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  • University of Massachusetts v. L’Oreal S.A. (Fed. Cir. 2022)

    By Kevin E. Noonan —

    Federal Circuit SealIn reviewing (and reversing) the District Court's claim construction in University of Massachusetts v. L'Oreal S.A., the Federal Circuit availed itself of both the disclosure in the specification and the prosecution history to construe a limitation in a wherein clause, based on its determination that the term did not have a plain meaning and thus other indicia of what the claim term at issue meant should be considered.  The Court also reviewed the District Court's favorable consideration of L'Oreal S.A.'s motion to dismiss on jurisdictional grounds, vacating this determination as an abuse of discretion for failure to grant the University jurisdictional discovery.

    The issue arose in the University's lawsuit for patent infringement against L'Oreal S.A. and L'Oreal USA, Inc. over U.S. Patent Nos. 6,423,327 and 6,645,513; the opinion sets forth claim 1 of the '327 patent as representative:

    1.  A method for enhancing the condition of unbroken skin of a mammal by reducing one or more of wrinkling, roughness, dryness, or laxity of the skin, without increasing dermal cell proliferation, the method comprising topically applying to the skin a composition comprising a concentration of adenosine in an amount effective to enhance the condition of the skin without increasing dermal cell proliferation, wherein the adenosine concentration applied to the dermal cells is 10-4 M to 10-7.

    (Where the District Court's construction of the italicized language was the basis for its determination that the claims were invalid for being indefinite.)

    While the District Court proceedings were ongoing, L'Oreal USA petitioned the Patent Trial and Appeal Board (PTAB) for institution of inter partes review, which the Board denied.  However, the Board in making its assessment of the institution petition construed the "wherein" clause of claim 1 of the '327 patent to mean the concentration of adenosine at the dermal cells (located underneath the skin surface) rather that the concentration at the skin surface (which comprises the epidermis) (the opinion noting that under 35 U.S.C. § 314(d) these determinations were "final and unappealable").  The District Court also construed the wherein clause to have this meaning without overt construction, holding that the clause was given its "plain and ordinary meaning without the need for further construction."

    In applying this construction to the question of invalidity under 35 U.S.C. § 112(b), the District Court granted summary judgment for L'Oreal USA that the claim was indefinite in reciting the limitation "topically applying to the skin a composition comprising a concentration of adenosine in an amount effective to enhance the condition of the skin without increasing dermal cell proliferation" because of the perceived distinctness between the amount of adenosine (directly) applied to the epidermis and the amount (indirectly) applied to the dermal cells and the resulting concentration that is sufficient to both enhance the condition of the skin while not increasing dermal cell proliferation.

    The Federal Circuit reversed the District Court's claim construction and vacated summary judgment of indefiniteness in an opinion by Judge Taranto, joined by Judges Mayer and Prost.  The University argued with regard to the claim construction issue that the concentration recited in the wherein clause should be construed to mean the amount of adenosine in the dermis after it has entered the dermal layer, i.e., "the number of moles of adenosine divided by the volume (liters) of the dermis itself."  The Federal Circuit disagreed, holding that the District Court had erred in its construction and vacating and remanding for proceedings based on the Court's construction as set forth in this opinion.  (Review was de novo, because  the District Court relied only upon intrinsic evidence.)  The Court's analysis began with its determination that the meaning of the concentration language in the wherein clause, viewed in the context of the claim as a whole, was not plain and even less plain under the University's construction of it.  The opinion notes that the clause recites adenosine concentration administered to the dermal cells, while the preceding clause relating to skin enhancement recited applying the adenosine-containing composition to the skin (the epidermis). While the way the claim is written with regard of the term "applied" suggested to the panel (as it did to the Board and District Court) a difference in meaning, that is not enough according to the opinion.  The panel recognized that "[t]he same [composition] can be applied directly to one object [(the skin)] and indirectly to the other [(the dermis)]."  Under the Federal Circuit's construction, the concentration of adenosine referenced in the two portions of the claim are the same concentration, which the opinion states is consistent with the language of the dependent claims as well.  The concentration referenced in the skin-enhancement clause refers to the concentration in the composition before it is applied to the skin, which is the same concentration referenced in the wherein clause in the Court's opinion, contrary to the University's proposed construction.  According to the opinion, the University's construction would have the concentration recited in the wherein clause refer to something that does not exist until the composition is applied (and the adenosine absorbed into the skin and the dermal layer).  But if that construction was followed, the wherein clause (in the Court's view) would need to be rewritten to recite "wherein the adenosine permeating to the dermal layer results in a concentration of adenosine in the dermal layer of 10-4 M to 10-7 M."  The need for these linguistic gymnastics was enough for the panel to hold that the claim language at issue had no plain meaning and that resort to the specification and prosecution history was in order.

