prior art Archives

prior art

New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

by Tessa Kroll | Aug 17, 2023 | Patents

Addressing the issue of new claim constructions presented by a patent owner after the institution of inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found that a petitioner is entitled to argue and present evidence under the new construction so long as it relies on the same prior art embodiments used in the petition. Axonics, Inc. v. Medtronic, Inc., Case No. 22-1532 (Fed. Cir. Aug. 7, 2023) (Dyk, Lourie, and Taranto, JJ.)

Medtronic owns two patents directed to the transcutaneous charging of implanted medical devices via inductive coupling between a primary coil in an external charger and a secondary coil in the implanted device. The relevant claims of each patent require the external charger’s power to be automatically varied based on “a value associated with the current passing through the internal power source” (the value limitation) and “a measured current associated with the current passing through the internal power source” (the measured current limitation).

Axonics filed two IPR petitions challenging Medtronic’s patents, arguing that the claims were anticipated by three prior art references. Axonics’s petitions did not propose any express claim constructions, but its claim charts stated that the measured current limitation simply narrows the “value” in the value limitation to “measured current” and does not require a separate measurement. Under this “one-input” construction, both limitations would be satisfied if the external power source automatically varied its power output based on the implanted device’s current. In its preliminary response, Medtronic agreed that while claim construction was not necessary, the prior art failed to anticipate the claimed device under the one-input construction. In its institutional decision, the Patent Trial & Appeal Board agreed that “no term requires express construction.”

In its patent owner response, Medtronic (for the first time) advanced a new claim construction, arguing that the value limitation and the measured current limitation required separate inputs (the two-input construction). In Axonics’ reply, it defended the one-input construction and further argued that the three prior art references also disclosed the claimed device under the two-input construction. In support of its reply, Axonics submitted a supplemental expert declaration citing additional disclosures in the prior art references pertaining to the same embodiments relied upon in the petition. Medtronic argued that it would be prejudicial for the Board to consider Axonics’ new reply arguments without providing Medtronic an opportunity to submit a supplemental expert declaration. Medtronic, however, did not seek leave to submit a new declaration.

In its final written decision, the Board adopted the two-input construction and declined to consider Axonics’ arguments and evidence under the new construction, considering them to be improper reply arguments. Axonics appealed.

The Federal Circuit acknowledged that a petition is required to identify “in writing and with particularity…the grounds on which the challenge to each claim is based, and the evidence that supports the grounds.” To that end, a petitioner may not submit new evidence or arguments in a reply that could have been raised earlier but may respond to new arguments [...]

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First Rule of the PTAB? Play by the Rules

by Christian Tatum | Jun 22, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed two Patent Trial & Appeal Board decisions holding the challenged claims unpatentable as obvious, even though the Board declined to consider evidence of antedating and found that the claims lacked written description support. Parus Holdings, Inc. v. Google LLC, Case Nos. 22-1269; -1270 (Fed. Cir. June 12, 2023) (Lourie, Bryson, Reyna, JJ.)

Parus Holdings owns two patents related to an interactive voice system to request information from a voice web browser. Google (among others) petitioned for inter partes review (IPR) of the patents.

During the IPR proceedings, the Board found that a publication (Kovatch) was prior art to the challenged patents. In reaching that decision, the Board declined to consider Parus’s arguments and evidence of an earlier conception and reduction to practice because they were only presented via incorporation by reference in violation of 37 C.F.R. § 42.6(a)(3). The Board ruled that Parus failed to meet its burden of production on antedating.

The Board also found that the publication of the application to which Parus’s challenged patents claimed priority (Kurganov-262) was prior art because the common specification failed to provide written description support for the challenged claims. Parus appealed the Board’s decision, raising two main arguments.

First, Parus contended that the Board erred when it declined to consider Parus’s arguments and evidence on antedating. Parus argued that § 42.6(a)(3)’s prohibition on incorporation by reference did not warrant the Board’s decision because Parus, as patent owner, need not have submitted a response at all. Parus also argued that the Federal Circuit’s 2017 decision in Aqua Products mandates that the Board consider all record evidence, regardless of the manner of presentation. The Federal Circuit rejected Parus’s arguments in turn.

