• By Donald Zuhn

    USPTO SealOn the same day that the
    Supreme Court handed down its decision in Association for Molecular
    Pathology v. Myriad Genetics, Inc
    .
    , the U.S. Patent and Trademark Office issued a one-page memorandum to its Patent Examining Corps to provide
    preliminary guidance on the decision. 
    The memo from Andrew Hirshfeld, the Deputy Commissioner for Patent
    Examination Policy, notes that in Myriad,
    "the Supreme Court held that claims to isolated DNA are not
    patent-eligible
    under 35 U.S.C. § 101," and that the decision "significantly
    changes the Office's examination policy regarding nucleic acid-related
    technology" (emphasis in original). 
    The memo advises the examining corps that:

    As of today,
    naturally occurring nucleic acids are not patent eligible merely because they have
    been isolated.  Examiners should now
    reject product claims drawn solely to naturally occurring nucleic acids or
    fragments thereof, whether isolated or not,
    as being ineligible subject
    matter under 35 U.S.C. § 101.  Claims
    clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a
    nucleic acid in which the order of the naturally-occurring nucleotides has been
    altered (e.g., a man-made variant sequence), remain eligible.  Other claims, including method claims, that
    involve naturally occurring nucleic acids may give rise to eligibility issues
    and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

    (emphasis in original).

    The memo concludes by
    noting that "[t]he USPTO is closely reviewing the decision in Myriad and will issue more comprehensive
    guidance on patent subject matter eligibility determinations, including the role
    isolation plays in those determinations."

    Patent Docs thanks Hal Wegner for alerting the patent community to the memorandum.

  • Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

    By Donald Zuhn

    Supreme Court Building #1In a much anticipated decision,
    the Supreme Court issued its opinion this morning in Association for Molecular Pathology v. Myriad Genetics, Inc.  In an opinion by Justice Thomas, joined by
    Chief Justice Roberts, Justices Kennedy, Ginsburg, Breyer, Alito, Sotomayor,
    and Kagan, and Justice Scalia concurring in part, the Court held that a naturally
    occurring DNA segment is a product of nature and not patent eligible merely
    because it has been isolated, but determined that cDNA is patent eligible
    because it is not naturally occurring.

    Noting that "[i]t is
    undisputed that Myriad did not create or alter any of the genetic information
    encoded in the BRCA1 and BRCA2 genes," the Court acknowledged that
    "[t]o be sure, [Myriad] found an important and useful gene," but
    indicated that "separating that gene from its surrounding genetic material
    is not an act of invention." 
    Justice Thomas also stated that Myriad's claims were not "saved by
    the fact that isolating DNA from the human genome severs chemical bonds and
    thereby creates a non-naturally occurring molecule" because "Myr­iad's
    claims are simply not expressed in terms of chemical composition, nor do they
    rely in any way on the chemi­cal changes that result from the isolation of a
    particular section of DNA."

    MyriadThe Court, however, also
    determined that "cDNA does not present the same obstacles to patentabil­ity
    as naturally occurring, isolated DNA segments."  In particular, Justice Thomas explained that "cDNA
    retains the naturally occurring exons of DNA, but it is distinct from the DNA
    from which it was derived," and therefore, "cDNA is not a 'product of
    nature' and is patent eligible under §101." Justice Thomas did provide one
    caveat, however, noting that "insofar as very short series of DNA may have
    no intervening introns to remove when creating cDNA," under such circumstance,
    "a short strand of cDNA may be indistinguishable from natural DNA."

    Importantly, the opinion
    concludes by stating that "[i]t is important to note what is not implicated
    by this decision."  In addition to
    noting that the case did not involve an innovative method of manipulating genes
    while searching for the BRCA1 and BRCA2 genes or new applications of
    knowledge about the BRCA1 and BRCA2 genes, the Court also indicated that it did
    not consider the patentability of DNA in which the order of the naturally
    occurring nucleotides has been altered. 
    Instead, the Court indicated that it was "merely hold[ing] that
    genes and the information they encode are not patent eligible under §101 simply
    because they have been isolated from the surrounding genetic material."

    Patent Docs will provide additional analysis of the opinion in a subsequent post.

