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Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

by Christopher M. Bruno | May 15, 2025 | Patents

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running clinical trial and new clinical trials and remanded for further consideration of whether prohibiting a request for an additional indication was appropriate. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, Case No. 24-2274 (Fed. Cir. May 6, 2025) (Lourie, Reyna, Taranto, JJ.)

This appeal is one of several disputes between Jazz and Avadel regarding their competing sodium oxybate products. Jazz markets two such products: Xyrem, approved for treating excessive daytime sleepiness and certain cataplexy, and Xywav, which, in addition to Xyrem’s indications, also may be used for treating idiopathic hypersomnia. Avadel filed a § 505(b)(2) new drug application (NDA) to market its own product, Lumryz. During the pendency of the Lumryz application, Jazz obtained a patent and asserted that Avadel infringed it under 35 U.S.C. § 271(e)(2), part of the Hatch-Waxman Act, based on its filing of the Lumryz NDA. The patent was never Orange Book listed, so Avadel did not need to submit any patent certification.

The US Food & Drug Administration (FDA) approved Lumryz. Avadel launched the product, and Jazz amended its complaint to assert traditional § 271(a) – (c) infringement. Ultimately, Avadel and Jazz stipulated infringement, the patent was determined not invalid, and the jury awarded damages based on the post-launch infringement. After further proceedings, the district court permanently enjoined Avadel from seeking an idiopathic hypersomnia indication for Lumryz, offering an OLE phase of its then-running Lumryz idiopathic hypersomnia clinical trial, and against initiating new clinical trials. Avadel appealed, arguing that each of these restrictions was improper.

The Federal Circuit largely agreed with Avadel, reversing the first two prohibitions, and remanded the case back to the district court for further consideration of the prohibition against any new clinical trials. Turning first to the prohibition on new clinical trials, the Court held that initiating new trials for the purposes of submission to the FDA fell squarely within the Hatch-Waxman Safe Harbor for experimentation (under § 271(e)(1)) and thus could not be enjoined (per §271(e)(3)). Jazz unsuccessfully argued that Avadel had waived its Safe Harbor position, which required factual development.

Next, the Federal Circuit rejected the district court’s injunction against an OLE, concluding that the district court had not applied the Supreme Court’s four-factor eBay (2006) test for injunctions when deciding the appropriateness of such extraordinary relief. Refusing to determine whether an OLE extension qualified as safe-harbored activity in the first instance, the Court explained that only if such activity were deemed to be infringing on an appropriate record could it be enjoined.

Finally, with respect to prohibiting Avadel from seeking an idiopathic hypersomnia indication for Lumryz, the Federal Circuit concluded that the propriety of that restriction may turn on whether the infringement qualified under the Hatch-Waxman Act, reasoning that an injunction might run afoul of the § 271(e)(4) limitation on the scope of injunctive relief. [...]

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New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

by Christopher M. Bruno | Apr 17, 2025 | Life Sciences, Patents

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

Based on [...]

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Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

by Benjamin Ediger, Ph.D. | Apr 3, 2025 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America Invents Act (AIA) 35 U.S.C. § 102(e) as of the provisional filing date, explaining that all portions of the published patent application that are relied upon by the US Patent & Trademark Office (PTO) to reject the claims must be sufficiently supported in the provisional application. In re Riggs, Case No. 22-1945 (Fed. Cir. Mar. 24, 2025) (Moore, Stoll, Cunningham, JJ.)

Several inventors who work for Odyssey Logistics filed a patent application directed to logistics systems and methods for the transportation of goods from various shippers by various carriers across different modes of transport (e.g., by rail, truck, ship, or air). PTO rejected the application under § 102(e) in view of Lettich, which claimed the benefit of a provisional application (Lettich provisional), and as obvious in view of Lettich in combination with the Rojek reference.

The inventors appealed the Lettich rejections to the Patent Trial & Appeal Board, arguing that Lettich did not qualify as prior art under § 102(e). The Board initially agreed with the inventors, but the Examiner assigned to the application requested a rehearing, asserting that the Board applied the incorrect standard for § 102(e) prior art. The Board ultimately issued its decision on the Request for Rehearing, stating that it had jurisdiction over the Examiner’s request and that the Examiner’s arguments regarding Lettich’s status as prior art under § 102(e) “[we]re well taken.” The Board amended its original decision “to determine that Lettich is proper prior art against the instant claims.” The Board then reviewed and affirmed the Examiner’s anticipation and obviousness rejections. The inventors appealed.

