• By Kevin E. Noonan

    AMPThe Association for Molecular Pathology released a survey last week regarding the state of reimbursement for medical diagnostic testing, according to GenomeWeb.

    It seems that the state is parlous, with reimbursement for "data analysis, test interpretation, and reporting requirements" being inadequate.  This reflects a need for "qualified molecular laboratory professionals" and of course reimbursement for these efforts.  These efforts are significant, with the majority (65%) of respondents reporting that these reports require extra effort (compared with more conventional diagnostic laboratory tests) and greater time burdens.  The only exceptions are so-called "single-gene tests," and oncology tests were typically delivered most rapidly (reflecting adequate time and personnel and, perhaps, their importance to proper diagnosis of what is, despite recent developments, frequently a deadly disease).

    AMP has developed five recommendations/next steps for ameliorating these issues:

    • work to develop informed perspectives on the future testing landscape, including the increasing adoption of more complex tests, and use this data to forecast future analysis burdens on labs;

    • explore case studies to understand how existing analysis burdens impact lab function and how this could increase with anticipated changes;

    • engage with physician and patient groups to better define negative outcomes from slow, expensive, or insufficient testing;

    • advocate for policy changes that will positively impact reimbursement for interpretive services and report preparation for pathologists and qualified doctoral scientists; and

    • educate payors about the complexities of molecular testing and intricacies involved in analysis, interpretation, and results reporting.

    AMP intends to use the survey results to address these issues with "payors, federal agencies, and members of Congress" in efforts to obtain "fair and reasonable reimbursement solutions" to these reimbursement issues.

    So maybe patents on genes weren't the problem after all, Myriad not the avaricious monster AMP made them out to be, and being permitted to infringe with impunity not the pot of gold they expected.  Which was not entirely unexpected (see "The ACLU, Working for the Man").

  • By Donald Zuhn

    Tillis  ThomOn Monday, Senators Thom Tillis (R-NC) and Tom Cotton (R-AR) sent a letter to Drew Hirshfeld, the Commissioner for Patents at the U.S. Patent and Trademark Office, to propose that the USPTO conduct a pilot program on a sequenced approach to patent examination.  In their letter, Sen. Tillis (at right), the Ranking Member of the Senate Subcommittee on Intellectual Property, and Sen. Cotton (at left), a member of the Subcommittee on Intellectual Property, suggest that a sequenced approach to patent examination, in which applications are first examined for compliance with 35 U.S.C. §§ 102, 103, and 112, and then for compliance with 35 U.S.C. § 101, could "avoid unnecessary and inefficient rejections on grounds of patent eligibility."

    Cotton  TomThe Senators express their concern that "by conducting an eligibility analysis as per current practice, patent examiners may be issuing Section 101 rejections without the benefit of addressing prior art, clarity and enablement issues that may well inform the examiner that the claim is eligible under Section 101."  While stating that examination under §§ 102, 103, and 112 is based on "well-developed and objective criteria under the law," the Senators assert that "current patent eligibility jurisprudence lacks the clarity, consistency, and objectiveness the other grounds of patentability possess."  They argue that:

    By conducting an inherently vague and subjective analysis of eligibility early in the examination process, examiners may be spending inordinate time on Section 101 at a time when it is difficult or impossible to conduct a meaningful examination under Section 101, at the expense of the more rigorous analysis and precise and thoughtful work that can be conducted at the outset of examination under Sections 102, 103, and 112.

    In view of discussions they have had with USPTO officials, the Senators note that by using a sequenced examination approach, Applicants "rarely receive[] a rejection on grounds of patent eligibility," because "by bringing claims into compliance with Sections 102, 103, and 112, examiners inevitably brought the claims into compliance with Section 101 as well."