  • By
    Andrew Williams

    There
    has been a lot of discussion recently in the mainstream press regarding the
    U.S. patent system and its perceived failings.  The current outcries stem from the apparent proliferation of "Patent
    Trolls," also known by the less derogatory term Patent Assertion Entities
    (or PAEs).  Prompted by this apparent
    threat, President Obama has proposed a series of legislative recommendations
    and executive actions, and Congress has introduced several new pieces of legislation,
    likely precipitated by the remarks of the President earlier this year.  In fact, the Chief Judge of the Federal
    Circuit, Judge Randall Rader, recently wrote an Op-Ed piece for The New York
    Times
    , with Colleen V. Chien and David Hricik, suggesting that judges might
    have the ability to curtail trolls by making them pay for abusive litigation ("Make Patent Trolls Pay in Court," New York Times, June 5, 2013).  Judge Rader explained that Section 285 of the
    Patent Act and Rule 11 of the Federal Rules of Civil Procedure gives judges
    the authority to shift the cost of litigation abuse from the defendant to the
    trolls.  It will be
    interesting to see if anything changes based on this response from all three
    branches of the U.S. government.

    NPRNevertheless,
    probably no one would argue that there has been in increase in abusive patent
    litigation in recent history, and that at least some of these problems stem
    from non-practicing entities.  However,
    it is clear that the mainstream media is not providing a balanced analysis of
    the issues involved, tending to quickly label any individual or organization
    that asserts its patent rights as a troll.  Lost in this discussion is a presentation of the merits of the patent
    system and the potential advantages of non-practicing entities (as even
    President Obama report acknowledged).  For example, NPR has mounted what appears to be an all-out assault on
    the allegedly "broken" patent system.  This recent barrage of criticism was anchored by an episode of "This
    American Life
    ," which aired a little over a week ago and focused almost
    exclusively on a single patent case stemming from an investigation of
    Intellectual Ventures (we provided some commentary on this episode; see "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues").  Shorter versions of this episode have been featured on other public
    radio shows since that time.

    One example
    that this episode touched on briefly was about a patent holder that has been
    asserting one of his patents against prominent podcasters, alleging that he invented podcasting back in the mid-'90s.  To further elaborate on this story, NPR's own podcast, "Planet
    Money," released an episode on May 31, 2013, entitled "When Patents
    Hit the Podcast
    ."  In this episode,
    Planet Money host Zoe Chace and correspondent Robert Smith explored the story
    of inventor Jim Logan and his company Personal Audio LLC ("Personal Audio").  Personal Audio had recently obtained a
    favorable jury verdict against Apple for infringing patents listing Mr. Logan
    as an inventor.  The parties later
    settled.  Mr. Logan has now turned his
    attention to podcasters themselves, thereby prompting the story.  The podcast did include a disclaimer that
    Planet Money had not been sued by Personal Audio, nor had it been approached
    about obtaining a license.  However, the
    clear implication was that if podcasters could be sued, anybody else could
    also.  In fact, during the Podcast, Mr.
    Logan's licensing attorney, Richard Baker, joked with Ms. Chace that because she
    had a playlist of summer songs, she owed him 15 cents.  "OK, sounds kind of scary, but he was
    actually joking," Ms. Chace
    explained.

    The
    episode was crafted to paint Mr. Logan in the worst possible light.  Listeners to the podcast unfamiliar with the
    patent system would definitely come away from the episode believing that Mr.
    Logan was attempting to hijack somebody else's idea and extort money out of
    them.  This story began in the mid-'90s,
    when Mr. Logan had the idea to provide audio content to customers in an
    episodic fashion.  He envisioned that
    this could be accomplished over the internet, but unfortunately the technology had
    not caught up with him yet.  Therefore, he
    established a business offering magazines on tape, which he named Personal
    Audio, by which customers could select different stories from different content
    providers and an audio version of those stories would be delivered on cassette
    tape.  This was mockingly referred to as the
    first podcast.  Mr. Logan applied for a
    patent, but his business never got off the ground, and all of his attempts at
    developing a player for digital content failed.  Mr. Logan had other ideas, though, such as pausing live TV (think TiVo),
    deep-tagging in videos (think YouTube), and enhancements to touch screens
    (which he sold to 3M).  But, except for
    the last one, all were deemed failures by the podcast.

