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Rough Seas Ahead? Supreme Court to Reconsider Chevron Doctrine

by Amol Parikh | Oct 26, 2023 | Cert Alert

The Supreme Court of the United States has agreed to reconsider the Chevron doctrine, which instructs courts to defer to a federal agency’s reasonable interpretation of an ambiguous statute that US Congress delegated to the agency to administer. Relentless, Inc. v. Department of Commerce, Case No. 22-1219 (Supr. Ct., Oct. 13, 2023) (certiorari granted). The question presented is:

Whether the Court should overrule Chevron or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency.

The case involves the Magnuson-Stevens Fishery Conservation and Management Act (MSA), which governs fishery management in federal waters. The MSA states that, with the approval of the US Secretary of Commerce, the National Marine Fisheries Service (NOAA Fisheries) may require fishing vessels to carry federal observers who enforce the agency’s regulations. Congress appropriates funds for these observers. Deeming annual congressional appropriations for the federal observers insufficient, NOAA Fisheries asserted a right to require fishing vessels to enter into contracts to pay the federal observers. The US Court of Appeals for the First Circuit approved this practice, finding that the mere fact that the MSA provides for federal observers gave the agency carte blanche to charge the regulated party for those observers.

This case will be heard in tandem with Loper Bright Enterprises v. Raimondo, which raises a similar Chervon doctrine (deference) issue, during the January 2024 argument session.

Here’s a Great Concept: Fraud After Registration Is Not a Basis for Cancellation

by Paul Devinsky | Oct 26, 2023 | Trademarks

In a split panel decision, the US Court of Appeals for the Federal Circuit overturned the Trademark Trial & Appeal Board and ruled that a fraudulent declaration under Section 15 of the Lanham Act is not a basis for cancellation of an otherwise incontestable registered mark. Great Concepts, LLC v. Chutter, Inc., Case No. 22-1212 (Fed. Cir. Oct. 18, 2023) (Dyk, Stark, JJ) (Renya, J., dissenting).

Great Concepts applied to register “DANTANNA’S” as a mark for a “steak and seafood restaurant” in 2003, which resulted in a registration in 2005.

In 2006, Chutter’s predecessor-in-interest, Dan Tana, petitioned the Board to cancel the registration based on an alleged likelihood of confusion with Tana’s common law “DAN TANA” mark for restaurant services. That cancellation proceeding was suspended during a pending civil action in which Tana successfully sued Great Concepts for trademark infringement.

Afterward, the Board dismissed Tana’s cancellation proceeding “based on petitioner’s apparent loss of interest” after he failed to respond to the Board’s order to show cause.

Meanwhile, prior to the finality of the infringement action, Great Concepts’ former attorney, Frederick Taylor, filed a combined declaration of use (pursuant to Section 8 of the Lanham Act) and a declaration of incontestability (pursuant to Section 15). In the Section 15 portion of the declaration, in relation to Great Concepts’ effort to obtain incontestable status for its already registered mark, Taylor falsely declared “there is no proceeding involving said rights pending and not disposed of either in the U.S. Patent and Trademark Office [PTO] or in the courts.”

Chutter then petitioned the PTO for cancellation of the registration based on Taylor’s false Section 15 affidavit. The Board found that Taylor’s Section 15 declaration was fraudulent and cancelled the registration under Section 14 of the Lanham Act. Great Concepts appealed.

The Federal Circuit was confronted with the issue of whether Section 14, which allows a third party to seek cancellation of a registration when the “registration was obtained fraudulently,” permits the Board to cancel a trademark’s registration based on a fraudulent Section 15 declaration, filed for the purpose of acquiring incontestability status for its already registered mark. Reversing the Board’s decision, the Court held that Section 14 does not permit the Board to cancel a registration in these circumstances.

Focusing on the statutory language, the Federal Circuit noted that Section 14 permits a third party to file “[a] petition to cancel a registration of a mark” … “[a]t any time if” the registered mark’s “registration was obtained fraudulently.” Explaining that the word “‘obtaining’ has a plain and ordinary meaning,” i.e., “[t]o get hold of by effort; to gain possession of; to procure…,” the Court then noted that, by contrast, Taylor’s fraudulent Section 15 declaration only sought incontestable status for its already registered trademark—a different right from registration.

Since “fraud committed in connection with obtaining incontestable status is distinctly not fraud committed in connection with obtaining the registration itself” and since fraud committed in connection with an incontestability declaration is not found among the “numerous bases [...]

