• By Michael Borella

    Washington - Capitol #5Patent eligibility is broken.

    The only semi-cogent arguments that I have ever heard in support of the status quo is that the U.S. Patent and Trademark Office issues too many broad, vague patents, and that 35 U.S.C. § 101 affords defendants a low-cost way of quickly invalidating bad-faith patent assertions on the pleadings.  The rest boil down to "I don't like patents."

    While the former point has a grain of truth, in that the USPTO does grant patents that it should not from time to time, the law's current remedy based on Alice v. CLS Bank Int'l has the nuance of a high-energy shrapnel bomb.  Collateral damage has already impacted plenty of narrowly-scoped and useful inventions.  And the latter is equivalent to saying "I'm fine with bad laws being on the books as long as they help me."

    To make an admittedly stark analogy, the Department of Justice has estimated that about 75% of violent crime in the U.S. is perpetrated by men.[1]  If a societal goal is to reduce violent crime, then incarcerating all men would cause the violent crime rate to drop dramatically and would eliminate the difficulty and cost of determining whether suspects were guilty or innocent through investigation, arrest, pleadings, trial, and so on.  Such a proposal is outrageous.  But not granting or invalidating certain types of patent matters on arbitrary grounds and with conclusory reasoning should generate at least a modicum of outrage.

    In any event, both of the arguments above can be addressed in a more equitable and logical fashion with narrowly-tailored legislation.  Enter Senators Tillis and Coons.

    This is the third time that one or both of the senators have proposed or introduced a bill to revise § 101.  The first two attempts garnered discussion but little tangible progress.  At this point, the patent community is feeling like Charlie Brown repeatedly getting the football yanked away.

    Nonetheless, such proposals are worth of consideration, so let's take a look at the bipartisan Patent Eligibility Restoration Act of 2023.

    First off, like previous proposals, the bill initially addresses definitions in § 100.  Notably:

    (k) The term 'useful' means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.

    Cool.  A POSITA gets to decide what has "specific and practical utility".  Keeping that in mind, here is the meaty part (and I will focus on the impact to engineering and computing innovations, as we have already published an analysis from the life sciences perspective):

    § 101. Patent eligibility

    (a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title.

    (b) ELIGIBILITY EXCLUSIONS.—

    (1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:

    (A) A mathematical formula that is not part of a claimed invention in a category described in subsection (a).

    (B)    (i) Subject to clause (ii), a process that is substantially economic, financial, business, social, cultural, or artistic, even though not less than 1 step in the process refers to a machine or manufacture.

    (ii) The process described in clause (i) shall not be excluded from eligibility for a patent if the process cannot practically be performed without the use of a machine or manufacture.

    (C) A process that—

    (i) is a mental process performed solely in the human mind; or

    (ii) occurs in nature wholly independent of, and prior to, any human activity.

    (D) An unmodified human gene, as that gene exists in the human body.

    (E) An unmodified natural material, as that material exists in nature.

    (2) CONDITIONS.—For the purposes of subparagraphs (D) and (E) of paragraph (1), a human gene or natural material shall not be considered to be unmodified if the gene or material, as applicable, is—

    (A) isolated, purified, enriched, or otherwise altered by human activity; or

    (B) otherwise employed in a useful invention or discovery.

    (c) ELIGIBILITY.—

    (1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—

    (A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and

    (B) without regard to—

    (i) the manner in which the claimed invention was made;

    (ii) whether a claim element is known, conventional, routine, or naturally occurring;

    (iii) the state of the applicable art, as of the date on which the claimed invention is invented; or

    (iv) any other consideration in section 102, 103, or 112.

    (2) INFRINGEMENT ACTION.—

    (A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact.

    (B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.

    Now let's break this down into a few bite-sized chunks.

