• PLI #1Practising Law Institute (PLI) will be offering a one-hour webcast on "Leveraging Active Voice in Patent Claims" on February 4, 2020 beginning at 1:00 pm (EST).  Jason M. Perilla of Thomas | Horstemeyer, LLP will introduce and explore the use of active voice in drafting patent claims and discuss:

    • How to organize and prioritize the important aspects of an invention before drafting patent claims;
    • How to identify the "actors" of an invention, particularly in the context of computer-environment-related inventions;
    • Avoiding the use of "wherein" clauses and other claim limitations that are unhinged from a particular actor and, perhaps, the invention itself; and
    • Leveraging active voice to help avoid "abstract idea" rejections under § 101.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • PLI #1Practising Law Institute (PLI) will be offering a one-hour webcast on "Litigating Civil and Criminal Trade Secret Cases: Trends, Best Practices, and Lessons Learned" on February 13, 2020 beginning at 1:00 pm (EST).  Jeffrey M. Fisher and Janice W. Reicher of Farella Braun + Martel LLP will provide an overview of:

    • Trends in trade secret litigation, both civil and criminal, and best practices in litigating these cases;
    • Differences in the trade secret law and considerations in civil vs. criminal cases;
    • How to protect your valuable intellectual property, including key issues relating to litigation involving non-disclosure agreements and employment agreements;
    • Lessons learned from recent civil trade secret jury trials, including Huawei v. CNEX and Bladeroom v. Facebook and Emerson; and
    Certain high profile criminal trade secret cases including US v. Levandowski and US v. Huawei.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • By Dan Feigelson* —

    IL PTOMany patent practitioners will never have need to file a patent application in Israel, a country of nine million people that's geographically smaller than New Jersey.  But if you're one of those practitioners who does file in Israel from time to time — and I suspect that readers of Patent Docs file in Israel at a higher rate than the general practitioner population — you'll be pleased to know that the Israel PTO (ILPTO) recently proposed a change in patent examination practice that portends relief for beleaguered applicants:  the ILPTO plans to tighten the criteria for rejecting claims of an applicant's application for "overlap" with the claims of another of the applicant's applications (or granted patents).  The upshot will be that the ILPTO will no longer make such rejections in the case of divisional applications on the basis of the claims of an ancestor application.

    By way of background, section 2 of the Israel patent statute says that an applicant may obtain a patent for his invention.  Like 35 U.S.C. § 101, Israel section 2 has been interpreted to mean you can get one patent per invention.  So you can't get two claims of the same scope in two different patents.

    Where the difficulty has arisen is when the claims of an applicant's separate applications are of different, but nevertheless overlapping, scope.  To illustrate, suppose a parent application claims a single chemical compound, and a related child application claims a genus of compounds that encompasses that compound.  In the U.S., such a situation would give rise not to a statutory double-patenting rejection under § 101 (since the claims are not of identical scope), but to an obviousness-type double-patent rejection.  And the response in the U.S. would be to file a terminal disclaimer, which would achieve two things:  it would ensure that the two patents expire at the same time (generally not an issue since June 1995, when the U.S. switched to a 20-years-from-earliest-filing-date-system); and it would ensure that the patents must be co-owned for the later-issuing patent to be enforceable.

    In Israel, until now, that same set of facts would also result in the ILPTO rejecting the child claim(s), and the assertion made by the ILPTO would be that the child claim(s) "overlap" with the parent claim(s).  The problem is that whereas in the U.S., it's recognized that obviousness-type double-patenting is a judicially created-doctrine, in Israel, there is no comparable case law.  Thus, despite the fact that the statute seems to be clear that only identical claims in two of an applicant's applications are forbidden (section 13 says that it's the claims that define the invention, which would seem to mean that as long as the claims aren't of identical scope, section 2 doesn't apply), the ILPTO has for years taken the view that section 2 precludes the allowance of such "overlapping" claims.  In other words, the ILPTO conflates statutory double-patenting with obviousness-type double-patenting.  As one might expect, this practice has not been without criticism, see, e.g., here, here, here, and here.