Regarding Parus’s violation of the incorporation by reference rule, the Federal Circuit explained that Parus had assumed an affirmative burden of production when it chose to submit a response to antedate Kovatch. Along with that burden came other responsibilities, such as complying with the US Patent & Trademark Office’s (PTO) rules and regulations, including § 42.6(a)(3). The Court further explained that this burden of production could not be met without some combination of citing evidence with specificity and explaining the significance of the cited material. Parus did neither.

The Federal Circuit also rejected Parus’s argument that the Board is required by law to review all evidence in the record. The Court clarified that, while its Aqua Products holding requires the Board to decide all issues properly before it, nothing in Aqua Products requires the Board to review evidence or issues not introduced or introduced in violation of the Board’s rules. As the Court noted, “[t]he burden of production cannot be met simply by throwing mountains of evidence at the Board without explanation or identification of the relevant portions of that evidence. One cannot reasonably expect the Board to sift through hundreds of documents, thousands of pages, to find the relevant facts.”

Parus also argued that the Board exceeded its statutory authority under 35 U.S.C. [...]

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The Best Option Is Obviously Not the Only Option

by Thomas DaMario | Jun 22, 2023 | Patents

Following a jury verdict finding infringement of two patents and awarding $2.2 billion, the Patent Trial & Appeal Board issued a final written decision finding all claims in one of the asserted patents invalid. The Board explained that an asserted prior art combination only needs to be a suitable option, not the best option. Patent Quality Assurance, LLC v. VLSI Tech. LLC, Case No. IPR2021-01229 (June 13, 2023) (Giannetti, McNamara, Melvin, APJs).

In March 2021, a jury found that Intel infringed two patents owned by VLSI. On July 7, 2021, Patent Quality Assurance filed an inter partes review petition against all claims of one of the patents Intel was found to infringe. The Board instituted review. After institution, Intel filed an identical petition and motion for joinder, both of which were granted.

The challenged patent is directed to a method of determining the minimum operating voltage for integrated-circuit memory, storing the value of that voltage in nonvolatile memory, and using the value to determine when an alternative power-supply voltage may be switched to the memory to ensure that the minimum operating voltage is met. Intel challenged the claims of the patent based primarily on a combination of three prior art references.

VLSI raised numerous arguments for why the combination of prior art references did not teach the claimed invention. VLSI argued that a skilled artisan would not have had reason to regulate the power supply voltage of one reference with the voltage regulator of another. VLSI asserted that there would have been no need to use the switching mechanism if voltage regulation was available from the outset. The Board disagreed and quoted the US Court of Appeals for the Federal Circuit’s 2022 decision in Intel v. Qualcomm, which stated that “a petitioner is required to show only that there is something in the prior art as a whole to suggest the desirability of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available.”

The Board reiterated this theme in response to another of VLSI’s arguments. VLSI contended that a person of skill in the art would not have combined the prior art disclosure of a system for determining minimum operating voltages and storing them in nonvolatile memory with a reference that uses SRAM, a type of volatile memory commonly used as an alternative to nonvolatile memory. The Board again noted that “there is no requirement that an asserted combination is the best option, only that it be a suitable option.”

Given the jury’s verdict and damages award in the district court case, VLSI also argued that the jury’s verdict showed commercial success and was objective indicia of nonobviousness. As part of its analysis, the Board reiterated that the nexus between the alleged commercial success and the asserted patent claims must be both embodied by the commercial product and coextensive with them. The Board went on to find that “the record before [the Board] does [...]

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Absent Nexus Secondary Considerations Come in Second

by Courtney Seams and Gaylon C. Hollis | Jun 15, 2023 | Patents

Addressing the nexus between a secondary consideration and the claimed invention in assessing obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board finding of nonobviousness because the Board erred in its nexus analysis regarding secondary considerations. Yita LLC v. MacNeil IP LLC, Case Nos. 22-1373; -1374 (Fed. Cir. June 6, 2023) (Taranto, Chen, Stoll, JJ.)

