• New York #3 Practising
    Law Institute (PLI) will be holding its Fundamentals of Patent Prosecution
    2010: A Boot Camp for Claim Drafting & Amendment Writing seminar on June
    16-18, 2010 in New York, NY and on July 7-9, 2010 in San Francisco, CA.  According to PLI's website, the three-day
    program, which is directed to patent attorneys, litigation attorneys and patent
    agents with little patent experience, will focus on teaching the basics of
    claim drafting, patent application preparation and prosecution, as well as a
    review of recent developments in the law. 
    The seminar will feature lectures in the morning followed by small
    clinic sessions in the afternoon, with day 1 focusing on invention disclosures
    and patent preparation, day 2 on prosecution and issuance, and day 3 on
    litigation.  Lectures will explain:


    How to interview the inventor;

    How to identify the invention;

    How to decide what elements of the invention should be included in the patent;

    How to prosecute an application to result in allowance of an enforceable patent;

    How to interview an Examiner;

    How to use reissues, reexaminations and other post-issuance proceedings; and

    How to anticipate patent litigation issues during the patent prosecution process.


    San Francisco #4 PLI
    faculty will offer presentations on the following topics:


    Taking Invention Disclosures;

    Overview of Claim Drafting and Preparation of Patent Application;

    Claim Drafting;

    Review of Model Claims;

    Patent Prosecution;

    Conducting the Examiner Interview;

    Review of Model Amendment; and

    Litigation Issues.

    A
    program schedule and list of speakers for the New York Patent Law Institute can
    be found here,
    and a program schedule and list of speakers for the San Franscisco Patent Law
    Institute can be found here.


    Practising Law Institute (PLI) #2 The
    registration fee for the conference is $1,795.  Those interested in registering for the conference can do so
    at the PLI website.

  •     By Sarah Fendrick


    USPTO Seal Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register
    (75 Fed. Reg. 22120) regarding two roundtables that the Office will be holding to obtain public input on methods
    that can be used to improve patent quality and the methods the Office uses to measure
    quality.  The roundtables are part
    of an initiative implemented by the USPTO and the Patent Public Advisory
    Committee to enhance overall patent quality.

    The
    first
    roundtable will be held at the Los Angeles Public Library-Central
    Library
    on May 10, 2010, beginning at 1 p.m.  The second roundtable
    will be held at the USPTO on May 18, 2010, beginning at 8:30 a.m.  Because admission to the roundtables will be limited, individuals
    wishing to
    be part of the patent improvement initiative can submit comments to patent_quality_comments@uspto.gov
    until June 18, 2010.

    In a press release that was issued on Friday, Under
    Secretary of Commerce for Intellectual Property and Director of the USPTO David
    Kappos stated:

    Quality patents are critical to
    the proper functioning of the patent system, and issuing high quality patents
    is a top priority for the USPTO.  Quality
    issuances provide certainty in the market and allow businesses and innovators
    to make informed and timely decisions on product and service development.

  •     By
    Donald Zuhn


    Deloitte White Paper On
    Wednesday, while the biotech industry gathered in Chicago for the 2010 BIO
    International Convention, Deloitte Touche Tohmatsu (DTT) released a white paper
    suggesting that the global recession has likely permanently reshaped the life
    sciences industry.  To assess the
    long- and short-term effects of the recession, and determine whether the
    financial crisis was just a difficult but not insurmountable event for life
    sciences companies or a turning point for the industry, Deloitte surveyed 281
    senior industry executives and a number of industry leaders during the fall of
    2009.  The paper, entitled
    "The future of the life sciences industries: Aftermath of the global
    recession
    ,"
    was jointly prepared with the Economist Intelligence Unit,
    the
    business information arm of The Economist Group, which publishes The Economist.

    In the paper, DTT reports that 44% of respondents believe that 20 to 40% of existing
    biotech companies won't exist in five years as a result of the global recession.  Senior industry executives responding
    to the survey were even more pessimistic, with 68% predicting the elimination
    of between 20 and 40% of current biotech companies.  More than 65% of the executives also indicated that the
    recession had moderately to significantly negatively affected their companies.

    The
    survey respondents noted that companies making it past the five-year mark
    post-recession, would do so by focusing on innovation.  Unfortunately, 43% respondents
    indicated that their companies had reduced R&D spending and were focusing
    instead on products providing immediate returns.  And almost a third of the respondents (32%) believed that
    R&D spending would continue to drop in the future. 
    The
    paper also
    suggests that the lines between biotech and pharmaceutical companies
    will
    become further blurred as major pharmaceutical players will expand more
    aggressively into large molecule research.

    In
    a press release issued with the paper, DTT asks whether the recession is "[t]he end of biotech as we know
    it?"  Robert Go, DTT Global Life Sciences and
    Health Care Industry Leader, noted that the recession had accelerated the
    impact of health plans driving out costs, expiring patents, and evolving
    generics legislation. 
    "With
    the dearth of
    new entrepreneurial entries, the talent flight, and the encroachment of
    large
    pharma," Reynold Mooney, DTT Global Life Sciences and Health Care
    Consulting Leader, predicted that "the future of biotech looks grim." 

    Of
    the 281 executives responding to the survey, 30% were from pharmaceutical
    companies, 16% were from medical device companies, 14% were from biotechnology companies,
    and the remainder were from contract research organizations, health care
    services, distribution, and health insurance.

