Economic Prong of Domestic Industry Requirement Includes All Sorts of Labor and Capital
Addressing the economic prong of the domestic industry requirement under Section 337(a)(3)(B) of the Tariff Act of 1930, the US Court of Appeals for the Federal Circuit reversed a US International Trade Commission decision, finding that the Commission had applied an overly narrow interpretation of the requirement. The Court explained that expenses related to sales, marketing, warehousing, quality control, and distribution may qualify as “labor and capital” for establishing the existence of a domestic industry, even if there is no domestic manufacturing. Lashify, Inc. v. International Trade Comm’n, Case No. 23-1245 (Fed. Cir. Mar. 5, 2025) (Taranto, Prost, Chen, JJ.)
Lashify is a US-based company that sells eyelash extension products. Concerned about the importation of similar goods, Lashify filed a complaint with the Commission, alleging that certain importers were infringing its patents. As an importer itself, Lashify had its products manufactured abroad before selling them to customers in the United States. In doing so, Lashify incurred significant expenses related to warehousing, distribution, quality control, sales, and marketing. These expenses were critical to Lashify’s domestic industry case.
The Commission rejected Lashify’s claims, reasoning that it did not demonstrate the establishment of, or effort to establish, a domestic industry. This is known as the “economic prong” of the domestic industry requirement. One way to satisfy this prong is by showing the expenditure of significant labor or capital within the US. Lashify’s domestic expenses were limited to warehousing, distribution, quality control, sales, and marketing costs, and in the Commission’s view, these expenses did not constitute significant “labor or capital” under Section 337 (a)(3)(B). The Commission determined that these expenses were no greater than those any importer would incur once its products arrived in the US. Lashify appealed.
The Federal Circuit reversed, citing the text of the provision recognizing significant labor or capital as a means of establishing a domestic industry and noted that the statutory language did not exclude expenses related to warehousing, distribution, quality control, sales, and marketing. Considering the domestic industry requirement under Section 337(a)(3)(C), the Court noted that the reference to labor and capital in part (B) was analogous to investments in plant and manufacturing in part (C), which similarly did not limit the “enterprise functions” to which the investments must be directed.
The Federal Circuit cited its 2015 decision in Lelo, which defined “labor” as “human activity that produces goods or provides the services in demand in an economy” and “capital” as “a stock of accumulated goods,” not simply money to finance an enterprise. The Court held that complainants may satisfy the economic prong by demonstrating the “employment of a large enough stock of accumulated goods [i.e., capital] or of a significant amount of human activity for production goods or providing the services in demand in an economy [i.e., labor].” The Court determined that Lashify’s warehousing, distribution, quality control, sales, and marketing expenses fit within this definition and should therefore be considered in assessing whether Lashify had employed sufficient labor and capital within the US to satisfy the economic prong.
Practice Note: This ruling broadens the scope of domestic industry in Section 337 cases, allowing intellectual property holders to count additional operational expenses toward establishing the domestic industry requirements. Those seeking to enforce their intellectual property rights at the Commission, particularly where their own products are manufactured abroad, will likely benefit from this decision.
PTO Reverts to Prior Post-Grant Guidelines for Cases Involving Parallel District Court Litigation
On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is ongoing district court litigation.
This announcement rescinds the PTO’s June 21, 2022, memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation.” The memorandum stated that the Patent Trial & Appeal Board “will not deny institution of an IPR or PGR under Fintiv (i) when a petition presents compelling evidence of unpatentability; (ii) when a request for denial under Fintiv is based on a parallel ITC proceeding; or (iii) where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” The memorandum effectively limited the discretion granted in Fintiv, which outlined six factors for the Board to consider when making decisions on post-grant proceedings involving parallel district court litigation.
Now that the 2022 memorandum has been rescinded, parties to post-grant proceedings should refer to Board precedent, including Fintiv and Sotera Wireless v. Masimo, for guidance when there are parallel district court proceedings. In accordance with prior guidelines, the PTO’s objective is to achieve greater consistency in its decision-making processes, especially in situations where patent validity is contested both in the courts and before the Board. The PTO emphasized that any portions of future Board decisions that rely on the 2022 memorandum will not be binding or persuasive.
