• ABAThe American Bar
    Association (ABA) Section of Intellectual Property Law, Section of Science and
    Technology Law, and Center for Professional Development will be offering a live
    webinar and teleconference entitled "Single Claim Restriction
    Requirements: The Interplay Between 35 USC § 112 and 35 USC § 121" on
    October 2, 2012 from 12:00 – 1:30 pm (Eastern). 
    Dr. Keisha Hylton-Rodić of Drinker Biddle & Reath LLP will moderate
    a panel including Thomas L. Irving of Finnegan, Henderson, Farabow, Garrett
    & Dunner, LLP and Dr. Orlando Lopez of Burns & Levinson LLP.  The panel will examine the balance between 35
    USC § 112 and 35 USC § 121, and their interplay in the context of single claim
    restriction requirements, as exemplified in Ex
    Parte Degrado
    , and address the tactics that can be used during prosecution
    to avoid the pitfall of single claim restrictions in chemical and biotech cases
    in contravention of current case law on the practice.

    The registration fee for
    the webcast is $95 for members of any of the sections sponsoring the webinar,
    $99 for government attorneys, $150 for ABA members, and $195 for the general
    public.  Those interested in registering
    for the webinar, can do so here or by
    calling 800-285-2221.

  • LSI - Law Seminars International - blueLaw
    Seminars International (LSI) will be offering a one-hour telebriefing on the
    "New Third Circuit Ruling in the K-Dur
    'Reverse Payments' Case: Practical Implications for Patent Litigation and FTC
    Enforcement" on September 20, 2012 from 1:00 – 2:00 pm (Eastern).  Jeffrey W. Brennan of McDermott Will &
    Emery will moderate a panel including Seth C. Silber of Wilson Sonsini Goodrich
    & Rosati PC and Thomas G. Krattenmaker of Krattenmaker Consulting.  The panel will analyze the K-Dur decision, compare and contrast it
    to the three preceding appellate decisions that involved a markedly different
    analytical approach to the issue, assess the likelihood of Supreme Court review
    and the issues on which the Court is most likely to focus, and discuss the K-Dur decision's implications for client
    counseling and future FTC enforcement. 
    Among the topics to be covered are:


    The evolution of pay-for-delay case law culminating in the K-Dur decision;

    The K-Dur court's analytical approach and core holding;

    The fundamental principles that separate the Third Circuit from the Eleventh,
    Federal and Second Circuits on pay-for-delay analysis;

    Whether the Supreme Court will hear the case and, if so, how the Court is
    likely to approach and decide the issues; and

    How K-Dur changes the dynamic for
    counseling clients trying to settle patent infringement litigation.

    A
    Q&A will follow the presentation and last for up to 30 minutes.

    The
    registration fee is $125 per caller and $50 each additional person on the same line
    who desires continuing education credit. 
    Those interested in registering for the telebriefing, can do so here.

  • By
    Andrew Williams

    SantarusLast
    week, the Federal Circuit partially overturned the U.S. District Court for the
    District of Delaware's decision in Santarus,
    Inc. v. Par Pharmaceutical, Inc.
    , thereby allowing Santarus to keep Par's
    generic version of Zegerid® off the market until the expiration of the Orange
    Book-listed patents.  Judge Newman
    provided a separate opinion, also finding that Santarus should have been
    successful, but disagreeing with the majority per curiam opinion on the issues of what is required for written
    description of a negative claim limitation, whether the subject matter in a
    parent patent can serve as prior art to a chain of continuation-in-part
    applications, and whether a claimed invention can be considered obvious in view
    of overwhelming evidence of unexpected results and skepticism in the field.

    The
    technology at issue in this case involved specialized formulations of
    benzimidazole proton pump inhibitors ("PPIs"), such as omeprazole or
    lansoprazole.  This class of compounds is
    able to inhibit gastric acid secretion to prevent and treat stomach
    acid-related diseases and disorders.  Even though these PPIs block stomach acid production, they are extremely
    sensitive to this same acid.  Therefore,
    the prior art FDA-approved formulations included an enteric coating to protect
    the active ingredient.  Dr. Phillips, at
    the University of Missouri, figured out how to formulate these drugs without
    the enteric coating by including a buffering agent that allowed the PPIs to be
    directly absorbed from the stomach into the blood stream.  This had numerous advantages, including rapid
    and consistent bioavailability, increased effectiveness, and ease of
    administration (thereby assisting patient compliance).  Dr. Phillips filed a first provisional on
    January 4, 1996, to which the first patent, U.S. Patent No.
    5,840,737 ("the '737 patent"), claimed priority.  All of the patents at issue in this case were
    either continuations or continuations-in-part in a chain that stretched back to
    the '737 patent.  The patents-in-suit
    included U.S. Patent Nos. 6,489,346 ("the '346 patent"), 6,645,988 ("the
    '988 patent"), 6,699,885 ("the '885 patent"), 6,780,882 ("the
    '882 patent"), and 7,399,772 ("the '772 patent").

    Par PharmaceuticalThe
    present action was initiated after Par filed an ANDA to market the same
    formulation as the Zegerid® PPI.  In
    response to Santarus' claims of infringement of selected claims of the
    patents-in-suit, Par alleged that it did not infringe, and asserted that the
    claims at issue were unenforceable, as well as invalid for either a lack of
    written description or as being obvious over the prior art.  The Delaware Court found that the claims were
    infringed, and that they were not unenforceable, but that some of the claims of
    the '772 patent were invalid as failing the written description requirement,
    and that all claims were invalid as obvious.  Both parties appealed the rulings adverse to it, but Par did not
    challenge the finding of infringement.

