Oregon Court of Appeals Issues Three Different Defense Opinions
Oregon’s Court of Appeals was busy issuing three different defense opinions on March 19, 2025. Circuit court errs by awarding attorneys’ fees based on a contingency fee.The first was Griffith v. Property and Casualty Ins. Co. of Hartford, where a homeowner submitted a fire loss and alleged the insurer did not pay the benefits owed quickly enough. The insureds filed a complaint, the insurer answered, and then a global settlement occurred. The insureds then filed a motion for summary judgment seeking prejudgment interest per ORS 82.010 as well as attorneys’ fees per ORS 742.061(1). They also sought costs as a prevailing party. The circuit court denied interest because no judgment had been entered and costs because there was no prevailing party, but granted $221,179.27 in attorneys’ fees. Both sides appealed. The insureds’ appeal about prejudgment interest was rejected for procedural reasons. The circuit court order on costs was affirmed because there was no prevailing party. Griffith is noteworthy only for its ruling about attorneys’ fees. The insurer did not dispute that ORS 742.061(1) applied or that the insureds were entitled to attorneys’ fees. It disputed only how the circuit court calculated the amount of the award. The circuit court determined that amount was a percentage of the insureds’ recovery. The Court of Appeals held that this was error.
When an award of attorneys’ fees is permitted, ORS 20.075 provides factors to determine the amount to award. Its factors generally align with the lodestar method. Although a percentage of the recovery might be appropriate in some circumstances, Griffith concluded the “lodestar method is the prevailing method for determining the reasonableness of a fee award in cases, such as this, involving a statutory fee-shifting award, even when, as here, the insured has retained counsel on a contingency-fee basis.” Further, the award “must be reasonable; a windfall award of attorney fees is to be avoided.” The Court of Appeals concluded using a percentage of the recovery was inappropriate in this instance. This is because coverage was never disputed, and the claim was immediately accepted. By the time the complaint was filed, the insurer had made several payments and was still adjusting the loss. There was minimal litigation and the delay paying the full claim “was caused by circumstances outside of the parties’ control.” The Court of Appeals ultimately concluded that the insureds had not met their burden to demonstrate the fees they sought were reasonable. The case was remanded to redetermine the fees owed.
No really, the recreational use statute applies to a city park.In Laxer v. City of Portland, the plaintiff entered Mount Tabor Park to “walk its trails” but tripped and fell due to a hole in the pavement. The plaintiff sued the City, but the circuit court granted the City’s motion to dismiss based on Oregon’s recreational use statute, ORS 105.682. The plaintiff appealed. Among other arguments, the plaintiff argued the paved road in the park was like a public sidewalk and thus exempt from ORS 105.682. The Court of Appeals concluded that while there are limits to ORS 105.682, “generally available land connected with recreation” is still typically protected. Since Mount Tabor Park is clearly connected with recreation, the dismissal was affirmed.
Defense verdict affirmed in slip-and-fall case.In Fisk v. Fred Meyer Stores, Inc., where a customer slipped “on a three-foot by five-foot laminated plastic sign, which had fallen from its stand onto the public walkway.” The sign belonged to the store and was placed there by store employees. The case was tried and produced a defense verdict.
On appeal, the customer conceded there was no evidence to prove the store (1) placed the sign on the ground, (2) knew the sign was on the ground and did not use reasonable diligence to remove it, or (3) the sign had been on the ground for enough time that the store should have discovered it. The customer instead argued the circuit court erred by not giving a res ipsa loquitur instruction. Although Oregon case law has concluded res ipsa loquitur does not apply to slip and falls, the customer argued this was not a slip and fall because an object caused the fall.
Fisk affirmed the circuit court’s refusal to give the res ipsa loquitur instruction. The customer’s attempted legal distinction was meaningless. “We agree with defendant that because plaintiff slipped on an object on the ground, plaintiff’s claim is correctly characterized as a slip-and-fall claim.”
ANCIENT TEXTS: Plaintiff Brings Class Action Against Ancient Cosmetics 3 years 364 Days After Text Was Sent
When people tell you the statute of limitations for a TCPA violation is four years– we really mean it.
Back on March 25, 2021 a company called Ancient Cosmetics allegedly sent a marketing text message to a lady named Patrice Gonzalez.