    In its review of the disclosure in the specification, the many recitations of the concentration of adenosine in the disclosed composition did not set forth this concentration after penetration into the dermal layer; instead they all disclose concentrations before the composition is applied to the skin.  The opinion states that "[t]his is significant evidence that the wherein clause is best read to refer to the concentration of adenosine in the composition applied to the surface of the skin," referencing Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc); VirnetX, Inc. v. Cisco Systems, Inc., 767 F.3d 1308, 1318 (Fed. Cir. 2014); and Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1397–98 (Fed. Cir. 2008).  And there is no disclosure of measuring adenosine concentration in the dermis or the need to do so.

    But it is in the prosecution history that the Court found the most persuasive evidence for its construction that the concentration recited in the claims should be construed as the adenosine concentration in the composition before application to the skin.  The Court first looked to the claims as filed, which did not recite the wherein clause present in the claims as granted (that limitation was recited in a dependent claim, but without any mention of dermal cells).  The applicants amended the claim to overcome prior art, and in incorporating the adenosine concentration limitation into the independent claim changed the wording to what was recited in claim 1 of the '327 patent.  However, in their response containing this amendment, the applicants maintained that "[t]his amendment would add no new matter, as it merely includes a range of concentrations of adenosine recited in dependent claims" (emphasis in opinion).  In this response the applicants further distinguished two other prior art references based on concentration of adenosine in the composition before being applied to the skin (as the opinion states, "with no suggestion of a difference in location of concentration measurement").  And the examiner's comments in the reasons for allowance, both in the '327 patent and the '513 patent, contained the statement that the "[i]nstant claims are directed to a method of enhancing the condition of unbroken skin . . . where the method comprises administering adenosine at a concentration of 10-4 M to 10-7 M, to the skin" (emphasis in opinion).  In view of this prosecution history, the Federal Circuit held that "the wherein clause's reference to the recited concentrations being 'applied to the dermal cells' be read as referring to concentrations of the composition applied to the skin's surface."  The construction the University advanced before the District Court and on appeal was inconsistent with this history according to the opinion, and "cannot fairly be squared with the understanding that both [the University] and the examiner expressed during prosecution, and on which skilled artisans are entitled to rely," this latter phrase perhaps providing the impetus for the Court's decision.

    And in remaining unpersuaded by the University's attempts to distinguish the prosecution history, the Court refused to credit statements in the prosecution history made in response to the examiner's reasons for allowance, which merely recited the claim language and asserted that the applicants did not concede that the examiner's reasons were the only reasons the claims should be allowed (illustrating the futility in believing that such statements would be persuasive in actions to enforce the patent).

    The Federal Circuit, applying its construction concluded that the District Court's finding that the claims were indefinite "must be vacated and . . . remanded for the district court to conduct any further proceedings that are necessary" (the panel refusing L'Oreal's suggestion that it enter a judgment of non-infringement directly).

    Regarding the jurisdictional question, the District Court adopted a magistrate judge's recommendation that the Court grant L'Oreal S.A.'s motion to dismiss under Federal Rule of Civil Procedure 12(b)(2) without permitting jurisdictional discovery to the University.  The Federal Circuit disapproved of that action, holding that under Third Circuit law it was an abuse of discretion.  The basis for this holding was that "at the very least" jurisdictional discovery was appropriate under Eurofins Pharma US Holdings v. BioAlliance Pharma SA, 623 F.3d 147, 157 (3d Cir. 2010).  The University had "made more than clearly frivolous, bare allegations that L'Oréal S.A. was subject to personal jurisdiction," these allegations including that "L'Oréal S.A. introduced the accused products into the stream of commerce" and that L'Oreal USA was "L'Oréal S.A.'s agent in certain potentially relevant respects."  There was also evidence that L'Oreal S.A. had performed product research on adenosine-containing compositions for treating skin and may have licensed the technology to L'Oreal USA.  Also telling for the panel was that "L'Oréal S.A. did not specifically deny allegations that it developed and licensed the relevant technology to L'Oréal USA" but instead had rather weakly asserted that it had not "directly developed" any of the skincare products at issue in the lawsuit.  The Federal Circuit held that because "this evidence raises the possibility that discovery might have uncovered the requisite contacts under our precedent" (emphasis in opinion), it vacated the District Court's jurisdictional determinations and held that on remand the University was entitled to jurisdictional discovery before the District Court came to and jurisdictional conclusions.

    University of Massachusetts v. L'Oreal S.A. (Fed. Cir. 2022)
    Panel: Circuit Judges Prost, Mayer, and Taranto
    Opinion by Circuit Judge Taranto

  • USPTO Provides Guidance on PTAB Discretionary Denials of Challenges Based on Parallel Litigation

    By Joshua Rich —

    USPTO SealOn June 22, 2022, the U.S. Patent and Trademark Office issued two documents regarding the Patent Trial and Appeals Board's discretionary denials of post-grant challenges based on parallel litigation: a retrospective study of such denials since 2019[1] and a prospective interim guidance memorandum from the Director regarding considerations for future decisions.[2]  Both documents discuss the circumstances in which the PTAB may choose to deny institution of post-grant challenges when the same patent is being asserted in district court or ITC litigation.  In combination, the two documents identify how to narrow the discretion that the PTAB will exercise in determining whether to proceed based on parallel litigation.

