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ANDA Filing Alone Insufficient for Induced Infringement of Method Patent

The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a drug used to treat idiopathic pulmonary fibrosis (IPF). The Court found that the first set of patents were obvious over the prior art and standard medical practice, while the second set were not directly infringed in light of actual physician prescription practice. Genentech, Inc. v. Sandoz Inc., Case No. 22-1595 (Fed. Cir. Dec. 22, 2022) (Newman, Lourie, Prost, JJ.) (Newman, J., dissenting).

Sandoz submitted two abbreviated new drug applications (ANDAs) for approval to market a generic version of pirfenidone, which Genentech sells under the brand name Esbriet®. Genentech sued Sandoz under the Hatch-Waxman Act, asserting that Sandoz’s generic version would induce infringement of two sets of patents: one directed to modifying dosages of pirfenidone in patients with abnormal liver biomarkers (LFT patents), and the other directed to avoiding adverse interactions in patients also taking fluvoxamine (DDI patents).

The LFT patents are directed to methods of administering pirfenidone to a patient who has exhibited Grade 2 abnormalities in liver function biomarkers alanine transaminase (ALT) and/or aspartate transaminase (AST) in response to pirfenidone. The LFT patents generally recite the following administration options:

  • Temporarily reducing the dose before returning to the full dose
  • Maintaining the full dose
  • Reducing the dose
  • Temporarily discontinuing pirfenidone before returning to the full dose
  • Temporarily discontinuing pirfenidone before returning to a reduced dose.

Sandoz’s proposed label included a “Dosage Modification due to Elevated Liver Enzymes” section, which stated that if a patient exhibits grade 2 elevations of ALT and/or AST, “[t]he full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated.” Genentech argued that these instructions constituted induced infringement of the LFT patents. The district court disagreed and held that the LFT patents were obvious over the prior art and standard medical practice and that the defendant would not induce infringement because the labels “merely described” the infringing uses but did not recommend them.

The DDI patents are directed to methods for avoiding adverse interactions between pirfenidone and fluvoxamine and generally involve the steps of discontinuing fluvoxamine or modifying the dose of pirfenidone and continuing fluvoxamine. Sandoz’s proposed label warned of the adverse interactions between pirfenidone and fluvoxamine and stated that fluvoxamine should be discontinued prior to administering pirfenidone or the dose of pirfenidone should be reduced. Genentech similarly argued that these instructions constituted induced infringement of its DDI patents, but the district court held that there was insufficient evidence for infringement because Genentech had not shown that a patient would actually be prescribed both pirfenidone and fluvoxamine in practice.

Genentech appealed the district court’s holdings with respect to both the LFT and DDI patents.

LFT Patents

The Federal Circuit first observed that “varying doses in response to the occurrence [...]

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Patent Owners Beware: Serial Filings, Rent-Seeking May Be Grounds for Adverse Fee Award

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s denial of attorney’s fees to an accused infringer, finding the district court did not properly consider the Patent Owner’s manner of litigation, including the history of plaintiff’s actions in other jurisdictions and the broader context of its litigation practices. Elec. Commc’n Techs., LLC v. ShoppersChoice.com, LLC, Case No. 19-2087 (Fed. Cir. July 1, 2020) (Wallach, J.).

Following a finding by a Florida district court that a patent asserted by Electronic Communication Technologies (ECT) was ineligible under 35 U.S.C. § 101, ShoppersChoice filed a motion for attorney’s fees, citing ECT’s use of standardized demand letters and repeated infringement actions seeking nuisance-value settlements. ShoppersChoice also informed the district court of a recent award of attorney’s fees against ECT in the Central District of California (the True Grit decision) for conduct relating to the same asserted patent. The district court denied ShoppersChoice’s motion, finding that the case was not exceptional and that ECT’s litigation position was not so obviously weak. ShoppersChoice appealed.