Practice Note: Because of this action, the Board will now enjoy greater discretion when ruling on post-grant petitions, which may result in an increase of discretionary denials.
Impact of the USPTO’s Rescission of its Discretionary Denial Memorandum
In May 2020, the PTAB panel in Apple Inc. v. Fintiv, Inc. (IPR2020-00019) denied institution of Apple’s petition in view of the advanced state of a parallel district court litigation and set forth six non-exclusive factors to be considered when a patent owner requested that the PTAB deny institution based on this ground. Those six factors would become known as the Fintiv factors and are:
whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted;
proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision;
investment in the parallel proceeding by the court and the parties;
overlap between issues raised in the petition and in the parallel proceeding;
whether the petitioner and the defendant in the parallel proceeding are the same party; and
other circumstances that impact the Board’s exercise of discretion, including the merits.
After the Fintiv decision, discretionary denials in view of parallel district court proceedings spiked considerable.
In June 2022, then-USPTO Director Kathi Vidal issued a memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (the “Interim Guidelines”) in response to this spike in discretionary denials. The Interim Guidelines stated that a petition would not be denied:
based on a parallel U.S. International Trade Commission (ITC) proceeding;
when a petitioner stipulates not to pursue in the parallel litigation the same grounds of invalidity as raised in the petition or any ground that could reasonably have been raised in the petition (referred to as a “Sotera stipulation” based on a PTAB decision by that same name); or
when a petition present “compelling evidence” of unpatentability.
The Interim Guidelines also recognized that a court’s scheduled trial date, a key factor in Fintiv discretionary denials, is not always a good indicator of when trial will actually occur. Accordingly, the Interim Guidelines allowed parties to present evidence of the median time-to-trial statistics for civil actions in the district court where the parallel litigation was pending.
After the Interim Guidelines, the pendulum swung back against discretionary denials with a notable decline in discretionary denials following thereafter.
On February 28, 2025, the USPTO issued an unsigned notice stating that the Interim Guidelines are rescinded and instructed parties and practitioners to again refer to the Fintiv and Sotera decisions when determining whether to deny institution based on a parallel proceeding.
The USPTO’s decision to rescind the Interim Guidelines is expected to increase the number of discretionary denials by removing the safe harbors for petitioners previously available under the Interim Guidelines. But it remains unclear how PTAB panels will address requests for discretionary denials where the parties’ arguments were submitted in view of the Interim Guidelines but were published after their rescission. The first such decisions are now being published and shed some early light on this question.
In Hulu LLC v. Piranha Media Distribution, LLC (IPR2024-01253), published March 4, 2025, the panel cited the USPTO’s Interim Guidelines before declining to deny institution based on the parallel proceeding. This decision was likely authored prior to the USPTO’s February 28, 2025 notice rescinding the Interim Guidelines and was simply published after without revision.
The first PTAB institution decision addressing the USPTO’s rescission of the Interim Guidelines was Savant Technologies LLC v. Feit Electric Company, Inc. (IPR2024-01357), published March 5, 2025. In this case, patent owner requested that the PTAB deny institution based on two related litigations in different districts—the Eastern District of Kentucky and the Northern District of Texas.
In considering the Kentucky litigation, where no trial date had been set, the board considered the parties’ proffered median time-to-trial statistics and found that the trial would likely occur “well after” a final written decision would issue.
Notably, in considering the Texas litigation, which was scheduled for trial on January 20, 2026, the panel noted that “[w]hen the parties filed their papers, the USPTO was following now-rescinded guidance” that allowed parties to present median time-to-trial statistics. Nevertheless, the panel stated that the time-to-trial evidence was not relevant “because we agree with Patent Owner that the time-to-trial statistics are congruent with the scheduled trial date.” In particular, the parallel litigation was schedule for trial on January 20, 2026, while the average time to trial in the Northern District of Texas suggested an earlier trial date in December 2025. After considering the other Fintiv factors, including the merits of Petitioner’s arguments, the panel instituted the IPR.