    Years
    later, Mr. Logan and his attorney discovered that Apple was utilizing a playlist
    in most of their products, and that this playlist functioned essentially how
    Mr. Logan had envisioned it when he filed his patent application.  After successfully suing Apple, Mr. Logan was
    said to have set his sights on the podcasters themselves.  First, he filed a divisional application with
    claims that could more easily be read on podcasting.  Of course, Ms. Chace didn't use the word
    divisional application, but explained it in a more sinister manner ("[S]o
    he pulled up the patent and added to it to make sure the part he thought
    covered podcasting was emphasized"), and Mr. Smith expressed surprise that
    it was completely legitimate to go back and "tweak" your patent.  After obtaining this divisional patent in
    February 2012, Mr. Logan approached select podcasters, such as Marc Maron of
    the WTF podcast, to inquire about licensing his patent.  When he was asked about these threats, Mr.
    Maron suggested that his podcast might have to shut down if they were carried
    out.  Personal Audio has filed suit
    against several podcasting organizations, including ACE Broadcasting Network,
    LLC, distributors of "The Adam Carolla Show," one of the most
    successful podcasts.  The Planet Money
    podcast concluded with an interview of Julie Samuels of the Electronic Frontier
    Foundation ("the EFF"), an organization seeking to invalidate this
    patent at the United States Patent Office, although it was unclear whether any
    such proceeding has yet been initiated.

    In
    discussing this podcast, Patent Docs is not commenting on the merits of Mr.
    Logan's patent or the actions of Personal Audio.  For those interested, the asserted patent is
    U.S. Patent No. 8,112,504, and according to the ACE Broadcasting complaint,
    Personal Audio is asserting at least claim 31 of this patent.  Patent Docs is also not taking a position on
    the EFF's actions at this time in attempting to invalidate Mr. Logan's
    patent.  In fact, the patent system allows
    EFF and organizations like it to seek reexamination at the Patent Office if
    they are able to uncover legitimate invalidating prior art.  The problem with the Planet Money podcast is
    that at best it was misleading, but at worst it got several crucial patent
    concepts wrong.  And, considering the
    size and make-up of the audience that it reaches, it was unfortunate that this
    podcast did do a better job at presenting the positive side of the patent
    system.  It is no surprise that public
    opinion of the patent system appears to be waning.

    As
    a brief refresher, the ability to, and reasoning for, establishing a patent
    system can be traced back to the beginning of this country.  The U.S. Constitution, in Article 1, Section
    8, Clause 8, says:

    [The Congress shall have Power] [t]o promote the Progress of Science and useful
    Arts, by securing for limited Times to Authors and Inventors the exclusive
    Right to their respective Writings and Discoveries.

    Also,
    as explained on the Patent Office website, "[a] patent is a property right
    granted by the Government of the United States of America to an inventor 'to
    exclude others from making, using, offering for sale, or selling the invention
    throughout the United States or importing the invention into the United States'
    for a limited time in exchange for public disclosure of the invention when the
    patent is granted."  In other words, the inventor gets something
    (a limited period of exclusivity), but the public gets something also,
    disclosure of the invention.  Without the
    patent system, innovators would be incentivized to keep any new invention as a
    trade secret, thereby depriving the public of the ability to learn and improve
    upon the invention.  Unfortunately, most
    accusations that the patent system stifles innovation are based on
    extrapolations of individual anecdotes and are often unsupported by any data.

    The
    first misconception perpetuated by the Planet Money podcast was that the patent
    system should only reward inventors if they create a new "thing."  For example, Mr. Smith lamented that "patents
    stopped being about protecting your gizmo from someone else's gizmo and making
    money off of this protected space."  First of all, this completely ignores all of the valuable patents that
    have been granted for methods of using a "gizmo," or methods of
    making a "gizmo."  But, more
    importantly, the implication was that if the patent holder did not make the "gizmo"
    himself, society has not benefited.  This
    is not the case.  In order to ensure that
    the invention is disclosed to the public, the patent must teach those skilled
    in the art how to make and use the invention (see 35 U.S.C. § 112).  For this public disclosure to occur, it is
    irrelevant whether the inventor ever actually made the invention.  In fact, the Patent Office stopped requiring
    the submission of models in 1880.  Ms.
    Chace was on the right track when she asked Mr. Baker, Personal Audio's
    licensing attorney, whether "[i]f you have the idea of the thing, don't
    you have to invent the way to get it?"  Of course the answer is yes, but Mr. Baker didn't directly answer the question,
    but instead stated that the '504 patent provides a roadmap to how to do
    podcasting.  Interestingly, Ms. Chace
    followed up with the question:  "Do you think that the guy that invented
    iTunes, like, read your roadmap?"  Of course, the answer is that it does not matter, but anyone listening
    to the question would come away with the impression that iTunes developer did
    not, in fact, read the patent.  Now, we
    do not know either way, but what if they did?  Would that matter?  If so, it can easily be imagined that the
    script would flip, and Apple would then be the bad guy for stealing someone
    else's invention and without providing them any compensation.  But this perspective was not provided.

