Patent Trial & Appeal Board Archives

Patent Trial & Appeal Board

No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by Mike Baldwin | Aug 31, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Tune to the Right Channel: Disclosure Lacking Fraud Information Isn’t an FCA Qui Tam Bar

by Cecilia Choy, Ph.D. | Aug 17, 2023 | Patents

The US Court of Appeals for the Ninth Circuit reversed a district court’s decision to dismiss a qui tam action brought under the False Claims Act (FCA) after analyzing the public disclosure bar channels. The case required the Ninth Circuit to examine Congress’s 2010 amendments to the FCA public disclosure bar to determine whether the claims were substantially the same as information publicly disclosed in any one of three enumerated channels. Silbersher v. Valeant Pharm. Int’l, Inc., No. 20-16176 (9th Cir. Aug. 3, 2023) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on anyone who knowingly presents a fraudulent claim for payment to the federal government. The FCA includes a qui tam provision that allows private citizens (or “relators”) to bring fraud claims on behalf of the government. In 2010, Congress’s public disclosure bar precluded qui tam actions if substantially the same allegations or transactions were publicly disclosed in one of three channels:

In a federal criminal, civil or administrative hearing in which the government or its agent is a party
In a congressional, Government Accountability Office (GAO) or other Federal Report hearing, audit or investigation
From the news media, unless the action is brought by the Attorney General or the person bringing the action is an original source of the information.

Valeant owns the “Otterbeck patents” for its drug Apriso’s delayed-release formula. Valeant initiated an infringement action against Lupin, a generic drug manufacturer that attested in an abbreviated new drug application (ANDA) that the Otterbeck patents were invalid because of prior art that described a similar delayed-release formula. Thereafter, Valeant extended its monopoly by applying for and being granted a new patent that claimed a recent discovery that Apriso was effective when taken without food. GeneriCo then challenged the new patent in an inter partes review (IPR) proceeding, arguing that it was obvious that Apriso would be effective without food. GeneriCo presented two medical studies as support. The Patent Trial & Appeal Board agreed and invalidated the claims in the new patent.

Zachary Silbersher, GeneriCo’s IPR lawyer and a relator in another FCA suit in the same court, discovered that Valeant failed to disclose certain information to the US Patent &Trademark Office (PTO) during the IPR proceeding. Specifically, he discovered that three years before applying for the new patent, Valeant applied for another patent where it claimed it made an unexpected finding that taking Apriso’s active ingredient with food made the drug more effective. This claim was the opposite of the claim made in the new application that had been invalidated in the IPR proceeding.

Silbersher brought an FCA case seeking damages from Valeant, alleging that Valeant fraudulently obtained the Otterbeck and new patent to prolong its monopoly and charge an artificially high price for Apriso. The district court dismissed Silbersher’s qui tam action as precluded by the public disclosure bar because the IPR qualified as an “other Federal hearing” under channel two of the bar, as described above. Silbersher appealed.

The Ninth Circuit analyzed whether [...]

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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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RIP for POP: PTO Updates Interim Director Review Procedures

by Amol Parikh | Aug 3, 2023 | Uncategorized

On July 24, 2023, the US Patent & Trademark Office (PTO) announced that a revised interim Director Review (DR) process and Appeals Review Panel (ARP) process will replace the Precedential Opinion Panel Process. Updates to the interim DR process include the following:

Expanding the process to permit parties to request DR of Patent Trial & Appeal Board decisions on institution in America Invents Act (AIA) proceedings
Providing updated guidance as to what types of issues the Director will consider in DR, as well as additional guidance on several topics, such as the initiation of DR at the sole discretion of the Director (sua sponte DR), remands to Board for further proceedings and the Director’s sanction authority
Providing the Director with the option to delegate review to a new independent panel called the Delegated Rehearing Panel (DRP)
Creating a new ARP, which may be convened by the Director sua sponte to review Board ex parte, reexamination or reissue appeal decisions.

Under the interim DR process, a party to a Board decision may now request DR of a Board decision, whether to institute trial, a final written decision or a decision granting a request for rehearing.

After a DR request is received and processed, the request will then be routed to an Advisory Committee that the Director has established to assist with the process. The Advisory Committee comprises 11 members and includes representatives from various PTO business units who serve at the discretion of the Director. A quorum of seven members is needed for the committee to meet. The Advisory Committee may include members from the following business units:

Office of the Under Secretary (not including the Director or Deputy Director)
The Board (not including members of the panel for each case under review)
Office of the Commissioner for Patents (not including the Commissioner for Patents or any persons involved in the examination of the challenged patent)
Office of the General Counsel
Office of Policy and International Affairs.