The Federal Circuit reviewed the district court’s denial of attorney’s fees under the abuse of discretion standard, analyzing whether the district court made “a clear error of judgment in weighing relevant factors or in basing its decision on an error of law or on clearly erroneous factual findings” and whether it provided a “concise but clear explanation of its reason[ing].” The Court explained that “a pattern of litigation abuses characterized by the repeated filing of patent infringement actions for the sole purpose of forcing settlements, with no intention of testing the merits of one’s claims, is relevant to a district court’s exceptional case determination under § 285.” The Court found that the district court failed to conduct this analysis and erred by not considering ECT’s manner of litigation and the broader context of ECT’s litigation practices. Addressing the True Grit decision, the Federal Circuit noted that the California district court provided a detailed account of the nuisance value rent-seeking practices of ECT (and other affiliated shell companies), but ultimately found that the court failed to conduct an adequate inquiry into ECT’s litigation conduct.

The Federal Circuit thus vacated the attorney’s fee award and remanded the case, directing the district court to consider both ECT’s manner of litigation and the objective unreasonableness of its claims.

Practice note: While the California District Court’s decision is not binding in the Florida court, the Federal Circuit made clear that a court cannot ignore developments in other jurisdictions in connection with § 285 fee determinations.




That Stings: Consent to Jurisdiction Must Be Effective at Filing to Invoke Fed. R. Civ. P. 4(k)(2)

The US Court of Appeals for the Federal Circuit, on petition for writ of mandamus, vacated the district court’s transfer order and remanded the transfer to be considered under the clarified parameters of Fed. R. Civ. P. 4(k)(2) and 28 U.S.C. § 1404. In re: Stingray IP Solutions, LLC, Case No. 2023-102 (Fed. Cir. Jan. 9, 2023) (Lourie, Taranto, Stark, JJ.)

Stingray filed patent infringement suits in the US District Court for the Eastern District of Texas against TP-Link, a company headquartered and organized in China. TP-Link moved to transfer to the Central District of California (CDCA) under 28 U.S.C. § 1406 citing an alleged lack of personal jurisdiction that Rule 4(k)(2) did not cure because TP-Link would be amenable to suit in the CDCA. TP-Link also moved for transfer under 28 U.S.C. § 1404(a). The district court granted the motion to transfer under § 1406 based on the rationale that TP-Link was amenable to suit in the CDCA and relying on affirmative reservations made by TP-Link that the CDCA had proper jurisdiction and venue. The district court denied TP-Link’s § 1404(a) motion as moot following the transfer. Stingray filed a mandamus petition asking the Federal Circuit to determine whether TP-Link’s unilateral, post-suit consent to personal jurisdiction in another state defeated application of Rule (4)(k)(2).

The Federal Circuit first determined that mandamus review was appropriate in this case in order to resolve the question of whether a defendant can defeat personal jurisdiction under Rule 4(k)(2) by unilaterally consenting to suit in a different district, a jurisdictional question that has divided district courts. Some district courts have held that personal jurisdiction cannot be established under Rule 4(k)(2) if a defendant states that it is amenable to suit in another state, while others have concluded that defendants must do more than simply designate an alternative forum in order to avoid application of Rule 4(k)(2).

Rule 4(k)(2) was originally introduced to close a loophole where non-resident defendants without minimum contact with any individual state suitable to support jurisdiction, but with sufficient contacts with the United States as a whole, were able to escape jurisdiction in all 50 states. The rule essentially provided that under federal claims, serving a summons or filing a waiver of service could establish personal jurisdiction if the defendant was not subject to a state’s general jurisdiction and exercising jurisdiction would be consistent with the US Constitution and laws.

Here, the case focused on the “negation requirement” of Rule 4(k)(2) where the defendant is not subject to any jurisdiction of a state court. This case addressed the question of whether a defendant’s post-suit, unilateral consent to suit in another state prevents the requirement that a defendant is not subject to a state’s general jurisdiction from being satisfied.

The Federal Circuit determined that the “negation requirement” requires defendants to identify a forum where jurisdiction would have been proper at the time of filing, regardless of consent. The Court determined that therefore a defendant cannot use a “unilateral statement of consent” to [...]

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PTO Update: COVID-19 Prioritized Examination Extended, Non-DOCX Filing Fee Deferred and More

On December 22, 2022, the US Patent & Trademark Office (PTO) announced the fifth extension of the Modified COVID-19 Prioritized Examination Pilot Program. The pilot program had been set to terminate on December 31, 2022, and is now extended to February 15, 2023. The program was implemented to support the acceleration of innovations in the fight against COVID-19. Under the pilot program, an applicant may request prioritized examination without payment of the prioritized examination fee and associated processing fee if the following criteria are met:

  • The patent application’s claim(s) cover a product or process related to COVID-19.
  • The product or process is subject to an applicable US Food & Drug Administration approval for COVID-19 use.
  • The applicant meets other requirements noted in the COVID-19 Track One Notice.

