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That Stings: Consent to Jurisdiction Must Be Effective at Filing to Invoke Fed. R. Civ. P. 4(k)(2)

by | Jan 19, 2023 |

The US Court of Appeals for the Federal Circuit, on petition for writ of mandamus, vacated the district court’s transfer order and remanded the transfer to be considered under the clarified parameters of Fed. R. Civ. P. 4(k)(2) and 28 U.S.C. § 1404. In re: Stingray IP Solutions, LLC, Case No. 2023-102 (Fed. Cir. Jan. 9, 2023) (Lourie, Taranto, Stark, JJ.)

Stingray filed patent infringement suits in the US District Court for the Eastern District of Texas against TP-Link, a company headquartered and organized in China. TP-Link moved to transfer to the Central District of California (CDCA) under 28 U.S.C. § 1406 citing an alleged lack of personal jurisdiction that Rule 4(k)(2) did not cure because TP-Link would be amenable to suit in the CDCA. TP-Link also moved for transfer under 28 U.S.C. § 1404(a). The district court granted the motion to transfer under § 1406 based on the rationale that TP-Link was amenable to suit in the CDCA and relying on affirmative reservations made by TP-Link that the CDCA had proper jurisdiction and venue. The district court denied TP-Link’s § 1404(a) motion as moot following the transfer. Stingray filed a mandamus petition asking the Federal Circuit to determine whether TP-Link’s unilateral, post-suit consent to personal jurisdiction in another state defeated application of Rule (4)(k)(2).

The Federal Circuit first determined that mandamus review was appropriate in this case in order to resolve the question of whether a defendant can defeat personal jurisdiction under Rule 4(k)(2) by unilaterally consenting to suit in a different district, a jurisdictional question that has divided district courts. Some district courts have held that personal jurisdiction cannot be established under Rule 4(k)(2) if a defendant states that it is amenable to suit in another state, while others have concluded that defendants must do more than simply designate an alternative forum in order to avoid application of Rule 4(k)(2).

Rule 4(k)(2) was originally introduced to close a loophole where non-resident defendants without minimum contact with any individual state suitable to support jurisdiction, but with sufficient contacts with the United States as a whole, were able to escape jurisdiction in all 50 states. The rule essentially provided that under federal claims, serving a summons or filing a waiver of service could establish personal jurisdiction if the defendant was not subject to a state’s general jurisdiction and exercising jurisdiction would be consistent with the US Constitution and laws.

Here, the case focused on the “negation requirement” of Rule 4(k)(2) where the defendant is not subject to any jurisdiction of a state court. This case addressed the question of whether a defendant’s post-suit, unilateral consent to suit in another state prevents the requirement that a defendant is not subject to a state’s general jurisdiction from being satisfied.

The Federal Circuit determined that the “negation requirement” requires defendants to identify a forum where jurisdiction would have been proper at the time of filing, regardless of consent. The Court determined that therefore a defendant cannot use a “unilateral statement of consent” to [...]

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Dictionaries Don’t Know Best: The Intrinsic Record Prevails (Again)

by | Jan 19, 2023 |

The US Court of Appeals for the Federal Circuit addressed the tension between the intrinsic and extrinsic record in claim construction, holding that the intrinsic record should be relied on first. The Court therefore reversed a district court finding of indefiniteness based on dictionary definitions and expert testimony. Grace Instrument Industries, LLC v. Chandler Instruments Company, LLC, Case Nos. 21-2370; -2370 (Fed. Cir. Jan. 12, 2023) (Chen, Cunningham, Stark, JJ.)

Grace owns a patent for a liquid pressurized viscometer used commonly to test the viscosity of drilling fluid that is used to drill oil wells. Grace’s viscometer uses an “enlarged chamber” between a lower chamber and a pressurization fluid inlet. According to the patent specification, this enlarged chamber was designed to reduce the measurement error in prior viscometer models that was caused by the mixing of sample fluid and pressurization fluid or by friction emanating from a seal in the viscometer. Within the lower chamber of the patented viscometer, there is a rotor having a “means for driving said rotor to rotate.”

Grace sued Chandler, claiming that Chandler infringed Grace’s viscometer patent. During claim construction, the district court found that the term “enlarged chamber” was indefinite, and that because it was a “term of degree,” it must be compared against something objective. The district court entered its final judgment in favor of Chandler. Grace appealed.