At that time Tom Brady had just won a Super Bowl over the Chiefs, that big ship Ever Given was still stuck in the Suez canal and the Czar was still working in big law.
Yeah, that was a looooong time ago.
But just this week Ms. Gonzalez filed a TCPA class action lawsuit against Ancient Cosmetics over the ancient text messages–what are the odds of that BTW?–and its a great reminder to folks.
Compare!
What you do today in TCPAWorld has consequences for a loooong time to come.
That means you need to be keeping records of consent–especially if you are buying leads–for that entire time.
And yes people WILL sue you 3 years, 364 days after you allegedly violate the TCPA.
Gross, right?
Let those who have ears to hear, hear.
What’s the (Re)issue? Patent Term Extensions for Reissue Patents
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)
Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.
The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.
Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.
Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).
The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of the Hatch-Waxman Act and its place within the statutory scheme. The purpose of the act is “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications,” and “the statute should be liberally interpreted to achieve that end.”
Having found that the Hatch-Waxman Act contemplates PTE for patents claiming drug products for which exclusivity was delayed by FDA review, the Federal Circuit found no reason to deny Merck compensation for the PTE period calculated by the PTO based on the original patent issue date.
Zone of Natural Expansion Is a Shield, Not a Sword
The US Court of Appeals for the Federal Circuit upheld a Trademark Trial & Appeal Board decision to partially cancel trademarks, ruling that an opposition challenger could not use the zone of natural expansion doctrine to claim priority because the doctrine is strictly defensive. Dollar Financial Group, Inc. v. Brittex Financial, Inc., Case No. 23-1375 (Fed. Cir. Mar. 19, 2025) (Prost, Taranto, Hughes, JJ.)
Dollar Financial Group (DFG) is a loan financing and check cashing business that has used the mark MONEY MART since the 1980s. In 2012, DFG expanded and started using the mark in connection with pawn brokerage and pawn shop services. DFG registered MONEY MART for these new services in 2014. Brittex petitioned to cancel the registration on several grounds, including that the registrations were improperly issued in violation of the Lanham Act, which bars registration of a mark that “so resembles . . . a mark or trade name previously used in the United States by another and not abandoned, as to be likely, when used on or in connection with the goods of the applicant, to cause confusion, or to cause mistake, or to deceive.” 15 U.S.C. § 1052(d). Brittex has operated pawn shops under the names Money Mart Pawn and Money Mart Pawn & Jewelry since the 1990s and claimed prior common law rights to the MONEY MART mark for pawn services.
The Board ruled in favor of Brittex, finding that Brittex had priority over DFG for pawn services due to its earlier use of the mark. The Board also determined that DFG could not rely on the zone of natural expansion doctrine to establish priority because this doctrine is purely defensive and does not grant a proactive right to register a mark on an expanded line of goods or services. The Board also concluded that there was a likelihood of confusion between the marks, given their high similarity and the overlapping nature of the services provided by both parties. DFG appealed.
The Federal Circuit agreed that Brittex had established priority because it was the first to use the MONEY MART mark in connection with pawn services. The Court also rejected DFG’s zone of natural expansion argument, reiterating that the doctrine is defensive and cannot be used to establish priority offensively.
The doctrine of natural expansion, as explained in Orange Bang v. Ole Mexican Foods (TTAB 2015), states that:
[T]he first user of a mark in connection with particular goods or services possesses superior rights in the mark as against subsequent users of the same or similar mark for any goods or services which purchasers might reasonably expect to emanate from it in the normal expansion of its business under the mark.
However, the doctrine does not give the senior mark user an offensive or proactive use.
The Federal Circuit also addressed DFG’s argument regarding the doctrine of tacking, which allows trademark holders to make minor modifications to their own mark while retaining the priority position of the older mark. Tacking is generally permitted to allow trademark holders to make minor adjustments to their marks to reflect changing consumer preferences, aesthetics, and marketing styles. However, the Federal Circuit determined that DFG had forfeited this argument by failing to present it during the initial cancellation proceeding before the Board. Consequently, the Court declined to consider the tacking argument on appeal.
