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Hit the Brakes: Experimental Use, Enhanced Damages Determinations Require Redo

by Paul Devinsky | May 12, 2022 | Patents

The US Court of Appeals for the Federal Circuit reversed and remanded a district court decision regarding experimental use under 35 U.S.C. § 102(b) and the application of enhanced damages based on an allegedly flawed noninfringement and invalidity opinion. Sunoco Partners Mktg. & Terminals L.P. v. U.S. Venture, Inc., Case Nos. 20-1640; -1641. (Fed. Cir. Apr. 29, 2022) (Prost, Reyna, Stoll, JJ.)

Sunoco sued Venture for infringement of four patents related to blending butane into gasoline. Venture argued that certain patent claims were invalid because they were subject to the on-sale bar of 35 U.S.C. § 102(b). The district court found that the sale at issue was primarily for experimentation and that the on-sale bar did not apply. Venture also argued that certain claim terms required measuring the actual vapor pressure of the butane and gasoline, but the district court rejected this argument. The district court found infringement and awarded Sunoco $2 million in damages, which it trebled to $6 million after finding that Venture lacked a good faith belief of invalidity or noninfringement because the legal opinion Venture relied upon was flawed. Venture appealed.

On appeal, Venture challenged numerous issues, including the district court’s rejection of its on-sale bar defense, construction of two claim terms and decision to enhance damages.

The Federal Circuit first addressed the district court’s finding that the on-sale bar did not apply to certain claims of two of the asserted patents. Reviewing de novo, the Court applied the Supreme Court’s 2019 Helsinn v. Teva decision, which requires that the on-sale bar applies if the invention was the subject of a commercial sale and ready for patenting. Analyzing the first prong, the Court looked to the contract language of the sale at issue. The inventor’s company offered to sell and install its butane blending technology at a customer’s fuel terminal more than one year before filing the patent application. The terms of the agreement required that the customer commit to purchasing at least 500,000 barrels of butane as consideration for the installation of the fuel mixing system. The Court noted that this agreement expressly described the transaction as a “sale” and did not reference any experimental purpose.

The Federal Circuit was not swayed by the lower court’s view that the contract did not require the customer to pay for the system directly, finding that a commitment to buy product in the future constituted a sale. The Court also gave little weight to the preinstallation testing terms of the agreement, finding that those tests were not experiments, but rather tests to confirm that the equipment was operating as contractually promised. Additional contract terms further cemented the Court’s view that this transaction was a sale, including language that the technology had already been “developed” and that title to the equipment transferred to the customer. The Court concluded that the sale of the system to the customer was not primarily for experimentation. The Court reversed the district court’s experimental-use determination and vacated its infringement determination, directing [...]

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Robotic Skepticism May Not Trump Motivation to Combine

by Joshua Revilla | May 12, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board (Board) decision finding the challenged claims patentable because the Board impermissibly rested its motivation-to-combine analysis on evidence of general skepticism in the field of invention. Auris Health, Inc. v. Intuitive Surgical Operations, Case No. 21-1732 (Fed. Cir. Apr. 29, 2022) (Dyk, Prost, JJ.) (Reyna, J., dissenting).

Intuitive owns a patent that describes an improvement over earlier robotic surgery systems that allows surgeons to remotely manipulate surgical tools using a controller. The patent focuses on solving the problem of swapping surgical tools by implementing a pulley system that allows tools to be swapped in and out more quickly. Auris petitioned for inter partes review (IPR) of the patent, arguing that a combination of two references disclosed every limitation of the challenged claims. Auris further argued that a skilled artisan would be motivated to combine the references to decrease the number of assistants needed during surgery. While the Board agreed that the combination of the two references disclosed every limitation of the challenged claims, it found that a person of ordinary skill in the art would not be motivated to combine the references because of general skepticism from surgeons “about performing robotic surgery in the first place.” Auris appealed.

The Federal Circuit began by explaining that the motivation-to-combine inquiry asks whether a skilled artisan “not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.” The Court also explained that as to the “‘would have’ question, ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.’”

The Federal Circuit concluded that generic industry skepticism about robotic surgery cannot, on its own, preclude a finding of a motivation to combine. The Court explained that although industry skepticism can play a role as a secondary consideration in an obviousness finding, such evidence must be specific to the invention and not simply the field as a whole. The Court concluded that the Board’s motivation-to-combine determination was based almost exclusively on evidence of general skepticism. Thus, the Court vacated the decision and remanded the case, directing the Board to examine the evidence using the correct obviousness criteria.