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Downloaded: No Relief From Stipulated Claim Construction

by Ian J. Howard | Oct 26, 2023 | Patents

The US Court of Appeals for the Federal Circuit ruled that a claim interpretation that flows naturally from the parties’ stipulated claim construction is binding on the parties even if the interpretation reads preferred embodiments out of the claims. Finjan LLC v. SonicWall, Inc., Case No. 22-1048 (Fed. Cir. Oct. 13, 2023) (Reyna, Cunningham, JJ.) (Bryson, J., dissenting).

In 2017, Finjan sued SonicWall for infringing several of Finjan’s patents related to cybersecurity technology systems that identify malicious material in downloadable content and programming code. The asserted patents included claims directed to ways to protect network-connectable devices from undesirable downloadable operations. During claim construction, the parties stipulated that a “downloadable” should be construed as “an executable application program, which is downloaded from a source computer and run on the destination computer.”

SonicWall moved for summary judgment, arguing that it did not infringe the patents because the accused devices received and inspected supposed “downloadables” as unextracted packets, which do not constitute executable files under the stipulated claim construction. The district court granted partial summary judgment in favor of SonicWall, finding that Finjan failed to offer evidence that “the accused […] products ‘ever possess a reassembled file or executable application.’” Finjan appealed.

Finjan argued that the district court’s ruling was incorrect because it impermissibly grafted additional requirements onto the stipulated claim construction, and that the district court’s interpretation was inconsistent with claim language found in other parts of the asserted patents. The Federal Circuit rejected these arguments, noting that the district court’s infringement ruling followed directly from the parties’ stipulated definition of the term “downloadables.” Under the stipulated claim construction and in accordance with Finjan’s own expert’s interpretation of the meaning of “executable,” a device “that merely receives and forwards packets without reassembling their contents does not receive a downloadable . . . because that device does not receive an executable application program.” The Court emphasized that Finjan could not challenge its earlier claim construction stipulation. Further, the Court noted that the stipulated definition of “downloadables” was derived verbatim from the specifications of two of the asserted patents.

Judge Bryson dissented for two reasons. First, he noted that the district court’s interpretation of the claims would read preferred embodiments out of the patent and effectively eviscerate from the patent’s scope any device that screens content from the internet. Second, Judge Bryson found that elsewhere in the asserted patents’ specifications it was clear that the meaning of “downloadables” used by the district court was incorrect. Contrary to the majority, Judge Bryson did not find the stipulated claim construction dispositive because Finjan merely challenged the meaning of the word “executable” within the stipulated claim construction, rather than the contents of the stipulation itself.

Practice Note: This decision offers a few helpful lessons for practitioners. First, it is important to write claims in language that is both expansive enough to encompass all intended embodiments but precise enough to survive invalidity challenges. By carefully selecting specific but broad language, and writing claims more accurately, patentees may avoid semantic noninfringement arguments. [...]

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Go With the Flow: “A” Still Means “One or More”

by Benjamin Ediger, Ph.D. | Oct 26, 2023 | Patents

The US Court of Appeals for the Federal Circuit reversed a claim construction that was adopted during an inter partes review (IPR) because the Patent Trial & Appeal Board erred in construing the contested limitation as limited to a single sample rather than including the possibility of plural samples. ABS Global, Inc. v. Cytonome/ST, LLC, Case No. 22-1761 (Fed. Cir. Oct. 19, 2023) (Reyna, Taranto, Stark, JJ.)

ABS and Genus plc (collectively, ABS) filed a petition to institute an IPR on a patent owned by Cytonome. The patent claims microfluidic devices for particle (e.g., cells, molecules and other particles of interest) processing. The claimed devices exploit the principles of laminar flow to hydrodynamically focus particles at a certain point along the flow path for inspection or other purposes. The claimed devices are capable of hydrodynamically focusing the flow of a particle-containing fluid (the sample fluid) by abutting the sample fluid on more than one side with a fluid that does not contain particles (the sheath fluid). Generally, the faster the sheath fluid flows relative to the sample fluid the more the sample fluid’s corresponding cross-section is compressed. Figure 3A of the patent is an example of how the claimed devices use sheath fluid (SF) to focus a sample fluid (S) along a channel (CL):

ABS’s petition argued that the challenged claims were anticipated or obvious at least in view of a prior publication that taught devices with a split sample stream. The Board disagreed, construing the challenged patent claims as directed to a single sample stream and concluding that ABS failed to demonstrate why those of ordinary skill—in view of the art cited in ABS’s petition—would have modified the prior art split sample stream into the claimed single sample stream. ABS appealed.

