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  • Merck KGaA v. Integra Lifesciences I, Ltd. (2005)

    Merck v. Integra: The Supreme Court Misses A Golden Opportunity

        By Kevin Noonan —

    The Supreme Court missed an opportunity to bring some
    certainty to the law concerning the scope of the "safe harbor"
    provisions of 35 U.S.C. § 271(e)(1) in its recent decision in Merck KGaA v.
    Integra Lifesciences I, Ltd., which was decided June 13, 2005.

    The case involved a patent infringement lawsuit against
    Merck for using Integra’s technology.  Specifically, Merck developed new antitumor agents from "RGD"
    peptides that inhibit angiogenesis.  The
    Federal Circuit affirmed the District Court’s decision that the work did not fall within
    the § 271(e)(1) safe harbor because it was not "reasonably related" to
    obtaining regulatory approval as required by the statute.  The Federal Circuit stated that Merck’s work was too far
    "back down the chain of experimentation" leading to the discovery of
    new drugs to fall within the scope of the exemption.

    The Supreme Court disagreed.  The Court found no statutory basis for making
    a distinction between preclinical and clinical activities.  The Court held that the plain wording of the
    statute made it "apparent" that the exemption "extends to all
    uses of patented inventions that are reasonably related to the development and
    submission of any information under the Food, Drug and Cosmetic
    Act]."  The Court asserted that
    "[t]here is simply no room in the statute for excluding certain
    information from the exemption on the basis of the phase of research in which
    it is developed or the particular submission in which is could have been
    included."

    The consequences of the Supreme Court’s decision favor
    neither small biotech companies nor innovator pharmaceutical companies.  As construed by the Court, whether any
    particular activity falls within the § 271(e)(1) safe harbor will depend on the
    reasonableness of the relationship between the infringing activity and the
    development of information for submission to the FDA.  Thus, every activity using a patented
    compound will have been done (in retrospect) "with the intent to develop a
    particular drug," and the safe harbor’s availability will decrease any
    incentive to license third party technology.  The profits from any such drug will provide ample incentive to litigate
    for small biotech companies whose compounds are used in drug development.  Unless Congress acts to better define the
    scope of § 271(e)(1), it is safe to predict that the Supreme Court’s Merck
    decision will provoke more litigation involving the permissible use of patented
    technology in drug development.

    Merck KGaA v. Integra Lifesciences I, Ltd. (2005)
    Opinion by Justice Scalia

    A more thorough discussion of this topic can be found in Dr. Noonan’s article in the Fall 2005 issue of The Patent Lawyer.

  • The “Anti-Commons” Aren’t So Tragic, After All

        By Kevin Noonan —

    Several years ago, it became current among certain
    academic commentators to opine that patenting genes could become a
    "tragedy of the anticommons."  By this they meant that permitting gene patenting would restrict
    progress, inhibit academic freedom and prevent scientists from working
    cooperatively.  Significantly, most of
    these commentators had neither a science background nor any experience as
    patent attorneys.  Their warnings rang
    hollow to those who had either type of experience, but they had (and continue
    to have) influence with policymakers, Congressional aides, and the Patent
    Office.

    As it turns out, they were wrong, at least with regard to
    academic freedom and cooperation.  In a
    revealing new study, LeRoy Walters of the Kennedy Institute of Ethics and
    Georgetown University and colleagues reports "consensus, diversity and
    flexibility in intellectual property management" (see Nature Biotechnology 24: 31-39 (2006)).  The authors found that research university
    practices were influenced primarily by market forces related to licensing
    opportunities, and also by guidelines from the National Institutes of Health.

    Licensing provides substantial economic benefit to
    universities; for example, Columbia University received $370 million between
    1983 and 2000 for the Axel patents.  The
    report reveals that universities actively promote licensing patent rights to
    for-profit companies, but that the licenses are rarely exclusive.  Indeed, the report finds that even exclusive
    licenses are limited, either due to "field of use" restrictions or
    serial "exclusive" licensing to different companies.  Large companies are much less likely to
    require an exclusive license than smaller start-up companies, who require
    exclusivity in order to attract investment.

    Universities have increasingly used the concept of
    "shop rights" to retain a research exemption, even to
    exclusively-licensed technology, to permit their own scientists to practice
    licensed technology.  Many universities have expanded the scope of this
    exemption to permit scientists to transfer rights to practice a patented
    invention to scientists at other universities doing basic (non-commercial)
    research.  Inclusion of such terms has become
    more important since the Madey v. Duke decision by the Federal Circuit, which
    eliminated the illusion of a common-law research exemption.