Judge Reyna issued a dissenting opinion in which he disagreed as to whether the Federal Circuit should implement a rule that general skepticism cannot support a finding of no motivation to combine. Judge Reyna expressed concern that the majority opinion could be understood to create an inflexible, rigid rule that the Board cannot consider evidence of skepticism toward the invention , including whether that skepticism would have dissuaded a skilled artisan from making the proposed combination. Judge Reyna also argued that notwithstanding the majority opinion, the Board did not rely solely on general skepticism, but rather provided additional explanation as to why the “no [...]

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Golden State of Mind: Witness Convenience Isn’t Based Solely on Travel Distance

by Amol Parikh | May 5, 2022 | Patents

The US Court of Appeals for the Federal Circuit ordered a district court to transfer a patent infringement case from Texas to California because the district court had wrongly assessed facts relating to the convenience of witnesses when it originally denied a motion to transfer venue. In re: Apple Inc., Case No. 22-128 (Fed. Cir. Apr. 22, 2022) (Dyk, Reyna, Chen, JJ.) (non-precedential).

CPC Patent Technologies PTY Ltd. filed a lawsuit against Apple in the Western District of Texas, alleging that Apple’s mobile phones, tablets and computing products equipped with Touch ID, Face ID or Apple Card features infringed three of CPC’s patents relating to biometric security. Apple moved to transfer to the Northern District of California, arguing that its employees responsible for the design, development and engineering of the accused functionality resided either in California or outside of the United States, and that the employees most knowledgeable about the marketing, licensing and financial issues relating to the accused products resided in California. Apple explained that no employees with relevant information worked in Western Texas.

The district court denied Apple’s motion. After acknowledging that the action might have been brought in Northern California, the district court analyzed the private and public interest factors governing transfer determinations. The court determined that the factor concerning the convenience of willing witnesses slightly favored transfer. However, the court determined that the factor accounting for the availability of compulsory process weighed strongly against transfer. The district court also determined that court congestion and practical problems factors weighed against transfer based on its ability to quickly reach trial and the fact that CPC had another pending infringement suit in Western Texas. The district court recognized that Apple had identified seven relevant witnesses in California who would have to travel to Texas but found that inconvenience was counterbalanced by the presence of two Apple employees in Austin who CPC insisted had relevant information, and an Apple witness in Florida who would “find it about twice as inconvenient to travel to [Northern California] than to [Western Texas] because Texas sits halfway from Florida to California.” The district court also relied on its ability to compel the third-party Mac Pro manufacturer in Western Texas to attend trial. Finally, the Court noted that there was local interest in the dispute because Apple employs thousands of workers in Western Texas. Balancing these facts, the district court determined that Apple had failed to meet the burden of proving that Northern California was clearly more convenient that Western Texas, and thus denied the motion. Apple petitioned for mandamus review.

The Federal Circuit reversed, finding that Apple had shown clear entitlement to transfer to the Northern District of California. The Court found that the district court erroneously relied on two Apple employees in Austin whom CPC identified as potential witnesses and concluded that it was far from clear that either employee had relevant or material information. One employee had testified that he worked on authentication technology that was different from that accused by CPC, [...]

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Terms of Degree Not Always Indefinite

by Tim Dunker | Apr 21, 2022 | Patents

The US Court of Appeals for the Federal Circuit overturned a district court determination that the claim terms “resilient” and “pliable” were indefinite. The Federal Circuit found that the claims, while broad, were sufficiently definite in view of both intrinsic and extrinsic evidence. The Federal Circuit also upheld the district court’s findings of no induced infringement, finding zero evidence of predicate direct infringement of the properly construed method claims. Niazi Licensing Corp. v. St. Jude Medical S.C., Inc., Case No. 21-1864 (Fed. Cir. Apr. 11, 2022) (Taranto, Bryson, Stoll, JJ.) The Federal Circuit also affirmed entry of sanctions excluding portions of the plaintiff’s technical and damages expert reports for failing to disclose predicate facts during discovery and also affirmed exclusion of portions of plaintiff’s damages expert report as unreliable for being conclusory and legally insufficient.