    Part (b)(1)(A):  This provision seems to be stating that inclusion of or reference to mathematical formulas in claimed inventions does not impact eligibility, but a claim to a formula itself and in isolation would be ineligible.  Under that assumption, this language seems fine and would get us out of the current situation where the Supreme Court tells us in Alice that the claim of Diamond vs. Diehr is still eligible but gives us a test vague enough to invalidate that claim.

    Part (b)(1)(B):  Here we have some problems.  Specifically, what is "a process that is substantially economic, financial, business, social, cultural, or artistic?"  How "substantially" does the process need to involve these excluded categories?  And does this provision only apply to process claims and not machine (e.g., device, system) or article of manufacture claims (e.g., computer readable media)?  As an example of the problems we can expect from use of vague terms like "artistic", what if my invention is an algorithm used by a digital camera to sharpen images?  The process might be technical but the outcome can be viewed as artistic.  Nonetheless, section (ii) seems to provide an out so long as the inventions can only be practically performed by computer.  This would positively impact patentees in the artificial intelligence and machine learning space where inventions often require training with large data sets.

    Part (b)(1)(C):  This provision seems to shut the door on the mental process exception, one that is remarkably problematic in practice, not to mention completely illogical.  In short, some USPTO examiners and judges have taken the position that anything that could be done in theory by a human with the help of a computer or other tools, even if doing so would take millions of years, is an ineligible mental process.  If the legislation would make it such that a computer-implemented process is by definition not a mental process, then that is progress.

    Part (c)(1):  This language is similar to that of Senator Tillis's proposed § 101 fix from last year, in that it is saying that "you need to consider the claim as a whole, and we really mean it".  Additionally, it reverses the ambiguity introduced when Alice and Mayo v. Prometheus misappropriated notions of §§ 102, 103, and 112 and shoved them into the § 101 inquiry.

    Part (c)(2):  And here we have a bone for fans of the quick kill.  A court can, at any time and based on its own discretion, allow § 101 invalidity arguments with limited discovery.  Hopefully that is enough to keep some stakeholders happy.

    So is this legislation perfect?  No.  There are still some ambiguities, mostly surrounding what we commonly refer to a business method inventions or hybrid business / technical inventions.  If litigated or left to USPTO interpretation, it is likely that we would end up right back where we are with the overly broad exception for "methods of organizing human activity" being used as a cudgel against claims with non-business merit.

    But as they say, perfection is the enemy of good enough.  So it may be best to hold our noses and support this legislation, as it is does seem to be an incremental improvement over the current eligibility mess.

    [1] https://bjs.ojp.gov/content/pub/pdf/cvus0702.pdf, table 38.

  • J A KempJ A Kemp will be offering a webinar entitled "The Clinical Trial Dilemma: Update on the EPO Position" on June 27, 2023 at 16:00 pm (BST).  Amanda Simons and Tanja Preissner of J A Kemp will provide an update on recent developments in EPO case law in relation to clinical trials, and their impact on the validity of patent claims, and discuss possible strategies for filing patent applications in light of a planned or existing clinical trial.  The webinar will address the following topics:

    • Is a disclosure of a proposed clinical trial relevant to novelty and inventive step?
    • Filing strategies for applications relating to clinical trials.
    • Is a clinical trial confidential for patent purposes?

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Effective Use of Patent Agents for In-House and Outside Counsel — Part 1," on June 29, 2023 from 1:00 pm to 2:00 pm (ET).  Karen Cochran of Shell USA, Inc.; Carey Jordan of Vorys; Kelly McGlashen of Robert Bosch LLC; Valerie Moore of Kilpatrick Townsend; and Angela Parsons of Fish & Richardson will address the benefits of having a patent agent program including how patent agents can support legal/business work outside of preparation and prosecution.  The panel will also discuss unique benefits to staffing with patent agents, including contributing to your organization's diversity.