    The Senators provide three reasons why a sequenced approach to examination may improve the examination process.  First, they argue that a sequenced approach would "focus[] initial examination on the objective areas of patentability as opposed to the abstract, vague, and subjective questions of eligibility, leaving eligibility examination to a point in the process where it can be conducted much more effectively."  Second, a sequenced approach would "improve[] efficiency by avoiding the waste of valuable examination and applicant time on vague questions of patent eligibility as a threshold matter."  And finally, the Senators argue that a sequenced approach would "lead[] to stronger, more reliable, and higher quality patents by focusing first on the more rigorous and easy to identify standards of patentability."

    The Senators conclude their letter by requesting that the Commissioner initiate a pilot program to determine whether a sequenced approach would be more effective and produce higher quality patents than the traditional compact examination approach.  They also ask the Commissioner to let them know by April 20, 2021 whether such a program will be implemented, and if the USPTO elects not to implement such a program, "provide us with a detailed explanation of why you will not conduct the requested pilot program."

  • By Kevin E. Noonan

    Federal Circuit SealEver since institution of the post-grant review proceedings enacted under the Leahy-Smith America Invents Act were implemented by the U.S. Patent and Trademark Office (through the newly constituted Patent Trial and Appeal Board), parties (particularly patentees who lost patent rights thereby) have challenged the outcome on procedural, substantive, and constitutional grounds (see "Cuozzo Speed Technologies LLC v. Lee"; "SAS Institute Inc. v. Iancu;  Return Mail, Inc. v. United States Postal Service"; "Thryv, Inc. v. Click-to-Call Technologies, LP ").  The most recent (and legally creative) challenge is pending before the Supreme Court (see "U.S. Government Petitions for Certiorari in Arthrex Case"; "Arthrex Files Certiorari Petition in Arthrex Case"), wherein patentee Appellants (and respondents before the Court) argued an Appointments Clause violation because Administrative Patent Judges on the PTAB are principal officers not properly installed with Senate approval.

    Appellant in New Vision Gaming and Development* v. SG Gaming (to be heard by the Federal Circuit on April 9th) has taken another tack, arguing that the administrative details of how APJs are paid, bonused, and controlled by the Director could be contrary to patentee's rights to due process (Corrected Brief of Appellant; Reply Brief of Appellant).  The argument is based on Supreme Court precedent in Tumey v. Ohio, 273 U.S. 510 (1927).  In that case, the Supreme Court reversed a criminal conviction under Ohio state law under conditions where the mayor of a village sat in judgment of a defendant accused of violating the state's Prohibition Act.  On appeal, the convicted petitioner argued that the mayor had pecuniary and other interests in his conviction and the petitioner was thus denied due process.  The basis of this allegation was a provision under the law that "[m]oney arising from fines and forfeited bonds shall be paid one-half into the state treasury credited to the general revenue fund, one-half to the treasury of the township, municipality or county where the prosecution is held, according as to whether the officer hearing the case is a township, municipal, or county officer."  Section 6212-19, General Code Ohio.  There were also allegations that monies raised from convictions like the plaintiff's inured to the mayor's benefit as a resident of the village, as well as the law providing direct payments to the mayor.

    The Supreme Court based its decision reversing plaintiff's conviction on the "general rule" that "officers acting in a judicial or quasi-judicial capacity are disqualified by their interest in the controversy to be decided" but that "[n]ice questions[] often arise as to what the degree or nature of the interest must be."  But as here, "it certainly violates the Fourteenth Amendment and deprives a defendant in a criminal case of due process of law to subject his liberty or property to the judgment of a court, the judge of which has a direct, personal, substantial pecuniary interest in reaching a conclusion against him in his case."  The Court held that, as a consequence of ratification of the Fourteenth Amendment, such an arrangement violates the requirement for due process of law.  Relevant to Appellant's argument here, the Court stated:

    The mayor is the chief executive of the village.  He supervises all the other executive officers.  He is charged with the business of looking after the finances of the village.  It appears from the evidence in this case, and would be plain if the evidence did not show it, that the law is calculated to awaken the interest of all those in the village charged with the responsibility of raising the public money and expending it, in the pecuniarily successful conduct of such a court.  The mayor represents the village and cannot escape his representative capacity.  On the other hand, [under this law] he is given the judicial duty, first, of determining whether the defendant is guilty at all; and, second, having found his guilt, to measure his punishment . . . .  With his interest as mayor in the financial condition of the village and his responsibility therefor, might not a defendant with reason say that he feared he could not get a fair trial or a fair sentence from one who would have so strong a motive to help his village by conviction and a heavy fine?  . . .  A situation in which an official perforce occupies two practically and seriously inconsistent positions, one partisan and the other judicial, necessarily involves a lack of due process of law in the trial of defendants charged with crimes before him.

    While acknowledging that the consideration at issue might not motivate some mayors to permit it to influence their judgment, the Court opined that:

    [T]he requirement of due process of law in judicial procedure is not satisfied by the argument that men of the highest honor and the greatest self-sacrifice could carry it on without danger of injustice.  Every procedure which would offer a possible temptation to the average man as a judge to forget the burden of proof required to convict the defendant, or which might lead him not to hold the balance nice, clear, and true between the state and the accused denies the latter due process of law.

    This led the Court to the conclusion that a "temptation" arising from "structural bias" in a statutory regime can violate the Due Process Clause even in the absence of actual bias.  The subtlety of this argument with regard to the current post-grant review regime is patent:  Appellant is not accusing the USPTO, its Director, or any individual APJs of anti-patent bias (a charge levied perhaps imprudently by others; see, e.g., "Is The PTAB a Death Sentence for Patent Rights?), but raising the structural possibility as being sufficient for the Constitutional infirmity.

    The principles enunciated in Tumey have also been the basis for consistent decisions in Dugan v. Ohio, 277 U.S. 61 (1928), and Ward v. Village of Monroeville, 409 U.S. 58 (1972) (notably, where the fines at issue accounted for between 35% to 50% of the village income).  However, it must be mentioned in passing that there are distinctions between Tumey and this case that could make a difference to a reviewing court, including that Tumey involved a criminal proceeding and that the statute at issue was state and not Federal law.

    Appellant's argument focuses on institution decisions and their relation to USPTO oversight and the system by which the Office financially rewards APJs based on the economic consequences of institution (versus refusing to institute).  Calling the current regime a "constitutional flaw," Appellant argues that the scheme "creates impermissible incentives for the PTAB, its leadership, and the individual administrative patent judges  . . . and that APJs are 'subjected to performance reviews and management tools by PTAB leadership, and the APJ's salary and bonus structures incentivize higher 'production,' which means more institutions.'"  Taken in conjunction with a lack of judicial independence, Appellant further argues that this raises "conflicting interests" that can raise the possibility — or appearance — of the PTAB granting "borderline petitions[] in order to ensure continued workflow, possible bonuses, and robust PTAB fee collections" (citing USPTO statistics that about $23 million in annual revenues depend on institution of post-grant review provisions).  These assertions are supported by citation to statute (35 U.S.C. § 42; 35 U.S.C. §§ 311(a), 321(a)) and USPTO official utterances such as Setting and Adjusting Patent Fees During Fiscal Year 2017, 82 Fed. Reg. 52,780, 52,780 (Nov. 14, 2017), as well as the PTAB's administrative and performance review structures and standards.

    A similar situation arose in the first decade of the 21st Century, where the Office's policies directed a severed diminution in granted patents (motivated by misguided reliance on arguments from academics and interest groups that the Office was granting too many patents of poor quality; see "Law Professors Back USPTO in Tafas v. Dudas Appeal"; "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal").  As a consequence, the Office received greatly diminished allowance fees and consequently greatly diminished maintenance fees, resulting in a budgetary shortfall as those fees made up a significant portion of the USPTO's annual revenues.  The consequences were forestalled, of course, by judicial obstruction of these rules; see "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas" and "No April Fool's Joke — Tafas and GSK Win on Summary Judgment" and later refusal by then-new Director Kappos to implement them when the Federal Circuit left open that possibility (see "New Rules' Officially Rescinded").