    Finally, the cause of the supposed problem, the profusion
    of gene patents, seems to be fading.  The
    39,000 DNA patents issued by the Patent and Trademark Office encompass only 20%
    of genes identified in human genomic databases.  Moreover, the number of gene patents granted per year has declined every
    year since 2001, a trend the authors indicate will continue.

  • Amgen Inc. v. Hoechst Marion Roussel, Inc. (Fed. Cir. 2006)

        By Kevin Noonan —

    The peripatetic case of Amgen Inc. v. Hoechst Marion Roussel, Inc. has once again been
    reviewed by the Federal Circuit (decided August 3,
    2006).  Once again the CAFC
    has failed to lay the several issues in the case to rest.  While affirming infringement and validity of
    two of the patents in suit, the Federal Circuit has remanded the matter once again to the District Court in view of its de novo claim construction, and perhaps
    predictably disagreed with the lower court and reversed a determination of
    infringement under the doctrine of equivalents.

    The case has two interesting aspects.  First, citing the rubrics of Phillips the Federal Circuit came to its own determination of the meaning of the term
    "therapeutically effective amount" with regard to a claim for recombinant
    erythropoietin (EPO).  EPO is a
    naturally-occurring hormone that stimulates the body to produce red blood
    cells, and its absence (or insufficiency) causes anemia.  The standard clinical measure of anemia is
    the hematocrit, or the percent of whole blood comprised of red blood cells.  In
    construing the term "therapeutically-effective amount," the District Court had required that EPO falling within the scope of the claim containing
    the term increase hematocrit and have any other biological properties of
    naturally-occurring EPO.

    The Federal Circuit disagreed, and in doing so provided a
    nice illustration that Phillips has not changed the Court’s capacity for
    arriving at its own idiosyncratic construction.  The CAFC determined that the lower court had improperly focused on
    hematocrit, which is one of EPO’s biological properties recited in the
    specification, to the exclusion of several others, including increasing
    stimulation of reticulocyte response, development of ferrokinetic effects,
    erythrocyte mass changes, and stimulation of hemoglobin.  The Federal Circuit noted in particular that the
    specification recited that the therapeutic properties of recombinant EPO
    "included" all of these, and that the specification further stated
    that recombinant EPO was therapeutically useful even if it lacked some but not
    all of these properties.

    Of course, the CAFC seems to have not considered the
    fact that all of the recited properties are related to the clinical measurement
    of hematocrit, since they are all part of the biological developmental pathway
    leading to an increase in the number of red blood cells in blood.  Thus, by cherry-picking the language of the
    specification, the Court was able to arrive at a facially-reasonable claim
    construction that seems to run contra to clinical reality.  This portion of the matter has been remanded,
    for further consideration in view of the CAFC’s claim construction, on the
    issue of invalidity over prior art references to EPO preparations that did not
    increase hematocrit but may have had one of the other recited biological
    properties.

    The second issue is the doctrine of equivalents.  The "predicted" recombinant EPO
    protein contains 166 amino acids, but as produced naturally (and using HMR’s
    recombinant process) EPO has only 165 amino acids.  The issue before the Federal Circuit was whether Amgen
    was entitled to assert claims to HMR’s recombinant EPO as an equivalent.  The District Court twice found in the
    affirmative, and the Federal Circuit remanded in its first review so the lower
    court could consider the issue in view of Festo Corp. v. Shoketsu Kinzoku Kogyo
    Kabushiki Co.    , 535 U.S. 722, 740-41 (2002).  The District Court
    having arrived at the same conclusion, infringement under the doctrine of
    equivalents, the Federal Circuit reversed, finding estoppel arising during
    prosecution.  Specifically, the CAFC
    held that preliminary amendments
    resulting in claim language reciting the 166 amino acid species were not made
    for reasons tangentially related to the asserted equivalent, as found below,
    but raised prosecution history estoppel that precluded asserting the claim
    against HMR’s 165-amino acid species.  The Federal Circuit’s holding was based in part on Amgen’s cancellation of claim
    limitations related to "fragments" of the 166-amino acid species, and
    in part because it found erroneous the District Court’s determination that the
    amendments were made to limit the species to human EPO (the CAFC noted that if
    Amgen had intended to so limit the claims the mere addition of the word
    "human" would have been sufficient).  Finally, the Federal Circuit rejected the notion that amendments made to avoid a
    double-patenting rejection were "tangential to patentability."