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

  • By Kevin E. Noonan –

    Washington - Capitol #6Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution.  They chaired a series of Congressional hearings in 2019 (see "Senators Tillis and Coons Release Statement on Recent Patent Reform Hearings"), have asked the Patent and Trademark Office for its statistics and other information on patent eligibility (see "Senators Request USPTO to Provide Information on Subject Matter Eligibility"), and have proposed several bills providing various iterations of these solutions (see "Senator Tillis Proposes Patent Eligibility Reform (Again)").  Today, they co-sponsored the latest attempt, entitled "The Patent Eligibility Restoration Act of 2023."

    The bill contains a preamble of "Findings" that amount to a litany of all the reasons why Supreme Court decisions and how they have been implemented by district courts, the Federal Circuit, and the Patent and Trademark Office have "led to extensive confusion and a lack of consistency" regarding eligibility.  This portion of the bill reads as a justification (to the Senators' colleagues, the judiciary, and the public) of the need for subject matter eligibility reform by Congress; it cites for example an "increasing number of inventions ineligible for patent protection" as a consequence of creation of the "judicial exceptions" by the Supreme Court and other courts.  It also asserts that "[m]any judges of the United States Court of Appeals for the Federal Circuit and of various district courts of the United States have explicitly expressed the need for more guidance with respect to the meaning of section 101 of title 35, United States Code" as well as "many patent owners, and persons that engage with patent owners, complain[ing] that the interpretation of that section is extremely confusing and difficult to discern and apply with any confidence."  The cosponsors' intentions with these amendments are plainly set out, starting with the elimination of all judicial exceptions and that "any" invention or discovery in the statutory categories (process, machine, manufacture, or composition of matter) be eligible for patenting apart from explicitly recited exceptions recited in the statute.  Also recited in this Findings section is that the other statutory requirements under Section 102, 103, and 112 are not to be used to determine patent eligibility.

    The bill provides then provides specific modifications to the patent statute.  These begin with the provisions defining a "process" (Section 100), which are amended by deleting the phrase  ''includes a new use of a known process'' and inserting ''includes a use, application, or method of manufacture of a known or naturally-occurring process."  Also provided is a definition of the word "useful" to mean "with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.''

    Section 101 is amended to abrogate the so-called "judicial exceptions" by enumerating an explicit and exclusive set of ineligible subject matter.  These exceptions include and are limited to:

    • a mathematical formula that is not part of a claimed invention in a statutory category [of process, machine, manufacture, or composition 16 of matter, or any useful improvement thereof];

    • a process that is substantially economic, financial, business, social, cultural, or artistic, even though not less than 1 step in the process refers to a machine or manufacture, but not if the process cannot be cannot practically be performed without the use of a machine or manufacture;

    • a mental process performed solely in the human mind, or that occurs in nature wholly independent of and prior to any human activity;

    • an unmodified human gene as it exists in the human body; or

    • an unmodified natural material as that material occurs in nature.

    Importantly, the term "unmodified" as it is used with regard to human genes or natural products is defined in the statute not to include embodiments that have been "isolated, purified, enriched, or otherwise altered by human activity" or "otherwise employed in a useful invention or discovery."

    The amendments to Section 101 also include a section on how eligibility is to be determined which includes:

    • 'by considering the claimed invention as a whole and without discounting or disregarding any claim element'; and

    • without regard to "the manner in which the claimed invention was made," "whether a claim element is known, conventional, routine, or naturally occurring," "the state of the applicable art, as of the date on which the claimed invention is invented," or any other considerations in the other statutory sections (specifically Section 102, 103, or 112).

    Finally, the amendments provide that in infringement actions, eligibility can be addressed by motion of a party when there are no genuine issues of material fact, and that a court can consider permitting "limited discovery" before ruling.

    As is frequently the case, introduction of the bill was accompanied by a press release, with the Senators joining in announcing their bill and the necessity for it.  In his statement, Senator Coons said:

    More than a decade after the Supreme Court waded into patent eligibility law, uncertainty remains about which areas of innovation are eligible for patent protection.  Critical technologies like medical diagnostics and artificial intelligence can be protected with patents in Europe and China, but not in the United States.  The Supreme Court has repeatedly failed to clarify the law, so Congress must act.  I'm proud to join Senator Tillis' bill that would reform patent eligibility law to bring vital clarity for inventors and innovators and ensure the United States maintains its competitive edge.  I look forward to working with all stakeholders as we move this bill in Congress to restore confidence in our patent system.