The Federal Circuit reversed, explaining that the “enlarged chamber[’s]” size did not need to be compared against any baseline object, but rather needed to be “large enough to accomplish a particular function.” The Court relied on the specification, which explained that the viscometer described in the patent reduced the mixing of sample fluid and pressurization fluid that was common in older viscometer models by using an “enlarged chamber.” The Court also cited the prosecution history, where the applicant explained that the invention solved a “long lasting problem” by reducing the measurement error caused by the friction of the seal or mixing of the fluids in older viscometer designs. Thus, the Court reasoned that a person of ordinary skill in the art would understand that the “enlarged chamber” must be large enough to prevent the mixing of the pressurization fluid and sample fluid to avoid the measurement errors associated with prior art viscometers.

Chandler argued that the term “enlarged chamber” was not a term of art. The Federal Circuit agreed but explained that “the intrinsic record sufficiently guides a skilled artisan as to the meaning of the term” as used in the patent. The Federal Circuit found that the district court erred in relying on a dictionary definition (extrinsic evidence) to contradict the meaning of the term found within the intrinsic record. The specification’s instructions for the meaning of a claim term should prevail over extrinsic evidence. Rebuffing Chandler’s argument, the Court explained that the specification does not need to explicitly define the claim term to govern the interpretation of that term.

The Federal Circuit remanded the case to the district court to reconsider indefiniteness in [...]

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More Delays: Appeal Dismissed under Collateral Order Doctrine

by | Jan 12, 2023 |

The US Court of Appeals for the Federal Circuit dismissed a patent holder’s interlocutory appeal for lack of jurisdiction under the collateral order doctrine. Modern Font Applications LLC v. Alaska Airlines, Inc., Case No. 21-1838 (Fed. Cir. Dec. 29, 2022) (Reyna, Cunningham, JJ.) (Newman, J., dissenting).

Modern Font Applications (MFA) is a nonpracticing entity that holds the exclusive license to a patent disclosing a method for operating systems to read and display nonstandard fonts. In 2019, MFA sued Alaska Airlines in district court for patent infringement. During the proceeding, Alaska Airlines designated portions of its source code files as confidential information for attorneys’ eyes only under the district court’s standing protective order. MFA moved to allow its in-house counsel to access the source code, and Alaska Airlines moved to keep it protected. The district court denied MFA’s motion and granted Alaska Airlines’ motion, finding that the source code amounted to a trade secret and MFA’s in-house attorney was properly excluded as a “competitive decisionmaker.” MFA sought interlocutory appeal of the order.

The Federal Circuit found that it lacked jurisdiction to review the discovery order. The Court explained that US Congress holds appellate courts to the final judgment rule, which states that decisions are only appealable if they end disputes on the merits, leaving nothing but execution of the judgment. A “practical construction” of this rule is the collateral order doctrine, which allows appellate review of a “small class” of attendant rulings. To qualify for review under this doctrine, a decision must be “conclusive”; address an important question, separate from the case’s merits; and be such that an appeal of the final judgment would not encompass a review of the decision at issue. The Federal Circuit stressed that the Supreme Court of the United States “has repeatedly emphasized the limited scope” of this doctrine.

The Federal Circuit found that MFA’s appeal failed the third prong of the collateral order doctrine. The Court noted that across appellate jurisdictions, pretrial discovery orders almost always fail this prong because review of final judgments can usually adequately address discovery issues. MFA argued that dismissing its appeal would prejudice MFA both financially and by eliminating its key litigation strategists and that the district court’s error would not be sufficient to overturn a final adverse judgment. The Court was not persuaded, noting that any financial harm was speculative, and that MFA could hire outside counsel or experts instead of relying on its in-house attorney. The Court also reiterated that to merit review under the collateral order doctrine, the issue must be “effectively unreviewable” on appeal, and the likelihood of an appellant’s success is irrelevant. The Court also found that MFA’s appeal failed the second prong because the exclusion of MFA’s attorney was too entangled with the ultimate outcome of the case to be considered an issue “separate” from the case. Because MFA failed two of three collateral order doctrine prongs, the Court did not address the first prong and dismissed the appeal for lack of jurisdiction.

In [...]

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Challenging Inventorship on Summary Judgment? Put a Cap on It

by | Jan 5, 2023 |

The US Court of Appeals for the Federal Circuit, citing a dispute as to material facts, held that a factfinder could reasonably conclude that an alleged joint inventor failed to sufficiently contribute to inventing the claimed technologies and thus reversed a district court order granting summary judgment of invalidity based on failure to join an inventor. Plastipak Packaging, Inc. v. Premium Waters, Inc., Case No. 21-2244 (Fed. Cir. Dec. 19, 2022) (Newman, Stoll, Stark, JJ.)