    Although it has been proposed that the ILPTO adopt a terminal disclaimer practice like that in the U.S., until now the only way for an applicant to overcome an "overlap" rejection has been to either remove the offending matter from the claims of one of the applications (either by deleting one or more positive recitations from the offending claim(s), or introducing one or more provisos), or to show that the offending claims constitute a non-obvious selection over the earlier claims.  (The latter option shows the paucity of the logical underpinnings of the ILPTO's position:  if the statute requires that there be no overlap between the scope of the claims in an applicant's different applications, a showing of non-obviousness doesn't obviate the double-patenting problem.)

    The ILPTO's approach to "overlap" has been vexing for pharma and biotech applicants in Israel.  For example, if an examiner is willing to allow claims of a narrower scope than the applicant believes it is entitled, in the U.S. the applicant will take the allowance of the narrower claims now, and fight for the broader claims in a continuation, knowing that it may be necessary to file terminal disclaimer to get around the claims of the parent case.  But in Israel, taking the narrower claims in the parent case might presage an "overlap" rejection, which at best would necessitate figuring out a way to eliminate that "overlap," a task that sometimes requires a significant investment of time, and in some cases might not be easily or satisfactorily accomplished.

    The ILPTO's obsession with overlap hasn't been a headache just for applicants and their patent counsel.  It's also been a source of wasted examiner time, as examiners have been instructed to conduct search-and-destroy mission against "overlap" as part of their job.

    It was apparently this last aspect of the practice that finally got the attention of the powers-that-be at the Israel PTO.  In a notice published on December 29, 2019, regarding proposed revisions to the Examination Guidelines (the ILPTO's equivalent of the MPEP), the ILPTO proposes to forego raising "overlap" rejections in cases of patent applications, or a patent application and a patent, which are (a) owned by the same entity and (b) have the same filing date, provided that the two documents do not contain claims of "literally or substantively" identical scope.  This means that the ILPTO plans to stop raising "overlap" rejections in cases of parent and divisional applications, as long as the claims are of different scopes.

    The specific proposed amended wording of the Examination Guidelines regarding "overlap" (in Hebrew) can be found here beginning at page 30.  The ILPTO has asked for comments on the proposed revisions to the Guidelines, to be sent to Patentim_Bhina@justice.gov.il by January 29, 2020.  It is expected that this proposal will be formally implemented soon thereafter; rumor has it that the ILPTO is in fact already implementing this change.

    * Daniel Feigelson is a patent practitioner based in Israel, who from time to time writes about U.S. and Israel patent issues at www.iliplaw.com.

  • By Donald Zuhn –-

    World Health OrganizationLast week, the World Health Organization (WHO) issued two reports suggesting that declining private investment and lack of innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections.  The WHO reports address fifty antibiotics (and ten antibacterial biologics) that are currently in clinical and preclinical development (see "Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline" and "Antibacterial agents in preclinical development").  However, the WHO reports indicate that these compounds "bring little benefit over existing treatments and very few target the most critical resistant bacteria (Gram-negative bacteria)."

    The Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, noted that "[n]ever has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent," adding that "[n]umerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines."  WHO also pointed out that research and development for antibiotics is primarily driven by small- or medium-sized enterprises, and that large pharmaceutical companies continue to exit the field of antibiotic research.

    With respect to its review of the clinical development of antibiotic agents, WHO noted that of the fifty antibiotics in the pipeline, 32 target pathogens that appeared on WHO's 2017 list of priority pathogens, but that the majority of antibiotics in clinical development have limited benefits when compared to existing antibiotics.  In addition, only two of the fifty antibiotics are active against multi-drug resistant Gram-negative bacteria, which WHO indicated are spreading rapidly and require urgent solutions.  The WHO report also highlights a "worrying gap in activity" against NDM-1 (New Delhi metallo-beta-lactamase 1), an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics.  According to the WHO report, there are only three antibiotics in the pipeline that can be used to treat resistant bacteria expressing NDM-1 (often referred to as "superbugs").  As for its review of the preclinical development of antibiotic agents, the WHO report suggests that an optimistic scenario is for the first two to five products to become available in about 10 years.

    WHO Assistant Director-General for Antimicrobial Resistance, Hanan Balkhy, stated that "[i]t's important to focus public and private investment on the development of treatments that are effective against the highly resistant bacteria because we are running out of options."  WHO also noted that with respect to antibiotic research and development, WHO and the Drugs for Neglected Diseases Initiative (DNDi) have established the Global Antibiotic Research and Development Partnership (GARDP), a non-profit research and development organization that is working with more than fifty public and private sector partners in twenty countries to accelerate the development of new and improved antibiotics to tackle drug-resistant infections.  GARDP's goal is to deliver five new treatments by 2025.