    For his part Senator Tillis's statement reads:

    I have long said that clear, strong, and predictable patent rights are imperative to enable investments in the broad array of innovative technologies that are critical to the economic and global competitiveness of the United States, and to its national security.  Unfortunately, our current Supreme Court's patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.  This bipartisan legislation with Senator Coons maintains the existing statutory categories of eligible subject matter, which have worked well for over two centuries, and addresses concerns regarding inappropriate eligibility constraints by enumerating a specific but extensive list of excluded subject matter.  I look forward to continuing to work with all interested stakeholders on this important matter.  Passing patent eligibility reform remains one of my top legislative priorities during my second term.

    Also set forth in Senator Coons' official website is a statement from two former Directors of the U.S. Patent and Trademark Office, David Kappos and Andrei Iancu, now Co-Chairs of the Council for Innovation Promotion (C4IP), who said:

    C4IP applauds Senators Tillis and Coons for introducing critically important legislation to correct patentable eligibility law.  The Patent Eligibility Restoration Act of 2023 is much-needed legislation to foster the development of next-generation technologies across many innovative industries, including artificial intelligence, medical diagnostics, quantum computing, and telecommunications, to name a few.  With products in these sectors currently categorically ineligible for patent protection, the United States is losing its standing as the world's innovation leader.  By introducing this legislation, Senators Tillis and Coons are standing up for American inventors and ingenuity, and are positioning the United States to continue its leadership in these technologies of the future.

    The draft bill has two immediate impediments to passage (others will no doubt arise during the legislative process).  The first and perhaps most significant is that to the extent the Supreme Court has based its subject matter eligibility jurisprudence as an exercise in its role in limiting Congress to the constraints in the Constitution, that its power to grant patents must "promote progress," it is likely to strike down any law that abrogates its judicial exceptions as being ultra vires of the proper exercise of Article I power.  Two generations ago Giles Sutherland Rich (and P.J. Federico) were able to introduce obviousness into the statute by casting it as an enactment of Supreme Court precedent reaching back to Hotchkiss that patentability required something more than novelty.  It was the Supreme Court's variable ex post facto definitions of what that ineluctable something was (flash of genius, etc.) that had made "the only patent that is valid . . . one which [the] Court [had] not been able to get its hands on" and that provided the impetus for introducing obviousness as a statutory requirement.  But how later-Judge Rich effected this enactment was done with sufficient subtlety and obeisance to the Court's precedent that in Graham v John Deere the Supreme Court opined that Section 103 was just that, codification of the principle it had enunciated all along.  This bill lacks that subtlety and accordingly is much less likely to pass supreme judicial muster.

    The other aspect of the bill likely to face stiff political rather than judicial opposition is in the changes to patent eligibility of human genes and natural products.  It is extremely likely that some groups, particularly the American Civil Liberties Union and its allies in the Myriad case will argue that the definition of "unmodified" would permit patenting of isolated human genes and oppose the bill on that basis (as they have in other embodiments of reform bills from the Senators (see "ACLU (Predictably) Opposes Patent Subject Matter Eligibility Proposal").

    Neither of these impediments are incapable of being overcome by amending the scope of the statute, of course but their existence makes less likely from the outset that the bill will provide the solution the Senators seek.

  • By Kevin E. Noonan –

    Federal Circuit CourtroomResponsive to the letter from Judge Pauline Newman's counsel sent June 15th (see "Judge Newman Matter Continues"), the Special Committee directing the Federal Circuit's inquiry regarding Judge Newman's fitness for continued service on the Court (consisting of Chief Judge Moore, former Chief Judge Prost, and Judge Taranto) issued a per curiam response.

