Patent Docs

USPTO Announces Extension of Certain Patent Deadlines

March 31, 2020

Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 31 UPDATE

By Donald Zuhn –-

In a USPTO Alert distributed earlier today, the U.S. Patent and Trademark Office announced the availability of extensions to the time allowed to file certain patent-related documents and to pay certain required fees. The extensions are a result of the temporary authority provided to the USPTO by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed by President Trump on March 27, 2020. Declaring that "[i]nventors and entrepreneurs are the lifeblood of our economy, and we recognize that many of them are having difficulty as a result of COVID-19," USPTO Director Andrei Iancu noted that the Office was working to provide as much relief as possible to its stakeholders. Director Iancu recognized that the Office was "especially mindful of the outsized impact on small businesses and independent inventors, and we have provided additional relief for these groups," adding that the Office's ultimate goal was "to ensure not only that inventors and entrepreneurs can weather the storm, but that they can also hit the ground running once it passes."

The Office provided more specific details regarding the patent-related extensions in a "Notice of Waiver of Patent-Related Timing Deadlines under the Coronavirus Aid, Relief, and Economic Security Act." In the Notice, the Office explains that pursuant to § 12004 of the CARES Act, the time to file certain patent-related documents or fees which otherwise would have been due on or after March 27, 2020 is being extended. As the result of the President's declaration on March 13, 2020 of a national emergency under the National Emergencies Act due to the COVID-19 outbreak, and pursuant to the CARES Act, the Notice indicates that:

The Director of the USPTO has determined that the emergency has prejudiced the rights of applicants, patent owners, or others appearing before the USPTO in patent matters, and has prevented applicants, patent owners, or others appearing before the USPTO in patent matters from filing a document or fee with the Office. Among other things, the spread of the virus has significantly disrupted the operations of numerous businesses, law firms, and inventors. Small businesses and independent inventors, who frequently have less access to capital and for whom patent-related fees may constitute a more significant expense, may face particular difficulties.

Thus, the Notice states that "a person who is unable to meet patent-related timing deadlines due to the COVID-19 outbreak may be eligible for a waiver of certain deadlines." The Notice sets forth the deadlines for which relief may be obtained:

i. reply to an Office notice issued during pre-examination processing by a small or micro entity;
ii. reply to an Office notice or action issued during examination or patent publication processing;
iii. issue fee;
iv. notice of appeal under 35 U.S.C. § 134 and 37 C.F.R. § 41.31;
v. appeal brief under 37 C.F.R. § 41.37;
vi. reply brief under 37 C.F.R. § 41.41;
vii. appeal forwarding fee under 37 C.F.R. § 41.45;
viii. request for an oral hearing before the Patent Trial and Appeal Board (PTAB) under 37 C.F.R. § 41.47;
ix. response to a substitute examiner's answer under 37 C.F.R. § 41.50(a)(2);
x. amendment when reopening prosecution in response to, or request for rehearing of, a PTAB decision designated as including a new ground of rejection under 37 C.F.R. § 41.50(b);
xi. maintenance fee, filed by a small or micro entity; or
xii. request for rehearing of a PTAB decision under 37 C.F.R. § 41.52

Only the deadlines that are set forth above, and which occur on March 27, 2020 to April 30, 2020, will be entitled to relief under the Office's Notice. The relief being afforded by the Office is that applicable deadlines will be extended 30 days from the initial date on which the reply or fee was due, "provided that the filing is accompanied by a statement that the delay in filing or payment was due to the COVID-19 outbreak" as defined in the Notice. The Notice defines a delay in filing or payment as being due to the COVID-19 outbreak:

[I]f a practitioner, applicant, patent owner, petitioner, third party requester, inventor, or other person associated with the filing or fee was personally affected by the COVID-19 outbreak, including, without limitation, through office closures, cash flow interruptions, inaccessibility of files or other materials, travel delays, personal or family illness, or similar circumstances, such that the outbreak materially interfered with timely filing or payment.

With respect to the deadlines set forth in the Notice, the Office points out that an Office notice issued during pre-examination processing (item i) includes, for example, a Notice of Omitted Items, Notice to File Corrected Application Papers, Notice of Incomplete Application, Notice to Comply with Nucleotide Sequence Requirements, Notice to File Missing Parts of Application, and Notification of Missing Requirements; that an Office notice or action issued during examination (item ii) includes, for example, an Office action (either final or non-final) and Notice of Non-Compliant Amendment; and that an Office notice or action issued during patent publication processing (item ii) includes, for example, a Notice to File Corrected Application Papers issued by the Office of Data Management.

The Office's Notice also provides additional relief before the PTAB. In particular, upon a request to the USPTO affirming that a filing that was due on March 27, 2020 to April 30, 2020 which was or may be delayed due to the COVID-19 outbreak as defined in the Notice (see above), the PTAB shall provide a 30-day extension of time for the following deadlines:

i. a request for rehearing of a PTAB decision under 37 C.F.R. § § 41.125(c), 41.127(d), or 42.71(d);
ii. a petition to the Chief Judge under 37 C.F.R. § 41.3; or
iii. a patent owner preliminary response in a trial proceeding under 3 7 C.F.R. §§ 42.107 or 42.207, or any related responsive filings.

The Notice also indicates that in the event that the USPTO extends a deadline for a patent owner preliminary response or any related responsive filings under subsection (2)(a)(iii), the PTAB may also extend the deadlines provided in 35 U.S.C. §§ 314(b) and 324(c). In addition, for situations not covered in the notice, a request for an extension of time where the COVID-19 outbreak has prevented or interfered with a filing before the Board can be made by contacting the PTAB by telephone at 571-272-9797 or by e-mail at Trials@uspto.gov (for AIA trials), PTAB_Appeals_Suggestions@uspto.gov (for PTAB appeals) or InterferenceTrialSection@uspto.gov (for interferences).