    For those keeping score, the Federal Circuit in its two decisions
    has affirmed the District Court’s judgment that two of Amgen’s patents are not
    invalid and are infringed, also affirmed that another Amgen patent is invalid,
    reversed a finding of infringement under the doctrine of equivalents (but
    affirmed that this patent is also not invalid), and for one patent remanded the
    issue of invalidity to the District Court while affirming that if valid this
    patent is also infringed.  As noted in
    Judge Michel’s dissent (over the claim construction issue), the District Court
    is now in position to decide whether to grant an injunction, keeping HMR’s competing
    EPO product off the market until at least the expiration of two of Amgen’s
    patents.  For the parties, that may be
    (or have to be) enough.

    Amgen Inc. v. Hoechst Marion Roussel, Inc. (Fed. Cir. 2006)
    Panel: Chief Judge Michel, Senior Circuit Judge Clevenger, and Circuit Judge Schall
    Opinion by Circuit Judge Schall; dissenting-in-part opinion by Chief Judge Michel

    This article was originally published on Patently-O on August 13, 2006.

  • Falkner v. Inglis (Fed. Cir. 2006)

        By Donald Zuhn —

    In an appeal from a decision of the Board of Patent Appeals and Interferences, the
    Federal Circuit affirmed judgment for Appellees (Inglis et al.) in an
    interference involving vaccines comprising modified viral vectors.  In particular, the subject matter of the
    interference concerned vaccines comprising a poxvirus vector having a deleted
    or inactivated essential gene, wherein the modified poxvirus is capable of
    producing infectious viral particles when grown in a host cell modified to
    produce the absent essential viral gene product.  In contrast with the vaccines of the
    invention, traditional vaccines had been prepared by deleting or inactivating
    inessential genes in the viral vector, since the deletion or inactivation of
    essential genes made it difficult to produce vaccines in commercial quantities.

    On appeal, Appellants (Falkner et al.) reiterated several
    arguments made before the Board, each concerning the common issue of whether
    Appellees had adequately described and enabled a poxvirus-based vaccine.  Specifically, Appellants argued that because
    Appellees did not identify any essential poxvirus genes or the inactivation of
    any such genes, Appellees had not sufficiently described and enabled vaccines
    comprising a poxvirus vector having a deleted or inactivated essential gene.

    With respect to the Board’s determination that Appellees
    had sufficiently described vaccines comprising poxvirus vectors having modified
    essential genes, the Federal Circuit noted that there was undisputed testimony before the
    Board that at the time of filing of Appellees’ earliest application, the DNA sequence of the poxvirus genome and the locations of essential poxvirus genes
    had been disclosed in the scientific literature.  Adhering to the well-established rule that
    "[a] patent need not teach . . . what is well known in the art," the CAFC held that "there is no per se rule that an adequate written
    description of an invention that involves a biological macromolecule must
    contain a recitation of known structure."  In affirming the Board’s determination that Appellees adequately
    described the invention, the Federal Circuit concluded that because "accessible
    literature sources clearly provided, as of the relevant date, [poxvirus] genes
    and their nucleotide sequences (here "essential genes"), satisfaction
    of the written description requirement does not require either the recitation
    or incorporation by reference (where permitted) of such genes and
    sequences."

    Falkner v. Inglis (Fed. Cir. 2006)
    Panel: Circuit Judge Gajarsa, Senior Circuit Judge Archer, and Circuit Judge Dyk
    Opinion by Circuit Judge Gajarsa

    This article was originally published on Patently-O on June 1, 2006.

  • Invitrogen Corp. v. Clontech Laboratories, Inc. (Fed. Cir. 2005)

        By Donald Zuhn —

    In an appeal from a District Court judgment invalidating
    more than two hundred claims in three Invitrogen patents as being anticipated
    under § 102(g)(2), the Federal Circuit vacated the District Court’s invalidity
    judgment and remanded the case for further proceedings, holding that the
    District Court misapplied the law of appreciation when determining the date of
    conception for researchers at Columbia University.  The Federal Circuit, however, affirmed the
    District Court’s rulings on enablement, written description, and infringement.

    The patents at issue relate to a genetically modified
    version of the enzyme reverse transcriptase, which has use in the field of
    molecular biology.  Naturally-occurring
    (or unmodified) reverse transcriptase possesses both DNA polymerase and RNase H activities, the former permitting the enzyme to
    synthesize a DNA copy (cDNA) of a messenger RNA (mRNA) template, and the latter permitting the enzyme to degrade the mRNA
    template following cDNA synthesis.  In
    contrast, the modified enzyme lacks RNase H activity, and therefore, is unable
    to degrade the mRNA template following cDNA synthesis, allowing researchers to
    reuse the mRNA template to create additional cDNA copies.

