LONG GAME: Is One-to-One Coming Back in January, 2026? NCLC Wants to Make that Happen– Here’s How It Might
CPAWorld is an absolutely fascinating place.
So many incredible storylines always intersecting. And the Czar at the center of it all.
Enjoyable beyond words.
So here’s the latest.
As I reported yesterday NCLC is seeking to intervene before the Eleventh Circuit Court of Appeals in an apparent effort to seek an en banc re-hearing of the Court’s determination that the FCC exceeded its authority in fashioning the one-to-one rule. If successful, the NCLC could theoretically resurrect the rule before the one-year stay runs that the FCC put into effect following R.E.A.C.H.’s emergency petition last month.
So, in theory, one-to-one could be back in January, 2026 after all.
So let’s back up to move forward and make sure everyone is following along.
Way back in December, 2022 Public Knowledge–a special interest group with high power over the Biden-era FCC–submitted a proposal to shut down lead generation by banning the sale or transfer of leads.
I went to work trying to spread the word and in April, 2023 the FCC issued a public notice that was a real headfake— the notice suggested it was considering only whether to ban leads that were not “topically and logically” related to the website at issue. Most people slept on this–and many lawyers in the industry told folks this was no big deal– but I told everyone PRECISELY what was at stake.
Regardless of my efforts industry’s comments were fairly week as very few companies came forward to oppose the new rule.
In November, 2023–as only the Czar had correctly predicted– the FCC circulated a proposed rule that looked nothing like their original version– THIS version required “one-to-one” consent, just as I said it would.
Working with the SBA, R.E.A.C.H. and others were able to convince the Commission to push the effective date for the rule from 6 months to 12 months to give time for another public notice period to evaluate the rule’s impact on small business.
This additional six months also gave time for another trade organization to challenge the ruling in court (you’re welcome).
Ultimately with the clock winding down the final week before the rule was set to go into effect January 27, 2025 R.E.A.C.H. filed an emergency petition to stay the ruling with the FCC.
On Friday January 24, 2025 at 4:35 pm the FCC issued the desired stay— pushing back the effective date for up to another year. Twenty minutes later the Eleventh Circuit court of appeals issued a ruling striking down the one-to-one rule completely.
Now the NCLC enters and is seeking to reverse the appellate court’s decision and reinstate the rule. To do so it would need to:
Be granted an unusual post-hac intervention; and either
Be granted an unusual en banc re-hearing and then win that re-hearing; or
Be granted an unusual Supreme Court cert and then win that Supreme Court challenge.
As anyone will tell you, every piece of this is a long shot.
Still, however, it is possible.
For instance the Eleventh Circuit standard for en banc review is high but not overwhelmingly so:
“11th Cir. R. 40-6 Extraordinary Nature of Petitions for En Banc Consideration. A petition for en banc consideration, whether upon initial hearing or rehearing, is an extraordinary procedure intended to bring to the attention of the entire court a precedent-setting error of exceptional importance in an appeal or other proceeding, and, with specific reference to a petition for en banc consideration upon rehearing, is intended to bring to the attention of the entire court a panel opinion that is allegedly in direct conflict with precedent of the Supreme Court or of this circuit. Alleged errors in a panel’s determination of state law, or in the facts of the case (including sufficiency of the evidence), or error asserted in the panel’s misapplication of correct precedent to the facts of the case, are matters for rehearing before the panel but not for en banc consideration.”
To be sure the Eleventh Circuit’s ruling was quite extraordinary. Turned appellate review of agency action more or less on its head. A complete departure from established analytic norms in such cases.
But, as I have said multiple times, we are living in a whole new world right now. So what was weird and inappropriate six months ago may be very much the new paradigm today.
Of course being granted the rehearing in this environment would just be step one. NCLC would then actually have to win the resulting en banc review– which is by no means guaranteed even if the rehearing is granted.
But from a timing perspective all of this could theoretically happen within one year.
If NCLC is denied a rehearing they could theoretically seek Supreme Court review which could theoretically result in a ruling sometime in May or June, 2026– in the meantime the FCC’s stay of proceedings would likely be extended in light of the Supreme Court taking the case. But the odds of the Supremes taking such an appeal and then reversing the one-to-one rule seem astronomically small given the current makeup of the Court.