  • By Donald Zuhn –-

    Federal Circuit SealLast week, the Federal Circuit issued a per curiam Order in BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc., denying a petition for a panel rehearing or rehearing en banc filed by Appellant BioDelivery Sciences International, Inc.  Judge Newman dissented from the denial of the petition for rehearing en banc.

    The dispute between the parties arose when BioDelivery sought inter partes review of claims 1, 4, 6–9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125–127 of U.S. Patent No. 8,765,167, citing seven prior art grounds of anticipation or obviousness.  The U.S. Patent and Trademark Office Patent Trial and Appeal Board instituted the IPR on most, but not all, of the challenged claims, and on one of the grounds.  The PTAB ultimately issued a Final Written Decision finding claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 of the '167 patent to be patentable.

    BioDelivery appealed to the Federal Circuit, which received briefing and argument before the Supreme Court issued its decision in SAS Institute Inc. v. Iancu.  On BioDelivery's motion, the Federal Circuit directed the PTAB "to implement the Court's decision in SAS."  In response, the PTAB "modif[ied its] Decision to Institute and instead deny the Petition in its entirety, thereby terminating [the] proceeding," and in particular, "ORDERED that Petitioner's request for inter partes review of claims 1, 4, 6–9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 125–127 of the '167 patent is denied and no inter partes review is instituted."

    Judge Newman, dissenting from the denial of the petition for rehearing en banc, stated that:  "I write because of the significance of the balance of agency and judicial authority, and the rules of procedural law in the administrative state."  Noting that the Supreme Court in SAS held that 35 U.S.C. § 318(a) requires that in an inter partes review the PTAB must decide all of the claims and grounds challenged in the petition, Judge Newman indicated that "the PTAB had not met this requirement for these cases [the appeal consolidated three separate PTAB decisions]."  In particular, Judge Newman noted that "[t]he PTAB did not comply with the Remand Order, stating that it would be inefficient and expensive to include the additional claims and grounds," with the PTAB explaining in its Decision on Remand that "[b]ecause the overwhelming majority of unpatentability grounds presented by Petitioner fail to meet the standard for institution of inter partes review, we find that instituting trial as to those grounds at this time is neither in the interest of the efficient administration of the Office, nor in the interest of securing an inexpensive resolution of this proceeding."  In her dissent, Judge Newman writes that:

    [M]y colleagues hold that the PTAB is not required to comply with the court's Remand Order, and further hold that this non-compliance is not reviewable.  This action raises critical issues of agency authority, judicial responsibility, and the constitutional plan.

    Judge Newman declares that "[m]y concern is with the PTAB's position that it need not follow the court's Remand Order, for reasons of efficiency and expense," adding that "[s]uch agency authority cannot be discerned in the America Invents Act, and contravenes decades of constitutional jurisprudence."  Citing Banks v. United States, 741 F.3d 1268, 1276 (Fed. Cir. 2014) (quoting Briggs v. Pa. R. Co., 334 U.S. 304, 306 (1948)), Judge Newman notes that agency action is bound by the mandate rule, which:

    [D]ictates that 'an inferior court has no power or authority to deviate from the mandate issued by an appellate court.'  Once a question has been considered and decided by an appellate court, the issue may not be reconsidered at any subsequent stage of the litigation, save on appeal.

    Judge Newman also observes that "[t]he legislative record contains no contemplation of a PTAB procedure whereby, after full PTAB trial and decision and appeal to the Federal Circuit, the PTAB could annul the appeal and remove the entire action and decisions and procedure from history, insulated from review."  As a result, Judge Newman found the PTAB's action in this case to be "seriously flawed."  According to Judge Newman, "[t]he PTAB's refusal to comply with our Remand Order to implement the Supreme Court's ruling warrants en banc attention," and she therefore dissented from the denial of the petition for rehearing en banc.

    BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc. (Fed. Cir. 2020)
    Per curiam
    Before Chief Judge Prost and Circuit Judges Newman, Lourie, Dyk, Moore, O'Malley, Reyna, Wallach, Taranto, Chen, and Hughes; dissenting opinion by Circuit Judge Newman

  • CalendarJanuary 22, 2020 – "Top Patent Law Stories of 2019" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 22, 2020 – "Pot Topic: IP Issues for the New Recreational Weed Industry in Illinois" (The Intellectual Property Law Association of Chicago Young Members' Committee) – 5:30 to 9:00 pm (CT), Chicago, IL

    January 23, 2020 – "PTAB Year in Review" (Foley & Lardner) – 1:00 to 2:00 pm (CT)

    January 23, 2020 – "Text and Data Mining Laws: International Developments" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    January 28, 2020 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – Alexandria, VA

    January 28, 2020 – "Obtaining Patent Protection for Polymorphs of Drug Compounds" (J A Kemp) – 3:30 to 4:30 pm (GMT)

    January 30, 2020 – "American Axle: Does Patent Subject Matter Eligibility Depend on Enablement?" (Fitch Even) – 12:00 to 1:00 pm (ET)

  • USPTO Building FacadeThe U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on January 28, 2020 at the USPTO Headquarters in Alexandria, VA.  The agenda for the meeting is as follows:

    • Welcoming and Opening Remarks (10:30 – 10:40 am ET) — Gary Jones and Andrew Wang, Directors, and Karl Skowronek, Director (Acting), TC1600, USPTO

    • Restriction practice (10:40 – 11:20 am) — Janet Andres, SPE, TC1600, USPTO

    • Orange Book and biologic patent study 11:20 – 12:00 pm) — Michelle Ankenbrand, Lead Administrative Patent Judge, and Jason Repko, Administrative Patent Judge, PTAB, USPTO

    • Lunch/Networking (12:00 – 1:00 pm)

    • Patent term adjustment (1:00 – 1:50 pm) — Kery Fries, Senior Legal Advisor, OPLA, USPTO

    • Satisfying the written description requirement for living inventions (1:50 – 2:50 pm) — Bethany Reid Roahrig, Patent Agent, Setter Roche LLP

    • Break (2:50 – 3:00 pm)

    • Subject matter eligibility (101) update (3:00 – 4:30 pm) – Zachariah Lucas, QAS, TC1600, USPTO

    • Closing Remarks (4:30 – 4:40 pm) – Directors, TC1600, USPTO

    Additional information regarding the BCP customer partnership meeting, including registration information for those wishing to attend the meeting or register for online participation, can be found here.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Text and Data Mining Laws: International Developments" on January 23, 2020, from 2:00 to 3:00 pm (ET).  Aaron Chalfoos of Jones Day, Professor Bernt Hugenholtz of the University of Amsterdam, and Gail Zarick of IBM will discuss:

    • The many aspects of law that govern text and data mining (TDM) in the U.S., including copyright, the Computer Fraud and Abuse Act, contract law, and state law claims such as criminal trespass and unjust enrichment
    • Basic relevant differences between EU and U.S. copyright law, including the difference between "fair dealing" and "fair use"
    • The importance of the EU Database Directive and the recently approved EU Directive on Copyright, which includes specific provisions on TDM
    • The relevant legal landscape in Japan and China
    • A roadmap for how in-house counsel should approach due diligence on TDM issues

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • J A KempJ A Kemp will be offering a webinar entitled "Obtaining Patent Protection for Polymorphs of Drug Compounds" on January 28, 2020 from 3:30 to 4:30 pm GMT (Greenwich Mean Time).  Chris Milton and Guy Brain of J A Kemp will discuss some of the issues faced during the drafting and prosecution of patent applications for polymorphs and how those issues can be addressed.  The webinar will also address the following topics:

    • How to draft claims directed to polymorphs
    • Other drafting tips for polymorph applications
    • Establishing novelty and inventive step for polymorphs

    Those wishing to register can do so here.

  • Fitch EvenFitch Even will be offering a webinar entitled "American Axle: Does Patent Subject Matter Eligibility Depend on Enablement?" on January 30, 2020 from 12:00 to 1:00 pm (ET).  Stanley A. Schlitter and Andrew C. Wood of Fitch Even will discuss the following:

    • The district court and Federal Circuit decisions in this case
    • Arguments presented in the amici briefs
    • How American Axle comports with the USPTO's patent eligibility guidance
    • Strategies for litigators and prosecutors regarding Alice in view of American Axle

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.