In reaching its decision on indefiniteness, the Federal Circuit focused on the terms “resilient” and “pliable” as used in a claim directed to a double catheter structure. Citing the 2014 Supreme Court decision in Nautilus v. Biosig Instruments, the Federal Circuit explained that language has “inherent limitations,” and stated that a “delicate balance” must be struck to provide “clear notice of what is claimed” and avoid the “zone of uncertainty” relating to infringement. The Court noted that under Nautilus, claims must provide “objective boundaries,” but the Court distinguished the present case from those in which “subjective boundaries” created uncertainty and rendered the claim indefinite. The Court pointed to its 2005 decision in Datamize v. Plumtree Software as a “classic example” of subjectivity where the term “aesthetically pleasing” was deemed indefinite because the patent provided no way to provide “some standard for measuring the scope of the phrase.” The Court also noted that a patent’s claims, written description and prosecution history—along with any relevant extrinsic evidence—can provide or help identify the necessary objective boundaries for claim scope

The Federal Circuit concluded that there was sufficient support in the intrinsic evidence, both in the claims themselves and the written description, to allow a skilled artisan to determine the scope of the claims with reasonable certainty. The Court explained that the claim at issue recited “an outer, resilient catheter having shape memory” that “itself provides guidance on what this term means—the outer catheter must have ‘shape memory,’ and ‘sufficient stiffness.’” The Court also cited to “[n]umerous dependent claims [that] further inform the meaning of this term by providing exemplary resilient materials of which the outer catheter could be made. . . . The written description provides similar guidance . . . . Thus, a person of ordinary skill reading the claims and written description would know of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape.”

The Federal Circuit distinguished this case from Datamize, where the claim scope depended on the eye of each observer, finding it more akin to its 2017 decision in Sonix Technologies. In that [...]

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Missed Connection: Avoid Claim Construction Rendering Independent Claim Narrower Than Dependent Claim

by Tessa Kroll | Apr 14, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated a district court’s claim constructions concerning generic independent claims that were amended after a species restriction requirement, because the district court disregarded the doctrine of claim differentiation after incorrectly concluding that the examiner had mistakenly rejoined withdrawn claims. Littelfuse, Inc. v. Mersen USA EP Corp., Case No. 21-2013 (Fed. Cir. Apr. 4, 2022) (Prost, Bryson, Stoll, JJ.)

Littelfuse owns a patent directed to a fuse end cap for providing an electrical connection between a fuse and an electrical conductor. The specification teaches three embodiments of the invention:

A single-piece machined end cap comprising a mounting cuff and a terminal
A single-piece stamped end cap comprising a mounting cuff and a terminal
A two-piece assembled end cap comprising a mounting cuff, a terminal and a fastening stem attaching the mounting cuff to the terminal.

The originally filed claims included independent claims covering an end cap with a mounting cuff and a terminal, and dependent claims directed to the three embodiments. The claims directed to the two-piece assembled end cap embodiment contained the limitation that the terminal is press-fit onto the fastening stem.

During prosecution, the examiner issued a restriction requirement, asserting that the independent claims were generic to the three species in the dependent claims. Littelfuse elected to prosecute the assembled end cap species and the examiner withdrew the claims directed to the other embodiments. In response to a novelty rejection, Littelfuse amended the independent claims by adding the fastening stem element without specifying that the terminal is press-fit onto the stem. After allowing the amended independent claims, the examiner concluded that the previously withdrawn claims “require all the limitations of the . . . allowable claims,” and thus rejoined them.

Littelfuse sued Mersen for selling allegedly infringing fuses. The parties asked the district court to determine whether the fastening stem element in the independent claims limited Littelfuse’s patent to multi-piece end caps, despite the rejoined dependent claims being directed to one-piece embodiments. The district court found that the claim language, the specification and the prosecution history required the invention to have a multi-piece construction. First, the district court determined that the plain meaning of “fastening stem” was “a stem that attached or joins the other two components of the apparatus.” The district court then noted that the fastening stem was only mentioned in the specification in relation to the multi-piece embodiment in which the terminal is joined to the mounting cuff by the fastening stem. While Littelfuse argued that the US Patent & Trademark Office’s rejoining of the withdrawn claims meant that the independent claims covered unitary and multi-piece embodiments, the district court reasoned that the claims were rejoined based on a “misunderstanding” because they referred to the original independent claim, which did not include a fastening stem. In light of the district court’s finding that the independent claims covered only a multi-piece apparatus, the parties stipulated to non-infringement. Littelfuse appealed.

Applying the doctrine of claim differentiation, the [...]

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Acts Supporting Induced Infringement Allegations Must Occur During Damages Period

by Katherine Pappas | Apr 14, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated a damages verdict because the acts supporting the induced infringement finding took place years before the statutory damages period and thus could not support a finding of specific intent to induce infringement. Roche Diagnostics Corporation v. Meso Scale Diagnostics, LLC, Case Nos. 21-1609; -1633 (Fed. Cir. Apr. 8, 2022) (Prost, Taranto, JJ.) (Newman, J., dissenting).

