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  • Court Report

            By Sherri Oslick —

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

    Reckitt Benckiser LLC v. Aurobindo Pharma Ltd. et al.
    1:14-cv-01203; filed September 17, 2014 in the District Court of Delaware

    • Plaintiff:  Reckitt Benckiser LLC
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002), 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005), and 7,838,032 ("Sustained Release of Guaifenesin," issued November 23, 2010 following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc. et al.
    2:14-cv-01602; filed September 17, 2014 in the Southern District of Ohio

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

    Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. et al.
    1:14-cv-01196; filed September 16, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 6,004,973 ("Pharmaceutical Compositions Comprising Rafamycin Coprecipitates," issued December 21, 1999), 6,239,124 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection or Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin," issued May 29, 2001), and 6,455,518 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin," issued September 24, 2002) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant).  View the Delaware complaint here.

    Genetic Technologies Ltd. v. Ambry Genetics Corp. et al.
    8:14-cv-01475; filed September 12, 2014 in the Central District of California

    • Plaintiff:  Genetic Technologies Ltd.
    • Defendants:  Ambry Genetics Corp.; DOES

    Infringement of U.S. Patent No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes," issued March 18, 1997) based on Ambry's provision of genetic disorder testing, including for cystic fibrosis.  View the complaint here.


    Celgene Corp. et al. v. InnoPharma Inc.
    1:14-cv-01188; filed September 12, 2014 in the District Court of Delaware

    • Plaintiffs:  Celgene Corp.; Astellas Pharma Inc.
    • Defendant:  InnoPharma Inc.

    Infringement of U.S. Patent Nos. 7,608,280 ("Method of Producing FR901228," issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Celgene's Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma).  View the complaint here.

    Shire LLC v. Corepharma, LLC
    2:14-cv-05694; filed September 12, 2014 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) and RE41,148 (same title, issued February 23, 2010) following a Paragraph IV certification as part of Corepharma's filing of an ANDA to manufacture a generic version of Shire's Adderall XR® (a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Teva Pharmaceuticals USA, Inc. et al. v. Doctor Reddy's Laboratories, Ltd. et al.
    3:14-cv-05672; filed September 11, 2014 in the District Court of New Jersey

    • Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
    • Defendants:  Doctor Reddy's Laboratories, Ltd.; Doctor Reddy's Laboratories, Inc.; Sandoz, Inc.; Momenta Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the complaint here.

  • Conference & CLE Calendar

    CalendarSeptember 23, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Alexandria, VA (webcast)

    September 24, 2014 – "Trade Secrets in the Life Sciences" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    September 25, 2014 – "Charting New Territory: Prosecution and Diligence Strategies in the Wake of the AIA" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    September 26, 2014 – IP & Diagnostics Symposium (Biotechnology Industry Organization) – Alexandria, VA

    September 30, 2014 – 2014 Intellectual Property Continuing Legal Education Seminar (DuPont and Widener University School of Law) – Wilmington, DE

    September 30, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Dallas, TX

    September 30 – October 1, 2014 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago, IL

    October 2, 2014 – "USPTO Guidance for Determining Subject Matter Eligibility In View of U.S. Supreme Court's Mayo and Myriad Decisions" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    October 2, 2014 – "Conflicts in Patent Prosecution: Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 2, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Denver, CO (webcast)

    October 9, 2014 – First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) – Atlanta, GA

    October 16, 2014 – "Patent Licensing: Advanced Tactics for Licensees Post-AIA — Structuring Contractual Protections and Responding When Licensed Patents Are Challenged in Post-Grant Proceedings" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 21, 2014 – "Recent Judicial Decisions Impacting Technology Licensing" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    October 21, 2014 – "Patent Reissue: Strategic Use for Pre- and Post-AIA — Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 20-22, 2014 – Business of Biosimilars (Institute for International Research) – Boston, MA

    October 29-30, 2014 - Congress on PIV Litigation (Momentum) – Philadelphia, PA

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

  • IPO Trade Secrets Webinar

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar on "Trade Secrets in the Life Sciences" on September 24, 2014 beginning at 2:00 pm (ET).  Dianna DeVore of Oblon, Spivak, McClelland, Maier & Neustadt, LLP; Matthew Pugmire of Pfizer, Inc.; and Michael Samardzija of Dentons US LLP examine the alternative of using trade secrets to protect intellectual property in the life sciences.  The webinar will review the following topics:

    • What kinds of IP in the life sciences are best suited to protection by trade secrets?
    • The potential value of "negative know-how," i.e., what doesn't work;
    • The risk of losing trade secrets through disclosure to regulators;
    • What kinds of information are amenable to trade secret protection in diagnostic laboratory-developed tests (LDTs)?
    • The risks to the makers of biosimilars posed by the disclosure requirements of the Biologics Price Competition and Innovation Act (BPCIA).

    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.

  • Webinar on Patent Reissue

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Reissue: Strategic Use for Pre- and Post-AIA — Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" on October 21, 2014 from 1:00 to 2:30 pm (EDT).  Erika H. Arner, Thomas L. Irving, and Deborah M. Herzfeld of Finnegan Henderson Farabow Garrett & Dunner; and Donna M. Meuth, Associate General Counsel – Intellectual Property, Eisai will provide patent counsel with an in-depth review of the pros and cons of using reissue to correct patent errors, whether before or after AIA, discuss the rule against recapture and the effect of reissue, and offer their experiences, perspectives and best practices on the strategic use of patent reissue to correct errors.  The webinar will review the following questions:

    • What factors should be considered in evaluating the possibility of reissue?
    • How have patent reissue implications changed post-AIA?
    • What are the risks and limitations of using reissue proceedings to resolve patent errors?
    • If you have a pending patent application, how good an idea is reissue?
    • When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place a supplemental examination would in a shorter time?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by September 26, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Webinar on Patent Licensing

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Licensing: Advanced Tactics for Licensees Post-AIA — Structuring Contractual Protections and Responding When Licensed Patents Are Challenged in Post-Grant Proceedings" on October 16, 2014 from 1:00 to 2:30 pm (EDT).  William C. Coppola, Senior Patent Counsel, Sanofi-Aventis; and April Weisbruch Goodwin Procter and Eleanor M. Yost of Goodwin Procter will provide guidance to patent counsel on addressing patent licensing issues for licensees post-AIA, and discuss incorporating protections in the license agreement and responding when a licensed patent is the subject of a post-grant proceeding.  The webinar will review the following questions:

    • How has the AIA impacted patent licensing?
    • What steps can licensee counsel take to effectively build protections into the license itself?
    • How should licensees respond when a challenger attempts to invalidate a licensed patent in an AIA post-grant proceeding?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • MBHB Webinar on Judicial Decisions Impacting Licensing

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Recent Judicial Decisions Impacting Technology Licensing " on October 21, 2014 from 10:00 am to 11:15 am (CT).  MBHB attorney Patrick Gattari give participants an overview of the recent judicial decisions and trends in technology licensing agreement through a review of current cases involving a number of important issues:

    • Patent Exhaustion
    • Definitions of Licensed Technology
    • Improvements
    • Forum Selection and Venue
    • Burden of Proof
    • Bankruptcy
    • Licensed Parties

    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, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • PTAB Update — A Review of the First Round of Comments (Part 1)

    By Andrew Williams —

    USPTO Seal - backgroundThe USPTO has been seeking feedback on the PTAB trial proceedings established by the Leahy-Smith America Invents Act.  A Federal Register Notice from June 27, 2014 contained the "Request for Comments on Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board" (79 Fed. Reg. 36474).  In it, the USPTO outlined 17 issues, or questions, for which the Office is most interested in receiving public comments.  The original deadline for submission was September 16, 2014, the two-year anniversary of the PTAB, but the period was extended this week until October 16, 2014.  Nevertheless, 11 comments were filed by the original deadline.  These can roughly be divided up into three categories: (1) companies, (2) individuals, and (3) intellectual property associations.  In this post, we review the first set of comments — those received from companies.

    Hospira

    Hospira's comments begin by explaining that it is a global specialty pharmaceutical and medication delivery company.  It then responded to each of the 17 questions posed by the Request for Comment found in the Federal Register notice.  Nevertheless, a common theme could be found — Hospira is generally satisfied with how the system has operated thus far and in most instances either advocated that no changes should be made or it deferred to the Board to use its discretion.  Even though it may sound incongruous to submit comments advocating no changes, it did so in anticipation of comments from others.  For example, in response to the question about the Board's practice regarding motions to amend, it is commonly believed that stakeholders are unhappy that the Board has only granted one such motion. Hospira noted that one particular proposal should be rejected –- the shifting of burdens to the petitioner to provide an expert to prove validity of any proposed amendment.  One problem that Hospira identified was that if the petitioner was required to provide an expert, the fixed timeline for PTAB trials would likely need to be adjusted (which is contrary to one of the perceived benefit of the IPR framework –- speed).  Moreover, Hospira noted that it is not unreasonable to require the patent owner to articulate its reasoning via an expert declaration.

    Hospira also commented on the factors enumerated in the Garmin v. Cuozzo case (IPR2012-00001) for requesting additional discovery.  Specifically, it noted that the Garmin factors are consistent with another of the perceived benefits of IPR — limited discovery.  With regard to the "multiple proceedings" questions (No. 7-13), Hospira deferred to the Board's exercise of discretion.  Nevertheless, it did argue that later petitioners should not be foreclosed from pursuing different arguments, even with regard to prior art already considered.  Hospira also addressed the topic of mandatory settlement discussions, and opposed any such requirement if it would impact the statutory timeline for IPR proceedings.

    Finally, in response to the "General" category of questions, Hospira had an interesting take on the interplay of post-issuance challenges before the PTAB and Hatch-Waxman-type litigations.  Hospira advocated that a PTAB written decision nullifying the claims of a challenged patent should serve to trigger the "failure-to-market" forfeiture provisions for first ANDA filers.  The argument went that, similar to a district court proceeding, the Patent Owner would have had the opportunity to present all of its evidence supporting validity.  Of course, this presumably would only become relevant if all remaining claims of the Orange Book listed patents were invalidity by the PTAB.  Nevertheless, this comment highlights the widely held belief that PTAB proceedings can be beneficial to secondary ANDA filers.

    SAS

    Two attorneys for SAS served as "commentators" for general question 17.  Specifically, they took issue with the PTAB's practice of instituting inter partes review on only some of the petitioned claims.  Instead, they argued, once the PTAB determines that the "reasonable likelihood" threshold has been met, all claims challenged in the petition should be included in the proceeding.  As it is, with partial institution, the petitioner is denied the right to appeal the non-instituted claims, which is allegedly contrary to the intent of Congress.

    SAS noted that in the past two years, IPR and CBM petitions have been used with increasing frequency.  In response, the Board has taken steps to ensure timely completion of the trials.  One of these is to treat institutions on a claim-by-claim basis, instead of the petition as a whole.  However, SAS points to several places in the statute which would suggest that this is inappropriate.  First, the standard for institution outlined in 35 U.S.C. § 314(a) is whether "there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition."  The use of the "at least one of the claims" language allegedly suggests that the trial would include more claims than the ones that exceed this threshold.  Moreover, the statute repeatedly uses the phrase "challenged patent claim," rather than "instituted patent claim."  For example, 35 U.S.C. § 318(a) provides that the final written decision must address "the patentability of any patent claim challenged by the petitioner."  Interestingly, SAS pointed out that in a CBM case, the Board noted that "[i]f Congress intended to limit the availability of the covered business method patent review on a claim-by-claim basis, . . . it could have used the term 'claim' rather than 'patent.'"  See Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co., CBM2012-00002, Paper 66 at 6 (Jan. 23, 2014).  The same logic applies to IPR institutions, SAS argued.

    So, what is the problem with the current claim-by-claim approach?  SAS alleged that partial institution complicates matters for district courts contemplating motions to stay litigation pending IPR trials.  If less than all of the claims are included in the PTAB trial, it might not serve to adequately simplify the issues in the district court.  Moreover, the claims or issues not deemed to have a reasonable likelihood of prevailing are non-appealable, and therefore not entitled to further review.  SAS pointed out that this issue had been raised by IBM when the rules were being developed.  In response, the PTO defended partial review because the statutory estoppel provision applies on a claim-by-claim basis.  Instead, SAS contended, this section demonstrated that Congress knew how to specify claim-by-claim treatment when it wanted to, which it clearly did not in the case of IPR institution.

    The solution — the PTAB should continue to address the patentability of all claims in the institution decision.  However, instead of foreclosing review of the other claims, they should be included in the institution.  The burden of providing sufficient attention to the various claims would fall to the parties because the page limits would force them to focus on the best arguments.  Nevertheless, if a party believed that a particular claim was important, it could provide the requisite evidence necessary for a complete record at the Federal Circuit.

    GEA Process Engineering, Inc.

    GEA Process responded to a single question — "#5 Should a patent owner be able to raise a challenge regarding a real party in interest at any time during trial."  The response — it depends.  The crucial factor, according to GEA Process, is which section of the statute is implicated.  On the one hand, if the challenge is to the Petitioner's standing under 35 U.S.C. § 315 as of the filing date of the petition, GEA Process believes that the patent owner should be allowed to raise this at any time.  However, if the challenge was whether all real parties in interest have been identified, this showing should be made reserved exclusively to the time before institution of the trial.  The distinction made by GEA Process was on jurisdictional grounds.  35 U.S.C. § 315 concerns whether a petitioner had standing, which in Federal court is a jurisdictional question.  As such, it should be allowed to be raised at any time during the trial.  However, 35 U.S.C. § 312, provides for determining whether the petition is complete, not whether someone can bring the suit in the first place.  Therefore, failure to satisfy this section should be waived if not raised before institution.

    Think Computer Corporation

    Think Computer prefaced its comments by pointing out that one of its two patents is being challenged in a CBM petition.  Also, it is a company that correlates a large amount of USPTO data for public use.  Therefore, it believes it has experienced the PTAB from two different perspectives.  In general, Think Computer is in favor of the PTAB and believes that it can serve a vital purpose.  Think Computer's criticism — the system should be set up such that it would not require an attorney.  Instead of the present system, Think Computer advocated for an error-checking web-based form which would allow even inexperienced individuals to construct arguments.  It also complained about the alleged "common practice" of experts submitting reports written entirely by law firm attorneys.  Think Computer did not address the fact that these experts are also subject to deposition, and that, regardless of who prepares what drafts, if the expert does provide final approval of the report, it will become evident during discovery.

    Think Computer's final complaint was with regard to the PTAB docketing system, which was described as "horrendous."  Of course, anyone who has attempted to use it will likely agree with this sentiment.  The PAIR system would have been an obvious alternative, but Think Computer believes that it "is a colossal disaster of its own."  Instead, it suggested that the Patent Office immediately issue an RFQ for both systems and to make a point to use a different vendor.

    Patent Docs will report on the additional comments in a future post, and will continue to monitor the PTAB website to see if any additional comments are submitted before the October 16, 2014 deadline.

  • USPTO Expected to Issue Revised Myriad-Mayo Guidance in October

    By Donald Zuhn —

    USPTO SealDuring a session at today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, the U.S. Patent and Trademark Office provided an update on the status of the Myriad-Mayo Guidance.  The BCP session on the Guidance, coming at the end of the Office's first Bicoastal BCP (BCBCP) event, included presentations and comments from June Cohan, Legal Advisor with the USPTO's Office of Patent Legal Administration; and Suzannah K. Sundby of Canady & Lortz LLP at the USPTO's Alexandria, VA campus; and from Jeffery Tung, Patent Counsel, Isis Pharmaceuticals; Paul Naik, Vice President, Intellectual Property, Genentech, Inc.; and Dan Sullivan, Director, TC1600, USPTO at San Jose State University.  Although the BCP session encompassed both the Myriad-Mayo Guidance and the Alice Corp. Guidance, the bulk of the session focused on the former.

    Ms. Cohan spoke first, reminding attendees that at the last BCP meeting in April she had given a presentation on the Guidance following its March release (unlike her earlier presentation, this one was not accompanied by slides).  Since the April BCP meeting, she noted that the Office had conducted a forum on the Guidance in May, had collected comments on the Guidance over the summer, and had taken the opportunity to discuss the Guidance at other events (including during a BIO IPCC workshop in April and at the BIO International Convention in June).  Before discussing the impact of the eighty comments the Office had received in response to the Myriad-Mayo Guidance, Ms. Cohan posed the question that has been on many practitioners' and applicants' minds the past few months:  are there things in the Guidance that the Office can change?  To that question, her answer was a simple "yes".  As a result, she indicated that the Office intended to release "revised" Guidance in about a month.

    Following this welcome announcement, Ms. Cohan discussed what the Office had learned from the comments and public feedback as well as what aspects of the Guidance it intended to change.  She noted that the Office did not explain things as clearly as it could have in the Guidance, and that it was not the Office's intent to give the impression that the Supreme Court has set a high bar for patent eligibility.  Rather, it is the Office's belief that the Court has set a low bar for eligibility.  She also indicated that the Office did not intend to create a per se rule on purified products, and could have provided a better explanation on this aspect as well.

    With respect to questions about the eligibility of hybrid plants, hybrid animals, and antibodies expressed in mouse cells (which otherwise would not have been expressed in such cells), Ms. Cohan noted that all of these constituted patent eligible subject matter.  As for comments questioning the Office's interpretation of certain cases, she pointed out that the Office has gone back a reconsidered those decisions.

    In crafting the Guidance that was issued in March, Ms. Cohan suggested that the Office had "cast too broad a net," and that the Guidance's "significantly different" test, which focuses only on structural differences, might be too narrow.  She indicated that the revised Guidance would permit applicants to establish that a claimed product was significantly different from a natural product by pointing to functional differences (or differences in biological activity).

    As for the factor-based analysis of the Guidance, Ms. Cohan acknowledged that the scheme presented in the Guidance was "too complicated," and that the analytical framework in the revised Guidance would be "simplified".  Practitioners and applicants can also expect to see more examples in the revised Guidance.  Once the revised Guidance is released, Ms. Cohan noted that the Office wants "to keep the dialog going," explaining that several cases are working their way through the courts that could impact the manner in which the Office examines claims for subject matter eligibility.

    Following Ms. Cohan's presentation, Mr. Tung provided a few comments regarding the impact of the Guidance.  He argued, as have other commentators, that in contrast with the Guidance, the Myriad holding is narrow — even in the context of nucleic acids.  Ms. Cohan, however, responded that the Guidance applied to more than just nucleic acids because cases like Funk Bros., Chakrabarty, and Roslin concern more than just nucleic acids (i.e., bacteria and sheep), and therefore, "I don't see how we can limit this to DNA."

    Dr. Naik provided two observations regarding the Guidance.  First, he agreed that more examples were needed, pointing out that examples are extremely powerful tools, especially given something as nebulous and vague as subject matter eligibility.  He also suggested that more examples that were closer to the eligibility line were needed, rather than examples that encompassed subject matter that was too clearly eligible or too clearly ineligible.  Second, he argued that the Guidance's filter was too low, explaining that an analysis in which the recitation of a protein in a claim forced the examiner to quickly move to the third prong of the subject matter eligibility analysis was "unnecessarily broad," and not a good use of either the examiner's or applicant's time.

    Ms. Sundby suggested, as have other commentators, that it would be useful for the Office to create a subject matter eligibility webpage on which it would compile relevant decisions and new examples of patent eligible or ineligible subject matter.

    Note:  Ms. Cohan will be participating in a session that will highlight the Myriad-Mayo Guidance at next week's Biotechnology Industry Organization (BIO) IP & Diagnostics symposium in Washington, DC.  The session, entitled "Squaring the Circle: Obtaining Patents That Are Valid, Commercially Meaningful, and Enforceable," which is sponsored by McDonnell Boehnen Hulbert & Berghoff LLP, will also feature Sherry Knowles of Knowles IP Strategies (former Senior Vice President and Chief Patent Counsel at GlaxoSmithKline) and Patent Docs authors Kevin Noonan and Donald Zuhn.

  • FDA Announces “Purple Book”

    By Paul Tully —

    FDAThe new phone book is here?  No, but close.  The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs.  The list will be supplemented with approved biosimilar alternatives to the biologic drugs, termed the "List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations."  Inevitably given a "color" designation (following the tradition of the "Orange Book" of approved small molecule drugs), the new listing of biologics is colloquially called the "Purple Book."  Both the Center for Drug Evaluation and Research ("CDER") and the Center for Biologic Evaluation and Research (CBER) have published their own versions of the Purple Book (CDER List of Licensed Biological Products; CBER List of Licensed Biological Products; FDA Purple Book webpage).

    Ucm412239The new lists disclose all approved biologic drugs and the date a product was licensed, as well as "whether the FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act."  The Purple Book is intended to permit users to determine whether the FDA has licensed a biosimilar and whether such a biosimilar is interchangeable with an already-licensed reference biological product (i.e., an already-licensed FDA biological product).  Both biosimilar and interchangeable biological products will be listed with regard to the reference product to which biosimilarity or interchangeability was demonstrated.  The agency further announced that these lists will be updated "periodically."

    This new resource is certain to become a valuable tool for life-sciences professionals, but it remains to be seen whether relevant patent information will ultimately make its way into the Purple Book, as is prevalent (and required) in its Orange Book cousin.  Stay tuned.

  • PTAB Decides Inter Partes Review of Patent at Issue in Ariosa v. Sequenom

    By Kevin E. Noonan —

    Ariosa DiagnosticsOn September 2nd, the Patent Trial and Appeals Board (PTAB) entered judgment in an inter partes review styled Ariosa Diagnostics v. Isis Innovation Ltd. (IPR 2012-00022).  The Board found that Ariosa demonstrated, by a preponderance of the evidence of record, that claims 1, 2, 4, 5, 8, 19, 20, 24, and 25 of U.S. Patent No. 6,258,540 are unpatentable under 35 U.S.C. § 102(b).  But the Board found that Ariosa did not carry its burden of showing by a preponderance of the evidence that claims 3, 12, 13, 15, 18, 21, and 22 of the '540 patent were unpatentable under 35 US.C. § 103(a).

    The claims under inter partes review are as follows:

    1.  A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
        amplifying a paternally inherited nucleic acid from the serum or plasma sample and
        detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

    2. The method according to claim 1, wherein the foetal nucleic acid is amplified by the polymerase chain reaction.

    3. The method according to claim 2, wherein at least one foetal sequence specific oligonucleotide primer is used in the amplification.

    4. The method according to claim 1, wherein the foetal nucleic acid is detected by means of a sequence specific probe.

    5. The method according to claim 1, wherein the presence of a foetal nucleic acid sequence from the Y chromosome is detected.

    8. The method according to claim 1, wherein the presence of a foetal nucleic acid from a paternally-inherited non-Y chromosome is detected.

    12. The method according to claim 5, for determining the sex of the foetus.

    13. The method according to claim 5, which comprises determining the concentration of the foetal nucleic acid sequence in the maternal serum or plasma.

    15. The method according to claim 13, for the detection of a maternal or foetal condition in which the level of foetal DNA in the maternal serum or plasma is higher or lower than normal.

    18. The method according to claim 13, for detection of a foetal chromosomal aneuploidy.

    19. The method according to claim 1, wherein the sample contains foetal DNA at a fractional concentration of total DNA of at least about 0.14%, without subjecting it to a foetal DNA enrichment step.

    20. The method according to claim 19, wherein the fractional concentration of foetal DNA is at least about 0.39%.

    21. A method of performing a prenatal diagnosis, which method comprises the steps of:
        (i) providing a maternal blood sample;
        (ii) separating the sample into a cellular and a non-cellular fraction;
        (iii) detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction according to the method of claim 1;
        (iv) providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid.

    22. The method according to claim 21, wherein the non-cellular fraction as used in step (iii) is a plasma fraction.

    24. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises:
        removing all or substantially all nucleated and anucleated cell populations from the blood sample,
        amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally inherited fetal nucleic acid.

    25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises
        obtaining a non-cellular fraction of the blood sample
        amplifying a paternally inherited nucleic acid from the non-cellular fraction
        and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

    (Italics indicating claims found unpatentable by the PTAB.)

    The decision provided the following synopsis of the asserted grounds of unpatentability:

    Table
    wherein the cited references are:

    • Lo et al., Presence of Fetal DNA in Maternal Plasma and Serum, 350 LANCET 485–487 (1997).

    • Simpson et al., Isolating Fetal Cells in Maternal Circulation for Prenatal Diagnosis, 14 PRENATAL DIAGNOSIS 1229–1242 (1994).

    • Kazakov et al., Extracellular DNA in the Blood of Pregnant Women, 37(3) CYTOLOGY (TSITOLOGIA) 232–236 (1995).

    • Bianchi et al., Fetal Cells in Maternal Blood: Determination of Purity and Yield by Quantitative Polymerase Chain Reaction, 171 AM. J. OBST.GYNECOL. 922–26 (1994).

    • Schallhammer et al., Phenotypic Comparison of Natural Killer Cells from Peripheral Blood and from Early Pregnancy Decidua, 3 EARLYPREGNANCY: BIOLOGY AND MEDICINE 15–22 (1997).

    The decision noted that Ariosa abandoned at oral argument its first two grounds of unpatentability set forth above.

    Isis InnovationArriving at its bases for deciding the questions before it, the Board reiterated its decision (as set forth in its Decision on Petition) rejecting Isis's arguments that Ariosa lacked standing under § 315 to petition for inter partes review based on the litigation between the parties.  Specifically, the Board addressed Isis's contention that "it 'is of no moment'" that Ariosa raised its validity challenge as an affirmative defense (in the face of Isis's infringement allegations prompted by Ariosa's declaratory judgment action for judgment of non-infringement).  Isis also argued unsuccessfully that the exception under § 315(a)(3) does not apply because Isis (and its licensee, Sequenom) did not initiate the civil action.  Finally, Isis argued (again unsuccessfully) that granting Ariosa's petition for inter partes review would "thwart the intent of Congress," inter alia, by permitting "patent owner harassment."  For clarity, the Board set forth the precise question decided in granting Ariosa's petition:

    [W]hether filing a Declaratory Judgment of non-infringement in District Court bars Ariosa from later filing a petition for Inter Partes Review under 35 U.S.C. § 315(a), and whether the express mention of a counterclaim of invalidity in 35 U.S.C. § 315(a)(3) mandates interpreting the statute such that raising an affirmative defense of invalidity in response to a compulsory counterclaim of infringement deprives Ariosa of standing to file for inter partes review.

    The Board's decision to grant Ariosa's petition was based on its determination that the plain meaning of the statute, as interpreted by the definitions of "filing" and "a civil action" provided by the Federal Rules of Civil Procedure, is that the bar arises when a petitioner has filed a complaint prior to filing the inter partes review petition.  The Board also distinguished between raising an affirmative defense and filing a counterclaim, based on its understanding of the differences defined by the Supreme Court in Altvater v. Freeman, 319 U.S. 359 (1943).  In that case, the Court decided that a counterclaim is "justiciable" even in the face of a determination of non-infringement, while an affirmative defense of invalidity under similar circumstances would be to "decide a hypothetical case."  Citing Cardinal Chem. Co. v. Morton Int'l, Inc., 508 U.S. 83 (1993), the Board decided that "it is clear []that there is a fundamental difference between an affirmative defense of invalidity and a counterclaim of invalidity," and thus that the declaratory judgment of non-infringement by Ariosa in this case did not fall within the activities the statute provides would bar the grant of the inter partes review petition.

    The Board also rejected Isis's contention that § 315(b) barred grant of the petition because Isis had filed its infringement lawsuit more than a year before filing the inter partes review petition, because the infringement complaint had been dismissed without prejudice, citing the Board's prior decision to this effect in Macauto U.S.A. v. BOS GmbH & KG, Case IPR2012-00004 (PTAB January 24, 2013).

    In the last of the procedural issues discussed in the decision, the Board rejected Isis's contention that granting Ariosa's Motion for Joinder (of two separate inter partes actions against different combinations of claims) was improper (despite the statutory language being limited to joinder of parties; § 315(c)) based on its practice in prior proceedings permitting such joinder, including Microsoft Corp. v. Proxycann, Inc., Case IPR2013-00109 (PTAB February 25, 2013), and Samsung Elecs. Co., Ltd. v. Virginia Innovation Scis., Inc., Case IPR2014-00557 (PTAB June 13,2014).  The Board found no prohibition of issue joinder in either the statutory language or the legislative history, and relied on its rules (37 CFR § 42.1(b)) implementing § 316, specifying that "[t]he rules are to be construed so as to ensure the just, speedy, and inexpensive resolution of a proceeding."

    Turning to the merits of Ariosa's invalidity contentions, the Board construed the claim term "detecting."  In doing so, the Board made the following claim construction determination applying the "broadest reasonable interpretation" standard under 37 C.F.R. § 42.100(b):

    "detecting" means that the amplified DNA was detected, but not that such DNA be identified as being of paternal or fetal origin.

    This construction, according to the Board, is consistent with the construction used by Isis's expert at trial, and further that in the context of the claims Isis could have limited what was detected to paternal and fetal DNA by stating that "only" this DNA was detected (but, says the Board, "they chose not to do so," implying a decision point that there is no evidence Isis ever encountered).  While the Board relies on claim construction canons (such as not reading limitations from the specification into the claims), it is incongruous that the Board rendered this construction decision (which is dispositive; see below) in interpreting the scope and meaning of claims specifically directed towards detecting paternal or fetal DNA in pregnant female blood.

    With this construction established, the decision turned to the cited references.  Regarding the Kazkov reference, asserted against claims 1, 2, 4, 5, 8, 19, 20, 24 and 25, the Board found that the practice of the methods disclosed in the reference inherently anticipated these claims, because amplification of DNA from maternal blood would necessarily detect "paternally inherited nucleic acid of fetal origin."  Specifically, the Board found that the reference taught that:  1) extracellular DNA is present in human blood; 2) the amount of this DNA increases with pregnancy; 3) this DNA was detected using PCR; 4) the amplified DNA was detected (using gel electrophoresis); and 5) the primers Kazakov used would have detected paternal DNA (insofar as the primers amplified sequences present (albeit not exclusively) on the Y chromosome).

    Under the Board's construction, "Kazakov discloses the same method of claim 1."  The Board stated that "all that is required by the amplification step of claim 1 is a step of amplifying nucleic acid from a serum or plasma sample from a pregnant female, such as by PCR, as such amplified nucleic acid would necessarily include fetal nucleic acid, and the fetal nucleic acid necessarily includes paternally inherited nucleic acid," so long as "the detecting step does not require that the detected nucleic acid specifically be identified as being inherited from the father or even as being from the fetus, only that it be identified as containing some level of nucleic acid, which would include, necessarily, nucleic acid from the fetus that was inherited from the father."  The Board further reasoned that:

    [I]f the ordinary artisan were to follow the teachings of Kazakov, and perform PCR on the serum obtained from the blood obtained from a pregnant female, that blood would inherently contain paternally inherited fetal nucleic acid.  That nucleic acid would be amplified and detected by the experiments of Kazakov as such a result is necessarily inherent.  That is, the amplification and detection of paternally inherited fetal nucleic acid would be a new benefit of a known process.

    The Board further "credited" the testimony of Ariosa's expert, that the methods disclosed in Kazakov were all "conventional," although there is no discussion on the significance of these findings to the Board's decision.  And Isis's arguments that the possibility that fetal or paternal DNA would not be detected received no traction with the Board in refuting its inherent anticipation determination (which is not surprising, because the Board's error was in claim construction not the application of the facts to the incorrectly construed claims).

    Having made this determination regarding claim 1, the Board did not find (and in some cases Isis did not provide) any basis for the same reasoning not to be applied to claims 2, 4, 5, 8, 19, 20, 24, and 25, and thus found these claims to also be inherently anticipated by the Kazakov reference.

    Regarding obviousness, the Board held that Ariosa had not borne its burden of establishing invalidity by a preponderance of the evidence.  Limiting its considerations to the combination of the Kazakov and Simpson references, the Board found that the Simpson reference taught detection of fetal cells, not fetal cell-derived DNA in maternal whole blood, and that the art taught that detecting fetal cells in maternal blood was "a rare occurrence."  Under these circumstances, the Board found that:

    [T]he ordinary artisan would not have used the serum sample of Kazakov, which is a cell-free sample, for the whole blood sample of Simpson, which contains the cellular fraction, for the analysis of fetal DNA as taught by Simpson.  The ordinary artisan would not have had a reasonable expectation that the fetal DNA would have been present in maternal serum in sufficient quantities for detection using amplification methods such as PCR given the understanding in the art that fetal cells were a rare occurrence in maternal blood.  Moreover, Kazakov's lack of teaching that the increase in extracellular DNA in the serum of pregnant females is due to the presence of cell-free fetal DNA in the serum further supports that conclusion.

    Ironically, the Board's decision on obviousness relies on the failure of the art to recognize that fetal or paternal DNA could be detected in maternal blood, a distinction that the Board did not credit in its claim construction leading to its contrary decision regarding (inherent) anticipation by the Kazakov reference.

    The Board also rejected Ariosa's obviousness contentions based in the combination of the Kazakov, Simpson, Schallhammer (earlier determined by the Board to be cumulative over the teachings of the Simpson reference) and Bianchi references (wherein Bianchi taught Y-chromosome specific primers), based on the same lack of expectation that fetal cells (or their DNA) would be expected by the skilled artisan to be present in maternal blood.

    The Board also denied Isis's motion to amend its claims, once again rendering a decision that contradicts the rationale for construing claims according to the broadest reasonable interpretation of its terms (i.e., that when before the PTO the patentee can amend her claims).  The proposed amended claims are as follows, and were proposed to overcome the Board's broad construction of the term "detected" in the patented claims:

    28.  A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
        amplifying a paternally inherited nucleic acid from the serum or plasma sample, and
        detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample by determining that the paternally inherited fetal nucleic acid contains a sequence not possessed by the pregnant female.

    31.  A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
        amplifying a paternally inherited nucleic acid from the serum or plasma sample, [and]
        detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample by determining that the paternally inherited nucleic acid of fetal origin contains a sequence not possessed by the pregnant female,
    and
    determining fetal sex, fetal chromosomal aneuploidy, fetal mutation, fetal RhD status, or fetal paternally-inherited DNA polymorphism    .

    In a Kafka-esque fashion, the Board denied the motion because the patentee is under a burden of showing she is "entitled" to the "relief" of amending claims, and the burden imposed is to establish that the claims are patentable under all sections of the Patent Act.  Even though inter partes review is limited to the issues of anticipation and obviousness based on prior art, the Board permits a challenge on the patentability of amended claims on all the statutory sections.  Here, citing the District Court's decision (and in the face of the pending Federal Circuit appeal), the Board determined that Isis had failed to carry its burden of showing that the proposed amended claims are patent-eligible under § 101.

    PTAB recognized that claims 1, 2, 4, 5, 8, 19–22, 24, and 25 of the '540 patent were declared invalid in Ariosa Diagnostics v. Sequenom.  With the exception of claim 21, this outcome suggests that Ariosa could have invalidated the claims in the district court under § 102(b) and done much less violence to the patent system in doing so.  It also raises the possibility that Sequenom may move the Federal Circuit to vacate the District Court's judgment based on § 101 in view of the Office's determination that the claims are invalid under § 102(b).

    The Board's decision provides Isis with another opportunity to appeal to the Federal Circuit, this time on the PTAB's decision invalidating these claims.  Assuming that the Court reverses the District Court on the patent eligibility issue, the Board has provided for review by the Court with issues of claim construction as well as procedural questions decided by the Board in instituting the petition in the first place.