    While neither party disputed the District Court’s
    determination that Invitrogen had reduced a modified reverse transcriptase
    lacking RNase H activity to practice in January of 1987, Invitrogen did find
    fault with the lower court’s ruling that Drs. Stephen Goff and Naoko Tanese,
    two researchers at Columbia University, had conceived of such an enzyme before
    Invitrogen had reduced the enzyme to practice.  Drs. Goff and Tanese had begun their work in 1984 by preparing a panel
    of bacterial mutants having modified reverse transcriptase genes.  The panel included two mutants that the
    Columbia University researchers would later show possess modified reverse
    transcriptase lacking RNase H activity.  However, due to limitations in the assays that Drs. Goff and Tanese were
    using to measure RNase H activity, they were unable to conclusively establish
    that any of the mutants possessed modified reverse transcriptase lacking RNase
    H activity at the time the mutant panel was prepared.  In March of 1987, Drs. Goff and Tanese used a
    new assay that they had developed to finally establish that two of the mutants
    from their panel possessed the modified enzyme.  They were also able to correlate the results obtained with their new
    assay with their late 1986 sequencing analysis of the mutants.

    Following a series of pre-trial motions regarding the
    issues of conception, enablement, written description, and infringement, the
    District Court determined, inter alia, that Drs. Goff and Tanese (a) had
    conceived of a genetically modified reverse transcriptase lacking RNase H
    activity either in December of 1984 when they had isolated mutants possessing
    modified reverse transcriptase, or in January of 1986 when they had sequenced
    the reverse transcriptase genes in these mutants; (b) had actually reduced
    their invention to practice in March of 1987 when they established that two
    mutants from their panel possessed modified reverse transcriptase; and (c) were
    diligent in reducing their invention to practice, and did not abandon, conceal,
    or suppress it.  However, despite these
    rulings, the District Court refused to find that the work of Drs. Goff and
    Tanese anticipated Invitrogen’s patents under § 102(g)(2), arguing that
    anticipation posed factual questions requiring resolution on a claim by claim
    basis.

    Stating that conception "require[s] more than
    unrecognized accidental creation," and instead "requires that the
    inventor appreciate that which he has invented," the Federal Circuit found
    that the District Court erred by establishing Drs. Goff and Tanese’s conception
    before January of 1987 and granting partial summary judgment for Clontech.  Relying on decisions of its predecessor
    Court, which "require some connection between the physical result (the
    invention) and the belief (by the inventor)," the Federal Circuit
    determined that the record was inconsistent with the District Court’s notion
    that Drs. Goff and Tanese set out to create a modified reverse transcriptase or
    appreciated in 1984 that their mutant panel contained two mutants possessing
    modified reverse transcriptase.  Rather,
    the Federal Circuit believed that this case "fit[] squarely within the
    unrecognized, accidental duplication cases."

    However, while the Federal Circuit determined that the
    evidence excluded both dates of conception proposed by the District Court, the
    Federal Circuit also found that Dr. Goff’s deposition testimony precluded it
    from finding that the District Court abused its discretion in refusing to grant
    partial summary judgment for Invitrogen on the issue of conception.  In particular, Dr. Goff had testified that he
    had formed a suspicion in late 1986, based on his difficulties analyzing the
    mutants, that two of the mutants possessed modified reverse transcriptase
    lacking RNase H activity.  Because a reasonable
    fact-finder presented with Dr. Goff’s testimony could conclude that the
    evidence preceding the researchers’ March 1987 testing might suffice, under the
    applicable standard, to corroborate Dr. Goff’s suspicions about the two
    mutants, the Federal Circuit vacated the District Court’s invalidity judgment
    and remanded the case for further proceedings.

    Invitrogen Corp. v. Clontech Lab., Inc. (Fed. Cir. 2005)
    Panel: Chief Judge Michel and Circuit Judges Rader and Gajarsa
    Opinion by Circuit Judge Gajarsa

    This article was originally published on Patently-O on November 20, 2005.

  • Ex parte Bandman (B.P.A.I. 2004)

        By Donald Zuhn —

    In an appeal from a final rejection of claims 3, 6, 7, 9,
    and 12 of U.S. Application No. 09/915,694, the Board of Patent Appeals and Interferences reversed the rejection
    of the claims under both the written description and enablement requirements of
    35 U.S.C. § 112, first paragraph, and entered a new ground of rejection under
    35 U.S.C. § 112, second paragraph, for claim 12.

    Claims 3 and 12 of the ‘694 application, which were
    representative of the subject matter on appeal, recite, inter alia, an isolated
    polynucleotide encoding a polypeptide comprising a naturally occurring amino
    acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO: 1
    (claim 3) and an isolated polynucleotide comprising a naturally occurring
    polynucleotide sequence at least 95% identical to the polynucleotide sequence
    of SEQ ID NO: 2 (claim 12).