Another decision published on March 5, 2025, Mobileye Global, Inc. v. Facet Technology Corp. (IPR2024-01110), also addressed patent owner’s request for discretionary denial. In that decision, the panel applied the Fintiv factors without any mention of the Interim Guidelines, which is notable because each party filed two post-preliminary response replies addressing the Interim Guidelines. After considering the Fintiv factors, the panel instituted IPR in this matter.
As can be seen from this small sample of decisions, there is no uptick in discretionary denials since the USPTO rescinded its Interim Guidelines. However, as shown by the Savant Technologies’s decision, the PTAB may continue to consider median time-to-trial statistics in the absence of a trial date but will likely disregard such evidence when a trial date is set. Accordingly, at this time, we suggest that parties continue to cite median time-to-trial statistics in the absence of a trial date but should be prepared for the PTAB to disregard such evidence if or when a trial date is set.
Interesting Delay: Prejudgment Interest Accrues Despite Unreasonable Delay
The US Court of Appeals for the Federal Circuit upheld a decision on enhanced damages and prejudgment interest, concluding that the district court correctly applied the appropriate standard for enhanced damages in accordance with established precedent. Halo Electronics, Inc. v. Pulse Electronics, Inc., Case Nos. 23-1772; -1966 (Fed. Cir. Feb. 28, 2025) (Prost, Bryson, Reyna, JJ.) (nonprecedential).
In 2013, following a jury verdict in favor of Halo, the district court entered a $1.5 million verdict against Pulse for willful infringement but denied Halo enhanced damages. Halo appealed and, in 2016, engendered a new enhanced damages standard from the Supreme Court. In 2015, while the case was pending before the Supreme Court, Halo filed for an award of supplemental damages for direct infringement between 2012 and 2013, and prejudgment and post-judgment interest on the initial $1.5 million judgment and on the supplemental damages. The district court awarded supplemental damages and prejudgment and post-judgment interest.
In 2017, the district court determined that Halo was not entitled to enhanced damages or attorneys’ fees under the Supreme Court’s new standard. Although the parties still disagreed on which method to use for prejudgment interest calculation – and briefed their positions accordingly – the district court mistakenly ordered the clerk to enter a final judgment and close the case. After the Supreme Court decided WesternGeco v. ION Geophysical in 2018, Halo (in 2020) filed a motion seeking prejudgment interest and a new damages trial, arguing that the district court had not made a final ruling on the issue of prejudgment interest and that WesternGeco was intervening case law that permitted it to seek additional damages for Pulse’s activities outside the United States.
Halo argued that because the final order closing the case ignored an outstanding issue (prejudgment interest), the case was merely administratively closed. Although Pulse argued that the resurrected case should remain closed under Federal Rule of Civil Procedure 41(b), the district court awarded limited prejudgment interest in March 2023. The district court rejected Halo’s request for a new trial regarding additional foreign damages under WesternGeco.
Halo appealed, and Pulse counter appealed. Halo raised two main arguments:
Enhanced damages were appropriate because of the jury’s finding of willfulness.
The district court should have allowed a limited trial on the issue of foreign infringement.
Pulse argued that FRCP 41(b) should have barred any prejudgment interest because Halo did not address the court’s oversight until 2020.
The Federal Circuit rejected both of Halo’s arguments. It explained that a jury’s finding of willfulness is “but one factor” in an enhanced damages determination under the Supreme Court’s highly discretionary Halo test. Willful infringement does not require the more egregious intent that gives rise to enhanced damages, nor does it merge with enhanced damages analyses procedurally – willfulness is a jury issue, while enhanced damages is an issue for the court.