    Appellant argues that the circumstances arising in the USPTO's implementation of the post-grant review provisions of the AIA "may very well be unique in the federal government" because "[i]t is entirely user-fee funded, and the PTO's budget is effectively based on its fee collections."  Relying on USPTO statistics, Appellant argues that "[a]bout 40% of the approximately $57 million in annual AIA fee collections depends on granting petitions to institute," thereby drawing the nexus between structural features and due process injury.  In addition, the brief notes the "dual roles" of PTAB leadership in exercising both executive and adjudicatory functions as raising the appearance of unfairness.  This argument is supported in the brief by noting that the Chief APJ, the Deputy, and the Vice Chief APJs all bear some responsibility for institution decisions due to their responsibility to "provide policy direction and ensure the quality and consistency of AIA decisions," while at the same time having "significant responsibilities managing the PTAB's finances as a distinct 'business unit' within the PTO."  These structural circumstances mirror those found to be due process violations in Tumey, Dugan, and Ward.

    Exacerbating these conditions is the dependence on institution decisions and the frequency and number thereof on how individual APJs are compensated, evaluated, and bonused, according to Appellant's brief (while being careful to disclaim any specific instance of unethical behavior as opposed to the appearance thereof engendered by PTAB structure; indeed, the brief characterizes the resulting pressures on individual APJs as "unfair"), citing Gibson v. Berryhill, 411 U.S. 564, 578 (1973):

    Although a decision to institute does not absolutely guarantee an economic benefit for the APJ, a guarantee is not necessary.  To violate due process, all that is necessary is a reasonable connection between the decision and the pecuniary benefit.

    Appellant's argument is thus rooted in structural violations of due process, which it argues "creates too strong a motive and unfair temptation for 'the average man as a judge,'" citing Ward, and which can "sometimes bar trial by judges who have no actual bias and who would do their very best to weigh the scales of justice equally between contending parties," citing Aetna Life Ins. Co. v Lavoie, 475 U.S. 813, 825 (1986).  And a possible balancing consideration, judicial independence, is unavailable to PTAB APJs according to the brief, because these officers lack the independence of Article III judges and Administrative Law Judges in other agencies (a distinction argued at length in Arthrex and referenced in Appellant's brief).

    Finally, the brief notes that the Supreme Court's recent decision in Thryv, Inc. v. Click-to-Call Technologies, LP exacerbates the temptation argument, because the Court restricted judicial review of institution decisions.

    In addition to these arguments, Appellant's brief raises the question of Appointments Clause infirmity (no doubt to preserve the issue in anticipation of a "favorable" decision by the Supreme Court in U.S. v. Arthrex) and on the merits whether the PTAB erred in holding the claims at issue invalid as being directed to patent-ineligible subject matter under 35 U.S.C. § 101.  On more particularly procedural grounds, the brief also argues that Appellee had eschewed recourse to the PTAB as part of prior licensing agreements between the parties.  But wisely Appellant argues that the USPTO has the ability to remedy the situation, giving the Federal Circuit or Supreme Court an alternative to deconstructing the post-grant review statutory edifice.

    The Federal Circuit has shown no inclination to abrogate Congressional prerogatives under the AIA with regard to its post-grant review provisions (and Appellant has provided alternative bases for finding in their favor).  However, the Supreme Court has acknowledged that Due Process concerns could be a basis for finding Congress had overstepped its constitutional authority in establishing the post-grant provisions of the AIA (see "Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (2018)").  Indeed, a running undercurrent in Arthrex at oral argument, from counsel and the Court, was whether the Appointments Clause issues implicated infringement on patentees' due process rights.  Appellant has been careful to ground its due process argument on Supreme Court precedent in this regard, and even more careful to base its argument Calpurnia-esque on the importance of avoiding the appearance of the possibility of impropriety.  To the extent that these concerns resonate either with the Federal Circuit or, failing that, the Supreme Court, Appellant's arguments may provide the most potent rationale for hobbling if not dismantling the post-grant review regime enacted under the AIA.