    The USPTO's retrospective study identified four cases as causing substantial inflections in discretionary denials of post-grant challenges:  (1) NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc., Case IPR2018- 00752, Paper 8 (Sept. 12, 2018); (2) Apple Inc. v. Fintiv, Inc., Case IPR2020-00019, Paper 11 (March 20, 2020); (3) Sand Revolution II, LLC v. Continental Intermodal Group – Trucking LLC, Case IPR2019-01393, Paper 24 (June 16, 2020); and (4) Sotera Wireless, Inc. v. Masimo Corporation (§ II.A), IPR2020-01019, Paper 12 (Dec. 1, 2020).

    In NHK, the PTAB denied institution both on the basis that the cited prior art had already been considered in the Office and because the same invalidity challenges were being raised in the IPR petition and district court litigation.  NHK was notable as the first decision expressly citing the "advanced state" of the district court litigation as a basis for denying the petition, namely that the trial was scheduled to occur before the inter partes review would have reached a final decision.  But it also served as the catalyst for many others to seek denial of institution on the basis of parallel litigation.

    Fintiv was one of those cases in which the patent owner asked the PTAB to deny institution.  By that time, there had been enough such requests that the PTAB decided to provide some guidance to parties regarding the considerations that would go into the exercise of its discretion.  The PTAB therefore provided a list of six non-exclusive factors that it would consider:
        (1) whether a stay exists in the parallel litigation or would likely be granted if a proceeding is instituted;
        (2) proximity of the court's trial date to the Board's projected statutory deadline;
        (3) investment in the parallel proceeding by the court and parties;
        (4) overlap between issues raised in the petition and in the parallel proceeding;
        (5) whether the petitioner and the defendant in the parallel proceeding are the same party; and
        (6) other circumstances that impact the Board's exercise of discretion, including the merits.

    The promulgation of the Fintiv factors brought increased clarity to whether the PTAB would exercise its discretion to deny institution of a petition, but it also brought a substantial upswing in the percentage of cases in which the argument would arise.  It also led to a similar upswing in the number of cases in which the existence of parallel proceedings would lead to denial of institution.

    The upward trend can be clearly seen in one of the USPTO's graphs of both the number of cases and percentage of cases in which discretionary denial was raised:

    Image 1
    A little over a year after the Fintiv factors were promulgated, the PTAB decided Sand.  There, the petitioner sought reconsideration of a decision denying institution of an IPR by submitting a stipulation stating that it would not raise the same grounds in the IPR and parallel proceeding.  The Board found that the stipulation, submitted to resolve the fourth Fintiv factor in the petitioner's favor, tipped the balance and instituted the proceeding.  The Sand decision caused the pendulum to swing back toward institution: more parties submitted similar stipulations and the number of discretionary denials based on parallel proceedings eventually shrank.

    The trend downward for discretionary denials really escalated with the Sotera decision.  There, the petitioner filed an even broader stipulation agreeing that it would not assert in the district any grounds "raised or that could have been reasonably raised in an IPR."  The PTAB instituted the review in Sotera, and many petitioners followed Sotera's lead, which has led the Board not to exercise its discretion to reject review of the post-grant challenges.

    Again, the USPTO's statistical picture tells the tale.  Once petitioners began filing robust Sotera-like petitions in the months after the decision, discretionary denials of institution dropped quickly:

    Image 2
    While these cases were being resolved, the USPTO asked for comments to support potential rules on approaches to the exercise of discretion.  It received 822.  So while the Office is sifting through those comments, Director Vidal issued interim guidance to help practitioners.  The guidance came in the form of four practices that the Board will implement.

    First, whether the PTAB will have discretion to deny institution depends on the strength of the petition.  If the petition's evidence is insufficient to justify institution on the merits, the Board will not rely on the Fintiv factors as an alternative ground for denial.  If the petition makes a sufficient showing under the statute — but not a strong one — the Fintiv factors will be in play.  But if the petition's evidence is compelling, the PTAB will not deny institution on the basis of the Fintiv factors.

    Second, the PTAB will consider the Fintiv factors only in relation to parallel district court litigation.  Although it has denied institution based on parallel ITC proceedings in the past, it will no longer do so because the ITC lacks the power to invalidate a patent and its rulings are not binding on the Office or district courts.

    Third, following Sotera, the PTAB will not discretionarily deny institution if the petitioner files a stipulation indicating that it will not pursue in the district court the same invalidity grounds or any grounds that could reasonably be raised before the PTAB.  That is, the Office is making the downward trend its full-time practice based on the overwhelming strength of the fourth Fintiv factor.