Addressing Pulse’s argument, the Federal Circuit found no abuse of discretion in either the district court’s refusal of a new trial or its decision to allow prejudgment interest. It was unreasonable for Halo to bring forward an argument under WesternGeco for a new trial two years after WesternGeco was decided. Waiting three years between the case’s 2017 closing and renewing its arguments about prejudgment interest also constituted unreasonable delay, but other equitable factors nevertheless permitted the award of prejudgment interest.
CBP Seizes Over $4 Million in Counterfeit Designer Jewelry
CBP Seizes Over $4 Million in Counterfeit Designer Jewelry. U.S. Customs and Border Protection (CBP) recently intercepted a massive shipment of counterfeit designer jewelry, with a potential retail value of over $4 million if the items were genuine. The fake jewelry, which was en route to a residence in Nashville, Tennessee, was seized at an […]
Federal Circuit Affirms ImmunoGen Patent Obviousness
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,” published on May 14, 2015, as US 2015/0132323) were obvious.
ImmunoGen, Inc. v COKE MORGAN STEWART, ACTING UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND ACTING DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, (2023-1762, Decided: March 6, 2025).
This case highlights the distinctions between the US law where the obviousness inquiry is generally agnostic to the particular motivation of the inventor, versus that in Europe and many other countries that evaluate inventive step/inventiveness based on a “problem–solution” approach not required in the US. The case also serves as a reminder of the risks attendant with the use of so-called boilerplate language, particularly when used in the context of ascribing a level of skill in the art regarding optimization of parameters. And it further underscores the challenges faced by patent applicants, particularly in the pharmaceutical and life sciences sectors, in balancing the scope of its own seminal patents covering new chemical entities, per se, against a reasonable foreseeability of filing of later, second-, and later-generation patent applications on various improvements, such as treatment regimens, dosage formulations, etc. This challenge has been exacerbated by a growing hostility towards building “patent thickets” around new drugs, based on the notion that they are responsible for high drug prices. This decision further adds to the growing arsenal of jurisprudence on which generic drug companies may rely on attacking later-generation Orange Book-listed patents covering drug compositions and uses thereof.
The claims at issue are directed to a dosing regimen for administering IMGN853 (mirvetuximab soravtansine), which is ImmunoGen’s patented and US Food and Drug Administration- (FDA) approved antibody drug conjugate (ADC) used for treating certain ovarian and peritoneal cancers. IMGN853 is a conjugate of an antibody known as “huMov19” linked via a charged sulfopSPDB linker to a toxic maytansinoid payload known as “DM4.” The key limitation in the claims was the recitation that immunoconjugate is administered at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.” The Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s obviousness rejection, which was based primarily on ImmunoGen’s own prior patent publication [2012/0282282] directed to IMGN853, per se. Immunogen filed a civil action under 35 U.S.C. § 145. The Eastern District Court of the Eastern District of Virginia affirmed PTAB’s decision.
On appeal, ImmunoGen stressed that at the time the invention was made, the art did not appreciate that IMGN853 caused ocular toxicity in humans. Thus, in its view, the solution to an unknown problem could not have been obvious — such as found in some prior Federal Circuit and the US Court of Customs and Patent Appeals (CCPA) cases. See, e.g., In re Sponnoble, 405 F.2d 578, 585 (C.C.P.A. 1969) (“a patentable invention may lie in the discovery of the source of a problem even though the remedy may be obvious once the source of the problem is identified.”); In re Omeprazole Patent Litigation, 536 F.3d 1361, 1380-81 (Fed. Cir. 2008) (upholding patent where coatings for omeprazole were discovered by the inventors to negatively interact with each other, and solution of providing a barrier therebetween was non-obvious even if providing a barrier would have been obvious if the interaction problem were known); Leo Pharmaceutical Products v. Rea, 726 F.3d 1346, 1353-54 (Fed. Cir. 2013) (“The inventors of the ‘013 patent recognized and solved a problem with the storage stability of certain formulations—a problem that the prior art did not recognize and a problem that was not solved for over a decade.”)