The Director will review each request for DR; the underlying decision, including the associated arguments and evidence; and the recommendation of the Advisory Committee. The Director will then determine whether to grant or deny review or delegate a decision to a Delegated Rehearing Panel (DRP). The DRP will be selected from among the Chief Judge, Deputy Chief Judge, Vice Chief Judges and Senior Lead Judges of the Board, excluding judges who served on the original panel for the case under review or otherwise have a conflict with the case. An appellant can request a rehearing of a DRP decision or appeal the decision to the US Court of Appeals for the Federal Circuit.

An ARP that consists of the Director, the Commissioner for Patents and the Chief Judge of the Board has now been created. The panel may be convened by the Director sua sponte to review ex parte, reexamination or reissue appeal decisions. Requests for ARP review will not be considered. ARP decisions are appealable to the Federal Circuit. An appellant may not [...]

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No Need for Unnecessary RPI Determinations

by Joshua Revilla | Jul 27, 2023 | Patents

The US Patent & Trademark Office Director partially vacated the Patent Trial & Appeal Board’s real-party-in-interest (RPI) determination because that determination was not necessary to resolve the underlying proceeding. Unified Patents, LLC v. MemoryWeb, LLC, IPR2021-01413, Paper 76 (PTAB May 22, 2023) (Vidal, Dir.)

Unified Patents filed a petition requesting inter partes review (IPR) of a patent owned by MemoryWeb. In its petition, Unified certified that it was the only RPI. Prior to institution, both parties briefed whether Unified should have identified two third parties as RPIs under 35 U.S.C. § 312(a)(2). In its institution decision, the Board declined to determine whether the third parties were RPIs because there was no allegation in the proceeding of a time bar or estoppel based on there being an unnamed RPI, and therefore the proceedings would not have created a time bar or estoppel under 35 U.S.C. § 315 even if the third parties were included as RPIs.

After institution, MemoryWeb continued to argue that the Board should terminate the proceeding because of Unified’s alleged failure to name the third parties as RPIs while also arguing that in the alternative, the Board should find the two third parties estopped from challenging the validity of the claims at issue in two different IPRs covering the same patent. The Board then issued an order identifying the third parties as RPIs, explaining that it was now appropriate to determine whether the two third parties were RPIs “[b]ecause the issue of Section 315(e) estoppel has been put before us [as relevant to the subsequent IPR challenges filed by the third parties], and we now have a complete factual record available to fully address the RPI question, and to avoid unnecessary prejudice to Patent Owner.” The Board also explained that it was now necessary to determine whether the third parties were RPIs in the case at hand to determine whether they would be estopped in a subsequent proceeding.

Unified filed a request for Director review of the Board’s RPI determination. Unified argued that the panel erred by issuing a non-binding advisory opinion on RPI that prejudiced the third parties by prejudging the RPI issue without their participation and where the decision could bind them in their later-filed proceedings. Unified also cited the Board’s precedential decision in SharkNinja v. iRobot, arguing that the Board should not resolve an RPI issue when it would not create a time bar or estoppel under 35 U.S.C. § 315 in the proceeding.

The Director concluded that the Board can and should determine the RPIs or real parties in privity in a proceeding where that determination may impact the underlying proceeding, including (but not limited to) a time bar under 35 U.S.C. § 315(b) or estoppel under 35 U.S.C. § 315(e) that might apply. However, the Director determined that such was not the situation here since determining the RPI issue was not necessary to resolve the proceeding. The Director, therefore, vacated the Board’s RPI determinations.

No Snipe Hunting: AIA Adherence Means No Interference (Proceedings)

by Jake B. Vallen | Jul 27, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit concluded that patents and applications that have only ever contained claims with an effective filing date after March 16, 2013—i.e., pure America Invents Act (AIA) patents—may not be subjected to an interference proceeding by the US Patent & Trademark Office (PTO) Director. SNIPR Techs. Ltd. v. Rockefeller Univ., Case No. 2022-1260 (Fed. Cir. July 14, 2023) (Chen, Wallach, Hughes, JJ.)

SNIPR Technologies owns a family of five patents directed to methods of selectively killing bacteria using clustered regulatory interspaced short palindromic repeats (CRISPR) gene editing. SNIPR was involved in an interference proceeding with Rockefeller University, which filed a patent application for technology also directed to selectively killing bacteria. The SNIPR patents claimed priority to a Patent Cooperation Treaty application filed on May 3, 2016, thus placing the SNIPR patents squarely within the scope of the AIA. The Rockefeller application claimed priority to, among other things, a US provisional application filed on February 7, 2013, making the Rockefeller application a pure pre-AIA application. The Patent Trial & Appeal Board initially declared an interference between claims 20 to 33 of the Rockefeller application and all claims of the SNIPR patents. The Board ultimately identified Rockefeller as the senior party and canceled all of SNIPR’s claims. SNIPR appealed.