Plastipak sued Premium Waters, asserting 12 patents directed in part to the neck portions of lightweight plastic containers and preforms. These neck portions include a dispensing opening, a tamper-evident formation (TEF) that indicates if the container has been opened and a support flange/ring to facilitate manufacturing handling:

The patents list Richard Darr and Edward Morgan as inventors. Premium Waters countered that the patents should have included a third co-inventor, Alessandro Falzoni, an employee of another company with whom Darr and Morgan had collaborated on a project involving a design that included a neck portion, a specialty closure and a discontinuous TEF. Premium Waters moved for summary judgment of invalidity on the theory that the failure to include Falzoni as a joint inventor rendered the patent invalid, contending that Falzoni contributed the following to the invention:

  • A discontinuous (as opposed to continuous) TEF that is claimed by five of the asserted patents
  • A neck portion with only 0.580 inches or less separating its dispensing opening from its support flange/ring’s lower surface (the X dimension, as shown in the diagram above) that is claimed by the other asserted patents.

Plastipak contended that the asserted inventors were the sole inventors and that discontinuous TEFs (Falzoni’s alleged contribution) were merely state-of-the-art.

In granting the motion for summary judgment, the district court observed that Falzoni was “at least” a joint inventor because he had disclosed to one of the named inventors a neck finish measuring less than 0.580 inches with a discontinuous TEF in the form of an image of a 3D model that “constituted clear and convincing evidence of Falzoni’s disclosure, leaving ‘no doubt’ that the image ‘contributed significantly to the conception of a complete neck finish.’”

That model’s support ring lacked a lower surface, however, and Plastipak argued that without a lower surface the 3D model’s X dimension was undeterminable.

Plastipak also argued that Falzoni’s email circulating the 3D model stated that “[t]he area below the neck support ring has been left undefined” and seemingly invited the named inventor (Darr) to finalize it. Darr did so and, on the same day, emailed Falzoni a schematic depicting a support ring with a lower surface and a 0.591-inch X dimension.

Falzoni testified that while he calculated that the model had a ~0.563-inch X dimension, that calculation was based on “a reasonable indication” of where the support ring’s lower surface should be, and that the absence of an [...]

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Burdens Can’t Be Avoided No Matter How They’re Dressed Up

by | Jan 5, 2023 |

Addressing a multitude of issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling dismissing infringement of one patent and finding a trade dress invalid but reversed the invalidation of the other patent and vacated dismissal of an inequitable conduct defense. Mosaic Brands, Inc. v. Ridge Wallet LLC, Case Nos. 22-1001, -1002 (Fed. Cir. Dec. 20, 2022) (Newman, Prost, Stark, JJ.)

Mosaic Brands sued Ridge Wallet alleging infringement of a patent relating to a combination money clip and card holder adapted to retain paper currency and to removably store flexible cards such as credit cards, as well as Mosaic’s associated trade dress. Ridge denied the allegations and counterclaimed that Mosaic infringed a Ridge patent directed to a nearly identical wallet. In response to the counterclaim, Mosaic raised inequitable conduct as an affirmative defense.

During claim construction, the district court construed the terms “lip” and “varying thickness” in Mosaic’s patent. Following claim construction, the parties stipulated to noninfringement of Mosaic’s patent. The district court also found the trade dress of Mosaic’s wallet to be functional and thus invalid. As to Ridge’s patent, the district court granted summary judgment of invalidity based on a prior art product sold by Mosaic, and further denied summary judgment that Ridge had obtained its patent through inequitable conduct. Mosaic filed a motion for reconsideration regarding the inequitable conduct defense and to clarify remaining merits issues. The district court exercised its discretion to address the defense and identify deficiencies. The district court noted that Mosaic had only met a portion of its burden and later proceedings would present an opportunity to present more evidence of inequitable conduct. Both parties appealed.

The Federal Circuit first addressed a potential issue of appellate jurisdiction since the assertion of inequitable conduct was an affirmative defense and not a counterclaim yielding a final judgment to review. The Court found it had jurisdiction because the inequitable conduct defense merged and became final when the judgment denying summary judgment for inequitable conduct was entered.