Then again, with Mr. Trump seizing control of independent agencies the rules regarding how courts review regulatory activity by these agencies just became INSANELY important. Again, we have a whole new paradigm and the Supremes may theoretically look for any vehicle to opine on the subject ahead of potentially catastrophic separation of power issues set up by Mr. Trump’s executive order this week.
The bottom line is this: one-to-one consent may rise again, and if the NCLC has its way–it will.
We will keep everyone posted on developments, of course, and the R.E.A.C.H. board will be discussing its own potential intervention efforts shortly.
More soon.
Guess Who’s Back? That’s Right – the CTA
Reporting Companies Are Now Required to Comply with the CTA by March 21, 2025
The U.S. District Court for the Eastern District of Texas lifted the stay on enforcement of the Corporate Transparency Act’s reporting requirements with its February 18, 2025, decision in Smith, et al. v. U.S. Department of the Treasury, et al.
As a result, BOI reporting is again mandatory.
As of the date of this alert, the new deadline for (a) reporting companies formed prior to January 1, 2024, to file an initial report and (b) all other reporting companies to file updated and/or corrected BOI reports is now March 21, 2025. However, if FinCEN previously gave a deadline later than March 21, 2025, to a reporting company (e.g., a disaster relief extension until April 2025), the later deadline continues to apply to that reporting company.
In FinCEN’s February 18, 2025 notice (available here: Beneficial Ownership Information Reporting | FinCEN.gov), it acknowledges that it may provide further guidance on reporting requirements prior to March 21, 2025, and as a result reporting companies may be granted additional time to comply with their BOI reporting obligations once this update (if any) is provided.
If you have been following our guidance to date, you have already gathered your BOI and should be able to file prior to March 21, 2025. If you still need assistance determining if your company is a “reporting company” or if you are required to report BOI, please reach out to your Bradley contact as soon as possible.
Legislative Note: The House of Representatives recently passed the “Protect Small Businesses from Excessive Paperwork Act,” which provides in part for an extension of the CTA reporting deadline until January 1, 2026, for reporting companies formed prior to January 1, 2024. That bill is now in committee in the Senate.
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The Supreme Court Gears Up to Resolve Circuit Split on Class Injury Requirements
On January 24, 2025, the Supreme Court granted certiorari in Laboratory Corp. of America v. Davis, No. 24-0304, which may result in the resolution of a long-standing circuit split on a dispute key to class certification. In its petition for writ of certiorari, petitioner Labcorp sought Supreme Court review of an issue that has divided federal circuit courts: what should courts do when a putative class contains numerous members who lack any Article III injury?
The underlying class action was filed against Labcorp, a leading clinical diagnostic laboratory, alleging that Labcorp’s self-service check-in kiosks, which are not independently accessible to blind individuals, violate the Americans with Disabilities Act (ADA) and California’s Unruh Act. The standing issue concerned how many members of the class were actually injured—Labcorp presented evidence that a significant percentage of visually-impaired patients were either unaware of or did not intend to use the self-service kiosks, preferring to check in with the front desk. Despite these standing issues, and applying existing Ninth Circuit law, the district court in the underlying action certified the class and the Ninth Circuit affirmed.
In its petition for certiorari, Labcorp identified three Circuit blocs that answer the question of absent class member injury in different ways: (1) “the Article III Circuits,” which deny class certification where the class includes members who have suffered no Article III injury; (2) “the De Minimis Circuits,” which apply Federal Rule of Civil Procedure 23(b)(3) and not Article III to reject classes where there are more than a de minimis number of uninjured members; and (3) “the Back-End Circuits” (including the Ninth Circuit), which do not deny class certification based on Article III issues with uninjured class members and only deny class certification under Rule 23(b)(3) if the class contains a large number of uninjured members.
The Supreme Court granted certiorari on the question: “Whether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” Notably, both the district court and Ninth Circuit’s decisions were unpublished. This suggests that the Court is likely poised to address the Circuit split and provide a definitive answer to the question whether any or many uninjured class members may be encompassed within a class in at the time of class certification. An answer restricting class certification to those who suffered harm from the alleged legal violation would be a game-changer for defendants facing lawsuits challenging practices that affect few people but present large potential exposure—such as those under the ADA and those concerning labels on consumer products that do not drive consumer purchasing decisions.
Nevada Bill Would Impose A Duty That Directors Be Informed
As I and others have pointed out, Nevada leans heavily on its statutes when it comes to corporate governance. Currently, NRS 78.135 provides:
The fiduciary duties of directors and officers are to exercise their respective powers in good faith and with a view to the interests of the corporation.