The Federal Circuit found that the Board erred in construing the challenged claims. In construing the independent claim as being limited to a single sample stream, the Board focused on two limitations: “an inlet configured to receive a sample stream” and “a fluid focusing region configured to focus the sample stream….” In limiting the claim to a single sample stream, the Board relied on the definite article preceding the second recitation of “sample stream” and noted that a plural-allowing interpretation would be inconsistent with a dependent claim that further requires the focusing fluid to be “introduced into the flow channel symmetrically with respect to a centerline of the sample stream.”

The Federal Circuit reversed the Board’s claim construction, concluding that the dependent claim was not inconsistent with a plural-streams interpretation for the independent claim and that the Board committed two errors in construing both claims. First, the Board did not properly apply what the Court refers to as the “general rule,” which is applicable to open-ended “comprising” claims that recite “a” or “an” before a noun. The Court explained that such a limitation should be construed to mean one or more unless context sufficiently indicates otherwise. Second, [...]

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Decoding Algorithms: Structural Sufficiency for Means-Plus-Function Claim Judged From Skilled Artisan’s Perspective

by Kavya Rallabhandi | Oct 19, 2023 | Patents

The US Court of Appeals for the Federal Circuit reiterated that in the context of construing computer-implemented means-plus-function limitations, if the specification discloses some arguable algorithm, even if a party contends that the algorithm is inadequate, the sufficiency of the purportedly-adequate structure disclosed in the specification must be evaluated in light of the knowledge possessed by a skilled artisan. Sisvel International S. A. v. Sierra Wireless, Inc., Case No. 22-1493 (Fed. Cir. Oct. 6, 2023) (Moore, Clevenger, Chen, JJ.)

Sisvel owns a patent directed to methods of channel coding when transmitting data in radio systems. The patent uses techniques called “link adaptation” and “incremental redundancy,” which are alleged to provide improvement over prior channel coding techniques. Sierra filed a petition for inter partes review (IPR) challenging certain claims as obvious over the Chen reference by itself and challenging those and other claims as obvious over the combination of the Chen and Eriksson references or the combination of the Chen and GSM references. The Patent Trial & Appeal Board found that some challenged claims were obvious based on Chen alone and that other claims were patentable over the proposed combination of references. Both parties appealed.

Sisvel appealed the Board’s unpatentability finding, arguing that Chen failed to disclose a second puncturing pattern. Sisvel also argued that the Board did not provide a sufficiently detailed explanation to support its finding that Chen disclosed the claimed “combining” limitation and ignored Sisvel’s rebuttal arguments. The Federal Circuit disagreed with Sisvel on both counts and affirmed the Board’s determination. Regarding the second puncturing pattern, the Court found that the independent claim required a “first puncturing pattern” and a “second puncturing pattern,” and that Chen expressly described that its coded transmissions are “generated by using punctured codes” and that “[p]uncturing reduces the number of code symbols to be retransmitted.” Therefore, the Court found that substantial evidence supported the Board’s finding that Chen taught a second puncturing pattern. Regarding the “combining” limitation, the Court affirmed the Board’s decision and concluded that Chen’s disclosure of “accumulating the code symbols from the transmitted and retransmitted coded data blocks,” also referred to in Chen as “interleaving,” taught the “combining” limitation. Overall, the Court determined that the Board’s analysis was sufficiently detailed, adequately addressed Sisvel’s related arguments and was supported by substantial evidence.

Sierra appealed the patentability finding, arguing that the Board’s finding that a skilled artisan would not have been motivated to combine Chen and the GSM references was not supported by substantial evidence. Sierra also argued that the Board erroneously found insufficient corresponding structure in the specification for the term “means for detecting.” The Federal Circuit concluded that substantial evidence supported the Board’s finding of a lack of motivation to combine Chen and the GSM references, but that the Board erred in analyzing the “means for detecting” limitation. Regarding motivation to combine, the Court explained that although an IPR petitioner has a low burden of explaining why a skilled artisan would have been motivated to combine various references to form [...]

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A Matter of Style: No Need to Select “Primary” Reference in Obviousness Challenge

by Cecilia Choy, Ph.D. | Oct 19, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed an obviousness decision by the Patent Trial & Appeal Board, explaining that nothing requires a petitioner to identify a prior art reference as a “primary reference” in an obviousness challenge. Schwendimann v. Neenah, Inc., Case Nos. 22-1333; -1334; -1427; -1432 (Fed. Cir. Oct. 6, 2023) (Prost, Clevenger, Cunningham, JJ.)