Meso Scale Diagnostics (Meso) was formed in 1995 pursuant to a joint venture agreement between IGEN and Meso Scale Technologies. As part of the agreement, IGEN granted Meso exclusive rights to certain patents. In 1998, Roche acquired Boehringer Mannheim GmbH, an entity that IGEN had previously licensed to develop, use, manufacture and sell ECL assays and instruments in a particular field. As a result of the acquisition, Roche acquired Boehringer’s license rights, including the field-of-use restrictions. In 2003, IGEN and Roche terminated the 1992 agreement and executed a new agreement granting Roche a non-exclusive license to IGEN’s ECL technology in the field of “human patient diagnostics.” As part of the transaction, IGEN transferred its ECL patents to a newly formed company, BioVeris. In 2007, Roche also acquired BioVeris, including the ECL patents. Roche believed the acquisition meant the elimination of the field-of-use restrictions (and hence no patent liability) and began selling its products without regard to those restrictions.

In 2017, Roche sued Meso seeking a declaratory judgment that it did not infringe Meso’s rights arising from the 1995 joint venture license agreement. Meso counterclaimed for infringement. At summary judgment, Roche argued that Meso’s 1995 license didn’t convey the rights Meso asserted. The district court denied Roche’s summary judgment motion, and the parties tried the case to a jury. The jury found that Meso held exclusive license rights to the asserted claims, that Roche directly infringed one patent and induced infringement of two others and that Roche’s infringement was willful. The district court denied Roche’s post-trial motions challenging the infringement verdict and damages award. The district court granted Roche’s motion for judgment as a matter of law (JMOL) on willfulness but denied Meso’s motion to enhance damages. The district court also rendered a non-infringement judgment on three additional patents on the ground that Meso waived compulsory counterclaims. Roche appealed the findings regarding the scope of Meso’s license rights, the induced infringement verdict and the damages award. Meso appealed the district court’s application of the compulsory counterclaim rule.

The Federal Circuit first addressed the scope of Meso’s rights under the 1995 license agreement, which was the only ground on which Roche challenged the direct infringement judgment. The Court found that there was clear testimony from the manager of the joint venture that the work involved in developing the patent that was found to be directly infringed was part of the joint venture. The Court dismissed Roche’s argument that Meso acted in a manner that demonstrated that it had accepted Roche’s rights to the asserted patents, finding that the argument was “made in passing only in a footnote,” [...]

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Game Reset: Extrinsic Evidence Can’t Limit Claim Scope Beyond Scope Based on Unambiguous Intrinsic Evidence

by McDermott Will & Emery | Apr 7, 2022 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s grant of summary judgment of noninfringement after concluding that the district court erred by relying on expert testimony to construe a claim term in a manner not contemplated by the intrinsic evidence. Genuine Enabling Tech. LLC v. Nintendo Co., Ltd., et al., Case No. 20-2167 (Fed. Cir. Apr. 1, 2022) (Newman, Reyna, Stoll, JJ.)

Genuine owns a patent directed to a user interface device (UID) that, in the process of synchronizing and merging data streams into a combined data stream, directly receives microphone speech input and transmits speech output via a speaker. During prosecution, the inventor distinguished “slow varying” physiological response signals discussed in a prior art reference from the “signals containing audio or higher frequencies” in his invention, arguing that the latter posed a signal “collision” problem that his invention solved. In distinguishing the prior art, the inventor explained that his invention “describes, in its representative embodiments, how to combine the data from a UID (mouse) and from a high-frequency signal, via a framer, which is unique and novel.”

Genuine subsequently filed a lawsuit against Nintendo, accusing Nintendo’s Wii Remote, Wii Remote Plus, Nunchuk, WiiU GamePad, Switch Joy-Con Controller and Switch Pro Controller of infringing the patent. During claim construction, the parties asked the district court to construe the term “input signal.” Genuine proposed the construction of the disputed claim term to be “a signal having an audio or higher frequency,” whereas Nintendo proposed the narrower construction of “[a] signal containing audio or higher frequencies.” Relying on expert testimony, Nintendo also argued that the inventor “disclaimed signals that are 500 [Hz] or less . . . generated from positional change information, user selection information, physiological response information, and other slow-varying information.”