    Fourth, in determining the second Fintiv factor (the proximity of the court's trial date to the Board's projected statutory deadline), the PTAB will consider not only scheduled trial date, but also time-to-trial statistics such as number of cases before the judge and speed and availability of other case dispostions.  This is because — as numerous comments pointed out — different courts have different practices regarding the likelihood of extensions of the trial date.  It is a point strongly reflected in the statistics published by the USPTO — in 2021, review of the Fintiv factors led to discretionary denial about 10% of the time when the case was pending in the District of Delaware, about 15% of the time when the case was pending in the Western District of Texas, and almost 65% of the time when the case was pending in the Eastern District of Texas.

    In light of Director Vidal's guidance, practitioners have much greater clarity regarding how to address discretionary challenges based on parallel litigation.  Patent owners know they should not raise the issue based on an ITC proceeding, and likely should not in a slower-to-trial jurisdiction.  But they also know that the argument fits nicely with an argument on the merits, as an attack on the strength of the petition can be couched as a Fintiv argument.  The petitioner, however, can moot the Fintiv argument if it is willing to provide a broad, Sotera-like stipulation not to pursue in the district court any invalidity grounds that it can raise before the PTAB.  As a result, the PTAB's discretion will be much more limited and Fintiv decisions will be far more predictable.

    [1] https://www.uspto.gov/sites/default/files/documents/ptab_parallel_litigation_study_20220621_.pdf
    [2] https://www.uspto.gov/sites/default/files/documents/interim_proc_discretionary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf

  • Conference & CLE Calendar

    CalendarJune 28-29, 2022 – Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace (American Conference Institute) – Boston

    June 28, 2022 – UPC Masterclass — Session 3: "The UPC Approach to Damages Actions and Compensation Claims" (Hoffmann Eitle)

    June 28, 2022 – "The Hand of History—The Mind of the Inventor" (U.S. Patent and Trademark Office) – Session 4: Toys, umbrellas, and more

    June 29, 2022 – "Life After Brexit – IP Developments in UK and Europe" (Intellectual Property Owners Association and Chartered Institute of Patent Attorneys) – 11:00 am to 12:00 pm (ET)

    June 29, 2022 – Artificial Intelligence (AI) and Emerging Technologies (ET) Partnership Series (U.S. Patent and Trademark Office) – 1:00 pm to 5:00 pm (ET)

    June 30, 2022 – UPC Masterclass — Session 3: "The UPC Approach to Damages Actions and Compensation Claims" (Hoffmann Eitle)

    June 30, 2022 – "Partnering with the Department of Defense to Protect the Warfighter: Investments in National Health Security" (Biotechnology Innovation Organization) – 1:00 pm to 3:00 pm (ET)

    July 5, 2022 – European biotech patent law update (D Young & Co) – 9:00 am, noon, and 5:00 pm (BST)

    July 8, 2022 – UPC Masterclass — Session 4: "The New Regime on the Revocation of European Patents/ The 'Long-arm Jurisdiction'" (Hoffmann Eitle)

  • USPTO AI/ET Partnership Series

    AI ET Partnership
    The U.S. Patent and Trademark Office will be holding the inaugural meeting of the Artificial Intelligence (AI) and Emerging Technologies (ET) Partnership Series from 1:00 pm to 5:00 pm (ET) on June 29, 2022.  The meeting will explore various patent policy issues including subject matter eligibility, inventorship, and disclosure practice, and also explore data from patent filings and how they inform innovation trends in these critical technology areas.  The meeting will include discussions of the following topics:

    • National Artificial Intelligence Initiative
    • Patent Eligibility Jurisprudence Report
    • Panel 1: Subject Matter Eligibility and the Impact on AI/ET Innovation
    • USPTO AI Dataset & Trends
    • Panel 2: Inventorship and the Advent of Machine-Generate Inventions
    • Panel 3: Disclosure and AI/ET Inventions

    Additional information regarding the customer partnership meeting, including how to participate online, can be found here.

  • BIO Webinar on Partnering with DoD

    Biotechnology Innovation OrganizationThe Biotechnology Innovation Organization will be offering a webinar entitled "Partnering with the Department of Defense to Protect the Warfighter: Investments in National Health Security" from 1:00 pm to 3:00 pm (ET) on June 30, 2022.  The webinar will detail the many new and previously available sources of capital, as well as the processes for applying for funding, from the U.S. Department of Defense (DoD).  The meeting will include discussions of the following topics:

    • Opening Remarks: Overview and DoD Priorities
    • Panel 1: Investing at the Speed of Need: Novel Technologies and Platforms to Accelerate Drug Development
    • Panel 2: Repurposing and Redirecting: An Alternate Approach to Accelerating Medical Countermeasures
    • Closing Remarks: How to Work with DoD

    Those interested in registering for the program, can do so here.

  • European Biotech Patent Law Webinar

    D Young & CoD Young & Co will be offering its next European biotech patent law update on July 5, 2022.  The webinar will be offered at three times:  9:00 am, noon, and 5:00 pm (BST).  D Young & Co European Patent Attorneys Simon O'Brien and Antony Latham will provide an update of new and important EPO biotechnology patent case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that reversed the District Court finding in that earlier opinion.