The issue before the Federal Circuit was whether the Board had the authority to cancel SNIPR’s pure AIA claims for lack of invention priority under pre-AIA § 102(g), and more broadly, whether pure AIA patents may, as a matter of law, be part of an interference proceeding.

First, the Federal Circuit examined the plain language of AIA § 3(n) and the statutory purpose and history of the AIA. The Court reasoned that “AIA § 3(n) makes clear that [unless Congress provides otherwise,] only pure pre-AIA and mixed patents may be part of an interference.” As the Court stated, AIA § 3(n)(1) does not permit the AIA’s amendments to apply retroactively and the AIA repealed the statutory grant of power to hear interferences (pre-AIA § 135), instead providing for derivation proceedings.

Next, the Federal Circuit addressed Rockefeller’s and the Director’s arguments that the statutory language of pre-AIA § 135(a) authorizes the Director to declare an interference for “any unexpired patent”—including unexpired pure AIA patents. Unpersuaded, the Court concluded that pre-AIA § 135(a), read in conjunction with the AIA, excludes pure AIA patents for the following reasons:

The AIA replaced interference proceedings with derivation proceedings.
The AIA deleted all other references to interferences.
The AIA repealed the first-to-invent system of patentability, rendering interference proceedings superfluous.
Permitting interferences for pure AIA patents would subject AIA patents to interferences “for over twenty years after the AIA’s effective date,” which would be contrary to the purpose of the AIA—to implement the first-to-file system of patentability.

Moreover, such a statutory construction would belie AIA § 3(n)(2), which expressly allows for interferences for mixed patents (i.e., patents and applications that contain, or contained at any time, at least one claim with [...]

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Reissue Boat Won’t Float: “Original Patent” Rule Sinks New Floating Grill Claims

by Kathleen Lynch | Jul 20, 2023 | Patents

Addressing the same invention requirement for reissue patents, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision to reject an overly broad reissue application. In re Float‘N’Grill LLC, Case No. 22-1438 (Fed. Cir. July 12, 2023) (Prost, Linn, Cunningham, JJ.)

Float‘N’Grill (FNG) owned a patent directed to a floating device that supports a grill so that users can grill food while in water. The patent’s specification lays out a single embodiment, illustrated in Figure 1 below, which includes a float (20) that has two supports (46, 48), each of which “includes a plurality of magnets” (60) so that the grill can be removably attached to the float:

FNG filed a reissue application that claimed new ways to “more generically” removably attach a grill to the float. In rejecting the reissue claims, the Examiner found that three of the new requested claims required zero magnets, three claims required one magnet, and one claim did not specifically require magnets but referred to a magnet in the preamble. This was in contrast to the issued patent’s only embodiment, which required multiple magnets. The Examiner, therefore, rejected the reissue claims for failure to meet the “original patent” requirement of 35 U.S.C. § 251. The Board affirmed. FNG appealed.

The question on appeal was whether FNG’s newly requested claims complied with § 251. The Federal Circuit explained that the only path to expanding the coverage of an issued patent is through a reissue application, which is subject to § 251’s limitations. Pertinent here, § 251 requires reissue claims to be directed to the same invention disclosed in the original patent. Citing Supreme Court and Federal Circuit decisions, the Court described the “original patent” requirement as a question of whether the issued patent’s disclosed invention “on its face, explicitly and unequivocally describe[s] the invention as recited in the reissue claims.”

Turning to FNG’s reissue claims, the Federal Circuit agreed with the Board, finding that the new claims were not directed to the same invention as the original patent and thus failed to satisfy § 251. The Court explained that the specification of FNG’s issued patent had just one embodiment, which featured “a plurality of magnets” to removably attach a grill to the floating device. The reissue claims, however, contemplated more general attachments without magnets.

FNG argued that its claims were acceptable under § 251 because the magnets were a “non-essential embodiment” of the invention. The Federal Circuit disagreed for four reasons:

An element of a patent may be deemed essential even if the patent does not explicitly state as much. Thus, the magnets were essential to FNG’s original patent, even if not labeled so.
It is irrelevant that a person of skill in the art may know to replace an original patent element with “some other undisclosed mechanism” to reach the same result. Here, a new way to attach a grill to the [...]

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Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

by Kavya Rallabhandi | Jul 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.

Coons and Tillis Introduce Two Bills Intended to Change Patent Landscape

by Christopher M. Bruno | Jul 13, 2023 | Patents

In late June 2023, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced two bills in Congress that, if enacted, would change the patent adjudication landscape:

The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act is the latest iteration of a multiyear effort to reform patent law to address perceived problems with the Patent Trial & Appeal Board’s inter partes review (IPR) and post-grant review (PGR) processes.
The Patent Eligibility Restoration Act of 2023 seeks to bring certainty to subject matter eligibility Section 101 jurisprudence.