This position is also consistent with jurisdictions, such as Europe, that apply a “problem-solution” approach to the determination of inventive step. Indeed, the European Patent Office granted to ImmunoGen at least one patent with claims similar to those at issue in the United States.
However, the District Court determined that because ocular toxicity was “a well-known adverse event in the administration of immunoconjugates that contain DM4,” and because IMGN853 includes a DM4 payload, a person of ordinary skill in the art would have been motivated to monitor for those side effects when administering the drug to humans, despite not knowing of IMGN853’s ocular toxicity.
The Federal Circuit agreed. It pointed to its prior decisions in reasoning that “[a]s an initial matter, although ImmunoGen is correct that “[w]here a problem was not known in the art, the solution to that problem may not be obvious,” Forest Lab’ys, LLC v. Sigmapharm Lab’ys, LLC, 918 F.3d 928, 935 (Fed. Cir. 2019), it does not follow that a claimed solution to an unknown problem is necessarily non-obvious.” (Emphasis in original). Relying on KSR for the proposition that “[i]n determining whether the subject matter of a patent claim [was] obvious, neither the particular motivation nor the avowed purpose of the patentee controls,” the Federal Circuit found no clear error in the District Court’s reasoning.
ImmunoGen also argued that the district court clearly erred in finding that a person of ordinary skill in the art would have been motivated to try AIBW dosing as a dosing methodology for IMGN853 to eliminate ocular toxicity or arrive at a dose of 6 mg/kg AIBW with a reasonable expectation of success. Regarding the former, AIBW was a known technique but had never been used as a methodology for an ADC. So, in ImmunoGen’s view, the district court “simply plucked AIBW dosing out of [a] multitude of possibilities.” In finding no clear error in the District Court’s reasoning, the Federal Circuit relied on ImmunoGen’s ‘282 publication and, in particular, for its teaching that “[t]he dosing regimen and dosages [of the disclosed ADCs] will depend on the particular cancer being treated, the extent of the disease and other factors familiar to the physician of skill in the art and can be determined by the physician.” (Emphasis in original). This reference to the level of skill in the art, especially at the time of drafting, most certainly came back to haunt ImmunoGen.
Regarding the latter, ImmunoGen was again thwarted by its own prior publication. Indeed, in view of its findings that Immunogen’s ’282 publication discloses dosing IMGN853 at around 6 mg/kg of TBW (total body weight) of the patient, an abstract from the American Society of Clinical Oncology disclosing that IMGN853 had been tested on humans at a dose of 5 mg/kg TBW, AIBW dosing was well known, and that “for patients who weigh exactly their ideal body weight, a dose of 6 mg/kg AIBW is identical to a dose of 6 mg/kg TBW,” the district court viewed ImmunoGen’s ‘809 application as an attempt “to cover a dose that was already disclosed in the prior art.” The Federal Circuit agreed, concluding: “[a] doctor dosing a patient at his or her IBW with IMGN853 at a dose of 6 mg/kg TBW would necessarily be dosing that patient at 6 mg/kg AIBW, as claimed. This would be true regardless of whether a doctor knew of AIBW dosing.” (Emphasis in original).
In sum, this case shows that, even if a problem was unknown at the time an invention was made, it may still be obvious. Moreover, this case demonstrates the difficulties of obtaining a patent to a specific method of treatment and dosage formulations in view of one’s own prior art.
Federal Circuit Refuses to Extend IPR Estoppel to Unadjudicated Patent Claims
In Kroy IP Holdings, LLC v. Groupon, Inc., 127 F.4th 1376 (Fed. Cir. 2025), the Federal Circuit held that patentees in district court are not collaterally estopped from asserting claims that were not immaterially different from other claims of the same patent that the US Patent Trial and Appeal Board (PTAB) already held to be unpatentable.
The Federal Circuit’s ruling significantly impacts practitioners involved on both sides of parallel patent litigation, offering patentees a strategic advantage in district courts while requiring petitioners to reevaluate their approach to challenging claims at the PTAB.
