• By Martin O'Brien

    Australia Coat of ArmsOn Friday, the Federal Court of Australia handed down its decision in the case of Cancer Voices Australia & Anor v Myriad Genetics Inc &
    Ors
    .  The presiding judge, Justice Nicholas, identified the issue in
    the case as one "of considerable importance," framing the question to
    be decided as whether a "valid patent may be granted for a claim that
    covers naturally occurring nucleic acid that has been isolated."

    Justice Nicholas answered that question in the affirmative.

    MyriadAlthough the patent includes 30 claims, it was only claims 1 to 3 that were in
    dispute.  Claim 1 of the patent is:  [an] isolated nucleic acid coding for a
    mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in
    comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1
    one or more mutations or polymorphisms selected from the mutations set forth in
    Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.  Claims 2 and 3 are dependent claims extending only to DNA.  The challenge to the
    claims was solely on the basis that they include non-patentable subject matter.  In particular, the applicants contended that each claim comprises "isolated"
    nucleic acid that is not materially different to the nucleic acid that occurs
    in nature.

    Under Australian law, other than specific exclusions of certain subject matter,
    the question as to what constitutes patentable subject matter is answered by
    reference to section 18(1)(a) which asks whether the invention "is a
    manner of manufacture within the meaning of section 6 of the Statute of
    Monopolies."  The leading case on that point is the decision of the High
    Court of Australia known as NRDC.  Following that decision, Justice Nicholas observed that "a composition of
    matter may constitute patentable subject matter if it consists of an artificial
    state of affairs, that has some discernible effect, and that is of utility in a
    field of economic endeavor."

    Justice Nicholas' decision identifies three considerations influential in
    leading to his conclusion that isolated nucleic acids are patentable.  First,
    that the High Court in NRDC
    was "deliberate in its use of very expansive language" to emphasise
    the "broad sweep" of patentability.  Secondly, the importance of "isolated"
    in that the claim is to a nucleic acid that is the product of human
    intervention.  Third, that it would "lead to very odd results if a person
    whose skill and effort culminated in the isolation of . . . an isolated DNA
    sequence could not be rewarded by grant of a patent because the [subject
    matter] . . . was held to be inherently unpatentable."

    Importantly, the decision emphasises that patentability of isolated nucleic
    acids "does not turn upon what changes have been made to the chemical
    composition of such substances as a result of them having been isolated,"
    thereby making it clear that there is no requirement for changes in chemical composition
    of the claimed nucleic acid.

    The patentability of gene sequences has received close attention in Australia
    over recent years, with several government-appointed inquiries having been
    held.  Justice Nicholas' decision makes reference to the Australian Government
    Response of November 2011 to the Reports of three of those inquiries, that
    response specifically accepting the recommendation of the Australian Law Reform
    Commission that the Patents Act
    not be amended to exclude genetic materials from patentable subject matter.  The
    decision also makes reference to the Senate Committee Report into a
    parliamentary Bill introduced in 2010 which sought to exclude from
    patentability biological materials, defined in that Bill as including DNA and
    RNA, Justice Nicholas noting that the Report recommended the Senate not pass
    the Bill (which has now lapsed).

    The decision identifies that one of the "main arguments" raised
    against the patentability of isolated DNA sequences is the impact that such
    patents may have on future research, for example in diagnostic and therapeutic
    technologies.  In making this observation, Justice Nicholas noted the "significance"
    of a recent amendment to the
    Patents Act,
    which introduced an explicit statutory exemption from
    infringement for research and experimental activities.  Thus, under new section
    119C of the Act "[a]
    person may, without infringing a patent for an invention, do an act that would
    infringe the patent apart from this subsection, if the act is done for
    experimental purposes relating to the subject matter of the invention."  Inclusive provisions in the Amended Act illustrate the scope of "experimental
    purposes" and include "improving or modifying the invention."  Section 119C applies in relation to acts done on or after 16 April 2012 in
    relation to patents granted before, on or after that date.

    Whilst the decision may again lead
    to calls for legislative change, it does make clear that isolated nucleic acids
    sequences are currently patentable in Australia.

    The deadline by which either party may appeal the decision to the Full Federal
    Court is 21 days from the date of the decision.

    Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia, specializing in molecular biology and biotechnology.

    For additional information regarding this topic, please see:

    • "The Gene Patents Debate in Australia — An Update," December 1, 2011
    • "Australian Senate Committee Issues Recommendation on Gene Patenting Bill," October 6, 2011
    • "Australian Senate to Release Gene Patenting Findings Next Week," June 8, 2010
    • "Gene Patenting: Australian Potpourri," December 28, 2009

    Patent Docs thanks Spruson and Ferguson for providing one of two views on the Cancer Voices Australia decision that we are able to pass along to our readers.

  • By Sherri Oslick

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

    Enzo Life
    Sciences Inc. v. Abbott Laboratories et al.

    1:13-cv-00225;
    filed February 11, 2013 in the District Court of Delaware

    • Plaintiff: 
    Enzo Life Sciences Inc.
    • Defendants: 
    Abbott Laboratories; Abbott Molecular Inc.

    Infringement
    of U.S. Patent No. 8,097,405 ("Nucleic Acid Sequencing Processes Using
    Non-Radioactive Detectable Modified or Labeled Nucleotide Analogs, and Other
    Processes for Nucleic Acid Detection and Chromosomal Characterization Using
    Such Non-Radioactive Detectable Modified or Labeled Nucelotides or Nucleotide
    Analogs," issued January 17, 2012) based on Abbott's manufacture and sale
    of certain DNA fluorescent in situ hybridization (FISH) probes.  View the complaint here.


    Sucampo AG et
    al. v. Anchen Pharmaceuticals Inc. et al.

    1:13-cv-00202;
    filed February 7, 2013 in the District Court of Delaware

    • Plaintiffs: 
    Sucampo AG; Sucampo Pharmaceuticals Inc.; R-Tech Ueno Ltd.; Takeda
    Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals USA Inc.; Takeda
    Pharmaceuticals America Inc.
    • Defendants: 
    Anchen Pharmaceuticals Inc.; Par Pharmaceutical Inc.; Par Pharmaceutical
    Companies Inc.

    Infringement
    of U.S. Patent Nos. 6,414,016 ("Anti-Constipation Composition,"
    issued July 2, 2002), 7,795,312 ("Method for Treating Abdominal
    Discomfort," issued September 14, 2010), 8,071,613 ("Anti-Constipation
    Composition," issued December 6, 2011), 8,097,653 ("Dosage Unit
    Comprising a Prostaglandin Analog for Treating Constipation," issued
    January 17, 2012), 8,026,393 ("Soft-Gelatin Capsule Formulation,"
    issued September 27, 2011), and 8,338,639 (same title, issued December 25,
    2012) following a Paragraph IV certification as part of Anchen's filing of an
    ANDA to manufacture a generic version of Amitiza® (lubiprostone, used to treat
    Chronic Idiopathic Constipation in adults and 
    to treat Irritable Bowel Syndrome with Constipation in women 18 years of
    age and older).  View the complaint here.

