• By Donald Zuhn

    CoverPatent services provider inovia has released its fifth annual report on global patent and IP trends.  In compiling "The 2014 U.S. Global Patent & IP Trends Indicator," inovia, which produces products for PCT national phase entry, European patent validation, and patent translations, surveyed more than 100 companies and universities in May 2014 to identify the trends having the greatest impact on the foreign filing strategies of U.S. patentees.

    The 2014 report notes that 20.4% of survey respondents are involved in the pharmaceuticals or biotech industries.  Other sectors or groups represented in the survey include chemicals/materials (13.6%), electrical/electronics (7.8%), mechanical/engineering (12.6%), IT/software/media (1.9%), and university/association/non-profit (16.5%).  The report also indicates that 24.3% of survey respondents had no in-house patent attorneys or agents, 51.5% had one to four attorneys or agents, 11.7% had five to nine attorneys or agents, 4.9% had ten to 24 attorneys or agents, and 7.8% had 25 or more attorneys or agents.  With respect to the number of in-house patent attorneys or agents, the trend was towards increasing numbers of in-house practitioners (in last year's report, 33% of survey respondents had no in-house patent attorneys or agents and 47% had one to four attorneys or agents, and in the 2012 report 37% of respondents had no in-house patent attorneys or agents and 46% had one to four attorneys or agents).  Also, fewer respondents experienced IP budget cuts in 2013 than in 2012, and fewer respondents brought some prosecution activies in house in 2013 (dropping to 45% of respondents in 2013 from 57% of respondents in 2012).

    Not surprisingly, the 2014 report indicates that for U.S. applicants, patent reform was the dominating issue in 2013.  With respect to filing expectations, 79% of respondents said they filed as many patent applications as they expected to file in 2013, 6% filed more than they expected, and 14% filed less than they expected.  In last year's survey, 73% of respondents said they filed as many applications as expected in 2012, 11% filed more, and 16% filed fewer, and in the 2012 survey, 67% of respondents said they filed as many applications as expected in 2011, while 18% filed more and 15% filed fewer.

    The 2014 report indicates continued growth for international patent protection, as 52.6% of respondents filed more than half of their patent applications abroad (up from 50% in last year's report and 42% in the 2012 report).  Respondents were also less selective with their filings abroad in 2013, with 12.4% of respondents filing corresponding applications in only 1-3 foreign countries and another 30.9% filed internationally in 4-19 countries.  In last year's survey, 22% of respondents drew the line at 1-3 foreign filings and 32% filed in only 4-19 countries, and in the 2012 survey, 37% filed corresponding applications in only 1-3 foreign countries.

    With regard to the countries in which respondents regularly filed, 20% added new countries to their list (down from from 23% in 2012), with China now considered a regular destination for many U.S. applicants.  A smaller percentage of respondents (15%) dropped countries from their lists (down from 19% in 2012), with respondents noting that market opportunity in Japan, Australia, and Canada was dwindling, prosecution was becoming more onerous in Saudi Arabia and too expensive in Japan.  As in last year's survey, respondents who dropped the European Patent Office believed that the high cost of pursuing such protection did not justify the value.  In ranking foreign jurisdictions, respondents placed Europe, China, and Japan first, second, and third, respectively, which was the same ranking respondents provided in the last two reports.  Finally, the report noted that a large majority of respondents (96%) rely on the PCT for foreign filing.  Of these respondents, 71% selected the EPO as an International Searching Authority (down from 75% in 2012), 45% selected the Korean IP Office (KIPO) (down from 50% in 2012), and 11% selected the Japan Patent Office (JPO) (no change from 2012).

  • By Donald Zuhn

    USPTO SealIn a notice published in the Federal Register last week (79 Fed. Reg. 56070), the U.S. Patent and Trademark Office announced that it would be holding a roundtable to obtain public input on several issues related to the international harmonization of substantive patent law.  In particular, the Office is interested in stakeholder feedback regarding the definition and scope of prior art, the grace period, and standards for assessing novelty and obviousness/inventive step.

    In the notice regarding the roundtable, the Office indicates that it has continued to focus on work sharing, which allows one patent office to leverage work done by another patent office on a corresponding application in order to improve quality and reduce duplicative search and examination efforts.  The notice suggests that harmonization can enhance the effectiveness of work sharing by better aligning the patentability standards of the two offices.  According to the Office, the areas of substantive patent law which are most relevant for work sharing purposes are those related to the search and application of prior art.  As a result, the Office is most interested in securing public feedback regarding the definition and scope of prior art and standards for assessing novelty and obviousness/inventive step.  The Office is also interested in obtaining public input regarding the grace period.

    While an agenda for the roundtable has yet to be released, the Office indicated that the event will consist of two panel discussions.  The first discussion will address key patent examination-related issues such as the definition of prior art, prior art effect of published applications, prior art not affecting patentability (grace period), and conditions for patentability — novelty and obviousness/inventive step.  In the second discussion, the Office will focus on how to best advance substantive patent law harmonization.  Those interested in serving as a panelist should submit their name, contact information (telephone number and email address), the name of the organization(s) the person represents, if any, relevant biographical information as it pertains to the topic(s) to be discussed during the session(s), and a few brief comments on the topic(s) to IP.Policy@uspto.gov before October 24, 2014.  Panelists will be selected approximately two weeks in advance of the roundtable.

    The roundtable will take place from 8:30 am to 12:00 pm on November 19, 2014 in the Madison Building on the USPTO's Alexandria campus. An agenda and webcast information for the roundtable will be made available a week prior to the event on the Office's Events webpage.  Those interested in registering for the event can do so here.  Attendees may also register at the door.

  •         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.

  • 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 #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.

  • 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.

  • 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 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.

  • 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.

  • 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.