since there is
    typically a much longer delay to first action in foreign offices compared with
    the U.S.; the Director suggested applicants can take steps to reduce this delay).  This suggests that foreign filers may
    benefit from the practice (which already is advantageous for creating § 102(e)
    prior art) of filing a U.S. provisional application on the same day that the
    foreign application is filed.  This
    would provide such applicants with a first U.S. filing that would enable them
    to avoid such delay.

    Finally, in response to a question from a Reuters
    reporter, the Director stated that the Office expects to collect between
    $146-242 million more than was appropriated to the Office (and likely, he said,
    to be towards the high end).  Thus,
    the rationale for a 15% surcharge in fees (and fee-setting authority generally)
    seems to have evaporated, but the Director notes that the Office has needs
    (like increased hiring and IT infrastructure improvements) that have not been
    addressed.  (He did not mention
    that the problem seems most easily resolved by preventing Congress from
    diverting these funds from the Office by the appropriations process.)  He also noted that another use for the
    monies would be to fund a reserve mandated by the Office of Management and
    Budget.

    This proposal incorporates features either
    instituted (accelerated application) or earlier proposed (delayed examination) intended to address both the backlog and arguments that the backlog is
    harming innovation.  The Director
    expressed the opinion that the proposal would provide the circumstances for "gobs
    of jobs" to be created based on more a efficient patent application
    system.  Clearly, the Director has
    the correct attitude (helping applicants get patents under the law efficiently
    and effectively) and recognizes the relationship between a properly-functioning
    patent system, innovation, and the economy.  It is an attitude that remains refreshing in view of recent
    history of the Office.

    In the Office's press release announcing the "Three Track" initiative, the Office noted that it was seeking input from the patent community regarding the proposal.  As part of that effort, the Office will be holding a public meeting on July
    20 at 1:30 pm (EDT) at the USPTO’s Madison building, 600 Dulany Street,
    Alexandria, Virginia.  Those interested in attending the meeting must
    register by 5:00 pm (EDT) on July 16.  The Office is also seeking written comments, which must be submitted by
    August 20.  A June 4 Federal Register notice will provide additional details regarding the initiative.

  •     By James DeGiulio

    Celgene,
    Barr Resolve Patent Dispute over Generic Thalomid


    Celgene Celgene
    Corp. and Barr Laboratories Inc. have resolved their patent dispute over the
    multiple myeloma cancer drug Thalomid, with Celgene agreeing to drop its patent
    infringement claims and Barr dropping its invalidity and antitrust claims.


    Barr Pharmaceuticals Celgene
    initiated the dispute in January 2007, after Barr filed an ANDA for generic
    thalidomide in September 2006 (see "Court Report," February 28, 2007).  Celgene claimed that Barr's product infringed
    seven of its patents, and then added another asserted patent in a second
    lawsuit against Barr in August 2007 (see "Court Report," September 3, 2007).  Barr responded in October 2007 by filing
    its own suit, alleging that Celgene failed to disclose material information to
    the U.S. Patent and Trademark Office and that Celgene interfered with its attempts to get the raw material
    needed for studies required to file its ANDA.  Celgene filed a third lawsuit before the District Court consolidated
    these actions in July 2008.  Finally, in December 2008, Celgene filed an amended
    complaint alleging infringement of the three patents currently at issue: U.S. Patent Nos. 5,629,327;
    6,235,756; and 7,435,745.

    On
    May 26, Judge Wigenton of the U.S. District Court for the District of New
    Jersey approved the parties' stipulation of dismissal without prejudice of all
    claims and counterclaims asserted in the case.  Barr's antitrust claims were dismissed with prejudice.  Each party agreed to bear its own costs
    and attorneys' fees in the matter.

    The
    parties' approved stipulation can be found
    here.


    GlaxoSmithKline
    and Teva Reach Settlement in Combivir Dispute


    GlaxoSmithKline GlaxoSmithKline
    PLC unit Glaxo Group Ltd. has settled with Teva Pharmaceuticals USA Inc. in its patent infringement suit over the HIV drug Combivir.


    Teva GSK
    sued Teva in November 2007, alleging that Teva's proposed generic product would
    infringe U.S. Patent No. 5,859,021 patent over Combivir (see "Court Report," November 11, 2007).  Teva's ANDA for its generic drug
    was tentatively approved in 2009, after which Teva said it planned to release
    the generic product May 17, about two years before the expiration of the '021
    patent.  Teva had already
    stipulated that its generic version would infringe the '021 patent, so the only
    issue remaining for trial was the validity of the patent.

    On
    May 26, Magistrate Judge Leonard Stark of the U.S. District Court for the
    District of Delaware approved the parties' stipulation dismissing the case.  Prior
    to the dismissal order, GSK had asked the District Court for a preliminary injunction
    barring Teva from launching a generic version in May.  However, the case was settled before the Court ruled on the
    motion.

    Terms of the settlement were not available.  Judge Stark's order and the parties'
    stipulation dismissing the case can be found
    here.


    Sandoz
    Counterclaims for Two Patents Dismissed in Merck's Emend Suit


    Sandoz Sandoz's
    counterclaims against Merck relating to two patents were dismissed in an
    infringement suit over Emend, a drug used to suppress nausea resulting from
    chemotherapy drugs and surgery.


    Merck The dispute began January 15, 2009 when Sandoz notified Merck in a letter that it had
    filed an ANDA seeking approval for a generic version of Emend.  Merck filed a complaint in February 2009 alleging
    infringement of four patents:  U.S. Patent Nos. 5,719,147; 6,048,859; 6,096,742; and 6,235,735 (see "Court Report," March 8, 2009).  In its answer, Sandoz included counterclaims for declaratory judgment of
    noninfringement, invalidity and/or unenforceability of the four patents listed,
    and additional patents, U.S. Patent Nos. 5,538,982 and 7,214,692.  The counterclaims state that if
    Sandoz were to prevail, it would still be faced with the threat of litigation
    over the additional patents, which cover the same products.

    In
    April 2010, the counterclaims relating to the original four allegedly infringed
    patents were dismissed.  On May 19,
    Sandoz sent a proposed order of dismissal to Judge Mary Cooper of the U.S.
    District Court for the District of New Jersey, but included no further
    details.  The next day, May 20,
    Judge Cooper dismissed Sandoz's counterclaims related to the '982
    and '692 patents.

    The
    May 20 dismissal order can be found
    here.

    James
    DeGiulio has a doctorate in molecular biology and genetics from
    Northwestern University and
    is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be
    contacted at degiulio@mbhb.com.

  •     By
    Donald Zuhn

    Last
    week, a post on Patently-O presented some interesting results regarding
    the percent of utility applications that had issued as patents as compared to the
    total number of issued patents and abandoned applications for eight technology
    centers
    (see "USPTO Grant Rate by Technology Center").
      The post indicated that the results had been obtained from an analysis of about 25,000
    utility applications filed over the past few years.  According to the post, TC 1600 (biotechnology and organic chemistry) had produced the lowest percent of issuances (less than 45%).

    For
    a presentation at last month's BIO International Convention on the impact of
    the recession on biotech patent prosecution, we looked at the number of
    biotech/pharma patents that had issued between 2000 and 2010 and the number of
    biotech/pharma applications that had published over this same time frame.  The results of this analysis are shown
    in the graph below (note: figures for 2010 are projected based on issuances and
    publications through June 1):

    Biotech-Pharma Patents & Apps

    In the graph above, the blue bars represent the number of patents designated as belonging to classes 424435, 436, 504, 506, and/or 514 that issued in the specified year.  The red line represents the number of patent applications designated as belonging to one of the above classes that published in the specified year (because the AIPA mandated publication of certain U.S. applications filed after November 28, 2000, no biotech/pharma applications were published in 2000 and only 3,920 biotech/pharma applications were published in 2001).

    If
    the numbers through May hold up during the remainder of the year,
    biotech/pharma patent issuances could return to levels not seen since 2003,
    indicating that the Patent Office may indeed be putting the days (years?) of "reject,
    reject, reject" behind them.

  •     By
    James DeGiulio —


    Gibson After
    a 15-year effort, the team of Daniel Gibson (at right), Hamilton Smith, and Craig
    Venter (below left) have created the first cell controlled by a purely synthetic
    genome.  In a press release
    and accompanying press conference, Dr. Venter described the converted cell as "the
    first self-replicating species we've had on the planet whose parent is a
    computer."


    Venter As
    reported in the May 20 issue of Science, in an article entitled "Creation of a Bacterial Cell Controlled by a Chemically Synthesized
    Genome
    ," the research team at the J. Craig Venter Institute
    in Rockville, Maryland designed 1,078 specific cassettes of DNA that were 1,080
    base pairs long and ordered them from DNA synthesis company Blue Heron
    Biotechnology.  To ensure that the assembled genome would be recognizable as
    synthetic, four of the ordered DNA sequences contained strings of bases that,
    in code, spell out an e-mail address, the names of the people involved in the
    project, and a few famous quotations from James Joyce and other authors.  The
    team then assembled the shorter lengths into a complete Mycoplasma mycoides genome.  The researchers transferred the synthetic genome into a recipient cell
    from a different bacterial species, replacing the endogenous DNA, and the cell
    became entirely controlled by the new synthetic genome.  The cell was
    essentially converted into a different species, for the finished product was
    capable of replication and had all the expected properties of a Mycoplasma mycoides bacterium.


    ScienceCover The
    cost of the project was $40 million, most of it paid for by Synthetic Genomics,
    a company Dr. Venter founded.  Not surprisingly, Venter has applied for several
    patents covering the work, assigning them to his company.  Synthetic Genomics has a contract from
    Exxon to generate biofuels from algae.  However, the bacterium used by the
    Venter group is unsuitable for biofuel production, and Dr. Venter said the team
    would move on to more suitable organisms.  Dr. Venter and his colleagues hope to
    design new bacteria that will perform useful functions, such as production of
    new fuel molecules, new food oils, and new biologically derived sources of
    plastic and chemicals.  Dr. Venter
    predicted that the first application the world may see could be as soon as next
    year.

    Dr.
    Venter's "synthetic cell" has the potential to rejuvenate nagging
    questions of ethics, law, and public safety about artificial life that
    bio-ethicists have been debating for more than a decade.  However, some
    scientists downplayed the development, finding it as merely a technical
    accomplishment, since the new cell can be viewed as an organism with a
    synthetic genome, not as a synthetic organism.

    President
    Obama has asked the White House bioethics commission to report back to him on
    the significance of this development, and
    Nature
    has published a series of opinions on Dr. Venter's article from
    synthetic biology experts.  Patent Docs
    will address the commentary and additional reactions to Dr. Venter's discovery
    in future posts.

    For additional information regarding this and other related topics, please see:

    • "Playing the Bioterror Card in the Synthetic Biology Debate," December 19, 2007
    • "The Synthetic Biology Sky Is Not Falling," December 16, 2007
    • "Patenting
    Life (Really)
    ," June 11, 2007

    James
    DeGiulio has a doctorate in molecular biology and genetics from
    Northwestern University and
    is a third-year law
    student at the Northwestern University School of Law.  Dr. DeGiulio
    was a member of MBHB's 2009 class of summer associates, and he can be
    contacted at degiulio@mbhb.com.

  •     By Nate Chongsiriwatana


    BioNanomatrix BioNanomatrix, Inc. recently announced the
    issuance
    of U.S. Patent No. 7,670,770 for nanochannel arrays that enable
    high-throughput
    macromolecular analysis.

    Previously, single-molecule DNA analysis has
    been
    limited by the difficulty of linearizing (untangling) and manipulating
    intact
    native DNA.  To address these
    limitations, a Princeton University research team, including Dr. Han
    Cao, the
    founder and chief scientific officer of BioNanomatrix, used a
    nanofluidic chip
    to untangle and guide individual DNA molecules into an array of
    nanochannels.  According to Dr. Cao, the founder and chief scientific officer of
    BioNanomatrix, "this invention allows for true linear analysis of very
    long biomolecules such as native genomic DNA hundreds of thousands of
    base
    pairs in length without cloning or PCR amplification."  This technique,
    which is the basis for the company's NanoAnalyzer® system, can be used
    for
    multiplexed parallel processing applications, such as direct imaging
    analysis
    of structural variations in a person's genome and DNA mapping and
    sequencing.


    Nanochannel Arrays At the crux of the invention are three
    critical
    dimensional qualities for nanochannel arrays that enable the
    simultaneous
    isolation and analysis of a multitude of elongated macromolecules.  Specifically, the '770 patent discloses
    that:  (1) the channels should be sufficiently narrow in order to elongate
    and
    isolate macromolecules; (2) the channels should be long enough to permit
    the
    instantaneous observation of the entire elongated macromolecule; and (3)
    a high
    number of channels should be provided in each array to permit the
    simultaneous
    observation of a large number of macromolecules.

    The lone independent claim of the '770 patent
    reads:

    1.  A method of isolating, imaging, and analyzing, in parallel,
    two or
    more individual nucleic acid biopolymers, comprising the steps of:
    providing a
    nanofluidic chip, comprising: a) nanochannel array, comprising: a
    surface
    having a plurality of parallel nanochannels running along the material
    of the surface,
    said nanochannels having a trench width of less than about 150
    nanometers and a
    trench depth of less than 200 nanometers; at least one of the plurality
    of
    nanochannels being surmounted by sealing material to render such
    nanochannels
    at least substantially enclosed; at least two of the nanochannels
    capable of
    admitting a fluid; b) at least one sample reservoir in fluid
    communication with
    at least two of the nanochannels, said sample reservoir capable of
    releasing a
    fluid containing at least two nucleic acid biopolymer; providing the at
    least
    one sample reservoir with at least one fluid, said fluid comprising at
    least
    two nucleic acid biopolymers; transporting the at least two nucleic acid
    biopolymers into the at least two nanochannels to elongate said at least
    two
    nucleic acid biopolymers, the at least two nucleic acid biopolymers
    being
    individually confined within the at least two nanochannels such that the
    at
    least two nucleic acid biopolymer are transported through the at least
    two
    nanochannels in an unfolded fashion; imaging in parallel at least one
    signal
    transmitted from the at least two elongated and isolated nucleic acid
    biopolymers within the nanochannels; and correlating the signal to at
    least one
    property of the at least two nucleic acid biopolymers to thereby analyze
    the
    two or more individual nucleic acid biopolymers.

    The specification also discloses methods of
    preparing nanochannel arrays and nanofluidic chips, methods of analyzing
    macromolecules, such as entire strands of genomic DNA, and systems for
    carrying
    out these methods.

  •     By Kevin E. Noonan


    Cover Sadly (you'd expect they would know better), the
    editorial board of Nature Biotechnology has decided to get on-board the
    anti-gene patenting bandwagon.  The
    editors are entitled to their opinion, of course, but it shouldn't be too much
    to ask that they be more informed about the issues.

    This development appears as an editorial in the May
    edition of the journal.  Entitled "Sitting up and taking notice," the editorial
    announces Judge Sweet's March 29th decision in favor of the
    plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office
    .  That announcement marks the last time
    the editorial makes completely factual statements, tending instead to promote
    the idea that gene patenting is a problem by inference direct and indirect.

    For example, the editorial characterizes the
    procedural aspects of Judge Sweet's decision, on summary judgment, as
    indicating that "the judge felt Myriad had no case to argue."  This is incorrect:  summary judgment is used when there are
    no disputed issues of material fact, and the court finds that it can decide the
    matter as a matter of law.  The
    prudence of this judgment can be questioned, not merely on the basis that the
    judge actually chose to make law on patentable subject matter by deciding that
    DNA is sui generis as "the physical embodiment of genetic information."  The editorial also is mistaken in
    stating that "[t]he plaintiffs won on virtually every count," in view
    of the fact that the District Court avoided the Constitutional issues that were the basis
    for the Court to deny defendants' motions to dismiss.  This is not a trivial matter, since as a consequence the PTO
    was dismissed from the case, and without these issues the breast cancer
    patients had no standing to bring the suit in the first place (not to mention
    that these are the issues that created the political frisson for the ACLU and
    PubPat).

    The editorial also continues to mistake the effects
    on research of the BRCA patents with the use of these patents to prevent
    infringing, for-profit commercial activity.  The editorial states that "Myriad's influence has been
    particularly pernicious.  Its lawyers have issued cease-and-desist letters to
    genetics laboratories in universities, hospitals and clinics that offered
    diagnostic services based on the BRCA1 and BRCA2 genes."  These uses of the patented tests
    constitute infringement — the fact that the infringer is a university,
    hospital, or clinic doesn't absolve them from for-profit, commercial,
    infringing activities.  The
    difference between this type of activity, which is not "research"
    (although the results can be used for research purposes) is in stark contrast
    to the several thousand basic research papers in scientific journals that have
    been published since the BRCA gene patents were granted.  That is where the research to support
    innovation is occurring, not in university, hospital, or clinic labs doing
    fee-based, diagnostic assays for patients, and there is no evidence that Myriad
    or any other gene patent holder has inhibited basic biological research by
    threatening patent infringement litigation.

    The piece also attempts to achieve "truth by
    association" in noting the several groups that have "concerns"
    about gene patents, including the International Center for Technology
    Assessment, Greenpeace, the Indigenous Peoples' Council on Biocolonialism, and
    the Council for Responsible Genetics, all of whom filed amicus briefs in the
    case.  Their contribution to the
    debate would be more welcome if it did not include patently incorrect
    statements regarding the consequences of gene patenting, including "the
    privatization of genetic heritage, the creation of private rights of unknown
    scope and consequences and the violation of patients' rights."  The editorial was correct in noting
    that "[t]he alignment of physicians' and patients' groups with what are,
    in effect, antibiotech lobbyists is a worrying development," albeit ignoring
    the fact that not only the biotech sector but the public should be worried if
    these groups should get their way.

    The editorial did supply a data point for the
    debate, in noting that Myriad reported "$326 million in revenue from
    diagnostic testing against $43 million in costs."  Assuming these numbers to be correct,
    and to reflect only BRCA testing, an indication of the profitability of BRCA
    testing results (perhaps unintentionally providing a motivation for the "universities,
    hospitals, and clinics" to be so keen on getting into the business,
    infringing or no).  However, the
    figures are completely out of context; there is no indication if these profits are out of the ordinary for
    diagnostics companies, traditional or genetic, or whether the "costs"
    include ancillary costs like genetic counseling or physician education (both
    critical in genetic diagnostics due to the consequences for a patient of
    receiving a genetic diagnosis).  Surely, if Myriad's profits were actually significantly higher that other
    companies, that fact would be relevant and the absence of any comparisons
    suggests that the absolute numbers were used because they better supported the
    editorial's views.

    Then there is the portion of the editorial that
    seems divorced from reality:

    It often seems unfair that the patent
    system rewards only the last inventive step — the small breakthrough that enables
    a concept to be realized.  The research
    enterprise, which continually renews itself, especially in rapidly moving areas
    like genetics, is increasingly at odds with the commercial conservatism of
    patent monopolies based on gene findings that are obsolescent compared with
    current art.  Despite both cultural and economic incentives for innovation, the
    difficulty in dislodging incumbent approaches is reinforced by a patent system
    that insists that any use, however small, of a protected method is
    infringement.  Is it so outrageous to expect that a properly functioning IP
    system could provide an unobstructed path to the market both for the initial
    innovators and for subsequent improvers?  Surely, a different balance of rights
    is possible that better serves the society with whom the patent bargain has been
    struck.

    The patent system rewards inventors who disclose
    how to make and use an invention that is new, useful, and non-obvious.  Whether the improvement is
    groundbreaking or incremental, satisfaction of the statutory requirements
    governs patentability.  Thus, if
    technology becomes "obsolescent," new technology takes its place — if
    only because patents expire, as indeed Myriad's patents will start to expire in
    2014.  The passage indicates just
    how little the writers understand the "balance of rights" that the
    patent bargain actually strikes.

    Finally,
    the editorial does touch on the coming issue of patent protection for methods
    of detecting specific genetic polymorphisms and techniques such as whole genome
    sequencing that could infringe such patent claims.  These are not "gene patents" per se, since they involve assays on genes (actually, fragments of
    genes) rather than the genes themselves.  The editorial thinks little of "patent pools" as a means for
    overcoming the potential issues, stating that such mechanisms "are not
    going to emerge in biotech of their own accord" and ignoring how the
    (unregulated) computer and telecommunications industries have developed just
    these types of patent pools.  Instead, the editorial posits that it will probably take some form of government
    or legal coercion to get things moving for gene tests, disagreeing with the
    recommendations for such tools from the U.S. Health and Human Services SACGHS
    report.

    The
    editorial ends by exhibiting a consistent lack of understanding of innovation as
    well as the patent process.  It
    suggests assigning rights to specific genes in multigene tests based on "the
    importance of any specific gene sequence to the utility of the test,"
    something the marketplace can be counted on to do without the government's
    help.  Saying that the "early
    gene mutant discoveries . . . now look trivial" (!), such a approach is
    suggested to provide incentive for "those who continue to develop tests of
    high medical value with commensurate financial remuneration."  Those "trivial . . . early gene
    mutant discoveries" are certainly not trivial to the patients benefiting
    from diagnostic assays or therapies based on them; moreover, if by "trivial"
    the writers meant "amenable to early discovery" that is just a
    reflection on the strength of the phenotype resulting from the mutation.  And while the last sentence of the
    piece was clearly meant to be exhortative:

    That this ideal is implausible within
    the current petrified patent system and commercial infrastructure doesn't have
    to stop the dream, and certainly shouldn't stop the discussion.

    It is merely incoherent:  the dream of better diagnostics and therapies is and has
    been realized by thirty years of biotechnology and protection thereof by an
    invigorated patent system in the U.S.  Changing that now, particularly if based on the wooly-headed arguments
    (really, sentiments) in the Nature Biotechnology editorial, is the fastest and
    surest way that those hopes and dreams will be dashed.

  •     By Sherri
    Oslick

    Gavel_2About
    Court
    Report:  Each week we will report briefly on recently filed
    biotech and pharma cases.


    Wyeth LLC v. Intervet Inc. et al.
    1:10-cv-00435; filed May 25, 2010 in the District
    Court of Delaware

    • Plaintiff:  Wyeth LLC
    • Defendants:  Intervet Inc. d/b/a
    Intervet/Schering-Plough Animal Health; Boehringer Ingelheim Vetmedica
    Inc.

    Infringement of U.S. Patent No. 7,722,883 ("Circovirus
    Sequences Associated with Piglet Weight Loss Disease," issued May 25,
    2010) based on defendants' manufacture and sale of their Circumvent® PCV and
    Porcilis® PCV vaccines (porcine circovirus vaccines).  View the complaint
    here.


    Ascio Pharmaceuticals, Inc. v. Three Rivers Pharmaceuticals,
    LLC

    1:10-cv-01583; filed May 25, 2010 in the Northern
    District of Georgia

    Declaratory judgment of unenforceability,
    invalidity, and non-infringement of U.S. Patent No. 7,723,310 ("Large Dose
    Ribavirin Formulations," issued May 25, 3010) based on Ascio's filing of
    an ANDA to manufacture a generic ribavirin product.  View the complaint
    here.


    Cornell University et al. v. Illumina Inc.
    1:10-cv-00433; filed May 24, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Cornell University; Cornell Research
    Foundation Inc.; Life Technologies Corp.; Applied Biosystems LLC
    • Defendant:  Illumina Inc.

    Infringement of U.S. Patent Nos. 6,797,479 ("Detection
    of Nucleic Acid Sequence Differences Using Coupled Ligase Detection and
    Polymerase Chain Reactions," issued September 28, 2004), 7,083,917 ("Detection
    of Nucleic Acid Sequence Differences Using the Ligase Detection Reaction with
    Addressable Arrays," issued August 1, 2006), 7,166,434 ("Detection of
    Nucleic Acid Sequence Differences Using Coupled Ligase Detection and Polymerase
    Chain Reactions," issued January 23, 2007), 7,312,039 (same title, issued
    December 25, 2007), 7,320,865 (same title, issued January 22, 2008), 7,332,285
    (same title, issued February 19, 2008), 7,364,858 (same title, issued April 29,
    2008), 7,429,453 (same title, issued September 30, 2008) based on Illumina's
    manufacture and sale of instruments, reagents, and kits to perform its
    GoldenGate Genotyping Assay and its DASL Assay (cDNA-mediated Annealing,
    Selection, Extension and Ligation Assay) and services using those assays.  View the complaint
    here.


    Genzyme Corp. v. Watson Laboratories, Inc.
    1:10-cv-01323; filed May 24, 2010 in the District
    Court of Maryland

    Infringement of U.S. Patent No. 5,667,775 ("Phosphate-Binding
    Polymers for Oral Administration," issued on September 16, 1997) following
    a Paragraph IV certification as part of Watson's filing of an ANDA to
    manufacture a generic version of Genzyme's Renavela® (sevelamer carbonate, used
    for the control of serum phosphorus in patients with chronic kidney disease on
    dialysis).  View the complaint
    here.


    Genzyme Corp. v. Sandoz Inc.
    1:10-cv-00429; filed May 21, 2010 in the District
    Court of Delaware

    Infringement of U.S. Patent Nos. 5,602,116 ("Method
    for Treating and Preventing Secondary Hyperparathyroidism," issued
    February 11, 1997) and 7,148,211 ("Formulation for Lipophilic Agents,"
    issued December 12, 2006) following Sandoz's filing of an ANDA to manufacture a
    generic version of Genzyme's Hectorol® (doxercalciferol, used to treat
    secondary hyperparathyroidism in patients with chronic kidney disease).  View the complaint
    here.


    Nycomed US Inc. et al. v. Tolmar, Inc.
    2:10-cv-02635; filed May 21, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Nycomed US Inc.; Jagotec AG
    • Defendant:  Tolmar, Inc.

    Declaration that Tolmar's Paragraph IV notice was
    invalid, improper, null, void, and without legal effect, that the Court
    therefore has no subject matter jurisdiction over the claims surrounding the
    patents at issue, that Tolmar's notice did not trigger the 45-day period for
    filing an infringement action under the Hatch-Waxman Act, and that Tolmar must
    serve new Paragraph IV notice upon Nycomed if and when the FDA accepts Tolmar's
    ANDA.  Also, infringement of U.S.
    Patent Nos. 5,639,738 ("Treatment of Basal Cell Carcinoma and Actinic
    Keratosis Employing Hyaluronic Acid and NSAIDs," issued June 17, 1997),
    5,792,753 ("Compositions Comprising Hyaluronic Acid and
    Prostaglandin-Synthesis-Inhibiting Drugs," issued August 11, 1998),
    5,852,002 ("Treatment of Conditions and Disease," issued December 22,
    1998), 5,914,322 ("Treatment of Disease and Conditions," issued June
    22, 1999), 5,929,048 ("Treatment of Conditions and Disease," issued
    July 27, 1999), and 5,985,850 ("Compositions Comprising Hyaluronic Acid
    and Drugs," issued November 16, 1999) following a Paragraph IV
    certification as part of Tolmar's filing of an ANDA to manufacture a generic
    version of Nycomed's Solaraze® (diclofenac sodium, used to actinic
    keratosis).  View the complaint
    here.


    Takeda Pharmaceutical Co. Ltd. et al. v. Dr. Reddy's
    Laboratories, Ltd. et al.

    1:10-cv-04168; filed May 20, 2010 in the Southern
    District of New York

    • Plaintiffs:  Takeda Pharmaceutical Co.
    Ltd.; Takeda Pharmaceuticals North America, Inc.
    • Defendants:  Dr. Reddy's Laboratories, Ltd.;
    Dr. Reddy's Laboratories, Inc.

    Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical
    Composition," issued October 12, 1999), 6,329,404 (same title, issued
    December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090
    (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3,
    2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same
    title, issued October 16, 2001) following a Paragraph IV certification as part
    of Dr. Reddy's filing of an ANDA to manufacture a generic version of Takeda's
    Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint
    here.


    Genentech, Inc. v. Trustees of the University of Pennsylvania
    4:10-cv-02037; filed May 11, 2010 in the Northern
    District of California

    Declaratory judgment of non-infringement and
    invalidity of U.S. Patent No. 6,733,752 ("Prevention of Tumors with
    Monoclonal Antibodies Against NEU," issued May 11, 2004) based on Genetech's
    manufacture and sale of its Herceptin® (trastuzumab, used to treat breast
    cancer).  View the complaint
    here.





  • Calendar

    June
    1, 2010 –
    Biotechnology/Chemical/Pharmaceutical
    (BCP) Customer Partnership Meeting
    (
    U.S.
    Patent and Trademark Office) –
    Alexandria,
    VA

    June
    10, 2010 –
    "Patents
    and the Written Description
    Requirement: Meeting Section 112 Disclosure Obligations After Ariad
    v. Lilly
    " (
    Strafford) – 1:00
    – 2:30 PM (EST)

    June
    11, 2010 –
    "The
    Future
    of U.S. Patent Law: An In-Depth
    Discussion on the Congress, the Courts, and the USPTO
    " (
    Patent
    Resources
    Group) –
    Alexandria,
    VA

    June
    15, 2010 –
    Patent
    Reform 2010:
    What Shape Will It Finally Take?
    (
    Analysis
    Group, Georgetown University's Center for Business and Public Policy,
    and McKool Smith) – Washington, DC

    June
    16-18,
    2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (
    Practising
    Law
    Institute) – New York, NY

    June
    21-22,
    2010 –
    Follow-on
    Biologics
    (
    American
    Conference
    Institute) –
    New
    York, NY

    June
    20-22,
    2010 –
    IP
    Business Congress
    (
    Intellectual
    Asset
    Management (IAM) magazine) –
    Munich,
    Germany

    June
    23,
    2010 –
    Regulatory
    and Intellectual Property Opportunities and
    Challenges for Life Science Companies Entering the U.S. Market
    (
    American
    Bar Association) –
    12:00
    – 1:30 PM (EST)

    June
    23-24, 2010 –
    Maximising
    Pharmaceutical Patent Life
    Cycles
    (C5) –
    London,
    England

    June
    29, 2010 –
    Navigating
    the U.S. Biosimilar Pathway
    (
    American
    Bar Association) –
    1:00
    – 2:30 PM (EST)

    June
    30, 2009 –
    Markman Hearings and Claim Construction
    in Patent Litigation 2010
    (
    Practising
    Law
    Institute) –
    New
    York, NY (
    with groupcasts in Atlanta, GA; Mechanicsburg, PA; Philadelphia, PA; and
    Pittsburgh, PA)

    July
    7, 2010 –
    Prior
    Art &
    Obviousness 2010: Current Trends
    in Sections 102 & 103
    (
    Practising
    Law
    Institute) –
    New
    York, NY

    July
    7-9, 2010 –
    Fundamentals
    of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing
    (Practising
    Law
    Institute) – San Francisco, CA

    July
    19-20,
    2010 –
    Hatch-Waxman
    Boot Camp
    *** (
    American
    Conference
    Institute) –
    Boston,
    MA

    July
    29-31, 2010 –
    Intensive
    Patent Law
    Training Workshop
    (Chisum
    Patent Academy) –
    Seattle,
    WA

    September
    15, 2010
    Prior
    Art &
    Obviousness 2010: Current Trends
    in Sections 102 & 103
    (
    Practising
    Law
    Institute) –
    San
    Francisco, CA

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