•     By Sherri Oslick

    Gavel_2About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Monsanto Co. et al. v. Germann
    4:09-cv-01848; filed November 11, 2009 in the
    Eastern District of Missouri

    • Plaintiffs: 
    Monsanto Co.; Monsanto Technology LLC
    • Defendant: 
    Dennis Germann

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric
    Genes for Transforming Plant Cells Using Viral Promoters," issued October
    4, 1994) and RE39,247 ("Glyphosate-tolerant
    5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006)
    based on defendants' use of soybean seed produced from earlier planted Roundup
    Ready® soybean seed.  View the
    complaint
    here.


    Takeda Pharmaceutical Co. Ltd. et al. v. Teva
    Pharmaceuticals USA Inc. et al.

    1:09-cv-00841; filed November 6, 2009 in the
    District Court of Delaware

    • Plaintiffs: 
    Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals North America
    Inc.
    • Defendants: 
    Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent No. 6,034,239 ("Tricyclic
    Compounds, Their Production and Use," issued March 7, 2000) following a
    Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a
    generic version of Takeda's Rozerem® (ramelteon, used to treat insomnia).  View the complaint
    here.


    Allergan, Inc. v. Alcon Laboratories, Inc. et al.
    2:09-cv-00348; filed November 6, 2009 in the
    Eastern District of Texas

    • Plaintiff: 
    Allergan, Inc.
    • Defendants: 
    Alcon Laboratories, Inc.; Alcon Research, Ltd.; Alcon, Inc.; Falcon
    Pharmaceuticals, Ltd.

    Infringement of U.S. Patent Nos. 7,030,149 ("Combination
    of Brimonidine Timolol For Topical Ophthalmic Use," issued April 18, 2006),
    7,320,976 (same title, issued January 22, 2008), and 7,323,463 (same title,
    issued January 29, 2008) following a Paragraph IV certification as part of Alcon's
    filing of an ANDA to manufacture a generic version of Allergan's Combigan®
    (brimonidine tartrate/timolol maleate ophthalmic solution, used to treat
    glaucoma).  View the complaint
    here.


    Purdue Pharma Products LP et al. v. Sun Pharmaceutical
    Industries Ltd. et al
    .
    1:09-cv-00833; filed November 5, 2009 in the District
    Court of Delaware

    • Plaintiffs: 
    Purdue Pharma Products LP; Napp Pharmaceutical Group Ltd.
    • Defendants: 
    Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.;
    Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories Ltd.

    Infringement of U.S. Patent Nos. 6,254,887 ("Controlled
    Release Tramadol," issued July 3, 2001) and 7,074,430 ("Controlled
    Release Tramadol Tramadol [sic] Formulation," issued July 11, 2006)
    following a Paragraph IV certification as part of Sun's filing of an ANDA to
    manufacture a generic version of plaintiffs' Ryzolt® (tramadol hydrochloride,
    used to treat moderate to moderately severe chronic pain).  View the compliant
    here.


    Novo Nordisk Inc. et al. v. Sandoz Inc.
    1:09-cv-09217; filed November 5, 2009 in the Southern
    District of New York

    • Plaintiffs: 
    Novo Nordisk Inc.; Novo Nordisk A/S
    • Defendant: 
    Sandoz Inc.

    Infringement of U.S. Patent No. 6,677,358 ("NIDDM
    Regimen," issued January 13, 2004) following a Paragraph IV certification
    as part of Sandoz's filing of an ANDA to manufacture a generic version of Novo
    Nordisk's PrandiMet® (repaglinide and metformin, used to treat type 2
    diabetes).  View the complaint
    here.


    Novartis AG et al. v. Apotex Inc. et al.
    2:09-cv-05614; filed November 3, 2009 in the
    District Court of New Jersey

    • Plaintiffs: 
    Novartis AG; Novartis Pharmaceuticals Corp.
    • Defendants: 
    Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-coated
    Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000),
    6,172,107 ("Entric-coated Pharmaceutical Compositions," issued on
    January 9, 2001), and 6,306,900 (same title, issued on October 23, 2001)
    following a Paragraph IV certification as part of Apotex's filing of an ANDA to
    manufacture a generic version of Novartis' Myfortic7 delayed-release tablets
    (mycophenolate sodium, used for the prevention of organ rejection in patients
    receiving allogeneic renal transplants, administered in combination with
    cyclosporine and corticosteroids).  View the complaint
    here.


    Eurand Inc. et al. v. Teva Pharamceuticals USA, Inc. et al.
    1:09-cv-00816; filed October 29, 2009 in the
    District Court of Delaware

    • Plaintiffs: 
    Eurand Inc.; Anesta AG
    • Defendants: 
    Teva Pharamceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.;
    Barr Laboratories Inc.

    Infringement of U.S. Patent Nos. 7,387,793 ("Modified
    Release Dosage Forms of Skeletal Muscle Relaxants," issued July 17, 2008)
    and 7,544,372 (same title, issued June 9, 2009), licensed to Cephalon,
    following a Paragraph IV certification as part of Teva's filing of an ANDA to
    manufacture a generic version of Cephalon's Amrix® (cyclobenzaprine
    hydrochloride, used for relief of muscle spasm associated with acute, painful
    musculoskeletal conditions).  View
    the complaint
    here.