The Notice also states that "[a]s the USPTO remains open for the filing of documents and fees, the waiver set forth in this notice is available only if the delay was due to the COVID-19 outbreak" as defined in the Notice.

The Notice does not impact the Office's March 16 announcement that the fee under 37 C.F.R. § 1.17(m) for petitions to revive applications under 37 C.F.R. § 1.137 is waived for applicants who were unable to timely reply to an office communication due to the COVID-19 outbreak.

Patent-related inquiries regarding the Office's notice can be directed by e-mail to Covid19PatentsRelief@uspto.gov or by telephone to the Office of Patent Legal Administration at 571-272-7704 or 571-272-7703 for reexamination. PTAB-related inquiries regarding the Office's notice can be directed by e-mail to Trials@uspto.gov for AIA trials, to PTAB_Appeals_Suggestions@uspto.gov for PTAB appeals, or to InterferenceTrialSection@uspto.gov for interferences, or by telephone to 571-272-9797.

The Office also announced extensions of time for filing certain trademark-related documents and to pay certain required trademark-related fees. Details regarding those extensions can be found here.

The Office noted that it will continue to evaluate the evolving situation around the COVID-19 pandemic and its impact on USPTO operations and stakeholders.

Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic. In addition, we encourage our readers to let us know about developments related to the COVID-19 pandemic at other patent offices.

For additional information regarding this and other related topics, please see:

• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 29 UPDATE," March 29, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 26 UPDATE," March 26, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 19 UPDATE," March 19, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 18 UPDATE," March 18, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 17 UPDATE," March 17, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – UPDATED," March 16, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020
Genentech, Inc. v. Iancu (Fed. Cir. 2020)

March 30, 2020

By Kevin E. Noonan —

The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) claim construction (and inter partes review (IPR) decision invalidating claims for obviousness) in it recent Genentech, Inc. v. Iancu decision, and also had the occasion to review and affirm the Board's procedure-based denial of patent owner Genentech's motion to amend when Petitioner requested the Board to enter adverse judgment on one ground of IPR institution.

The IPR involved U.S. Patent Nos. 7,846,441 (claims 1-14) and U.S. Patent No. 7,892,549 (claims 1–17) and was brought (in separate petitions consolidated after institution) by Hospira, Samsung Bioepsis, Celltrion, and Pfizer. The patents were directed to methods for treating disorders characterized by overexpression of Her2 (encoded by the erbB2 gene), which include breast cancer, by administering an anti-ErbB2 antibody (such as Herceptin) and a taxoid, in the absence of an anthracycline derivative (in the '441 patent claims) or in the presence of "a further growth-inhibitory agent" or "a further therapeutic agent." Claim 1 of the '441 patent and claims 1 and 5 of the '549 patent are representative:

The '441 patent:

1. A method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an in-tact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

The '549 patent:

1. A method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

5. A method for the treatment of a human patient with breast cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 antibody which binds epitope 4D5 within the ErbB2 extracellular domain sequence, a taxoid, and a further therapeutic agent, to the human patient.

(where the italicized limitations were relevant to the Board's decision).

The Board rendered Final Written Decisions finding all claims in these patents to be obvious. The Board's decision was based on its construction of the phrases "an amount effective to extend the time to disease progression in the human patient" and "an effective amount" to be in the context of situations where there is no treatment.

The Federal Circuit affirmed, in an opinion by Judge Moore joined by Judges Lourie and Wallach. The Federal Circuit noted that Genentech did not challenge the Board's obviousness determination, just the claim construction upon which it was based. The panel reviewed the Board's claim construction de novo, under Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015), and focused on the prosecution history in its analysis, because neither the claim language nor the specification "clearly define[d]" the terms at issue before the Court. The Examiner rejected the term "extend the time to disease progression" as being indefinite, without the specification providing "a standard for ascertaining the requisite degree," wherein "one of ordinary skill would not be reasonably apprised of the scope of the invention." The opinion sets forth the "give and take" between the Examiner and applicant on this issue:

The Examiner:

Specifically, it is never set forth what the extension of time to disease progress is relative to, for example, is the extension of time to disease progress relative to untreated patients? Patients who received antibody or taxoid alone? Patients who received antibody and an anthracycline?

Applicant's response:

[T]he expressions "extend the time to disease progression" and "response rate" are clear from the specification (see, in particular, page 15, lines 15-17; and pages 42-43) and would be readily under-stood by a skilled oncologist. Clearly, the combination of an anti-ErbB2 antibody and a taxoid is administered in an amount effective to extend the time to disease progression relative to an untreated patient.

The Board considered Genentech to have made an "express choice" in making this response, and that the Examiner allowed the claims of the '441 patent based on this response. The Federal Circuit agreed with the Board's apprehension in this regard, saying that Genentech had "provided an unequivocal, direct response to the examiner's inquiry—that the term 'extend the time to disease progression' was compared to an untreated patient." The construction Genentech advocated before the Board and on appeal was one the Examiner suggested and that Genentech rejected, according to the opinion.

On these facts, the panel found no error in how the Board had construed the claims. Specifically, the panel held that "[t]he Board's construction of the term 'extend the time to disease progression' as requiring comparison to an untreated patient is consistent with the claims, specifications, and prosecution histories of the '441 and '549 patents."