    The Examiner had rejected claims 3, 6, 7, 9, and 12 for
    failing to comply with the written description requirement, asserting that the
    specification provides only a single representative species — the
    polynucleotide of SEQ ID NO: 2, and fails to disclose any structure-function
    relationship in this species.  The
    Examiner had also rejected claims 3, 6, 7, 9, and 12 for failing to comply with
    the enablement requirement, asserting that because the specification does not
    teach the specific amino acids and structural motifs in the proteins encoded by
    the claimed polynucleotides that are essential for protein activity
    (specifically, malate dehydrogenase activity), the amount of experimentation required
    to make the claimed polynucleotides was undue.  Appellants contended that because the claims at issue recite
    polynucleotides having a naturally occurring polynucleotide sequence, or that
    encode a polypeptide having a naturally occurring amino acid sequence,
    "through the process of natural selection, nature will have determined the
    appropriate amino acid sequences [i.e., those retaining malate dehydrogenase
    activity]."

    With regard to the written description rejection, the
    Board noted that "[t]he written description requirement . . . does not
    require a description of the complete structure of every species with a
    chemical genus" (Ex parte Bandman, No. 2004-2319, slip op. at 3 (B.P.A.I. January 6, 2005)).  The Board also compared the circumstances of
    the instant case with those faced by the Federal Circuit in Enzo Biochem, Inc.
    v. Gen-Probe Inc.    , 296 F.3d 1316 (Fed. Cir. 2002).  In Enzo Biochem, the Federal Circuit
    determined that an "[a]dequate written description may be present for a
    genus of nucleic acids based on their hybridization properties, ‘if they
    hybridize under highly stringent conditions to known sequences because such
    conditions dictate that all species within the genus will be structurally
    similar’" (Ex parte Bandman, No. 2004-2319, slip op. at 4 (B.P.A.I. January 6, 2005) (citing
    Enzo Biochem, Inc., 296 F.3d at 1327)).  In the instant case, the Board determined that the genus of molecules
    defined by the claims was similarly limited and reversed the Examiner’s written
    description rejection.

    With regard to the enablement rejection, the Board
    disagreed with the Examiner’s assertion that in order to satisfy this
    requirement, the specification must provide guidance regarding the specific
    amino acid residues that are tolerant to change without affecting malate
    dehydrogenase activity.  Instead, the
    Board deemed persuasive Appellants’ argument that because the claims were
    limited to naturally occurring sequences, nature will have determined the amino
    acid residues that are tolerant to change (i.e., naturally occurring variants
    will presumably retain malate dehydrogenase activity).  In particular, in reversing the Examiner’s
    enablement rejection, the Board determined that the Examiner had not provided
    sufficient evidence that a naturally occurring polypeptide that is at least 95%
    identical to the amino acid sequence of SEQ ID NO: 1 or a polypeptide encoded
    by a naturally occurring polynucleotide sequence that is at least 95% identical
    to the polynucleotide sequence of SEQ ID NO: 2 would not retain malate
    dehydrogenase activity.

    Although the Board reversed both the written description
    and enablement rejections, it also entered a new ground of rejection for claim
    12 under 35 U.S.C. § 112, second paragraph.  The Board found that the specification provided no guidance that would
    allow one of ordinary skill in the art to determine, with a reasonable degree
    of confidence, whether a polynucleotide sequence that is at least 95% identical
    to the polynucleotide sequence of SEQ ID NO: 2 occurs naturally.  The Board concluded that the metes and bounds
    of claim 12 were unclear, and therefore, that the claim was indefinite.

    Ex parte Bandman (B.P.A.I. 2004)
    Panel: Administrative Patent Judges Smith, Grimes, and Green
    Opinion by Administrative Patent Judge Green

    This article was originally published on Patently-O on June 14, 2005.

  • In re Fisher: EST Utility Redux

        By Donald Zuhn —

    On Tuesday, the Federal Circuit will hear In re Fisher,
    in which the Court will address the utility requirement for the first time
    since the Patent Office set forth revised Utility Examination Guidelines in
    January 2001.  Specifically, in Fisher,
    the issue of patentable utility is being raised with respect to nucleic acid
    molecules.  In commenting on the possible
    importance of this case, Harold Wegner has described Fisher as having "the
    potential of being either the single most important pharmaceutical patent case
    in recent years – or a yawn."  Amicus briefs filed by such well-known biotech and pharmaceutical companies as Affymetrix, Eli Lilly, and Genentech in support of the Board’s decision
    in Ex parte Fisher suggest that it may be the former as opposed to the latter.

