• IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "International Patent Filing: Best Practices" on June 25, 2015 from 2:00 to 3:15 pm (ET).  Philip Cupitt of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Michael Gnibus of General Electric Co.; and Robert Siminski of Harness, Dickey & Pierce, P.L.C. will provide expert guidance on where and how to file foreign patent applications and address the following topics:

    • Factors to consider when deciding whether to file international patents;
    • Comparisons between PCT, EPO and direct filing options;
    • How to reduce costs;
    • Hidden landmines, including the requirement of foreign filing waivers when inventors reside in certain countries; and
    • What’s new, including use of the Hague Agreement for design patents; will Austria become the “Delaware” of the Unitary Patent in Europe?

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • ABAThe American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division will be offering a live webinar entitled "Practical Patent Prosecution Strategies and Considerations" on June 23, 2015 from 1:00 to 2:30 pm (ET).  Ida Wahlquist-Ortiz (moderator); Carlos Armando Garcia, Counsel – Innovation, Proctor and Gamble; Jameson Quinn-Houng Ma of Bookoff McAndrews, PLLC; Michael Van Handel of Wilmer Hale; and Richard W. Goldstein of Goldstein Patent Law will provide practice pointers for everyone from the beginner level lawyer to the most experienced patent prosecutors, and take attorneys and patent agents through patent application prosecution from the first Office Action through Allowance.  The panel will cover the following:

    • Cite examples of common rejections, and also show participants how to identify the most important aspects of the examiner's rejection in order to sucessfully distill that information to his or her client.
    • Address the most effective ways to tackle each issue, whether it is arguing, amending, conducting an interview with the examiner, appealing, or some combination thereof.
    • Present how to craft effective strategies that will result in issued patents able to withstand USPTO post-grant proceedings and litigation.
    • Address various claim strategies resulting from recent Supreme Court, Federal Circuit, and PTO guidance, with respect to joint infringement issues, business methods, and claim construction.

    The registration fee for the webcast is $150 for members, $95 for sponsor members, and $195 for the general public.  Those interested in registering for the webinar, can do so here.

  • IPLACThe Intellectual Property Law Association of Chicago (IPLAC) and IIT Chicago-Kent College of Law will be offering a U.S. Patent and Trademark Office Legal Lecture and Expert Panel Discussion entitled "101 Post Alice: How USPTO & Practitioners Are Reacting" on June 26, 2015 from 2:00 to 3:30 pm (Central) at IIT Chicago-Kent College of Law.  Michael Cygan of the USPTO Office of Patent Legal Administration will present on the December 2014 interim guidance for patentable subject matter eligibility, and Director Christal Sheppard of the USPTO Detroit Satellite Office will moderate a panel of experts on a discussion of how the Supreme Court’s Alice Corporation v. CLS Bank International decision has impacted the USPTO and practitioners.  Those interested in registering for event can do so by here.

  • MomentumMomentum will be offering a webinar entitled "Key Developments in Biosimilar Litigation, Part II" on June 23, 2015 from 1:00 to 1:45 pm (Eastern).  Louis E. Fogel, Paul D. Margolis, Steven R. Trybus of Jenner & Block will explore new Federal Circuit arguments being made and considered in interpreting the Amgen v. Sandoz cases relating to the BPCIA, and discuss whether the patent dance is mandatory and when the Notice of Commercial Sale is appropriate.

    There is no fee for the webinar.  Those interested in registering for the webinar, can do so here.

  • BIO International Convention_shortFrom the 2015 BIO International Convention in Philadelphia, PA

    Will a rose by any other name . . .?

    By Kevin E. Noonan

    As part of his remarks during the Keynote Luncheon earlier today at the Biotechnology Industry Organization (BIO) International Meeting, New BIO Chairman of the Board Ron Cohen announced that BIO will be changing its name to the Biotechnology Innovation Organization.  The change "better expresses the essence of what our member companies represent," according to Mr. Cohen, who is also CEO of Acorda Therapeutics.  Jim Greenwood, longtime BIO President and CEO, called it "a great move that will help clarify for policymakers and the public the heart of our industry — scientific innovation that will help to heal, feed and fuel the world."

    The change will be effective early in 2016.  At least they won't have to change the monogrammed towels.

  • By Claire Gregg & Martin O'Brien

    Australia Coat of ArmsThe High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids1.