    Inequitable
    Conduct

    Federal Circuit SealAs
    an initial matter, the Federal Circuit affirmed the lower court's finding that
    the applicant did not commit inequitable conduct.  Par had alleged that Dr. Phillips had
    intentionally withheld information during the prosecution of the parent
    application, and only submitted it during the prosecution of subsequent
    applications.  Dr. Phillips claimed that
    he was not aware that he needed to submit information related to the
    experimental administration to patients.  In addition, once the University's patent counsel became aware of the
    information, he submitted it in an Information Disclosure Statement.  The lower court found that Dr. Phillips's
    explanation "strained credibility," but that there was insufficient
    evidence to establish by clear and convincing evidence that there was an
    affirmative intent to deceive.  On
    appeal, Par stressed the "strained credibility" comment, but the
    entire panel agreed that the lower court's decision was in accord with Therasense.  This determination is good news for
    pharmaceutical companies that in-license technology from Universities.  With a different outcome, entire patent
    portfolios could have been jeopardized based solely on the misconceptions of
    inventors who are not always aware of the intricacies of patent law.

    Written
    Description

    The next issue related to the adequacy of disclosure involving certain claims of
    the '772 patent that had the negative limitation "wherein the composition
    contains no sucralfate."  This
    limitation was apparently added during the prosecution of the application, citing
    to the specification's highlighting that sucralfate and other compounds have certain
    disadvantages.  The lower court,
    majority, and concurrence all took different views of what is required to
    support a negative limitation.  On the
    one hand, the District Court held that the negative limitation could only be
    added if the specification demonstrated that sucralfate was
    contraindicated.  The lower court
    concluded that, because the Phillips' composition was only described as
    advantageous in the specification, the negative limitation could not satisfy
    the written description requirement.  The
    majority took a more lenient approach, pointing out that "[n]egative claim
    limitations are adequately supported when the specification describes a reason to
    exclude the relevant limitation."  Because those skilled in the art would
    understand that the disadvantages of including sucralfate could be avoided by
    the Phillips formulation, the written description was satisfied.  Furthermore, because the originally filed
    application contained the same disclosure related to sucralfate, these claims
    were entitled to claim priority back to the '737 patent (which is an important
    consideration for the obviousness analysis).

    Judge
    Newman agreed that the negative limitation had adequate written description
    support, and that these claims were entitled to the priority claim, but she
    complained that the majority opinion unnecessarily created a new requirement
    that a specification "describe a reason" for a claim limitation.  In justifying her criticism, she pointed out
    that applicants routinely amend claims during prosecution in response to prior
    art cited by the Patent Office.  Moreover, she pointed out that data may be generated during the
    application process that may necessitate claim amendments that were not necessarily
    appreciated when the application was filed.  By requiring a reason in the specification for a negative limitation,
    she warned, a patent applicant may no longer be able to sufficiently narrow an
    application to get around the prior art.  Ultimately, she concluded, the Court's new requirement adds uncertainty,
    which will be to the detriment of commerce.

    Obviousness
    – '737 patent as prior art

    The
    more interesting issue relating to sufficiency of disclosure involved the use
    of the ultimate parent, the '737 patent, as prior art against a subset of the
    asserted claims.  The patents at issue
    were all continuations and continuations-in-part that reached back to the '737
    patent.  The District Court had made a
    priority determination for all of the claims, and because it determined that a
    subset of the claims could not claim priority to the '737 patent, that patent
    could be cited as prior art.  Interestingly,
    except for the sucralfate claims mentioned above, Santarus did not challenge
    the lower court's priority determination as to any of the claims.

    The
    Federal Circuit overturned the obviousness determination with regard to the
    sucralfate negative limitation claims.  However, because the '737 patent disclosed all of the limitations of the
    other asserted claims, the Court upheld the obviousness determination.  The dissent pointed out that the problem with
    this decision was that, if the '737 patent did, in fact, contain all of these limitations,
    why were these patents unable to claim priority back to the same
    disclosure.  In fact, Judge Newman
    appears to take the position that subject matter common to a patent and a
    priority document can never be used to invalidate a patent claim.

    Santarus
    had made three arguments as to why the '737 patent failed to disclose the
    claimed subject matter.  In the first two
    arguments, it alleged that the '737 patent failed to disclose non-enteric
    coated PPIs and buffer within the claimed ratios, and failed to disclose that
    the buffering agent be sodium bicarbonate "in an amount from about 1000 mg
    to about 2000 mg."  For both of
    these arguments, the majority went to great effort to point out how these
    ratios or ranges overlap ranges disclosed in the '737 patent.  However, the majority opinion did not explain
    why one skilled in the art would have selected the particular claimed range, or
    would have had any expectation that such a range would work.  Presumably, therefore, the overlap was so
    great that such a determination was unnecessary.  If this was the case, though, it is unclear
    why the '737 patent did not anticipate the claims at issue rather than just
    render them obvious.  Santarus' final
    argument was that the '737 patent did not recite the specific blood serum
    concentrations of PPI that were recited in some of the claims.  The Court pointed out that such
    concentrations were inherent properties of the '737 patent, and therefore their
    inclusion in the claim could not otherwise make an invalid claim valid.  Again, the problem is that the Court was
    undertaking an obviousness determination, and as such, inherency should not be
    a factor.  Instead, the analysis should
    focus on why one skilled in the art would have selected the particular
    concentrations to arrive at the claimed blood serum concentrations.  Of course, if the '737 patent "anticipated"
    the claims, than it is unquestionable that one could not simply claim the
    inherent properties of carrying out the disclosure.