    To recap, the case arose in ANDA litigation over U.S. Patent No. 9,187,405, which recites methods for treating recurring remitting multiple sclerosis (RRMS), a degenerative disorder of the myelin surrounding nervous tissue, with fingolimod (2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol) sold by Novartis under the brand name Gilenya®.  Claim 1 was included in the opinion as representative:

    A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.

    The italicized limitation in this claim was the focus of that appeal, the Court's opinion, and Chief Judge Moore's dissent.  As set forth therein, the practice in the prior art had been (for drugs having a necessary therapeutic threshold) to administer a "loading dose," defined as "a higher-than-therapeutic level dose, usually given . . . as the first dose in order to get therapeutic levels up quickly" by undisputed expert testimony.  Similarly undisputed was that loading dose regimens had been used in the prior art for treating multiple sclerosis (MS).  Defendant HEC Pharm Co. Ltd. (the only remaining defendant at trial from more than two dozen generic drug makers and ANDA filers sued by Novartis under 35 U.S.C. § 271(e)(2)) maintained that the '405 patent was invalid because its specification and its priority British patent application (filed eight years before) did not provide an adequate written description of an invention comprising the "absent an immediately preceding loading dose regimen" limitation under 35 U.S.C. § 112(a).  As the Federal Circuit's earlier opinion set out, these applications both disclosed results of an animal model of MS by treatment by oral administration of a hydrochloride salt of fingolimod at 0.3 mg/kg/week dosages.  Both also recited a prophetic example of a human clinical trial using "preferred daily dosage range [of] about from 0.1 to 100 mg" and "a dose of 0.5 to 30 mg [of fingolimod hydrochloride] every other day or once a week" and specifically "0.5, 1.25, or 2.5mg[/day]."  Nowhere in either specification was there express disclosure that a loading dose was to be avoided (but similarly nowhere in either specification was administration of a loading dose expressly taught).

    The District Court found that HEC's ANDA product would infringe the '405 patent and that HEC had not shown by clear and convincing evidence that the '405 patent failed to satisfy the written description provisions of § 112(a).  The Court found that the skilled worker would "make the leap" of increasing the dose from 0.3 mg in a rat to 0.5 mg in a human based on expert testimony, and that this specific dosage was found in the recited range of "from 0.1 to 100 mg."  Regarding the absence of a loading dose in the claimed regimen, the District Court found persuasive expert testimony that "'[i]f a loading dose were directed, the Patent would say that a loading dose should be administered 'initially.'"  This was enough for the District Court to find that the specification provided an adequate written description of this negative limitation.

    The Federal Circuit affirmed in the earlier appeal, with the majority holding that the District Court's decision regarding the adequacy of the '405 patent specification's disclosure of this limitation was supported by substantial evidence including expert testimony.  With regard to that expert testimony (and its consistency with the disclosure in the '405 specification), the Court noted that "[a] 'disclosure need not recite the claimed invention in haec verba,'" citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010), and held that "[t]o accept HEC's argument would require us to ignore the perspective of the person of ordinary skill in the art and require literal description of every limitation, in violation of our precedent."  Furthermore, the majority rejected HEC's assertion that the '405 specification contained insufficient "blazemarks" regarding the 0.5 mg/day dose because the blazemarks considerations are only relevant "where the specification describes a broad genus and the claims are directed to a single species or a narrow subgenus"; in such cases "'blazemarks' . . . would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities," citing Novozymes v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349 (Fed. Cir. 2013).  But the need for blazemarks does not arise "where the claimed species is expressly described in the specification, as the 0.5 mg daily dosage is here" according to the majority, citing Snitzer v. Etzel, 465 F.2d 899, 902 (C.C.P.A. 1972).  The absence of "laundry-list-type disclosure" (which Judge O'Malley discussed in her dissent in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.) made a difference in this regard, further used by the majority in supporting its decision.  Finally, the majority opinion noted that the specification had literal description support for the 0.5 mg/day dose.  Accordingly, the majority held that the District Court's determination that HEC failed to show inadequate written description on these grounds was supported by both the specification and "ample expert testimony" and thus affirmed.