Jodi Schwendimann filed lawsuits accusing Neenah of infringing several patents related to transfer sheets and methods for transferring images onto dark fabrics. Neenah filed several petitions for inter partes review (IPR) challenging various claims based on obviousness. The Board instituted the IPR challenges.

Schwendimann’s patents addressed a method for ensuring that dark images could be seen when transferred onto dark fabrics. Multilayer image transfer sheets were known in the prior art, teaching a two-step process to first apply a light background onto dark fabric and then apply the dark image on top. Schwendimann’s claims described a single-step solution, incorporating a white background, possibly of titanium dioxide, into the image transfer sheet so that a white background and dark image could be applied simultaneously onto a dark fabric.

All of the IPR petitions cited Kronzer as a prior art reference. Kronzer described multilayered image transfer sheets with varying configurations, although it lacked white pigment in a layer to transfer an image onto dark fabric. Another prior art reference, Oez, taught the use of a white pigment, such as titanium dioxide, in multilayered image transfer sheets. Schwendimann did not dispute that Kronzer and Oez taught or suggested all limitations recited in the challenged claims. Instead, she argued that there was no motivation for a skilled artisan to combine the references or to expect that such combination would yield a reasonable expectation of success. The Board considered and addressed each argument, relying on Neenah and Schwendimann’s experts’ testimony and the complementary and compatible nature of the references. The Board found the challenged claims obvious over Kronzer in view of Oez. Schwendimann appealed.

Schwendimann argued that substantial evidence did not support the Board’s findings that a skilled artisan would have been motivated to combine Kronzer and Oez and would have had a reasonable expectation of success in making the proposed combination. The Federal Circuit explained that substantial evidence means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion” and considered these two arguments together.

The Federal Circuit found that Schwendimann failed to show that the Board’s findings were not supported by “substantial evidence.” Like the Board, the Federal Circuit used both expert witnesses’ testimonies to explain that the references shared a common goal of improving image transfer characteristics. The Court found that Schwendimann’s arguments that Oez taught away from the proposed combination failed because Oez’s disclosure did not discourage a skilled artisan from using white pigment identified in the challenged patents or lead the skilled artisan in a direction divergent from the path taken in the challenged patents. Her argument that adding titanium dioxide into Kronzer’s transfer sheets could [...]

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PTO Proposes Rules Promoting Independence in Board Decision-Making

by Peter Brunovskis, PhD | Oct 19, 2023 | Uncategorized

Seeking to bolster the independence of administrative patent judge (APJ) panels when issuing decisions and increase transparency regarding Patent Trial & Appeal Board processes, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking concerning the pre-issuance internal circulation and review of decisions. Rules Governing Pre-Issuance Internal Circulation and Review of Decisions Within the Patent Trial and Appeal Board, 88 Fed. Reg. 69578 (Oct. 6, 2023)

The proposed rules were developed in response to a July 2022 request for comments and would refine and codify interim processes and standards that have been in place since May 2022. If adopted, the proposed rules would be codified as Section 43 in Title 37 of the Code of Federal Regulations (37 C.F.R. §§ 43.1-43.6) relating to Board proceedings pending under 37 C.F.R. §§ 41 and 42.

Under the rules in newly proposed §§ 43.3 and 43.4, prior to issuance of a decision by the panel, senior PTO management and non-management APJs at the PTO (as defined in § 43.2) would be barred from communicating, directly or through intermediaries, with any panel member (unless they were themselves panel members) regarding the decision. Limited communications would be permitted for procedural status and generally applicable paneling guidance that don’t directly or otherwise influence the paneling or repaneling of any specific proceeding. The proposed rules would not forbid a panel member from requesting input on a decision prior to issuance from non-panel senior APJs, however. The proposed rules would stipulate that it is within the panel’s sole discretion to adopt any edits, suggestions or feedback from non-panel APJs.

The proposed rules substantially follow the interim processes in place except for a change regarding pre-issuance circulation of decisions to a pool of non-management APJs, known as the circulation judge pool (CPJ). Under the interim process, certain categories of Board decisions are required to be circulated to the CPJ prior to issuance. Those decisions include all America Invents Act (AIA) institution decisions, AIA final written decisions, AIA decisions on rehearing, inter partes reexamination appeal decisions, designated categories of ex parte appeals, ex parte reexamination appeals and reissue appeal decisions and all Board decisions (including AIA and ex parte appeal decisions) following a remand from the US Court of Appeals for the Federal Circuit. Under the proposed rules, circulation to the CJP would be optional.