  •     By Kevin E. Noonan


    Federal Circuit Seal Last week, the Court of Appeals for the Federal
    Circuit in Therasense Inc. v. Becton
    Dickinson & Co
    . issued an order granting plaintiffs' motion for rehearing
    en banc on the Court's previous
    affirmance that the patents-in-suit were unenforceable for inequitable
    conduct.  In its order, the Court
    certified six questions relating to its inequitable conduct jurisprudence,
    asking the parties and amici to
    provide their views on the standards of materiality and intent and the "balancing"
    test first enunciated in Kingsdown
    Medical Consutants Inc. v. Hollister
    (see "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson")
    .  The very
    next day, a panel of the Federal Circuit nicely illustrated the current disjointed state
    of the Court's inequitable conduct jurisprudence, suggesting that whatever
    decision the Court reached en banc in
    Therasense may not "solve" for
    long the doctrinal inconsistencies that seem to arise inexorably when courts
    attempt to decide whether a patent has been obtained through inequitable
    conduct.


    AVID The technology involved will be familiar to most
    pet owners:  detection of biocompatible chips used to identify lost pets
    unambiguously.  Plaintiff Avid
    Identification Systems was started by its president, Dr. Hannis Stoddard, after
    losing his own dog.  Dr. Stoddard
    testified that he realized that most of the animals in pounds and shelters were
    lost pets, but that there had been no way to reunite the pets and their
    owners.  While the company first
    used chips obtained from an independent supplier, Dr. Stoddard testified that
    he changed the business model in 1985, by developing a chip reader that could
    read both Avid's own encrypted chips as well as unencrypted chips then
    commercially available.  Not being
    an engineer, Dr. Stoddard testified that he hired "at least" three
    engineers, the named inventors of the patent-in-suit, U.S. Patent No.
    5,235,326.  These engineers had
    developed both specifically-encrypted chips as well as the desired chip reader
    that recognized both encrypted and unencrypted chips.

    More than a year before filing a patent application
    on this technology, it was undisputed that Dr. Stoddard demonstrated "some
    of Avid's technology" at a livestock trade show.  At trial, the District Court granted defendant's motion that
    this demonstration was material prior art under 35 U.S.C. § 102(b), that this
    information was withheld from the patent examiner during prosecution of the '326
    patent, and that the information was withheld with deceptive intent.  In making this determination, the District Court specifically found that Dr. Stoddard had a duty of candor to the
    U.S. Patent and Trademark Office under 37 C.F.R. § 1.56.  This was the issue decided by the
    Federal Circuit in affirming the District Court's judgment.

    The Federal Circuit opinion was written by Judge
    Prost joined by Judge Mayer and joined in part (relating to a standing issue)
    by Judge Linn, who also filed an opinion dissenting in part (on the Court's
    substantive decision on who owes a duty of candor to the office).  Avid conceded the issue of deceptive
    intent on appeal, relying on a challenge to whether Dr. Stoddard's
    demonstration was material and whether he fell within the scope of the
    individuals owing a duty of candor to the Office.

    With regard to materiality, the panel applied the
    definition contained in Rule 56 itself:  "
    Information is material where a reasonable examiner would
    find it important to a determination of patentability," citing Astrazeneca Pharm. LP v. Teva Pharm. USA,
    583 F.3d 766, 773 (Fed. Cir. 2009).  The majority rejected Avid's contention that the reference was not
    material by clear and convincing evidence because the jury did not find the
    claims invalid over evidence of the disclosure.  Illustrating at least one of the principles underlying the ad hoc nature of inequitable conduct
    determinations, the Court stated that "[w]e have often held that a
    reasonable examiner may find a particular piece of information important to a
    determination of patentability, even if that piece of information does not
    actually invalidate the patent," citing Praxair, Inc. v. ATMI, Inc., 543
    F.3d 1306, 1314-15 (Fed. Cir. 2008), Upjohn Co. v. Mova Pharm. Corp., 225 F.3d
    1306, 1312 (Fed. Cir. 2000), and Molins PLC v. Textron, Inc., 48 F.3d 1172,
    1179-80 (Fed. Cir. 1995).  Regarding Avid's contention that what was demonstrated was not what was
    patented, but a precursor that did not comprise all the features of the
    patented invention, the Court held that as such the precursor "reflected
    the closest prior art" and thus was material to patentability.  The majority found that this determination
    was not clearly erroneous.

    The majority's
    decision depended on whether Dr. Stoddard was bound by a duty of candor under
    Rule 56, it being hornbook law that only individuals having the duty could have committed inequitable conduct in procuring a patent.  Individuals having a duty of candor are defined in Rule 56(c):

    "[I]individual[s] associated with the
    filing or prosecution of a patent application" as (1) each named inventor,
    (2) each attorney or agent that prepares or prosecutes the application, and (3)
    every other person who is substantively involved in the preparation or prosecution
    of the application and who is associated with the inventor or assignee. 37
    C.F.R. § 1.56(c).