    The question before the High Court is whether the invention claimed in claims 1-3 of Australian Patent No. 686004,2 owned by Myriad Genetics, is a manner of manufacture within the meaning of s 6 of the Statute of Monopolies, as required by section 18(1)(a) of the Patents Act 1990.  The test for "manner of manufacture" was defined by the High Court in NRDC,3 and requires that the claimed invention involve an artificially created state of affairs in a field of economic utility.

    Today's hearing follows yesterday's decision by the High Court to deny leave to the Institute of Patent and Trade Mark Attorneys (IPTA) to be heard as amicus curiae.  IPTA made submissions to the Court on the basis that section 51(xviii) of the Constitution is broad enough to cover isolated nucleic acids, and that in the absence of explicit exclusions the Patents Act should be interpreted to "occupy the full permissible landscape given by section 51(xviii) of the Constitution".4

    MyriadThe Commonwealth, through the Attorney-General, also sought to intervene in the event that the High Court granted IPTA leave to be heardWhilst explicitly stating that the Commonwealth makes no submissions on the ultimate question of whether isolated nucleic acid is patentable, the Attorney-General was critical of IPTA's submissions, noting that the question before the Court "can be decided fully and completely on the proper construction of the Patents Act without the need to examine the reach of the grant of power under s 51(xviii) of the Constitution".Further that the "Court should not resolve the appeal by deciding a constitutional question in circumstances where this not necessary of the matter".6

    The decision of the High Court to deny IPTA leave to be heard meant that the Court only heard from the original two parties today and no new arguments were heard.

    In today's hearing, counsel for the Appellant, Mr Catterns QC, argued that, while the isolation of the BRCA1 gene by Myriad may be a "fine and laborious piece of science", claims to isolated nucleic acids without any limitation to a useful application are claims to products of nature, which Mr Catterns submitted is the "antithesis of an artificially created state of affairs" and therefore excluded from patentability.

    The Appellant's arguments relied heavily on the reasoning of the US Supreme Court in AMP v Myriad Genetics7, asserting that the isolated nucleic acids are in substance identical to the corresponding sequences in nature.  Contrary to Myriad's submissions that isolated nucleic acids are chemically, structurally and functionally different from the naturally occurring nucleic acids and have new applications which do not apply to the sequences as found in nature,8 Mr Catterns argued that the isolated polynucleotide sequences code for the same polypeptides as encoded by the gene as found in nature and are therefore, in substance, the same.

    Following the Appellant's submissions, counsel for Myriad, Mr Shavin QC, argued that claims 1-3 of the Myriad patent are not to genetic information, rather they are claims to a new chemical entity and that there is "no jurisprudential basis or normative principle upon which claims to isolated nucleic acids should be treated differently from any other technology".9

    Myriad's arguments centered on the notion that the isolated nucleic acids have utility in isolated form that they do not possess in their native form inside a cell.  Accordingly, Mr Shavin argued that an isolated nucleic acid is "different from nature in the critical sense that it has utility".  The Court accepted that utility is inextricably linked to what is isolated, however the Court also noted the utility needs to be linked to the artificiality in order to define patentable subject matter.  In light of the fact that the sequence of nucleic acids is substantially unaltered by the isolation process, the Court did not appear to consider that the utility was sufficiently linked to the artificiality of the isolated material.

    While Mr Shavin cautioned the Court against "carving out" from the principles of NRDC, it may not be necessary for the Court to do so in order to find that the claims at issue do not relate to an artificially created state of affairs.  Further, the day's proceedings suggest that the Court's consideration will be confined to claims to isolated nucleic acids, leaving aside any broader question of patentability of isolated biological material.

    The decision, expected later this year, will be keenly awaited.


    1 D'Arcy v Myriad Genetics Inc. [2014] FCAFC 115.
    2 Due to expire on 11 August 2015.
    3 National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; endorsed by the High Court in Apotex Pty Ltd v Sanofi Aventis [2013] HCA 50.
    4 IPTA Submissions at [34].
    5 Attorney-General's Submissions at [6].
    6 Ibid at [10].
    7 Association for Molecular Pathology v Myriad Genetics 569 US 12-398 (2013)
    8 First Respondent's Submissions at [48]-[50].
    9 Ibid at [45]

    Dr. Gregg is a Patent Scientist and Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia.