    Judge
    Newman appears to have a valid point that the subject matter of the '737 patent
    should not be used as prior art against the claims at issue, especially in view
    of the fact that the obviousness determination was in view of only the single
    reference, and that reference appears to anticipate the claims more than render
    them obvious.  Of course, if the '737
    patent "anticipated" the claims at issue, then it must have supported
    the claims in the first place.  As
    unsatisfactory as it is, the answer probably lies in the fact that Santarus did
    not challenge the lower court's priority determination.  It would be very interesting to see if the
    majority opinion would have been different would Santarus have done so.

    Obviousness
    – '737 patent not prior art

    Finally,
    the lower court had held that the remaining asserted claims were invalid as
    obvious in view of two references, Pilbrant and Lammers.  The majority overturned this determination
    with regard to conventional oral dosage forms, such as tablets, capsules, or
    granules with non-enteric coated PPIs, because it found that Pilbrant taught
    away from formulating omeprazole according to the claims with regard to these
    forms.  However, the majority did not
    accept Santarus' assertion that Pilbrant taught away from all non-enteric
    coated omeprazole formulations.  As a result, the Court upheld the obviousness
    determination with regard to these claims.

    The
    dissent, again, would have overturned the invalidity determination with regard
    to all of the claims.  As Judge Newman
    pointed out, the majority opinion failed to take into account the entirety of
    the Pilbrant teaching.  Apparently, when
    read properly, Pilbrant actually taught away from using omeprazole without the
    enteric coating.  Moreover, according to
    Judge Newman, the majority erred by only focusing on these two references, and
    failed to take into account the state of the art, in which every patent or
    publication stated that PPI must be enteric coated.  In fact, there was apparently much skepticism
    in the art that the Phillips formulation would even work.  As such, Judge Newman accused the majority of
    using hindsight reasoning.  Finally,
    Zegerid® had sales of over $100 million in 2008, demonstrating commercial
    success, which the dissent pointed out can be highly probative of the
    non-obviousness.

    Santarus, Inc. v. Par
    Pharmaceutical, Inc.
    (Fed. Cir. 2012)

    Panel: Chief Judge Rader and Circuit Judges Newman and Moore
    Opinion for the court Per Curiam; opinion concurring in part and dissenting in part by Circuit Judge Newman

  • By
    Kevin E. Noonan

    Supreme Court SealFarmer
    Vernon Hugh Bowman, losing patent infringement defendant in Monsanto Co. v. Bowman, has filed a supplemental brief in
    response to the brief submitted to the Supreme Court by the Solicitor General pursuant
    to a request for the Government's views on whether the Court should grant certiorari.  The brief raises arguments both cogent and
    otherwise, and reflects the political realities of preparing a petition to the
    Court having the greatest chance of being granted.

    Bowman
    makes three arguments.  First, he argues
    that the Solicitor General was wrong when he told the Court that the Federal
    Circuit's decision was not based on the "conditional sale" doctrine
    of Mallinckrodt, Inc. v. Medipart, Inc., as
    earlier applied in Monsanto Co. v. Scruggs
    and Monsanto Co. v. McFarling.  This argument correctly notes that the District Court relied on this Federal Circuit precedent, including language
    reciting that Monsanto was entitled to damages for Bowman's use of patented soybeans in his second
    planting.  The brief also cites the District Court for basing its decision on language in the licenses and other
    agreements between Monsanto and its distributors prohibiting saved seed or
    replanting of harvested seed.  Indeed, the District Court specifically found that there had been no unconditioned sale of the seed "because the farmers could
    not convey to the grain dealers what they did not possess themselves."

    The
    brief then extends this argument by asserting that the Federal Circuit necessarily agreed with the District Court's grounds for finding against Bowman based on the conditional sale
    doctrine.  (This argument seems to put
    the jurisprudential horse before the cart:  it is certainly the case that the District Court was following Federal Circuit precedent, but it does not follow
    that the appellate court affirmed this application of its precedent merely
    because it affirmed the District Court's judgment.)  The basis for this argument does not come
    from language from the Federal Circuit opinion, but appears to arise merely
    from the fact that the Federal Circuit refused to find that Monsanto's patent
    rights were exhausted, i.e., failed to find in Bowman's favor based on Bowman's
    arguments.  According to Bowman, a
    finding of patent exhaustion mandated a finding in his favor and (at least) a
    remand to reconsider the extent of the damage award.  Bowman also argues that remand was necessary
    because damages were based on acres planted, and "[a]s any Indiana farmer
    can confirm . . . acres of commodity soybeans planted as a risky second crop
    late in the growing season may not produce any
    progeny" (emphasis in original).  (There
    were no allegations in the brief that the damages calculation was otherwise
    defective, inter alia, because planted seed in fact produced no progeny
    soybeans.)  According to Mr. Bowman, this potential (but
    not established) disparity between acres planted and progeny soybean plants
    produced (made) renders the conditional sale doctrine the only grounds under
    which the Federal Circuit could affirm the judgment.