Yita petitioned for inter partes review (IPR) of all claims of two patents. The patents share a common specification and cover vehicle floor trays that are theraformed from a polymer sheet of substantially uniform thickness. These trays (illustrated below) were designed to closely conform to the walls of the vehicle foot well so that the trays would stay in place once installed.

The Board found that the claims of one of the patents were not obvious even though an artisan would have been motivated to combine the prior art asserted (which disclosed the “close conformance” limitation) and would have had a reasonable expectation of success because the evidence of secondary considerations was overpowering and included a nexus between the evidence of success and the patented invention. The Board also found that the claims of the other patent were not obvious because the “1/8 inch limitation” regarding the thickness of the foot well was not disclosed in the prior art. The Board declined to consider Yita’s argument, which was raised for the first time in its reply brief. Yita appealed.

Yita argued that the Board committed a legal error in its analysis of the secondary consideration evidence for the first patent and abused its discretion by not considering the argument Yita raised in its reply brief regarding the other patent.

On the secondary considerations issue, the Federal Circuit explained that the Board erred in finding a nexus between the secondary consideration evidence of success and the claimed invention because the Board exclusively related to a feature that was well-known in the prior art (i.e., the close conformance between the tray and the vehicle floor). The Court explained that where the prior art teaches a well-known feature and an artisan would have been motivated to combine such prior art with an expectation of success, any secondary consideration that is exclusively related to the well-known feature will not rescue the claim from obviousness. The Court noted that while secondary considerations can be linked to an individual element of the claimed invention or to an inventive combination of elements, here the Board relied on secondary consideration evidence that was related entirely to the already well-known close conformance of the tray and vehicle floor.

The Federal Circuit next addressed Yita’s argument that the Board should have considered an argument raised in Yita’s reply brief regarding the 1/8-inch limitation. Yita failed to raise the argument that it would have been obvious to modify a prior art reference to arrive at the “1/8 inch limitation” [...]

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Blunt Rejection of Attorney Fees in Stipulated Dismissal

by Lillian Spetrino | May 18, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the rejection of attorney fees, finding that neither inequitable conduct nor a conflict of interest rendered the case exceptional given the limited factual record following a stipulated dismissal in a patent case. United Cannabis Corp. v. Pure Hemp Collective Inc., Case No. 22-1363 (Fed. Cir. May 8, 2023) (Lourie, Cunningham, Stark, JJ.).

United Cannabis Corporation (UCANN) sued Pure Hemp for patent infringement. After the litigation was stayed pending bankruptcy proceedings, the parties stipulated to the dismissal. Pure Hemp then sought attorney fees based on alleged inequitable conduct by UCANN during prosecution of the asserted patent due to nondisclosure of a prior art reference used in the patent’s specification and based on a purported conflict of interest by UCANN’s litigation counsel. The district court denied Pure Hemp’s request, finding that the case was not exceptional. Pure Hemp appealed.

Pure Hemp argued that the district court erred by (1) failing to find Pure Hemp to be the prevailing party in the litigation, (2) not concluding that the undisputed facts established inequitable conduct and (3) not recognizing that UCANN’s attorneys had a conflict of interest.

The Federal Circuit found that although the district court erred in not finding Pure Hemp to be the prevailing party, this was a harmless error. The Court explained that by fending off UCANN’s lawsuit with a stipulation dismissing UCANN’s claims with prejudice, Pure Hemp is a prevailing party under § 285. However, the Court concluded that this error was harmless because the district court ultimately concluded that this case was unexceptional.

The Federal Circuit found Pure Hemp’s arguments on inequitable conduct without merit. The Court explained that it had no findings to review because Pure Hemp voluntarily dismissed its inequitable conduct counterclaim and did not seek any post-dismissal inequitable conduct proceedings. Although Pure Hemp argued that it could prevail based on the undisputed facts in the record, the Court disagreed. It explained that even the limited record demonstrated at least a genuine dispute as to both the materiality and intent prongs of inequitable conduct and, therefore, the district court properly determined that Pure Hemp did not demonstrate that this case was exceptional.