The PTO will accept comments until December 5, 2023, through the Federal eRulemaking Portal.

Missed Shot: Lawsuit Against Related Company Doesn’t Toll Prescriptive Period

by Joshua Revilla | Oct 12, 2023 | Trademarks

The US Court of Appeals for the Fifth Circuit affirmed a district court’s decision to dismiss claims under the Louisiana Unfair Trade Practices Act (LUTPA), finding that a dispute against a related company did not toll the statute of limitations. Carbon Six Barrels, LLC v. Proof Research, Inc., Case No. 22-30772 (5th Cir. Sept. 29, 2023) (Clement, Elrod, Willett, JJ.)

Proof Research and Carbon Six Barrels both manufacture gun barrels made of carbon fiber. Proof was the first of the parties to enter the market and in 2013 trademarked the unique mottled appearance of its barrels. In 2016, Proof discovered that Carbon Six intended to manufacture and sell similar-looking carbon-fiber barrels and sent a cease-and-desist letter. Carbon Six began production in 2017, sourcing barrel blanks from its sister company McGowen Precision Barrels. Proof filed a trademark infringement suit against McGowen, instead of Carbon Six, in the District of Montana. McGowen initiated a separate proceeding in the Trademark Trial & Appeal Board to cancel Proof’s trademark and was successful in doing so.

After the Board cancelled Proof’s trademark, Carbon Six sued Proof in the Middle District of Louisiana alleging that Proof fraudulently registered its trademark, violated LUTPA, and defamed Carbon Six during the initial litigation and Board proceeding. McGowen brought a similar suit in the District of Montana. Proof asserted several defenses in the lawsuit filed by Carbon Six, including a Rule 12(b)(6) motion to dismiss for failure to state a claim, arguing that Carbon Six’s claims were both untimely and legally insufficient. The district court denied Proof’s other defenses but granted the Rule 12(b)(6) motion, finding that Carbon Six’s claims were time-barred by Louisiana’s one-year prescriptive period and that Carbon Six’s LUTPA claim was also legally insufficient. Carbon Six appealed.

The Fifth Circuit affirmed, explaining that LUTPA has a one-year prescriptive period and that there was no doubt that the violations alleged by Carbon Six occurred more than a year before Carbon Six filed suit in early 2022. The Court reviewed all actions that could potentially give rise to liability under LUTPA and stated that even if any of these acts could give rise to liability, all actions occurred more than a year before Carbon Six’s suit.

Carbon Six attempted to rely on the continuing tort doctrine, alleging that the acts continuously violated LUTPA up until the Board cancelled Proof’s trademark in May 2021. Reviewing Louisiana law, the Fifth Circuit determined that the general principle of a continuing tort is a conduct-based question “asking whether the tortfeasor perpetuates the injury through overt, persistent, and ongoing acts.” The Court agreed with the district court that LUTPA’s prescriptive period is not suspended if a perpetuator of fraud fails to correct false statements, as that proposition would transform almost every business dispute into a continuing tort. The Fifth Circuit also determined that the district court’s conclusion that Carbon Six could not recover for Proof’s lawsuit against McGowan was correct, because the law supported the position that a sister corporation cannot sue on behalf [...]

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Just How Similar Must Competing Marks Be to Survive Dismissal?

by Mike Baldwin | Oct 5, 2023 | Trademarks

After a de novo review, the US Court of Appeals for the Sixth Circuit affirmed in part and reversed in part a district court’s motion to dismiss, finding the competing marks sufficiently similar to avoid dismissal, and the attorneys’ fee award. Bliss Collection, LLC v. Latham Companies, LLC, Case Nos. 21-5723; -5361 (6th Cir. Sept 21, 2023) (Mathis, Bush, JJ.) (Larsen, J., dissenting).

This case between Bliss and Latham was the latest installment in a series of cases between the children’s clothing companies after a Bliss founder left to start Latham as a competitor company. Here, Bliss sued Latham for infringement of three trademarks for Bliss’s stylized lowercase “b” logo, appearing as if stitched out in thread. Bliss sued for federal copyright infringement, federal trademark infringement, federal trade dress infringement, federal false designation of origin and misappropriation of source, federal unfair competition, trademark under Kentucky law and unfair competition under Kentucky law.