  • By Grantland Drutchas

    USPTO SealAs of Tuesday, June 16th, we have been living with the U.S. Patent and Trademark Office's "2014 Interim Guidance on Patent Subject Matter Eligibility" ("Guidance") for six months.  Although the USPTO subsequently issued some examples and sought public comment, it started training examiners on the new Guidance almost immediately.  And, of course, the PTAB has started implementing these standards as well.  So the question stands, where are we now?

    Several organizations and individuals, including the IPO, the ABA,  and AIPLA, submitted comments that were directed to perceived shortcomings in the Guidance.  These comments can be found here.  Persistent themes throughout many of these comments include the hope that the USPTO and Examiners should tread lightly when applying a judicial exception, concerns over the application of the "significantly more" test, the need for greater emphasis by the USPTO on preemption, and clarifying the evidentiary burden on the USPTO to establish the bases for a prima facie 101 rejection.  Six months later, these concerns remain.

    Reportedly, the application of the Guidance has varied on a Technology Center-by-Technology Center basis, fueled, perhaps, by the lack of examples in many technology areas.  Although it is difficult to quantitatively assess the application of the Guidance on a center-by-center basis, implementation of § 101 principles by the PTAB provide some indication of the USPTO's approach in implementing the Guidance.  In all, the PTAB has addressed § 101 in about 40 separate decisions since the implementation of the Guidance.  In more than 20 other decisions, although it didn't address the § 101 issues itself, it suggested that the Examiner consider the Guidance in further review of the claims sent back on other grounds.

    USPTO's Evidentiary Burden:

    The Guidance was silent, for example, on the USPTO's evidentiary burden in examination in establishing such grounds for unpatentability as whether a claim recites "a law of nature, natural phenomenon, or an abstract idea" under step 2A of the analysis, or whether the claim adds "significantly more" or simply "routine or conventional" under step 2B of the analysis.  On rejections on other grounds, the USPTO bears the initial burden of presenting a prima facie case supported by substantial evidence; an "assessment of basic knowledge and common sense not based on any evidence in the record" fails to meet this standard.  See In Re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); In re Zurko, 258 F.3d 1379, 1385 (Fed. Cir. 2001).  That is, "the PTO [must] stat[e] the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of [the] application."  In re Jung, 637 F. 3d 1356, 1362 (Fed. Cir. 2011) (citing 35 U.S.C. § 132 and Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990)).

    The PTAB has itself found that this same burden applies to § 101 decisions under the two-step analysis required by Alice:

    The PTO bears the initial burden of establishing a prima facie case of patent-ineligible subject matter under 35 U.S.C. § 101.  Because the facts and evidence do not support the finding that claim 1 is "an attempt to claim a new set of rules for playing a card game" and therefore, necessarily, is an abstract idea, a prima facie case of patent-ineligible subject matter under 35 U.S.C. § 101 has not been established in the first instance by a preponderance of the evidence.

    In re Renald Poisson, Appeal 2012-011084 (Feb. 27, 2015).  See also Ex parte Martin (Appeal 2012-001578) (March 24, 2015) (reversing rejection where Examiner failed to address factors other than the "machine-or-transformation" analysis in support of its prima facie rejection);

    Application of the "significantly more" test:

    The PTAB has addressed issues involving the "significantly more" test in a number of decisions.  In one, it grappled with the difference, if any, between the novel and nonobvious standards on the one hand and "conventional and routine" on the other.  The PTAB has tried to differentiate these standards, finding, for example that a step can be a "routine and conventional" implementation of an abstract idea, even though the step itself may be both novel and nonobvious:

    Appellant appears to argue that, because the claimed subject matter is novel, the game cannot be "conventional."  We find this argument unpersuasive as it misapplies the law governing compliance with 35 U.S.C. § 101.  The Supreme Court has made clear that the analysis of whether claims satisfy the requirements of 35 U.S.C. § 101 is independent of whether those claims satisfy the other requirements for patentability under the patent statute — indeed, the § 101 analysis is a threshold inquiry.  See Bilski v. Kappos, 561 U.S. 593, 594 (2010).  In other words, whether the subject matter of the claims under appeal are novel and non-obvious is immaterial to the § 101 inquiry.