Navigating Whistleblower Protections and Compliance with DEI Executive Orders
As Polsinelli has discussed, President Donald Trump issued Executive Order No. 14151 titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” and Executive Order No. 14173 titled “Ending Radical and Wasteful Government DEI Programs and Preferencing” (collectively, the “Orders”) shortly after taking office, and that a District Court of Maryland enjoined certain aspects of those Orders. The Trump administration appealed the District Court’s decision, and on March 14, 2025, the U.S. Court of Appeals for the Fourth Circuit granted the Trump administration’s request for a stay (i.e., pause) of the injunction pending the outcome of the appeal. This means that during the appeal, the Orders are in full force and effect.
There are many articles discussing the importance of employers taking steps to determine whether their actions, policies and procedures may violate the Orders.
Given the back-and-forth nature of the decisions related to the Orders, a question that some employers may have is whether an employee is protected from retaliation if they report that they believe their employer is violating one of the Orders, but that Order is eventually struck down. Employers may be surprised to learn that if an employee reasonably believes the employer’s activity violates a legal provision (here, for example, the Orders), then they may be protected even if the Orders are later revoked or struck down.
Whistleblower Protections and Potential Activity Related to the DEI Executive Orders
What might protected activity look like with regard to these Orders? Examples of potential whistleblowing activity could include:
An employee may report the employer is continuing DEI programs, trainings or initiatives that they believe violate the Orders prohibiting race- or gender-based preferences.
An employee may report that an employer or an employee of the employer is prioritizing hiring, promotions or contracting decisions based on race, gender or other DEI-related criteria.
An employee may report that their employer is requiring them to participate in DEI training and claim such training promotes race- or gender-based biases, in violation of the Orders.
Employees working for federal contractors may report that their employer is not following the Orders’ requirements regarding DEI restrictions in government-funded projects or is inaccurately certifying compliance with DEI-related contract terms.
How Should Employers Respond to Whistleblowing?
When an employee reports a concern or engages in whistleblowing activities, employers should carefully evaluate and respond to the allegations. Steps an employer should consider taking include:
Assessing the complexity and seriousness of the employee’s complaint and, if appropriate, consider an investigation conducted under the attorney-client privilege or by an external investigator in conjunction with human resources.
Documenting findings and actions taken.
Maintaining a communication channel with the employee throughout the process.
Communicating with the employee that the investigation has concluded, sharing appropriate information considering the privacy of other employees and privilege considerations.
A well-handled response not only helps address and potentially resolve immediate concerns but also demonstrates the company’s commitment to compliance and transparency, reducing potential legal exposure.
Given the current fast-changing circumstances, now may be a good time for employers to review their complaint reporting procedures. An effective internal reporting system typically will be accessible, confidential and supported by a clear policy that outlines the process for handling reports and the protections available to employees.
How Should Employers Treat Whistleblowers?
Employers should not try to identify who made a report of an alleged violation of law to a governmental agency, particularly if the agency is then investigating the employer. That information is usually not necessary to respond to the report and could create additional risk for the employer.
If an employer knows who has made a complaint, then the employer should treat that employee with the same level of care it would afford its other employees. In particular, the complaining employee should not be held to a higher performance or behavior standard.
That said, making a complaint does not mean that an employee cannot be held to performance and behavior standards. Nor does making a complaint mean that an employee cannot be separated from employment for lawful reasons. However, as in many areas, employers would be wise to consult counsel before taking adverse action against an employee if the employee has recently complained that the employer has violated the law. This is so because many courts have held that close timing is enough to infer a retaliatory motive. Thus, employers should be very careful to show that it has a legitimate, non-retaliatory reason for separating an employee who it knows has complained (rightly or wrongly) of a violation of law, particularly if that complaint occurred close in time to when the separation will occur.
Next Steps for Employers
Employers should also consider regularly reviewing their policies and procedures to ensure ongoing compliance with applicable law. Reviewing policies and procedures with legal counsel can help identify areas of risk and ways to implement changes. By taking a proactive approach to compliance and employee relations, employers can create a positive work environment that supports both legal obligations and business objectives.
Finally, employers particularly impacted by the recent changes may want to consider offering training to managers by knowledgeable trainers who can explain these new laws and how they may change the way an employer operates.
Still in the Dark After Loper Bright: SCOTUS Declines to Shine a Light on NLRB Deference Post-Chevron
Last year, the United States Supreme Court’s Loper Bright decision put an end to “Chevron deference,” a judicial practice of deferring to federal agency interpretations of ambiguous statutory language. While the legal blogosphere has spent considerable ink weighing the impact of Loper Bright, the Supreme Court recently rejected a pair of petitions on the amount of deference owed to the National Labor Relations Board (NLRB), casting an even longer shadow over Loper Bright. So, what can we learn from the Supreme Court’s inaction?