The analogous provision of the California General Corporation Law provides:
A director shall perform the duties of a director, including duties as a member of any committee of the board upon which the director may serve, in good faith, in a manner such director believes to be in the best interests of the corporation and its shareholders and with such care, including reasonable inquiry, as an ordinarily prudent person in a like position would use under similar circumstances.
Cal. Corp. Code § 309(a). Neither statute specifically requires that a director act on an informed basis. But application of the business judgment rule in California likely requires that directors act on an informed basis. See Palm Springs Villas II Homeowners Ass’n, Inc. v. Parth, 248 Cal. App. 4th 268, 286 (2016) (“Permitting directors to remain ignorant and to rely on their uninformed beliefs to obtain summary judgment would gut the reasonable diligence element of the rule and, quite possibly, incentivize directors to remain ignorant.”). It is more debatable that Nevada’s “good faith” requires a director to act on an informed basis. After all, even an ignorant person might be considered to act in good faith if he or she has an honesty of intention.
The Nevada Legislature is now considering an amendment to NRS 78.135 to add “on an informed basis” after “in good faith”. Delaware Supreme Court Justice Henry Ridgely Horsey (the author of Smith v. Van Gorkum, 488 A.2d 858 (Del. 1985). The bill, AB 239, would make numerous other changes to Nevada’s corporate laws and I hope to cover at least some of these in future posts.
FinCEN Resumes Corporate Transparency Act Enforcement
The last remaining nationwide injunction prohibiting enforcement of the Corporate Transparency Act (CTA) has been stayed, clearing the way for the federal government to resume enforcing the CTA.
In the case of Smith, et al. v. U.S. Department of the Treasury, District Court Judge Jeremy Kernodle stated that, in light of the Supreme Court’s recent order in the Texas Top Cop Shop litigation, he would stay his previously issued nationwide injunction pending disposition of the matters on appeal.
As a result of Judge Kernodle’s order, the federal government may proceed to enforce the CTA and FinCEN intends to do so, stating that “beneficial ownership information (BOI) reporting obligations are once again back in effect.”
FinCEN also extended the reporting deadline for most companies.
For the vast majority of reporting companies, the new deadline to file an initial, updated, and/or corrected BOI report is now March 21, 2025. Reporting companies that were previously given a reporting deadline later than the March 21, 2025 deadline must file their initial BOI report by that later deadline. For example, if a company’s reporting deadline is in April 2025 because it qualifies for certain disaster relief extensions, it should follow the April deadline, not the March deadline.
Further adjustments to reporting deadlines and obligations could occur. FinCEN stated that, during the current thirty-day extension period, it will “assess its options to further modify deadlines, while prioritizing reporting for those entities that pose the most significant national security risks.” FinCEN further stated that it “intends to initiate a process this year to revise the BOI reporting rule to reduce burden for lower-risk entities, including many U.S. small businesses.” Litigation in the Texas Top Cop Shop and Smith v. Treasury cases is ongoing and the plaintiffs in these cases could prevail on their claims.
Because the CTA is back in effect, reporting companies should be prepared to file their BOI reports by March 21, 2025. Reporting companies that have already filed their initial beneficial ownership reports should review those reports to determine if they need to submit updated filings (e.g., because the previously reported information has changed).
Given the possibility of further extensions being granted before March 21, 2025, reporting companies may want to refrain from submitting their BOI reports until a date that is closer to the applicable reporting deadline.
Risky Business: Distressed Companies and Payments in the Shadow of Bankruptcy
Doing business with a customer in the shadow of bankruptcy is risky.
A hallmark of bankruptcy law is equal treatment of similarly-situated creditors. The Bankruptcy Code frowns upon a debtor who, while insolvent, pays some creditors but not others in the run-up to bankruptcy – whether voluntarily or due to pressure. Under the Bankruptcy Code, payments by an insolvent debtor to creditors in the 90 days before bankruptcy, on account of an antecedent debt, are presumptively avoidable. That means if you get one of these “preference payments,” you may be forced to return it.
There are, however, defenses to a preference payment, one of which is the “ordinary course of business” defense. A recent decision from a bankruptcy court in Delaware provides an illuminating case study on behavior that will and won’t be considered “ordinary course.” In doing so, it educates companies on best practices in dealing with a customer headed towards bankruptcy and suggests the likelihood that a bankruptcy court would order you to disgorge preference payments you received.