  • Calendar

    February 20, 2013 – AIA Strategy Considerations for Patent Filings in
    2013: Should You File on March 15 or March 16 (or Both)?
    (Intellectual Property Owners Association) – Washington, DC

    February 20, 2013 – First to File: Final Rules and Guidance — Navigating
    Significant Changes to Derivation Practice, What Constitutes Prior Art and More
    (Strafford) – 1:00 – 2:30 pm (EST)

    February 20-22, 2013 – Intensive Patent Law Seminar (Chisum Patent Academy) – New York, NY

    February
    21, 2013 – When Trade Secrets Go Abroad:
    Strategies for Combating Trade Secret Misappropriation
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    February 22, 2013 – Bowman v. Monsanto: The U.S. Supreme Court Hearing (Intellectual Property Owners Association) – 1:00 to 2:00 pm (ET)

    February
    26-27, 2013 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

    February 27-28, 2013 – Life Sciences
    Collaborative Agreements and Acquisitions
    *** (American Conference
    Institute) – New
    York, NY

    March 1, 2013 – Intellectual Property Panel
    Symposium
    (George
    Washington University Law School) – San Francisco, CA

    March 5-6, 2013 – Medical Device
    Patents
    *** (American Conference
    Institute) – Chicago, IL

    March 7, 2013 – Implementing the New
    Priority Rules Under the AIA
    (Technology
    Transfer Tactics) – 1:00 – 2:00 pm
    (Eastern)

    March 7, 2013 – Patent Inventorship:
    Best Practices for Determination and Correction
    (Strafford) – 1:00 – 2:30 pm (EST)

    March 10-13, 2013 – Genes & Diagnostics: A Myriad
    of Issues in Biotech IP
    (Cold
    Spring Harbor Laboratory) – Cold
    Spring Harbor Laboratory

    March 19-20, 2013 – FDA Boot Camp*** (American Conference
    Institute) – New York, NY

    March 20, 2013 – Improving the Success of Appeals to the
    Patent Trial and Appeal Board
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am (CT)

    March 20, 2013 – Patent Claim Drafting
    and Construction in 2013: Crafting Claims to Withstand Scrutiny and Avoiding
    Claim Limitation Attack
    (Strafford) – 1:00 – 2:30 pm
    (EST)

    March 25-27, 2013 – 2013 Spring Intellectual
    Property Counsels Committee (IPCC) Conference
    (Biotechnology
    Industry Organization) – San
    Diego, CA

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

  • IPO #2The
    Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled
    "Bowman v. Monsanto: The U.S. Supreme Court Hearing"
    on February 22, 2013 beginning at 1:00 pm (ET). 
    A panel consisting of Prof.
    Shubha Ghosh of the University of
    Wisconsin Law School, Patent Docs author Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP,
    and Andrew Pincus of Mayer Brown LLP
    will discuss the February 19 oral argument in Bowman v. Monsanto,
    including the questioning by the Court and attempt to tally the Justices' votes.

    The
    registration fee for the webinar is $120 (government and academic rates are
    available upon request).  Those
    interested in registering for the webinar can do so here.

  • BIO IPCC
    The Biotechnology
    Industry Organization (BIO) will be holding its 2013 Spring Intellectual
    Property Counsels Committee (IPCC) Conference on March 25-27, 2013 in San
    Diego, CA.  The semi-annual IPCC
    conference will once again be open to the public.

    The conference will
    offer presentations on the following topics:

    Monday, March 25:

    • Effecting and Managing Change
    (Pre-Conference Workshop)

    Tuesday, March 26:

    • Seeds of Exhaustion: Analysis of Bowman v.
    Monsanto
    & the Shifting Doctrine of Patent Exhaustion
    • Any Port in a Storm – Section 271(e)(1)
    and the Continuing Debate Over Boundaries of Safe Harbor Exception
    • The Honorable Marilyn L. Huff, District
    Judge, U.S. District Court for the Southern District of California (luncheon speaker)
    • The Method Patent Rollercoaster
    • Patent Opinions Revisited: New Risks, New
    Rewards

    Wednesday, March 27:

    • The AIA and APA: Oversight of Patents and the
    Agency That Grants Them
    • Case Law Updates

    In addition, there
    will be a welcome reception at Andaz Wine Bar from 5:45 pm to 7:30 pm on March
    25, and a dinner reception at R.H. Fleet Science Center from 5:00 pm to 8:30
    pm on March 26.

    A program agenda
    for this conference, including a list of speakers and descriptions of the
    presentations and events can be obtained here.

    Registration information
    can be found here.  Additional information regarding the
    conference can be found at the conference website.

  • By Kevin E. Noonan

    Whether
    ANDA litigation has had a positive or negative impact on generic drug
    availability is an open question, in view of several recent reports looking at
    the effects such litigation has had on both branded and generic drugs over the
    past thirty years.  Indeed, the current squabble
    over "reverse payment" settlement agreements of lawsuits under the
    ANDA provisions of the Hatch-Waxman Act (codified at 35 U.S.C. § 271(e)(2))
    involves many of these same issues, revolving around the question of whether it
    is prudent for both branded and generic parties of ANDA lawsuits to settle
    rather than wage protracted, often pyrrhic, patent litigation (see "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation").  Occasionally, of
    course, both parties get an outcome they can live with, and one such occasion
    occurred today in Cephalon v. Watson
    Pharmaceuticals
    , where the Federal Circuit affirmed a District Court
    decision that the generic drug did not infringe the patent-in-suit but reversed
    the District Court on the issue of whether the patents were invalid for lack of
    enablement.

    Cephalon #2The
    case involved a formulation of fentanyl, an opioid sold by NDA holder Cephalon
    under the brand name FENTORA®.  Cephalon
    listed U.S. Patent Nos. 6,200,604 and 6,974,590 in the Orange Book and asserted
    both patents in response to Watson's ANDA filing; claim 1 of the '604 patent:

    1.  A method of
    administering at least one systemically distributable pharmaceutical agent
    across the oral mucosa comprising:
        a) providing a
    solid oral dosage form including a pharmaceutically effective amount of an
    orally administerable medicament; and at least one effervescent agent in an
    amount sufficient to increase absorption of said orally administerable
    medicament across the oral mucosa
    ; wherein said orally administerable medicament
    is not substantially encompassed by or dispersed in a material that prevents
    absorption of said medicament across the oral mucosa;
        b) placing said
    solid oral dosage form in the mouth of a patient so that saliva in said patient's
    mouth activates said at least one effervescent agent in said tablet; and
        c) holding said
    solid oral dosage form and the dissolving contents of said solid oral dosage
    form in the mouth of a patient whereby said at least one effervescent agent
    promotes absorption of said orally administerable medicament across the oral
    mucosa.

    and
    claim 1 of the '590 patent:

    1. A method of administration of
    fentanyl to a mammal across the oral mucosa thereof, said method comprising:
        providing a solid
    oral dosage form comprising fentanyl or a pharmaceutically acceptable salt
    thereof and at least one saliva activated effervescent agent in an amount
    sufficient to increase absorption of said fentanyl or pharmaceutically
    acceptable salt thereof across said oral mucosa
    , at least one pH adjusting
    substance, and wherein said amount of said at least one effervescent agent is
    between about 5% by weight and about 80% by weight; and buccally, sublingually
    or gingivally administrating said solid oral dosage form to said mammal.

    are
    representative (emphases in original
    opinion).