    Another
    issue that was at least misleading in the podcast was the suggestion that
    podcasters are the "end users" of the technology.  The podcasters are not the typical end users
    that come to mind.  Instead, most people
    would consider the term "end user" to refer to anyone that has ever
    listened to a podcast.  The only reason
    that this use of the term might make sense here is that claim 13 of the '504
    patent covers an "[a]pparatus for acquiring and reproducing media files
    representing episodes in a series of episodes as said episodes become
    available."  And even though it is
    incredibly unlikely that podcasters like Mr. Carolla are infringing the patent because
    they have made such an apparatus, they are still using such an apparatus
    (whether it is covered by the asserted claim or not).  Again, without taking any position on the
    merits of the case, we find it difficult to believe that ACE broadcasting does
    not benefit in some way from its podcast offerings.  To make the point, Mr. Smith used the example
    in the podcast that this case was akin to someone having a patent on the automobile,
    but instead of suing rival manufacturers, they sued the owners that bought and
    drove the cars.  This is not an
    appropriate analogy.  The more apropos
    analogy for this particular scenario would have been to compare the podcasters
    to taxi drivers — sure, the taxi drivers do not make the automobiles that this hypothetical patent covers, but the drivers sure do profit from using them.  It is likely that the same can be said of
    most commercial podcasters.

    Probably
    the most frustrating thing about this podcast was that the term "patent
    troll" was thrown around without ever truly being defined.  In fact, Ms. Chace never referred to Personal
    Audio as a troll herself, but instead she reported that:

    Julie Samuels [of EFF] uses a term for Jim and people like him, she calls
    them Patent Trolls.  It just means
    someone who doesn't build, doesn't make, doesn't create jobs.  A patent troll extracts money from people
    who do those things.

    The
    problem is that in this case, Mr. Logan was one of the original inventors on
    the patent at issue.  Therefore, this was
    not a case of a large patent-holding company that buys up other people's
    patents in an effort to assert them against others.  In fact, perhaps unwittingly, the podcast
    painted Mr. Logan as the quintessential small inventor trying to stand-up
    against Apple, the large corporation.  But, instead of the hero of American ingenuity, he was made to be the
    villain.  And why?  Because he was unsuccessful at developing his
    invention that he envisioned all those years ago.  Of course, it is easier to paint Mr. Logan in
    a negative light now because he is has been targeting podcasters, and that
    probably hits a little too close to home for Planet Money.  But, we must continue to ask ourselves
    whether there is a place in the U.S. patent system for the small inventor, and
    if so, what is that place.  It is these
    inventors that may not have the financial or technical resources to compete
    with the larger corporations without the protection of a patent, but they now
    risk being labeled a troll for asserting their patent rights, or worse yet,
    capitalizing on their invention by selling their patents to non-practicing
    entities that might have more leveraging power to help the patents receive full
    value.  Unfortunately, Mr. Logan might
    not be the best example, but the on-going debate should present both sides
    fairly in order to allow the public to come to an informed decision.

  • GenentechThe
    Court of Appeal recently heard a case relating to Genentech's patent, which
    claimed the use of human vascular endothelial growth factor (hVEGF) antagonists
    for the treatment of non-cancerous diseases which are characterised by
    excessive blood vessel growth (neovascularisation or angiogenesis).  Regeneron
    and Bayer sought a declaration of non-infringement and revocation of the patent
    based on construction, novelty, inventive step, and sufficiency arguments, all
    of which were rejected at first instance.  Regeneron and Bayer then appealed.

    RegeneronThe
    main issue discussed in the appeal proceedings was that of sufficiency.  The
    appellants argued that the patent's scope was too broad as it covered a wide
    range of antagonists and diseases.  It would therefore impose an undue burden on
    the skilled person to identify which diseases can be treated with which
    antagonists.  The judge held that if it is plausible or credible that the
    invention will work over substantially the entire scope of the claims, the
    claims can be defined in general terms.  This was found to be the case in the
    present proceedings due to the common thread of angiogenesis between the
    claimed disease states and so the scope of the claims was considered
    appropriate.  However, if only a few embodiments would work, these must be
    claimed specifically.  As for evidence to support the claims, it was held that there
    is no need to report results of clinical trials, but the evidence must show
    that the therapeutic effect is plausible.