Differing Sources of Deference
Issued in 1984, Chevron created a “bedrock principle of administrative law that a reviewing court must defer to a federal agency’s reasonable interpretation of an ambiguous statute it administers.” According to Kent Barnett and Christopher J. Walker in Chevron in the Circuit Courts, Chevron was “one of the most cited Supreme Court decisions of all time.” Under Chevron, a court would first determine whether a statute clearly answered a particular question. If it did, the court would simply apply the statute’s answer. If the statute was “silent or ambiguous,” however, the court would defer to the interpretation of the federal agency charged with enforcing the statute if the agency’s interpretation was “based on a permissible construction of the statute.”
Loper Bright put an end to Chevron’s reign, however, holding that deference to an administrative agency violated the Administrative Procedures Act (APA) because courts and judges were supposed to interpret statutes unless a statute specifically reflected Congressional delegations of discretionary power to the federal agency. In other words, if Congress specifically delegated authority to agencies to promulgate regulations and relevant definitions, Loper Bright appeared to leave that deference intact. After all, in those situations, Congress, not Chevron, required courts to defer to agencies. If Congress did not make that delegation, however, a court, not the agency, was responsible for interpreting an ambiguous statute.
The NLRB is supposedly one of those agencies Congress tapped to promulgate regulations and relevant definitions for the NLRA. Indeed, the Supreme Court noted in Ford Motor Co. v. NLRB, years before Chevron, that Congress had made a “conscious decision” to delegate to the NLRB “the primary responsibility of marking out the scope of the statutory language.” Similar delegations to federal agencies exist in the Age Discrimination in Employment Act (ADEA), the Americans with Disabilities Act (ADA), the Genetic Information Nondiscrimination Act (GINA), and the recently passed Pregnant Workers Fairness Act and the PUMP Act.
So, Loper Bright should have little impact on the NLRB’s interpretation of the NLRA and other labor statutes, right? Not so fast. Reasonable minds, like the Sixth and Ninth circuits, might disagree.
Circuital Thinking
The Ninth Circuit’s Approach
The dispute started in the Ninth Circuit between a group of hospitals and their employees’ union. Per the collective bargaining agreement, the hospitals deducted union fees from participating employees if the employees executed a written assignment authorizing the deduction. After the collective bargaining agreement expired, the hospitals continued to deduct dues for several months but then stopped. They notified the union that they believed the written assignments violated the Taft-Hartley Act because the union’s assignments did not have specific language regarding revocability upon the expiration of the collective bargaining agreement.
The union filed an unfair labor practice charge, the NLRB filed a complaint, and an administrative law judge determined that the hospitals committed an unfair labor practice by unilaterally ending the practice of collecting union dues. After a series of decisions, the NLRB determined that the Taft-Hartley Act did not require specific language and found that the hospitals engaged in unfair labor practices. On appeal, the Ninth Circuit agreed with the NLRB’s decision.
After the Supreme Court issued Loper Bright, the hospitals petitioned the Supreme Court for a writ of certiorari, arguing that the Ninth Circuit improperly deferred to the NLRB’s interpretation of the NLRA instead of performing its own statutory analysis.
The Sixth Circuit’s Approach
The Sixth Circuit took a slightly different approach. There, a union and a road paving company began negotiating a collective bargaining agreement. When negotiations broke down, the union began picketing. As negotiations continued, the union requested information from the company regarding bargaining unit employees. However, the company did not provide that information, and the union filed unfair labor practices charge against the company based on picketing violations and the failure to provide that information. The NLRB brought a complaint, and an administrative law judge issued a decision finding that the company violated the NLRA by refusing to provide the employee bargaining unit information. The NRLB affirmed the administrative law judge’s decision.
On appeal, the Sixth Circuit, citing Loper Bright, declined to defer to the NLRB’s interpretation of the NLRA and decided to exercise independent judgment in deciding whether an agency acted within its statutory authority. Performing its own analysis, the Sixth Circuit affirmed the NLRB’s decision.