    Turning to the negative limitation regarding the absence of a loading dose, the majority opinion began by noting that, under Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015), there is no "new and heightened standard for negative claim limitations" and supported the continued vitality of this principle by citation to several Federal Circuit opinions, including Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344, 1350–51 (Fed. Cir. 2012); In re Bimeda Research. & Development Ltd., 724 F.3d 1320, 1324 (Fed. Cir. 2013); and Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1348 (Fed. Cir. 2016).  The majority perceived HEC's argument as "attempt[ing] to create a new heightened written description standard for negative limitations" contrary to the "central tenet of [the Court's] written description jurisprudence—that the disclosure must be read from the perspective of a person of skill in the art" as well as specific precedent such as All Dental Prodx, LLC v. Advantage Dental Prod., Inc., 309 F.3d 774, 779 (Fed. Cir. 2002).  The majority opinion distinguished HEC's argument (and Chief Judge Moore's dissent, vide infra) that "[t]he mere absence of a positive recitation is not a basis for an exclusion" (M.P.E.P. § 2173.05(i)), and "silence alone is insufficient" (citing the dissent) with the concept of context, specifically "how a skilled artisan reads a disclosure" which is what "matters" to the majority.  For Judges O'Malley and Linn, both HEC and the Chief Judge "urge us to elevate form over substance by creating a new rule that a limitation which is not expressly recited in the disclosure is never adequately described, regardless of how a skilled artisan would read that disclosure."  The adequacy of the '405 specification's written description regarding the negative loading dose limitation was supported, according to the majority, by the District Court who "correctly, and quite carefully, conducted 'an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art'" (which the opinion then summarized and quoted).  Based on this analysis, the majority stated that they could find no clear error and thus affirmed.

    In the earlier appeal, Chief Judge Moore's dissent focused on the adequacy vel non of the written description of the negative limitation regarding the absence of a loading dose of fingolimod hydrochloride.  The Chief Judge asserted that "[t]he majority dramatically expands a patentee's ability to add, years after filing a patent application, negative claim limitations that have zero support in the written description" (emphasis added), summarizing her position as "[s]ilence is not disclosure."  The dissent illustrated how readily answers to questions like the one before the Court can be completely divergent depending on which "policy lever" (as legal academics might call them) are considered most relevant.  The Chief focused on disclosure, which carries with it a requirement for affirmative statements and definitions that without question are not found in the '405 specification.  The dissent noted that the limitation was added in response to an obviousness rejection asserted against claims in a co-pending priority application to the '405 patent.  According to the dissent "the district court (and now the majority) [engaged in] rewriting the specification with expert testimony" to arrive at their conclusion regarding such adequacy.  The Chief concluded her dissent by stating:

    The inventors do not get to claim as their invention something they did not disclose in the patent.  There are no fact findings here to defer to—the patent is silent as to loading doses.  The district court relied upon that silence: "The absence of an immediately preceding loading dose from the specification, and from the Prophetic Trial, would tell a person of skill that loading doses are excluded from the invention."  . . .  This is not a finding of fact; it is a misunderstanding of the law.  An inventor cannot satisfy the written description requirement through silence.  And when the majority concludes otherwise, it creates a conflict with our long-standing, uniformly-applied precedent . . . .  While the negative limitation need not be recited in the specification in haec verba, there must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion:  disadvantages, alternatives, inconsistencies, just something.  This specification is entirely silent and ambivalent about loading doses.  These inventors did not disclose treatment that must exclude a loading dose, and the district court's finding to the contrary is clearly erroneous.  After this case, negative limitations are supported by a specification that simply never mentions them [citations to the record and precedent omitted].

    In the current decision, by Chief Judge Moore joined by Judge Hughes (Judge O'Malley having left the Court in May), and with a dissent by Judge Linn, the Chief's understanding and opinion on the issues before the Court prevailed ("the district court clearly erred in finding that the negative claim limitation 'absent an immediately preceding loading dose' added during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a)").  The panel majority opinion tracks the Chief Judge's dissent in the Court's earlier decision, that negative limitations do bear a burden of disclosure different from affirmative ones.  As set forth in the opinion, this burden can be satisfied for example by including "a reason to exclude the relevant [element]," citing inter alia Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012); and Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1355 (Fed. Cir. 2015), or by including "'statements in the specification expressly listing the disadvantages of using' that element," or by distinguishing among the excluded element and advantageous alternatives.  The opinion calls "the common denominator" of all these rubrics disclosure of the element to be excluded, repeating the Chief's aphorism from her earlier dissent that "silence is not disclosure."  While not disputing the principle that "a negative limitation need not be recited in the specification in haec verba," the majority opinion asserts the need for "something" to be disclosed in the specification "that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives."  The opinion concedes under some circumstances in some particular fields where "the absence of mention of a limitation necessarily excluded that limitation, [then] written description could be satisfied despite the specification's silence," citing Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (constituting a kind of inherent disclosure of the excluded element, an argument Novartis expressly did not make at trial or on appeal).  And expert testimony does not suffice, according to the panel majority, because if it could "such testimony could effectively eliminate the written description requirement."  In coming to its conclusion, the panel majority revisits and reinterprets the evidence adduced at trial in finding the District Court's consideration thereof to be clearly erroneous.

    The opinion does contain a nod to Judge O'Malley's concerns in the original panel opinion, that the Court was being asked to create a "heightened standard for negative claim limitations," which the opinion says it is not (although it is clear from elsewhere in the opinion that requiring "something" imposes more than the original panel majority required).  The further concession that it is possible that under some circumstances "it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure," the opinion states clearly that "[t]his is not such a case."