    Having
    made this logical leap, Bowman's argument easily follows:  because (in his view)
    the Supreme Court abrogated (or at least seriously questioned) the conditional
    sale doctrine by virtue of its Quanta Computer, Inc. v. LG Electronics, Inc. decision, this case becomes "an appropriate
    vehicle through which the Court may resolve uncertainty created by the Federal
    Circuit's continued reliance on the Mallinckrodt
    line of cases."  This uncertainty is
    created by the Federal Circuit not only by this case but, according to Bowman,
    by the appellate court's decisions in Princo Corp. v. International Trade Commission, characterizing that decision as being
    contrary to the Supreme Court's Quanta
    decision.

    Regardless
    of whether the Federal Circuit retains any inclination to follow the
    conditional sale doctrine in the face of the Court's Quanta decision, where Bowman's argument fails to hold water is
    with regard to the grounds of the Federal Circuit's decision in this case.  As set forth in the Solicitor General's brief,
    conditional exhaustion was not the basis for the Federal
    Circuit's decision in this case.  Rather, the Solicitor's brief quotes the
    Federal Circuit as saying that "'[e]ven if [respondent's] patent rights in
    the commodity seeds are exhausted, such a conclusion would be of no consequence
    because once a grower, like [petitioner], plants the commodity seeds containing
    [respondent's] Roundup Ready technology and the next generation of seed
    develops, the grower has created a newly infringing article."  In addition,
    "[t]he right to use [] do[es] not include the right to construct an
    essentially new article on the template of the original, for the right to make
    the article remains with the patentee.'"  The Solicitor further notes
    that the Court rejected the argument that replanting was the only use for the "commodity
    seed," noting that the seed was useful, inter alia, as animal feed.  Thus, Bowman's responsive brief
    mischaracterizes both the grounds for the Federal Circuit's decision and the
    Solicitor General's argument regarding that decision.  Indeed, the Solicitor General's argument was
    that the Court was not presented with
    a case where the Federal Circuit had decided contrary to the Court's direction
    (in Quanta); the cases where the Federal Circuit had applied the conditional sales doctrine (Scruggs and McFarling)
    were decided prior to the Court's Quanta decision.

    Bowman's second argument is that the
    Solicitor General's distinction between sold seed and progeny seed, wherein
    planting progeny seed is an infringement for "making" new seed
    regardless of whether the patent right had been exhausted for sold seed, is
    unsupported by the statute and inconsistent with" the distinctions created
    by Supreme Court law between "repair" and "reconstruction."  The principal basis for this argument is that
    planting seed to produce progeny soybean plants is a "use," which
    Bowman argues is an exhausted patent right upon first sale.  "[A]ny attempt by Monsanto to retain
    rights under the patent to exclude use is inconsistent with the doctrine of
    patent exhaustion as articulated by [the] Court for over 150 years," he
    argues, citing Adams v. Burke and U.S. v. Univis Lens for the proposition
    that "an authorized sale carries with it the right to use that machine to the full extent to which it can be used"
    (emphasis in the brief).  The issue, of
    course, is that a genetically engineered soybean is different in kind from 19th
    and 20th Century machines, making the principles established in such
    cases less than illuminating and certainly not determinative.

    Bowman's brief acknowledges that the
    Solicitor General agreed that Monsanto's patent rights were exhausted as for
    use of the commodity seed he planted.  However, for Bowman patent exhaustion permits any use (akin to "the full extent to which [a machine] could
    be used") including replanting, whereas the Solicitor General recognizes
    that there are exhausted uses (e.g.,
    as animal feed) and non-exhausted uses (replanting, which constitutes a "making"
    of new seed).  According to Bowman, the
    Solicitor General's position "eliminates the doctrine of patent exhaustion
    for self-replicating technologies" because certain uses, limited for now
    to "making" additional soybeans and seed, do not fall within the
    scope of the exhaustion.  In the type of
    rhetoric that arises in briefs in support of certiorari petitions, such an
    outcome would "exact[] an abhorrent servitude on these items of personal
    property as they meander through streams of commerce."

    The brief further disputes the Solicitor
    General's application of the "repair" vs. "reconstruction"
    dichotomy to the situation before the Court.  According to Bowman, "[t]hese cases are not germane to the use of
    patented seeds."  The reason:  the "use" of the sold seeds "may
    simply result in the creation of a
    new item" (emphasis in the brief).  The distinction between seeds and the repair
    reconstruction cases is that in the latter the "use" that attached to
    the sold seeds was "no longer possible" because the article had "become
    worn or destroyed."  Repair was
    permitted in this earlier Supreme Court precedent precisely because the sold
    article had not yet come to the end of its useful life (which, presumably,
    would trigger a further sale of a new embodiment of the patent product),
    whereas reconstruction occurs after that "point of no return" had been
    reached (presumably denying the patentee of a sale of a new embodiment of the
    patented product).

    Bowman's brief makes a valid point that
    seed is not "beyond repair" when it is replanted; the brief fails to
    acknowledge that, like reconstruction, replanting seed is essentially making ("reconstructing")
    a patented article, and not one where the patent right has been exhausted by a
    sale (unless that first "sale" is capable of echoing down the
    generation after generation of seed that can be made from that first planting
    of the sold seed).  Bowman concedes that
    private contractual arrangements may preclude replanting but would have the
    Court decide that protection against unlawful "reconstruction" by
    replanting patented seed is outside the protections of the Patent Act.