The Federal Circuit also upheld the Board's decision not to grant Genentech's motion to amend, based on failure to show good cause. The Board rejected Genentech's argument that it had a statutory right to amend under § 316(d)(1) and based its "good cause" requirement on 37 C.F.R. § 42.121(c). In addition, because Petitioner had requested an adverse judgment on one of the grounds for institution under 37 C.F.R. § 42.73(b), the Board held (and the Federal Circuit agreed) the issue was mooted. And the Court responded to Genentech's argument that the rules do not permit "partial" adverse judgment by relying on 37 C.F.R. § 42.5(b), which gives the Board discretion to "waive or suspend a requirement of part[] . . . 42." The Board's use of this discretion was consistent with the Supreme Court's statement in SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018), that "Congress chose to structure a process in which it's the petitioner, not the Director, who gets to define the contours of the proceeding." The significance of these procedural issues was that Genentech had submitted a motion to amend in the remaining IPR ground and in the absence of any showing of prejudice (that the opinion states Genentech had not shown) the Board was within its discretion require a showing of good cause, and in its absence, to deny a further motion to amend. And, on appeal, Genentech was unable to satisfy the stringent requirement of establishing an abuse of discretion by the Board. ("The Board abuses its discretion if the decision: (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision." Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1271 (Fed. Cir. 2017)).

Genentech, Inc. v. Iancu (Fed. Cir. 2020)
Panel: Circuit Judges Lourie, Moore, and Wallach
Opinion by Circuit Judge Moore
Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 29 UPDATE

March 29, 2020

By Donald Zuhn —

On March 11, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear." At the time of the announcement, the WHO noted that there were 118,000 cases reported globally; in its latest situation report, the WHO indicates that there have been 634,835 cases as of March 29. The WHO's declaration earlier this month — and global developments since then — raise the question of how the pandemic has been affecting the patent community.

We have been reporting (see links below) on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), Canadian Intellectual Property Office (CIPO), Mexican Institute of Industrial Property (IMPI), National Office of Intellectual Property (ONAPI) in the Dominican Republic, Intellectual Property India, National Intellectual Property Office (NIPO) in Sri Lanka, Israel Patent Office, Intellectual Property Office of Vietnam (NOIP), and Directorate General of Intellectual Property (DGIP) in Indonesia, as well as U.S. Federal courts, including, in particular, the Supreme Court and Federal Circuit. Today we present further developments in Mexico, Indonesia, and at the Federal Circuit in response to the COVID-19 pandemic.

Last week, Mexican patent law firm OLIVARES notified the patent community that the Mexican Patent and Trademark Office (IMPI) had issued a decree stating that no terms would run from March 24 to April 19, 2020. At the time, OLIVARES noted "that IMPI will remain open and that it will be possible to file applications and briefs even though their filing date will be considered as April 20, 2020," and that the suspension would not apply to the release of preliminary injunctions imposed by IMPI during an infringement proceeding.

On Friday, OLIVARES provided an update on IMPI developments, noting that the IMPI issued an additional decree on March 26, suspending all of its activities from March 27 to April 19, 2020. As a result, it will not be possible to file motions until April 20, 2020. While it will be possible to pre-file applications online, such applications will have to be digitally signed on April 20, at which time an application number will be assigned by the IMPI. The IMPI decree also indicated that the Office could summon a limited staff to attend to procedures that are necessary to mitigate the consequences of the pandemic, or related to the release of preliminary injunctions imposed by the IMPI during an infringement proceeding.

On Saturday, OLIVARES provided a further update, noting that the Ministry of Health had issued a decree in which it was suspending, due to force majeure, the legal terms during the period from March 26 to April 19, 2020, in all administrative actions and procedures that are processed with the Ministry of Health, its administrative units and decentralized administrative bodies, including the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS). As a result, only authorizations for medicines, medical devices, and import of supplies strictly related to attending to the COVID-19 pandemic may continue before COFEPRIS during said period. COFEPRIS issued a statement in which it specified that its Comprehensive Services Center (CIS) would also remain open to receive and attend to non-COVID-19-related procedures necessary to continue the supply of medical products in response to the health needs of the Mexican population.

Last week, we noted that the Directorate General of Intellectual Property (DGIP) in Indonesia had announced that until April 5, the Intellectual Property Integrated Service Counters at the DGIP would be closed and that dispensations would be provided by the DGIP for the late filing of all formality documents for Intellectual Property applications that would otherwise have been due in March 2020. On Friday, Indonesia patent law firm LSP Partnership notified the patent community that the DGIP was temporarily closed (with LSP indicating that such closure would run until March 31), that IP applications could be filed online (except for the payment of annuities), and that the DGIP would provide extensions of time for any formality documents and payment of fees (including for patent maintenance) that are due in March 2020, and up until the DGIP resumes for services.

In a notice posted on its website on Friday, the U.S. Court of Appeals for the Federal Circuit noted that the Clerk's Office has issued new guidance on how counsel may accomplish service outside of CM/ECF (Case Management/Electronic Case Files), which is most frequently required when serving pro se parties or confidential materials. In particular, the Court explained that:

Under Federal Rule of Appellate Procedure 25(c)(2), parties may electronically serve each other outside of the court's electronic filing system "by sending it by other electronic means that the person to be served consented to in writing." Service through this method is complete on "sending, unless the party making service is notified that the paper was not received by the party served." Fed. R. App. P. 25(c)(4). The court is not involved when parties agree in writing to provide service through alternate electronic means, such as through email. Consistent with the court's November 1, 2019 notice, the filing party must include a proof of service noting the form of service [emphasis in original].

The Clerk's Office also recommended two other options when a person to be served does not consent to an alternate method of service. Those options can be found in the new guidance.

Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic. In addition, we encourage our readers to let us know about developments related to the COVID-19 pandemic at other patent offices.

For additional information regarding this topic, please see:

• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 26 UPDATE," March 26, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 19 UPDATE," March 19, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 18 UPDATE," March 18, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 17 UPDATE," March 17, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – UPDATED," March 16, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020
Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)

March 29, 2020

By Kevin E. Noonan —

The Federal Circuit continued its recent willingness to affirm findings of infringement under the doctrine of equivalents (see, e.g., "Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)"), in Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC.