    The response sets forth the basis and scope of the June 1st Order which identified Judge Newman's refusal to comply with the Committee's demands, including to "undergo medical examinations, to provide medical records, and to sit for an interview with the Committee" set forth in prior Order, as in itself judicial misconduct under Rule 4(a)(5) ("Cognizable misconduct includes refusing, without good cause shown, to cooperate in the investigation of a complaint or enforcement of a decision rendered under these Rules.")   The response provides a recitation of the Committee's previous orders that parallels the history set forth in counsel's letter, with certain differences in characterization thereof.  For example, regarding their April 6th Order, the response characterizes the issue as "Judge Newman's disclosure of a confidential employment dispute matter and statements made in regard to that matter."  The April 20th Order, according to the response, was expanded to include potential misconduct related to "Judge Newman's alleged retaliatory, unprofessional, and abusive behavior towards her own and other court staff."  Not included in counsel's letter were Orders dated April 17th, May 3rd, and May 16th regarding the Committee's demands that Judge Newman provide medical records and undergo medical testing including "neurological and neuropsychological testing."

    Counsel's letter purported to ask the Committee for "clarification" regarding the status of the grounds for misconduct asserted in these various Orders, characterizing them as 1) allegations of mental or physical disability; 2) improper behavior towards staff; and 3) failure/refusal to cooperate.  The Committee's Order makes plain that:

    All the foregoing aspects of the investigation remain open and pending before the Committee.  No part of the investigation has been terminated.  In particular, the investigation into whether Judge Newman suffers from a disability that impairs her ability to perform the duties of her office remains ongoing.

    But the Committee's response also makes plain that these various grounds of complaint cannot substantively go forward without Judge Newman's cooperation (or compliance) which is not forthcoming.  Accordingly the Committee has Ordered briefing by July 5th and a hearing on July 13th to address the somewhat meta (or Kafkaesque) question of whether Judge Newman's refusal to comply with these Orders is itself judicial misconduct.  This question unavoidably presents the due process and Constitutional issues raised in Judge Newman's complaint to the D.C. District Court (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") but which (apparently) will not be addressed in the upcoming briefing and hearing.  The Committee's asserted basis for this course of action is that:

    [T]he Committee's investigation into whether Judge Newman suffers from such a disability has been seriously impeded by Judge Newman's refusal to undergo neurological and neuropsychological examinations, to provide medical records, and to sit for an interview with the Committee.  Her refusal to cooperate in those respects impairs the ability of the Committee to gather sufficient information to come to a definitive conclusion and recommendation for the Judicial Council on the disability issue.

    The consequences to Judge Newman are clearly laid out in the response, wherein the Committee asserts its rationale that "it would be most efficient for the Committee to focus immediate proceedings on a more discrete issue on which the Committee could likely reach a conclusion and make a final recommendation to the Judicial Council despite Judge Newman's lack of cooperation," i.e. a finding of judicial misconduct without needing to establish the purported prerequisites of mental, psychological, or physical disability that was the presumed basis for the Special Committee's actions in the first place.

    The response also denies Judge Newman's counsel's request that the hearing be open to the public.  The reason for this decision is that traditionally such inquiries on judicial fitness are kept confidential under the Judicial Conduct and Disability Act of 1980 and by the Rules for Judicial-Conduct and Judicial-Disability Proceedings, according to the Committee.  This creates a "strong presumption" for the Committee that the proceedings should remain confidential.  As a practical matter, the response asserts that confidentiality "facilitates the investigative process" and its beneficial effects in this regard "ha[ve] been almost universally accepted," citing First Amendment Coalition v. Judicial Inquiry & Review Bd., 784 F.2d 467, 475 (3d Cir. 1986).  In particular, despite there having been "a great deal about the current proceedings" that have been open to the public the Committee "has taken particular care to ensure that publicly released material does not identify witnesses or confidential details of witness statements and that the public releases would not compromise the investigative process."  Opening the hearing to the public would pose "grave risk[s]" of "inadvertent" disclosure of such information in the Committee's view.  The response also contends that there is no prejudice to Judge Newman by maintaining this confidentiality because "all affidavit and deposition transcripts" have been turned over to the Judge's counsel (thus making their existence public knowledge).  Because this evidence has provided the basis for the various Orders by the Special Committee, and whether Judge Newman's non-compliance therewith constitutes judicial misconduct raises the possibility that argument on this points might result in disclosure of at least some of this evidence, which the Committee does not want to happen.  And in attempts to prevent such disclosure the Committee asserts their fears that witnesses will "censor themselves in real time" to prevent disclosure.