    BayerFurther,
    the fact that regulatory approval would be hard to obtain was deemed to be
    irrelevant, as it takes into account factors such as side effects, which are
    not considered by the patent.  The appellants also cited various diseases as not
    being treated by the invention.  However, it was highlighted that it was only
    the angiogenic component that needed to be treated.  There was no evidence that
    there was no effect on the angiogenic component of the cited diseases, despite other
    components not being affected.  When discussing the construction of the claim,
    the judge found that angiogenesis must contribute to the pathology of the
    diseases covered, but need not be the cause of it.  This construction also meant
    that the skilled person would be able to easily identify the diseases covered
    by the claims.

    Finally,
    it was argued that the patent was insufficient if it extended to the allegedly
    infringing molecule (a chimeric molecule demonstrating high affinity and
    improved pharmacokinetics), as production of such molecules would require undue
    effort and is not described in the patent.  However, it was held that the
    skilled person would have regarded chimeric molecules as variants falling
    within the scope of the claim.  It was emphasised that a claim for a broad
    invention could cover embodiments that may be invented in the future and which
    may have further advantageous properties.  The allegedly infringing molecule was
    such an embodiment as it encompassed the technical contribution of the claimed
    invention by binding VEGF and inhibiting its biological activity, despite
    requiring in itself a good deal of ingenuity.

    The
    appellants also raised novelty and inventiveness objections over a document
    that discussed in vivo assays using VEGF
    antibodies and disclosed that the VEGF antibodies "may have therapeutic
    potential."  However, the judge held that the document did not disclose a
    therapeutic effect of the antibodies, or clear and unmistakeable directions to
    perform the invention.  Further, while the prior art suggested that VEGF may
    have therapeutic applications, it was disclosed as one of many factors being
    investigated.  The document also disclosed the antibodies as a research tool and
    so gave no reasonable expectation of success of using such antibodies therapeutically.

    The
    claims were therefore found to be novel and inventive.  The appeal was dismissed
    and the patent was found to be valid and infringed on all counts.

    This
    report comes from European Patent Attorneys at WP
    Thompson & Co.
    , 55 Drury Lane, London UK.  Further details and
    commentary can be obtained from Gill Smaggasgale,
    a partner at the firm.

  • By Donald Zuhn

    Washington - Capitol #3It has been less than three
    months since the remaining provisions of the Leahy-Smith America Invents Act (AIA)
    took effect, and just short of five months since the AIA Technical Corrections
    Act was enacted to "correct and improve certain provisions" of that
    legislation.  Nevertheless, Congress is
    once again looking to further reform (or tweak) U.S. patent law, with three
    patent-related bills and a discussion draft for a fourth bill having been
    introduced or released in the past four weeks.

    On May 16, the first of the
    three new patent bills was introduced in the House by Rep. Theodore Deutch
    (D-FL).  The "End Anonymous Patents
    Act" (H.R. 2024)
    would require the disclosure of ownership and transfers of ownership of patents.  In particular, the Act would require:

    (1) The entity to which a
    patent is issued shall, upon issuance of the patent, file with the USPTO a
    disclosure of the patent owner and any real party in interest in the patent.

    (2) The owner of a patent
    shall, upon payment of the maintenance fee, file with the USPTO a disclosure of
    the identity of the patent owner and any real party in interest in the patent.

    (3) The entity to which a
    patent, application, or interest therein is sold, granted, or conveyed shall,
    within 90 days after the date of the sale, grant, or conveyance, file with the USPTO
    a disclosure of the sale, grant, or conveyance, and any real party in interest
    in the patent, application, or interest.

    H.R. 2024 specifies that
    the failure to comply with the above requirements will result in the patent
    owner or real party in interest being limited to "damages from the date on
    which such requirement is met" in any infringement action brought by the
    patent owner or real party in interest. 
    After being introduced, H.R. 2024 was referred to the House Committee on
    the Judiciary.

    On May 22, Sen. John Cornyn
    (R-TX) introduced the "Patent Abuse Reduction Act of 2013" (S. 1013)
    in the Senate.  S. 1013 would add
    procedural requirements for patent infringement suits to Title 35.  In addition to requiring a party alleging
    infringement to include in its complaint, counterclaim, or cross-claim an
    identification of each patent, and each claim of each patent, allegedly
    infringed, as well as a specific identification of each accused instrumentality
    alleged to infringe the claim, the party alleging infringement would also be
    required to provide "a description of the principal business of the party
    alleging infringement" and to identify co-owners, assignees, and exclusive
    licensees of the asserted patent.  S.
    1013 would also limit discovery prior to claim construction "to
    information necessary for the court to determine the meaning of the terms used
    in the patent claim, including any interpretation of those terms used to
    support the claim of infringement." 
    After being introduced, S. 1013 was referred to the Senate Committee on
    the Judiciary.