The case came to the Court after ANDA litigation over Galderma's low dose formulations of doxycycline for treating acne or rosacea. Galderma asserted two sets of patents: the Chang patents (U.S. Patent Nos. 8,206,740; 8,394,405; and 8,470,364) and the Ashley II patents (U.S. Patent Nos. 8,603,506 and 9,241,946). Claim 1 of the '740 patent was set forth in the Court's opinion as representative:

1. An oral pharmaceutical composition of doxycycline, which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of (i) an immediate release (IR) portion comprising 30 mg doxycycline; (ii) a delayed release (DR) portion comprising 10 mg doxycycline; and optionally, (iii) one or more pharmaceutically acceptable excipients.

The specification expressly defined the immediate-release component of the pharmaceutical composition as "a dosage form that is intended to release substantially all of the active ingredient on administration with no enhanced, delayed or extended release effect." In contrast, the delayed release component was not strictly defined.

Relevant to the issues on appeal was Amneal's inter partes review proceeding against the '740 and '405 patents, and the arguments the patent owner made regarding claim construction. Specifically, the patent owner argued that the DR portion of the pharmaceutical composition "requires no substantial release from the [DR] portion until some time other than promptly after administration – and in particular, until after the DR portion passes through the acidic stomach and sections of the GI tract below pH 4.5" (emphases in opinion). The patent owner also argued that prior art "secondary loading" portion was "intentionally designed to be 'leaky' in the stomach," but that "the Chang '740 patent expressly stated that for the 'DR portion' described and claimed therein, 'there is no substantial release of doxycycline in the acidic stomach environment of approximately below pH 4.5.'" Thus the distinction the patent owner attempted to draw between its claimed invention and the prior art was that the '740 patent had essentially no release of the delayed release component in stomach, while the prior art had some stomach release (characterized as being "leaky").

The Board disagreed; applying the broadest reasonable interpretation standard, the Board construed the claims to mean that the DR component of the claimed pharmaceutical composition "is not limited to formulations requiring that there be no substantial release in the stomach" and "[t]he portion of the '740 patent specification upon which [Patent Owner] relies to support its narrower construction addresses properties of 'enteric coated pellets,' not a delayed-release component" and hence did not provide a basis for distinguishing the claims. The Board based its construction on the rubric that it would have be improper to read limitations reciting a narrow embodiment in construing a claim term that is read more broadly elsewhere in the specification. As set forth in the Federal Circuit's opinion, "the Board construed 'delayed release' to mean 'release of a drug at a time other than immediately following oral administration'" and that the cited art did not disclose a delayed release formulation as the term was construed.

In the ensuing ANDA litigation, the District Court held that Amneal's generic product infringed under the doctrine of equivalents, construing the "delayed release" limitation as the Board had in the IPR. Under this construction, the Court held that Amneal's proposed generic version of Galderma's delayed release doxycycline pharmaceutical formulation contained the "equivalent" of the DR formulation in Galderma's claimed formulation and hence would infringe.

Regarding the asserted Ashley II patents, the representative claim considered by the Federal Circuit was claim 15 of the '946 patent:

15. A method for treating papules and pustules of rosacea in a human in need thereof, the method comprising administering orally to said human doxycycline, or a pharmaceutically acceptable salt thereof, in an amount of 40 mg per day, wherein the amount results in no reduction of skin micro-flora during a six-month treatment, without ad-ministering a bisphosphonate compound.

The District Court construed the phrase "wherein the amount results in no reduction of skin microflora during a six-month treatment" to mean "wherein the amount results in no reduction of skin microflora vis-à-vis a placebo control during a six-month treatment, with microbiological sampling at base-line and month six." Under this construction, the Court also found that the use of Amneal's generic version of Galderma's delayed release doxycycline formulation would be infringed under the doctrine of equivalents.

The Federal Circuit affirmed the District Court's decision regarding infringement under the doctrine of equivalents of the asserted Chang patents and reversed as to doctrine of equivalents infringement of the Ashley II patents, in an opinion by Judge Moore joined by Judges Lourie and Stoll. And the Court found infringement under the DOE. Regarding the Chang patents, Amneal asserted argument-based estoppel, amendment-based estoppel, and claim vitiation, based on patent owner's arguments and representations in the IPR.

On the argument-based estoppel prong of its argument, Amneal relied on patent owner's representations to the Board during the IPR to the effect that infringing formulations should not encompass ones that began dissolving in the stomach. The Federal Circuit agreed that Galderma's counterargument that the patent owner's arguments in the IPR did not amounted to a "clear and unmistakable surrender" of claim scope as argument by Amneal. The panel acknowledged that "statements made by a patent owner during an IPR proceeding can be considered during claim construction and relied upon to support a finding of prosecution disclaimer" so long as the statements are "both clear and unmistakable," citing Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1361–62 (Fed. Cir. 2017), and its utility in satisfying the "public notice function" regarding proper claim scope. But, the opinion states, such statements should not be considered "in a vacuum" and a court need to review prosecution history "as a whole," citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993). Here, "the record before the Patent Office clearly put the public on notice that the meaning of delayed release with respect to the Chang Patents is not limited to formulations requiring that there be no substantial release in the stomach." The patent owner had made assertions, but these putatively limiting statements had been rejected by the PTO, and thus there was no disclaimer. With regard to this argument, the opinion illustrates nice nuance between the situation (and legal conclusion) in this case and the seemingly contrary outcome in Am. Piledriving Equip., Inc. v. Geoquip, Inc., 637 F.3d 1324, 1336 (Fed. Cir. 2011), where disclaimer was found from statements made in reexamination to distinguish prior art. While distinguishing the circumstances under which the putatively disclaiming arguments were made in the two cases (including "that the statements were not made during inter partes review, the statements were used to inform claim construction not prosecution history disclaimer and our court did not find that the examiner had clearly and expressly rejected the patentee's proposed construction") the gist of the differences for the Court was that "[a] prosecution history statement may inform the proper construction of a term without rising to the level of a clear and unmistakable disclaimer," citing Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1366 (Fed. Cir. 2015). According to the opinion, in American Piledriving, the statements merely confirmed construction based on the specification and prosecution history, while here Amneal attempted to use those statements to rebut undisputed claim construction and raise an estoppel precluding DOE infringement. "A person of ordinary skill in the art would not read the prosecution history in this case and conclude that the patent owner's claim construction that the Board expressly rejected was a clear and unmistakable surrender," according to the Court and thus the panel declined to do so.