    Here, it was
    "undisputed that Dr. Stoddard is not an inventor of the '326
    patent, or an attorney or agent who prepared the '326 patent application."  Thus, in order for Dr. Stoddard's
    actions to constitute inequitable conduct, the Court considered whether he was "substantively
    involved in the preparation or prosecution of the application" and "associated
    with the inventor or assignee," citing 37 C.F.R. § 1.56(c)(3).  Calling the question of who other than
    an inventor or a patent attorney/agent is "substantively involved an the
    preparation or prosecution of a patent application" one that the Court had not
    previously considered, the Court considered the meaning of the phrase "substantively
    involved."  One thing the
    majority determined it was not was involvement that was "wholly
    administrative or secretarial in nature."  The District Court made three findings of fact with regard
    to what was known by Dr. Stoddard (although seemingly attributing either his
    knowledge to Avid or vice versa):

    1)  That Avid was aware of the consequences of selling or
    offering to sell its reader and tag before filing the '326 patent application,
    2)  That Avid attempted to file the '326
    patent application in advance of the 102(b) date, i.e., within one year after
    its first sales, but failed, and
    3)  That Avid intentionally withheld
    evidence of such sales from the PTO in an effort to deceive the PTO and secure
    allowance of the '326 patent.

    The District Court was
    express in its linkage of Avid and Dr. Stoddard.  According to the majority, these included "
    the nature of his position as president
    and founder of Avid, that Avid is a closely held company, and that Stoddard
    hired the inventors to reduce his encrypted chip concept to practice," and
    thus that Dr. Stoddard satisfied the requirementa of 37 C.F.R. § 1.56(c)(3) that
    individuals in Dr. Stoddard's position must be "associated" with the
    inventors.  Moreover, the District Court found that Dr. Stoddard was "substantively involved" in
    preparing or prosecuting the application because he was "involved in all
    aspects of the company's operation, from marketing and sales to research and
    development."  This led
    to the "reasonable inference" that Dr. Stoddard was also involved in
    preparing an application.  The District Court also cited as evidence two communications relating to the
    patent, one to the European associate from one of the named '326 inventors
    relating to the European counterpart (Dr. Stoddard was included in a cc) and
    one from the inventor to Dr. Stoddard regarding nondisclosure of the
    invention.  This evidence, Dr.
    Stoddard's role in the company, and "the nature and content of these
    communications," strongly supported the District Court's decision
    regarding the "inference."

    In addition,
    the Court found that Dr. Stoddard's testimony at trial was not credible,
    because "his memory of facts was suspiciously selective, and he refused to
    acknowledge certain incontrovertible events."  In addition, the panel stated that "[o]ur
    conclusion that the district court's duty of candor analysis was not clearly
    erroneous is reinforced by our own review of the entire record and relevant
    case law, which reveals sufficient reason to uphold the district court's
    judgment."  And what was Dr.
    Stoddard's contribution?

    Dr. Stoddard
    was personally responsible for the disputed prior art demonstrations.  He was in
    contact with at least one of the inventors during the preparation of the '326
    patent application regarding patent-related matters.  He was also advised by
    that inventor to check with a patent attorney before disclosing information about
    Avid's technology to the public.  He signed the small entity status affidavit
    shortly before the application was filed.  These facts lend further support to
    the inference that Dr. Stoddard was substantively involved in preparations for
    filing the application, and demonstrate that Dr. Stoddard spoke for Avid in
    representations to the PTO.

    Although Dr.
    Stoddard did not contribute enough to the patentable features of the claims to
    be considered an inventor, the functionality of the system described in the '326
    patent was his idea.  The inventors he hired were specifically instructed to
    reduce his idea to practice.  Dr. Stoddard's inclusion on substantive
    communications related to the preparation of the European counterpart to the '326
    patent application further support the more general conclusion that he was
    substantively involved in preparation of the patent application covering the system
    he conceived.

    Under the terms of Rule 56, the PTO
    does not assign a duty of candor to persons not associated with a patent
    application, or to those involved only in a ministerial capacity.  Such persons
    would not be in a position to appreciate that their conduct or knowledge might
    be relevant to the PTO.

    The district
    court did not clearly err in determining that Dr. Stoddard was not such an
    exempt person.  Indeed, to accept Avid's argument that a person such as Dr.
    Stoddard owes no duty of candor would allow intentional deception by the types
    of people most likely to have knowledge of § 102(b) prior art, i.e., those on
    the commercial side of patented product development.

    The majority then rebutted the dissenting Judge's
    views on the grounds that the Rule 56 requirement for substantial involvement
    was not the same (and did not require) "
    knowledge that the undisclosed information is material."  There is no such "knowledge"
    requirement, according to the majority, and thus materiality (even
    after-appreciated materiality) plus intent equals inequitable conduct.

    Dissenting Judge Linn took a different view.  Initially
    Judge Linn "parted company" with the majority on the issue of whether
    Dr. Stoddard was "substantively involved" with preparing or
    prosecuting the application.  The Judge "finds no basis" in either Rule 56 or policy to
    extend the scope of the duty of candor as the majority has done, particularly
    with regard to "those on the commercial side of patented product
    development," because they are "the types of people most likely to
    have knowledge of § 102(b) prior art."  The Judge's point is simple:  since the Rule imposes a duty to disclose any information "material
    to patentability," anyone having the duty must of necessity have "knowledge
    of the technical details or legal merits of an application"; otherwise how
    would they know whether something was material (and thus needed to be
    disclosed) or not.  Unlike the
    majority view, Judge Linn's view seems to reasonably require that those having
    a duty to disclose know what it is that they are required to disclose.  Thus, excluded from the duty are not
    only "'typists, clerks, and similar personnel who assist with the
    application' in a non-substantive way" but also but also corporate
    officers, managers, employees, and all other individuals who are neither aware
    of the technical details or legal merits of the application nor engaged in the
    preparation or prosecution thereof."  For Judge Linn, "[s]imply having
    a general interest or even a financial interest in the invention or a general
    awareness of the application is not enough."  Contrary to the majority, Judge Linn contends that the key
    phrase in Rule 56(c)(3)is "substantively involved," which requires "specific
    understanding of the substance of the application" as  a threshold for imposing the duty of
    candor.  Otherwise, according to
    the Judge, the duty would be imposed on individuals insufficiently informed
    about the content of the application to be able to know what was and was not
    material, and thus what needed to be disclosed:

    The majority's interpretation places on
    persons who are not in a position to assess materiality an obligation to
    disclose information the relevance of which they have no way of determining.  The effect is either to encourage the filing of information regardless of its
    materiality, just to be on the safe side, or to widen the net of inequitable
    conduct that may be cast by accused infringers after the fact in litigation.

    The decision,
    and the dissent, in this case illustrate some of the problems with how
    inequitable conduct is determined.  It seems from the record that the District Court did not credit Dr.
    Stoddard's testimony, particularly in view of the uncontested nature of his
    intent to deceive on appeal.  Whatever culpability he may have had in this regard certainly seems to
    have amounted to a "something smells" instinct in the District Court.  Moreover, the "coulda-woulda-shoulda"
    nature of the ex post facto determination
    of what is (or is not) material, the determination that Dr. Stoddard's
    presentation must represent the "closest prior art" to claims
    presented (and drafted) months after that presentation, makes it easy for a
    defendant to satisfy the two prongs (materiality and intent) of the current
    inequitable conduct standard.  And
    once a District Court has made that determination, having the Federal Circuit
    use the "abuse of discretion" standard of review effectively
    insulates the District Court's decision from any kind of skeptical (or even
    neutral) reconsideration.  Requiring some objective indicia of both intent and materiality (for
    example, evidence of mens rea or a
    determination that the undisclosed information invalidated one or more claims)
    would avoid the kind of hindsight reconstruction of both the facts, and the
    motivations, that characterize this and so many other inequitable conduct
    cases.

    Avid
    Identification Systems, Inc. v. Crystal
    Import Corp.
    (Fed. Cir. 2010)

    Panel:  Circuit Judges Mayer, Linn, and Prost
    Opinion for the court by Circuit Judge Prost, concurring-in-part and dissenting-in-part opinion by Circuit Judge Linn

  •     By Andrew Williams


    Concerta Last week, in ALZA
    Corp. v. Andrx Pharms., LLC
    , the Federal Circuit affirmed the U.S.
    District Court for the District of Delaware's decision that ALZA's patent
    related to treating Attention Deficit and Hyperactivity Disorder ("ADHD")
    was invalid for lack of enablement.  ALZA markets the drug Concerta® for the treatment of ADHD, which
    releases methylphenidate after ingestion at an ascending rate over an extended
    period of time.  Methylphenidate is the same active ingredient as found in
    Ritalin®.  However, because Ritalin®
    is an immediate-release formulation, it had to be administered two to three
    times a day.  And, as many of the
    patients that took Ritalin® were children, at least one of these doses had to
    be administered during the school day.  As a result, there was a desire to create a once-a-day method of
    treating ADHD by developing a sustained or controlled-release dosage form, also
    known as an extended-release formulation.

    ALZA undertook to create such a dosage form.  It discovered after a series of
    clinical trials that MPH plasma concentrations that had ascending patterns had
    greater efficacy than when concentrations were constant.  ALZA was able to use this information
    to develop a safe and effective once-a-day extended release oral dosage form.  Subsequently, ALZA obtained U.S. Patent
    No. 6,919,373 ("the '373 patent"), whose only independent claim reads:  "A
    method for treating ADD or ADHD comprising administering a dosage form
    comprising methylphenidate that provides a release of methylphenidate at an
    ascending release rate over an extending period of time."  ALZA spent most of its effort
    developing an osmotic dosage form, and therefore the '373 patent specification
    focused on adapting osmotic systems to create ascending release dosage
    forms.  However, the '373 patent
    did mention non-osmotic dosage forms.


    Andrx Andrx filed an Abbreviated New Drug Application ("ANDA")
    to sell a generic version of Concerta®.  However, Andrx asserted that its product did not infringe the '373
    patent.  It is likely that Andrx
    believed that its ANDA product was a non-osmotic dosage form, because it
    attempted to limit the scope of the claims to osmotic dosage forms.  Nevertheless, the District Court
    construed the claims to include both osmotic and non-osmotic dosage forms.  ALZA successfully argued for the
    broader claim interpretation, but ultimately it was because the claims were
    construed broadly that they were found to be invalid.  The District Court held that the asserted claims were invalid for
    lack of enablement because the specification did not enable the full scope of
    the claims, namely non-osmotic dosages forms.