The Federal Circuit also rejected Pure Hemp’s argument that copying and pasting portions from the prior art in the patent’s specification (but not disclosing the same prior art references) was inequitable conduct. The Court explained that unlike the nonbinding cases Pure Hemp relied on, the district court here did not find that the copied prior art was material, and the record gave no reason to disbelieve the explanation provided by UCANN’s prosecution counsel. The Court was also unpersuaded by Pure Hemp’s arguments to support inequitable conduct, explaining that the Court was not free to make its own findings on intent to deceive and materiality and, further, the district court was not required to provide its reasoning for its decision in attorney fee cases.

As to Pure Hemp’s argument that the case was exceptional because UCANN’s attorneys [...]

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If Prior Art Discloses Ingredients and How to Mix Them, the “Cake” Is Anticipated

by Kyle Sorenson, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed that challenged claims were invalid as anticipated based on principles of inherency where the disclosed prior art formulations and processes necessarily met a disputed claim limitation. Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 20-1183 (Fed. Cir. April 11, 2023) (Reyna, Schall, Chen, JJ.)

Arbutus Biopharma owns a patent that matured from an application filed on March 9, 2015, that claims priority to a provisional application filed on June 30, 2010. The claimed invention provides stable nucleic acid-lipid particle (SNALP) formulations with a non-lamellar structure that function to increase the efficiency of nucleic acid entry into cells to promote the downregulation of gene expression. The non-lamellar morphology of a SNALP formulation was known to depend on two factors: the lipids incorporated into the SNALP formulation, and the process used to form the SNALPs. The patent disclosed five SNALP formulations of various compositions that can be used and incorporated by reference two US patent publications, which describe two methods that can be used to make SNALP formulations: the Direct Dilution Method (DDM) and the Stepwise Dilution Method (SDM). The representative independent claim recites a composition of SNALPs, wherein each particle in the plurality of SNALP particles comprises a nucleic acid and various lipid types. The claim also requires that at least 95% of the particles in the plurality of particles have a non-lamellar morphology (the Morphology Limitation).

Moderna filed a petition for inter partes review (IPR) asserting that all the claims of the Arbutus patent were anticipated by a prior art patent. The Patent Trial & Appeal Board found that although the Morphology Limitation was not expressly found in the prior art, the claims were anticipated. The Board determined that the Morphology Limitation was an inherent property (or natural result) of the prior art disclosures. On appeal, Arbutus challenged the Board’s inherent and express anticipation findings for many of the challenged claims, including for the Morphology Limitation.

A limitation is inherent if it is the natural result flowing from the prior art’s explicit disclosure. In other words, a limitation is inherent when the limitation is a property necessarily present in the invention and not actually an additional requirement imposed by the claims. In the IPR proceeding, Moderna argued that the Morphology Limitation was inherent because one skilled in the art would necessarily obtain formulations meeting this limitation by making formulations using the five formulations disclosed by the patent and using the DDM method (from the incorporated-by-reference disclosures) to prepare the formulations.

Both the challenged patent and the prior art disclosed five formulations that can be used to obtain the SNALP formulations. Evidence showed that any differences between the formulations disclosed in these patents would not impact the Morphology Limitation. The Federal Circuit found that substantial evidence supported a finding that the formulations disclosed in both the challenged patent and the prior art were the same or essentially the same.

The Federal Circuit further explained that both the challenged patent and the [...]

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Overlapping Ranges in Prior Art Put Burden on Patentee to Show Criticality

by Alexandra Cavazos, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit found that the challenged patents were invalid as anticipated and obvious in a case involving claimed ranges and prior art that included teachings with overlapping ranges. UCB, Inc. v. Actavis Laboratories UT, Inc., Case No. 21-1924 (Fed. Cir. Apr. 12, 2023) (Moore, C.J.; Chen, Stoll, JJ.)