    The particular controversy presented in Fisher can be
    traced back as far as 1991, when a group of NIH investigators led by J. Craig
    Venter sought to protect thousands of DNA sequences corresponding to portions of expressed genes.  Venter called these gene fragments expressed
    sequence tags, or ESTs.  Venter’s group
    sought to protect not only the ESTs themselves, but also the full-length
    sequences from which the ESTs were derived and the protein products encoded by
    the full-length sequences, without first determining the biological function of
    the encoded protein products.  In several
    applications filed on its ESTs, the NIH asserted a number of utilities,
    including the design of oligonucleotides for use in chromosomal analysis, PCR amplification, and recovering the corresponding full-length gene.  After receiving a second rejection on its
    initial filing, the NIH abruptly abandoned its attempts to protect the ESTs,
    and withdrew all of its pending EST applications from consideration.

    While the withdrawal of these applications temporarily
    quieted the debate surrounding EST patentability, the Patent Office again
    stoked the fires of controversy in 1995, when it published new Utility
    Examination Guidelines    .  The new
    Guidelines removed some of the obstacles to EST patenting by only requiring
    that an applicant assert a utility that was "specific" and
    "credible."  The new Guidelines
    had thus omitted the requirement that the assertion of utility also be
    "substantial," as set forth by the Supreme Court in 1966 in Brenner
    v. Manson    .  In 1997, the Patent Office
    further declared that since ESTs were acknowledged to have utility apart from
    the full-length sequences from which they were derived, an applicant would no
    longer be prevented from securing protection for an EST by the failure to
    specify the function of the full-length sequence from which that EST was
    derived.

    The Patent Office reversed course again in 2001 when it
    publishing revised Utility Examination Guidelines, reinstating the Brenner
    substantial utility prong.  The revised
    Guidelines now required that an applicant assert a specific and substantial
    utility for the claimed invention that would be considered credible by a person
    of ordinary skill in the art.  The Patent
    Office also issued Revised Interim Utility Guidelines Training Materials, which
    provided Examples indicating how the revised Guidelines were to be applied to
    thirteen different types of biochemical subject matter, including ESTs, as well
    as definitions of the three utility prongs.  In particular, the Training Materials defined "specific
    utility" as utility that is specific to the subject matter claimed, as
    contrasted with a general utility that would be applicable to the broad class
    of the invention; "substantial utility" as utility having a
    "real world" use; and "credible utility" as utility that is
    believable to a person of ordinary skill in the art based on the totality of
    evidence and reasoning provided.

    In the appeal to be heard Tuesday, Appellants Dane Fisher
    and Raghunath Lalgudi (employees of Monsanto Co., the real party in interest)
    seek to reverse the Board’s decision affirming the final rejection of a claim
    directed to five ESTs isolated from maize leaf tissue.  The five ESTs constitute only a small portion
    of the 4,013 sequences that Appellants originally claimed and an even smaller
    portion of the 32,236 sequences that Appellants disclosed in their
    application.  Appellants also asserted a
    number of utilities for the claimed ESTs in their application, including the
    use of the ESTs to identify polymorphisms (i.e., alternate forms, or alleles,
    of the claimed sequences), to design oligonucleotide probes or primers for use
    in isolating DNA sequences from other plants
    and organisms, and to measure mRNA expression levels in plant cells using
    microarray technology.

    The Board, in Ex parte Fisher, analyzed Brenner and
    subsequent CCPA and CAFC decisions in In re Kirk, In re Ziegler, In re Jolles,
    Cross v. Iizuka, and In re Brana, and determined that "[r]ather than
    setting a de minimis standard, Section 101 requires a utility that is
    ‘substantial’," or in the words of the Brenner court, "one that
    provides a specific benefit in currently available form."  The Board then examined Appellants’ asserted
    utilities and determined that none of the claimed ESTs provided a specific
    benefit in its currently available form.  In particular, with regard to Appellants’ assertion that the claimed ESTs
    could be used to measure mRNA expression levels in plant cells using microarray
    technology, the Board declared that "the asserted utility of the claimed
    nucleic acid – as one component of an assay for monitoring gene expression –
    does not satisfy the utility requirement of Section 101."