    Federal Circuit Seal The issue presented to the Federal Circuit was
    whether the specification would have enabled a person of ordinary skill in the
    art to create non-osmotic oral dosage forms (such as tablets and capsules) with
    ascending release rates without undue experimentation at the time of
    filing.  As with all cases dealing
    with undue experimentation, the Court looked at the Wands factors, and
    agreed with the District Court that seven of the eight factors weighed in favor
    of undue experimentation.  One of
    the most significant reasons identified by the Federal Circuit was that the
    specification did not contain "such full, clear, concise, and exact terms
    as to enable any person skilled in the art" to make and use such
    non-osmotic oral dosage forms.  ALZA
    pointed to the specification that contained a ten-line disclosure of various
    non-osmotic forms with a reference to a textbook that discusses how to make and
    use these forms.  The problem, however,
    was not that the claims encompassed non-osmotic forms themselves, but that the
    claims included a functional limitation — the non-osmotic oral dosage forms were
    required to have ascending release rates.  And, ALZA was trying to rely on the knowledge of a person of ordinary
    skill to serve as a substitute for missing information in the specification.  Interestingly, ALZA argued that a person
    skilled in the art could derive this functional limitation if they engaged in
    an iterative, trial-and-error process.  Apparently, however, according to the Federal Circuit, iterative,
    trial-and-error is undue experimentation.

    ALZA also challenged the District Court's reliance
    on the testimony of the fact and expert witnesses.  ALZA's expert witness, Dr. Martyn Davies, testified that the
    experimentation required to obtain non-osmotic dosage forms was routine.  However, the level of skill upon which
    his analysis was based was at a level higher than the one the District Court
    adopted.  In addition, ALZA
    challenged the testimony of its own employees, who explained that ALZA had been
    unable to develop these "routine" non-osmotic dosage forms.  Specifically, ALZA argued that at least
    one of these employees was not skilled in the art.  However, the Federal Circuit found the level of the
    employees' knowledge to be irrelevant, because their testimony related to ALZA's
    difficulty in creating a non-osmotic form, not to the knowledge of one skilled
    in the art.

    The Federal Circuit commented on the irony that it
    was precisely because ALZA argued for broader claim construction that its
    claims were found to be invalid.  The Court failed, however, to mention that ALZA may have been required
    to argue for the broader construction in order for the claims to cover Andrx's
    ANDA product.  Nevertheless, one
    lesson to be learned from this case is that you better be careful what you ask
    for, because you might not like what you get.

    ALZA Corp. v. Andrx Pharmaceuticals, LLC (Fed. Cir. 2010)
    Panel:  Circuit Judges Dyk, Schall, and Prost
    Opinion by Circuit Judge Prost

  •     By
    James DeGiulio —

    After
    over a decade of suspicion following the death of an 18-year-old patient, gene
    therapy is experiencing a revival among scientists and drugmakers, according to
    a recent Bloomberg report ("'Dead as Doornail' Gene Therapy Revival Spurs Genzyme")
    .  Since the patient's death in 1999,
    scientists have linked many of the safety problems with gene therapy to the
    modified adenovirus vectors used to deliver the gene.  Current trials utilize a new generation of gene delivery
    vectors, such as adeno-associated virus (AAV), which trigger a milder immune
    response than the adenovirus used in previous studies and are consequently much
    safer.


    Genzyme Recent
    successes have rejuvenated the gene therapy field.  The Bloomberg report highlights
    Genzyme, which has invested more than $200 million over the past 10 years on
    gene therapy technology.  Genzyme's recent Parkinson's disease trial showed a
    dopamine gene injected into patients' brains effectively reached the targeted
    nerve cells in the region of the brain controlling movement.  This is an important discovery because
    efficient gene delivery is a major limitation of gene therapy.  Genzyme is preparing to test the
    therapy in a larger trial using AAV that could begin next year.


    Covermed Other
    recent successes have been reported in high impact factor journals.  The
    November 6 issue of Science contained a report
    that showed brain damage in two 7-year-olds with an inherited condition called
    adrenoleukodystrophy was halted or reversed using gene therapy ("Hematopoietic
    Stem Cell Gene Therapy with a Lentiviral Vector in X-Linked
    Adrenoleukodystrophy
    ")
    .  In this study, doctors
    removed the patients' blood-forming stem cells, inserted gene-bearing viruses
    into them, and reinfused the patients with the modified cells.

    The
    November 7 issue of The Lancet reported that delivery of a therapeutic gene to patients with Leber's congenital
    amaurosis resulted in significant vision recovery, with the most improvement
    noted in children ("Age-dependent effects of RPE65 gene therapy for Leber's congenital amaurosis: a phase 1 dose-escalation trial")
    .  In this study, genes
    were delivered directly to target cells using AAV virus injected into patients.


    Novartis Large
    drug companies are forming partnerships to further gene therapy development.  In
    January, Novartis licensed gene treatments for hearing loss and balance
    disorders from GenVec in a deal worth up to $213 million.  In February, startup Tacere
    Therapeutics announced that Pfizer would license its hepatitis C treatment in
    an agreement valued at as much as $145 million.

    Other
    trends show the industry's renewed interest in gene therapy.  According to the
    FDA, there are currently 354 U.S. gene therapy studies under way, up from only
    116 worldwide in 2008.  A Jain Pharmabiotech report released this month indicates that a total of 189 companies are currently
    developing gene therapies, up from only 44 in 1995.

    However,
    despite the recent scientific successes, gene therapy is unlikely to produce
    revenue for any U.S. company for several years, as no gene therapies have been
    approved for actual medical use.  Only China has approved gene therapies for two
    types of cancers.  Nonetheless,
    there is no shortage of economic optimism.  An October 2008 report from Global Industry Analysts predicts gene therapy products will have revenue
    of $465 million in 2015.