    The
    formulation involved orally administered fentanyl designed to use the mucosal
    membranes of the mouth and oral cavity to introduce the drug into the body
    (thus avoiding the gastrointestinal tract).  The claims of the patents-in-suit were directed to the use of effervescent
    agents as penetration enhancers to promote uptake of fentanyl (or other drugs)
    into the oral mucous membranes.  In
    addition, the patent claims included in the formulation a "pH adjusting
    substance" that worked together with the effervescent agent in promoting
    drug uptake.  As explained in the
    Federal Circuit opinion, effervescence agents falling within the scope of the
    patent claims included "at least one compound that evolves a gas,"
    typically via a chemical reaction between the agent and water (saliva) in the
    mouth.  These agents included an acid
    source, such as citric acid, and a carbon dioxide source (such as carbonate or
    bicarbonate), wherein the reaction resulted in carbon dioxide production.  The pH adjusting substance was included
    because the effervescence reaction reduces the pH of saliva in the mouth, which
    can affect the solubility of fentanyl or other drug in the formulation.

    Watson PharmaceuticalsThe District Court found that Watson's ANDA
    product did not infringe, based on its construction of the claim term "at
    least one [saliva activated] effervescent agent in an amount sufficient to
    increase absorption . . . across [the] oral mucosa."  In the District Court's construction, the
    effervescent agent was required to be activated by contact with saliva, which
    raised the question of whether the potassium bicarbonate and mannitol
    components of Watson's accused infringing generic drug reacted to have this
    effect.  (Cephalon's Fentora® product
    contained fentanyl citrate, mannitol, sodium starch glycolate, magenesium
    stearate, citric acid, sodium bicarbonate, and sodium carbonate, wherein the
    sodium bicarbonate and citric acid are an effervescent couple that react to
    evolve carbon dioxide, whereas Watson's generic version contained fentanyl
    citrate and mannitol, sodium starch glycolate, potassium bicarbonate, and
    magnesium stearate.)  The District Court
    did not credit Cephalon's expert's testimony that mannitol was the acidic
    component of an effervescent agent, despite testimony that the higher the
    mannitol concentration levels the more acidic a water solution containing it, in part because Cephalon provided no
    evidence of the effect of mannitol on saliva.  Rather, the Court determined that Watson's
    expert was more persuasive when he testified that "the important piece of information that
    is missing [in this case] is what the potential or alleged acidity of mannitol
    in either artificial saliva or, even more important, in the human mouth . . .
    and there is no evidence that mannitol would be acidic under those conditions."

    Regarding invalidity, the District Court
    construed the term "effervescent agent" to require that "at
    least one compound
    that evolves gas by means of an effervescent reaction"
    (emphasis in original opinion) and further determined that the claim language
    required the "effervescent agent" to be a single compound.  Watson argued that the "effervescent
    agent" is disclosed in the Cephalon patents as comprising a "couple"
    (the acidic compound and the carbon dioxide-releasing compound) and thus that
    the term should require "a combination of two or more compounds that
    evolve gas."  Under the District Court's construction, the soluble acid
    source must be in a separate dosage form from the effervescent agent itself and
    that these separate dosage forms be co-administered.  Using this construction, the District Court
    found that the patents-in-suit were not enabling, being devoid of any
    disclosure relating to co-administration of two separate dosage forms and thus
    requiring undue experimentation.

    The Federal Circuit reversed in part and
    affirmed in part, in an opinion by Judge Wallach joined by Judges Bryson and
    Reyna.  The opinion affirmed the finding
    of no infringement on the grounds that there was no clear error by the District Court in deciding in Watson's favor on this issue.  With regard to invalidity, the panel noted
    that the District Court erred by reasoning that Watson had raised a prima facie case of non-enablement
    against Cephalon's claims, which Cephalon did not rebut at trial.  The panel, citing Morton Int'l, Inc. v.
    Cardinal Chem. Co.
    , 5 F.3d 1464, 1469–70 (Fed. Cir. 1993), invoked the
    statutory presumption of validity in asserting that this was error, and that
    the challenger (Watson) bore the burden of proving invalidity by clear and
    convincing evidence.  Turning to this
    question, the panel considered the District Court's reliance on Watson's
    proffered expert testimony that amounted (according to the Federal Circuit) to
    mere "ipse dixit" opinion
    that did not rise to the level of clear and convincing evidence.  And the District Court's interpretation of
    Cephalon's expert's testimony regarding whether experimentation per se would be required to satisfy the
    enablement portion of the statute in view of the District Court's claim
    construction was also improper, according to the opinion, because the mere fact
    of experimentation is not the standard; the question is whether whatever
    experimentation that may be required is undue.  Here, the Federal Circuit considered Watson's showing that the extent of
    experimentation that might be required was undue to be insufficient to arise to
    the level of clear and convincing evidence.  Specifically, the panel stated that "[u]nsubstantiated statements
    indicating that experimentation would be 'difficult' and 'complicated are not
    sufficient" to establish undue experimentation.  Thus, Watson had failed to establish
    non-enablement as a matter of law and the panel reversed.

    Cephalon, Inc. v. Watson
    Pharmaceuticals, Inc
    .
    (Fed. Cir. 2013)

    Panel: Circuit Judges Reyna, Bryson, and Wallach
    Opinion
    by Circuit Judge Wallach

  • By Donald Zuhn

    USPTO SealIn a press release
    issued earlier today, the U.S. Patent and Trademark Office announced that
    examination guidelines and the final rule for implementing the
    first-inventor-to-file (FITF) provisions of the Leahy-Smith America Invents Act
    (AIA) would be published in the Federal Register on February 14 — thirty days
    before the FITF provisions take effect on March 16, 2013.  According to the Office's announcement, the
    move to a FITF system is "one of the hallmarks of the AIA," and
    constitutes "a major step towards harmonization of the U.S. patent system with
    those of the United States' major trading partners, allowing greater consistency
    in the prosecution and enforcement of U.S. patents."