    On June 4, Rep. Steve
    Chabot (R-OH) introduced the "Promoting Startup Innovation Act" (H.R.
    2236
    )
    in the House.  The bill, which was
    co-sponsored by Rep. Jason Chaffetz (R-UT), Judy Chu (D-CA), Howard Coble
    (R-NC), Anna Eshoo (D-CA), Blake Farenthold (R-TX), and Zoe Lofgren (D-CA), would
    modify the definition of micro entity in Title 35.  In particular, the legislation would:

    (A) Increase from 4 to 7
    the number of previously filed patent applications (excluding foreign applications,
    provisional applications, or international applications for which the basic
    national fee under was not paid) on which the applicant as been named as an
    inventor.

    (B) Increase from 3 times
    to 5 times the amount by which an applicant's gross income exceeds the median
    household income for the preceding calendar year.

    (C) Increase from 3 times
    to 5 times the amount by which the gross income of an entity having an
    ownership interest in the application exceeds the median household income for
    the preceding calendar year.

    H.R. 2236 would also
    require the Director to approve or deny any application for status as a micro
    entity not later than 45 days after the date on which the application is filed.  After being introduced, H.R. 2236 was
    referred to the House Committee on the Judiciary.

    In addition to the three
    bills discussed above, Rep. Bob Goodlatte (R-VA), the Chairman of the House
    Committee on the Judiciary, announced the release on May 23 of a discussion draft of legislation "designed to address the
    ever increasing problem of abusive patent litigation."  According to Chairman Goodlatte, the
    discussion draft
    "helps to address the issues that businesses of all sizes and industries
    face from patent troll-type behavior and aims to correct the current
    asymmetries surrounding abusive patent litigation" and marks "the
    first step in enacting meaningful legislation that reduces the costs of
    frivolous litigation, increases patent certainty and promotes the creation of
    American jobs."  A summary of the
    draft legislation can be found herePatent
    Docs
    will provide more information regarding the bill once the legislation,
    or its Senate companion, is introduced.

    For additional information
    regarding this and other related topics, please see:

    • "USPTO Issues Rules to Implement AIA Technical
    Corrections
    ," April 3, 2013

  • Human Embryonic Stem CellIn
    Oliver
    Brüstle v Greenpeace
    (Case
    34/10) the Court
    of Justice of the European Union (CJEU) ruled that any non-fertilised but parthenogenically stimulated
    human ovum constitutes a "human embryo" within the meaning of Article
    6(2)(c) as it is capable of commencing the process of development of a human
    being in the same way as an embryo created by fertilisation of an ovum.  Clarification of the scope term "human
    embryo" is important as it will determine whether technologies involving stem cells obtained from parthenogenically
    stimulated ova, but which cannot develop into a human being, are excluded from
    patentability as "human embryos" under the Directive.

    International Stem Cell CorporationThe
    UK High Court has now referred this question to the CJEU.  The referral stems from the UK Intellectual
    Patent Office's decision to refuse two patent applications filed by International Stem Cell Corporation (ISCC) relating
    to human stem cells.  The technology
    covered by the patent applications related to unfertilised human ova, subject to division and further development only
    by parthenogenesis (a form of asexual reproduction whereby embryos can grow and
    develop without fertilisation).  The ova produced
    by the methods covered by the patent applications only contained pluripotent
    cells.  These cells undergo division as
    would an embryo formed by fertilization, but are incapable of developing into a
    human being.  The patent
    applications were refused by the UKIPO on the grounds that the inventions were
    excluded from patentability under paragraph 3(d) of Schedule A2 to the Patents
    Act 1977 as covering the use of human embryos.

    UKIPOISCC argued that
    the UKIPO had incorrectly applied the test of "capable of commencing the process of development of a human being"
    not only to technologies involving embryos formed by fertilisation but also to technologies
    involving parthenogenesis and other processes such as somatic-cell nuclear
    transfer in non-fertilised ova.  ISCC argued
    that the correct application of the test was to exclude only technologies that
    enable the commencement of development which leads to a human being and not
    those technologies which enable the commencement of a process of development
    even if that process is incapable of leading to a human being.

    The UKIPO
    considered that the test laid down by the CJEU may apply only on the start of a
    development process but the exclusion did not necessarily require completion of
    the process which results in the birth of a human being in order for the method
    to be excluded.  However, the UKIPO
    submitted that the test developed by the CJEU was unclear and supported the
    referral of the question to the CJEU for clarification on the matter.

