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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.

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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Patent by Secret Process: Perils of Pre-Patent Profiting

by Connor S. Romm | Aug 22, 2024 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit affirmed the International Trade Commission’s (ITC) determination that the asserted process patents were invalid under the America Invents Act (AIA) because products made using the patented process were sold more than one year before the patents’ effective filing dates. Celanese International Corporation, et al. v. International Trade Commission, Case No. 22-1827 (Fed. Cir. Aug. 12, 2024) (Reyna, Mayer, Cunningham, JJ.)

Celanese owns patents that cover a process for making the artificial sweetener acesulfame potassium (Ace-K). It was undisputed that Celanese’s patented process was in secret use in Europe and that Ace-K produced using this process had been sold in the United States before the patents’ effective filing dates. Under pre-AIA caselaw, such sales of products made using a secret process before the critical date would trigger the on-sale bar and invalidate any later-sought patent claims on that process. However, because Celanese’s patents had effective filing dates after March 15, 2013, the AIA rules applied. Thus, the case hinged on whether the AIA altered this rule.

In 2019, in Helsinn v. Teva, the Supreme Court addressed similar facts and confirmed that the Federal Circuit’s pre-AIA “on sale” case law, which established that “secret sales” could invalidate a patent, still applied. In Helsinn, the patentee had obtained a patent related to a fixed dose of palonosetron. Prior to the critical date, the patentee entered into a supply and purchase agreement with a third party that covered this same fixed dose of palonosetron. The Supreme Court concluded that Congress, by reenacting similar language in the AIA concerning the on-sale bar, appeared to have adopted the Federal Circuit’s pre-AIA interpretation of the on-sale bar. Accordingly, the Supreme Court held that, consistent with Federal Circuit pre-AIA precedent, an inventor’s prior sale of an invention to a third party can qualify as invalidating prior art even if the third party is obligated to keep the invention confidential.

However, unlike in Helsinn, where the claimed invention was the very subject of the commercial sale at issue, Celanese’s patents covered the secret process used to make Ace-K, and it was only the resulting Ace-K that was the subject of commercial sale – not the patented process itself. Although this distinction would not alter the outcome under pre-AIA law, Celanese averred that the AIA had revised the rules for this specific situation. To support its theory, Celanese referenced, among other things, the AIA’s use of the phrase “claimed invention” as opposed to simply “invention” as recited in pre-AIA discussion of the on-sale bar. According to Celanese, this change implied that the invention specifically “claimed” must be on sale to qualify as invalidating prior art.

The ITC rejected Celanese’s argument, concluding that the AIA did not alter the pre-AIA rule that “a patentee’s sale of an unpatented product made according to a secret method triggers the on-sale bar to patentability.” Accordingly, the ITC found that Celanese’s patents were invalid because Celanese sold Ace-K made using its secret process more [...]

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Section 337 Doesn’t Require Article III Standing for Claimant but Claimant Must Be “Patentee”

by Alexander P. Ott | May 30, 2024 | Patents

Addressing an initial determination by an administrative law judge (ALJ) granting summary determination and terminating a Section 337 investigation for lack of Article III standing, the US International Trade Commission reversed and held that Section 337 does not require claimants to have Article III standing. Certain Active Matrix Organic Light-Emitting Diode Display Panels and Modules for Mobile Devices, and Components Thereof, Inv. No. 337-TA-1351, Commission Opinion (May 15, 2024).

In late 2022, Samsung Display filed a complaint seeking to institute a Section 337 investigation based on its infringement allegations regarding four patents and seeking an exclusion order against replacement displays sold by various companies. In late 2023, on the eve of the evidentiary hearing, the ALJ granted the respondents’ motion for summary determination that the complainant lacked constitutional standing because Samsung Display had granted its parent company, Samsung Electronics Co., an implied license to the asserted patents with an unrestricted right to sublicense. Samsung Display petitioned for Commission review. On review, the Commission reversed.

The Commission first noted that because it’s an administrative tribunal and not an Article III court, the “case or controversy” requirement does not apply to parties before it and standing is instead based on its governing statute. The Commission acknowledged its previous decisions where it had applied a constitutional standing requirement and expressly overruled those decisions. It further noted that its statute does not include the “patentee” requirement of 35 U.S.C. § 281 that applies to plaintiffs in district court actions but reiterated its long-standing practice of requiring a complainant be the owner or exclusive licensee of the asserted patent(s) at the time of filing the complaint.

The Commission held that there were genuine issues of material fact as to whether Samsung Display was a “patentee” when it filed the complaint. The Commission found there was an open question as to whether Samsung Electronics actually had a right to sublicense without Samsung Display’s explicit or implicit authorization. The Commission thus remanded the investigation to the ALJ to conduct further proceedings to develop the factual record.