Turning to the merits, the Federal Circuit addressed the two claim terms appealed by Mosaic. Mosaic argued that the district court’s interpretation of “lip” was too narrow because it required the lip to be made of “extruded plastic.” The Court quickly dispatched this argument by citing the specification of Mosaic’s patent, which described the lip as being made of extrudable plastic and extolled the benefits of such material. The Court focused on the context of how the patent used the phrase “the present invention” and found it to be limiting. As to the other claim term (“varying thickness”), Mosaic advocated for a plain and ordinary meaning of the term. The Court rejected Mosaic’s argument, finding that Mosaic failed to provide intrinsic evidence or meaningful explanation of how the district court’s construction differed from the plain and ordinary meaning. As such, the Court found that the district court made no error in either construction.

Turning to the appeal of Ridge’s patent, the Federal Circuit found that [...]

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Tag, You’re It: Sanctions Award Must Reflect Violative Conduct

by | Dec 22, 2022 |

The US Court of Appeals for the Federal Circuit determined that an accused infringer was entitled to a new trial relating to validity issues but still faced sanctions for its continuous disregard of its discovery obligations. ADASA Inc. v. Avery Dennison Corp., Case No. 22-1092 (Fed. Cir. Dec. 16, 2022) (Moore, Hughes, Stark, JJ.)

ADASA owns a patent relating to methods and systems for commissioning radio-frequency identification (RFID) transponders. ADASA sued Avery Dennison for patent infringement, alleging that its manufacture and sale of certain RFID tags infringed ADASA’s patent. Both parties sought summary judgment following discovery. Avery Dennison asserted that the patent was ineligible for patent protection under 35 U.S.C. § 101, and ADASA argued that the asserted claims were not anticipated or obvious based on the book RFID for Dummies. The district court granted ADASA’s motion on validity and denied Avery Dennison’s motion for patent ineligibility. Prior to trial, ADASA moved in limine to exclude Avery Dennison’s damages expert’s testimony related to certain licenses, and the district court granted the motion.

At trial, ADASA entered licenses into evidence as part of its damages case and alleged that they reflected lump-sum agreements to practice the asserted patent. The district court declined to include a jury instruction on lump-sum damages and a lump-sum option on the verdict form, observing that Avery Dennison’s expert had not offered a lump-sum damages opinion and concluding that the licenses alone were insufficient for the jury to award lump-sum damages. The jury returned an infringement verdict and awarded ADASA a running royalty of $0.0045 per infringing RFID tag, which resulted in an award of $26.6 million.

In its post-trial motions, Avery Dennison moved for a new trial, arguing it was reversible error for the district court to exclude its damages expert’s testimony and to decline to provide a jury instruction for a lump-sum damages award. Before the district court ruled on its motion, Avery Dennison revealed to ADASA that it had discovered additional previously undisclosed RFID tags in its databases. A subsequent investigation determined that the number of undisclosed tags was more than two billion. Avery Dennison agreed to pay an additional $9.5 million in damages, which corresponded to the royalty rate determined by the jury. ADASA subsequently moved for sanctions. The district court award $20 million in sanctions after finding that Avery Dennison had engaged in protracted discovery failures and a continuous disregard for the seriousness of the litigation and its expected obligations. The sanctions award corresponded to a $0.0025 per-tag rate applied to both the adjudicated and late-disclosed tags. Avery Dennison appealed.

Avery Dennison challenged the district court’s summary judgment rulings, its denial of a new trial and its imposition of sanctions. The Federal Circuit affirmed the district court’s patent eligibility determination, finding that the patent “is directed to a specific, hardware-based RFID serial number data structure designed to enable technological improvements to the commissioning process,” which “is not a mere mental process,” and concluded that the claim was directed to patent-eligible subject matter.

[...]

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Full Speed Ahead: District Court Entitled to Explore Litigation Funding Arrangements

by | Dec 15, 2022 |

The US Court of Appeals for the Federal Circuit denied a patent owner’s mandamus petition, clearing the way for a district court to probe who is funding the patent owner’s infringement litigation. In re Nimitz Techs. LLC, Case No. 23-103 (Fed. Cir. Dec. 8, 2022) (Lourie, Reyna, Taranto, JJ.) (per curiam) (nonprecedential).

Nimitz filed a complaint for patent infringement against Buzzfeed in the US District Court for the District of Delaware. The case was assigned to Chief Judge Connelly. Judge Connelly has two standing orders that require parties to disclose third-party litigation funders and the name of every individual and corporation with a direct or indirect ownership interest in the party. Nimitz filed a disclosure statement identifying Mark Hall as the sole owner and LLC member of Nimitz, and a statement representing that Nimitz has not entered any arrangement with third-party funders.