    When considering
    the Oliver Brüstle v Greenpeace case, the
    evidence before the CJEU was that parthenotes (bundle of cells produced
    following parthenogenises of an ova) have the potential to create a human being.  This is in contrast to the present case
    where it was accepted by all parties that the parthenotes produced by the
    methods of the invention were incapable of normal development.

    On appeal, the
    Judge was persuaded by the view that parthenotes were not the same as
    fertilised ova at any stage and that if the process of development was
    incapable of leading to a human being, then it should not be excluded from
    patentability as a 'human embryo'.  The Judge
    therefore allowed the referral to the CJEU to seek clarification of the test.

    It is
    apparent that the ISCC case turns on different facts to the Brustle decision since
    the technology covered by the ISCC patent applications produce parthenotes
    which cannot develop into a human being.  The UK High Court Judge stated that "excluding processes of development
    which are incapable of leading to a human being from patentability would not
    strike the purported balance sought by the Biotech Directive."

    We will report
    again when the CJEU's judgement is handed down.

    This
    report comes from European Patent Attorneys at WP
    Thompson & Co.
    , 55 Drury Lane, London UK.  Further details and
    commentary can be obtained from Gill Smaggasgale,
    a partner at the firm.

  • By Donald Zuhn

    Earlier this year, the U.S.
    Patent and Trademark Office and European Patent Office announced the formal
    launch of the Cooperative Patent Classification (CPC) system, a global
    classification system for patent documents. 
    The CPC system includes approximately 250,000 classification symbols
    based on the International Patent Classification (IPC), which is administered
    by the World Intellectual Property Organization (WIPO), and incorporates classification
    practices from both the U.S. and European systems.  At the formal launch of the CPC system, the
    USPTO noted that the system would be used by the USPTO and more than 45 patent
    offices.

    SIPOLast week, the State
    Intellectual Property Office of the People's Republic of China (SIPO) and the
    Korean Intellectual Property Office (KIPO) announced that each would be using
    the CPC system for at least some technical fields.  In a release
    issued on Tuesday, the EPO and SIPO announced that the two offices had signed a
    Memorandum of Understanding to enhance their cooperation in the area of patent
    classification.  Under the terms of the Memorandum,
    SIPO will start classifying patent applications in some selected technical
    fields using the CPC beginning in January of 2014.  In the interim, the EPO will provide dedicated
    training on the CPC system to SIPO.  By
    January 2016, SIPO aims to classify patent applications in all technical areas
    using the CPC.  EPO President Benoît
    Battistelli noted that "[w]ith the SIPO introducing the CPC as its
    internal classification scheme alongside the International Patent
    Classification, access to Chinese patent documentation will be dramatically improved."  SIPO Commissioner Tian Lipu indicated that
    "[c]lassifying Chinese patent documents into the CPC will undoubtedly
    improve the search efficiency of these documents by the examiners of various
    patent offices worldwide, and help these documents better serve global users as
    well."

    KIPO #2One day after the EPO and
    SIPO announced their Memorandum of Understanding on the CPC, the USPTO and KIPO
    announced the launch of a new
    pilot program in which KIPO will classify some of its patent documents using
    the CPC.  Under the pilot program, KIPO
    will use the CPC to classify patent applications in technology areas for which
    filings have been especially active at KIPO. 
    KIPO will work with the USPTO to identify these technology areas.  Acting USPTO Director Teresa Stanek Rea
    stated that "[t]he USPTO looks forward to working with KIPO as it begins
    the process of classifying documents into the Cooperative Patent Classification
    system."  KIPO Commissioner Young-min
    Kim noted that "KIPO expects that the pilot project will help improve the
    quality of examination at both offices by enabling examiners to retrieve Korean
    patent documents more effectively."

    For additional information
    regarding this topic, please see:

    • "USPTO News
    Briefs
    ," January 8, 2013
    • "USPTO
    Takes Next Step Towards Cooperative Patent Classification System
    ,"
    June 25, 2012
    • "USPTO
    and EPO Launch Patent Classification Website
    ," October 26, 2011
    • "USPTO
    and EPO Agree to Principles of Joint Patent Classification System
    ,"
    February 14, 2011
    • "USPTO
    and EPO to Develop Joint Patent Classification System
    ," October 25,
    2010

  • CalendarJune 9-11, 2013 – IP Business Congress (Intellectual Asset
    Management) – Boston, MA

    June 11, 2013 – Preventing Chinese Trade Secret
    Theft: The Obama Administration's Strategy on Mitigating the Theft of U.S.
    Trade Secrets
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am
    (CT)