The company petitioned the Supreme Court for a writ of certiorari, arguing, in part, that the Sixth Circuit was required to defer to the NLRB’s interpretation of the NLRA pursuant to Loper Bright. The company also was seeking to challenge the president’s removal authority, and may have made its Loper Bright argument to sweeten the deal for Supreme Court review (since both the NLRB and Sixth Circuit reached the same result on statutory interpretation).
Supreme Inaction
Given these two apparently conflicting interpretations of Loper Bright, it seemed the Supreme Court was primed to clarify the appropriate approach. Was the Ninth Circuit correct in deferring to the NLRB’s analysis of the NLRA or was the Sixth Circuit correct in adhering to Loper Bright’s direction that it decide the meaning of ambiguous statute? At any rate, certainly a circuit split requires Supreme Court review?
Apparently not. The Supreme Court denied certiorari in both cases without any clarifying statement, leaving it unclear whether Loper Bright will impact NLRB or other agency decisions in the future. So, what does this mean? On one hand, in both cases the federal circuit courts ultimately affirmed the NLRB’s decisions, albeit after performing different analyses. Maybe the Supreme Court was unwilling to wade into these waters if both courts ultimately reached the correct decision. On the other hand, were these simply cases where the statutory text was unambiguous, such that agency interpretations were not even truly implicated?
Unfortunately, we’re left to wait until the next dispute. Perhaps time will tell, even if the Supreme Court won’t. In the interim, Bradley is available to answer any questions you might have regarding new administrative rules or decisions.
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When “It’s Obvious” Just Isn’t Enough: Challenger’s Burden to Prove Obviousness
The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision that a patent was not obvious because the petitioner failed to show sufficient support of obviousness based on prior art. AMP Plus, Inc. v. DMF, Inc., Case No. 23-1997 (Fed. Cir. Mar. 19, 2025) (Lourie, Bryson, Reyna, JJ.)
DMF owns a patent directed to a compact recessed lighting system designed for installation in a standard electrical junction box. In 2019, AMP, doing business as ELCO, petitioned for inter partes review of several claims of the patent on three grounds of unpatentability:
Anticipation by a prior reference
Obviousness based on a combination of two references
Further obviousness based on an additional source.
The Board found that one claim was anticipated but ruled that ELCO failed to prove unpatentability of the other claims, including the claim at issue on appeal. The claim at issue describes a system with wires connected to a driver and a first connector, coupled to a second connector that in turn is connected to the building’s electrical system. This specific connection was referred to as “Limitation M.” ELCO appealed. In that earlier appeal (2022), the Federal Circuit affirmed the Board’s ruling on all claims except the claim at issue and remanded the case back to the Board for further analysis.
On remand, the Board concluded that ELCO failed to demonstrate the unpatentability of the claim at issue because ELCO’s petition lacked a substantive analysis of Limitation M. The Board found ELCO’s argument that a prior art marine lighting system could be adapted for the claimed building use unsupported by evidence and ruled that the claim at issue was not obvious. Again, ELCO appealed.
ELCO raised two main arguments. First, it argued that the Board erred in not determining that the claim at issue was anticipated by a prior reference, as the Board had previously found another claim to be anticipated by the same reference. The Federal Circuit rejected this argument because ELCO had only challenged the claim at issue on the basis of obviousness in its original petition, not anticipation. Since the issue of anticipation was not raised in the petition, the Court determined that ELCO could not introduce this new ground of unpatentability on appeal.
Second, ELCO argued that its petition had sufficiently demonstrated the obviousness of Limitation M based on the prior references. The Federal Circuit disagreed, finding that ELCO’s petition did not adequately address the specific requirement for coupling the system to a building’s electrical infrastructure. The petition failed to discuss how the recessed lighting system would be installed in a building, and the references cited did not provide adequate support for the argument of obviousness for this particular limitation.
The Federal Circuit emphasized that it was not the Board’s responsibility to supplement the petitioner’s arguments or search for evidence to support an inadequately supported claim challenge. The Court reiterated that an obviousness analysis does not require the Board to fill gaps in the petitioner’s original filing. In this case, the Board had appropriately determined that ELCO failed to meet its burden of demonstrating the obviousness of Limitation M.
No APA Review of Commission Refusal to Issue Sua Sponte Show Cause Order
The US Court of Appeals for the Federal Circuit dismissed an appeal challenging a US International Trade Commission decision that upheld an administrative law judge’s (ALJ) order, ruling that such an order was within the Commission’s discretion and unreviewable. Realtek Semiconductor Corp. v. International Trade Commission, Case No. 23-1095 (Fed. Cir. Mar. 18, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)
DivX filed a complaint at the Commission against Realtek alleging a violation of § 1337 of the Tarriff Act. DivX later withdrew the complaint. Realtek subsequently filed a motion for sanctions against DivX, alleging certain misconduct. The ALJ denied the motion on procedural grounds. Realtek subsequently petitioned for Commission review, asking the Commission to exercise its authority to issue a sua sponte order requiring DivX to show cause explaining why it had not engaged in sanctionable conduct. The Commission decided not to review and adopted the ALJ’s order without comment.
Realtek appealed, contending that the Commission violated the Administrative Procedure Act (APA) by not issuing a sua sponte show cause order. The Commission argued that Realtek’s appeal should be dismissed, contending that the issue raised was unreviewable.
The Federal Circuit agreed with the Commission, stating that under § 701(a)(2) of the APA, decisions made by an agency are unreviewable by the Court when they are entrusted to the agency’s discretion by law. The Court explained that the sua sponte issuance of a show cause order is a decision that “may be, not must be,” entered by the ALJ or on the Commission’s initiative. Therefore, the decision not to act sua sponte is a decision that remains wholly within the agency’s discretion.
The Federal Circuit rejected Realtek’s argument that the Commission’s refusal to act was reviewable because the Commission failed to provide reasoning, and that Commission review would have allowed the Court to determine if there were “illegal shenanigans” in exercising discretion. However, the case cited by Realtek involved the review of “shenanigans” that fell within the Court’s reviewable categories, not one related to the Commission’s refusal to issue a show cause order sua sponte. The Court found no support for Realtek’s claim that discretionary agency actions under § 701(a)(2) become reviewable under the APA simply because the agency fails to provide its reasoning.
Even Jepson Preambles Require Written Description Support
The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well known in the prior art. In re Xencor, Inc., Case No. 24-1870 (Fed. Cir. Mar. 13, 2025) (Hughes, Stark, Schroeder, JJ.)
Xencor filed a patent application claiming a modified anti-C5 antibody treatment with certain amino acid substitutions that provide for longer serum half-lives and reduce the need for more frequent treatment. The application included:
A Jepson claim reciting, “[i]n a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising” certain amino acid substitutions, wherein the modified antibody has “increased in vivo half-life.”
A non-Jepson claim directed to “a method of treating a patient by administering an anti-C5 antibody comprising” certain amino acid substitutions, wherein the modified antibody “has increased in vivo half-life.”
The specification provided one example of an anti-C5 antibody, 5G1.1, and three high-level examples of potential uses for anti-C5 antibodies. The examiner rejected the claims for lack of written description. Xencor unsuccessfully appealed the rejection to the Patent Trial & Appeal Board. Xencor then unsuccessfully petitioned the Board for reconsideration. Xencor appealed to the Federal Circuit, which resulted in a remand to the Board’s Appeals Review Panel (ARP).
The ARP concluded that Jepson claim preambles require written description support and that the preamble language of “treating a patient” was limiting – even without the Jepson claim format – because it gave life and meaning to the claim recitations “increased in vivo half-life” and “administering.” Because the specification did not provide a representative number of species to support the broad genus of anti-C5 antibodies, a description of conditions that can successfully be treated with an anti-C5 antibody, or even a single working example describing treatment with an anti-C5 antibody with the claimed modifications, the ARP found that the claims lacked written description and that Xencor had not shown that anti-C5 antibodies were well known. Xencor again appealed, arguing that “treating a patient” was not limiting and that Jepson preambles do not require written description support.
With respect to the preamble of the method claim, the Federal Circuit noted that Xencor agreed that the “administering” portion was limiting but nonetheless argued that “treating a patient” was not. Although a preamble can be split into limiting and non-limiting parts, the Court reasoned that the preamble here could not be neatly packaged into separate portions because the phrase “treating a patient” was directly connected through the word “by” to the phrase “administering an anti-C5 antibody,” and each phrase gave meaning to the other. The Court further explained that the entire preamble provided the raison d’être of the claimed method: When a patient is treated with the modified anti-C5 antibody, the treatment lasts longer, reducing the frequency of treatments. Accordingly, the Court agreed with the ARP that the recitation “treating a patient” was limiting.
The Federal Circuit next concluded that substantial evidence supported the ARP’s determination that the specification did not provide written description support for “treating a patient.” Because the specification was not limited to treating a particular disease, “treating a patient” meant “treating all patients and all diseases.” While the specification provided three examples of classes of diseases that might benefit from the claimed treatment, the Court agreed with the ARP that this disclosure was inadequate to demonstrate possession of a method of treating any particular disease, let alone all diseases.
Finally, the Federal Circuit explained that a Jepson claim preamble requires written description support because it is used to define the claimed invention and the claim scope. The Court cautioned that a patentee cannot obviate the written description requirement by using a Jepson claim to avoid the requirement that the inventor be in possession of the claimed invention – otherwise, a patentee could obtain a Jepson claim with a preamble that recited a time machine as well known in the art without describing a time machine. To provide adequate written description for a Jepson claim, the applicant must establish that what is claimed to be well known in the art actually is well known in the art. The Court explained that the amount of disclosure necessary varies depending on the level of knowledge of the person skilled in the art, the unpredictability of the art, and the newness of the technology.
Given the large number of possible antibodies in the anti-C5 antibody genus and the limited disclosure in the specification, the Federal Circuit affirmed the ARP’s determination that the Jepson claim lacked adequate written description.
Trump Administration Terminates Humanitarian Parole for Citizens of Cuba, Haiti, Nicaragua, Venezuela
Department of Homeland Security (DHS) Secretary Kristi Noem announced the termination of humanitarian parole for citizens of Cuba, Haiti, Nicaragua, and Venezuela, also known as the CHNV program, in the Federal Register on March 25, 2025. Humanitarian parole for citizens of these countries will expire no later than 30 days from March 25, 2025, or April 24, 2025.
CHNV beneficiaries who did not file some other immigration benefit application prior to publication of the termination notice must depart the United States on or before April 24, 2025, or the expiration of their humanitarian parole, whichever date is sooner. DHS will prioritize removal of CHNV beneficiaries without pending immigration applications who remain in the United States beyond the expiration of their humanitarian parole.
DHS has determined that, after termination of the parole, the condition upon which employment authorizations were granted no longer exists, and DHS intends to revoke parole-based employment authorizations.
The CHNV program was instituted by DHS under former President Joe Biden. It allowed citizens of Cuba, Haiti, Nicaragua, and Venezuela who obtained U.S. financial sponsors to enter the United States by humanitarian parole for up to two years. Once in the United States, parolees could apply for work authorization. Humanitarian parole was renewable, however, on Oct. 4, 2024, the Biden Administration announced it would not renew the program. About 530,000 individuals benefited from the CHNV program.
Seeking to enjoin termination of the program, on Feb. 28, 2025, Haitian Bridge Alliance and several individuals affected by the termination of the CHNV program filed a lawsuit in U.S. District Court for the District of Massachusetts, alleging violations of the Administrative Procedure Act and the Due Process Clause of the Fifth Amendment. The lawsuit is pending.
Operation Allies Welcome, the humanitarian parole program for Afghanis who assisted U.S. forces during the war in Afghanistan, and Uniting for Ukraine, the humanitarian parole program for individuals fleeing the war in Ukraine, are unaffected by the latest announcement.
The Perils of Interpreting Your Own Rules Too Strictly, Especially When They Don’t Exist (UK)
So here it is, 2025’s first serious contender for the What On Earth Were They Thinking? Awards, an unfair dismissal case with a common-sense answer so clear you could see it from Mars, but which it nonetheless took five years and the Court of Appeal to arrive at.
Mr Hewston was employed by Ofsted as a Social Care Regulatory Inspector. In 2019, in the course of a school inspection, he brushed water off the head and touched the shoulder of a boy of 12 or 13 who had been caught in a rainstorm.
That contact was reported to Ofsted by the school as a case of “inappropriate touching”. The terms of the school’s reports were, said the Court of Appeal, “redolent with hostility against the inspectors and the inspection”. They described the incident in fairly hyperbolic terms – that contact had created a “very precarious situation” and had “put the safety of a student at risk”, both allegations which Ofsted itself quickly dismissed as arrant nonsense. It knew that the same school had made complaints about a number of previous inspectors, allegations not necessarily unconnected with its having serially failed to receive the Ofsted gradings it wanted.