The district court later became aware that an entity called IP Edge was arranging assignments of patents to various LLCs that were plaintiffs in other actions before the district court. Based on the review of the documents in the other cases, it appeared to the district court that Hall had a connection with IP Edge. The district court ordered Hall and Nimitz’s counsel to appear at a hearing. During the hearing, the district court explored the relationship between Nimitz and an entity called Mavexar. After the hearing, the district court ordered production of communications between Hall, Mavexar and IP Edge, and communication and documents relating to the formation of Nimitz, Nimitz’s assets, Nimitz’s potential scope of liability resulting from the acquisition of the patent, the settlement or potential settlement of the cases and the prior evidentiary hearing. The district court also ordered production of monthly bank statements from Nimitz. Nimitz appealed to the Federal Circuit by filing a petition for writ of mandamus seeking an order vacating the district court’s order.

The Federal Circuit initially stayed the district court’s order pending the Court’s decision. While the mandamus petition was pending, the district court issued a memorandum explaining that the records sought in its prior order were relevant to addressing several concerns, including the following:

  • Compliance with the Rules of Professional Conduct
  • Compliance with the district court’s orders
  • Determining whether real parties in interest other than Nimitz, such as Mavexar and IP Edge, were hidden from the Court and the defendants
  • Determining whether those real parties in interest perpetrated a fraud on the district court by fraudulently conveying to a shell LLC the patent-in-suit and filing a fictitious patent assignment with the US Patent & Trademark Office designed to shield those parties from the potential liability they would otherwise face in asserting the patent in litigation.

Nimitz had argued that the district court’s order was improper because it would require disclosure of highly confidential litigation materials, including material protected by the attorney-client privilege and work-product immunity. In its decision on mandamus, the Federal Circuit rejected that argument, finding that the district court order made clear that Nimitz [...]

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Court Uncorks New Way to Serve Trademark Complaints

by | Nov 29, 2022 |

The US Court of Appeals for the Ninth Circuit concluded that Section 1051(e) of the Lanham Act permits a plaintiff in a district court case to serve a complaint against a foreign defendant via the Director of the US Patent & Trademark Office (PTO). San Antonio Winery, Inc. v. Jiaxing Micarose Trade Co., Ltd., Case No. 21-56036 (9th Cir. Nov. 14, 2022) (Siler, Callahan, Thomas, JJ.)

San Antonio Winery is a Los Angeles-based winery best known for its Stella Rosa brand of wines. The winery is owned and operated by the Riboli family. San Antonio has registered the trademarks RIBOLI and RIBOLI FAMILY, which it has used since at least 1998 to market its wines and other products.

Jiaxing is a Chinese company that has sold products using the Riboli name. In 2018, Jiaxing registered the mark RIBOLI for use in connection with articles of clothing and shoes. In 2020, Jiaxing applied to register the mark RIBOLI for use with additional types of products, including wine pourers, bottle stands, containers, cocktail shakers, dishware and various other kitchen and household items.

After learning that Jiaxing was using the Riboli name to sell products in the United States, San Antonio filed a complaint asserting Lanham Act claims for trademark infringement, trademark dilution and false designation of origin, as well as related state-law claims. San Antonio also sought an injunction prohibiting Jiaxing from using the RIBOLI mark in connection with its products, an order canceling Jiaxing’s 2018 registration of the RIBOLI mark, and an order either directing Jiaxing to abandon its 2020 application to register RIBOLI for additional uses or prohibiting the PTO from granting the application.

Because Jiaxing is a Chinese company, San Antonio’s service of process was governed by rules for serving parties abroad, such as by the Hague Convention. Concerned with the amount of time it might take to effect service under the Hague Convention, San Antonio instead sought to serve Jiaxing under Section 1051(e) of the Lanham Act, which applies to foreign domiciliaries who apply to register a trademark. Section 1051(e) states that if a trademark applicant is not domiciled in the United States, the applicant may designate the name and address of a person in the United States who may be served with notices or processes in proceedings affecting the mark. If the designated person cannot be found at the address, the notices or processes may be served on the PTO Director.