    Judge Linn (who with Judge O'Malley formed the majority in the earlier opinion) dissented, expressing his view that imposing a heightened standard for negative limitation disclosure in satisfying the written description requirement was exactly that the majority was doing.  Ultimately the question is the metes and bounds of what is required for a specification to "reasonably disclose" possession of the claimed invention, and Judge Linn cites some of the same cases (Inphi, for example) for the principle that "there is no 'new and heightened standard for negative claim limitations'" that the panel majority cited in support of the opposite conclusion.  And in Santarus, Judge Linn notes that while the Court "observed" that a specification could describe a reason to exclude a limitation or element, the decision did not require it to provide adequate written description support for a negative limitation.  While acknowledging that the panel majority cited principles regarding the adequacy of a written description with which he agreed, Judge Linn did not agree with the heightened standard of necessary exclusion enunciated in their opinion.  Citing In re Bimeda Research & Development Ltd., 724 F.3d 1320, 1324 (Fed. Cir. 2013), Judge Linn identified instances where a negative limitation was not adequately supported to include where "a negative limitation which is inconsistent with the disclosure is not adequately described."  And the dissent cites multiple examples of cases stating the lack of an in haec verba requirement (see All Dental Prods., LLC v. Advantage Dental Prod., Inc., 309 F.3d 774, 779 (Fed. Cir. 2002) (citing Eiselstein v. Frank, 52 F.3d 1035, 1039 (Fed. Cir. 1995)) and the lack of a heightened disclosure requirement for negative limitations, see Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1348 (Fed. Cir. 2016), overruled on other grounds by Aqua Prods., Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc).  Judge Linn even cites the M.P.E.P., explaining in a footnote "not because the court is bound by it but because I find its reasoning informative and persuasive."

    In his own explication of the factual bases of the District Court's decision, Judge Linn finds that the District Court conducted "an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art" in arriving at its conclusion, supported by expert testimony to make "the unremarkable, and factually supported, determination that 'starting with a daily dose plainly implies that there is no loading dose.'"  With regard to the majority's reliance on its own interpretation of the word "initially," Judge Linn states the equally unremarkable rubric of appellate review that:

    We are not free to substitute our own factual findings for those of the district court absent clear error because 'a district court judge who has presided over, and listened to, the entire proceeding has a comparatively greater opportunity to gain the necessary "familiarity with specific scientific problems and principles," . . . than an appeals court judge who must read a written transcript or perhaps just those portions referenced by the parties,'" citing Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 319 (2015) (quoting Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 610 (1950)).

    The majority decision, while well-reasoned, illustrates the flexibility of the deference reviewing courts are required under precedent to give district court decisions on questions of fact (written description being quintessentially a question of fact).  As set out in the opinion, a district court's factual determination is not to be overturned "in the absence of a definite and firm conviction that a mistake has been made," citing Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008), and at trial HEC had the burden to show invalidity by clear and convincing evidence (under Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1351 (Fed. Cir. 2011), and ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1376 (Fed. Cir. 2009), as cited in the opinion).  It is understandable that the majority thought rehearing and reversal was the proper outcome, but perhaps the issue might have been better reviewed en banc.

    Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)
    Panel: Chief Judge Moore and Circuit Judges Linn and Hughes
    Opinion by Chief Judge Moore; dissenting opinion by Circuit Judge Linn

  • Cornell Research Foundation, Inc. v. Vidal (Fed. Cir. 2022)

    By Kevin E. Noonan —

    Federal Circuit SealLast month in Cornell Research Foundation, Inc. v. Vidal, the Federal Circuit affirmed the Patent Trial and Appeal Board's determinations in six inter partes review proceedings that invalidated the challenged claims for being obvious.

    The claims of the challenged patents were directed to methods for producing phytases (enzymes that help livestock absorb phosphate from the diet) for supplementing animal feed using genetic engineering to introduce and express a bacterial (Escherichia coli) phytase gene in fungal (typically yeast such as Saccharomyces cerevisiae and Pichia pastoris) cells.  The opinion sets forth the following as representative claims of U.S. Patent No. 8,993,300, one of the challenged patents:

    1.  A method of producing a phytase in fungal cells, the method comprising:
        providing a polynucleotide encoding an Escherichia coli phytase;
        expressing the polynucleotide in the fungal cells; and
        isolating the expressed Escherichia coli phytase wherein the Escherichia coli phytase catalyzes the release of phosphate from phytate.

    10.  The method of claim 1 wherein the Escherichia coli phytase has an optimum activity at a temperature range of 57 degrees C to 65 degrees C.

    11.  The method of claim 1 wherein the Escherichia coli phytase retains at least 40% of its activity after heating the phytase for 15 minutes at 80 degrees C.

    12.  The method of claim 1 wherein the Escherichia coli phytase retains at least 60% of its activity after heating the phytase for 15 minutes at 60 degrees C.