    Although the two notices
    will not be published in the Federal Register until Thursday, unpublished copies
    of the "Examination Guidelines for Implementing the First Inventor To File
    Provisions of the Leahy-Smith America Invents Act" can be found here,
    and the final rule entitled "Changes To Implement the First Inventor To
    File Provisions of the Leahy-Smith America Invents Act" can be found here.  The unpublished notices come in at 120 and
    160 pages, respectively.

    The Office's announcement
    indicates that the examination guidelines "set[] forth the agency's
    interpretation of how the first-inventor-to-file provision alters novelty and
    obviousness determinations for an invention claimed in a patent
    application," and in particular "inform the public and patent
    examiners how the AIA's changes to the novelty provisions of law alter the
    scope of what is prior art to a claimed invention and how the new grace period
    operates."  Acting Under Secretary
    of Commerce for Intellectual Property and Acting Director of the USPTO Teresa
    Stanek Rea stated that the "[m]igration to a first-inventor-to-file system
    will bring greater transparency, objectivity, predictability, and simplicity to
    patentability determinations and is another step towards harmonizing U.S.
    patent law with that of other industrialized countries."

    The press release also
    noted the Office would be providing more information on the
    first-inventor-to-file final rules and examination guidelines at a public
    training session to be held on Friday March 8, 2013 at the Office's
    headquarters in Alexandria, VA.  The
    training session will be webcast (with details about the webcast to be announced).

    Given the length of the two
    notices, we will present an overview of the final rule today and will address
    the examination guidelines in a subsequent post.  The final rule notes that AIA § 3 amends U.S.
    patent law to:

    (1) convert the U.S. patent system from a
    "first to invent" system to a "first inventor to file"
    system;
    (2) treat U.S. patents and
    U.S. patent application publications as prior art as of their earliest
    effective filing date, regardless of whether the earliest effective filing date
    is based upon an application filed in the United States or in another country;
    (3) eliminate the
    requirement that a prior public use or sale be "in this country" to
    be a prior art activity; and
    (4) treat commonly owned or
    joint research agreement patents and patent application publications as being
    by the same inventive entity for purposes of 35 U.S.C. 102, as well as 35
    U.S.C. 103.

    While the above changes
    take effect on March 16, 2013, the final rule points out that the changes
    "apply only to certain applications filed on or after March 16, 2013."  This is due to the effective date provision
    of AIA § 3(n)(1), which states that:

    Except as
    otherwise provided in this section, the amendments made by this section shall
    take effect upon the expiration of the 18-month period beginning on the date of
    the enactment of this Act [i.e.,
    March 16, 2013], and shall apply to any application for patent, and to any
    patent issuing thereon, that contains or contained at any time–
        (A) a claim to a claimed
    invention that has an effective filing date as defined in section 100(i) of
    title 35, United States Code, that is on or after the effective date described in
    this paragraph; or
        (B) a specific reference
    under section 120, 121, or 365(c) of title 35, United States Code, to any
    patent or application that contains or contained at any time such a claim.

    AIA § 3(a) defines the
    "effective filing date" for a claimed invention in a patent or
    application for patent as:

    (A) if subparagraph (B) does not apply, the
    actual filing date of the patent or the application for the patent containing a
    claim to the invention; or
    (B) the filing date of the
    earliest application for which the patent or application is entitled, as to
    such invention, to a right of priority under section 119, 365(a), or 365(b) or to
    the benefit of an earlier filing date under section 120, 121, or 365(c).

    According to the final rule
    notice, the rules of practice in title 37 of the Code of Federal Regulations (C.F.R.)
    are being revised "for consistency with, and to address the examination
    issues raised by, the changes in section 3 of the AIA."  Among the changes to the rules of practice
    are the following:

    • Where a U.S. patent or
    U.S. patent application publication has a prior art effect as of the filing
    date of a foreign priority application, a certified copy of the foreign
    application or an interim copy of the foreign application must be filed within
    the later of four months from the actual filing date of the application filed
    under 35 U.S.C. 111(a) or sixteen months from the filing date of the prior
    foreign application.  Under some
    circumstances, the above requirement will not apply — e.g., the foreign application was filed in a foreign intellectual
    property office participating with the USPTO in a bilateral or multilateral
    priority document exchange agreement (such offices currently consist of the
    European Patent Office (EPO), the Japan Patent Office (JPO), the Korean
    Intellectual Property Office (KIPO), and the World Intellectual Property
    Organization (WIPO)).

    • For a nonprovisional
    application filed on or after March 16, 2013 that claims the benefit of the
    filing date of an application (i.e.,
    foreign, provisional, or nonprovisional application, or international
    application designating the U.S.) filed prior to March 16, 2013, wherein the nonprovisional
    application filed on or after March 16, 2013 contains, or contained at any time,
    a claim to a claimed invention that has an effective filing date on or after
    March 16, 2013, the applicant must provide a statement to that effect.  Such statement must be provided within the
    later of:

    (a) four months from the
    actual filing date of the later-filed application,
    (b) four months from the
    date of entry into the national stage in an international application,
    (c) sixteen months from the
    filing date of the prior-filed application, or
    (d) the date that a first
    claim to a claimed invention that has an effective filing date on or after March
    16, 2013 is presented in the application.

    According to the final
    rule, "[t]his procedure will permit the Office to readily determine
    whether the nonprovisional application is subject to the changes to 35 U.S.C.
    102 and 103 in the AIA."

    As a result of public input
    regarding the Office's notices of proposed rulemaking and proposed examination
    guidelines, the Office made some changes to the Office's proposed rules of
    practice pertaining to the FITF provisions of the AIA.  With respect to the requirement to submit a
    certified copy of the foreign application, the final rule indicates that the
    requirement will not apply in some circumstances, and that applicants will be permitted to
    submit an interim copy within the required time frame and then submit a
    certified copy before a patent is granted.

    With respect to the
    requirement that the applicant provide a statement regarding the effective
    filing date of the claims in an application, the final rule indicates that "a
    statement is required only if a transition application contains, or contained
    at any time, a claim to a claimed invention that has an effective filing date
    on or after March 16, 2013."  The
    final rule defines a "transition" application as "a
    nonprovisional application filed on or after March 16, 2013, that claims
    priority to, or the benefit of the filing date of an earlier application (i.e.,
    foreign, provisional, or nonprovisional application, or an international application
    designating the United States) filed prior to March 16, 2013."  The proposed rulemaking had also required a
    statement if a transition application discloses subject matter not also
    disclosed in the prior-filed foreign, provisional, nonprovisional application,
    or international application designating the U.S. but did not ever contain a
    claim to a claimed invention that has an effective filing date on or after
    March 16, 2013.  The final rule
    eliminates the requirement to make this latter statement.

    As for the changes made to
    the proposed rules, the Office states that it "sought to address the
    concerns of its stakeholders as expressed in the public comment, and plans to
    seek additional public comment on the rules of practice pertaining to the first
    inventor to file provisions of section 3 of the AIA after the Office and the
    public have gained experience with the rules of practice pertaining to the
    first inventor to file provisions in operation."

    In addition to a discussion
    of the specific rules changes (on pages 17-59 of the notice), the final rule
    also addresses the nearly seventy written comments the Office received in
    response to its notice of proposed rulemaking (primarily on pages 60 to 106).  Although several comments opposed or expressed
    concerns with the statement requirements in the proposed rulemaking, the final
    rule maintains the requirement to provide a statement in a transition
    application "if the application contains, or contained at any time, a
    claim to a claimed invention that has an effective filing date on or after
    March 16, 2013."  A statement is no
    longer required if a transition application discloses subject matter not also
    disclosed in the prior-filed foreign, provisional, nonprovisional application,
    or international application designating the U.S.

    For the statement that is
    still required, the final rule states that "this statement is needed
    to assist the Office in determining whether the application is subject to AIA
    35 U.S.C. 102 and 103 (an AIA application) or pre-AIA 35 U.S.C. 102 and 103 (a
    pre-AIA application)."  The final
    rule asserts that "if the Office must determine on its own the effective filing
    date of every claim ever presented in an application filed on or after March
    16, 2013, that claims priority to or the benefit of an application filed prior
    to March 16, 2013, examination costs will significantly increase."  The final rule notes that applicants will not
    have to indicate the specific claims that have a post March 16, 2013 effective
    filing date, or the effective filing date of each claim, as the Office does not
    need this information to determine whether the application is an AIA
    application or a pre-AIA application.  In
    addition, the final rule specifies that "no statement is required if the
    applicant reasonably believes on the basis of information already known to the
    individuals identified in § 1.56(c) that the nonprovisional application does
    not, and did not at any time, contain a claim to a claimed invention that has
    an effective filing date on or after March 16, 2013."

    In response to several
    comments regarding the mechanism for making the statement, the Office noted
    that it is revising the application data sheet to include a check box to allow
    applicants to easily indicate whether a transition application contains or ever
    contained a claim to a claimed invention having an effective filing date that
    is on or after March 16, 2013.

    A number of the Office's other responses were particularly enlightening.  For example, in response to a comment
    that questioned how long the statement requirement would be applicable, the
    Office responded that (emphasis added):

    The requirement
    for a statement for certain transition applications in §§ 1.55 and 1.78 as
    adopted in this final rule is implicated whenever an application filed on or after
    March 16, 2013, claims a right of priority to or the benefit of the filing date
    of an application filed prior to March 16, 2013.  This
    requirement, however, should not affect continuation or divisional applications
    because a continuation or divisional application discloses and claims only
    subject matter also disclosed in the prior-filed application.
      See MPEP § 201.06 (defines divisional
    application), and § 201.07 (defines continuation application).  In addition, an application claiming a right
    of priority to a foreign application or the benefit of a provisional
    application must be filed within one year of the filing date of the foreign or
    provisional application.  See 35
    U.S.C. 119(a) and 119(e).  In view of the
    one-year filing period requirement in 35 U.S.C. 119(a) and 119(e), this requirement
    should not affect applications filed after May 16, 2014, that claim only a right
    of priority to one or more foreign applications, or that only claim the benefit
    of one or more provisional applications (the critical date is May 16, 2014,
    rather than March 16, 2014, in view of the
    changes to 35 U.S.C. 119 in section 201(c) of the [] Patent Law Treaties
    Implementation Act of 2012
    , Pub. L. 112-211 (2012)).  Therefore,
    after March 16, 2014, (or May 16, 2014, the statement required by §§ 1.55 and
    1.78 as adopted in this final rule for certain transition applications should
    be necessary only in certain continuation-in-part applications
    .

    In response to several
    comments requesting that the Office clarify that an amendment to the claims
    that lacks support under 35 U.S.C. 112(a) does not convert that application
    into an AIA application, the Office responded as follows (emphasis added):

    For an application filed on or after March
    16, 2013, that discloses and claims only subject matter also disclosed in a
    previously filed pre-AIA application to which the application filed on or after
    March 16, 2013, is entitled to priority or benefit under 35 U.S.C. 119, 120,
    121, or 365, an amendment (other than a preliminary amendment filed on the same
    day as such application) seeking to add a claim to a claimed invention that is
    directed to new matter would not convert the application into an AIA
    application.  35 U.S.C. 132(a) prohibits the introduction of new matter into the
    disclosure and thus an application may not actually "contain" a claim
    to a claimed invention that is directed to new matter
    .  The Office notes that the MPEP sets forth the
    following process for treating amendments that are believed to contain new
    matter: (1) a new drawing should not be entered if the examiner discovers that
    the drawing contains new matter (MPEP § 608.02); and (2) amendments to the
    written description or claims involving new matter are ordinarily entered, but
    the new matter is required to be cancelled from the written description and the
    claims directed to the new matter are rejected under 35 U.S.C. 112(a) (MPEP §
    608.04).  This process for treating amendments
    containing new matter is purely an administrative process for handling an
    amendment seeking to introduce new matter into the disclosure of the invention
    in violation of 35 U.S.C. 132(a) and resolving disputes between the applicant
    and an examiner as to whether a new drawing or amendment to the written
    description or claims would actually introduce new matter.

    In response to one comment
    suggesting that the rules should provide recourse in the situation where there
    has been an inadvertent addition of a claim, or a specific reference to a
    prior-filed application, that causes the application to be subject to AIA 35
    U.S.C. §§ 102 and 103, the Office responded as follows (emphasis added):

    There is no provision in the AIA for an application
    (or any patent issuing thereon) that contains, or contained at any time, such a
    claim or specific reference to be subject to pre-AIA 35 U.S.C. 102 and 103
    instead of AIA 35 U.S.C. 102 and 103 on the basis of the claim or specific
    reference being submitted by inadvertence . . . .  As discussed previously, however, for an
    application filed on or after March 16, 2013, that discloses and claims only
    subject matter also disclosed in a previously filed pre-AIA application to
    which the application filed on or after March 16, 2013, is entitled to priority
    or benefit under 35 U.S.C. 119, 120, 121, or 365, an amendment (other than a preliminary amendment filed on
    the same day as such application
    ) seeking to add a claim to a claimed
    invention that is directed to new matter would not convert the application into
    an AIA application.

    In response to a related
    comment suggesting that the Office provide an applicant with the opportunity to
    cancel any claims to a claimed invention having an effective filing date before
    March 16, 2013 from the application, and file a divisional application directed
    to the cancelled subject matter to permit applicants to have the claims in the divisional
    application examined under pre-AIA 35 U.S.C 102 and 103, the Office responded as follows (emphasis added):

    If an application on filing contains at least one claim
    having an effective filing date before March 16, 2013, and at least one claim
    having an effective filing date on or after March 16, 2013, the application will be examined under AIA
    even if the latter claims are cancelled

    However, if a pre-AIA parent application is pending and an applicant
    inadvertently files a continuing application with claims having an effective filing
    date on or after March 16, 2013, the applicant could file a continuation or divisional
    application from the pre-AIA parent application without any claim to the benefit
    of the AIA application and without any claim to a claimed invention having an effective
    filing date on or after March 16, 2013.  In
    this situation, the continuation or divisional application would be examined as
    a pre-AIA application under pre-AIA 35 U.S.C. 102 and 103.

    The above responses from
    the Office suggest that if an applicant wants to have a transition application
    examined as a pre-AIA application under pre-AIA 35 U.S.C. §§ 102 and 103, the
    applicant must include claims directed only to subject matter disclosed in
    a previously filed pre-AIA application. 
    For this reason, applicants may also want to consider filing only one claim
    with a transition application.  In view
    of the Office's responses, any other claims or claim amendments should be presented
    after
    the filing date and not in a preliminary amendment filed on the same day as the
    transition application.  This is because
    claim amendments or new claims presented in an amendment other than a preliminary amendment filed on the same day as such
    application
    that are not supported by a pre-AIA application would be
    treated as new matter.  As the Office indicates
    in the final rule notice, "an application may not actually 'contain' a
    claim to a claimed invention that is directed to new matter," and
    therefore, "a claim to a claimed invention that is directed to new matter
    would not convert the application into an AIA application."  The final rule makes clear that if an
    application on filing contains at least one claim having an effective
    filing date on or after March 16, 2013, the application cannot be examined as a
    pre-AIA application under pre-AIA 35 U.S.C. §§ 102 and 103 simply by cancelling
    the claim having an effective filing date on or after March 16, 2013.  The final rule notice also makes clear that
    if a claim having an effective filing date on or after March 16, 2013 is inadvertently
    presented on filing, the application cannot be examined as a pre-AIA application
    under pre-AIA 35 U.S.C. §§ 102 and 103.

    The final rule concludes
    with a discussion of rulemaking considerations (pages 106-128) and the text of
    the changed rules (pages 128-160).

  • By Donald Zuhn

    Department of Justice (DOJ) SealIn an amicus brief filed last month in Association for Molecular Pathology v. Myriad Genetics, Inc., the
    United States asks the Supreme Court to affirm the judgment of the Federal
    Circuit that cDNA is patent-eligible and reverse the judgment of the appellate
    court that isolated but otherwise unmodified DNA is patent-eligible.  The government argues that:

    Synthesized genetic materials such as cDNA
    are patent-eligible subject matter because they do not occur in nature but
    instead are the product of significant human creativity.  By contrast, isolated but otherwise
    unmodified DNA is not patent-eligible. 
    The public's ability to study and use native DNA would be unduly
    compromised if changes caused by the extraction of naturally-occurring substances
    from their native environments were sufficient to trigger
    patent-eligibility.  And while the
    process of isolating DNA entails physical changes, those changes do not
    significantly alter the structure or function of the relevant DNA segments.

    The government explains
    that "[c]reating cDNA requires significant manipulation and alteration of
    naturally occurring genetic materials rather than simply the extraction of those
    materials from their native environment," adding that "[i]ssuing patents
    on cDNA creates no risk of preempting other uses of the raw materials from
    which cDNA is created."  However,
    the brief argues that "isolated but otherwise unmodified genomic DNA" molecules
    — like DNA molecules claimed in Myriad's patents — are not patent eligible
    because "[t]he process of isolation does not transform those molecules
    into human-made inventions."  Thus,
    "[i]solated DNA . . . is not patent-eligible because it has merely been
    "isolated" — i.e., extracted
    from its cellular environment and separated from extraneous material — rather
    than significantly altered by human intervention."

    To prevent claims to
    isolated DNA from preempting the use of the underlying native DNA, the
    government contends that "the mere act of culling a natural product from
    its environment to exploit its preexisting natural qualities — however useful
    those qualities may be — should be treated as insufficient to create
    patent-eligible subject matter."  In
    explaining the government's change in position on DNA molecules — before the
    district court, the government had noted that "the USPTO's position" on
    whether "DNA molecules" are patent-eligible "remains as set
    forth in its utility guidelines" — the brief states that:

    The district court's judgment in this case,
    however, prompted the United States to reevaluate whether such patents are consistent
    with the settled principle that patent protection does not extend to products
    of nature.  Based on that review, the
    United States concluded that, although the PTO has properly issued patents on
    cDNA and other synthesized genetic materials, isolated DNA is not patent-eligible
    subject matter.

    In reassessing its
    position, the government looked to the Supreme Court's decision in Mayo
    Collaborative Services v. Prometheus Laboratories, Inc
    .  Although Mayo
    concerned process claims rather than composition claims, the government argues
    that the decision "provides
    useful guidance for determining whether particular modifications to a naturally
    occurring substance are sufficient
    to render the modified substance patent-eligible."  And while "[n]ot every nuance of Mayo's
    process-claim analysis applies
    directly to patents directed to compositions of matter," the brief argues that "the law-of-nature and
    product-of-nature exceptions to
    Section 101 do, however, reflect the same basic principle:  a person
    should not receive a patent for
    simply discovering the existence and useful properties of something that already exists in nature."

    In contrast with isolated
    but otherwise unmodified genomic DNA, the government argues for the
    patent-eligibility of cDNA molecules.  In
    particular, the government states that:

    With exceptions not relevant here (such as
    retroviruses that use cDNA-like structures to replicate themselves), cDNA
    molecules generally do not occur in nature, either in isolation or as
    contiguous sequences contained within longer natural molecules.   . . .  To create cDNA, a scientist therefore does
    not simply remove existing cDNA from its natural environment.

    According to the
    government, "cDNA is thus analogous to the genetically modified bacterium
    in Chakrabarty."  Countering the petitioners' argument that
    cDNAs are not patent-eligible because they contain the same protein-coding
    information as DNA in the body, the government notes that:

    [T]he properties of any product originally derived
    from nature, including the bacterium in Chakrabarty,
    can be traced to the operation of natural principles.  While the coding properties of cDNA
    molecules' exons are determined by nature, those properties operate within a
    molecule (a DNA strand with the regulatory and intron regions spliced out) that
    does not exist in nature and that has increased utility relative to naturally occurring
    genetic materials or isolated but unmodified DNA.  The fact that a cDNA incorporates nucleotide sequences
    whose significance is derived from nature therefore does not mean that the
    molecule as a whole is a product of nature.

    As for Myriad's composition
    claims, the brief points out that "[a]bsent the 'isolated' limitation,
    claim 1 of the '282 patent, for example, would encompass the native BRCA1 gene
    in the human body, which 'cod(es) for a BRCA1 polypeptide'," and that
    "[i]n their pre-isolation form — i.e.,
    as a portion of a larger native gene within a cell — the BRCA sequences clearly
    are products of nature."

    In addressing Myriad's
    reliance on early lower-court decisions upholding patents on natural compounds
    that have been so refined and purified through human intervention as to become
    a substance different "in kind" from the natural product, the
    government explains that:

    Those decisions indicate that certain
    purification processes — i.e.,
    processes that involve human manipulation of a substance that has been removed
    in impure form from its natural environment — may sometimes result in an
    altered substance that has structural features and⁄or operative properties that
    render the product markedly different from the impure substance that occurs in
    nature.  For instance, cDNA could be
    thought of as a "purified" gene, as it incorporates into a single
    contiguous, synthetic molecule only the coding regions of the naturally
    occurring gene.  But isolated DNA
    reflects no such transformation. 
    [Rather], isolated DNA has simply been removed from its natural
    environment within the human body, with minor structural changes that have no
    effect on its intrinsic properties . . . . 
    To label the process of removing DNA from a cell
    "purification," and to hold the culled DNA segments patent-eligible
    on that ground, would "make patent eligibility depend simply on the
    draftsman's art," without reference to the nature and extent of the
    underlying transformation, or the consequences for the public's ability to use
    the underlying substance.

    In response to the argument
    that Congress' failure to amend U.S. patent law to prohibit the patenting of
    isolated DNA implies congressional approval of such patents, the government argues that "[i]n these circumstances, Congress's failure to enact
    legislation abrogating the PTO's practice of issuing isolated DNA patents does
    not give rise to any inference of congressional endorsement of the PTO's
    interpretation."  The brief notes
    that "although bills relating to patents on genetic materials have occasionally
    been introduced in Congress, there is little 'evidence that Congress considered
    . . . the precise issue presented before the Court.'"  In particular, the government explains that
    "[b]ecause 'Congress takes no governmental action except by legislation,'
    and bills can be proposed and rejected for any number of reasons, none of these
    bills raises any inference that Congress approved the PTO's practice of granting
    patents on isolated DNA."

    As for the "concern
    that invalidating patents on isolated DNA would unduly disturb the 'settled
    expectations' of biotechnology patent holders and investors," the
    government notes that "[a] patentee's legitimate expectations . . . are always tempered by the possibility that a court could subsequently disagree
    with the PTO and hold that the patent is invalid under Section 101 or other
    provisions of the Patent Act." 
    Finally, with respect to the argument that isolated DNA should remain
    patent-eligible in order to encourage biotech innovation, the government acknowledges
    that "[t]he prospect of patent protection for isolated genomic DNA has
    undoubtedly encouraged valuable discoveries," but counters that "[a]s
    between the reliance interests of patent holders whose research efforts may have
    been prompted in part by the PTO'ss patenting standards, and the public
    interest in avoiding undue restrictions imposed by patents that effectively
    preempt natural laws and substances, the interest of the public has
    consistently been given precedence."


    Patent Docs
    plans to review a number of the briefs filed in this case,
    including the briefs on the merits filed by the petitioners and the
    respondents, as well as several of the amicus
    briefs that were filed.  According to the
    docket for this case on the Supreme Court website, amicus briefs have been filed by the Juhasz Law Firm, P.C., the
    American Medical Association et al., GeneDx
    and Law Professors, the National Women's Health Network et al., Federation Internationale Des Conseils En Propriete
    Intellectuelle, CLS Bank International, the United States, the International Center
    for Technology Assessment et al., Genformatic
    LLC, Academics in Law, Medicine, Health Policy and Clinical Genetics, James D.
    Watson, Ph.D., Fifteen Law Professors, Sigram Schindler
    Beteiligungsgesellschaft mbH, the AARP, Kali N. Murray and Erika R. George, the
    Institute of Professional Representatives Before the European Patent Office
    (EPI), the Ethics & Religious Liberty Commission of the Southern Baptist
    Convention and Prof. D. Brian Scarnecchia, Eric S. Lander, the American
    Intellectual Property Law Association, the Canavan Foundation et al., Professor Eileen M. Kane, Knowledge
    Ecology International, and InVitae Corporation.

    On Monday, the Supreme Court set argument for this case for April 15,
    2013.

  • By Donald Zuhn

    USPTO SealIn December, the U.S.
    Patent and Trademark Office published a notice in the Federal Register (77 Fed.
    Reg. 72830
    ) seeking public feedback on Request for Continued Examination
    (RCE) practice.  The notice provided a
    series of questions for which the Office specifically was seeking comment:

    (1) If within your
    practice you file a higher or lower number of RCEs for certain clients or areas
    of technology as compared to others, what factor(s) can you identify for the
    difference in filings
    ?

    (2) What change(s), if
    any, in Office procedure(s) or regulation(s) would reduce your need to file
    RCEs
    ?

    (3) What effect(s), if
    any, does the Office’s interview practice have on your decision to file an RCE
    ?

    (4) If, on average,
    interviews with examiners lead you to file fewer RCEs, at what point during
    prosecution do interviews most regularly produce this effect
    ?

    (5) What actions could
    be taken by either the Office or applicants to reduce the need to file evidence
    (not including an IDS) after a final rejection
    ?

    (6) When considering how
    to respond to a final rejection, what factor(s) cause you to favor the filing
    of an RCE
    ?

    (7) When considering how
    to respond to a final rejection, what factor(s) cause you to favor the filing
    of an amendment after final (37 CFR 1.116)
    ?

    (8) Was your after final
    practice impacted by the Office’s change to the order of examination of RCEs in
    November 2009
    ? If so, how?

    (9) How does client
    preference drive your decision to file an RCE or other response after final
    ?

    (10) What
    strategy/strategies do you employ to avoid RCEs
    ?

    (11) Do you have other
    reasons for filing an RCE that you would like to share
    ?

    According to the notice, feedback
    regarding RCE practice could be provided by submitting written comments by
    e-mail to rceoutreach@uspto.gov; by regular mail to the United States Patent
    and Trademark Office, Mail Stop Comments — Patents, Office of Commissioner for
    Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of
    Raul Tamayo; or by using the web-based collaboration tool IdeaScale®, which allows users
    to post comments, view and respond to others' comments, and indicate agreement
    or disagreement with particular comments.  At the time the notice was
    published, the deadline of submitting comments was February 4, 2013.  However, as indicated on the Office's RCE
    Outreach webpage
    ,
    the deadline for submitting comments has now been extended to March 11, 2013.

    In addition to requesting
    comments on RCE practice, the notice also indicated that the Office would be
    holding five roundtables on the topic. 
    The dates and locations of the roundtables have now been announced:

    • February 20 — Santa
    Clara University School of Law, Santa Clara, CA — Roundtable from 9:00 to 11:00
    am (PT) and focus session from 2:00 to 4:00 pm (PT)

    • February 26 — Southern Methodist
    University, Dedman School of Law, Dallas, TX — Roundtable from 9:00 to 11:00
    am (CT) and focus session from 2:00 to 4:00 pm (CT)

    • February 28 — New York
    University School of Law, New York, NY — Roundtable from 9:00 to 11:00 am (ET)
    and focus session from 2:00 to 4:00 pm (ET)

    • March 6 — USPTO
    Headquarters, Alexandria, VA — Roundtable from 9:00 to 11:00 am (ET) and focus
    session from 2:00 to 4:00 pm (ET)

    • March 8 — Chicago-Kent
    College of Law, Chicago, IL — Roundtable from 9:00 to 11:00 am (CT) and focus
    session from 2:00 to 4:00 pm (CT)

    The RCE Outreach webpage includes
    an invitation to
    participate
    in the roundtable and focus sessions on RCE practice.  According to the invitation, the Office's
    current analysis of RCE practice is aimed at "learn[ing] more about the root causes for RCE filings as a
    basis for the consideration and design of procedural modifications and
    educational initiatives to promote compact prosecution."  The Office notes that "[t]he purpose of
    this effort is not to eliminate RCE practice, or in any way disadvantage it,
    [b]ut rather, the purpose is to enable applicants to use RCE practice when
    needed, while avoiding it where equal or better options are available."  The roundtable/focus session portion of the
    RCE Outreach program consists of a series of roundtable discussions (of 75-100
    people) and focus sessions (of 10-15 people) to "share ideas, feedback,
    experiences, and insights on RCE related prosecution strategies."

    Those interested in
    participating in any of the roundtables or focus sessions can register by sending an e-mail message to rceoutreach@uspto.gov and
    providing the following information:  (1)
    Your name, title, and if applicable, company or organization, address, phone
    number, and e-mail address; (2) which event you wish to attend; (3) which
    session you wish to attend (i.e.,
    roundtable and/or focus session); and (4) if you wish to make an oral
    presentation at the roundtable, the specific topic or issue to be addressed and
    the approximate desired length of your presentation.  Registration for the roundtables/focus
    sessions is requested by the following dates: 
    Santa Clara, CA — February 15; Dallas, TX — February 22; New York, NY
    –February 22; Alexandria, VA — March 1; Chicago, IL — March 1.

    Although the Office has
    implemented several programs aimed at reducing the RCE backlog (which currently
    numbers more than 103,000; see
    Patents Dashboard), the Office's
    request for comments and its announcement of roundtables/focus sessions on the
    topic suggests that the Office may now be turning to its stakeholders for ways to decrease the RCE backlog.  Of course, the Office's efforts to decrease the backlog by raising the cost of filing a first RCE to $1,200, and further raising the cost of filing subsequent RCEs to $1,700 (see "USPTO Publishes Final Rule Setting Patent Fees"), despite the fact that the Patent Public Advisory Committee (PPAC) called such fees "illogical" (see "PPAC Issues Report on USPTO Patent Fees Proposal"), might leave some stakeholders with doubts.

    Additional information regarding the Office's
    efforts to address the RCE backlog can be found on the RCE Outreach
    webpage
    and in the
    Office's Federal Register notice
    (see
    also
    "USPTO Seeks Public Feedback on RCE Practice").

  • By Sherri Oslick

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

    Cadence
    Pharmaceuticals, Inc. et al. v. Sandoz Inc.

    3:13-cv-00733;
    filed February 5, 2013 in the District Court of New Jersey

    • Plaintiffs: 
    Cadence Pharmaceuticals, Inc.; SCR Pharmatop
    • Defendant: 
    Sandoz Inc.

    Cadence
    Pharmaceuticals, Inc. et al. v. Sandoz, Inc.

    3:13-cv-00278;
    filed February 4, 2013 in the Southern District of California

    • Plaintiffs: 
    Cadence Pharmaceuticals, Inc.; SCR Pharmatop
    • Defendant: 
    Sandoz, Inc.

    The
    complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,028,222 ("Stable
    Liquid Paracetamol Compositions, and Method for Preparing the Same,"
    issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous
    Formulations of Oxidation-Sensitive Active Principles," issued January 31,
    2006), both licensed to Cadence, following a Paragraph IV certification as part
    of Sandoz's filing of an ANDA to manufacture a generic version of Cadence's
    Ofirmev® (acetaminophen injection, used for the management of mild to moderate
    pain, the management of moderate to severe pain with adjunctive opioid
    analgesics, and the reduction of fevers). 
    View the SD California complaint here.


    Purdue Pharma
    L.P. et al. v. Watson Laboratories, Inc. et al.

    1:13-cv-00762;
    filed February 4, 2013 in the Southern District of New York

    • Plaintiffs: 
    Purdue Pharma L.P.; Grunenthal GmbH
    • Defendants: 
    Watson Laboratories, Inc.; Andrx Labs, L.L.C.

    Infringement
    of U.S. Patent No. 8,309,060 ("Abuse-Proofed Dosage Form," issued
    November 13, 2012) following a Paragraph IV certification as part of Watson's
    filing of an ANDA to manufacture a generic version of Purdue Pharma's
    OxyContin® (controlled release oxycodone hydrochloride, used to treat
    pain).  View the complaint here.


    Purdue Pharma
    L.P. et al. v. IMPAX Laboratories, Inc.

    1:13-cv-00763;
    filed February 1, 2013 in the Southern District of New York

    • Plaintiffs: 
    Purdue Pharma L.P.; Grunenthal GmbH
    • Defendant: 
    IMPAX Laboratories, Inc.

    Infringement
    of U.S. Patent Nos. 8,114,383 ("Abuse-Proofed Dosage Form," issued
    February 14, 2012) and 8,309,060 (same title, issued November 13, 2012)
    following a Paragraph IV certification as part of Impax's filing of an ANDA to
    manufacture a generic version of Purdue Pharma's OxyContin® (controlled release
    oxycodone hydrochloride, used to treat pain). 
    View the complaint here.


    Merck Sharp
    & Dohme Corp. et al. v. APP Pharmaceuticals Inc. et al.

    1:13-cv-00166;
    filed January 31, 2013 in the District Court of Delaware

    • Plaintiffs: 
    Merck Sharp & Dohme Corp.; Millennium Pharmaceuticals Inc.
    • Defendants: 
    APP Pharmaceuticals Inc.; APP Pharmaceuticals LLC; Fresenius Kabi
    Pharmaceuticals Holding Inc.; Fresenius Kabi USA Inc.; Fresenius Kabi USA
    LLC

    Infringement
    of U.S. Patent Nos. 5,807,825 ("Platelet Aggregation Inhibitors,"
    issued September 15, 1998), 5,747,447 ("Stable Polypeptide Composition,"
    issued May 5, 1998) and 5,968,902 ("Platelet Aggregation Inhibitors,"
    issued October 19, 1999), licensed to Merck, following a Paragraph IV
    certification as part of APP's filing of an amendment to their ANDA (adding an
    additional dosage form) to manufacture a generic version of Merck's Integrilin®
    (eptifibatide injection, used to treat acute coronary syndrome).  View the complaint here.