Seeking to avail itself of Section 1051(e), San Antonio inquired whether the US-based lawyer who had represented Jiaxing in connection with its trademark applications would accept service on Jiaxing’s behalf. When the lawyer did not respond, San Antonio served the district court complaint on the PTO Director, who then sent a letter to Jiaxing confirming service of process was effectuated pursuant to Section 1051(e).

After Jiaxing did not appear to defend itself in the action, San Antonio filed a motion for default judgment. The district court denied the motion on the ground that Jiaxing had not [...]

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Not So Clean: Federal Circuit Upholds Trade Dress Preliminary Injunction, Finds Defenses Improperly Plead

by | Nov 17, 2022 |

The US Court of Appeals for the Federal Circuit upheld a “narrow” preliminary injunction in a trade dress case, finding that the opponent of a registered configuration mark failed to prove its lack of secondary meaning and functionality defenses. SoClean, Inc. v. Sunset Healthcare Solutions, Inc., Case No. 21-2311 (Fed. Cir. Nov. 9, 2022) (Newman, Lourie, Prost, JJ.)

SoClean manufactures Continuous Positive Airway Pressure (CPAP) machines. SoClean sued Sunset—a former distributor of SoClean products—for patent infringement and later added trademark infringement claims. At issue in this appeal was a single SoClean mark “for the configuration of replacement filters for its sanitizing devices.”

SoClean requested a preliminary injunction to stop Sunset from making or selling allegedly infringing CPAP filters. The district court granted the injunction but narrowly tailored the injunction to only enjoin Sunset from selling its filter cartridges without Sunset’s own brand name attached to the filter drawing so that customers would not falsely believe they were buying SoClean products. Sunset appealed.

While a party seeking preliminary injunction must prove all four eBay elements, this appeal focused on just one: “likelihood of success on the merits.” Sunset argued that the district court abused its discretion in finding that SoClean would likely defeat Sunset’s lack of secondary meaning defense and its functionality defense.

After noting that the parties agreed that SoClean’s trade dress was protectable only upon a showing that it had obtained secondary meaning, the Federal Circuit divided the secondary meaning issue into two subparts:

  1. Whether the district court should have questioned the validity of SoClean’s registration in light of Sunset’s evidence
  2. Whether the district court held Sunset to an improperly high standard of proof.

As to the first issue, the Court noted that federal registration is prima facie evidence of a mark’s validity. When, as here, the challenged mark was registered fewer than five years prior, the burden shifts from plaintiff to defendant, such that the defendant must rebut the presumption of validity. Sunset acknowledged that it had this burden, but its arguments to the district court focused only on the US Patent & Trademark Office’s decision to grant SoClean’s registration. The Court rebuffed that argument, noting that “scrutinizing the application process and deciding whether the trademark examiner was correct to issue the registration in the first place is the opposite” of the statutory presumption of validity.

Next, the Federal Circuit addressed Sunset’s standard of proof argument. The Court acknowledged that the district court misstated the law by suggesting that there was a “vigorous evidentiary requirement” on the challenging party, instead of simply a “preponderance of the evidence.” However, the Court also noted that the district court considered Sunset’s lack of secondary meaning evidence to be “equivocal, at best,” which “plainly fails to satisfy a preponderance-of-the-evidence standard.” Therefore, the Court judged the error to be harmless.

The Federal Circuit thus affirmed the finding that SoClean would likely defeat Sunset’s secondary meaning challenges.

The Federal Circuit next [...]

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Supreme Court to Consider Enablement Requirement

by | Nov 10, 2022 | ,

The Supreme Court of the United States agreed to consider how much a patent must disclose in order to meet the enablement requirement under 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (Supr. Ct. Nov. 4, 2022) (certiorari granted). The question presented is as follows:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.

Amgen owns two patents that describe antibodies that bind to PCSK9 protein and lower LDL cholesterol levels by blocking PCSK9 from binding to LDL receptors. After a jury determined that Sanofi failed to prove that the asserted claims were invalid for lack of enablement, the district court granted Sanofi’s post-trial motion for invalidity based on lack of enablement. The US Court of Appeals for the Federal Circuit affirmed, finding that the scope of the claims encompassed millions of antibodies and that the patent thus did not meet the enablement requirement because practicing the full scope of the claims would require “undue experimentation.”

The Supreme Court declined to consider the first question presented in Amgen’s petition: whether enablement should be a question of law (under current Federal Circuit precedent) or be designated a question of fact to be decided by a jury. In granting certiorari, the Supreme Court proceeded contrary to the recommendation of the US Solicitor General.



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