The Federal Circuit vacated and remanded the Board’s decision. With respect to whether Lettich qualified as § 102(e) prior art, the Court found that the Board’s analysis was incomplete. The Court concluded that the Board correctly applied the test set forth in the Federal Circuit’s 2015 decision in Dynamic Drinkware v. National Graphics by determining that the Lettich provisional supported at least one of Lettich’s as-published claims. However, the Court found that this test was insufficient because all portions of the disclosure that are relied upon by the PTO to reject the claims must also be sufficiently supported in the priority document. Although the PTO asserted that the Board had conducted this additional analysis, the Federal Circuit disagreed and vacated and remanded for the Board to determine whether the Lettich provisional supported the entirety of the Lettich disclosure that the Examiner relied on in rejecting the claims.

Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

by Matthew J. Blaney | Apr 3, 2025 | Life Sciences

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code, entitling an abbreviated new drug application (ANDA) filer to deduct litigation expenses incurred defending against a patent infringement lawsuit. Actavis Labs. FL, Inc. v. United States, Case No. 23-1320 (Fed. Cir. Mar. 21, 2025) (Chen, Cunningham, Stark, JJ.)

Actavis filed ANDAs with the US Food and Drug Administration (FDA) seeking approval to market and sell a generic version of a drug already offered for sale in the United States. Per the Hatch-Waxman Act, filing an ANDA is an act of patent infringement where the ANDA holder seeks FDA approval prior to the expiration of the new drug application (NDA) holder’s patent. Following Actavis’s filing, the NDA holder brought a patent infringement lawsuit against Actavis.

Actavis subsequently treated litigation expenses incurred in defending the patent infringement lawsuit as ordinary and necessary expenses. Actavis deducted those litigation expenses on its tax returns for that year. However, the Internal Revenue Service (IRS) considered these expenses to be nondeductible capital expenditures since they were incurred “in pursuit of an intangible capital asset: namely, FDA approval to lawfully market a generic drug product in this country.”

Actavis eventually paid its tax liability but then sued the IRS in the Court of Federal Claims to recover what Actavis considered an overpayment of its taxes. The claims court agreed with Actavis, holding that Hatch-Waxman litigation expenses were deductible as ordinary and necessary business expenses. The IRS appealed.

The Federal Circuit affirmed. When determining whether Hatch-Waxman litigation expenses are deductible under Code § 162(a), the Federal Circuit uses two tests to settle the issue: the “origin of the claim” test and the “most significant benefit” test. However, as the Court emphasized, regardless of which test applied, Actavis prevailed.

The Federal Circuit first explained that Actavis prevailed under either test because patent infringement (not the FDA approval process) is what triggers incurring litigation expenses. Further evidence that the “origin of the claim rests in the patentholder’s decision to sue, and not in the ANDA filer’s decision to seek drug approval from the FDA, is the fact that infringement litigation cannot provide the ANDA filer what it wants – only the FDA can,” the Court stated.

Relying on the Third Circuit’s 2023 decision in Mylan v. Comm’r of Internal Revenue, the Federal Circuit delved into the fairness aspect of allowing Hatch-Waxman litigation expenses to be deductible. Citing Mylan, the Court explained that generic manufacturers defending against patent infringement suits “obtain no rights from a successful outcome. They acquire neither the intangible asset of a patent nor an FDA approval.” The Court also noted that brand-name drug companies in Hatch-Waxman lawsuits may deduct litigation expenses incurred while enforcing their patent rights. “[I]mposing very different tax treatment on the warring sides in an ANDA dispute, as the Commissioner advocates, is at odds with the careful statutory [...]

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When “It’s Obvious” Just Isn’t Enough: Challenger’s Burden to Prove Obviousness

by Keval Amin | Mar 27, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision that a patent was not obvious because the petitioner failed to show sufficient support of obviousness based on prior art. AMP Plus, Inc. v. DMF, Inc., Case No. 23-1997 (Fed. Cir. Mar. 19, 2025) (Lourie, Bryson, Reyna, JJ.)

DMF owns a patent directed to a compact recessed lighting system designed for installation in a standard electrical junction box. In 2019, AMP, doing business as ELCO, petitioned for inter partes review of several claims of the patent on three grounds of unpatentability:

Anticipation by a prior reference
Obviousness based on a combination of two references
Further obviousness based on an additional source.

The Board found that one claim was anticipated but ruled that ELCO failed to prove unpatentability of the other claims, including the claim at issue on appeal. The claim at issue describes a system with wires connected to a driver and a first connector, coupled to a second connector that in turn is connected to the building’s electrical system. This specific connection was referred to as “Limitation M.” ELCO appealed. In that earlier appeal (2022), the Federal Circuit affirmed the Board’s ruling on all claims except the claim at issue and remanded the case back to the Board for further analysis.

On remand, the Board concluded that ELCO failed to demonstrate the unpatentability of the claim at issue because ELCO’s petition lacked a substantive analysis of Limitation M. The Board found ELCO’s argument that a prior art marine lighting system could be adapted for the claimed building use unsupported by evidence and ruled that the claim at issue was not obvious. Again, ELCO appealed.

ELCO raised two main arguments. First, it argued that the Board erred in not determining that the claim at issue was anticipated by a prior reference, as the Board had previously found another claim to be anticipated by the same reference. The Federal Circuit rejected this argument because ELCO had only challenged the claim at issue on the basis of obviousness in its original petition, not anticipation. Since the issue of anticipation was not raised in the petition, the Court determined that ELCO could not introduce this new ground of unpatentability on appeal.

Second, ELCO argued that its petition had sufficiently demonstrated the obviousness of Limitation M based on the prior references. The Federal Circuit disagreed, finding that ELCO’s petition did not adequately address the specific requirement for coupling the system to a building’s electrical infrastructure. The petition failed to discuss how the recessed lighting system would be installed in a building, and the references cited did not provide adequate support for the argument of obviousness for this particular limitation.

The Federal Circuit emphasized that it was not the Board’s responsibility to supplement the petitioner’s arguments or search for evidence to support an inadequately supported claim challenge. The Court reiterated that an obviousness analysis does not require the Board to fill gaps in the petitioner’s original [...]

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Rules Are Rules, Especially in Trademark Proceedings

by Abigail A. Rubinstein | Feb 6, 2025 | Trademarks

The Commissioner for Trademarks recently issued a precedential decision terminating a reexamination proceeding for the registrant’s failure to respond within a statutory time period, where there was insufficient justification to waive the response requirement. In re Trigroup USA LLC, Reg. No. 7094794 (Jan. 24, 2025) (Gooder, Comm’r for Trademarks)

The Trademark Modernization Act of 2020 (TMA) created two new trademark proceedings: expungement and reexamination. The US Patent & Trademark Office (PTO) began accepting petitions for these proceedings in 2021. The reexamination proceeding must be filed within the first five years after the registration of a trademark and can only be filed against applications filed on the basis of use (§ 1(a)) or intent to use (§ 1(b)). The proceeding questions whether the mark was in use by a certain date:

In the case of a use-based application, the mark must have been in use on all the goods or services identified in the application by the filing date of the application.
In the case of an intent-to-use application, the mark must have been in use on all the goods or services identified in the application by either the date the Allegation of Use was filed or the deadline for filing the Statement of Use.

A party filing for reexamination must submit evidence that the mark was not in use by those relevant dates.

When the PTO institutes a reexamination proceeding, it issues an Office Action providing the registrant with the opportunity to rebut the claims of non-use. The rules require a response within three months of the Office Action issue date, and failure to respond results in the cancellation of the registration.

Here, the registrant did not respond to the Office Action, and the PTO cancelled the registration. The registrant then filed a Petition to the Director requesting reinstatement of the registration. Such a petition is required to include a response to the original Office Action. However, in this case, the registrant did not provide such a response, and on that basis the Commissioner found that the Petition should not be granted.

The Commissioner further found that even if the petition had included a complete response, it did not set forth sufficient facts to justify a late response. Trademark Rule 2.146(a)(5) permits the Director to waive any requirement of the rules that is not mandated by statute only “in an extraordinary situation, when justice requires, and no other party is injured.” 37 C.F.R. § 2.146(a)(5).

The registrant explained that it had an ongoing matter in China and the failure to respond was due to inadvertent error because it was dealing with the Chinese matter. The Commissioner found that this was not an extraordinary circumstance. The registrant also explained that cancellation of the registration would hinder its ongoing efforts in China and prevent it from manufacturing its products there. The Commissioner found that justice did not require the waiver of the PTO rules just because there would be harm to the registrant: “a party cannot be excused from the [...]

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Skilled Artisan’s View Is Decisive in Assessing Asserted Claim Drafting Error

by Dominik Rissmann | Jan 16, 2025 | EU Update, Patents

The Court of Appeal (CoA) of the Unified Patent Court (UPC) clarified the legal standard for correcting obvious type inaccuracies in patent claims, explaining that the view of a skilled person at the filing date is decisive when assessing whether a patent claim contains an obvious error. Alexion Pharmaceuticals, Inc. v. Samsung Bioepis NL B.V., Case No. UPC_CoA_402/2024; APL_40470/2024 (CoA Luxembourg Dec. 20, 2024) (Grabinski, Blok, Gougé, JJ.; Enderlin, Hedberg, TJ.)

Alexion owns a European patent directed to a drug comprising an antibody that includes the “SEQ ID NO:4” amino acid sequence and that binds “complement component 5” (C5). The description refers to SEQ ID NO:4 as a sequence of 236 amino acids, and the claims also refer to SEQ ID NO:4. It is known in the state of the art that an antibody comprising the entire amino acid sequence, including amino acids forming a “signal peptide,” is unlikely to bind C5. Alexion sought provisional measures, arguing that Samsung infringed Alexion’s patent even though Samsung’s drug did not include the first 22 amino acids (i.e., the signal peptide in this case) of SEQ ID NO:4.

Originally, Alexion applied for the patent as granted but later requested to amend the claims to exclude the first 22 amino acids because of an obvious error during prosecution. The Technical Board of Appeal (TBA) of the European Patent Office (EPO) rejected the request and found that the requested amendment was not a correction of an obvious error.

The Court of First Instance similarly rejected Alexion’s request, although it found that Samsung made literal use of the patent. The Court of First Instance argued, contrary to the TBA, that the first 22 amino acids were meant to be excluded from SEQ ID NO:4 in the patent claim, and that this sequence was obviously not correctly reproduced in the view of a skilled person because otherwise the claimed drug would be unsuitable to bind to C5 (as was undisputed by the parties). However, the Court of First Instance rejected Alexion’s request for provisional measures against Samsung. The Court of First Instance clarified that it must consider not only its own claim interpretation but also the TBA’s different interpretation. Its rationale was that because it is the infringement-focused court, the Court of First Instance should, before ordering provisional measures, consider whether the TBA, based on its interpretation, would revoke the patent in parallel proceedings because of insufficient disclosure under Article 83 of the European Patent Convention. Ultimately, considering the TBA’s claim interpretation, the Court of First Instance found that the patent’s validity was not certain to the extent required to provide provisional measures. Alexion appealed.

The CoA rejected Alexion’s appeal, finding that the Court of First Instance’s claim interpretation (i.e., excluding the first 22 amino acids from the claim ) was legally flawed. The CoA instead adopted the TBA’s claim interpretation and argued (on this point, not much different from the Court of First Instance) that the EPO was likely to revoke the patent. The [...]

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Neck or Nothing? “Quotation” Invalidates On-Sale Bar

by Keval Amin | Dec 19, 2024 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit found the patents at issue invalid based on the patent owner’s “quotation” letter to a third party, concluding it was a commercial offer for sale under pre-America Invents Act (AIA) 35 U.S.C. § 102(b) notwithstanding the patent owner’s reservation of a post-quote acceptance. Crown Packaging Technology, Inc. v. Belvac Production Machinery, Inc., Case Nos. 22-2299; -2300 (Fed. Cir. Dec. 10, 2024) (Dyk, Hughes, Cunningham, JJ.)

Crown Packaging Technology owns patents for necking machines, which reduce the top diameter of metal beverage cans. The earliest priority date for the patents was April 24, 2008, setting the critical date of April 24, 2007. On November 14, 2006, Crown sent Complete Packaging Machinery a letter quoting one of its necking machines that embodied the claims of its patents.

Crown sued Belvac Production Machinery for infringing Crown’s patents. Belvac raised an invalidity defense under § 102(b), contending that Crown’s pre-critical-date letter to Complete Packaging constituted a commercial offer for sale, which rendered the patents invalid. On summary judgment, Crown argued that its letter could not create a binding contract, was not a commercial offer for sale, and was not an offer for sale “in this country” as required by § 102(b). The district court agreed with Crown, finding that the letter was merely an invitation to make an offer, not an offer in itself. At trial, the jury found the patents valid but not infringed. Both parties appealed.

The Federal Circuit reversed the district court’s validity determination, finding that Crown’s letter was an invalidating offer for sale under § 102(b). The Court’s analysis involved five factors:

Whether the subject of the offer embodied the claims of the patents.
Whether the offer occurred “in this country.”
Whether the offer predated the critical date.
Whether the invention was the subject of a commercial offer for sale.
Whether the invention was ready for patenting.

Crown conceded that the necking machine embodied the asserted patent claims, was ready for patenting, and that the letter predated the critical date. Thus, the dispute focused on whether the letter was a commercial offer for sale and whether it was made “in this country.”

The Federal Circuit determined that the letter was a commercial offer for sale. While labeled as a “quotation,” the letter included definite terms typically associated with a binding offer, such as pricing, delivery schedules, payment terms, warranties, and liability conditions. These terms established the mutual obligations of the parties. The Court found that the letter required immediate performance since Complete Packaging was obligated to pay 50% of the purchase price upfront and Crown committed to begin manufacturing upon receipt of payment. Also, despite an explicit clause requiring Crown’s written acceptance, the Court found that the letter was still a commercial offer for sale under established legal precedent.

The Federal Circuit also rejected Crown’s argument that the letter was not made “in this country.” Pre-AIA § 102(b) defines an offer made to a US company at its US [...]

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For Deterrence: Inherent Power to the Rescue to Punish Meritless Lawsuit

by James M. Oehler | Dec 19, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s decision to use its inherent power to award deterrence sanctions for filing a nuisance patent infringement lawsuit. PS Products Inc. v. Panther Trading Co. Inc., Case No. 2023-1665 (Fed. Cir. Dec. 6, 2024) (Moore, Stoll, Cunningham, JJ.)

PSP filed a design patent infringement lawsuit against Panther. PSP voluntarily dismissed the case with prejudice after Panther threatened to seek Rule 11 sanctions for the filing of a frivolous lawsuit. After the case was dismissed, Panther filed a motion seeking its attorneys’ fees under 35 U.S.C. § 285 and $100,000 in deterrence sanctions under the court’s inherent power. The district court found the case exceptional under § 285 and awarded Panther its attorneys’ fees. The district court also found PSP and its counsel joint and severally liable for $25,000 in deterrence sanctions. PSP did not appeal the finding that the case was exceptional or the decision to grant attorneys’ fees, but it did appeal the award of deterrence sanctions under the court’s inherent power.

Design patent infringement requires showing that an ordinary observer would find the accused product and claimed design “substantially the same” such that the observer would be deceived into believing that the accused product was the patented design. However, in some cases the accused product and the patented design are “plainly dissimilar” such that it would be clear to an ordinary observer the two designs were not “substantially the same.”

The Federal Circuit affirmed the district court’s award of deterrence sanctions, finding that the district court did not err by inferring PSP’s bad faith conduct based on the clear lack of legal merit of the case against Panther. The Court found that Panther’s accused product was “plainly dissimilar” to the patented design (shown below), such that PSP’s case was a nuisance lawsuit.

The Federal Circuit found that bad faith was also reasonably inferred based on PSP’s history of filing 25 meritless lawsuits in the same district, even though the district court did not analyze each suit. PSP cited the general venue statute in all 25 lawsuits rather than the required patent-specific venue statute, and PSP did not have proper venue in the lawsuit against Panther.

The Federal Circuit also found no abuse of discretion when the district court imposed sanctions under its inherent power. Rule 11 sanctions were unavailable since the case was already dismissed, but the district court had no other mechanism to sanction PSP’s bad faith conduct of filing multiple meritless lawsuits except the court’s inherent power. Finally, the Court found that imposing deterrence sanctions under the district court’s inherent power was proper even when it had already awarded attorneys’ fees and costs under § 285 because the statute does not preclude separate sanctions.

The Federal Circuit declined to award Panther its attorneys’ fees for the appeal because while PSP’s [...]

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New Year, New Fees: PTO Issues 2025 Fee Schedule

by Amol Parikh | Dec 5, 2024 | Patents

The US Patent & Trademark Office (PTO) issued its final rule setting and adjusting patent fees that will take effect on January 19, 2025. 89 Fed. Reg. 91898 (Nov. 20, 2024).

The final rule sets or adjusts 433 patent fees for undiscounted, small, and micro entities, including the introduction of 52 new fees. The fee adjustments are grouped into three categories:

Across-the-board adjustment to patent fees.
Adjustment to front-end fees.
Targeted fees.

Fees not covered by the targeted adjustments will increase by approximately 7.5%. Front-end fees to obtain a patent (i.e., filing, search, examination, and issue fees) are set to increase by an additional 2.5% on top of the 7.5% across-the-board adjustment. Targeted adjustments include increasing fees related to continuing applications, design patent applications, filing excess claims, extensions of time for provisional applications, information disclosure statement sizes, patent term adjustments, patent term extensions, requests for continued examinations, suspension of actions, terminal disclaimers, unintentional delay petitions, and Requests for Director Review of a Patent Trial & Appeal Board decision.

More information, including the new fee schedule, is available on the PTO’s website.