    *Appellant is represented by Matthew J. Dowd, David Boundy, and Robert J. Scheffel.

  • By Michael Borella

    District Court for the Western District of TexasThere is an undercurrent in patent law these days that litigation favors the defendant.  Rather than contending infringement of a few claims of one patent, plaintiffs are now advised to assert multiple claims across several patents.  After 35 U.S.C. § 101 challenges, IPR filings, and summary judgment motions, plaintiffs are lucky if they are left with a few claims of one patent to bring to trial.  Analogies have been made that patent portfolios are like Swiss cheese.

    But every so often, a patentee wins big, giving the viability of patent assertion campaigns a much-needed shot in the arm.

    To that point, patent holder VLSI has won a whopping $2.175 billion jury verdict in the Western District of Texas.  VLSI is the owner of U.S. Patent Nos. 7,523,373 and 7,725,759.  Claim 1 of the '373 patent involves determining the minimum operating voltage of a memory and storing this value in non-volatile memory.  Two voltage sources are provided, and the second is selected to operate the memory if the first is below the minimum value.  Claim 14 of the '759 patent involves a programmable clock controller that can receive a request from a first device coupled to a variable clock frequency bus.  The controller then changes the frequency of a high-speed clock that is used to control the clock frequency of a second device coupled to the bus as well as the bus itself.  Both patents purport to reduce the power consumption of chips.

    The jury found that Intel literally infringed claims 1, 5, 6, 9, and 11 of the '373 patent, and infringed claims 14, 17, 18, and 24 of the '759 patent under the doctrine of equivalents.  The jury also found that this infringement was not willful and that Intel had failed to establish anticipation of '759 patent (the validity of the '373 patent was apparently not at issue).

    All said, the jury found Intel on the hook for $1.5 billion due to its infringement of the '373 patent and $675 million for its infringement of the '759 patent.  The main justification for damages of this magnitude is that Intel has sold billions of devices infringing the patents.

    VLSI is a non-practicing entity, which Intel attempted to use against it at trial.  These efforts fell on deaf ears, but along with the 10-figure sum is likely to drive the ongoing "patent troll" narrative.

    This is the second largest patent infringement verdict ever, and it will be the largest if it holds.  A $2.5 billion award to Idenix Pharmaceuticals in 2016 was overturned on invalidity grounds.  Here, an Intel appeal is inevitable, so VLSI will not be counting its money any time soon.

  • Calendar March 23, 2021 – "How Allyship Advances Diversity & Inclusion in the Legal Profession: Part 3 — Practical Tips for Pulling it All Together" (Intellectual Property Owners Association) – 2:00 pm to 3:00 pm (ET)

    March 24, 2021 – "2021 Women's Entrepreneurship Symposium — Investing in Innovation" (U.S. Patent and Trademark Office) – 12:00 pm to 1:30 pm (EDT)

    March 24, 2021 – "Being Ready for Patent Litigation in Australia" (Shelston IP) – 5:00 pm (ET)

    March 24-25, 2021 – FDA Boot Camp (American Conference Institute)

    March 25, 2021 – "Patent Term Extensions in Emerging Markets: The Case of Mexico" (Moeller IP) – 11:00 am (ET)

    March 25, 2021 – "Patent Drafting for Success in Europe" (Mathys & Squire) – 2:00 pm (ET)

    April 16, 2020 – "Strategies for Federal Circuit, District Court, ITC, and PTAB" (UIC John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 7:40 am to 3:15 pm