    More significantly, the Decision did not determine that the steps of the claimed invention were "conventional" in the sense that they are not novel or are obvious.  Instead, the test under Alice is whether the elements of the claim, alone or in combination, amounts to significantly more than a patent upon the [ineligible concept] itself — in this case, the abstract rules of playing and wagering on a type of card game.  See Alice, 134 S. Ct. at 2355.  In other words, "[i]f, to implement the abstract concept" — play Blackjack under then claimed set of rules — "one must perform the additional step, or the step is a routine and conventional aspect of the abstract idea, then the step merely restates an element of the abstract idea, and thus does not further limit the abstract concept to a practical application."  Ultramerical, Inc. v. Hulu, LLC, 722 F.3d 1335, 1348 (Fed. Cir. 2013).

    Ex parte Christian A. Schlumbrecht, Appeal 2012-012597 (May 13, 2015).

    Although claims to games are typically deemed patent ineligible, a couple of cases showcase how providing something more — whether or not it complies with the machine-or-transformation test — can render even a game patentable.  In Ex Parte Kuester, Appeal  2013-001127 (May 6, 2015), the PTAB reversed a § 101 rejection for a claim to a card game that required a base that includes compartments "sized and shaped to receive and retain each card in place for the duration of a game after said cards have been arranged in one of a plurality of different configurations" and "retaining each card in place for the duration of a game."  The added specific structural components — which would meet the machine-or-transformation test — added a degree of particularity so as to transform the claimed abstract idea into patent eligible subject matter.

    In Ex parte Jimick, Appeal 2012-009601 (February 2, 2015), by contrast, the PTAB found that a claim to a game was patentable under § 101 that had steps involving setting up markers on a specific board and requiring specific jumping arrangements based in part on the lack of preemption.  Although this game did not meet the machine-or-transformation test, this is not the only test.

    Importance of Preemption:

    Like the Ex parte Jimick case noted above, the PTAB has found that the lack of preemption was grounds for finding a claim patentable in several other cases as well.  In Ex parte Schmid et al., Appeal 2012-002155 (December 26, 2014) (reversing § 101 rejection of claims for "communicating information concerning the sleep position of an infant to the infant's caregiver" that were limited to "use of an infant sleep garment"), for example, it found that limiting the use of an abstract idea to a specific structure provided the "additional features" that ensure the claims are "more than a drafting effort designed to monopolize the [abstract idea]."

    Preemption also figures heavily in several of the other cases discussed elsewhere in this note.

    Machine-or-transformation test:

    In Ex Parte Nguyen, Appeal 2012-006173 (Jan. 9, 2015), the PTAB found that a claim directed to a web "portal" ('a transaction management portal engine, a management database, and a user interface") is a physical entity, i.e., a machine, and as such, it falls within one of the four statutory categories of patentable subject matter.  Although the claim also called for the portal engine to execute a "business rule" and was coupled to a "management database," the PTAB found the focus of the claim on the portal was sufficient to confer patentability.

    In Ex Parte Hyde, Appeal 2012-009430 (April 29, 2015), the PTAB found that claims broad enough to read on software per se were unpatentable under section 101, but that claims with means-plus-function limitations, which necessarily required the specific structure (circuitry) disclosed in the patent or equivalent, were patentable.

    On the other hand, where the claims are not directed to the machine itself, the mere recitation of a machine (even other than a computer) is not enough.  In Ex parte Huynh, Appeal 2013-006708 (May 26, 2015), the PTAB found that a method for designing a machine (in this case, an integrated circuit) was itself not patentable under § 101.  The PTAB found a method for generating a physical layout for an integrated circuit using modular tiles was unpatentable where the claimed method was not tied to a particular machine or apparatus, did not transform an article to a different state or thing, and did not require the manufacture of the integrated circuit itself.  Moreover, such tile modules used to specify and form the IC involved "a standard IC fabrication process," and thus were themselves routine and conventional.

    In conclusion, the PTAB has worked to implement these principles and its decisions provide a blueprint for argument that may help in prosecution.  Although many of these decisions are simply "informative" and not "precedential," they still provide an important bellwether of the USPTO's views on these 101 issues and application of the Guidance.

