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ANDA Filing Alone Insufficient for Induced Infringement of Method Patent

by Tessa Kroll | Jan 5, 2023 | Patents

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

by Paul Devinsky | Jul 15, 2020 | Patents

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.

PTO Stands by Patent Fee Increases

by Amol Parikh | Apr 11, 2024 | Patents

The US Patent & Trademark Office (PTO) issued a notice of rulemaking announcing proposed patent fee increases beginning next year. 89 Fed. Reg. 23226 (April 3, 2024). The proposed increases are generally consistent with the PTO’s May 2023 proposal.

The Notice states that the PTO needs the proposed fee adjustments to provide sufficient revenue to recover costs of patent operations in future years. To that end, the PTO proposes to set or adjust 455 patent fees, including 73 new fees. Complete information about the fee adjustments, including the Notice, is available on the PTO’s website.

The fee increases include higher amounts for routine fees necessary to obtain a patent, including filing, search, examination and issue fees. Excess claim fees will also increase to $200 for each claim over 20 and $600 for each independent claim over three. There will also be an escalating fee structure for terminal disclaimers, ranging from $200 if filed before the first office action to $1,400 if filed after the PTO grants the patent. The fees for filing requests for continued examination (RCE) will now use a tiered fee structure and will increase to $1,500 for the first RCE, $2,500 for the second RCE and $3,600 for the third RCE. Patent Trial & Appeal Board fees will increase by about 25%, and a new fee of $400 will be required for a Request for Director Review of a Board decision.

Written comments on proposed patent fees must be submitted by June 3, 2024, through the Federal eRulemaking Portal.

PTO Proposes Trademark Application Filing Changes, Fee Adjustments

by Peter Brunovskis, PhD | Apr 4, 2024 | Trademarks

On March 26, 2024, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking in the Federal Register concerning changes to trademark application filings and fee adjustments in trademark cases for 2025. The PTO solicits written comments from the public on the proposed rule changes on or before May 28, 2024. The proposed rules seek to generate sufficient multiyear revenue for trademark operations in future years based on projections described in the notice.

The changes are recommended to support the PTO’s strategic goals and objectives, including optimizing trademark application pendency through the promotion of efficient operations and filing behaviors, issuing accurate and reliable trademark registrations, and encouraging access to the trademark system for stakeholders.

The proposal seeks to incentivize more complete and timely filings, improve prosecution, adjust 31 trademark fees and impose 12 new fees while discontinuing six existing fees. The proposal also seeks to consolidate the present Trademark Electronic Application System (TEAS) filing options (i.e., TEAS Plus and TEAS standard) into a single electronic filing option. The single option would include most of the same requirements as TEAS Plus, while eliminating those under TEAS Standard. The new filing framework would discontinue the previous filing fees and fees for failing to meet the requirements of a TEAS Plus application. Similar to TEAS Plus, however, applicants complying with the proposed requirements in their initial filing would pay the lowest fees.

The proposed fee adjustments would:

Set the fee for a base application at $350 using the ID Master List (which is $100 more than the current fee for a TEAS Plus application)
Discontinue current fees for filing an application under the Madrid Protocol
Require surcharge fees between $100 and $200 for applications that are noncompliant with the base filing requirements
Require an additional $200 fee per class for the identification of goods and services entered in the free-form text field to incentivize use of the Trademark ID Manual for such identifications instead
Require an additional $200 fee for each additional group of 1,000 characters in the free-form text field; identifications directly from the ID Manual would not incur these fees
Increase fees by $50 for filing amendments to allege use (AAU) and statements of use (SOU), with fees being discounted $100 for electronic filings
Increase post-registration maintenance fees from $50 to $75
Increase the letter of protest fee from $50 to $150.

Regarding the proposed fee adjustments, the notice describes changes to 37 CFR 2.6 and 7.6. The notice further describes changes to 37 CFR 2.22 and 2.71 with respect to base application fees and amendments to correct informalities, respectively.

For further details, see the Federal Register notice.

Patenting Web Advertising? Ask Alice, I Think She’ll Know

by Daniel Sternberg | Mar 14, 2024 | Patents

In a wide-ranging opinion, the US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of invalidity for lack of patent eligible subject matter under 35 U.S.C. § 101 with respect to claims directed to web-based advertising. Chewy, Inc. v. International Business Machines, Corp., Case No. 22-1756 (Fed. Cir. March 5, 2024) (Moore, Stoll, Cunningham, JJ.)