    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.


  • Chicago #2 The
    Biotechnology Industry Organization (BIO) is holding its annual BIO International
    Convention this week at McCormick Place in Chicago, IL.  Founded in 1993,
    BIO is a nonprofit association seeking supportive biotechnology policies on
    behalf of more than 1,200 biotechnology companies, state and international
    affiliates, and related organizations, as well as providing business
    development services for many emerging biotech companies.


    BIO International Convention As part of the Convention, more than
    2,200 biotech companies, organizations, and institutions are expected to
    participate in the BIO Exhibition.  Patent
    Docs
    Donald Zuhn, Kevin Noonan, Sherri Oslick, Sarah Fendrick, Andrew
    Williams, and Brad Crawford will also be attending BIO as part of the MBHB
    contingent
    , and will be
    participating in BIO's blogger network throughout the weekPatent Docs readers
    who may be attending BIO this week are encouraged to stop by booth #5348 to
    meet the Docs, at the times indicated below, and talk a little biotech patent law.

    Tuesday, May 4

    1:00 – 3:00 pm — Sherri Oslick &
    Andrew Williams

    5:00 – 6:30 pm — Sherri Oslick &
    Brad Crawford

     

    Wednesday, May 5

    11:00 am – 1:00 pm — Donald Zuhn

    3:00 pm – 5:00 pm — Sarah Fendrick

     

    Thursday, May 6

    8:45 – 11:00 am — Sarah Fendrick &
    Brad Crawford

    11:00 am – 1:00 pm — Donald Zuhn &
    Sherri Oslick

    1:00 pm – 3:00 pm — Kevin Noonan

    In addition, many of the Docs will be
    attending MBHB's reception at Fado Irish Pub, 100 West Grand Avenue, from 7:00
    to 11:00 pm on Tuesday, May 4.  Additional information about the reception, including an RSVP for the event, can be found here.

  •     By Sherri
    Oslick

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


    Pfizer Inc. et al. v. Watson Pharmaceuticals, Inc. et al.
    0:10-cv-60674; filed April 29, 2010 in the Southern
    District of Florida

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth
    Pharmaceuticals Inc.
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson
    Laboratories, Inc.-Florida; Watson Laboratories, Inc.; Watson Pharma, Inc.

    Pfizer Inc. et al. v. Watson Pharmaceuticals Inc. et al.
    1:10-cv-00357; filed April 28, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth
    Pharmaceuticals, Inc.
    • Defendants:  Watson Pharmaceuticals Inc.; Watson
    Laboratories Inc. – Florida; Watson Laboratories Inc.; Watson Pharma Inc.;
    Ranbaxy Laboratories Ltd.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Inc.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent No. 5,100,899 ("Methods of Inhibiting Transplant Rejection in Mammals
    Using Rapamycin and Derivatives and Prodrugs Thereof," issued March 31, 1992)
    following a Paragraph IV certification as part of Watson's filing of an ANDA to
    manufacture a generic version of Pfizer's Rapamune® (sirolimus, used for the
    prophylaxis of organ rejection in patients aged 13 years or older receiving
    renal transplants).  View the
    Delaware complaint
    here.


    Abbott Laboratories et al. v. Watson Laboratories, Inc.-Florida
    et al
    .
    0:10-cv-60677; filed April 29, 2010 in the Southern
    District of Florida

    • Plaintiffs:  Abbott Laboratories; Fournier
    Laboratories Ireland Ltd.
    • Defendants:  Watson Laboratories, Inc.-Florida;
    Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

    Abbott Laboratories et al. v. Watson Laboratories, Inc.-Florida
    et al
    .
    2:10-cv-02139; filed April 27, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Abbott Laboratories; Fournier
    Laboratories Ireland Ltd.
    • Defendants:  Watson Laboratories, Inc.-Florida;
    Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

    Abbott Laboratories et al. v. Mylan Pharmaceuticals Inc. et al.
    2:10-cv-02073; filed April 23, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Abbott Laboratories; Fournier
    Laboratories Ireland Ltd.
    • Defendants:  Mylan Pharmaceuticals Inc.;
    Mylan, Inc.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent No. 7,259,186 ("Salts of Fenofibric Acid and Pharmaceutical
    Formulations Thereof," issued August 21, 2007) following a Paragraph IV
    certification as part of defendants' filing of an ANDA to manufacture a generic
    version of Abbott's Trilipix® (choline fenofibrate delayed release, used to
    treat increased triglyceride levels).  View the Florida Watson complaint
    here.


    Shionogi Pharma Inc. et al. v. Impax Laboratories Inc.
    1:10-cv-00358; filed April 28, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Shionogi Pharma Inc.; LifeCycle
    Pharma AS
    • Defendant:  Impax Laboratories Inc.

    Infringement of U.S. Patent No. 7,658,944 ("Solid
    Dosage Form Comprising a Fibrate," issued February 9, 2010) following a
    Paragraph IV certification as part of Impax's filing of an ANDA to manufacture
    a generic version of Shionogi's Fenoglide® (fenofibrate, used to treat
    hyperlipidemia, mixed dyslipidemia, or hypertriglyceridemia).  View the complaint
    here.


    Medicis Pharmaceutical Corp. v. Taro Pharmaceutical USA
    Inc. et al

    1:10-cv-00359; filed April 28, 2010 in the District
    Court of Delaware

    • Plaintiff:  Medicis Pharmaceutical Corp.
    • Defendants:  Taro Pharmaceutical USA Inc.; Taro
    Pharmaceutical Industries Ltd.