Turning from disclaimer to IPR estoppel, Amneal argued that the District Court's infringement determination was contrary to positions patent owner took in the IPR, specifically:

[T]hat (1) release of the drug in the stomach from "leaky" SR portions was "substantially different" from the claimed DR portion, and (2) "substantially constant release" from [sustained-release] SR-containing formulations was "significantly different" from the two-pulse dissolution of the claimed "IR/DR only" formulations.

On this point, the standard of review on questions of fact, clear error, was dispositive, because Federal Circuit did not find that here:

The district court found that Amneal's product contains a DR portion of doxycycline and a separate portion of doxycycline that is not available for release until a time "other than immediately following oral administration." . . . The district court found that these portions together satisfy the DR limitation

Because the panel found that this determination was based on record evidence, there was no reason to overturn the District Court and thus the Federal Circuit affirmed.

With regard to the Ashley II patents, Galderma first argued (after oral argument under Fed. R. App. Proc. 28(j)) that the Court had lost jurisdiction to hear the appeal because Amneal had ceased to pursue its ANDA. The panel disagreed, stating that this alone does not divest jurisdiction because the action is not moot and a justiciable controversy remains on the basis that the alleged infringing conduct "could reasonably be expected to recur," citing Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc., 528 U.S. 167, 189 (2000).

On the merits, the panel held that "Galderma did not present particularized testimony and linking argument as to the reduction in skin microflora term." Stating that the record "wholly lacked the requisite particularized testimony required to find infringement under the doctrine of equivalents," the Federal Circuit reversed the District Court's decision that Amneal's generic version of Galderma's delayed-release doxycycline pharmaceutical formulation would infringe the asserted claims of the Ashley II patents.

Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Moore, and Stoll
Opinion by Circuit Judge Moore
Conference & CLE Calendar

March 29, 2020

March 31, 2020 – "Preserving Businesses During the COVID-19 Recession: Understanding the Business and Tax Impact of the CARES Act" (myLawCLE) – 1:00 to 3:00 pm (ET)

April 2, 2020 – "Indefiniteness after Samsung v. Prisua" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

April 2, 2020 – "Antiviral Patents — How prepared are we to combat novel viral diseases?" (LexisNexis® and IPWatchdog) – 12:00 pm (ET)
CLE on CARES Act

March 28, 2020

MyLawCLE will be offering a live video broadcast entitled "Preserving Businesses During the COVID-19 Recession: Understanding the Business and Tax Impact of the CARES Act" on March 31, 2020 from 1:00 to 3:00 pm (ET). Eric L. Green, Jeffrey M. Sklarz, Jason A. Marsh, Shelby L. Wilson, and Mark Sklarz of Green & Sklarz LLC will provide business owners and their advisors, including accountant, lawyers, and financial advisors, with key information regarding the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"). The webinar will address the following topics:

• An explanation of how the CARES Act will assist businesses
• Discussion of relevant tax business tax provisions
• An update concerning insurance coverage for COVID-19 related claims
• The effect of COVID-19 on contract and lease provisions
• IRS Enforcement changes and programs
• Discussion of relevant succession planning and related tax issues

The registration fee for this webcast is $195. Those interested in registering for the webcast, can do so here.
IPO Webinar on Indefiniteness

March 27, 2020

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Indefiniteness after Samsung v. Prisua" on April 2, 2020, from 2:00 to 3:00 pm (ET). Mark Feldstein of Finnegan, Kirby Lee of Ecolab, and Robert Sterne of Sterne, Kessler, Goldstein & Fox, PLLC will consider the many implications of Samsung v. Prisua and possible tactics for parties in or considering IPR proceedings including:

• Should patent challengers avoid IPRs on any claims that might be found indefinite?
• What other types of indefinite claims may eventually be found proper to evaluate for anticipation and obviousness in an IPR?
• What is the status now of “means-plus-function” claims at the PTAB?
• Will the petitioner be estopped from challenging claims as anticipated or obvious in other proceedings when the PTAB can't reach a final decision on patentability claims because the claims are indefinite?
• Approaches to try to litigate indefiniteness before filing an IPR, and
• Efforts to assume definiteness for purposes of the IPR, while expressly reserving the right to later assert indefiniteness in the district court.

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

March 27, 2020

LexisNexis® and IPWatchdog will be offering a webinar on "Antiviral Patents — How prepared are we to combat novel viral diseases?" on April 2, 2020 at 12:00 pm (ET). Gene Quinn of IPWatchdog.com and William Mansfield of LexisNexis® PatentSight® will discuss the patent landscape of antiviral vaccines. The webinar will address the following topics:

• The entire technology field and key players in antiviral vaccine market
• Review of selected companies who have technologies related to coronavirus
• Portfolio landscaping of global pharma leaders in this technology field
• How PatentSight metrics evaluate the portfolio strength

There is no registration fee for this webcast. However, those interested in registering for the webinar, should do so here.
Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 26 UPDATE

March 26, 2020

By Donald Zuhn —

On March 11, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear." At the time of the announcement, the WHO noted that there were 118,000 cases reported globally. In the fifteen days since the COVID-19 outbreak was declared a pandemic, the number of global cases has almost quadrupled, with the WHO reporting in its latest situation report that as of March 26 there have been 462,684 cases. The Director-General also stated that "[t]his is not just a public health crisis, it is a crisis that will touch every sector – so every sector and every individual must be involved in the fight." The WHO's March 11 declaration — and global developments since then — raise the question of how the pandemic is affecting the patent community.