Chewy filed suit against International Business Machines (IBM) seeking a declaration that Chewy’s website did not infringe multiple patents related to web-based advertising. IBM responded by filing infringement counterclaims. After claim construction and discovery, the district court granted Chewy’s motions for summary judgment of invalidity for lack of patent eligible subject matter with regard to the asserted claims of one patent and noninfringement of the asserted claims of a second patent.

The claims of the first patent relate to providing a targeted advertisement from an “information repository” to a user based on the user’s internet search. In affirming the district court, the Federal Circuit first determined that, under Alice step 1, “[t]he claims broadly recite correlating advertisements with search results using a generic process.” The Court noted that the claims “merely recite the concept of identifying advertisements based on search results, without any specificity as to how this is accomplished,” and are directed to “the abstract idea of identifying advertisements based on search results.”

Turning to Alice step 2, the Federal Circuit found that the claims used a generic database and conventional processing steps, and “claimed use of a conventional repository for storing advertisements and associated search results in a well-known way.” Because “the claims recite the generic process for obtaining search results from a search query and using the search results to identify advertisements,” they failed under Alice step 2 and did not claim patent eligible subject matter under § 101.

Regarding the second asserted patent, the district court construed the claim term “selectively storing advertising objects at a store established at the reception system” as requiring the “advertising objects” to be “pre-fetched” and retrieved before the user requested a page on a website. Because it was undisputed that “Chewy retrieves advertisements in response to a user requesting a page” and not before, the district court ruled that Chewy’s website did not meet this claim limitation. Looking to the intrinsic claim construction evidence, the Federal Circuit held that the district court’s claim construction was amply supported by the specification and prosecution history and affirmed the district court’s grant of summary judgment of noninfringement. Of note, the Court explained that the specification made multiple references to pre-fetching as being part “of the present invention” and therefore limited the scope of the claims.

With respect to one asserted claim of the second patent, which did not include the limitation at issue, the district court found that Chewy’s website did not practice the limitation of “establishing characterizations for respective users based on the compiled data” because “the record undisputedly showed they deliver advertisements based on the page the user is currently viewing, [...]

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PTO Proposes Patent Fee Increases

by Amol Parikh | May 4, 2023 | Patents

The US Patent & Trademark Office (PTO) announced proposed patent fee increases. Patent fees would increase by about 5% across the board because of inflation.

Certain fees would be increased by substantially more than the 5% inflationary increase to reduce subsidization from other fee sources. For example, the overall design patent fees would increase by 48%, based on a 27% increase in filing, search and examination fees and a 76% issue fee increase. The PTO also proposes a 100% increase in the excess claim fee for each claim over 20, and a 25% increase in the fee for each independent claim over three. Because the costs of reviewing patent term extensions is complex, the PTO proposes fee increases of 196% to 468%. The PTO also proposes a fee of $500 for filing an After Final Consideration Pilot (AFCP) 2.0 request, and new fees for filing an information disclosure statement (IDS) that causes the number of applicant-provided citations to exceed 50, 100 or 200 citations, respectively.

To offset the loss of future maintenance fee payments, the PTO proposes fees of $1,500 for continuing applications filed more than three years from the earliest benefit date and $3,000 for continuing applications filed more than seven years from the earliest benefit date.

Other proposed fee increases are intended to expedite the patent examination process. For example, the PTO proposes a 25% increase in the fee for a second request for continued examination (RCE) and an 80% increase for a third or subsequent RCE. The fee for a terminal disclaimer filed after the first action on the merits and before a final rejection would increase by 194%. After a final rejection or notice of allowance, the fee would increase by 371%. On or after a notice of appeal, the increase would be 547%, and the proposed increase for filing a terminal disclaimer in an issued patent would be 724%.

The PTO further proposes increasing Patent Trial & Appeal Board America Invents Act (AIA) trial fees by 25%. The PTO also proposes new fees for inter partes review (IPR) and post grant review (PGR) petitions that exceed the word count limits. For example, the PTO proposes a 50% higher fee for petitions that exceed the word count limit by up to 50%, and a 100% higher fee for those that exceed the limit by up to 100%.

A public hearing is scheduled for May 18, 2023. Those wishing to present oral testimony at the hearing must submit a written request by May 11, 2023. Written comments on the proposed fees will be accepted until May 25, 2023.

The PTO anticipates that the fee changes will be implemented around January 2025.

More details, including a complete list of the proposed fee increases, can be found on the PTO website.