UCB owns two prior art patents (the Mueller patents), one directed to methods for stabilizing rotigotine that covers a drug used in UCB’s Neupro® transdermal patches to treat Parkinson’s disease, and the other directed to the stable dispersions of rotigotine used in Neupro® transdermal patches.

Soon after UCB began marketing its original Neupro® transdermal patch in 2007, it discovered that rotigotine crystallized when the patch was kept at room temperature, which lowered the amount of rotigotine available to cross the skin/blood barrier and enter the patient’s circulation and reduced the product’s effectiveness. UCB recalled Neupro® from the market in the United States. In Europe, it marketed Neupro® only under “cold chain” conditions, which reduced the rotigotine crystallization.

The challenged patent in this case solved the problem of room temperature crystallization using dispersions in which the ratio of rotigotine to the stabilizer polyvinylpyrrolidone (PVP) ranged from “about 9.4 to about 9.6.” The original Neupro® formulation had a rotigotine to PVP ratio of 9:2, and the Mueller patents disclosed a partially overlapping range of 9:1.5 to 9:5, as shown in the following graphic from the Federal Circuit’s opinion:

The reformulated Neupro had a ratio of 9:4 rotigotine to PVP and exhibited stability for up to two years at room temperature.

The district court held that the Mueller patents anticipated all asserted claims because a person of ordinary skill in the art (POSA) would “readily envisage” a combination of 9% rotigotine with 4% to 5% of PVP. The district court also determined that all claims were obvious in light of the Mueller patents and other prior art.

Anticipation/Overlapping Ranges

The Federal Circuit first noted that although the prior art that discloses a point within a claimed range generally anticipates that claim, such was not the case here, and the district court committed legal error treating it thus.

Instead, the Federal Circuit treated this case as one of overlapping ranges. Under that legal rubric, once a patent challenger establishes a prima facie case of anticipation by showing that the claimed range partially overlaps with the cited art, the burden shifts to the patentee to show that the “claimed range is critical to the operability of the claimed invention.” The Court stopped short of ruling that UCB had not met its burden of showing the criticality of the range because it concluded that the two patents in question were obvious in light of the overlap between the claimed ranges and those of the Mueller patents.

Teaching Away

The Federal Circuit affirmed the district court’s rejection of UCB’s arguments that Tang, another prior [...]

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Prior Art Coherency and Cache Incoherency: “Known-Technique” Rationale for Motivation to Combine

by Jake B. Vallen | Mar 23, 2023 | Patents

The US Court of Appeals for the Federal Circuit, addressing the issue of whether certain factual and legal conclusions relating to obviousness were supported by substantial evidence, held that the Patent Trial & Appeal Board improperly rejected evidence of “known-technique” rationale to provide a motivation to combine. Intel Corp. v. PACT XPP Schweiz AG, Case No. 22-1037 (Fed. Cir. Mar. 13, 2023) (Newman, Prost, Hughes, JJ.)

PACT owns a patent that “relates to multiprocessor systems and how processors in those systems access data.” The claimed multiprocessor system addressed cache incoherency, a problem associated with the use of multiple cache memories to store data, particularly local copies of the same data stored on multiple processors. Cache incoherency (i.e., inconsistencies among different cache processors) “may arise if one processor changes its local copy of the data and that change isn’t propagated to the other copies of that data.”

Intel petitioned for inter partes review of claims 4 and 5 of the patent, relying on two prior art references, Kabemoto and Bauman. Kabemoto and Bauman both address the problem of cache incoherency. As the Federal Circuit explained, Kabemoto maintains cache coherency “by ‘snooping’ along a shared ‘bus,’” while Bauman “us[es] a global, segmented secondary cache.”

The Board upheld the patentability of the challenged claims, concluding that “Intel failed to prove the obviousness of each limitation of [independent] claim 4,” from which claim 5 depended. Intel had contended that a person of ordinary skill in the art would combine Kabemoto and Bauman to teach all limitations in claim 4 by “replac[ing] Kabemoto’s secondary caches” with “Bauman’s segmented global [secondary cache],” which is a separate cache. PACT did not dispute that the combination of Kabemoto and Bauman taught each limitation of claim 4 but argued that Intel failed to demonstrate a motivation to combine Kabemoto and Bauman.