  •         By Sherri Oslick

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

    Janssen Pharmaceuticals Inc. v. Vintage Pharmaceuticals, LLC
    1:15-cv-00429; filed May 28, 2015 in the District Court of Delaware

    Janssen Pharmaceuticals, Inc. v. Vintage Pharmaceuticals, LLC
    2:15-cv-03542; filed May 26, 2015 in the District Court of New Jersey

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Vintage's filing of an ANDA to manufacture a generic version of Janssen's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception).  View the New Jersey complaint here.

    Duchesnay Inc. et al. v. Mylan Pharmaceuticals Inc.
    1:15-cv-00092; filed May 27, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Duchesnay Inc.; Duchesnay USA Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.; Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 6,340,695 ("Rapid Onset Formulation," issued January 22, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Duchesnay's Diclegis® (doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management).  View the complaint here.


    Takeda GmbH et al. v. Mylan Pharmaceuticals Inc.
    1:15-cv-00093; filed May 27, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Takeda GmbH; Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 5,712,298 ("Fluoroalkoxy-Substituted Benzamides And Their Use As Cyclic Nucleotide Phosphodiestrerase Inhibitors," issued January 27, 1998), 8,536,206 ("Process for the Preparation of Roflumilast," issued September 17, 2013), 8,604,064 (same title, issued December 10, 2013), and 8,618,142 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Daliresp® (roflumilast, used to reduce the risk of COPD exacerbation in patients with severe COPD associated with chronic bronchitis and a history of exacerbation).  View the complaint here.

    Cipla Ltd. v. Sunovion Pharmaceuticals Inc.
    1:15-cv-00424; filed May 26, 2015 in the District Court of Delaware

    Infringement of U.S. Patent No. RE43,984 ("Process for Preparing Isomers of Salbutamol," issued February 3, 2015) based on Sunovion's manufacture and sale of its Xopenex® HFA product (levalbuterol hydrochloride inhalation aerosol, used to treat bronchospasm caused by asthma and chronic obstructive pulmonary disease).  View the complaint here.

  • CalendarJune 15, 2015 – "Patent Eligibility, Prior Art and Obviousness 2015: Current Trends in Sections 101, 102 and 103" (Practising Law Institute) – San Francisco, CA (also offered as webcast)

    June 15-17, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

    June 15-18, 2015 – BIO International Convention (Biotechnology Industry Organization) – Philadelphia, PA

    June 18, 2015 – "Patent Infringement Letters: Considerations and Best Practices for Senders and Recipients — Patent Holder Strategies for Leveraging Letters and Avoiding DJ Actions; Defense and Response Strategies for Alleged Infringers" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 23, 2015 – "Practical Patent Prosecution Strategies and Considerations" (American Bar Association (ABA) Center for Professional Development, Section of Intellectual Property Law, and Young Lawyers Division) – 1:00 to 2:30 pm (ET)

    June 25, 2015 – "Patent Inventorship: Best Practices for Determination and Correction" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 8-10, 2015 – Fundamentals of Patent Prosecution 2015: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    July 9, 2015 – "Leveraging Post-Grant Patent Proceedings Before the PTAB — Best Practices for Patentees and Third Parties in Inter Partes Review, Post-Grant Review and Covered Business Method Patent Challenges" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 14, 2015 – Patent Quality Chat webinar series – Face-to-face Examiner Interviews: A Demonstration of USPTO Tools – noon to 1:00 pm (EDT)

    August 11, 2015 – Patent Quality Chat webinar series – Measuring Patent Quality – noon to 1:00 pm (EDT)

    August 12-14, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Leveraging Post-Grant Patent Proceedings Before the PTAB — Best Practices for Patentees and Third Parties in Inter Partes Review, Post-Grant Review and Covered Business Method Patent Challenges" on July 9, 2015 from 1:00 to 2:30 pm (EDT).  Greg H. Gardella and Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt will discuss post-grant patent practice and offer best practices for counsel to either patentees or third parties in inter partes review, post-grant review, and covered business method challenges.  The webinar will review the following questions:

    • How has post-grant practice developed since the PTAB started?
    • How is the PTAB adapting to the increased workflow and what rule changes are anticipated in the months ahead?
    • What are the best practices for these proceedings together with concurrent litigation?
    • How are patentees adapting to the threat of PTAB challenges and what concurrent office proceedings are available to hedge against such attacks?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by June 19, 2015 will receive a $100 discount ($165 discount for registration and CLE processing).  Those interested in registering for the webinar, can do so here.