    June 12, 2013 – Post-Grant Patent Proceedings Before the PTAB (Strafford) – 1:00 – 2:30 pm (EDT)

    June 12-14, 2013 – Fundamentals of Patent Prosecution
    2013: A Boot Camp for Claim Drafting & Amendment Writing
    (Practising
    Law Institute) – New York, NY

    June 13, 2013 – Legal Issues of Protection and Enforcement of Biopharmaceutical Patent Rights in Russia (Gorodissky
    & Partners) – 12:15 to 1:15 pm (EST)

    July 15-16, 2013 – Global Patenting Strategy and Practice (American Conference
    Institute) – New
    York, NY

    July 15-19, 2013 – Patent Law Summer
    Intensive
    (Benjamin N. Cardozo School of Law) – New York, NY

    June 25, 2013 – AIA Impact on Section 103 and Non-Obviousness:
    Navigating Timing Changes, Post-AIA Treatment of KSR, and Secondary Considerations to Meet Patent Validity
    Requirements
    (Strafford) – 1:00 – 2:30 pm (EDT)

    June 25-26, 2013 – Maximising
    Pharma Patents
    (C5 (UK)) – London, England

    July 10, 2013 – CLS Bank v. Alice Corp.: Navigating Patent
    Eligibility of Software-Related Inventions Absent Clear Guidance
    (Strafford) – 1:00 to 2:30 pm (EDT)

    July
    10-12, 2013 – Fundamentals of Patent Prosecution
    2013: A Boot Camp for Claim Drafting & Amendment Writing
    (Practising
    Law Institute) – San Francisco, CA

    July 11, 2013 – Biotechnology Patents at the U.S. Supreme
    Court: 2012-2013 Term
    (McDonnell
    Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am
    (CT)

    July 31 to August 2, 2013 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 5-7, 2013 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

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

  • MBHB Logo 2McDonnell
    Boehnen Hulbert & Berghoff LLP will be offering a live webinar on "Biotechnology Patents at the U.S. Supreme
    Court: 2012-2013 Term" on July 11, 2013 from 10:00 am to 11:15 am
    (CT).  Patent Docs co-author and MBHB attorney Dr. Kevin Noonan will
    discuss the outcome of three cases that have been or will be decided by the
    U.S. Supreme Court this year:


    Bowman v. Monsanto
    , a case involving the application of the
    patent exhaustion doctrine to recombinant soybeans


    FTC v. Watson
    , involving the FTC's allegations that
    "reverse payment" settlement agreements between branded and generic
    drug companies in ANDA litigation are anticompetitive and violate antitrust law


    Association for Molecular Pathology v. Myriad Genetics, Inc.,
    addressing
    the question "Are human genes patentable?"

    Dr.
    Noonan will discuss these cases and their effects on the biotechnology
    industry, particularly in view of recent trends at the Supreme Court regarding
    the scope of patenting, as well as discuss the Supreme Court's decision in Mayo
    Collaborative Services v. Prometheus Laboratories, Inc.
     from last
    term, which reintroduced patent law concepts that have been dormant for half a
    century.

    While
    there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California,
    Georgia, Illinois, North Carolina, New Jersey, New York and Virginia.

  • Gorodissky & PartnersGorodissky
    & Partners will be offering a webinar entitled "Legal issues of
    protection and enforcement of biopharmaceutical patent rights in Russia" from
    12:15 to  1:15 pm (EST) on June 13, 2013.  Dmitry Klimenko, PhD., and Evgeny Alexandrov,
    PhD. will highlight selected aspects of getting patent protection for
    biopharmaceutical inventions in Russia via the Russian PTO & Eurasian PO,
    and in particular, matters that are treated differently by the EPO, USPTO, or
    JPO, as well as enforcement of patent rights specifically in the pharma field.  Among the topics to be covered during the
    webinar are the following:


    Patentable and non-patentable biopharmaceutical inventions

    General info on drafting claims

    Allowable claim formats

    Drafting claims for popular biopharmaceutical subject-matter

    Examples of granted biopharmaceutical claims

    Approach to evaluating "industrial applicability"

    Ways of widening scope of protection

    Patent term extension

    Medicaments: data exclusivity protection

    Conditions for patent infringement

    Sufficiency and validity of evidence of infringement

    Availability of preliminary/interim injunctions

    Recent court cases in pharma field

    While
    the webinar is free, attendees must register in advance.  Those wishing to register can do so by
    clicking on the register buttons on the webinar announcement.