The district court found that the inventor’s arguments amounted to a disclaimer. Crediting Nintendo’s expert testimony, the district court construed “input signal” as “signals above 500 Hz and excluding signals generated from positional change information, user selection information, physiological response information, and other slow-varying information.” The district court subsequently granted summary judgment of noninfringement, finding that the accused controllers produced the types of slow-varying signals that the inventor had disclaimed during prosecution. Genuine appealed.

Genuine argued that the district court erred in construing “input signal” by improperly relying on extrinsic evidence and improperly finding that the inventor disclaimed certain claim scope during prosecution. The Federal Circuit agreed, reiterating that although extrinsic evidence can be helpful in claim construction, “the intrinsic record ‘must be considered and where clear must be followed,’” such that “where the patent documents are unambiguous, expert testimony regarding the meaning of a claim is entitled to no weight.” In this case, although the parties agreed that the inventor had disavowed claim scope during prosecution, there was a dispute as to the scope of the disclaimer beyond signals below the audio frequency spectrum.

The Federal Circuit explained that for a statement made during prosecution to qualify as a disavowal of claim scope, it [...]

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Not a Bullseye: Defendant Must Rebut Presumption That Claims Lacking “Means” Language Don’t Fall Under § 112 ¶ 6

by Paul Devinsky | Mar 31, 2022 | Patents

Reversing a district court finding of indefiniteness under 35 U.S.C. § 112 ¶ 6, the US Court of Appeals for the Federal Circuit found that the district court erred by ignoring unrebutted evidence that the challenged claim terms would have been understood to connote sufficiently definite structure to avoid means-plus-function construction. Dyfan, LLC v. Target Corp., Case No. 21-1725 (Fed. Cir. Mar. 24, 2022) (Lourie, Dyk, Stoll, JJ.)

Dyfan sued Target for infringement of two patents directed to location-based message delivery. During claim construction proceedings, Target argued that certain claim limitations should be construed as means-plus-function limitations and that the specification failed to disclose the requisite corresponding structure. The district court found that three claim terms were subject to § 112 ¶ 6. For the terms “code” and “application,” the court assigned a “special-purpose computer function” as the corresponding structure and found that the specification did not disclose a requisite algorithm for the functions of the computer. The district court also found that the claim term “system” was subject to § 112 ¶ 6 because it recited purely functional language without disclosing sufficient corresponding structure, and that it was unclear which of the recited components performed the recited function. The district court concluded that all three terms were indefinite under § 112 ¶ 2 for lack of corresponding structure. Dyfan appealed.

Reviewing de novo, the Federal Circuit first addressed whether the claim language invoked § 112 ¶ 6. As the Court had stated previously, there is a rebuttable presumption that a claim limitation is not drafted in a means-plus-function format if it does not contain the term “means.” However, that presumption can be overcome if a challenger demonstrates that the term fails to recite sufficiently definite structure. The Court also explained that for purposes of § 112 ¶ 6, certain “nonce words that reflect nothing more than verbal constructs” are tantamount to using the word “means.”

Turning to the case merits, the Federal Circuit first considered the terms “code” and “application.” Given the absence of “means” language, Target was required to show by a preponderance of the evidence that persons of ordinary skill in the art would not have understood those terms to connote structure considering the claim as a whole. The Court found that the district court erred in concluding that Target overcame the presumption that § 112 ¶ 6 did not apply. The Court relied on unrebutted testimony from Target’s expert witness that the district court ignored. The expert testified that both terms would have connoted structure, such as off-the-shelf software. The Court found that this unrebutted testimony demonstrated that neither claim limitation recited purely functional language.

The Federal Circuit explained that the district court failed to follow its 2018 decision in Zeroclick v. Apple. In that case, the Court reversed a district court’s finding that the claim terms “program” and “user interface” invoked § 112 ¶ 6, finding that both terms were references to conventional program code existing in the prior [...]

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Only under Rare Circumstances Can the Patent Trial & Appeal Board Find Proposed Substitute Claims Unpatentable on Its Own

by James M. Oehler | Mar 31, 2022 | Patents

The US Court of Appeals for the Federal Circuit addressed, for the first time, the issue of when the Patent Trial & Appeal Board (Board) may raise a ground of unpatentability that was not advanced by a petitioner in relation to proposed substitute claims. The Court upheld the standard defining the “rare circumstances” in which such a ruling is proper while questioning the Board’s reasoning and application of the standard. Hunting Titan, Inc. v. DynaEnergetics Europe GMBH, Case Nos. 20-2163; -2191 (Fed. Cir. Mar. 24, 2022) (Prost, C.J., Reyna, Hughes, JJ.) (Prost, C.J., concurring).