We have been reporting (see links below) on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), Canadian Intellectual Property Office (CIPO), Mexican Institute of Industrial Property (IMPI), and National Office of Intellectual Property (ONAPI) in the Dominican Republic, as well as U.S. Federal courts, including, in particular, the Supreme Court and Federal Circuit. Today we present recent developments in India, Sri Lanka, Israel, Mexico, Australia, New Zealand, Vietnam, and Indonesia in response to the COVID-19 pandemic.

In a Public Notice issued on March 19 by the Office of Controller General for Patents, Designs & Trademarks of Intellectual Property India, the Controller General indicated that "all in person hearings in Patents and Designs matters scheduled on or before 15th April, 2020 by the Controller should be changed to Video Conferencing (VC) hearings," and further, that "[w]herever the applicant is unable to agree for the VC hearing, the Controller shall adjourn such hearing for a date later than 15th April, 2020." The Public Notice also indicated that hearings scheduled for after April 15, 2020 will remain as is (at least for now). The Controller General also declared that pursuant to sub-rule (6) of Rule 6 of the Patents Rules, "the delay in transmitting or resubmitting documents to the Patent Office will be condoned/timeline be extended by the Controller on a petition for such condonation of delay/extension of time made not later than one month from the date when such COVID-19 outbreak ceased to exist."

However, only days later, on March 23, the Government of India announced a nationwide lockdown that would extend until March 31, and two days later, extended the lockdown until April 15. In a notice distributed to the patent community on March 25, Indian patent law firm D. P. Ahuja & Co. indicated that as a result of the shutdown, the Patent and Trademark Offices have been closed, that no filings will be possible at the Patent and Trademark Offices until the lockdown is lifted, and that all deadlines will be automatically extended or extendable with petitions. Indian patent law firm Chadha & Chadha confirmed that cases in India with deadlines on or before April 14, 2020 shall have a new deadline of April 15, 2020.

On Saturday, Sri Lankan patent law firm Varners noted that the Government of Sri Lanka had declared a public holiday from March 13-19 for all non-essential services, and then declared the period from March 20-27 as a period to work from home or remotely for all public sector and private sector personnel. Travel into Sri Lanka was also restricted for two weeks beginning March 17. As a result of these declarations, all Courts and the National Intellectual Property Office (NIPO) have been closed. Varners also noted that it was working with other leaders in the IP field to request the Director General of the National Intellectual Property Office to grant an extension of four weeks in respect of impending deadlines in view of the current circumstances.

On Monday, Dan Feigelson of 4th Dimension IP posted an article on his America-Israel Patent Law weblog, informing readers of a notice issued by the Israel PTO on Sunday implementing a Saturday night decision by the Israel cabinet to reduce the number of public sector employees that are still working. The ILPTO's implementation of the decision will remain in effect until May 1, 2020 or until the ILPTO publishes a new notice. As discussed in the article, the main points of the ILPTO's implementation include:

• many employees were already working from home, and will continue to do so; registration certificates will continue to issue, and the Patents, Trademarks and Designs Journals will continue to publish at the end of each month;
• the ILPTO will strive to meet its obligations under treaties (e.g. providing PCT search reports on time), and to issue renewal certificates on time, but certain services (recording assignments, licensing new practitioners, notices of formal defects in PCT national stage applications, daily notices of outgoing correspondence) will be delayed at least until after Passover (April 15, 2020);
• the ILPTO will continue to accept submissions electronically and, for those parties permitted to do so, in person or by regular post, but in-person meetings and proceedings before the ILPTO, including hearings in adjudicatory proceedings, will remain in suspension;
• deadlines for filing new applications, responses to office actions and the like will not be held in abeyance, but non-statutory deadlines in adjudicatory proceedings will be suspended;
• applicants or other parties in proceedings before the ILPTO who are unable to timely make submissions as a result of coronavirus-related circumstances may request extensions or reinstatement based on those circumstances, which will be taken into account when deciding whether or not to grant the extension or reinstatement;
• in cases in which the ILPTO has an announced policy capping the number of extensions, that cap will be temporarily be waived, but statutory deadlines (e.g. for opposing a patent application or requesting a patent term extension) cannot be waived;
• in order to allow applicants/owners to file requests for extension/reinstatement, at least until May 1, 2020, no files will be closed for an applicant's/owner's failure to take an action, nor will the ILPTO send pre-file closure notices (which in many instances are a prerequisite for closing a file).

Additional information regarding the points above can be found on the America-Israel Patent Law weblog. Most importantly, in an e-mail distributed to members of the patent community, Dr. Feigelson noted that "deadlines for PCT national phase entry, for payment of renewal fees, and for filing for patent term extensions remain in place," and further, "if any of your clients have a new drug that was recently approved or is about to be approved in Israel, the deadline for filing for PTE remains 90 days from the date of approval by the Israel Ministry of Health," which is not extendible.

Also on Monday, Mexican patent law firm OLIVARES notified the patent community that the Mexican Patent and Trademark Office (IMPI) had issued a decree stating that no terms would run from March 24 to April 19, 2020. OLIVARES noted "that IMPI will remain open and that it will be possible to file applications and briefs even though their filing date will be considered as April 20, 2020," and that the suspension would not apply to the release of preliminary injunctions imposed by IMPI during an infringement proceeding.

On Tuesday, Australian and New Zealand patent law firm Griffith Hack updated the patent community about developments in Australia and New Zealand. In particular, Griffith Hack reported that as of Monday, the Australian Federal Court's public-facing counters and face-to-face services had been closed until further notice, which had effectively stalled operation of the Court. The Court, however, was working on protocols to resume trials electronically. Griffith Hack also noted that both IP Australia and the Intellectual Property Office of New Zealand (IPONZ) were operating as usual, but both indicated that if circumstances related to the COVID-19 pandemic have affected or are affecting a business' ability to respond by a deadline, an extension of time could be requested (in the normal way) and would be assessed on a case-by-case basis. Additional news about the impact of the COVID-19 pandemic on IP Australia and IPONZ can be found at the patent offices' websites (IP Australia and IPONZ).