    Bowman's brief also argues that the
    Solicitor General's use of the term "make" in 35 U.S.C. § 271(a) to create the non-exhausted patent
    right is wrong; conceding that the statute does not define "make," he
    argues that adopting the Solicitor General's view would encompass both
    inducement to infringe (prohibited by 35 U.S.C. § 271(b)) and contributory infringement (35
    U.S.C. §
    271(c)).  The basis for this argument is
    that indirect infringers can be involved in "caus[ing] to exist" the
    patented article, and thus all indirect infringement would be direct
    infringement.  However, this argument is
    diminished if not vitiated by the Solicitor General's argument that replanting
    seeds and making new soybeans is an act of direct infringement that is supported
    by the literal language of 35 U.S.C. §
    271(a).  And the brief's citation of Deepsouth Packing Co. v. Laitram Corp.
    is unavailing because while true that "making"
    under the statute requires "an operable assembly of the whole and not the
    manufacture of its parts," replanting a seed is a making of "an operable assembly" of the whole
    soybean plant, an act performed in toto
    by Bowman (even though the brief argues that it is the seed that "'physically
    connected' all the elements of the claimed invention into an 'operable whole.'").

    In the final portion of this part of his
    argument, Bowman resurrects an argument that has been made before in cases
    involving genetically engineered cells (such as Amgen v. Elanex, 1996
    U.S. Dist. LEXIS 22015 (W.D. Wash, Feb. 6, 1996):  that the recombinant seed is "made"
    only upon introduction of the recombinant construct into the germline, and that
    because "Bowman did not form the plant cell with the claimed DNA sequence"
    he should be absolved of patent infringement liability.

    As the Solicitor General noted, the
    Federal Circuit recognized that "[t]he fact that a patented technology can
    replicate itself does not give a purchaser the right to use replicated copies
    of the technology," and "[a]pplying the first sale [patent
    exhaustion] doctrine to subsequent generations of self-replicating technology
    would eviscerate the rights of the patent holder."  According to the Federal Circuit, the right
    to use patented technology upon purchase "do[es] not include the right to
    construct an essentially new article on the template of the original, for the
    right to make the article remains with the patentee," citing Jazz Photo Corp. v.
    Int'l Trade Comm'n
    , 264
    F.3d 1094, 1102 (Fed. Cir. 2001).  "While
    farmers, like Bowman, may have the right to use commodity seeds as feed, or for
    any other conceivable use, they cannot 'replicate' Monsanto's patented
    technology by planting it in the ground to create newly infringing genetic
    material, seeds, and plants."  These
    differing views on the scope of the patent right provide the best argument for
    Supreme Court review (but certainly does not mandate it).  And while the Government acknowledges that
    the case presents something of a novelty, the dual nature of replanting as
    being both an (arguably) exhausted use and
    a non-exhausted making would appear to mitigate in favor of finding
    infringement for replanting ("the planting and harvesting of soybeans also
    constitutes the 'making' of newly infringing seed" (emphasis in
    original
    )).  Regarding the "making
    only occurs upon creation of the genetically engineered seed" argument, the
    Solicitor General cogently counterargued that "[p]etitioner 'cause[d] [the
    progeny seed] to exist,'" and it was immaterial that how that was accomplished
    differed from how the patentee had created the recombinant seed in the first
    place.  The Solicitor General's
    assessment of Bowman's culpability is also compelling:

    [P]etitioner did not simply leave the seed "untended on a field." 
    . . .  Rather, he intentionally planted the commodity seed in order to
    create a new crop of soybeans; he saved some of that new crop to replant the
    next growing season; he continued to plant, harvest, and save seed for eight
    successive years; and he exploited the known glyphosate-resistant properties of
    the progeny seed by treating his crops with a glyphosate-based herbicide.

    In his final argument, Mr. Bowman
    contends, contrary to the Solicitor General's brief, that deciding in his favor
    would be consistent with the Plant Variety Protection Act and the Court's J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. decision.  Mr. Bowman correctly
    notes that the Court's J.E.M. case
    does not speak to the scope and meaning of the word "make" in the
    statute.  But he argues (correctly) that
    the Court's J.E.M. decision does not
    indicate or mandate that principles of patent exhaustion.  This is a strawman, however; the Solicitor
    General's actual argument was that the Court refused to find that the presence
    of an affirmative exemption for farmers to save seed that can be used for
    replanting in the PVPA provided a contrast to the absence of any such exemption in for utility patents.  The Solicitor General argued that there would
    be "no practical significance" for this distinction (between plant
    and utility patents) "if the unauthorized creation of new seed was treated
    as non-infringing under 35 U.S.C. 154 and 271 [] based on the patent-exhaustion
    doctrine.  Petitioner would effectively read a seed-saving exemption into
    the Patent Act."  And this outcome
    would create a statutory inconsistency:

    If, as petitioner contends, the authorized sale of patented seed
    exhausts a patentee's rights in that seed, as well as in its progeny, then a
    grower could save second-generation seed and sell that seed commercially
    without infringing the patent.  That would, in turn, afford greater rights
    of exclusion to holders of a PVPA certificate than to utility patent holders,
    contrary to this Court's understanding in J.E.M. Asgrow Seed Co. v. Winterboer,
    513 U.S. 179 (1995), another case involving the seed-saving exemption of the
    PVPA.