For more information, see the Federal Register notice.

The PTO also announced on December 29, 2022, that the new fee for filing nonprovisional utility patent applications that do not conform to the PTO requirements for submission in DOCX format will be deferred to the new effective date of April 3, 2023. The fee was originally scheduled to become effective on January 1, 2023. For more information, see the Federal Register notice.

The PTO and the US Copyright Office announced on December 23, 2022, that the deadline for submitting written comments on intellectual property considerations related to non-fungible tokens (NFTs) has been extended from January 9, 2023, to February 3, 2023. The dates for the public roundtables directed to patents, trademarks and copyrights, respectively, also have changed as follows:

  • The first roundtable, Trademarks and NFTs, is now set for January 24, 2023 (originally scheduled for January 12, 2023).
  • The second roundtable, Patents and NFTs, has been moved to January 26, 2023 (originally scheduled for January 10, 2023).
  • The third roundtable, Copyrights and NFTs, has been moved to January 31, 2023.

The roundtables will be livestreamed, and the PTO and Copyright Office will post instructions for the public to register to view them live. Click here for more information about the topics that will be discussed. For more information about the schedule change, see the Federal Register notice.

The PTO also announced that small entity filing fee discounts are increased from 50% to 60% and micro entity filing fee discounts are increased from 75% to 80%. The discount increases went into effect on December 29, 2022, when US President Joe Biden signed into law the Consolidated Appropriations Act, 2023, which included the Unleashing American Innovators Act of 2022. The new PTO fee schedule can be found here.




EU Unified Patent Court Announces Intent to Launch on April 1, 2023

The EU Unified Patent Court (UPC) announced a launch date of April 1, 2023, however, the announced date should be regarded as a statement of intent for it could change. The launch timing has been the subject of various delays and setbacks, several due to unresolved legal issues. The UPC has also published an almost final list of judges. German Federal Court of Justice Judge Klaus Grabinski, who played a key role in drafting the UPC Rules of Procedure, will head the UPC. The majority of UPC judges will only be engaged with their UPC activities part-time (about 50% or 20% of their total work commitment).

The UPC judges are set to receive special training starting in March 2023, only one month prior to the announced launch date of the UPC, leading many to doubt that the April 1 date will be met. Once the new court is operational, owners of European patents will be able to litigate patent disputes across most EU Member States in a single proceeding, eliminating the need to proceed on a country-by-country basis.

Assuming the announced launch date is maintained, the “sunrise period” before the UPC becomes fully operational will commence on January 1, 2023. This sunrise period will last for three months, during which patent owners that do not wish for their existing European patents to be subject to UPC jurisdiction may opt out of such jurisdiction by filing a formal notification to that effect. The European Patent Office has also announced that during the sunrise period, European patent applicants whose applications are ready for grant will, if they wish, be able to delay the formal grant of the application until the UPC becomes operational so that unitary patent protection can be obtained.

The UPC has issued an implementation roadmap for events leading up to the entry into force of the UPC Agreement, with the court opening its doors and starting to receive cases as of April 1, 2023.




PTO Requests Comments on Initiatives to Ensure Patent Robustness, Reliability

The US Patent & Trademark Office (PTO) is seeking public input and guidance on proposed initiatives directed at bolstering the robustness and reliability of patents. The request for comments was spurred in part by US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and a June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun raising concerns about patent thickets.

The PTO identified four broad topics and initiatives that it is considering:

  • Prior Art Searching
  • Support for Patent Claims
  • Request for Continued Examination (RCE) Practice
  • Restriction, Divisional, Rejoinder and Non-Statutory Double Patenting Practice.

The PTO seeks comments on 11 main questions and several sub-questions. The first five questions are directed to the PTO initiatives while questions six through 11 address concerns raised by the senators.