The competing marks are depicted below:

Latham moved to dismiss, and the district court dismissed the federal copyright and trade dress claims. The district court did not initially dismiss the remaining claims, but later did so after a motion for reconsideration. The district court determined that Latham was not entitled to attorneys’ fees because the case was not exceptional, and Bliss had brought the suit in good faith. Bliss appealed the federal trademark infringement, federal trade dress infringement and trademark infringement under Kentucky common law only.

The Sixth Circuit focused its analysis on whether the amended complaint properly alleged that Latham’s logo was a use of Bliss’s trademark. The Court noted that dismissal was not warranted for anything but the most extreme cases, concluded that this was not such a case and reversed.

The Sixth Circuit found that Latham used the accused mark “in a trademark way” (i.e., to identify goods). Then, weighing the Frisch factors to determine likelihood of confusion between the marks, the Court found that the similarity between the marks and their “impression” favored Bliss despite the fact “that the logos share no words or homophones.” Overall, the Court found that five of the eight factors favored Bliss and that two were neutral. Only the likelihood of purchaser care factor was found to favor Latham. The Court thus found that Bliss had plausibly alleged a likelihood of confusion and that its complaint stated a federal trademark infringement claim. Applying the same logic to the state trademark claims, the Court also reversed the dismissal of those claims.

The Sixth Circuit affirmed the dismissal of the trade dress claim, however, because Bliss failed in its affirmative duty to plead facts in support of nonfunctional trade dress.

Turning to the attorneys’ fee award, the Sixth Circuit found that the mere fact that Bliss sued Latham was not sufficient to warrant an “exceptional” case finding in terms of an award for fees. The Court was also unpersuaded that the trade dress claim was worthy of a fee award as [...]

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Beware Enablement of Genus Antibody Claims

by Jayita Guhaniyogi, PhD | Oct 5, 2023 | Patents

The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v. Sanofi. The Federal Circuit concluded that patent claims covering a class of antibodies targeting functions of blood clotting factors were invalid for lack of enablement, echoing the reasoning followed by fellow Circuit Judge Dyk, who sat by designation in the district court. Baxalta Inc. and Baxalta GMBH v. Genentech, Inc., Case No. 2022-1461 (Fed. Cir. Sept. 20, 2023) (Moore, Clevenger, Chen, JJ.)

This case involves Baxalta’s patent covering antibody preparations that bind to blood clotting Factors IX/IXa and thereby increase the procoagulant activity of Factor IXa. This in turn activates another blood clotting factor, Factor X, that is useful to treat hemophilia, particularly in patients who develop inhibitors to blood clotting Factor VIII. The claim at issue recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases procoagulant activity of Factor IXa.”

Baxalta sued Genentech for infringement. In a prior appeal involving claim construction, the Federal Circuit vacated the district court’s grant of summary judgment of noninfringement and remanded for further proceedings. On remand, the district court granted Genentech’s motion for summary judgment for lack of enablement. Baxalta appealed.

Baxalta challenged the summary judgment of invalidity on enablement. Baxalta argued that a skilled artisan could make the full scope of the claimed antibodies without undue experimentation. With reference to the subject patent’s disclosure of using a prior art method known as the hybridoma technique for generating Factors IX/IXa antibodies, Baxalta argued that using routine screenings to find the antibodies exhibiting the claimed functions (i.e., those that bind Factors IX/IXa and increase procoagulant activity of Factor IXa) was within the skill of a skilled artisan without undue experimentation.

The Federal Circuit, citing Amgen, explained that the enablement standard under Section 112(a) requires that “the specification [] enable the full scope of the invention as defined by its claims,” allowing for “a reasonable amount of experimentation.” The Court explained that in Amgen, the patents at issue generically claimed all antibodies that bind to specific amino acid residues on a protein and blocked the protein from binding to LDL receptors. The Court observed that while the Amgen patent disclosed amino acid sequences of 26 antibodies, the claim scope could cover millions. Similarly, the Amgen patent disclosed a roadmap and another conservative substitution method for generating new antibodies and testing them for the claimed functions. In Amgen, the Supreme Court held that such methods were nothing more than “trial-and-error experimentation,” which, in the absence of “some general quality . . . running through the class that gives it a peculiar fitness for the particular purpose,” failed to enable the full scope in that case.

The Federal Circuit found the facts in this case “materially indistinguishable” from Amgen. Like the claims at issue in Amgen, Baxalta’s patent claims all [...]

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