The Delaware case involved Fred’s, a chain of retail stores like Dollar General. C.H. Robinson provided transportation and logistics to Fred’s under a $3 million credit line. Fred’s was required to pay invoices within 30 days. When Fred’s started closing stores and struggling to make payments, C.H. Robinson tightened the credit terms by reducing the credit line to $1.75 million and then $1 million. C.H. Robinson also warned Fred’s that it would not ship Fred’s product if Fred’s did not pay to catch-up on past-due invoices. C.H. Robinson also threatened to reduce the credit terms to a 14-day payment on invoices.
Fred’s ultimately filed bankruptcy and confirmed a liquidating plan. The court-appointed liquidating trustee sued C.H. Robinson to recover 15 payments totaling over $3.4 million it received from Fred’s during the 90-day preference period.
In defense, C.H. Robinson raised the “ordinary course” defense. They argued that it was standard practice in the transportation and logistics industry to tighten credit limits based on changes in a client’s financial status and predicted future performance, so any payments resulting from that tightening were in the “ordinary course of business.”
The Bankruptcy Code requires the recipient of a preference payment to show that the debt itself was incurred in the ordinary course of the business of both parties and that the payment of that debt was (a) made in the ordinary course of the business of both parties (what is sometimes described as the “subjective” test) or (b) made according to ordinary business terms (the “objective” test). The phrase “ordinary business terms” in the objective test looks to the general norms of the creditor’s industry.
The Court stressed that “ordinary course” and “ordinary business terms” mean conduct that is ordinary when dealing with a healthy company. “Ordinary course” does not apply to how either the defendant or the industry treats a distressed company. Thus, preference payments made under a payment plan are not “ordinary course,” nor are payments resulting from pressure tactics. The relevant yardstick is a healthy debtor, not a distressed one.
The upshot is that “ordinary course” means business as usual. A distressed debtor can pay you the way they always paid you. But if the distressed debtor singles you out as special among all his creditors and brings your past-due obligation current before bankruptcy, it might not be ordinary course. And if you resorted to a demand letter, threat, workout agreement, or full nelson to get the distressed debtor to cough up his payments, then it’s probably not ordinary course.
Doing business with a distressed debtor can pose a dilemma for companies. When faced with this situation, seek all the financial information you can get your hands on to understand the debtor’s situation. Continuing to provide the debtor credit or goods and services under ordinary terms may save it from bankruptcy. And if they stop paying you, you can do everything allowed under your contract to collect. But you need to be prepared for a preference claim if the debtor files bankruptcy.
The Boundaries of Chapter 93A
The scope of Chapter 93A is not unlimited, as the Appeals Court of Massachusetts recently confirmed in Beaudoin v. Massachusetts School of Law at Andover, Inc. The case involved a law student who was disenrolled from the school for not obtaining a COVID-19 vaccination, contrary to what he alleged were the school’s representations. He brought claims for breach of contract, promissory estoppel, breach of the implied covenant of good faith and fair dealing, negligent misrepresentation, Chapter 93A, and unjust enrichment. The trial court dismissed the complaint under Mass. R. Civ. P. 12(b)(6) for failure to state a claim.
The Appeals Court affirmed the dismissal of the Chapter 93A claim, noting that (i) Chapter 93A, Section 2 prohibits unlawful acts and practices occurring “in the conduct of any trade or commerce” and (ii) although charitable corporations “are not immune” from Chapter 93A’s reach, in most cases, a charitable corporate’s activities in furtherance of its core mission will not be engaged in “trade or commerce” under Section 2. This decision relies on the Supreme Judicial Court’s oft-quoted decision in Linkage Corporation v. Boston Univ. Trustees (1997) and the First Circuit’s Squeri v. Mount Ida Coll. (2020). As the law student’s Chapter 93A claims focused on the alleged unfair and deceptive recruiting of students to enroll at the school, the claims arose from the nonprofit law school’s provision of education to students and, as such, the challenged acts and practices did not fall into “the conduct of any trade or commerce.” The Appeals Court, however, reversed the Trial Court’s dismissal of various common law claims.
This case demonstrates that plaintiffs and defendants alike must always consider whether challenged conduct under Chapter 93A fits the definitions required to trigger coverage and whether adding a Chapter 93A count is appropriate or will cause initial dispositive motion practice.