Background
Kroy IP Holdings, LLC filed suit against Groupon, Inc., alleging infringement of 13 exemplary claims of US Patent No. 6,061,660. Groupon timely filed two inter partes reviews (IPRs), successfully invalidating 21 claims of the ’660 Patent. After Groupon’s deadline to file additional IPRs had passed, Kroy amended its complaint to allege infringement of newly asserted claims of the ’660 Patent that were not at issue in the prior IPR proceedings. Groupon moved to dismiss this complaint on grounds that Kroy was collaterally estopped from asserting these newly asserted claims based on the PTAB’s unpatentability rulings. The district court granted Groupon’s motion, dismissing Kroy’s case with prejudice after determining that the new claims were “immaterially different” from the invalidated claims. Kroy appealed.
The issue before the Federal Circuit was whether a prior decision by the PTAB declaring certain claims unpatentable can prevent a patentee from asserting other immaterially different claims from the same patent in district court.
As recently as September 2024, the Federal Circuit revisited the doctrine of collateral estoppel and considered the effect that prior final written decisions at the PTAB may have on subsequent district court litigation. The court concluded that a finding of unpatentability of apparatus claims in an IPR does not bar a patentee from contesting the validity of separate but related method claims of the same patent in district court. The Federal Circuit reasoned that collateral estoppel does not apply when different legal standards, such as burdens of proof, are involved across the two actions. Indeed, a petitioner in an IPR proceeding need only prove invalidity under the preponderance of the evidence standard, whereas in district courts, a defendant must meet the higher and more exacting clear and convincing evidence standard. Otherwise, the application of collateral estoppel in separate actions involving differing burdens of proof “would deprive patent owners of their property right.” Kroy IP Holdings, LLC, 127 F.4th at 1380-81.
Relying on this rationale, the Federal Circuit in Kroy IP Holdings, LLC v. Groupon, Inc. found that the patent owner was not barred from asserting previously unadjudicated claims that were immaterially different from claims that the PTAB had declared were unpatentable. Indeed, the PTAB’s unpatentable rulings under the preponderance of the evidence standard cannot estop a patentee from asserting other new but immaterially different claims in district court, which require the higher clear and convincing evidence standard. In holding that collateral estoppel did not apply, the Federal Circuit reversed the district court’s dismissal.
Practical Considerations
The Federal Circuit’s ruling in Kroy has significant implications for practitioners involved in parallel patent litigation at the PTAB and district courts.
For patent owners, the Federal Circuit’s ruling offers a strategic advantage by limiting the scope of collateral estoppel to only those claims that were actually challenged and adjudicated in IPR proceedings. Further, this allows patentees to pursue claims in district court that were not at issue in the IPRs, even if they are similar to the already invalidated claims. Patentees should consider strategically selecting which claims to include or exclude in enforcement actions based on the strength of their validity arguments and the likelihood of success at both the PTAB and in district courts.
For petitioners, the Kroy ruling necessitates a reevaluation of challenging claims at the PTAB, as reliance on successful IPR outcomes may not be sufficient to invalidate patent claims in district court. Petitioners should be prepared to meet the higher burden of proof required in district courts and plan for the possibility of patentees asserting unadjudicated claims in later-amended complaints or in future infringement actions.
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Limits on Physician Noncompete Agreements: Navigating New State Laws and Legislation
As anticipated, following the end of the Federal Trade Commission’s proposed rule prohibiting employer noncompetes, states have ramped up their efforts toward limiting noncompete agreements, including some states that have specifically focused on health care noncompetes.
We previously reported in 2024 that Pennsylvania passed The Fair Contracting for Health Care Practitioners Act that prohibited the enforcement of certain noncompete covenants entered into by health care practitioners and employers. Now, Louisiana, Maryland, and Indiana join the list of states limiting, or attempting to limit, the use of noncompete agreements in the health care industry.
Louisiana
On January 1, 2025, Act No. 273 (f/k/a Senate Bill 165) (the “Act”) became effective following Governor Jeff Landry’s approval. The Act enacts three subsections to Section 23:921, M, N, and O, which, as discussed further below, generally limit the timeframe and geographical scope of noncompetes for primary care and specialty physicians.