PTO Initiatives

  1. How should the PTO facilitate an applicant’s submission of prior art that is not accessible in the Patents End-to-End Search system (e.g., “on sale” or prior public use)?
  1. How, if at all, should the PTO change claim support requirements and/or continuation practice?
  1. How, if at all, should the PTO change RCE practice?
  1. How, if at all, should the PTO limit or change restriction, divisional, rejoinder and/or non-statutory double patenting practice?
  1. Provide any other input on any of the proposals listed under the PTO initiatives.

Senator Inquiries

  1. How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variants of one another, affect patent prosecution strategies and overall patent quality?
  1. Should patents that are tied together by a terminal disclaimer because of an obviousness-type double patenting rejection stand or fall together if their validity is subsequently challenged?
  1. Should the PTO require a second look by a team of patent quality specialists before issuing a continuation patent on a first office action?
  1. Should there be heightened examination requirements for continuation patents?
  1. Should the PTO implement a rule change that requires any continuation application to be filed within a set timeframe of the ultimate parent application?
  1. If filing fees were increased to cover the actual cost of obtaining a patent, would this increase patent quality? And if the fees for continuation applications were increased, would applicants be less likely to file continuations for obvious variants?

Among the proposals under consideration are whether to require applicants to identify corresponding support in the original disclosure for each claim in a continuation application, whether applications should be reassigned to a different examiner after a set number of RCEs are filed, whether the PTO should adopt the unity of invention standard, and whether divisionals should be filed within a set time period.

Click here for further details on the PTO initiatives.

Comments must be received by January 3, 2023, to ensure consideration.




PTO Switches to New Public Search Tools, New PTAB Filing System

The US Patent & Trademark Office (PTO) will replace four legacy tools—Public-Examiner’s Automated Search Tool, Public-Web-Based Examiner’s Search Tool, Patent Full-Text and Image Database (PatFT) and Patent Application Full-Text and Image Database (AppFT)—with the new Patent Public Search Tool (PPUBS) on September 30, 2022. The PTO first announced the transition to the new tool in February 2022.

Existing links to US patents and US pre-grant publications in PatFT and AppFT will be terminated following the retirement of these services. US patents and US pre-grant publications can be directly accessed via PPUBS, and links for direct document access to US patents and US pre-grant publications can be set up on a webpage or document. According to the PTO, PPUBS provides more convenient, remote and robust full-text searching of all US patents and US pre-grant publications. PPUBS also streamlines the search process for users, provides alternatives for existing services and incorporates new features. Step-by-step instructions for performing these functions can be found here.

The PTO also announced that as of October 11, 2022, the Patent Trial & Appeal Board E2E system used for electronically filing all documents related to Inter Partes and Post Grant reviews, Transitional Program for Covered Business Mmethod Patents, and Derivation Proceedings will be replaced by the Patent Trial & Appeal Tracking System (P-TACTS) platform. The E2E system will be unavailable starting at 5:00 pm EDT on October 9, 2022, through 11:00 pm EDT on October 10, 2022 (which is a federal holiday). For more information about the platform migration and how to register to use P-TACTS, click here.




PTO Proposes Standardization of the Patent Term Adjustment Statement Regarding Information Disclosure Statements

The US Patent & Trademark Office (PTO) announced on July 12, 2022, that it intends to revise the rules pertaining to patent term adjustment to require that the patent term adjustment statement regarding information disclosure statements (IDS) be submitted on a PTO form. The PTO believes that the use of the form will streamline prosecution and be more accurate and efficient by eliminating the need for a manual review of the patent term adjustment statement.

The regulations in 37 CFR 1.704(c)(1) through (14) establish the circumstances that constitute an applicant’s failure to engage in reasonable efforts to conclude processing or examination of an application and the resulting reduction of any patent term adjustment. 37 CFR 1.704(d)(1) also provides a safe harbor for filing IDS. Filing only an IDS in compliance with §§ 1.97 and 1.98 or a request for continued examination with only a compliant IDS is not considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (8), (9) or (10) if it is accompanied by the required statement. The statement required to accompany the paper or request for continued examination must affirm that each item of information contained in the IDS meets one of the following requirements:

  • It was first cited in any communication from a patent office in a counterpart foreign or international application or from the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.
  • It is a communication that was issued by a patent office in a counterpart foreign or international application or by the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.