Important Update – Corporate Transparency Act Filing Obligations Reinstated and Mandatory
CTA filings are obligatory again. Most reporting companies have until March 21, 2025 to complete their filings. If you adopted a wait-and-see posture in regard to making your CTA BOIR filings, the wait is unfortunately over.
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Since December 2024, the CTA has been subject to nationwide injunctions (which have prohibited FinCEN’s enforcement of the CTA’s filing deadlines). Such deadlines are divided into two primary parts: the filing deadline for (i) reporting companies that were in existence prior to 1/1/2024 (“Pre-‘24 Companies”) and (ii) reporting companies formed on or after 1/1/2024 (“New Companies”).
Because the last of the injunctions (in Smith v Treasury in the 5th Circuit) has now been put on hold, FinCEN may immediately begin enforcing the CTA filing deadlines again, including for Pre-‘24 Companies.
In response to the Smith v Treasury ruling, FinCEN announced on February 19, 2025 the following:
With the February 18, 2025, decision by the U.S. District Court for the Eastern District of Texas in Smith, et al. v. U.S. Department of the Treasury, et al., 6:24-cv-00336 (E.D. Tex.), beneficial ownership information (BOI) reporting requirements under the Corporate Transparency Act (CTA) are once again back in effect. However, because the Department of the Treasury (Treasury) recognizes that reporting companies may need additional time to comply with their BOI reporting obligations, FinCEN is generally extending the deadline 30 calendar days from February 19, 2025, for most companies.
Notably, in keeping with Treasury’s commitment to reducing regulatory burden on businesses, during this 30-day period FinCEN will assess its options to further modify deadlines, while prioritizing reporting for those entities that pose the most significant national security risks.
FinCEN also intends to initiate a process this year to revise the BOI reporting rule to reduce burden for lower-risk entities, including many U.S. small businesses.
FinCEN then stated specifically with regard to the current CTA reporting deadlines:
For the vast majority of reporting companies, the new deadline to file an initial, updated and/ or corrected BOI report is now March 21, 2025. FinCEN will provide an update before then of any further modification of this deadline, recognizing that reporting companies may need additional time to comply with their BOI reporting obligations once this update is provided.
Reporting companies that were previously given a reporting deadline later than the March 21, 2025 deadline must file their initial BOI report by that later deadline. For example, if a company’s reporting deadline is in April 2025 because it qualifies for certain disaster relief extensions, it should follow the April deadline, not the March deadline.
As indicated in the alert titled “Notice Regarding National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala.)”, Plaintiffs in National Small Business United v. Yellen, No. 5:22-cv01448 (N.D. Ala.)—namely, Isaac Winkles, reporting companies for which Isaac Winkles is the beneficial owner or applicant, the National Small Business Association, and members of the National Small Business Association (as of March 1, 2024)—are not currently required to report their beneficial ownership information to FinCEN at this time.
As a result:
All Pre-‘24 Companies (entities formed prior to 1/1/2024) are required to complete their initial filing by March 21, 2025. Note that the Pre-’24 Companies originally had a 1/1/2025 filing deadline, prior to the court actions.
All New Companies (entities formed on or after 1/1/2024) are required to complete their initial filing by March 21, 2025.
Additional Information:
Courts: While there are ongoing court proceedings that could impact the CTA in the future, there are no currently applicable injunctions (and no additional court rulings are anticipated that would alter the deadlines above). The injunctions that were recently effective were preliminary injunctions (i.e., they were issued before the courts had ruled on the merits of the cases) and courts, including the U.S. Supreme Court, have indicated that a preliminary injunction is not appropriate in this case. Courts have split as to whether or not they find the CTA to be “constitutional” (or, whether they presume the CTA to be “constitutional” in cases where a finding has not yet been made). To date, multiple courts in the 1st Circuit, 4th Circuit and 9th Circuit have issued rulings favorable to the CTA and its constitutionality, and multiple courts in the 5th Circuit and 11th Circuit have issued rulings against the constitutionality of the CTA.
Administration: While the new Administration has not made public statements regarding its intention for the CTA, and it could always change its tact, it has thus far supported the CTA in CTA related cases through recent court filings and the above FinCEN pronouncement.
Congress: The U.S. House of Representatives, on February 11, 2025, by a vote of 408 – 0, approved a bill to extend the BOIR filing deadline for only Pre-‘24 Companies to January 1, 2026. This bill has not been passed by the Senate, and, as drafted, would only delay a portion of the filings due under the CTA, and would not impact the filing obligations of New Companies.
The Intellectual Property Enterprise Court
In the UK, intellectual property (IP) infringement claims and other disputes in which IP is a major concern can be brought in either the High Court or in many cases the specialist Intellectual Property Enterprise Court (IPEC). Based at the Rolls Building in central London, the IPEC has a more streamlined procedure than the High Court and employs a full-time specialist IP judge (currently Judge Hacon) and a number of specialist deputy judges, which aids the development of a consistent approach to cases that can often cost less than in the High Court.
Is IPEC Suitable for a Claim?
The IPEC can hear all types of IP disputes, including IP infringement claims along with other disputes in which IP is a major concern. Importantly, the court has the power to award all of the same remedies available in the High Court (interim injunctions, damages, delivery up etc.). Examples of the types of cases which have previously been heard in the IPEC include: IP infringement claims, amendments of patents, compensation for employees in respect of patented inventions created by them and claims relating to a breach of confidentiality including misuse of trade secrets.
However, limitations are placed on the value of claims which can be heard by the IPEC as it offers either a small claims track for low value disputes (where the amount in dispute is £10,000 or less) or a multitrack option for claims valued between £10,000 to £500,000, meaning that any claim above £500,000 must be brought in the High Court.
A number of procedural restrictions also apply for IPEC claims. As such, in practice the IPEC is generally best-placed to hear less complex IP disputes that do not involve very complex legal or fact heavy disputes as these restrictions include:
IPEC trials should last for two days or less (and in practice many cases are heard in a single day).
The default position is that there is no disclosure of documents as part of an IPEC trial unless IPEC orders that; however, IPEC may order the disclosure of “adverse” documents known by the parties to an IP dispute.
IPEC has strict controls regarding the cross-examination of witnesses, which is only permitted on topics which the judge deems necessary.
Orders for recovery of legal costs are capped at £60,000 meaning that the losing party will only ever have to pay the other party’s costs up to £60,000 (excluding court fees and wasted costs orders).
Whilst an important benefit of the streamlined IPEC procedure is improved access to justice for small and medium sized companies involved in IP disputes, it is important to remember that access to the IPEC is not limited only to small and medium-sized companies and is available to all claimants regardless of size. As such, at the outset of any IP dispute claimants should always consider whether the IPEC as opposed to the High Court may be the most suitable forum. For more details of IPEC click here.
This Week in 340B: February 11 – 17, 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; Medicare Payment; Rebate Model
In a case challenging a proposed state law governing contract pharmacy arrangements in Missouri, the court granted in part and denied in part defendant’s and intervenor’s separate motions to dismiss.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants filed a reply in support of their motion to compel plaintiff’s claims spreadsheets.
In five cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
Five amicus briefs were filed in support of the drug manufacturer.
In four such cases, drug manufacturers filed a joint position statement on consolidation.
In one such case, a drug manufacturer filed a notice of opposition to consolidation and memorandum in opposition to intervenors.
In one such case, the government filed a position statement in support of consolidation.
Kelsey Reinhardt and Nadine Tejadilla also contributed to this article.
Personal Jurisdiction Considerations for International Biosimilars Companies
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States. Specifically, the Federal Circuit held that international biosimilars companies are subject to jurisdiction in the United States when they have submitted an aBLA with the intent to market the finished product in the forum state.
1. Regeneron’s Patent Infringement Lawsuits
The plaintiff in each case is Regeneron Pharmaceuticals, Inc., which holds Biologics License Application (BLA) No. 125387 for EYELEA®, which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with angiogenic eye diseases—Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)—via injection into the body of the eye.
Regeneron sued several companies, including Samsung Bioepis Co., Ltd. (SB) and Formycon AG (Formycon), that had filed aBLAs with the FDA seeking approval under the Biologics Price Competition and Innovation Act (BPCIA) to market EYLEA® biosimilars. The cases were consolidated in the U.S. District for the Northern District of West Virginia and the district issued preliminary injunctions against SB and Formycon, barring them from offering for sale or selling the products described in their aBLAs, which have been approved by the FDA. SB appealed the preliminary injunction on several grounds, including that they were not subject to personal jurisdiction, which is the focus of this article.