Subsection (M) of the Act prohibits agreements that restrain a primary care physician—defined as “a physician who predominantly practices general family medicine, general internal medicine, general pediatrics, general obstetrics, or general gynecology”—from practicing medicine for more than three years from the effective date of the initial contract or agreement. A subsequent agreement between the employer and primary care physician after the three-year term cannot include a noncompete. Should a primary care physician terminate the agreement prior to the three-year term, the primary care physician can be prohibited, for no more than two years from termination of employment, from “carrying on or engaging in a business similar to that of the employer in the parish[1] [defined in employer agreement] in which the primary care physician’s principal place of practice is located and no more than two contiguous parishes in which the employer carries on a like business.”
Subsection (N) applies to “any physician other than a primary care physician,” generally defined as a “specialty physician.” Subsection (N) prohibits a contract or agreement that restrains a specialty physician from practicing medicine for more than five years from the effective date of the initial contract or agreement, and a subsequent agreement after five years cannot include a noncompete. Should a specialty physician terminate the agreement prior to the five-year term, the same limiting provision as subsection (M) applies.
Lastly, subsection (O) of the Act exempts from the Act’s prohibitions (1) a “physician who is employed by or under contract with a rural hospital as provided for in the Rural Hospital Preservation Act,” and (2) a “physician who is employed by or under contract with a federally qualified healthcare center[.]”
The Act applies to any contract or agreement entered into on or after January 1, 2025. For any contract or agreement prior to the effective date, the initial three-or-five-year term and geographical limitation listed in the Act will begin on January 1, 2025.
Maryland
Maryland also joins the list of states limiting physician noncompetes. Maryland House Bill 1388 (HB 1388), will become effective July 1, 2025, and amends Maryland’s Annotated Code Labor and Employment Section 3-716(a) to ban certain veterinary and health care noncompete agreements and conflict of interest provisions “that restrict the ability of an employee to enter into employment with a new employer or to become self-employed in the same or similar business.”
HB 1388 prohibits noncompetes and conflict of interest provisions between an employer and employee who (1) “earns equal to or less than 150% of the State minimum wage . . . ,” (2) is required to be licensed under Maryland’s Health Occupations Article or is employed in a position that “provides direct patient care,” and earns equal to or less than $350,000 per year, or (3) is a licensed veterinary practitioner or technician under Maryland’s Agriculture Article.
For an employee who is required to be licensed under Maryland’s Health Occupations Article or “provides direct patient care,” and earns more than $350,000 per year, a noncompete agreement or conflict of interest provision is permitted only for one year from the last day of employment and cannot exceed ten miles from the primary place of employment. If a patient requests the new location of the former employee, an employer must provide the requested information.
Indiana
As recent as January 13, 2025, Indiana’s Senate introduced Senate Bill 45 (SB 45) which, if enacted, would, among other things unrelated to noncompetes, ban physicians and employers from entering into any noncompete. SB 45 would not apply to any physician noncompete entered into before the effective date, but rather, only apply proactively. SB 45 does not contain any other exceptions.
These three states are just the recent developments in legislation across the country which demonstrate a growing trend toward limiting or banning noncompete agreements, particularly in healthcare industries. It is likely other states will follow. We will continue to monitor SB 45 and provide further updates on this topic.
Gianna Dano, a Law Clerk in Epstein Becker & Green’s Newark Office (not admitted to practice), contributed to the preparation of this piece.
[1] “Parish” refers to a local government subdivision in Louisiana, which is analogous to a county in other states.
Federal Circuit Expands Scope of Activities That Can Establish a ‘Domestic Industry’ Under Section 337
On March 5, the US Court of Appeals for the Federal Circuit issued a decision in Lashify, Inc. v. International Trade Commission, No. 23-1245, vacating in part the International Trade Commission’s (ITC) determination that Lashify failed to satisfy the economic prong of the Section 337 domestic industry requirement and affirming in part the finding that Lashify failed to satisfy the technical prong of the domestic industry requirement.