    Challenger Associated British Foods (ABF) asserted two combinations of prior art according to the opinion, depending on whether U.S. Patent No. 5,876,997 to Kretz was included.  Taking the non-Kretz containing combinations first, the opinion recites two subcombinations:  U.S. Patent No. 5,985,605 to Cheng in combination with a first scientific reference (Dassa) disclosing the nucleotide sequence of a first E. coli phytase and a second scientific reference (Greiner) disclosing more generally E. coli phytase genetics, and a second subcombination of the Dassa and Grenier references with U.S. Patent No. 5,436,156 to Van Gorcom and a third scientific reference (Romanos) disclosing recombinant genetics in yeast.  ABF argued that the thermostability-reciting claims (claims 10-12 of the '300 patent) would have been obvious either as being inherent properties of the combination of references or having been expressly disclosed in a fourth scientific reference (Olson).  The Board held in its Final Written Decision that ABF had established both a motivation to combine and a reasonable expectation of success on the record to establish obviousness of the challenged claims.  Regarding those combinations that included the Kretz reference the Board held that this reference alone anticipated certain claims under 35 U.S.C. § 102(e) or rendered the challenged claims obvious in combination with the other asserted references.

    The Federal Circuit affirmed, in an opinion by Judge Prost, joined by Judges Reyna and Taranto.  On appeal, Cornell challenged the Board's determination that there was a motivation to combine and reasonable expectation of success sufficient to render the challenged claims obvious, that the thermostability properties of the claimed phytases were an inherent property of the phytases disclosed in the cited art, and that Cornell failed to antedate the Kretz reference (although the opinion states that the panel did not reach this third ground of appeal).

    Cornell's first ground of appeal was unpersuasive because of the Board's reliance on fact evidence, specifically expert testimony, and the deference the Federal Circuit must give to the Office's factual determinations under Dickerson v. Zurko.  Regarding whether thermostability of the recombinant phytases was inherent, this was another question of fact the panel reviewed for substantial evidence.  The Board relied on testimony from Cornell's own expert witness that "express[ing] the same enzyme in the same host under the same conditions" produces "inherent results," including thermostability (emphasis in opinion).  This was enough for the panel to satisfy the substantial evidence requirement, and Cornell's arguments to the contrary, that this finding was inconsistent with a finding of no inherency regarding anticipation by the Kretz reference and the Board restricting its assessment of inherency to the disclosure of the '300 patent, were not persuasive, based in part on the Kretz reference disclosing a different E. coli phytase gene.

    Accordingly, the Federal Circuit affirmed the PTAB's decision that the challenged claims were obvious and awarded costs to the government.

    Cornell Research Foundation, Inc. v. Vidal (Fed. Cir. 2022)
    Nonprecedential disposition
    Panel: Circuit Judges Prost, Reyna, and Taranto
    Opinion by Circuit Judge Prost

  • Conference & CLE Calendar

    CalendarJune 21, 2022 – "The Hand of History—The Mind of the Inventor" (U.S. Patent and Trademark Office) – Session 3: Automobiles and Aviation

    June 22, 2022 – Proud Innovation series — "Making your passion profitable" (Office of Innovation Outreach of the U.S. Patent and Trademark Office) – 3:00 pm to 4:05 pm (ET)

    June 28-29, 2022 – Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace (American Conference Institute) – Boston

    June 28, 2022 – UPC Masterclass — Session 3: "The UPC Approach to Damages Actions and Compensation Claims" (Hoffmann Eitle)

    June 28, 2022 – "The Hand of History—The Mind of the Inventor" (U.S. Patent and Trademark Office) – Session 4: Toys, umbrellas, and more

    June 29, 2022 – "Life After Brexit – IP Developments in UK and Europe" (Intellectual Property Owners Association and Chartered Institute of Patent Attorneys) – 11:00 am to 12:00 pm (ET)

    June 30, 2022 – UPC Masterclass — Session 3: "The UPC Approach to Damages Actions and Compensation Claims" (Hoffmann Eitle)

    July 8, 2022 – UPC Masterclass — Session 4: "The New Regime on the Revocation of European Patents/ The 'Long-arm Jurisdiction'" (Hoffmann Eitle)

  • IPO & CIPA Webinar on Life After Brexit

    IPO #2The Intellectual Property Owners Association (IPO) and Chartered Institute of Patent Attorneys (CIPA) will be offering a one-hour webinar entitled "Life After Brexit – IP Developments in UK and Europe" on June 29, 2022 from 11:00 am to 12:00 pm (ET).  Caelia Bryn-Jacobsen of Kilburn & Strode, Matthew Georgiou of Carpmaels & Ransford, and Leythem Wall of Oxon IP will address recent IP developments in the United Kingdom and Europe post-Brexit.  The panel will provide an overview of IP rights, the UK and European litigation landscape, and address what has (and has not) changed in the UK.  The webinar will also address the following topics:

    • Impact of Brexit on European IP
    • The Unitary Patent and Unified Patent Court (UPC)
    • UK patent, trademark, and design rights
    • Representation rights UK, EPO, and UPC

    The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request).  Those interested in attending the webinar should register here.