2. SB’s Connections to the United States
SB is a biosimilar-products company headquartered in Incheon, South Korea. SB argued it has no facilities or employees in the United States; is not registered to do business and has no registered agent in West Virginia; and does not do business with entities in West Virginia. SB also argued that although it would sell its finished product to Biogen MA Inc. (a U.S. company) in a state other than West Virginia, it would not distribute, market or otherwise sell the product in the United States.
3. Formycon’s Connections to the United States
Formycon is a biopharmaceutical company based in Bavaria, Germany. Formycon argued that it has no “direct” ties to West Virginia; is not registered to do business and has no registered agent there; has no assets or employees there; and that it had contracted with manufacturers and packaging partners who would produce the finished product and related materials in other states. Formycon further argued that having developed the product pursuant to an agreement with another German company, it had no plans or rights to itself commercialize the product in the United States. Instead, the product would be sold to another company for marketing and distribution, and Formycon would have no control over the selection of that company or its decisions regarding commercialization.
4. The Federal Circuit’s Jurisdiction Analysis
When evaluating if a defendant is subject to personal jurisdiction in the forum of a particular state, the court looks to (1) whether the state’s long-arm statute permits service of process and (2) whether the assertion of jurisdiction would be inconsistent with due process under the U.S. Constitution. In many states, including West Virginia, the long-arm statutes are “coextensive with the full reach of due process,” so the questions collapse into one constitutional inquiry.
Under the U.S. Constitution, a court in a state may exercise jurisdiction over a defendant that has sufficient “minimum contacts” with the state that it would not “offend traditional notions of fair play and substantial justice.” This standard requires that the defendant’s suit-related conduct create a “substantial connection” with the forum state. The application of the standard in these cases is not necessarily straightforward because patent infringement cases based on an aBLA filing are not easily analogized to other types of actions or even traditional patent infringement cases.
The Federal Circuit, therefore, relied on its precedent in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016), which considered the jurisdictional question in the context of a suit arising out of the filing of an Abbreviated New Drug Application (ANDA). In Acorda, the court had held that “minimum contacts” were satisfied by planned future interactions with the state. The submission of an ANDA with the intent to distribute the generic product in a state was held sufficient to support exercising jurisdiction.
Extending Acorda to aBLA cases, the Federal Circuit found similar evidence of conduct sufficient to exercise jurisdiction. Specifically as to SB, the court observed that SB had filed an aBLA; had served Regeneron with a Notice of Commercial Marketing, which communicates an intent to market upon FDA approval; had engaged various partners within the United States; and had entered into a nationwide distribution agreement with a U.S. company, through which SB retained “significant involvement” in commercialization activities.
Notwithstanding the apparent differences in involvement in commercialization activities, the Federal Circuit also found that Formycon intended to market the finished product in West Virginia and other states. As with SB, the court relied on Formycon’s filing of the aBLA, service of Notice of Commercial Marketing, and partnering with U.S. companies to manufacture, package and label its product. Although it had not yet entered into an agreement with a marketing partner, the court found Formycon intended to ultimately distribute the finished product nationwide.
Thus, filing an aBLA, providing Notice of Commercial Marketing, and having more than speculative plans to market the finished product throughout the United States appears sufficient to subject an international biosimilar company to jurisdiction in any state having a long-arm statute coextensive with the U.S. Constitution. The stronger the relationship to commercialization plans, the stronger the argument will be for jurisdiction, although these factors appear to primarily support a finding of jurisdiction as opposed to playing a significant role in the analysis in the first instance.
5. Guidance for International Biosimilars Companies
International biosimilars companies that file aBLAs in the United States with plans to market the finished product should expect a high likelihood of being subject to jurisdiction for related patent infringement cases. Some steps may mitigate the risk, however, and increase the likelihood of avoiding jurisdiction:
Reduce contact with the United States as much as possible. For example, perform all development, sourcing, manufacturing, packaging and labeling outside the United States.
Introduce layers between the aBLA filer and the ultimate marketer. For example, the aBLA filer may contract with other international companies that, in turn, independently contract with a marketing partner in the United States. If the agreement between the aBLA filer and the second international company is not limited to marketing rights in the United States, that may further help.
Carve out particular states. If there are states in which the international biosimilar company does not want to be subject to jurisdiction, expressly exclude those states from commercialization agreements.
These and other factors can significantly affect whether a company is ultimately subject to jurisdiction in the United States, and similar considerations may affect other partners in the international supply chain.