Patent Thicket Avoidance: PTO Proposes Changes to Terminal Disclaimer Practice

by Peter Brunovskis, PhD | May 23, 2024 | Patents

On May 10, 2024, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking (Notice) concerning major changes to the terminal disclaimer (TD) practice, which may lead to a sea change in patent prosecution strategies. The proposed change would require a TD to include an agreement from the patent owner that the patent will be unenforceable if it’s tied directly or indirectly to another patent having any patent claim invalidated or canceled based on prior art. 89 Fed. Reg. 40439 (May 10, 2024).

The rule change is a potential boon for patent challengers and is intended to promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by TDs to patents with claims finally held unpatentable or invalid. Under current practice, invalidation of a patent tied to another patent by a TD does not directly affect the patentability of the other patent. Under the new rule, a competitor could target a single patent in a validity dispute in a post-grant challenge without the need to seek review and invalidation of other related patents. As a result, invalidating one claim in a patent tied to other patents by TDs would render all other tied patents unenforceable.

According to the Notice, the proposed change aligns with the US government’s intent to reduce drug costs and promote competition by reducing barriers to market entry in accordance with President Biden’s Executive Order 14036 on “Promoting Competition in the American Economy.” Part of the reduced costs are said to come from bringing down the cost of challenging large “patent thickets” of multiple patents covering a single product or minor variations of the product tied by TDs.

The proposed rule change would represent a paradigm shift for TD practice. Current TD practice under 37 CFR 1.321(c) or (d) allows applicants to file multiple patents with claims varying in only minor ways from one another by filing TDs to obviate obviousness-type double patenting (ODP) rejections over closely related patent claims issued or pending in applications commonly owned or commonly owned on the basis of a joint research agreement. In filing a TD, the applicant agrees to disclaim any patent term extending beyond the term of the prior patent having similar patent claims.

The proposed rule seeks “to revise 37 CFR 1.321 (c) and (d) to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the subject patent or any patent granted on the subject application shall be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which:

(1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 . . . by a Federal court in a civil action or by the PTO, and all appeal rights have been exhausted; or

(2) a [...]

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Prime Delivery: Amazon Program Now Offers Personal Jurisdiction to Patent Holders

by Courtney Seams | May 16, 2024 | Patents

Addressing the issue of personal jurisdiction in the context of a declaratory judgment case involving a program for resolving patent infringement claims, the US Court of Appeals for the Federal Circuit concluded that a patent owner has personal jurisdiction in the forum of an alleged infringer when it files a program claim against the alleged infringer. SnapRays, dba SnapPower v. Lighting Defense Group, Case No. 23-1184 (Fed. Cir. May 2, 2024) (Moore, CJ. Lourie, Dyk, JJ.)

The Amazon Patent Evaluation Express (APEX) program helps resolve patent infringement claims against sellers on Amazon. Under APEX, a patent owner submits an APEX Agreement to Amazon that identifies the allegedly infringed patent claim and the Amazon listings with the alleged infringing products. Amazon then sends this APEX Agreement to the seller, who can do one of the following to avoid removal of their accused listings:

Opt into APEX and let a third party determine whether their product likely infringes
Resolve the claim directly with the patent owner
File a lawsuit for declaratory judgment of noninfringement. If the seller does nothing, its listings are automatically removed from Amazon within three weeks of receipt of the APEX Agreement.

Lighting Defense Group (LDG), a Delaware company whose principal place of business is in Arizona, submitted an APEX Agreement alleging that SnapPower’s Amazon products (electrical outlet covers with integrated technology) infringed one of its patents. SnapPower, a Utah company whose principal place of business is in Utah, then filed a declaratory judgment action against LDG in Utah. LDG then filed a motion to dismiss for lack of personal jurisdiction. The district court granted the motion, finding that SnapPower did not demonstrate that LDG purposefully directed activities at SnapPower in Utah and that there was no evidence that LDG reached out to Utah other than through responses to SnapPower’s communications. SnapPower appealed.

The Federal Circuit reversed, finding that LDG was subject to personal jurisdiction under the Court’s three-prong test because (1) LDG purposefully directed its activities at SnapPower in Utah, (2) LDG’s submission of the APEX Agreement was directed to SnapPower in Utah and aimed to affect activities in Utah and (3) it would not be unreasonable to find personal jurisdiction over LDG in Utah.

In assessing the first prong, the Federal Circuit found that LDG knew, via APEX’s terms, that Amazon would notify SnapPower of the APEX Agreement and that the options available to SnapPower included a claim for declaratory judgment. Further, the Court found that the APEX Agreement had more power than cease and desist letters because of the automatic removal of the listings after three weeks, which would affect sales and activities in Utah.

In assessing the second prong, the Federal Circuit found that personal jurisdiction comported with due process because LDG’s actions aimed to affect marketing, sales and other activities in Utah and because the suit arose out of LDG’s activities in the forum.

In assessing the final prong, the Federal Circuit rejected LDG’s argument that allowing personal jurisdiction would “open the [...]

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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.

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