On Wednesday, Vietnamese patent law firm Vision & Associates notified the patent community that the Intellectual Property Office of Vietnam (IP Vietnam) is continuing to operate on its normal schedule at the present time, but in response to the COVID-19 pandemic is limiting in-person interviews with IP Vietnam's examiners until the situation is back to normal.

Earlier today, Indonesian patent law firm Biro Oktroi Roosseno notified the patent community that on Monday, the Directorate General of Intellectual Property (DGIP) issued Circular Letter Nomor: HKI-OT.02.02-10 regarding The Temporary Suspension of Activities in order to prevent the spread of COVID-19 at the DGIP. In its Circular, the DGIP announced that until April 5, the Intellectual Property Integrated Service Counters at the DGIP would be closed, that Applicants can still file applications online, and that dispensations would be provided by the DGIP for the late filing of all formality documents for Intellectual Property applications that would otherwise have been due in March 2020.

Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic. In addition, we encourage our readers to let us know about developments related to the COVID-19 pandemic at other patent offices.

For additional information regarding this topic, please see:

• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 19 UPDATE," March 19, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 18 UPDATE," March 18, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 17 UPDATE," March 17, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – UPDATED," March 16, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020
Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020)

March 25, 2020

By Kevin E. Noonan —

Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome Patent Office determinations of obviousness, due to the deference to factual issues the Zurko case imposed on the Federal Circuit in reviewing PTO decisions. But one Achilles' heel to these difficulties arises over how the PTO construes claims, which remains subject to de novo review (because all the evidence before the Patent Office is inherently intrinsic evidence). And when the Office (through the PTAB) makes an error in construing a claim, the Federal Circuit remains ready to pounce, which was the basis for the Court overturning the PTAB's invalidation on obviousness grounds of Kaken Pharmaceutical's claims in the recent Kaken Pharmaceutical Co. v. Iancu decision.

The case arose in an IPR over all the claims of U.S. Patent No. 7,214,506, which are directed to methods for topically treating fungal infections in human nails. The Board initiated the IPR on petition by Acrux Ltd. and Acrux DDS Pty. Ltd. (who are not party to the appeal), and found all claims of the '506 patent to be unpatentable as obvious.

Claim 1 is representative:

1. A method for treating a subject having onychomycosis wherein the method comprises topically administering to a nail of said subject having onychomycosis a therapeutically effective amount of an antifungal compound represented by the following formula:


    wherein, Ar is a non-substituted phenyl group or a phenyl group substituted with 1 to 3 substituents selected from a halogen atom and trifluoromethyl group,
    R1 and R2 are the same or different and are hydrogen atom, C1-6 alkyl group, a non-substituted aryl group, an aryl group substituted with 1 to 3 substituents selected from a halogen atom, trifluoromethyl group, nitro group and C1-16 alkyl group, C2-8 alkenyl group, C2-6 alkynyl group, or C7-12 aralkyl group,
    m is 2 or 3,
    n is 1 or 2,
    X is nitrogen atom or CH, and
    *1 and *2 mean an asymmetric carbon atom.

The opinion notes that the specification provides a "series of interlocking definitions" for some of the terms used in the claims. For example, the specification defines "'[o]nychomycosis' [as] a class of 'superficial mycosis' that affects the 'nail of [a] human or an animal'" and defines "superficial mycosis" as "encompass[ing] infections that attack tissues of the 'skin or visible mucosa.'" These definitions are illustrated in a Figure from the '506 patent reproduced in the opinion:

And a specific form of onychomycosis, tinea unguium, fell within the scope of onychomycosis to the extent that the patent used the terms interchangeably. These definitions vary somewhat with what the Federal Circuit termed "common usage" but these differences were not dispositive to the Court's opinion.

The patented methods were directed at solving a problem in the art whereas oral administration of antifungal drugs had undesirable features (long treatment times, unpleasant side effects) while prior art topical approaches were "largely ineffective" due to their inability to permeate the nail plate. As it turns out, the patented invention was effective when the alternative recited for substituent X is nitrogen, and this compound is identified as KP-103; the specification notes that the effectiveness of this compound as an antifungal was known in the art but not its ability to prevent onychomycosis.

Acrux relied on two sets of prior art references in its IPR petition based on obviousness. The first consisted of the three references "Japanese Patent Application No. 10-226639 (JP '639); U.S. Patent No. 5,391,367; and R.J. Hay et al., Tioconazole nail solution—an open study of its efficacy in onychomycosis, 10 CLINICAL AND EXPERIMENTAL DERMATOLOGY 111 (1985)." These references teach onychomycosis treatment using various azole compounds, according to Acrux. The second set of references consisted of "H. Ogura et al., Synthesis and Antifungal Activities of (2R,3R)-2-Aryl-1-az-olyl-3-(substituted amino)-2-butanol Derivatives and Topical Antifungal Agents, 47 CHEM. PHARM. BULL. 1417 (1999) (Ogura); and Abstracts F78, F79, and F80, 36 INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY 113 (1996) (Kaken Abstracts)." These references taught that KP-103 was an effect antifungal agent. Acrux presented six combinations in making its obviousness arguments; the Board in its Final Written Decision (FWD) found the claims obvious over the combination of "JP '639, the '367 patent, and Hay, each in combination with the Kaken Abstracts." Relevant to the Board's FWD and the Federal Circuit's reversal thereof, Kaken argued (and the Board rejected) that the claim term "treating a subject having onychomycosis" means "treating the infection at least where it primarily resides in the keratinized nail plate and underlying nail bed." In the Board's view this construction was too narrow, because onychomycosis was expressly defined to include "superficial mycosis, which in turn is expressly defined as a disease that lies in the skin or visible mucosa" and also that the express definition of the term "nail" in the specification included "the tissue or skin around the nail plate, nail bed, and nail matrix." Based on this construction, the Board held that a skilled artisan would have been motivated to combine the references to achieve the claimed invention. The Board also gave little weight to Kaken's asserted secondary considerations of non-obviousness.