The Board nevertheless found that Intel failed to demonstrate that the prior art disclosed the segment-to-segment limitation and concluded that Intel failed to show that a person of ordinary skill in the art would have been motivated to combine the teachings of Kabemoto and Bauman. Intel appealed.

The Federal Circuit first addressed Intel’s contention “that substantial evidence d[id] not support the Board’s determination that the prior art fails to disclose the segment-by-segment limitation” of claim 4. The Court found that “Bauman’s Figure 6 teaches—if not plainly illustrates—the segment-to-segment limitation of the claims interconnect system” and reversed the Board’s contrary conclusion.

Next, the Federal Circuit addressed Intel’s contention that the Board’s determination that there was no motivation to combine Kabemoto and Bauman was not supported by substantial evidence. On this issue, the Court reasoned that under KSR, it was “enough for Intel to show that there was a known problem of cache incoherency in the art, that Bauman’s secondary cache helped address that issue, and that combining the teachings of Kabemoto and Bauman wasn’t beyond the skill of an ordinary artisan.” As the Court put it, “[n]othing more is required to show a motivation to combine under KSR.”

Explaining [...]

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Absent Expressed Rationale of Obviousness, Federal Circuit Calls for Do-Over

by Anisa Noorassa | Jan 19, 2023 | Patents

The US Court of Appeals for the Federal Circuit reversed a ruling by the Patent Trial & Appeal Board (Board) where, on appeal, the US Patent & Trademark Office’s (PTO) rationale for sustaining the Board’s obviousness rejection did not reflect “the reasoning or findings the Board actually invoked.” In Re Google, LLC, Case No. 22-1012 (Fed. Cir. Jan. 9, 2023) (Moore, C.J., Lourie, Prost, JJ.)

Google’s patent application covers a method of filtering search results to display age-appropriate results using a “content rating score” in combination with a predetermined threshold value to determine which results will be presented. The application discloses several ways that the threshold value can be calculated, including using the length of the search query as a proxy for the age of the user, with longer queries being associated with older users and leading to a lower threshold score (allowing more mature content to be shown).

The application received a final rejection from the examiner, who asserted that the claims would have been obvious under 35 U.S.C. § 103 based on two prior art references, Parthasarathy and Rose. Parthasarathy disclosed a method to determine a content score to use for ranking results, while Rose disclosed a method to assign result importance based on query length. The examiner argued that it would be obvious to combine Rose and Parthasarathy to achieve the claimed method that recited a “predetermined threshold value” based on the number of words in a query. The examiner acknowledged that Parthasarathy did not disclose a threshold based on a number of words but found that Rose did, citing Rose’s modified relevance-ranking algorithm. He reasoned that it would have been obvious to combine Rose and Parthasarathy to achieve the claimed threshold because “analyzing a query for determining the query length and using the query length as a threshold is very well known in the art and doing so would further provide for assigning weight to a long or a short query for retrieving documents.” Google appealed the examiner’s decision to the Board, which affirmed the examiner’s rejection and adopted the examiner’s findings. Google appealed to the Federal Circuit.

On appeal, the PTO argued that because there were only two ways a person of ordinary skill in the art could modify Parthasarathy’s threshold to incorporate Rose, either of the modifications would have been obvious. However, the Federal Circuit found that this argument was not supported by the Board’s decision. The Court explained that while the Board did conclude that modifying Parthasarathy’s threshold to take into account the length of the query would have been obvious, the Board did not provide any detail as to how that would be achieved. In the absence of specific fact-based findings by the Board, the Court explained that it could not adopt the PTO’s argument, which rested on facts not found in the Board’s decision. A ruling relying on these facts would have resulted in a violation of basic administrative law principles since a court may only uphold an agency action on [...]

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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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