    The response also provides the Committee's rebuttal to the case law cited by Judge Newman's counsel.  Waller v. Georgia is inapposite, the response asserts, because that was a criminal case, and thus precluded from being held in private based on a defendant's Sixth Amendment right to a public trial.  The response also contradicts Judge Newman's counsel's argument that the hearing will be based on the paper record, because inter alia "the entire record has not been made public" (although they have been provided to counsel).

    Nevertheless, the Committee "will consider" releasing a transcript redacted as to witness identities and other confidential material in due course after the hearing is held.  This would permit "some public transparency" and "allow a more considered approach to redacting [confidential] material" than could be achieved at a live hearing, while at the same time it would "not hamper the efficiency of the Committee's investigation by impeding the flow of the argument itself."

    Briefing will be submitted by July 5th and a hearing transcript sometime thereafter (although it is unlikely that there will be publication of the recorded hearing in view of the Committee's discussion in its response).

  • By Kevin E. Noonan –

    Federal Circuit CourtroomThe Federal Circuit's Special Committee released two documents relevant to their continuing assessment of Judge Pauline Newman's fitness for the bench today, neither of which can be considered comforting to the patent community or those concerned about the Judge or the Court.

    The first is a letter from Judge Newman's counsel in the action brought by the Judge's complaint filed in D.C. District Court last month.  Counsel's letter was sent "in response to the Special Committee's Orders of June 1, 2023" that the Committee's investigation is not directed to the substantive issues initially raised but is now focused on whether the Judge's "refusal to cooperate" with the investigation is itself misconduct.  (Those familiar with the complaint will realize that the refusal was with the manner in which the investigation was to be performed and not a blanket refusal to cooperate.)

    The letter is appropriately deferential and respectful while at the same time managing to set forth the expanding scope of the investigation from its initiation.  These include the April 6th Order, expanding the investigation to include Judge Newman's alleged (mis)conduct related to an "employment dispute" in her chambers.  This was followed, on April 13th, by an Order that included Judge Newman's alleged "failure to cooperate" by refusing to accept service of Orders issued under Rule 15(a)91)(b).  Then on April 20th, the letter asserts that the scope of the investigation was expanded again to include "retaliatory statements and conduct toward and about" a staff member in the Judge's chambers, the Judge's refusal to allow one of her clerks to be reassigned to a different judge and "requiring the clerk to 'stay or resign,'" and the Judge's alleged conduct towards the IT department.  Lastly, the letter describes the Order of May 26th that was directed to Judge Newman's alleged refusal to cooperate with "ordered neurological and neuropsychological testing, to produce certain medical records, and to meet with the Committee for a recorded interview."  The letter summarizes the categories of allegations in the various letters to be 1) allegations of mental or physical disability; 2) improper behavior towards staff; and 3) failure/refusal to cooperate.

    Turning to the Special Committee's June 1st Order, the letter states that the Committee decided it will not pursue the first category of allegations (due to the impracticalities occasioned by the Judge's refusal to cooperate) but would focus its inquiries on the third category.  The letter requests the Committee for "formal clarification" of its intentions regarding the second category, improper behavior towards Court staff, "out of an abundance of caution and to protect Judge Newman's rights."  The letter also asks the Committee to clarify whether it is continuing its investigation into the Judge's alleged failure to cooperate with the Rule 15(a)(1)(b) orders and if the current status of these allegations is also in abeyance.