  • CalendarNovember 16-17, 2009 – Patent Litigation 2009 (Practising Law Institute) – New York, NY

    November
    17-18, 2009 –
    Structuring,
    Negotiating, and Managing Pharma/Biotech Collaborative Agreements
    (
    American Conference
    Institute) – New York, NY

    November 19, 2009 – Patentable Subject Matter After the Bilski Oral Argument (American University Washington College of Law
    and the Federal
    Circuit Bar Association) –
    4:30-6:30 pm (EST)

    December 7, 2009 – 20th Annual Conference on U.S. Patent and
    Trademark Office Law and Practice (PTO Day)
    (
    Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark
    Office) – Washington, DC

    December 7-8, 2009 – Foreign Patent Law &
    Regulation
    ***
    (American Conference
    Institute) – New York, NY

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

  • Washington College of Law On
    Thursday, November 19, 2009, the American University Washington College of Law
    Program on Information Justice and Intellectual Property and the Federal
    Circuit Bar Association (FCBA) will be offering a panel discussion entitled
    "Patentable Subject Matter After the Bilski Oral Argument."  The panel discussion, which will be
    held in Room 603 at the Washington College of Law, will take place from
    4:30-6:30 pm (EST).  Panelists for the
    program will include:  Raymond T.
    Chen, Solicitor of U.S. Patent and Trademark Office and Counsel for Respondent;
    J. Michael Jakes of Finnegan Henderson and Counsel of Record for Petitioners,
    Nancy Linck of Rothwell, Figg and Counsel for Amicus Curiae Biotechnology Industry Oragnization (BIO); and
    Randolph Moss of WilmerHale and Counsel for Amici
    Curiae
    Bank of America et al.  The panel discussion will be moderated
    by Thomas C. Goldstein of Akin, Gump and Counsel for Amicus Curiae American Bar Association, and Professor Joshua
    Sarnoff of the American University Washington College of Law and Counsel for Amici Eleven Law Professors and the AARP.

    A
    webcast of the panel discussion will be available for a registration fee of $15
    (government/academic/retired FCBA member), $35 (government/academic/retired
    nonmember), $65 (private practitioner FCBA member), or $105 (private
    practitioner nonmember). 
    Instructions for accessing the webcast can be found here.  Those interested in obtaining group
    pricing and university law schools interested in free internet participation
    should contact Elisabeth Reed at reed@fedcirbar.org.

  •     By Kevin E. Noonan

    Federal Circuit Seal Chief Judge Paul Michel, writing for most of the en banc
    Court of Appeals for the Federal Circuit (Judge Lourie took no part in the
    decision), today granted the joint motion of all parties to dismiss the appeal
    of Tafas v. Kappos.  Thus, the infamous "continuation
    and claims rules" are now really, most sincerely dead.  Importantly, the Court denied the joint
    motion (the U.S. Patent and Trademark Office joined by one of the plaintiffs,
    GlaxoSmithKline but not Dr. Triantafyllos Tafas) to vacate the District Court's
    opinion that was the subject of the appeal (see "Dr. Tafas Files Reply to USPTO/GSK Motion to Dismiss Appeal and Vacate District Court Judgment").

    The Court's ruling was based on its interpretation
    of
    U.S. Bancorp Mortgage Co. v. Bonner Mall Partnership, 513 U.S. 18 (1994), that there are two
    instances where an appeal is mooted, with different consequences for
    vacatur.  Vacating the decision of
    the court below when dismissing an appeal is proper, according to the Federal
    Circuit's interpretation of Supreme Court precedent, "if the mootness
    arises from external causes over which the parties have no control, or from the
    unilateral act of the prevailing party."  Vacatur is not proper, however, "when the mootness is
    due to a voluntary act by the losing party, such as a settlement."

    USPTO Seal The Federal Circuit
    held that the withdrawal of the rules at issue by the Patent Office fell into
    the second, voluntary category rather than the first, involuntary one, despite
    the Patent Office position that the "intervening" regulatory change
    is analogous to an intervening statutory change (which the Court suggested
    might be considered involuntary).  "The
    agency does not control Congress; but it does control the decision to rescind
    the regulations," said the Court and accordingly "it was the USPTO
    (the losing party in the district court action) that acted unilaterally to
    render the case moot, and vacatur is not appropriate."

    (Interestingly,
    the Patent Office did not raise the issue of independent executive branch
    action, such as the rumored action by the Office of Management and Budget to
    prohibit implementation of the rules package for failure to comply with (or
    more properly, to substantially ignore or misrepresent) Federal regulations
    regarding the economic burden of the rules (see "Response to Rescission of Claims and Continuations Rules").  While such action might have increased the "involuntary"
    nature of the withdrawal, it could also have brought to the Court's attention
    the alleged fact that the substantive basis for the appeal was mooted several
    months before the Federal Circuit panel heard the appeal.)