The PREVAIL Act is essentially a reintroduction of the previously unsuccessful STRONGER Patents Act of 2019 bill and would change fundamental aspects of how the Board operates. Under current practice, the Board judges who rules on institution and also decides the outcome of an instituted proceeding. Under the PREVAIL Act, institution decisions would be made by a separate set of judges from those that render a decision on a petition’s merits. Through proposed changes to the initiation and estoppel provisions, a patent challenger could bring its attack on patent validity in either the district court or the Board, but not both. And as part of the harmonization of district court and Board proceedings, the PREVAIL Act would adopt the “clear and convincing” standard for Board review and codify existing Board practice of applying the same claim construction standard as district courts apply.

The PREVAIL Act would also change who can bring issues to the Board by imposing standing and revised real-party-in-interest requirements. An IPR petitioner would have to establish standing equivalent to that required for a district court declaratory judgment action. Moreover, anyone who financially contributes to an IPR would be deemed a real party in interest to avoid multiple petitions backed by the same entity. To reduce the multiplicity of proceedings, the PREVAIL Act would establish a presumption against a joinder for time-barred petitions. The PREVAIL Act also includes several provisions directed to the independence and transparency of the Board’s decision-making, including establishing a code of conduct and requiring recordation of the Director’s actions that affect Board proceedings.

Turning to subject matter eligibility, the Patent Eligibility Restoration Act would overrule Supreme Court decisions importing a judicial exception to Section 101 and would codify many of the existing categories of ineligible subject matter, including mathematical formulae; substantially economic, financial, social, cultural and artistic practices (in other words, fundamental human activity); natural processes and products made independent of human activity; and mental processes. The Patent Eligibility Restoration Act specifically would authorize early resolution and limited discovery on Section 101 ineligibility.

Practice Note: Although both acts have been introduced before without much success, Congress’s present focus on technology (such as artificial intelligence) may serve to propel one or both bills forward. Of course, it remains to be seen whether Congress has an appetite for modifying patent law, particularly in the lead-up to an election year.

Amending a Range? Better Enable It

by Alexander Piala, PhD | Jul 13, 2023 | Patents

In a post-grant review appeal, the US Court of Appeals for the Federal Circuit explained that patent claims reciting a range must enable the full scope of that range and, under the Administrative Procedure Act (APA), the Patent Trial & Appeal Board is not bound to decisions rendered in a Preliminary Guidance. Medytox, Inc. v. Galderma S.A., Case No. 22-1165 (Fed. Cir. June 27, 2023) (Dyk, Reyna, Stark, JJ.)

Medytox owns a patent directed to the use of animal-protein-free botulinum toxins with long-lasting effects. Galderma challenged the validity of Medytox’s patent in a post-grant review. In response to the challenge, Medytox filed a motion to amend the patent under the Board’s Pilot Program, which allows a petitioner to amend the patent claims and receive a preliminary decision as to whether the amendment would preserve the patent’s validity (Preliminary Guidance). Medytox proposed modifying the claims so that they only encompassed treatment methods that possessed a patient response rate of “50% or greater.” Galderma opposed the motion, arguing that claiming a 50% to 100% response rate constituted new matter, meaning the claim language improperly claimed an invention that was not described in the patent application as filed.

The Board issued a Preliminary Guidance construing the new claim language and explaining that it did not believe that Medytox’s amended claims represented new matter. According to the Board, the new limitation did not “necessarily” claim a range of 50% to 100% and instead could just be claiming 50% or greater. The Board explained that since the patent contained the concept of a greater than 50% response rate, claiming that rate was not new matter. As a consequence of the Board’s positive reception, Medytox amended all the claims to include the new language. Galderma once again opposed the motion and further argued that the amended claims were not enabled. The Board held an oral hearing and questioned the parties on the proper construction of the “50% or greater” claim language.

In its final written decision, the Board decided that the limitation was a range of 50% to 100%, contrary to its statement in the Preliminary Guidance. Because the claimed limitation was a range, the Board—citing the Supreme Court’s 2023 decision in Amgen v. Sanofi and the Federal Circuit’s 2012 decision in Magsil v. Hitachi Global Storage—explained that the entire range must be enabled. The patent, however, only described a response rate of up to 62%, so the Board found that the claimed range was not enabled. Medytox appealed.

Medytox alleged three errors. First, Medytox argued that the Board’s new construction was wrong. Second, Medytox argued that the claims were enabled. Finally, Medytox argued that the Board violated the APA by capriciously departing from its Preliminary Guidance. The Federal Circuit rejected Medytox’s arguments and affirmed the Board’s decision.

First, the Federal Circuit determined that there was no meaningful difference between the two possible constructions—claiming a response rate greater than 50% was essentially the same as claiming a response rate of [...]

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