    The final request in the letter is for any oral argument on the matter be made public, i.e., that the public be allowed to attend the hearing scheduled for 2:00 pm on July 13th.  One basis for the request is the Committee's statement that there are no fact witnesses necessary and the argument will be based on the "paper record" and legal argument.  Insofar as all the factual evidence has been disclosed to the public, counsel contends that there is "no weighty reason" for the hearings to be behind closed doors.  The letter cites Supreme Court precedent to support holding the hearings in public absent reasons not present here.  There is also no danger to Judge Newman's reputation, counsel notes, because "the sum and substance of the allegations have already been released to the public," and "[p]ermitting public participation in the upcoming hearing will serve only to increase the public's confidence in Judge Newman's abilities and the disciplinary process."

    Discussion of the Court's Order will be the subject of a following post.

  • By Kevin E. Noonan –

    Federal Circuit SealIn its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed patents in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.

    The case arose in ANDA litigation involving Vanda's tasimelteon drug (Hetlioz®) for non-24-hour sleep-wake disorder described in the opinion as a circadian rhythm disorder prevalent amongst blind individuals.  Defendants Teva and Apotex filed ANDAs having Paragraph IV certifications that prompted Vanda's assertion of these four claims:

    • RE46,604 (Claim 3) (wherein the limitations recited in claims from which the asserted claims depend are set forth in italics):

    3.  A method of entraining a patient suffering from Non-24 to a 24 hour sleep-wake cycle in which the patient awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours, and maintaining said 24 hour sleep-wake cycle said method comprising: treating the patient by orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime, wherein the patient is totally blind and wherein the tasimelteon is administered 0.5 to 1.5 hours before the target bedtime.

    • U.S. Patent No. 10,149,829 (Claim 13):

    13.  A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil, the method comprising: (A) discontinuing treatment with the strong CYP1A2 inhibitor and then (B) treating the patient with 20 mg of tasimelteon once daily, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.

    • U.S. Patent No. 9,730,910 (Claim 4):

    4.  A method of treating a patient for a circadian rhythm disorder wherein the patient is being treated with rifampicin, the method comprising: (A) discontinuing the rifampicin treatment and then (B) treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with rifampicin and also thereby avoiding reduced exposure to tasimelteon caused by induction of CYP3A4 by rifampicin, [the method] compris[ing] treating the patient for Non-24-Hour Sleep-Wake Disorder, wherein the patient is light perception impaired (LPI) and wherein treating the patient with tasimelteon comprises orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime.

    • U.S. Patent No. 10,376,487 (Claim 5):

    5.  A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder that comprises orally administering to the patient an effective dose of tasimelteon without food, wherein the effective dose is 20 mg/d wherein the patient is suffering from a circadian rhythm disorder, and wherein the circadian rhythm disorder is Non-24 Disorder.

    Regarding claim 3 of Reissue Patent No. RE46,604, the District Court found this claim to be obvious over two combinations of four references:  Hack et al., 2003, "The Effects of Low-Dose 0.5-mg Melatonin on the Free-Running Circadian Rhythms of Blind Subjects," 18 J. Biological Rhythms 420; PCT Publication No. WO 2007/137244; and Lankford, 2011, "Tasimelteon for Insomnia," 20 Expert Op. Investigational Drugs 987; or Hack, the '244 application, and Hardeland, 2009, "Tasimelteon, a Melatonin Agonist for the Treatment of Insomnia and Circadian Rhythm Sleep Disorders," 10 Current Op. Investigational Drugs 691.