    Not mentioned in Mr. Bowman's brief are
    the policy considerations involved (besides how the outcome of this case
    affects Mr. Bowman), something directly (and appropriately) addressed by the
    Solicitor General.  If, as Mr. Bowman
    contends, "the court of appeals' decision will eliminate commodity
    soybeans as a low-cost alternative for second-crop plantings, and will
    otherwise alter traditional farming practices," these are decisions
    best left for Congress.  In addition, the Solicitor General's brief
    reminds the Court that a Supreme Court decision on recombinant seeds "could
    also affect the enforcement of patents for man-made cell lines, DNA molecules,
    nanotechnologies, organic computers, and other technologies that involve
    self-replicating features."  Instead of deciding this issue in this
    case, "[t]he Court should allow the case law to develop further before
    considering whether to adopt a more restrictive definition of 'making' that
    could have unforeseen consequences for other present and future
    self-replicating technologies, citing the Court's own cautionary statements in
    this regard in Bilski v. Kappos, 130 S. Ct. 3218, 3227 (2010).

    Whether the Court heeds this warning will
    be seen when the Court has its petition conference on September 24th.

  • By Donald Zuhn

    USPTO SealLast week, the U.S. Patent
    and Trademark Office published a notice of proposed rulemaking in the Federal
    Register (77 Fed. Reg. 55028)
    presenting its proposal for setting and adjusting patent fees.  In proposing new fees, the Office is exercising
    the fee setting authority conferred upon it by § 10 of the Leahy-Smith America
    Invents Act.  The 59-page notice states
    that:

    The proposed fees
    will provide the Office with a sufficient amount of aggregate revenue to
    recover its aggregate cost of patent operations, while helping the Office implement
    a sustainable funding model, reduce the current patent application backlog,
    decrease patent pendency, improve patent quality, and upgrade the Office’s
    patent business information technology (IT) capability and infrastructure.

    The notice also states that
    "[t]he proposed fees also will further key policy considerations,"
    pointing to multipart and staged fees for requests for continued examination
    and appeals, which the notice indicates "aim to increase patent prosecution options for applicants" (emphasis
    in notice).

    As the Office's notice is one of proposed rulemaking, the Office is soliciting comments from the
    public regarding the proposed new fees. 
    Written comments must be submitted by November 5, 2012 to be
    considered.  Comments can be sent by
    e-mail to fee.setting@uspto.gov; by regular mail to Mail Stop — Office of the Chief
    Financial Officer, Director of the United States Patent and Trademark Office,
    P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of
    "Michelle Picard"; or via the Federal eRulemaking Portal.

    Pursuant to § 10 of the AIA,
    the Director is allowed to set or adjust any fee established, authorized, or
    charged under Title 35 (but "only to recover the aggregate estimated costs
    to the Office for processing, activities, services, and materials relating to
    patents").  AIA § 10 specifies that
    the Director submit proposed fee changes to the Patent Public Advisory
    Committee (PPAC) not less than 45 days before publishing the proposed fees in
    the Federal Register (which the Office did last February; see "USPTO Proposes Fees Changes"),
    after which the PPAC shall have 30 days to deliberate, consider, and comment on
    the proposal as well as hold a public hearing on the proposal (the Office held
    two public hearings on fees in February). 
    Pursuant to § 10, the Director shall then consider and analyze PPAC's
    comments, advice, or recommendations before setting or adjusting the fee (which
    last week's notice of proposed rulemaking does).  AIA § 10 also requires that the Director
    provide the public with a 45-day period in which to comment on any fee change
    (thus the November 5, 2012 deadline to submit comments), and specifies that fee changes shall not
    become effective until 45 days after the final rule regarding such change is
    published in the Federal Register (in order to give Congress an opportunity to
    enact a law disapproving of the fee change).

    With regard to the impact
    of the proposed fees on patent pendency, the notice states that:

    The Office estimates that the additional
    aggregate revenue derived from the proposed fee schedule will enable a decrease
    in total patent pendency by 12 months for the five-year planning horizon (FY
    2013–FY 2017), thus permitting a patentee to obtain a patent sooner than he or
    she would have under the status quo fee schedule.

    The notice also indicates
    that implementation of the Office's proposed fee structure would mean that
    "for all applicants the routine fees to obtain a patent (i.e., filing, search, examination,
    publication, and issue fees) will decrease by at least 22 percent relative to
    the current fee schedule."

    The proposed fees in the
    current notice differ from the fee increase proposed last week to reflect
    fluctuations in the Consumer Price Index (CPI) under 35 U.S.C. § 41(f) (see "USPTO Proposes New Patent Fees
    and CPI Adjustments to Certain Fees
    "),
    and fee proposals made earlier this year for new patent-related services that must
    be in place one year from the AIA's enactment (the Office notes that such fees
    could not be in place by September 16, 2012 given the requirements under § 10).  With respect to the CPI-based increase, the
    notice explains that it "is planned as a bridge to provide resources until
    the instant section 10 rulemaking (this NPRM) becomes final (at which time the anticipated
    section 10 fees would supersede the fees in the CPI rulemaking)."  The fee proposals made earlier this year are
    also viewed by the Office as being "needed on a temporary basis, from
    September 16, 2012, until this rulemaking becomes final."