    In briefing the issues before the Federal Circuit, Appellants argue that the Board erred in concluding that an EST is
    "subject to a heightened standard of utility . . . that hinges upon some
    undefined ‘spectrum’ of knowledge about the function of the gene that
    corresponds to the EST."  Appellants
    also contend that the Board erred in concluding that the claimed ESTs lack
    patentable utility "despite the undisputed existence of eight
    scientifically useful applications for the claimed ESTs and a commercially
    successful industry built upon the sale and licensing of ESTs corresponding to
    genes of unknown function, just like those at issue here."  In arguing against the Patent Office’s
    application of a "heightened standard" of utility in this case, Appellants note that the Patent Office has set forth "three substantially
    different constructions of the utility standard over the last decade
    alone," and that the Board has adopted a test "so ambiguous and
    impracticable that even the PTO cannot articulate with any reasonable certainty
    when the claimed ESTs – or any other EST – might be entitled to patent
    protection."  Appellants also
    contend that the Patent Office has applied the wrong test in determining
    whether there is an assertion of specific utility, since "the specific
    utility prong only requires the existence of an identifiable benefit for the
    claimed invention; it does not require a benefit that is unique to the claimed
    invention."

    The Patent Office, on the other hand, denies that Appellants’ ESTs have been subjected to a heightened standard, arguing instead
    that Appellants merely failed to assert a specific and substantial utility for
    the claimed ESTs that would be considered credible by a person of ordinary
    skill in the art.  In its brief, the Patent
    Office often focuses on Appellants’ failure to satisfy the specific utility
    prong, arguing, for example, that Appellants’ asserted utilities "would
    apply not only to the over 32,000 ESTs Fisher discloses, and to the over
    600,000 ESTs disclosed in Monsanto’s [six] related appeals, but also to any
    ESTs derived from any organism."  In
    particular, the Patent Office counters Appellants’ argument that because each
    EST only specifically binds to its complement, the specific sequence of each
    EST makes its use as a probe or primer specific, by stating that "there is
    no specific reason for using the EST to bind its complement," and
    therefore, "[t]o the extent that more sequence data could be acquired by
    using the ESTs as probes, that result would likely be true for any scrap of DNA derived from nature."  Finally, in
    responding to Appellants’ assertion that ESTs have a real world value as part
    of a multi-billion dollar industry, the Patent Office contends that
    "batches of ESTs of unknown significance are sold for the purpose of
    finding targets worthy of further development, not because the individual ESTs
    have any specific currently available benefit."

    Dr. Zuhn’s article "DNA Patentability: Shutting the Door to the Utility Requirement," which was published in the summer 2001 issue of the John Marshall Law Review, contains a
    more thorough discussion of the history of the utility requirement,
    particularly with respect to DNA sequences.

    This article was originally published on Patently-O on May 2, 2005.

  • In re Crish (Fed. Cir. 2004)

        By Donald Zuhn —

    In an appeal from a decision of the Board of Patent Appeals and Interferences, the
    Federal Circuit affirmed the rejection of claims directed to purified DNA molecules having promoter activity for the human involucrin gene (hINV) as
    unpatentable under 35 U.S.C. § 102(b).

    After isolating and sequencing the promoter sequence for
    hINV in the plasmid pSP64λI-3 H6B, Appellants pursued claims directed to
    specific portions of the promoter sequence having promoter activity.  The claims were rejected under § 102(b) as
    being anticipated by one of Appellants’ own publications, disclosing the
    approximate size and structure — but not the sequence — of the hINV promoter,
    and by a second publication, disclosing protein-binding sites on the hINV
    promoter.  In Appellants’ own publication
    the plasmid pSP64λI-3 H6B was used to determine the structure of the hINV
    promoter, while in the second publication the plasmid pSP64λI-3 H/Hc was used
    to identify protein-binding sites on the hINV promoter.  Appellants appealed the Examiner’s final
    rejection to the Board.

    Appellants first asserted that even if the publications
    cited against their application used plasmids containing the same hINV promoter
    region, other workers had sequenced the hINV promoter region in the plasmid pSP64λI-3 H6B, and had obtained a sequence that differed significantly from the
    promoter sequence described in Appellants’ application.  In addition, Appellants asserted that because
    neither prior art publication specifically disclosed the nucleotide sequence
    recited in their application, neither publication could anticipate their
    application.  The Board affirmed the
    Examiner’s final rejection, concluding that Appellants had failed to
    demonstrate that the plasmids used in the prior art publications possessed hINV
    promoter sequences that differed from the sequence described in Appellants’
    application.  The Board also determined
    that although neither prior art publication disclosed the hINV promoter
    sequence, the plasmids described in each publication necessarily possessed an hINV
    promoter sequence that was identical to the sequence described in Appellants’
    application.