    The Federal Circuit affirmed, in an opinion by Judge Dyk, joined by Judges Bryson and Prost.  Vanda argued on appeal that the District Court erred in considering the Hack reference, which taught using melatonin to entrain circadian rhythms; the Federal Circuit disagreed.  While conceding that "tasimelteon and melatonin are not identical," Defendants asserted expert testimony that tasimelteon binds to melatonin receptors and that the Hardeland art taught that tasimelteon could be used to treat patients having circadian rhythm disorders.  The panel found no error in the District Court crediting this testimony or the statements in the prior art regarding the similarities between tasimelteon and melatonin.  The panel also rejected Vanda's argument that the prior art would provide no reasonable expectation of success in the claimed dose (20mg/d) because the Hardeland and '244 PCT application disclosed a study by Rajaratnam that disclosed that "[t]he most effective doses of tasimelteon were in the range of 20 to 50mg/day," supported by expert testimony), and the Lankford reference disclosed Vanda's own phase III clinical study for entraining blind individuals with 20 mg/d tasimelteon.  Finally, the panel held that the District Court was properly unconvinced that the objective indicia of non-obviousness did not rebut Defendants' prima facie obviousness case regarding long-felt need (regarding evidence from a single case) and industry praise (the evidence not being commensurate in scope with what it was being used to support).

    Turning to the '487 patent, the panel affirmed the District Court's obviousness determination based on the limitation "without food," which the District Court held would have been an obvious-to-try limitation, citing Section C of KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).  The panel recognized evidence of there being a "market pressure" to determine the effect of food administration on tasimelteon, which was a consideration for new drugs.  There were only two alternatives after all, the opinion states, and they amounted to "two identifiable and predictable options."  This situation satisfied the Supreme Court's criteria in KSR and the Federal Circuit affirmed the District Court's reliance thereupon in making its obviousness determination.

    The Federal Circuit rejected Vanda's arguments against the District Court's obviousness determination on claim 4 of the '910 patent, the limitation at issue being "(A) discontinuing the rifampicin treatment and then (B) treating the patient with tasimelteon."  According to the panel, the District Court properly relied on knowledge in the art that a related drug, ramelteon, had an 80% reduction in blood plasma levels when co-administered with rifampin.  Thus it would have been obvious to claim discontinuing rifampicin before treating a patient with tasimelteon, based inter alia on tasimelteon binding to the same receptor as ramelteon in the panel's view.  The panel also rejected evidence that a further reference to Vachharajani taught away from the conclusion that an enzyme induced by rifampicin would metabolize tasimelteon because the study did not show the enzyme did not do so after it had been induced by rifampicin as required in the claim.  This conjecture, that the enzyme in its rifampicin-induced state would have a different effect than in the uninduced state disclosed by the Vachharajani reference was supported by expert testimony, and the Federal Circuit held that the District Court did not err in relying on this evidence.

    Finally, the Court affirmed the District Court's obviousness determination regarding claim 14 of the '829 patent, concerning the limitation "(A) discontinuing treatment with the strong CYP1A2 inhibitor and then (B) treating the patient with  . . . tasimelteon."  The evidence relied upon by the District Court was found in the Hardeland reference, which taught that "[a]s tasimelteon is metabolized by [CYP1A2] . . . , coadministration of any drug that inhibits [this enzyme] should be regarded with caution," and taught that the blood plasma levels of ramelteon increased 100-fold upon co-administration with a CYP1A2 inhibitor.  The panel rejected Vanda's assertion that the prior art did not teach the skilled worker not to administer tasimelteon with a CYP1A2 inhibitor.  The opinion rejects this contention as illustrating a misunderstanding regarding the standards for obviousness, specifically that certainty is not required, just a reasonable expectation of success, citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).  Using this standard, the opinion states that "a skilled artisan would have expected that taking a CYP1A2 inhibitor with tasimelteon would have negatively impacted the efficacy of tasimelteon and so the two should not be given together," which renders claim 14 of the '847 patent obvious according to the Federal Circuit.

    Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2023)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Bryson, and Prost
    Opinion by Circuit Judge Dyk

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