The Federal Circuit reversed the PTAB's judgment based on its incorrect claim construction, vacated the decision and remanded to the PTAB for further consideration based on the correct construction as determined by the Court, in an opinion by Judge Taranto, joined by Judges Newman and O'Malley. Applying the broadest reasonable interpretation standard, the Court held that the disputed claim term, "treating a subject having onychomycosis," means "penetrating the nail plate to treat a fungal infection inside the nail plate or in the nail bed under it," based on the specification and prosecution history. In its analysis of the specification the Federal Circuit opinion recognized that the definition of onychomycosis "links to three other crucial passages in the specification—two that provide express definitions of other terms and one that characterizes another term." Specifically, the specification discloses that onychomycosis is "a kind of the above-mentioned superficial mycosis, in the other word a disease which is caused by invading and proliferating in the nail of human or an animal." The opinion interprets this disclosure to mean, first, that onychomycosis is a nail disease and that it is a superficial mycosis. This does not compel the Board's conclusion that the claim term involves "any part of what is defined as the 'nail,' including parts other than the nail plate or nail bed, such as skin in its ordinary sense" (emphasis in opinion). The opinion finds fault in the Board's interpretation of the term to include "nail plate, nail bed, nail matrix, further side nail wall, posterial nail wall, eponychium and hyponychium which make up a tissue around thereof" which includes skin surrounding the nail. The opinion characterizes as "an unwarranted inference" that a statement that a disease that invades the body can involve (by implication) any part of the body. As pertinent illustration, the opinion states that "[a] disease that invades the nail plate or bed only is still a disease that invades the 'nail' as defined." Thus, "this language alone does not support the Board's conclusion that an infection of any individual structure of the nail constitutes onychomycosis."

The Federal Circuit also found fault in the Board's application of the specifications disclosure regarding onychomycosis as being a "superficial mycosis." Because the specification distinguished such mycosis from "deep" mycosis, the Board interpreted the term to mean fungal infection of the skin in contrast to Kaken's limitation to infections of the nail. The panel found this interpretation contrary to express disclosure in the specification distinguishing skin from nail, whereby characterization in the specification regarding the term "superficial mycosis" does not compel a construction where "every type of superficial mycosis affects every type of 'skin' structure."

The panel found other portions of the specification that supported Kaken's construction, wherein an "effective" topical treatment would need to penetrate the nail plate. The significance of this disclosure for the panel is that "[a] patent's statement of the described invention's purpose informs the proper construction of claim terms, including when the task is to identify the broadest reasonable interpretation," citing In re Power Integrations, Inc., 884 F.3d 1370, 1376–77 (Fed. Cir. 2018). And if the term was to be properly construed under the Board's interpretation, many of the recited features of the invention (such as "high activity in [the] nail plate") would be unnecessary, according to the panel. And, relevant perhaps to the Board's reaction on remand, the opinion also notes that the Board had a "flawed understanding of the relationship between onychomycosis and tinea unguium" that contributed to its claim construction error.

Turning to the prosecution history, the Federal Circuit's opinion states there is "decisive support for limiting the claim phrase at issue to a plate-penetrating treatment of an infection inside or under the nail plate." This support includes rejection, on obviousness-type double patenting grounds, over a parent application directed to using KP-103 to treat "mycosis." In responding to this rejection, Kaken expressly asserted the distinction between mycosis and onychomycosis to be that "[o]nychomycosis is a condition that specifically affects the nail plate" and that the invention "shows the unexpected ability of an azolylamine derivate to penetrate nail and be retained by the nail" (emphases in opinion). The Examiner expressly noted his reliance on these distinctions in his "Reasons for Allowance," stating "unexpectedly and in contrast to previously evaluated compositions/methods, the instantly claimed method cures the onychomycosis because the medicament upon direct administration to the nail, penetrates through the nail plate and eradicates the infection at the site" (emphasis in opinion). The consequence of this sequence of events during prosecution is dispositive, according to the opinion:

This exchange would leave a skilled artisan with no reasonable uncertainty about the scope of the claim language in the respect at issue here. Kaken is bound by its arguments made to convince the examiner that claims 1 and 2 are patentable. See Standard Oil[ v. American Cyanamid Co., 774 F.2d 448,] 452 (Fed. Cir. 1985). Thus, Kaken's unambiguous statement that onychomycosis affects the nail plate, and the examiner's concomitant action based on this statement, make clear that "treating onychomycosis" requires penetrating the nail plate to treat an infection inside the nail plate or in the nail bed under it.

The Board's disregard of these aspects of the prosecution history raises a significant question regarding whether the Board considers mere institution of an IPR as evidence that the prosecution history is necessarily flawed, its consequence having resulted in an improvidently granted patent. And any such implied disregard for the prosecution history raises conflicts at least with proper claim construction that can, as here, result in the Board coming to the wrong conclusion on patentability.

The Federal Circuit reversed the Board's obviousness determination based on its erroneous claim construction, finding in the FWD statements interpreting how a skilled worker would have applied the asserted prior art that relied on this construction. The same error affected the Board's consideration of Kaken's asserted objective indicia of non-obviousness (inter alia, that there was no nexus between these indicia and the claims). The Court remanded, based on precedent including Arista Networks, Inc. v. Cisco Sys., Inc., 908 F.3d 792, 798 (Fed. Cir. 2018), and Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1300 (Fed. Cir. 2016), while expressing no opinion on the outcome of the IPR when the Board applies the properly construed claims mandated by the Court's opinion.

Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020)
Panel: Circuit Judges Newman, O'Malley, and Taranto
Opinion by Circuit Judge Taranto

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