    Medicis Pharmaceutical Corp. v. Taro Pharmaceutical
    U.S.A., Inc. et al
    .
    1:10-cv-03549; filed April 28, 2010 in the Southern
    District of New York

    • Plaintiff:  Medicis Pharmaceutical Corp.
    • Defendants:  Taro Pharmaceutical U.S.A., Inc.;
    Taro Pharmaceutical Industries, Ltd.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent Nos. 6,765,001 ("Compositions and Methods for Enhancing
    Corticosteroid Delivery," issued July 20, 2004), 7,220,424 (same title,
    issued May 22, 2007), and 7,217,422 (same title, issued May 15, 2007) following
    a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture
    a generic version of plaintiff's Vanos® (fluocinonide cream, used to relieve
    inflammation and itching caused by certain skin conditions that respond to
    corticosteroids).  View the
    Delaware complaint
    here.


    Celgene Corp. v. Cyclacel Pharmaceuticals Inc.
    1:10-cv-00348; filed April 27, 2010 in the District
    Court of Delaware

    Declaratory judgment of non-infringement and
    invalidity of U.S. Patent Nos. 6,403,555 ("Depsipeptide and Congeners Thereof
    for Use as Immunosuppressants," issued June 11, 2002), 6,548,479 ("Therapeutic
    Uses of Depsipeptide and Congeners Thereof," issued April 15, 2003), 6,828,302
    ("same title, issued December 7, 2004), and 7,041,639 ("Depsipeptide and
    Congeners Thereof for Use as Immunosuppressants," issued May 9, 2006) based on
    Celgene's manufacture and sale of its Istodax® product (romidepsin, used to
    treat cutaneous T-cell lymphoma).  View the complaint
    here.


    AstraZeneca Pharmaceuticals LP et al. v. Apotex Corp.
    1:10-cv-00338; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendant:  Apotex Corp.

    AstraZeneca Pharmaceuticals LP et al. v. Aurobindo Pharma
    Ltd. et al
    .
    1:10-cv-00339; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo
    Pharma USA Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Cobalt Pharmaceuticals
    Inc. et al
    .
    1:10-cv-00340; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendants:  Cobalt Pharmaceuticals Inc.; Cobalt
    Laboratories Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Cobalt Pharmaceuticals
    Inc. et al
    .
    1:10-cv-00340; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendants:  Cobalt Pharmaceuticals Inc.; Cobalt
    Laboratories Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Glenmark Generics Inc.
    USA

    1:10-cv-00341; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendant:  Glenmark Generics Inc. USA

    AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals
    Inc.

    1:10-cv-00342; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Par Pharmaceutical Inc.
    1:10-cv-00343; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs: AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendant: Par Pharmaceutical Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Sandoz Inc.
    1:10-cv-00344; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendant:  Sandoz Inc.

    AstraZeneca Pharmaceuticals LP et al. v. Sun Pharmaceutical
    Industries Ltd. et al
    .
    1:10-cv-00345; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital,
    Inc.
    • Defendants:  Sun Pharmaceutical Industries Ltd.;
    Sun Pharmaceutical Industries Inc.; Caraco Pharmaceutical Laboratories
    Ltd.

    AstraZeneca Pharmaceuticals LP et al. v. Teva Pharamceuticals
    USA, Inc.

    1:10-cv-00346; filed April 26, 2010 in the District
    Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR
    Pharmaceuticals Inc.; AstraZeneca AB; The Brigham and Women's Hospital, Inc.
    • Defendant:  Teva Pharamceuticals USA, Inc.

    The complaints in these cases are substantially
    identical.  Infringement of U.S.
    Patent Nos. 6,858,618 ("Use of Rosuvastatin (ZD-4522) in the Treatment of
    Heterozygous Familial Hypercholesterolemia," issued February 22, 2005) and
    7,030,152 ("Systematic Inflammatory Markers as Diagnostic Tools in the
    Prevention of Atherosclerotic Diseases and as Tools to Aid in the Selection of
    Agents to be Used for the Prevention and Treatment of Atherosclerotic Disease,"
    issued April 18, 2006) following a Paragraph IV certification as part of
    defendants' filing of an amended ANDA to manufacture a generic version of
    AstraZeneca's Crestor® (rosuvastatin calcium, used to treat high
    cholesterol).  View the Apotex
    complaint
    here.


    Teva Women's Health, Inc. v. Watson Laboratories, Inc. et al.
    2:10-cv-02061; filed April 23, 2010 in the District
    Court of New Jersey

    • Plaintiff:  Teva Women's Health, Inc.
    • Defendants:  Watson Laboratories, Inc.; Watson
    Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 5,908,638
    ("Pharmaceutical Compositions of Conjugated Estrogens and Methods for
    Their Use," issued June 1, 1999) following a Paragraph IV certification as
    part of Watson's filing of an ANDA to manufacture a generic version of Teva
    Women's Health's Cenestin® (synthetic conjugated estrogens, used to treat
    peri-menopausal, menopausal, and post-menopausal disorders).  View the complaint
    here.