Ofsted itself never made any suggestion that there had been any improper motivation on Hewston’s part. It accepted from the outset that the conduct was “a friendly act of sympathy and assistance”. Nonetheless, it dismissed Hewston for gross misconduct a month later. Why?
The disciplinary charges referred to his having without consent or invitation touched a child on the head and shoulder “contrary to Ofsted core values, professional standards and the Civil Service Code”. It was not Ofsted’s case that any of those values or standards or the Code contained any explicit reference to the circumstances in which school inspectors should make physical contact with a child, still less any blanket no-touch rule. Nonetheless, Hewston found himself in an impossible position at the disciplinary Hearing – even though promising that he had learnt his lesson, the more he denied that he had acted improperly (not least in the absence of any such rule), the more fuel he added to Ofsted’s claimed view that he could not be trusted not to do it again.
By the time the question reached the Court of Appeal, the issues had for practical purposes been boiled down to whether it was reasonable for Ofsted to treat that conduct as justifying Hewston’s dismissal, and as part of that, whether even without that no-touch rule, Hewston should have appreciated that his conduct could lead to his dismissal.
The ruling was clear that Hewston’s actions had been a misjudgement, however well-intentioned, but also that Ofsted could not reasonably have determined that they were sufficient to justify his dismissal. There had never been any safeguarding issue nor any risk to the child. Hewston had made it clear that he would undertake whatever training was required and would not repeat his conduct. Even if Ofsted thought that he harboured some continuing doubt about whether he had in fact acted inappropriately, it had no real reason to fear a recurrence. In any case, it was not allowed to turn sub-dismissable conduct into gross misconduct merely because Hewston didn’t seem in its perception to show the appropriate remorse or understanding.
Most of all, Hewston’s trip to the Court of Appeal was successful for the reasons in one short paragraph in a judgement of nearly 30 pages – the “fundamental point was that in the absence of a no-touch rule or other explicit guidance covering a situation of the relevant kind, Hewston had no reason to believe that he was doing anything so seriously wrong as to justify dismissal”. As a result, said the Court, it seemed “deeply regrettable that [Hewston], who was an experienced inspector with an unblemished disciplinary record on safeguarding issues, should have been summarily dismissed for conduct which, on any reasonable appraisal, amounted to no more than a momentary and well-meaning lapse of professional judgement of a kind which he was most unlikely ever to repeat”.
So for employers, the immediate moral of this story is that if you have a principle of conduct in your business which is as important to you as Ofsted said its non-existent no-touch rule was to it, make it express. And the more stringent that rule is, the more it might lead to dismissal for conduct which isn’t on its face that big a deal, the louder you have to shout about it.
But even then, that is not necessarily the end of the matter. As employer, you cannot safely go straight from breach of that rule to dismissal without consideration of the specific circumstances of the case. That is particularly the position where the wider the rule, the easier it is to breach it for wholly innocuous reasons. Even writing as a committed adherent to the instructions on packs of dishwasher tablets to “keep well away from children”, there are limits. Could a school inspector touch a child to help it up after a playground accident? To pull it out of the way of a car or a collision with another child, something corrosive spilt in the Chemistry Lab, an errant javelin on Sports Day? Could you sit it down and dry its tears if it were clearly distressed about something, or help it to the Sick-room? Exactly where is the line between protecting a child’s physical health and safety on the one hand and its comfort, happiness or wellbeing on the other? With the possible exception of that one about not taking the boron rods out of nuclear reactors, every hard rule has its fuzzy edges.
As soon as Ofsted accepted that no harm to the child had been intended or done, that should have been the end of the matter. A warning at its absolute highest. However, to pursue the principle of a rule which did not exist as far as the Court of Appeal at vast cost to both Hewston and the taxpayer shows, with respect, a serious loss of self-awareness from the point of dismissal and ever since. Don’t let this happen to you – remember that fairness trumps rules every time.
This Week in 340B: March 18 – 24, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: Contract Pharmacy; Rebate Model
In a case by a drug manufacturer challenging a state law, the intervenor defendant filed a brief in support of its motion to compel discovery, and the drug manufacturer filed a brief in opposition to the intervenor’s motion for judgment on the pleadings.
In four cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models, the intervenor defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
In one such case, 37 state and regional hospital associates filed a motion for leave to file an amici brief in support of HRSA.