Console Yourself: Patent Owner Bears IPR Estoppel Burden

by James M. Oehler | Apr 13, 2023 | Patents

Addressing for the first time the standard and burden of proof for the “reasonably could have raised” requirement for inter partes review (IPR) estoppel to apply, the US Court of Appeals for the Federal Circuit concluded that a patent owner bears the burden of proving that an IPR petitioner is estopped from using invalidity grounds that a skilled searcher conducting a diligent search reasonably could have been expected to discover. Ironburg Inventions Ltd. v. Valve Corp., Case Nos. 21-2296; -2297; 22-1070 (Fed. Cir. Apr. 3, 2023) (Lourie, Stark, JJ.) (Clevenger, J., dissenting).

Ironburg sued Valve for infringing Ironburg’s video game controller patent. Valve responded by filing an IPR petition in 2016. The Patent Trial & Appeal Board partially instituted on three grounds but declined to institute on two other grounds (the Non-Instituted Grounds), as was permitted prior to the Supreme Court’s 2018 decision in SAS Institute Inc. v. Iancu. Valve did not seek remand pursuant to SAS, which would have allowed the Board to consider the Non-Instituted Grounds. In the district court litigation, Valve alleged invalidity based on the Non-Instituted Grounds and grounds Valve learned of from a third party’s IPR filed after Valve filed its IPR (the Non-Petitioned Grounds). Ironburg filed a motion asserting that Valve was estopped, pursuant to 35 U.S.C. § 315(e)(2), from asserting both the Non-Instituted Grounds and the Non-Petitioned Grounds. The district court granted Ironburg’s motion in full, removing all of Valve’s invalidity defenses. After trial, the jury returned a verdict finding that Valve willfully infringed the patent. Valve appealed.

35 U.S.C. § 315(e)(2) precludes an IPR petitioner from asserting invalidity during a district court proceeding based on “any ground that the petitioner raised or reasonably could have raised during that [IPR].” The Federal Circuit first addressed the legal standard needed to meet the “reasonably could have raised” requirement for IPR estoppel. The Court found that the “skilled searcher” standard used by several district courts is appropriate, as opposed to a higher “scorched earth” search standard. The “skilled searcher” standard is consistent with the § 315(e)(2) statutory requirement of discovering prior art references that “reasonably could have been raised.”

The Federal Circuit next addressed which party has the burden to prove what prior art references a skilled searcher reasonably would, or would not, have been expected to discover. The district court placed the burden on Valve, the party challenging the patent’s validity, and determined that Valve did not show how difficult it was to find the Non-Petitioned Grounds that Valve did not initially uncover. The Court noted that the third party that did find the Non-Petitioned Grounds may have used a “scorched earth” search, which would make its discovery of the Non-Petitioned Grounds irrelevant to estoppel. The Court concluded that the patent owner has the burden of proving what a skilled searcher reasonably would have found because the patent holder is looking to benefit from estoppel. The Court explained that this conclusion is consistent with the practice of placing the burden on the party asserting [...]

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PTO to Begin Issuing Electronic Patent Grants

by Amol Parikh | Mar 2, 2023 | Patents

On February 28, 2023, the US Patent & Trademark Office (PTO) issued a final rule announcing it would begin issuing electronic patent grants (eGrants) starting April 18, 2023. These eGrants are the official copies of patent grants in an electronic format. During a limited transition period, the PTO will also provide a bound paper version as a ceremonial copy. Once the transition period is over, a bound paper version will be available for a nominal fee. The PTO did not specify when the transition period would end. The Federal Register notice can be found here.

To implement the eGrant, the PTO is removing and reserving 37 CFR 1.315, which states that “[t]he patent will be delivered or mailed upon issuance to the correspondence address of record.” Because patents will be issued electronically, the PTO will no longer physically deliver the patent grant by mailing it to the correspondence address. Instead, the eGrant will issue electronically via the Patent Center.

In addition to the ceremonial paper copy, for a fee, the PTO will still offer certified copies (in accordance with 37 CFR 1.13) and presentation copies. The PTO will no longer accept orders for advance copies of issued patents.

By moving to eGrants, the interval between issue fee payment and patent issuance will be shorter. Thus, applicants will need to be more diligent in filing continuations, divisionals and Quick Path Information Disclosure Statements. For example, Issue Notifications will be available electronically via the Patent Center after the issue fee is paid, usually on the Wednesday or Thursday before the patent issues. The PTO envisions that for those who do not participate in the e-Office action program, a patent may issue electronically before the applicant even receives the mailed Issue Notification.

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

by Joshua Revilla | Jan 19, 2023 | Patents

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

by Amol Parikh | Jan 5, 2023 | Patents

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.

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