Beware Broader Insurance Coverage Exclusions for Biometric Information Privacy Law Claims
It has been nearly two decades since Illinois introduced the first biometric information privacy law in the country in 2008, the Illinois Biometric Information Privacy Act (“BIPA”). Since then, litigation relating to biometric information privacy laws has mushroomed, and the insurance industry has responded with increasingly broad exclusions for claims stemming from the litigation. A recent Illinois Appellate Court decision in Ohio Security Ins. Co. and the Ohio Cas. Ins. Co. v. Wexford Home Corp., 2024 IL App (1st) 232311-U, demonstrates this ongoing evolution.
The plaintiff in a putative class action lawsuit sued Wexford Home Corporation (“Wexford”), alleging that Wexford violated BIPA by collecting, recording, storing, sharing and discussing its employees’ biometric information without complying with BIPA’s statutory disclosure limitations. Wexford tendered the putative class action lawsuit to its insurers, Ohio Security Insurance Company and Ohio Casualty Insurance Company, both of which denied coverage and filed a declaratory judgment action seeking a ruling that the insurers had no duty to defend or indemnify Wexford.
The insurers argued that there was no duty to defend or indemnify based on three exclusions: (1) the “Recording And Distribution Of Material Or Information In Violation Of Law” exclusion (“Recording and Distribution Exclusion”), (2) the “Exclusion-Access Or Disclosure Of Confidential And Data-Related Liability-With Limited Bodily Injury Exception,” and (3) the “Employment-Related Practices Exclusion.”
The parties cross-moved for judgment on the pleadings, and the trial court granted judgment for Wexford, finding that the insurers owed a defense. The trial court reasoned that publication of material that violates a person’s right to privacy met the policies’ definition of personal and advertising injury, and therefore no exclusions applied to bar coverage. The insurers appealed. Although the insurers did not challenge the trial court’s ruling that the alleged BIPA claims qualified as personal or advertising injury sufficient to trigger coverage, they maintained that the trial court erred by not applying the three exclusions.
On appeal, the court focused on the Recording and Distribution Exclusion, which purports to bar coverage where the personal or advertising injury arises from the violation of any of three enumerated statutes (TCPA, CAN-SPAM Act, and FCRA) or any other statute that falls within a broad “catch all” provision that expands the exclusion to include violations of “[a]ny federal, state or local statute, ordinance or regulations other than the [three enumerated statutes] that addresses, prohibits, or limits the printing, dissemination, disposal, collecting, recording, sending, transmitting, communicating or distribution of material or information.”
The court relied on its earlier decision, National Fire Ins. Co. of Hartford and Cont’l Ins. Co. v. Visual Park Co., Inc., 2023 IL App (1st) 221160, in which it found an identical Recording and Distribution Exclusion to bar coverage for BIPA claims. That decision, however, represented a departure from earlier decisions that found similar catchall provisions did not encompass BIPA claims. For example, in W. Bend Mut. Ins. Co. v. Krishna Schaumburg Tan, Inc., 2021 IL 125978, 183 N.E.3d 47 (May 20, 2021), the same appellate court that decided Visual Park explained that the interpretive canon of ejusdem generis (which requires that general words following an enumeration of specific persons or things are deemed to apply only to persons or things of the same general kind or class of the specifically enumerated persons or things) required a finding that a similar catchall exclusion would be afforded limited reach and not extend to BIPA claims. In the Visual Park case, on the other hand, the appellate court concluded that a catchall provision like the one in Wexford was materially different and broader than prior versions of the exclusion. According to the Visual Park court, the exclusion’s reference to “disposal,” “collecting,” or “recording” of material or information sufficiently encompassed BIPA violations, whereas prior versions apparently did not. The appellate court again applied the interpretive canon of ejusdem generis to reach conclusions about the exclusion’s intended reach. The court reasoned that because the specifically enumerated statutes in the Recording and Distribution Exclusion protected personal information and privacy, the general catchall must have been intended to do so as well.
As Wexford, Visual Park, and the pre-Visual Park decisions illustrate, insurers are broadening the scope of exclusions that potentially apply to BIPA-related claims. Policyholders should carefully review their policies annually to identify changes in wording that might have a material impact on the scope of coverage. Experienced brokers and coverage counsel can help to ensure that material changes are identified early and, where appropriate, modified or deleted by endorsement.