    In the last week's notice,
    the Office sets or adjusts 352 patent fees, 94 of which apply to large
    entities, 94 to small entities, 93 to micro entities, and 71 of which are not
    entity-specific.  The Office notes that
    there were three primary steps involved in setting or adjusting fees:

    Step 1: Determine
    the prospective aggregate costs of patent operations over the five-year period
    [FY 2013-FY 2017], including the cost of implementing new initiatives to achieve
    strategic goals and objectives.
    Step 2: Calculate the
    prospective revenue streams derived from the individual fee amounts (from Step
    3) that will collectively recover the prospective aggregate cost over the five-year
    period.
    Step 3: Set or adjust
    individual fee amounts to collectively (through executing Step 2) recover
    projected aggregate cost over the five-year period, while furthering key policy
    considerations.

    Patent Docs will provide additional analysis of the Office's proposed new
    fees — including a list of the highest proposed utility fees, the utility fees
    that would increase the most under the proposed fee structure, and a comparison
    with the fees proposed last spring — in a subsequent post.

  • By Donald Zuhn

    EFS-WebIn a Patents Alert e-mail
    distributed last month, the U.S. Patent and Trademark Office announced that it
    was examining ways to modernize electronic filing.  One proposal, Text2PTO, would allow
    applicants to submit applications in a text format.  According to the Office's Alert, by
    submitting a text version of the application, applicants could use a validation
    wizard during the submission process to assure that any formatting (such as
    tracked changes) and private information are not part of the file, and that
    application parts can be recognized.  Applicants
    could also run an optional analytics report to identify any errors in claims
    numbering and ensure that the abstract length is correct.  In order to define and design the Text2PTO
    process so that it is user-friendly and best fits customer needs, the Office is
    seeking online filers to assist in gathering requirements, creating functional
    designs, and evaluating product releases. 
    The Office will also be holding focus sessions to discuss the proposed process
    changes.  Online filers interested in
    participating in the process are being asked to send an e-mail to efilingmodernization@USPTO.GOV.

    USPTO Director David Kappos
    provided additional information regarding the Text2PTO proposal on his
    Director's Forum blog.  The Director explains that under the new
    process, applicants would compose their applications using the same word
    processing software that they currently use, and then instead of converting the
    file to PDF format, would simply upload the text file to the USPTO.  By submitting a text-based document instead
    of a PDF, the Director notes that applicants will be able to retrieve a copy of
    the document from the USPTO at any time throughout prosecution, facilitating
    review and/or amendment.  In addition, a
    Text2PTO amendment validation tool will allow applicants to generate properly
    formatted mark-up language based on the types of changes made to the document.  The Office expects the Text2PTO to provide
    significant cost savings by eliminating the need to scan, OCR, and error-correct
    incoming patent applications, and the Director indicates that such cost savings
    would be passed on to applicants through filing fee discounts for applications
    submitted through Text2PTO.

    The Office is also looking
    at replacing its current fee collection system.  As it kicks off its fee collection system
    replacement effort, the Office will be conducting a number of outreach efforts,
    including focus sessions, to solicit user input.  Those interested in providing feedback are
    being asked to send their contact information; status as (1) individual pro se
    inventor or applicant, (2) in-house counsel, (3) law firm attorney
    practitioner, or (4) legal assistant or administrator; and approximate number
    of patent and/or trademark applications filed per year to fpng@uspto.gov.

  • By Sherri Oslick

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

    Teva Branded Pharmaceutical
    Products R&D Inc. et al. v. Perrigo Pharmaceuticals Co. et al.

    1:12-cv-01101; filed September
    5, 2012 in the District Court of Delaware

    • Plaintiffs:  Teva Branded
    Pharmaceutical Products R&D Inc.; Teva Respiratory LLC; Norton (Waterford) Ltd.; Norton Healthcare Ltd.
    • Defendants:  Perrigo
    Pharmaceuticals Co.; Perrigo Co.; Catalent Pharma Solutions LLC

    Infringement of U.S. Patent
    Nos. 7,566,445 ("Medicinal Aerosols and Methods of Delivery Thereof,"
    issued July 28, 2009) and 7,105,152 ("Suspension Aerosol Formulations,"
    issued September 12, 2006) following a Paragraph IV certification as part of
    Perrigo's filing of an ANDA to manufacture a generic version of Teva's ProAir®
    HFA Inhalation Aerosol (albuterol sulfate, used for the treatment or prevention
    of bronchospasm with reversible obstructive airway disease in patients 4 years
    of age and older and for the prevention of exercise-induced bronchospasm in
    patients 4 years of age and older).  View
    the complaint here.


    Medicis Pharmaceutical
    Corp. v. Actavis Mid Atlantic LLC

    1:12-cv-01091; filed August
    31, 2012 in the District Court of Delaware

    Infringement of U.S. Patent
    No. 8,236,816 ("2x2x2 Week Dosing Regimen for Treating Actinic Keratosis
    with Pharmaceutical Compositions Formulated with 3.75% Imiquimod," issued
    August 7, 2012) following a Paragraph IV certification as part of Actavis'
    filing of an ANDA to manufacture a generic version of Medicis' Zyclara® Cream
    (3.75% imiquimod cream, used for the topical treatment of clinically typical,
    visible, or palpable actinic keratoses ("AK") of the full face or
    balding scalp in immunocompetent adults). 
    View the complaint here.