Hunting Titan challenged DynaEnergetics’ patent in an inter partes review (IPR) based on anticipation and obviousness grounds. The Board found all the original claims of the patent unpatentable as anticipated. DynaEnergetics moved to amend to add proposed substitute claims. Hunting Titan opposed the motion to amend but advanced only obviousness grounds against the proposed substitute claims. The Board determined sua sponte that the proposed substitute claims were unpatentable as anticipated and, therefore, denied the motion to amend. DynaEnergetics requested rehearing, and the Precedential Opinion Panel (POP) reversed the Board’s denial of the motion to amend and determined that Hunting Titan did not prove that the proposed substitute claims were unpatentable.

The POP decided that “only under rare circumstances” should the Board sua sponte raise a ground for unpatentability not advanced by the petitioner in relation to proposed substitute claims. The rare circumstances include only two situations:

When the petitioner is not involved in the motion to amend, such as when a petitioner chooses not to oppose the motion or ceases to participate in the proceeding altogether
When evidence of unpatentability is readily identifiable and persuasive, such as if the substitute claims are unpatentable for the same reasons as the original claims.

The POP stated that in most circumstances, it is best to rely on the adversarial system and expect the petitioner to raise the unpatentability grounds for consideration.

The Federal Circuit upheld the POP’s standard for when the Board may sua sponte find proposed substitute claims unpatentable but also found the POP’s reasoning “problematic” because it placed too much emphasis on the adversarial system. The Court noted that Board proceedings, such as IPRs, are fundamentally a review of an earlier administrative proceeding, as opposed to civil litigation, The POP’s rationale was based on the public interest being served by an adversarial system rather than on the public interest being served by maintaining integrity of the patent system.

The Federal Circuit also questioned the POP’s application of its new standard to the case at hand, noting that the readily identifiable evidence exception should have been applied when the Board found the proposed substitute claims unpatentable for the same reasons it found the original claims to be unpatentable.

In her concurring opinion, Chief Judge Prost noted that “[i]t makes little sense to limit the [Board], in its role within the agency responsible for issuing patents, to the petitioner’s arguments.” Instead, “the Board must determine whether the [...]

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Outlier? Split Federal Circuit Denies En Banc Review of Written Description Requirement

by Jenny Chen, Ph.D. | Mar 31, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s request for en banc rehearing of a panel decision that invalidated a patent for lack of written description on the basis that a person of skill in the art would not be able to recognize the clinical efficacy of the claimed dose and thus would not recognize that the inventors were in possession of the claimed invention at filing. Biogen International GMBH, Biogen MA, Inc. v. Mylan Pharmaceuticals Inc., Case No. 20-1933 (Fed. Cir. March 16, 2022) (per curiam) (Moore, C.J., Lourie, Newman, JJ., dissenting).

Biogen owns a patent relating to the drug Tecfidera®. The patent claims a method of treating multiple sclerosis with dimethyl fumarate (DMF) at a specific dose of 480 mg per day via oral administration (DMF480). In the written description, the patent describes a method for treating a neurological disease using DMF and states that the neurological disease can be multiple sclerosis. The patent discloses that an effective dose of DMF for oral administration can be “from about 0.1 g to 1 g per day, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day, or from about 480 mg to about 720 mg per day; or about 720 mg per day).”

Biogen sued Mylan for infringement after Mylan submitted an abbreviated new drug application (ANDA) for a generic version of Tecfidera®. Mylan challenged the validity of the patent based on lack of written description. The district court invalidated the patent, finding that the claimed method lacked written description support because the DMF480 dose was listed only once in the specification and finding that the specification’s focus on basic research and broad DMF-dosage ranges showed that the inventors did not possess a therapeutically effective DMF480 dose at the time of filing. Biogen appealed.

In a 2–1 panel decision, the Federal Circuit affirmed the district court finding, explaining that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF-dosage range and not listed as an independent therapeutically efficacious dose.”

Judge O’Malley issued a dissenting opinion, questioning whether the district court erred in requesting clinical data showing efficacy of the claimed DMF480 dose under the written description context.

Biogen timely petitioned for en banc review, raising two questions:

Must a “written description” prove the invention’s efficacy?
Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?

The Federal Circuit issued a 6–3 decision denying the en banc petition. Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman, calling this case “an outlier” at “the farthest end of the spectrum of cases where written description has not been found” given that every claim limitation was expressly described [...]

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