    There are
    several important consequences to this action.  For the parties, claims for fees (made by Tafas and perhaps
    available to GSK) are intact in view of the patency of the judgment below.  The Patent Office is required to use "notice
    and comment" proceedings for all rulemaking (and as David Boundy has
    noted, the Office must observe the Regulatory Flexibility Act procedures for
    all rulemaking).  Most importantly,
    perhaps, is that the Office has forgone its right to appeal the District Court's
    decision, and while merely persuasive but not binding authority, it is the only
    judicial decision on the scope of Patent Office authority on these types of
    rules packages.

    As a
    reminder (and keep in mind that as part of the Federal Circuit's en banc order,
    the panel decision was also vacated and has no precedential value), District
    Court Judge James Cacheris of the Eastern District of Virginia ruled that
    "the Final Rules are substantive in
    nature and exceed the scope of the USPTO's rulemaking authority under 35 U.S.C.
    § 2(b)(2)."  Moreover, the judgment
    voided the claims and continuation rules as "otherwise not in accordance
    with law" and "in excess of statutory jurisdiction [and] authority,"
    and thus, in contravention of the Administrative Procedure Act (APA).

    Specifically,
    Judge Cacheris determined that "[u]nder Federal Circuit precedent . . .
    Section 2(b)(2) [of the Patent Act] does not vest the USPTO with any general
    substantive rulemaking power," citing
    Merck & Co., Inc. v. Kessler, 80
    F.3d 1543, 1550 (Fed. Cir. 1996).  Judge Cacheris also noted that this reading
    of Section 2(b)(2) was "further supported by the fact that, since 2005,
    Congress has debated and considered whether it should grant the USPTO
    substantive rulemaking authority but has declined to do so."  Thus, the
    Court determined that the relevant case law was clear:  "Section
    2(b)(2)'s authority is limited to rules governing the 'conduct of proceedings'
    before the Office, the USPTO does not have the authority to issue substantive
    rules, and it does not have the authority to make substantive declarations
    interpreting the Patent Act."  In doing so Judge Cacheris swept aside the Patent Office's attempts to "abolish
    the substantive-procedural distinction," stating that "any rule that 'affect[s]
    individual rights and obligations' is substantive."

    For a fuller
    discussion of Judge Cacheris' decision, once again assuming relevance for
    future Patent Office adventures in rulemaking, please see "No April Fool's Joke — Tafas and GSK Win on Summary Judgment."

  •     By Christopher P. Singer

    PAIR Maintenance

    EFS-Web The USPTO posted a message on the front page of
    PAIR announcing that both Public and Private PAIR will be down for maintenance
    for part of this weekend.  The
    maintenance is expected to begin at 10:00 pm EST on Saturday, November 14th and last until about 11:00 am EST on Sunday, November 15th.


    USPTO Form Usage

    In a prior message, the USPTO published an advisory
    regarding the use and modification of the patent forms it provides the public
    for use in the patenting process.  The Office stated that "[u]se of the forms for purposes for which
    they were not designed is prohibited."  In particular, the USPTO expressed a clear message that no
    modification can be made to a certification statement that is contained within
    a USPTO-provided form (such as declarations, terminal disclaimers, petitions,
    and non-publication requests).

    While practitioners and applicants are forbidden
    from changing the language in a certification statement, they can modify the
    other language in a USPTO-provided form, as long as all text identifying
    the form as an Office form is removed.  This is an important step when using any modified document because, as
    stated in the notice:

    The presentation to the
    Office (whether by signing, filing, submitting, or later advocating) of any
    Office form with text identifying the form as an Office form by a party,
    whether a practitioner or non-practitioner, constitutes a certification under
    37 CFR 10.18(b) that the existing text and any certification statements on the
    form have not been altered other than permitted by EFS-Web customization.  See
    37 CFR 1.4(d)(3).

    The Office also indicated that it is in the process
    of making all existing forms available in a "fillable" format and
    that it would update the forms as they become ready for use.  Problems relating to fillable patent
    forms can be reported to the electronic business center by e-mail at ebc@uspto.gov.

  •     By Donald Zuhn

    Kappos, David On Tuesday, the U.S. Patent and Trademark
    Office announced that USPTO
    Director David Kappos (at right) has launched a new blog "
    to foster a direct dialogue with the USPTO's
    stakeholders and the general public."  The blog, running under the heading "Director's Forum:
    David Kappos' Public Blog," can be reached through a link on the USPTO
    homepage or at www.uspto.gov/blog.  The Director's initial post is entitled
    "Putting the USPTO to Work for Independent Inventors."

    In explaining why he started the blog, Director Kappos noted that "[i]t's
    important for me to be able to hear directly from the IP community, and that is
    why we are establishing this open channel for sustained dialogue and the
    exchange of ideas."  The
    Director also said that he hoped the public would find the blog "to be a
    useful vehicle for providing input to me directly and giving us the feedback we
    need to be able to better serve our constituents and the American people."  According to the Office's press
    release, "[t]he new blog is part of an extensive effort to reach out to
    the IP community and actively engage USPTO stakeholders in an effort help to
    the agency better serve the American public."

  •     By Christopher P. Singer

    USPTO Seal On October 27, 2009, the U.S. Patent and Trademark Office published a notice in the Federal Register (74 Fed. Reg. 55212) outlining a new "Patents Ombudsman Pilot
    Program."  The program is
    intended to provide patent applicants and practitioners with an additional
    resource for application-specific prosecution issues, particularly when
    prosecution of the application has stalled.

    The
    USPTO intends for the Patents Ombudsman to be a dedicated resource
    that will interact with applicants and practitioners who have concerns about
    the progress of their applications.  The Office envisions that the ombudsman will be contactable
    through a link on the USPTO website, where applicants or representatives can submit their contact information and select an ombudsman for a particular
    Technology Center.  The bulk of the
    communications will be done by telephone and will be kept of a general nature
    such that the specific communications would not be made of record, but rather
    merely a broad description of the issue will be memorialized in the record
    (intended to be completed within one business day of initial contact).  When possible, the ombudsman would
    immediately resolve the issue, however in situations that are not immediately
    resolvable, the ombudsman would shepherd the issue to the appropriate party and
    attempt to resolve all issues within ten business days.

    The Office has requested that the public submit written
    comments regarding the Pilot Program by November 27, 2009.  Written comments can be sent by e-mail
    to ombudsmanprogram@uspto.gov
    or by U.S. Mail to:  Mail Stop Comments (Attention: Patents Ombudsman Pilot
    Program), Commissioner for Patents, P.O. Box 1450, Alexandria, VA
    22313-1450.  If you would like more
    information regarding the Pilot Program, the Office asks that you contact Mindy
    Fleisher, Special Programs Advisor (TC 2400) at 571-272-3365, or Pinchus M.
    Laufer, Legal Advisor, OPLA, Office of the Deputy Commissioner for Patent
    Examination Policy at 571-272-7726.

  •     By Suresh Pillai

    Infosint
    Seeks Increased Damages Award in Citalopram Suit

    Lundbeck Following a decision by the U.S. District Court for the Southern District of New York in October finding Forest
    Laboratories
    and
    Lundbeck A/S liable for infringement of Infosint's patent covering the antidepressant citalopram,
    Infosint has now returned to the District Court seeking an increase in its damages
    award.  In particular, Infosint seeks additional damages and interest totaling $43 million.  At the close of trial,
    Infosint was awarded $15 million as a reasonable royalty (see "Biotech/Pharma
    Docket
    ," October 21, 2009).

    Forest Laboratories Logo In April 2006, Infosint filed suit against Lundbeck and Forest Labs, accusing them of infringing U.S. Patent No. 6,458,973.  Lundbeck and Forest Labs responded by filing a
    counterclaim against Infosint for infringement of Lundbeck's U.S. Patent No. 6,403,813.  At trial, a jury found that Lundbeck's process for
    preparing the starting material for
    citalopram
    infringed the '973 patent, but that other processes used by Lundbeck did
    not infringe that patent.  Infosint then sought judgment as a matter of law that
    Lundbeck and Forest Labs infringed claim 24
    of the '973 patent by selling citalopram manufactured through the
    infringing process.

    In its most recent filing, Infosint seeks an increase in the award that would reflect
    interest and additional infringement.  However, both
    Lundbeck and Forest Labs also filed post trial motions in which
    the defendants argue that claim 24 of the '973 patent is invalid on grounds of
    obviousness.


    Court
    Upholds Record $1.7 Billion Infringement Judgment

    Abbott A The U.S. District Court for the Eastern District of
    Texas has upheld a record $1.7 billion award against Abbott Laboratories for Abbott's
    infringement of patents belonging to Centocor Ortho Biotech Inc.
    and New York University.  In June 2009, the District Court found Abbott liable for infringement of U.S. Patent Nos. 7,070,775
    and 7,276,239 with respect to
    Abbott's blockbuster arthritis drug Humira® (see "Biotech/Pharma Docket," June 30,
    2009).  In the wake of that decision, Abbott asked the Court to rule that the '775 was
    invalid on grounds of inequitable conduct and prosecution laches.  Abbott also alleged that the asserted
    claims of the '775 patent were indefinite because those having ordinary skill
    in the art would not understand the claim limitations as disclosed in the
    patent.

    Centocor The District Court disagreed with Abbott's
    allegations, holding that Abbott had failed to prove by clear and convincing
    evidence that the '775 patent was either unenforceable or invalid.  The Court left undisturbed its award,
    which includes $1.17 billion in lost profits and $504 million in
    royalties.


    Settlement
    Announced in Carbatrol® Suit

    Shire Pharmaceuticals The U.S. District Court for the District of New
    Jersey has approved a settlement agreement between Shire and Apotex Inc. over their patent dispute regarding Shire's epilepsy drug, Carbatrol®.  Shire originally filed suit in 2008
    following receipt of a letter from Apotex that alerted Shire to Apotex's filing
    of an Abbreviated New Drug Application with the FDA seeking permission to
    market and manufacture generic extended-release capsules containing carbamazepine,
    the active ingredient in Carbatrol® (see "Court Report," July 27,
    2008).  Shire's complaint alleged that Apotex's
    proposed generic would infringe upon two Shire patents, U.S. Patent Nos.
    5,326,570
    and 5,912,013, and sought to have Apotex enjoined from making its generic product before the
    expiration of Shire's patents.  Apotex responded by filing a motion seeking a declaratory judgment that
    the patents were either invalid or would not be infringed.

    Apotex #1 Under the terms of the settlement agreement, Shire
    has agreed to grant Apotex a license to both patents-in-suit and a covenant not
    to sue.  Apotex has agreed to
    acknowledge that all claims of one of the patents are valid and that Apotex's
    proposed product would have infringed the claims of that patent.  Other terms and conditions of the agreement
    remain confidential.

  •     By
    Donald Zuhn

    Ariad With
    oral argument before the Supreme Court in In
    re Bilski
    now concluded, patent practitioners can begin to turn their
    attention toward the next big patent case awaiting oral argument:  the Federal Circuit's en banc rehearing of Ariad Pharmaceuticals, Inc. v. Eli Lilly &
    Co.
    , which is scheduled for December 7th.  Last month, Plaintiffs-Appellees Ariad Pharmaceuticals,
    Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research,
    and the Presidents and Fellows of Harvard College ("Ariad") filed
    their
    principal brief for rehearing en
    banc
    .  In response to the two
    questions presented by the Federal Circuit's en banc order, Ariad answered that "§ 112, ¶ 1, does not contain
    a written description requirement separate from an enablement requirement [and
    that] it necessarily follows that the statute provides no scope or purpose for
    a separate written description requirement."

    Ariad
    contends that "[u]nder a plain reading of [§ 112, ¶ 1], a patent
    specification must be in writing and must contain a description (i) of the
    invention, and (ii) of the manner and process of making and using it."  According to Ariad, the first paragraph
    of § 112 can thus be represented as follows:

    The
    specification shall contain

    [A]
    a written description

    [i]
    of the invention, and

    [ii]
    of the manner and process of making and using it,

    [B]
    in such full, clear, concise, and exact terms as to enable any person skilled
    in the art to which it pertains, or with which it is most nearly connected, to
    make and use the same . . . .

    Under
    the above construction:

    [C]lauses
    [i] and [ii] are components of [A]; they are both parts of the "written
    description."  The final
    prepositional phrase [B] ("in such full . . . terms as to enable") modifies the
    noun [A], "a written description," and thereby provides the standard to assess
    the legal adequacy of the whole of the written description.  This construction has the important benefit
    of following ordinary rules of English grammar.

    Instead of construing § 112 in this manner, Ariad argues that the Federal
    Circuit's written description cases "tend to truncate the statutory
    language after the phrase 'written description of the invention,' and solely
    focus on only this one phrase, ignoring the remaining language in the
    paragraph."  Ariad notes that
    the Federal Circuit's approach yields an alternate construction, which can be
    represented as follows:

    The
    specification shall contain

    [A]
    a written description

    [i]
    of the invention, and

    [ii]
    of the manner and process of making and using it,
    [B]
    in such full, clear, concise, and exact terms as to enable
    any person skilled in the art to which it pertains,
    or with which it is most nearly connected, to make
    and use the same . . . .

    Ariad
    asserts that there are three significant problems with the above
    construction:  (1) "the
    statute provides no standard for testing the legal adequacy of the 'written
    description of the invention,'" (2) "this alternate construction of
    the statute does not make sense as a matter of grammar because, in the context
    of the sentence, the prepositional phrase [B] ('in such . . . terms') can only
    modify the word 'description,'" and (3) "under the alternative
    reading of the statute, the addition of a comma between the phrases 'the manner
    and process of making and using it' and 'in such . . . terms' is inexplicable."

    In
    its brief, Ariad also argues that none of the four earlier major revisions of
    the patent laws (i.e., the Patent
    Acts of 1790, 1793, 1836, and 1870) support a separate written description
    requirement.  It contends that
    the Patent Acts of 1790 and 1793 "required a written description that
    served two purposes: (i) to distinguish the invention from the prior art, and
    (ii) to enable those of ordinary skill in the art to make and use the
    invention."  Ariad asserts
    that beginning with the Patent Act of 1836, the first purpose was eliminated
    from the written description requirement and transferred to the claims and
    "the 'written description' henceforth served a single purpose: enablement."

    According to Ariad, neither Supreme Court nor CCPA precedent supports the existence of
    a separate written description requirement.  Noting that Federal Circuit opinions focusing on the written
    description requirement primarily rely on the Supreme Court's decision in Evans v. Eaton, Ariad states that "Evans interpreted the 1793 Patent Act
    which . . . differs from the 1836 and subsequent Patent Acts in that the 1793
    Act required the written description of the invention to serve two purposes."

    As
    for the CCPA, Ariad argues that "[f]or at least the first fifteen years
    after adoption of the 1952 Patent Act, cases interpreting § 112, ¶ 1 'did not
    differentiate written description from enablement.'"  Ariad cites two examples of CCPA cases
    in which it contends the CCPA so interpreted the statute:  In
    re Gay
    and In re Wilke.  In both cases, Ariad asserts that
    "the CCPA explained that § 112, ¶ 1 had just two aspects – (i) to describe
    the invention so a person of ordinary skill can make and use it, and (ii) to describe
    the best mode contemplated by the inventor for carrying out the invention."  Ariad also argues that a "careful
    reading" of the CCPA's decision in In
    re Ruschig
    , "frequently cited as the leading case construing § 112, ¶
    1 as containing separate written description requirement separate from
    enablement," demonstrates that this case has been misread.  Finally, noting
    that Judge Markey once observed (in In re
    Barker
    ) that he could not see how one may, in "full, clear, concise
    and exact terms," enable the skilled artisan to practice an invention and
    still have failed to describe it, Ariad states that it is "in complete
    agreement with Judge Markey's opinion in Barker
    and believe[s] it should be adopted by this Court en banc."

    As
    for the Federal Circuit's creation of a separate written description
    requirement (and a standard for assessing compliance with this separate
    requirement), Ariad argues that:

    Enablement
    is clearly provided for in the statute, whereas a separate written description
    doctrine requiring evidence of "possession" is not.  Yet many patents challenged under §
    112, first paragraph are resolved under the non-statutory written description
    doctrine rather than under statutory requirement of enablement.  The present case is simply one such
    example.

    The
    reason for this is simple.  Once
    written description was de-linked from enablement, it was necessary to frame
    some other test for determining whether the judicially-construed "separate
    written description requirement" was satisfied.  For this purpose, the Court created a new standard: "the
    applicant must convey with reasonable clarity to those skilled in the art that, as
    of the filing date sought, he or she was in possession of the invention."

    Ariad
    also contends that the Federal Circuit's separate "written
    description-possession" requirement has severe adverse
    consequences for research universities.  Noting that university patentees were involved in Ariad, Regents of the University of California v. Eli Lilly & Co., and
    University of Rochester v. G.D. Searle
    & Co.
    , the Ariad brief states that the university's patents "were
    held invalid under the 'separate written description' doctrine at the behest of
    pharmaceutical companies whose commercial activities are downstream of, and
    benefit from, the type of discoveries that universities make."

    In
    the last portion of its brief, Ariad explains how the specification of the
    patent-in-suit would satisfy a properly construed written description
    requirement.  In particular, Ariad
    argues that:

    [T]he
    inventors of the patent-in-suit discovered a previously unknown protein in
    cells, NF-κB, that plays a crucial role in regulating the immune response to
    inflammatory stimuli.  They
    realized the important benefits that would flow from reducing NF-κB activity in
    cells and promptly published their discoveries both in the scientific
    literature and in patent applications that described how to achieve such
    reduction.  Other scientists promptly
    practiced these teachings and expressly cited and referred to the publications
    of the present inventors as the basis for their own results.

    Contending
    that the proper test for assessing the adequacy of a description is not
    possession, but rather whether the description enables any person skilled in
    the art to make and use the claimed invention, and further that this test
    "is well illustrated in the Supreme Court cases, which focus on whether the
    claimed scope matches the inventor's contribution," Ariad asserts that "[t]he
    claimed methods [of the patent-in-suit] encompass no more than the important
    contribution that these inventor[s] described in the 1989 priority application."

    For additional information regarding this and other related topics, please see:
    • "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
    • "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
    • "Amgen, Inc. v. Ariad Pharmaceuticals, Inc. (Fed. Cir. 2009)," June 1, 2009
    • "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
    • "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

  •     By Kevin E. Noonan

    Supreme Court Building #2 The highest form of tea leaf-reading is guessing
    how the Supreme Court will rule based on oral argument.  Yet occasionally the Court's questioning
    suggests general trends and tendencies, and today's argument in Bilski v. Kappos may be one of those
    times.

    The claims at issue are directed to a method for
    hedging risk in a commodities trade, and are broadly directed to such methods (i.e., there is no requirement that the
    method be performed using a computer or other particular machine).  The claims were rejected by the Patent
    Office and appealed to a Federal Circuit panel, but before the panel decision
    was issued, the CAFC sua sponte
    ordered rehearing en banc.  In its en banc decision, the Federal Circuit promulgated a new, exclusive
    test for patent eligibility of method claims, requiring that a method either be
    tied to a machine or transform a particular article into a different state or
    thing (the "machine or transformation" test).  The Supreme Court granted certiorari to consider whether this test
    was contrary to the Court's "
    precedent
    declining to limit the broad statutory grant of patent eligibility for 'any'
    new and useful process beyond excluding patents for 'laws of nature, physical
    phenomena, and abstract ideas'."

    In today's
    argument, it became clear that the Justices thought little of the argument that
    Bilski's claim should be patent-eligible.  Bilski's advocate, J.
    Michael Jakes, staunchly kept to his position that what should be considered a
    patent-eligible process be broadly construed, refusing to concede that any
    method posed as a hypothetical by the Court should be per se ineligible.  These far-fetched hypothetical methods included methods for teaching
    antitrust law without putting students to sleep (Justice Breyer), speed-dating
    (Justice Sotomayor), horse-whispering (Justice Scalia), as well as more
    concrete examples ("an estate plan, tax avoidance, how to resist a
    corporate takeover [or] how to choose a jury," by Justice Ginsberg).  The Court was clearly concerned about
    conferring the broadest scope to method claims, such as "anything that
    helps any businessman succeed is patentable because we reduce it to a number of
    steps," according to Justice Breyer.  To each of these instances, Mr. Jakes argued that such a claim was "potentially
    patentable," subject to the other requirements of the statute.  To Justice Sotomayor's question about
    how to limit patent eligibility to "something reasonable" if it is
    not limited to technology or the sciences, Mr. Jakes argued that the useful
    arts excludes "[s]peaking, literature, poems" and that "a
    corporation [or] a human being" were not included in the statutory
    categories of the useful arts.  However, Mr. Jakes did not specifically assert that Bilski's claim
    should be patent-eligible, merely that the Federal Circuit's test was without
    support in the plain language of the statute or any of the Court's earlier
    precedent.

    The Chief
    Justice asked how the claim was not disqualified as being a mere abstract idea,
    in the process conflating what may not be patentable ("classic commodity
    hedging that has been going on for centuries") with what should be
    patent-eligible.  Justice Kennedy,
    citing the development of actuarial tables and methods for calculating risk by
    the nascent insurance industry in the 17th Century, asked whether
    Congress would have intended that "only one person [would have] the capacity
    to issue insurance."  Mr.
    Jakes did not directly answer this question, but maintained that such methods
    could be patent-eligible, falling within the ambit of the statutory definitions
    of patent-eligible inventions.

    Justice
    Ginsburg was concerned about the practices in other countries, which do not
    include methods like the Bilski method within the scope of patent-eligible
    subject matter.  Mr. Jakes
    responded by reminding the Court that other countries have defined "technology"
    differently than the U.S. has, and it was these definitions that provide the
    basis for excluding types of inventions patent-eligible under 35 U.S.C. § 101.  Mr. Jakes also challenged the
    assertion by Justice Sotomayor that "a patent limits the free flow of
    information," asserting (correctly) that patents promote disclosure of
    inventions, so that "information gets to the public generally," while
    conceding Justice Scalia's point that the public cannot use an invention until
    the patent expires.

    Justice Stevens
    asked two interesting jurisprudential questions.  The first was for Mr. Jakes to identify the "strongest
    case" from the Court's jurisprudence that supported his position, and
    without apparent irony (in view of the Federal Circuit majority's reliance upon
    it) he answer Diamond v. Diehr.  (Justice Stevens did not appear to
    think the Diehr case provided much
    support for Mr. Jakes's position.)  Second, the Justice asked whether Judge Rich had
    ever written on the scope of patent-eligibility for process claims, to which
    Mr. Jakes answered that he had written the Alappat
    decision as well as the State Street
    decision.

    Supreme Court Seal Turning to the Diehr decision, the Court seemed to
    grapple with the similarities and distinctions between methods for curing rubber
    ("an industrial process of the conventional type," as characterized
    by Mr. Jakes) and methods for manipulating information or electronic signals
    (although Justice Sotomayor drew a distinction between manipulation of
    electronic signals and manipulation of information as being "different in
    kind").  Justice Breyer
    made the distinction explicit, saying that there are "four things in
    patent law that everyone accepts."  These include "two that are a plus" (increased innovation and
    disclosure) and "two that are a minus" (higher prices and "having
    to get permission [that] can really slow things down and destroy advance").  (Despite the negative tone, he
    characterized this situation as "a balance.")  In the 19th Century, he
    said, methods were directed towards machines, whereas Mr. Jakes's position is
    that today patent-eligible methods should include those performed on information.  To that proposition and how the
    appropriate balance should be drawn the Justice candidly admitted "I don't
    know.  And I don't know whether
    across the board or in this area or that area patent protection would do no
    harm or more harm than good."

    The Court also
    considered the Morse and Bell patents, with Justice Scalia arguing that the Bell
    claims would pass the "transformation" prong of the Federal Circuit's
    test, since sound was transformed into electrical signals and vice versa in the
    practice of the claimed method for transmitting sound over a distance.

    The Court closely
    questioned the government's position as articulated by Deputy Solicitor General
    Malcolm Stewart.  Speaking
    for the first time, Justice Alito asked whether the Court should render a
    decision on the "very broad issue" raised by Bilski, to which Mr.
    Stewart answered that the government would prefer to prevail more
    narrowly.  In doing so, Mr. Stewart
    asserted that the Federal Circuit's "machine or transformation" test
    was not "rigid or inflexible" based in large part in the questions
    left unanswered in the opinion (such
    as the extent to which a process is "tied to a particular machine").  Justice Sotomayor asked the fundamental question of whether
    the Court should simply declare that business methods are unpatentable and
    avoid the issues of destroying the computer or biomedical industries as had
    been argued by various amici.  This wouldn't solve the
    problem, according to Mr. Stewart, because the basis for business method
    patents (the State Street case) involved a machine rather than a process
    (Justice Sotomayor impliedly agreeing by saying "[n]o ruling in this case
    is going to change State Street").  Justice Breyer characterized the Federal Circuit's
    decision as a "pull back" on the scope of patent-eligible methods,
    but with little guidance from the Federal Circuit on the scope of how far they CAFC has "pulled back," in view of the failure to define the extent
    of transformation or ties to a particular machine that would satisfy the
    standard.

    The Chief
    Justice took Mr. Stewart to task for "the last footnote" of the
    government's brief, which he understood to assert that the use of a computer in
    Bilski's method might make the process patentable — he characterized this as
    the equivalent of saying that using a typewriter to type out a method would
    make a process patentable.  Mr. Stewart attempted to distinguish this interpretation using a
    hypothetical involving an interactive website for practicing the method but with
    little success; the Chief Justice
    said that the government's hypothetical "involves the most tangential and
    insignificant use of a machine."  Importantly, Mr. Stewart then indicated that the government did not want
    the Court to opine broadly in its decision:

    I
    guess the point I'm trying to make is simply that we don't want the Court, for
    instance, in the area of software innovations or medical diagnostic techniques
    to be trying to use this case as the vehicle for identifying the circumstances
    in which innovations of that sort would and would not be patent eligible,
    because the case really doesn't present any — any question regarding those
    technologies.

    Justice
    Sotomayor agreed with this sentiment, saying in response that
    "by saying that we exclusively
    rely on the machine-or-transformation test, that we're precluding applications
    of the patent law in those fields, the things we can't imagine.  Once you
    announce an exclusive test, you're shoe-horning technologies that might be
    different."  She also
    asked the Deputy's help in fashioning a test "that doesn't go to the
    extreme the Federal Circuit did" with regard to having to reverse earlier
    precedent that did not preclude methods that would fail the "machine or
    transformation" test.  Justice Ginsburg asked whether Judge Mayer's calculus in his concurrence — "if it's technology, then it's within the realm of patent, and if it's
    not technology, it isn't" — wasn't the simplest test to be used, and Mr.
    Stewart answered that "our test . . . has a shorthand version of that,"
    suggesting at least an acquiescence to a "technology arts"
    standard.  He went on to say however
    that this was not the simple solution it appeared to be, based on the
    definition of "technology" and what should be "properly regarded
    as technological advances," as well as whether the "technology"
    component was "sufficiently substantial" to render a process claim
    patent-eligible.  Several of
    the Justices also voiced the view that merely programming a computer to perform
    a new process did not convert the computer into a "new" machine, again
    seeming to conflate patent eligibility with patentability.

    Returning
    to the government's view of the appropriate scope of the Court's decision in
    this case, the Deputy argued:

    We thought that this case would provide an unsuitable vehicle for
    resolving the hard questions because the case doesn't involve computer software
    or medical diagnostic techniques, and therefore, we thought the Court would
    arrive at the position that I think, at least some members are feeling that you
    have arrived at, that you will decide this case, and most of the hard questions
    remain unresolved.  And, frankly, we think that's true.

    To
    Justice Steven's remark following this statement that "[w]e know that
    things that we haven't yet contemplated may be around the corner, and when they
    happen, we will deal with them," Mr. Stewart responded that the government
    "would be entirely content with a ruling like that."

    In
    his brief rebuttal, Mr. Jakes appeared to agree with this sentiment:

    The Federal Circuit did announce this test as the sole test for
    all processes.  It said it applied no matter what the process was, so we do have
    to face these difficult questions.  I think the question can be avoided, because we don't need a rigid test
    of this type based on machine-or-transformation.  The question we are looking at
    and should be looking at is:  Are we trying to patent an abstract idea?

    It appears evident that the Court does not believe
    that Bilski's claims are patentable, but that this case is not the case to make
    any broad pronouncements on subject matter eligibility for computer software or
    diagnostic methods claims.  While
    it is reassuring to believe that the Court is thus disinclined to "shoehorn"
    the patent-eligibility of these types of method claims into its decision on Bilski's
    claims (and the Federal Circuit's "machine or transformation" test),
    it also suggests that the Court (or at least Justices Breyer and Stevens, whose
    views are on record in the Metabolite dissent)
    may recognize that a more appropriate occasion to consider diagnostic method
    claims is available with the certiorari petition in Prometheus Laboratories, Inc. v. Mayo Collaborative Services case.  Until the Court decides whether it will
    hear that case, the status of diagnostic method claims will remain in doubt no
    matter how the Court rules in Bilski.

    A transcript of today's oral argument is available here.