  • Calendar

    September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

    September 18,
    2012 – New USPTO Rules for Post-Grant Proceedings (Strafford) – 1:00 – 2:30 pm (EDT)

    September 18, 2012 – Supplemental Examination: Rules and Strategy (Intellectual Property Owners Association ) – 2:00 – 3:00 pm

    September 19, 2012 – New Post Grant Proceeding Rules: Adjusting to the New Reality (Technology Transfer Tactics) – 1:00 – 2:15 pm (Eastern)

    September 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

    September 24-25, 2012 – Biosimilars and Biobetters*** (SMi) – London, UK

    September 25-26, 2012 – EU Pharma Regulatory Law*** (C5) – Brussels, Belgium

    September 28, 2012 – Focus on Biologics and Biosimilars (Catalyzing Collaboration Between Industry and Academia in the Life Sciences) – Hospira, Inc., Lake Forest, IL

    October 4,
    2012 – Myriad: The Gene Patent Fight Continues . . . (Technology
    Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

    October 10-11, 2012 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) – New York, NY

    October 10-11, 2012 – Biotech & Pharmaceutical Patenting*** (C5) – London, UK

    October 22-23, 2012 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – John Hopkins University, Montgomery County, MD

    October 24-25, 2012 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

    October 25-26, 2012 – Life Sciences Congress on
    Paragraph IV Disputes
    (Center for
    Business Intelligence) – Washington, DC

    October 25-27, 2012 – AIPLA 2012 Annual Meeting (American
    Intellectual Property Law Association) – Washington, DC

    November 28-29, 2012 – Biotech Patents*** (American Conference
    Institute) – Boston, MA

    November 28-29, 2012 – Orphan Drugs and Rare Diseases*** (American Conference
    Institute) – Boston, MA

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

  • BostonAmerican Conference
    Institute (ACI) will be holding its 14th Advanced Forum on Biotech Patents on
    November 28-29, 2012 in Boston, MA.  The
    conference will allow attendees to:

    • Prepare for the
    impending first-to-file regime and decide whether to file under the old or new
    patent code;
    • Analyze the
    outcome in Prometheus and its impact
    on personalized medicine;
    • Determine the
    implications of the Myriad case for subject matter patentability;
    • Design systems to
    rapidly respond to new post-grant and inter
    partes
    review procedures;
    • Explore ways in
    which the Therasense decision has
    changed how patent attorneys approach inequitable conduct concerns;
    • Utilize superior
    techniques to better protect antibodies and immunological innovations;
    • Scrutinize the
    recently issued biosimilars pathway regulations and craft a winning biologic
    patenting strategy; and
    • Assess how the
    combined evolution of prior art obviousness and obvious-type double patenting
    are influencing the future of secondary patents.

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

    • USPTO keynote: A
    primer on the USPTO's efforts to implement the America Invents Act — to be
    presented by Teresa Stanek Rea, Deputy Director of the U.S. Patent &
    Trademark Office;
    • The sky is not
    falling: Protecting your IP after Prometheus
    and Myriad;
    • Scrutinizing the
    CAFC'S decisions in Akamai and McKesson and protecting technology in their
    wake;
    • The complete
    guide to formulating a biosimilars patent strategy following the implementation
    of the FDA's approval pathway;
    • Overcoming the
    challenges and grasping the opportunities presented by the PTO's new post-grant
    review and inter partes review
    procedures;
    • Understanding the
    obligations and defenses afforded biotech patent attorneys post-Therasense — to be presented in part by
    Patent Docs
    author Dr. Kevin Noonan of McDonnell, Boehnen, Hulbert & Berghoff LLP;
    • Producing a robust written description to satisfy
    ever-shifting requirements and ensure patent validity;
    • Crafting a global strategy: Best practices for
    international prosecution and litigation to maximize the value of your biotech
    patent portfolio; and
    • Demystifying the current obviousness standard and
    its implications for biotech patenting.

    An interactive
    working group session entitled: "Integrating Changes at the PTO into
    Biotech Patent Practices" will be offered from 9:00 am to 12:00 pm on November
    28, 2012.  A post-conference master class
    entitled: "Successful and Practical Strategies for Patenting
    Antibodies" will be offered from 9:00 am to 12:00 pm on November 30, 2012.

    The agenda for the
    Biotech Patents conference can be found here.  A complete brochure for this conference,
    including an agenda, detailed descriptions of conference sessions, list of
    speakers, and registration form can be obtained here.

    ACI - American Conference InstituteThe registration
    fee is $2,295 (conference alone), $2,995 (conference plus group session or master
    class), or $3,495 (conference, group session, and master class).  Those registering on or before September 27,
    2012 will receive a $300 discount and those registering by October 26, 2012
    will receive a $200 discount.  Patent
    Docs
    readers who reference the discount code "PD
    200" will receive $200 off the current price tier when registering.  Those
    interested in registering for the conference can do so here,
    by e-mailing CustomerService@AmericanConference.com calling 1-888-224-2480, or
    by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Biotech Patents conference.

  • Technology
    Transfer Tactics will be offering a webinar entitled "Myriad: The Gene Patent Fight Continues . . ." on October 4,
    2012 from 1:00 – 2:00 pm (Eastern).  Patent Docs author Dr. Kevin Noonan of
    McDonnell, Boehnen, Hulbert & Berghoff LLP will analyze the most recent
    decision in the AMP v. USPTO case and
    discuss how the opinion affects universities and their relevant IP.  The webinar will cover the following topics:


    What the past has revealed:


    The first CAFC decision


    Enter Prometheus – GVR from the
    Supreme Court

    The second CAFC decision


    What the future holds:


    En banc considerations

    Certiorari petition

    The
    registration fee for the webinar is $197. 
    Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics