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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.

Patentee that retains exclusionary rights has constitutional standing notwithstanding broad license grant

by Anisa Noorassa | May 28, 2026 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court decision dismissing a patent infringement suit for lack of constitutional standing, concluding that patentees that retain exclusionary rights, even after granting a broad license, maintain Article III standing. A.L.M Holding Company v. Zydex Industries Private Ltd., Case No. 25-1317 (Fed. Cir. May 19, 2026) (Chen, Cunningham, Stark, JJ.)

A.L.M. and Ergon co-own six patents directed to warm-mix asphalt technology. Prior to filing suit, the patentees entered into a licensing agreement with Ingevity Corporation, granting Ingevity an exclusive, worldwide, royalty-bearing license to manufacture, import, use, and sell products covered by the patents. The agreement also provided for shared control of infringement actions and an equal split of any resulting recoveries and costs. Despite the breadth of the license, the patentees retained certain rights, including the ability to make, import, and use the licensed products.

A.L.M. filed suit against Zydex. The district court dismissed the action, concluding that the patentees lacked constitutional standing because the license transferred away sufficient exclusionary rights, leaving A.L.M. without a cognizable injury under Article III.

Reviewing the issue de novo, the Federal Circuit reversed. The Court framed the proper inquiry for constitutional standing as whether the plaintiff retains an exclusionary interest in the asserted patents. The Court explained that, absent a transfer of all exclusionary rights, a patentee generally maintains the concrete injury necessary to satisfy Article III.

The Federal Circuit emphasized that the constitutional standing inquiry is distinct from the question of statutory standing under 35 U.S.C. § 281. While statutory standing concerns whether a party is entitled to bring suit under the Patent Act and may be cured by joinder of necessary parties, constitutional standing requires a threshold showing of injury in fact and cannot be remedied after the fact.

Applying that framework, the Federal Circuit found that the plaintiffs retained sufficient exclusionary interests. In particular, the patentees preserved rights to royalties and maintained a degree of control over sublicensing, including a veto right. These retained interests demonstrated that the patentees had not transferred all substantial rights in the patents and therefore continued to suffer a legally cognizable injury from alleged infringement.

Accordingly, the Federal Circuit concluded that the plaintiffs satisfied Article III standing requirements and reversed the district court’s dismissal.

Practice note: On the same day that the Federal Circuit issued its decision in A.L.M. Holdings, the same panel also issued a nonprecedential decision in Recor Medical, Inc. v. Medtronic Ireland Manufacturing Unlimited Co., in which it stated, “[i]n a precedential opinion we issued today in a different appeal addressing constitutional standing, A.L.M. Holding Co. v. Zydex Industries Private Ltd., No. 25-1317 (Fed. Cir. May 18, 2026), we held that the patent owner in that case had constitutional standing because it retained a right to sue for patent infringement that was not rendered illusory by the rights it granted to its licensee. Because Medtronic Ireland’s retained rights are materially the same as the patent owner’s in A.L.M., we hold that Medtronic [...]

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Ticket to ride: USPTO requires counsel for foreign patent applicants

by Lauren Hong | Apr 2, 2026 | Patents

The United States Patent and Trademark Office (USPTO) adopted a final rule requiring foreign-domiciled patent applicants and patent owners to be represented by a registered US patent practitioner, signaling a meaningful procedural shift aimed at harmonization, efficiency, compliance, and fraud prevention. 91 Fed. Reg. 13510 (Mar. 20, 2026).

The USPTO explained that the rule is intended primarily to address recurring compliance and fraud concerns, such as false or improper certifications, including micro entity certifications, and other filings that misrepresent eligibility for fee reductions or expedited treatment. Because registered US practitioners are subject to the USPTO’s Rules of Professional Conduct and disciplinary authority, the agency views mandatory representation as a more reliable accountability mechanism.

The USPTO also cited practical administrative considerations, indicating that foreign pro se filings are more likely to be procedurally deficient and therefore consume disproportionate examination and processing resources, particularly when application papers are not in condition for publication or examination upon receipt.

The final rule clarifies how the requirement will operate in practice. While a foreign domiciled applicant may still obtain a filing date without a practitioner’s signature, any subsequent papers will not be entered unless signed by a registered US patent practitioner. This includes application data sheets, micro entity certifications, petitions, amendments, and other key prosecution documents. In some circumstances, the consequences for noncompliance may be significant. For example, if an unsigned application data sheet is treated merely as a transmittal letter, inventorship, priority, or benefit claims may not be properly established at filing, necessitating corrective petitions and additional cost. Likewise, requests that must be made at filing, such as nonpublication or prioritized examination requests, may be forfeited if not properly signed.

The USPTO emphasized that the rule is procedural rather than substantive. It does not alter the standards of patentability or the requirements for securing a filing date. The rule applies to all filings received on or after its effective date, regardless of the application’s effective filing date. The USPTO also noted that an applicant that believes it has been incorrectly designated as foreign domiciled may respond to that determination even before retaining counsel, although conclusory or unsupported assertions are unlikely to succeed.

Practice note: Foreign applicants and patent owners should now assume that US practitioner involvement is essential to preserve rights and avoid preventable procedural defects.

No curtain call yet: Mixed verdict in patent, trademark, standing case

by Hannah Hurley | Oct 9, 2025 | Patents, Trademarks

The US Court of Appeals for the Federal Circuit addressed a wide array of issues in a long-running dispute over shower curtain technology. The Court provided important guidance on patent claim scope using intrinsic evidence, trademark standing and ownership of the mark in issue, trade dress functionality under TrafFix, and the need for district courts to provide a reviewable explanation when issuing patent infringement summary judgment based on the facts of this case. Focus Products Grp. Int’l, LLC v. Kartri Sales Co., Inc., Case No. 23-1446 (Fed Cir. Sept. 30, 2025) (Moore, Clevenger, Chen, JJ.)

The decade-long dispute started when Focus Products sent a cease-and-desist letter to Kartri Sales and its supplier, Marquis Mills International. The letter asserted patent infringement but was largely ignored. Focus Products then filed suit asserting three utility patents, two trademarks (HOOKLESS® and EZ ON), and unregistered trade dress rights in the appearance of its shower curtains.

Four months after the Supreme Court’s 2017 decision in TC Heartland v. Kraft Foods Group Brands, Kartri raised a venue objection and filed a motion to dismiss or transfer venue. The district court denied the motion, finding it to be unreasonably late, especially considering that Kartri actively conducted litigation after TC Heartland.

The district court construed several disputed claim terms. Based on its constructions, it found no triable issue of fact and granted summary judgment of patent infringement to Focus Products. However, the district court found genuine disputes of material fact regarding trademark and trade dress infringement and ordered a bench trial on those issues.

On the eve of trial, Kartri asserted unclean hands and equitable estoppel defenses. The district court denied these defenses because they were improperly raised for the first time immediately preceding trial.

After a bench trial, the district court held that:

Focus Products had standing to enforce the unregistered EZ ON mark.
Kartri infringed the mark and Focus Products’ trade dress, which was determined to be nonfunctional.
Kartri infringed Focus Products’ HOOKLESS® mark.

Accordingly, the district court awarded lost profits, reasonable royalties, attorneys’ fees, and enhanced damages for willful infringement. Kartri appealed.

The Federal Circuit affirmed the district court’s denial of Kartri’s motion to transfer venue under TC Heartland, finding Kartri’s objection untimely. Kartri waited four months after TC Heartland to raise the issue, during which time discovery had progressed significantly. The Court emphasized that venue objections must be raised seasonably and that continued litigation in the chosen forum may constitute forfeiture.

The Federal Circuit largely reversed the district court’s infringement findings, explaining that the district court erred in its claim construction because Focus Products had disclaimed shower rings with a flat upper edge during prosecution. While an affirmative disclaimer usually originates from the patent applicant, the Court found clear and unmistakable disavowal through the applicant’s acquiescence to the examiner’s species election, claim cancellation, and narrowed claim scope. This disclaimer was reinforced by the prosecution of a related asserted patent, which explicitly claimed the disclaimed feature. A patentee cannot try [...]

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PTO Accelerates Patent Issuance Timeline

by Amol Parikh | Apr 24, 2025 | Patents

The US Patent & Trademark Office (PTO) announced that it has shortened the time between the issue notification and the issue date for patents. Historically, the time between these two events averaged about three weeks. Seeking to provide earlier protection for inventions, the PTO intends to reduce that time to about two weeks. The PTO is making the move because publishing electronic grants via the PTO online platform has allowed the PTO to eliminate redundancies and reduce the time between grant notification and the issuance date. The shortened wait time has the added benefit of potentially allowing patent applicants to avoid the Quick Path Information Disclosure Statement (IDS), which attempts to streamline filing an IDS after payment of the issue fee.

Practice Note: Given the accelerated timeline, the PTO recommends that applicants file continuation applications before payment of the issue fee to ensure codependency.

A Patent Without a Pulse: Provisional Rights Don’t Outlive the Patent

by Keval Amin | Apr 10, 2025 | Patents

The US Court of Appeals for the Federal Circuit dismissed an appeal from a patent applicant seeking provisional rights on a patent that would issue only after it had already expired, finding that the applicant lacked the necessary exclusionary rights to support a claim for provisional rights. In re: Donald K. Forest, Case No. 23-1178 (Fed. Cir. Apr. 3, 2025) (Taranto, Schall, Chen, JJ.)

Donald K. Forest applied for a patent on December 27, 2016. Forest’s patent application claimed priority through a chain of earlier-filed patent applications dating back to March 27, 1995. If Forest’s patent application matured into a patent, it would have expired 20 years after the 1995 priority date (i.e., prior to the 2016 filing date). The patent examiner nevertheless examined and rejected the proposed claims. The Patent Trial & Appeal Board partially affirmed the examiner’s rejection of certain claims on grounds of obviousness and double patenting. Forest appealed.

The Patent & Trademark Office raised a threshold issue that since Forest’s application could only result in an expired patent, he lacked a personal stake in the appeal sufficient to establish jurisdiction. Forest countered that he could still acquire “provisional rights” under 35 U.S.C. § 154(d) – a limited right to royalties for certain pre-issuance activities – despite the expiration of any issued patent as it issued.

The Federal Circuit dismissed the appeal, explaining that since Forest could not be granted a patent until after the patent’s expiration date, he would never receive any exclusionary rights. The Court clarified that provisional rights only arise once a patent issues and crucially do not extend beyond the statutory patent term. Because Forest sought the issuance of a patent that would confer no enforceable rights – either exclusionary or provisional – the Court dismissed the appeal for lack of jurisdiction.

The Federal Circuit’s primary conclusion was predicated on the principle that provisional rights are only available when a patent issues with enforceable exclusionary rights, meaning the patent must issue before its expiration date. The Court emphasized that provisional rights under § 154(d) are expressly provided “in addition to other rights provided by” the patent statute. Because this statutory language indicates that provisional rights are not standalone, the Court determined that provisional rights depend on the existence of a valid, enforceable patent.

According to the Federal Circuit, the entire purpose of provisional rights is to provide temporary relief to the patentee during the gap between publication of a patent application and issuance of a patent. However, such rights only arise if the issued patent provides enforceable rights. The Court reasoned that provisional rights are meant to encourage early publication and protect patentees from pre-issuance infringement, but only as a precursor to full patent protection.

The Court rejected Forest’s interpretation of § 154(d), explaining it would create an anomalous situation where provisional rights could survive without any corresponding enforceable rights, allowing a patentee to collect royalties on a patent that could never be asserted in infringement litigation.

Practice Note: Patent rights, whether provisional [...]

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A Lynk to the Past: Published Applications Are Prior Art as of Filing Date

by Dexter Hamilton | Jan 23, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision finding challenged claims invalid based on a published patent application that, in an inter partes review (IPR) proceeding, was found to be prior art as of its filing date rather than its publication date. Lynk Labs, Inc. v. Samsung Electronics Co., Ltd., Case No. 23-2346 (Fed. Cir. Jan. 14, 2025) (Prost, Lourie, Stark, JJ.)

Samsung filed a petition for IPR challenging claims of a Lynk Labs patent. Samsung’s challenge relied on a patent application filed before the priority date of the challenged patent. However, the application was not published until after the priority date of the challenged patent. The Board rejected Lynk Labs’ argument that the application could not serve as prior art and determined the challenged claims to be unpatentable. Lynk Labs appealed to the Federal Circuit, raising three arguments.

Lynk Labs’ first argument was that the application could not serve as prior art because the publication date meant that it was not publicly available until after the priority date of the challenged patent. Pre-America Invents Act (AIA) law applied. Lynk Labs cited 35 U.S.C. § 311(b), restricting IPR petitioners to challenges “on the basis of prior art consisting of patents or printed publications.” While Lynk Labs admitted that the published application was a printed application, it denied that it was a prior art printed publication.

The Federal Circuit reviewed the issue de novo as a question of statutory interpretation. The Court noted that §§ 102(e)(1) and (2) carve out a different rule for published patent applications than the test for §§ 102(a) and (b) prior art. Under the statute, a patent application filed in the United States before an invention claimed in a later filed application qualifies as prior art if the application is published or a patent is granted on it.

Lynk Labs did not dispute that, under § 102(e)(2), an application resulting in an issued patent can be prior art, even if the patent is granted after an invention’s priority date, as long as the application is filed before the challenged invention priority date. However, Lynk Labs took issue with the fact that the Board applied the same principle, under § 102(e)(1), to applications that are published but do not become patents.

The Federal Circuit explained that the plain language of the statute permitted IPR challenges based on such applications and rejected Lynk Labs’ arguments that the statute should be interpreted differently. Lynk Labs argued that when Congress enacted § 311(b), it transplanted the term “printed publications” from case law, along with that case law’s “old soil” that established that the application would not be prior art.

In support of its argument, Lynk Labs cited case law that in its view suggested that patent applications are never prior art printed publications. However, the Federal Circuit distinguished those cases on the basis they were decided at a time before applications were published and therefore did not address published applications. Lynk [...]

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Promises, Promises: Covenant Not to Sue for Patent Infringement Includes Downstream Users

by Karen Gover | Oct 31, 2024 | Patents

The US Court of Appeals for the Tenth Circuit affirmed that a district court did not err in applying ordinary rules of contract construction to a covenant not to sue and properly found that under the patent exhaustion doctrine, the covenant encompassed downstream users. Fuel Automation Station, LLC v. Energera Inc., Case Nos. 23-1123; -1358 (10th Cir. Oct. 21, 2024) (Carson, Rossman, Federico, JJ.)

Fuel Automation Station (FAS) and Energera compete in the manufacture of automated fuel delivery equipment and related services. Energera holds patents related to its fuel delivery equipment. In 2016 and 2018, Energera sued FAS, alleging that it infringed two of its patents. The parties resolved the suits with a single settlement agreement in 2019. The agreement described the scope of the patent rights at issue and provided mutual covenants not to sue.

Less than a year later, FAS contracted with a Canadian corporation to operate its fuel automation equipment. Energera sued the Canadian corporation for infringement of one of its patents. FAS intervened, then separately sued Energera seeking a declaration that the covenant not to sue authorized FAS to sell or lease its own equipment and, therefore, the patent exhaustion doctrine prohibited Energera from suing downstream users, such as the Canadian corporation. FAS also brought two breach of contract claims asserting that Energera violated the settlement agreement and its included covenant since it was prohibited from suing the Canadian corporation for downstream use or from suing or “otherwise engag[ing]” FAS in legal proceedings.

FAS moved for summary judgment on its declaratory judgment count, which the district court granted. However, the court denied both parties’ later motions for summary judgment on the issue of whether the settlement agreement covered the asserted patent, finding that an ambiguity in the agreement created genuine issues of material fact. A jury subsequently found that the agreement did cover the asserted patent and that Energera breached the covenant. Energera appealed.

After first determining that the district court’s summary judgment ruling was an appealable legal ruling on the issue of the scope of the covenant, the Tenth Circuit found that the district court correctly interpreted the covenant to include downstream users. In the covenant, Energera promised “not to sue [FAS] or otherwise engage [FAS] in any domestic or foreign legal or administrative proceeding” related to the Patent Rights. Citing dictionary definitions of “engage” in its analysis, the Tenth Circuit found that the term “otherwise engage” reasonably could show the parties’ intent to prohibit Energera from suing FAS’s downstream users. The Court then invoked the patent exhaustion doctrine, which it called “the brooding omnipresence in the sky of patent law.” The Court explained that if a patent holder promises not to sue an entity for patent infringement when the entity sells or leases an item, “the doctrine recognizes an inherent promise not to sue downstream users of those items.” Otherwise, the Court pointed out, no reasonable customer would want to buy or lease a patented item from an authorized seller.

As to whether the [...]

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Later-Filed, Earlier-Expiring Patent Not an ODP Reference

by Alexander P. Ott | Aug 29, 2024 | Patents

Addressing invalidity due to obvious-type double patenting (ODP) based on later-filed-related patents, the US Court of Appeals for the Federal Circuit reversed a district court’s application of In re Cellect (Fed. Cir. 2023) and held that the later-filed, earlier-expiring continuation patents were not available as ODP references against the earlier-filed, later-expiring patent. Allergan USA, Inc. v. MSN Labs Private Ltd., Case No. 24-1061 (Fed. Cir. Aug. 13, 2024) (Lourie, Dyk, Reyna JJ.)

In 2015, the US Food and Drug Administration approved a new drug application for a drug sold by Allergan to treat the symptoms of irritable bowel syndrome. In 2019, Sun Pharma filed an abbreviated new drug application (ANDA) seeking to market a generic version of the drug. Allergan then sued Sun Pharma and MSN Labs for infringement of four patents related to the drug. One of the patents, which claims a compound of the drug, had been granted almost three years of patent term adjustment (PTA) and was followed by two more patents from continuation applications in the same patent family. The other three patents all claimed tablet forms of the drug. The claims of one of the patents recited that a glidant was optional while the claims of the other two patents did not require a glidant at all.

The US District Court for the District of Delaware held a three-day bench trial and concluded that the asserted claim of the compound patent was invalid under the ODP doctrine and that the claims of the three tablet patents were invalid for lack of written description. On the issue of ODP, the district court found Allergan’s “first-filed, first-issued” distinction “immaterial.” The district court stated that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates.” Allergan appealed.

The Federal Circuit reversed on both issues. The Court held that the claims of the later-filed, earlier-expiring continuation patents were not available as ODP references against the first patent because the purpose of the ODP doctrine is to prevent patentees from obtaining a second patent to effectively extend the life of the first patent. The Federal Circuit explained that the district court misread Cellect as binding it to solely consider expiration dates in the ODP analysis. The Court explained that Cellect only controls to the extent that it requires a court to consider the later-filed patent’s expiration date (i.e., the expiration date after the addition of PTA) in its ODP analysis, not the expiration date that it would have shared with the reference patents in the absence of a PTA award. The panel majority emphasized that it does not follow that the later-filed patent must be invalidated by the earlier-filed reference patents simply because it expires later. The majority noted that “Cellect does not address, let alone resolve, any variation of the question presented here – namely, under what circumstances can a claim properly serve as an ODP reference – and therefore has little to say on the precise issue before us.”

The Federal Circuit also [...]

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