The PTO proposes adding new paragraph (d)(3) to 37 CFR 1.704(d), which requires filers to submit the patent term adjustment statement under 37 CFR 1.704(d)(1) on a form PTO/SB/133 to derive the safe harbor benefit under 37 CFR 1.704(d). Form PTO/SB/133 includes the required statement described above. Filers who submit a 37 CFR 1.704(d)(1) patent term adjustment statement without using the form PTO/SB/133 and filers who submit the form PTO/SB/133 with any modification to the patent term adjustment statement will not receive the benefit of the safe harbor under 37 CFR 1.704(d). Under such circumstances, the IDS or the request for continued examination, with no submission other than an IDS, will be treated as unaccompanied by a patent term adjustment statement under 37 CFR 1.704(d)(1).

Comments on the proposed rule must be received by September 12, 2022, to ensure consideration.




PTO Updates DOCX Filings, Delays Surcharge Fee

The US Patent & Trademark Office (PTO) recently announced that the surcharge fee for patent applications that are not filed in DOCX format will not go into effect until January 1, 2023. During the period before non-DOCX filings are hit with the surcharge fee, the PTO is encouraging applicants to begin filing patent applications in DOCX format (87 Fed. Reg. 25226). To address concerns some applicants have raised and to allow applicants to get acclimated to the process of filing applications in DOCX format, the PTO is providing applicants with the option to submit an applicant-generated PDF version of their application along with the DOCX file(s) when filing an application in the Patent Center without having to pay additional fees, such as application size fees.

Applicants who choose to submit an applicant-generated PDF with the validated DOCX file(s) will be able to rely on the applicant-generated PDF if a discrepancy occurs during the filing process. Once the non-DOCX filing surcharge fee officially goes into effect, applicants who submit an applicant-generated PDF with the validated DOCX file(s) will need to pay the surcharge fee and any other additional fees as a consequence for filing the applicant-generated PDF. This new document description is called “Auxiliary PDF of application,” and the corresponding document code is AUX.PDF.

The PTO advises:

Applicants are strongly encouraged to review their applications, including the USPTO-generated PDF, shortly after filing the application to identify any errors or discrepancies in the record, as discussed above. The applicant should file any necessary petition to correct the record early in prosecution and promptly after discovering any errors or discrepancies.




Judge Albright Issues Another Round of Updated Patent Rules for WDTX

As previously reported, Judge Albright issued standing orders for his patent cases. On March 7, 2022, Judge Albright issued another set of rules applicable to his large portfolio of patent cases in the Western District of Texas, with some modifications to his prior rules.

This round of new orders includes the following:

  • In the “Amended Standing Order Regarding Coronavirus (COVID-19) and Other Court Proceedings,” Judge Albright stated that all non-pretrial conference hearings will default to video conference unless otherwise requested by the parties.
  • Under the “Standing Order Governing Proceedings (OGP) 4.0—Patent Cases,” defendants must serve preliminary invalidity contentions seven weeks after the case management conference, with the below requirements:
    • The contentions must be in chart form identifying where in the prior art references each element of the asserted claims is found.
    • The contentions must identify limitations that defendants contend are indefinite or lack written description under § 112.
    • The contentions must identify any claims that defendants contend are directed to ineligible subject matter under § 101. This requirement has additional sub-requirements. The § 101 contentions must “(1) identify the alleged abstract idea, law of nature, and/or natural phenomenon in each challenged claim; (2) identify each claim element alleged to be well-understood, routine, and/or conventional; and (3) to the extent not duplicative of 102/103 prior art contentions, prior art for the contention that claim elements are well-understood, routine, and/or conventional.” The defendants must also produce all prior art referenced in the invalidity contentions and technical documents (which includes software) sufficient to show the operation of the accused products.
  • If there is a discovery dispute, the new rules require the requesting party to send an email with a maximum of 500 words for one issue, or a combined 1,000 words for multiple issues, to opposing counsel. The responding party has three business days to respond with an email with the same word limitations. Judge Albright encouraged use of a table to organize the disputed issues and provided an example.
  • The orders include additional rules for venue discovery, including a requirement that venue or jurisdictional discovery be completed no later than 10 weeks after the filing of an initial venue motion. The Federal Circuit recently decided against Judge Albrights’ justification of venue using car dealerships.
  • A separate “Standing Order Regarding Notice of Readiness for Patent Cases” provides an example Case Readiness Status Report with further guidelines on timing.



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