    In affirming the Board’s decision, the Federal Circuit determined
    that the Board had reasonably concluded that the plasmids used in Appellants’
    prior publication and in Appellants’ application were identical.  The Court next concluded, in addressing
    Appellants’ first assertion, that it was irrelevant whether other workers had
    obtained a different sequence for the promoter region of hINV since Appellants
    could not rely upon the inability of another worker to correctly sequence the
    promoter region of the hINV gene from plasmid pSP64λI-3 H6B when they had
    accurately sequenced the promoter region themselves.  Finally, with regard to Appellants’ second
    assertion, the CAFC determined that "[Appellants’] characterization that
    the pending claims cover a novel DNA sequence having promoter activity, whereas the references disclose only the
    starting material plasmid, is unsound," since "[t]he starting
    material plasmid necessarily contains the gene of interest, including the
    promoter region."

    In re Crish (Fed. Cir. 2004)
    Panel: Chief Judge Mayer and Circuit Judges Lourie and Dyk
    Opinion by Circuit Judge Lourie

    This article was originally published on Patently-O on January 3, 2005.

  • In re Wallach (Fed. Cir. 2004)

        By Donald Zuhn —

    In an appeal from a decision of the Board of Patent Appeals and Interferences, the
    Federal Circuit affirmed the rejection of claims directed to isolated DNA
    molecules encoding TNF binding protein II (TBP-II) under the written
    description requirement of 35 U.S.C. § 112.

    Appellants had purified TBP-II from urine and determined
    (a) the amino acid sequence of an N-terminal portion of the protein, (b) the
    protein’s molecular weight, and (c) that the protein inhibited TNF
    activity.  Appellants then pursued, in
    separate divisional applications, claims directed to proteins having the
    partial sequence, molecular weight, and inhibitory activity described and
    claims directed to isolated DNA molecules encoding such proteins.  The DNA claims were rejected under § 112 as
    lacking an adequate written description in the specification.  Appellants appealed to the Board, which
    affirmed.

    Appellants asserted that because the PTO had effectively
    conceded that claims to the TBP-II protein were adequately described in the
    specification, the claims to isolated DNA molecules encoding the TBP-II protein
    were therefore adequately described in the specification.  Specifically, Appellants argued that because
    the complete amino acid sequence of a protein is an inherent property of an
    isolated, fully characterized protein, and the determination of a protein’s
    complete amino acid sequence puts one in possession of all DNA sequences
    encoding that protein (as a result of the unequivocal correspondence between
    amino acids and DNA codons in the genetic code), Appellants’ full
    characterization of TBP-II (i.e., determination of its N-terminal amino acid
    sequence, molecular weight, and inhibitory activity) demonstrated possession of
    all DNA sequences encoding TBP-II.  The
    PTO countered that because Appellants’ specification included neither the
    complete amino acid sequence of TBP-II nor any actual DNA sequence, and
    disclosed the sequence of only ten of the 185-192 amino acids that make up
    TBP-II, Appellants had not demonstrated possession of all DNA sequences
    encoding TBP-II.

    The Federal Circuit noted that while "the state of the art has
    developed such that the complete amino acid sequence of a protein may put one
    in possession of the genus of DNA sequences encoding it," Appellants had
    not disclosed the complete amino acid sequence of TBP-II, but rather, had
    provided only a partial sequence of the protein.  In addition, the Court concluded that
    Appellants’ possession of TBP-II "says nothing about whether they were in
    possession of the protein’s amino acid sequence [since] Appellants have not
    provided any evidence that the full amino acid sequence of a protein can be
    deduced from a partial sequence and the limited additional physical
    characteristics that they have identified."  With respect to the DNA claims at issue, the CAFC determined that absent a description of the complete TBP-II amino acid
    sequence or any evidence of a "known or disclosed correlation between the
    combination of a partial structure of a protein, the protein’s biological
    activity, and the protein’s molecular weight, on the one hand, and the
    structure of the DNA encoding the protein on the other," the Board’s
    decision to affirm the rejection of Appellants’ DNA claims was proper.

    In re Wallach (Fed. Cir. 2004)
    Panel: Chief Judge Mayer and Circuit Judges Lourie and Gajarsa
    Opinion by Circuit Judge Lourie

    This article was originally published on Patently-O on August 11, 2004.

  • Patent Docs: New Patent Law Weblog

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    Patent Docs     is a new weblog focusing on recent developments in biotech and pharma patent law.  This weblog will offer updates regarding changes in Patent Office rules and procedures affecting biotech and pharma patent prosecution, and provide summaries of recent court and board decisions impacting biotech and pharma patent litigation and prosecution.  In addition, Patent Docs will report on biotech and pharma news and highlight newly issued biotech and pharma patents.  The news and information presented on Patent Docs is provided by a group of patent practitioners holding doctorates in a diverse array of biotech and chemical disciplines.