    April 26-27, 2021 – Paragraph IV Disputes Conference (American Conference Institute)

  • USPTO SealThe U.S. Patent and Trademark Office will be holding the next installment of the 2021 Women's Entrepreneurship Symposium, entitled "Investing in Innovation," on March 24, 2021, from 12:00 pm to 1:30 pm (EDT).  The Symposium, which is being held as a free online event, will allow attendees to learn about:

    • Small business loans to help launch your vision
    • Understanding crowdfunding
    • Other investment funding sources for aspiring entrepreneurs

    Hope Shimabuku, Director of the U.S. Patent and Trademark Office's Texas Regional Office, will moderate a panel consisting of Natalie Madeira Cofield, Assistant Administrator, Office of Women's Business Ownership, Small Business Administration; Elizabeth Galbut, Founder, SoGal Ventures; Ruth Hedges, CEO, Crowdfundingroadmap Inc.; and Corinne Hodges, CEO, Association of Women's Business Centers.

    Additional information regarding the Symposium can be found here.  Those interested in registering for the event, can do so here.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "How Allyship Advances Diversity & Inclusion in the Legal Profession: Part 3 — Practical Tips for Pulling it All Together" on March 23, 2021 from 2:00 pm to 3:00 pm (ET).  Brian Brookey of Tucker Ellis LLP; Serena Farquharson-Torres of Bristol-Meyers Squibb; Gloria Fuentes of Merck & Co. Inc.; John Harrity of Harrity & Harrity, LLP; and Rachael Rodman of Ulmer & Berne LLP will discuss the learnings from the first two sessions, bringing together different perspectives to provide practical tips for improving allyship personally, organizationally, and systemically.

    There is no registration fee for the webinar.  However, those interested in attending the webinar should register here.

  • UIC JMLSThe UIC John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be hosting an IP Master Class virtual seminar on "Strategies for Federal Circuit, District Court, ITC, and PTAB" from 7:40 am to 3:15 pm on April 16, 2020.  The program will consist of the following sessions:

    • Session 1: Patent Trial and Appeal Board Practice
    • Session 2: District Court Practice
    • Session 3: International Trade Commission Practice
    • Session 4: Court of Appeals for the Federal Circuit Practice

    Hon. Kent A. Jordan, U.S. District Court of Appeals for the Third Circuit, will provide a keynote address.

    Additional information about the program, including an agenda and list of speakers, can be found here.  Those interested in registering for the program can do so here; the registration fee is $95 (general admission) and UIC students, faculty, adjunct professors, staff, IP Center advisory board members, and government attendees can apply for free registration.  The first ten Patent Docs readers to register for the program will be entitled to a 20% discount off of the registration fee using discount code patentdocs2021.

    Patent Docs is an Institutional Partner of the UIC JMLS IP Center.

  • Shelston IPShelston IP will be offering a webinar entitled "Being Ready for Patent Litigation in Australia" on March 24, 2021 at 5:00 pm (ET).  Tam Huynh will moderate a panel consisting of Duncan Longstaff and Andrew Rankine who will identify aspects of Australian patent law and litigation practice that present potential traps for the unwary, and provide practical guidance on steps that can be taken before commencing litigation, or in its early stages, to maximise prospects of success.  Topics to be addressed by the panel will include patent ownership and licensing, standing, pre-action discovery and preliminary injunctions, as well as post-grant patent amendments.

    Those wishing to register can do so here.

  • Moeller IPMoeller IP will be offering a webinar entitled "Patent Term Extensions in Emerging Markets: The Case of Mexico" on March 25, 2021 at 11:00 am (ET).  The webinar will address patent term extensions in Mexico, including a judicial case decided in October 2020 by the Supreme Court extending the term of a patent claiming a pharmaceutical product, which had been prosecuted for over 5 years.

    While there is no cost to participate in the program, those interested in attending the webinar can register here.