    Shire LLC et al v. Teva Pharmaceuticals USA Inc. et al.
    1:10-cv-00329; filed April 22, 2010 in the District
    Court of Delaware

    • Plaintiffs:  Shire LLC; Supernus
    Pharmaceuticals Inc.
    • Defendants:  Teva Pharmaceuticals USA Inc.; Teva
    Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent Nos. 6,287,599
    ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent
    Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title,
    issued November 2, 2004) based on Teva's filing of an ANDA to manufacture a
    generic version of Shire's Intuniv (guanfacine, used to treat attention-deficit
    hyperactivity disorder).  View the
    complaint
    here.


    Wyeth LLC v. Aurobindo Pharma Ltd. et al.
    3:10-cv-02084; filed April 22, 2010 in the District
    Court of New Jersey

    • Plaintiffs:  Wyeth LLC
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo
    Pharma USA Inc.

    Infringement of U.S. Patent Nos. 6,274,171
    ("Extended release formulation of venlafaxine hydrochloride," issued
    August 14, 2001), 6,403,120 (same title, issued June 11, 2002), and 6,419,958
    (same title, issued July 16, 2002) following a Paragraph IV certification as
    part of Aurobindo's filing of an ANDA to manufacture a generic version of
    Wyeth's EFFEXOR XR® (venlafaxine hydrochloride, extended release, used to treat
    depression).  View the complaint
    here.




  • Calendar

    May
    3-6, 2010 – 2010
    BIO International Convention
    (Biotechnology
    Industry Organization) – Chicago, IL

    May
    11, 2010 –
    Law
    Symposium on Intellectual Property
    (
    George
    Washington
    University Law School, Howrey LLP & Cornerstone Research) –
    Washington, DC

    May
    18, 2010 –
    "The
    Role
    of Patent Agents in Intellectual Property in the Changing Economy
    " (
    Intellectual
    Property Law Association of Chicago) –
    Chicago, IL

    May
    20, 2010 –
    "The
    Federal Circuit: A
    National Court of Appeals: Approaching 30 Years
    "
    (U.S.
    Court of
    Appeals for the Federal Circuit) –
    Washington,
    DC

    May
    24-25,
    2010 –
    Hatch-Waxman
    Boot Camp
    *** (
    American
    Conference
    Institute) –
    San
    Diego, CA

    May
    24-26, 2010 –
    Pharmaceutical
    & Biotech Patent Litigation
    Strategies
    *** (Pharma IQ) –
    London,
    England

    May
    25, 2010 –
    Corporate
    Intellectual Property Law Conference
    (
    Law
    Bulletin) – Chicago, IL

    May
    26-27, 2010 –
    7th
    International Forum on Freedom to Operate
    (C5) –

    Munich, Germany

    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
    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

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


  • New York #2 American Conference
    Institute (ACI) will be holding a conference on Follow-on Biologics on June
    21-22, 2010 in New York, NY.  ACI
    faculty will help attendees:

    • Prepare for
    follow-on patent litigation and understand what mechanisms are and will be in
    place for resolving patent disputes;
    • Analyze the
    impact of the 12-year exclusivity period on the financial viability of
    development of follow-ons;
    • Develop methods
    for demonstrating or disproving similarity "in terms of safety, purity and
    potency of the product";
    • Determine what
    safety data and technical level of support bio applicants will have to provide
    in order to get approval of follow-ons;
    • Examine and learn
    from the global development of biosimiliars;
    • Maximize the biologic
    patent lifecycle and protect the value of intellectual property for biologics;
    • Investigate
    alternative approval methods for biosimilars including BLA applications and
    FD&C 505(b)2 applications; and
    • Evaluate the
    impact of follow-ons on existing and future licensing agreements and strategic
    alliances.


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

    • Overview, status
    and history of biosimiliars legislation in the U.S.:  The inside story;
    • Practical
    implications for the biosimilars market under the new regime;
    • Current FDA
    position and initiatives regarding follow-on biologics;
    • Defining
    biosimilars:  Proving (or
    disproving) interchangeability and biosimilarity — to be presented in part by Patent Docs author Kevin Noonan;
    • An overview of
    dispute resolution mechanisms under PHS § 351;
    • Developing
    procedures and strategies in preparation of follow-on litigation;
    • Maximizing the
    biologic patent lifecycle and protecting the value of IP for biologics in light
    of new legislation:  Written
    description, enablement, the doctrine of equivalents and more;
    • FTC
    spotlight:  Addressing the
    antitrust concerns resulting from follow-on legislation;
    • Lessons learned
    from the development of biosimilars on the international stage;
    • Understanding
    proposed clinical trials requirements and overcoming safety concerns associated
    with follow-ons;
    • Developing
    alternative pathways for getting biosimilars on the market;
    • Renegotiating and
    reworking licensing agreements with companies and universities in anticipation
    of follow-on biologics; and
    • Overcoming
    challenges to marketing, branding, and promotion of biosimilars.

    A post-conference
    workshop, entitled "Applying Patent Term Adjustments and Patent Term
    Extensions to Biosimilars to Optimize the Biologic Patent Lifecycle," will
    be offered from 9:00 am to 12:00 pm on June 23, 2010.  The workshop will take attendees through the intricacies of
    the major ways of getting an extension on biologics patents, and provide
    attendees with the tools needed to accomplish this goal in a time of changing
    rules and regulations.

    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 (conference alone) or $2,795 (conference and
    workshop).  Those registering by
    May 28, 2010 will receive a $300 discount.  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 Follow-on Biologics conference.