This ruling expands the types of activities that a complainant can use to establish a domestic industry, including domestic sales, marketing, warehousing, quality control, and distribution activities.
Background
Lashify, Inc. filed a Section 337 complaint at the ITC, alleging that importers infringed three patents (one utility and two design patents) covering artificial eyelash extensions. The ITC found no Section 337 violation because Lashify failed to establish a domestic industry. For the economic prong, the ITC excluded Lashify’s evidence about expenses relating to sales, marketing, warehousing, quality control, and distribution. Without that evidence, the ITC held that Lashify failed to establish a “significant employment of labor or capital” domestically under 19 U.S.C. § 1337(a)(3)(B). The ITC excluded many expenses such as warehousing, quality-control, and distribution because there were “no additional steps required to make these products saleable” upon arrival into the United States, and because the quality-control measures were “no more than what a normal importer would perform upon receipt.” Further, the ITC excluded sales and marketing expenditures because “Lashify did not meet its burden to establish significant qualifying expenses in other areas.” Lashify appealed.
Federal Circuit Decision
Economic Prong of the Domestic Industry Requirement
The Federal Circuit vacated the ITC’s ruling that Lashify failed to establish a domestic industry under 19 U.S.C. § 1337(a)(3)(B) because the ITC improperly excluded Lashify’s expenditures on sales, marketing, warehousing, quality control, and distribution. The court explained that Section 337(a)(3)(B) requires a “significant employment of labor or capital” without any limitation of the type of activities that could constitute labor or capital. The statute does not exclude sales, marketing, warehousing, quality control, or distribution activities, nor does it require such activities to be tied to employment or manufacturing considerations.
The court further clarified that there is no requirement that a stock of accumulated goods be manufactured domestically. As long as the activities relate to providing the goods or services in demand in a domestic economy, they can be counted toward the domestic industry requirement. The court also cited with approval its previous decision in Wuhan Healthgen Biotechnology Corp. v. International Trade Commission, No. 2023-1389 (Fed. Cir. Feb. 7, 2025), which held that smaller market segments can still be significant and substantial enough to meet the domestic industry requirement.
The ruling marks a departure from the ITC’s longstanding approach of excluding certain types of expenditures as insufficient to establish a domestic industry absent domestic manufacturing. The Federal Circuit’s reasoning opens the door for more Section 337 actions by companies that design products in the United States but manufacture them abroad, as long as they make significant domestic investments in activities such as marketing and distribution.
Technical Prong and Claim Construction
The court affirmed the ITC’s construction of the claim term “heat fused,” holding that the artificial hairs in Lashify’s products must be “joined by applying heat to form a single entity.” Based on this construction, the court upheld the ITC’s finding that Lashify’s products, which use a heated adhesive instead of actually using heat to bond hairs, did not meet the technical prong.
Key Takeaways
Expanded Scope of Domestic Industry: The decision clarifies that Section 337 complainants may rely on investments or expenses in sales, marketing, warehousing, quality control, or distribution activities to establish a domestic industry. This expands the types of activities, investments, or expenses that a complainant may use in satisfying the economic prong of the domestic industry requirement.
No Absolute Dollar Requirement: The decision reinforces the notion that the economic prong analysis considers whether investments or expenses are significant and substantial enough relative to the company’s US footprint, and not the absolute dollar values of the investments themselves.
Potential Impact on Foreign Companies: The decision is not limited to US companies. It potentially allows a foreign company to satisfy the domestic industry requirement if it invests in US distribution and marketing efforts.
GLP-1 Receptor Agonists and Patent Strategy: Securing Patent Protection for New Use of Old Drugs
GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health conditions. Discovering drugs with pleiotropic effects beyond their original purpose can facilitate drug repurposing and extend the market lifespans of existing drugs. However, leveraging newly discovered pleiotropic effects of existing drugs requires careful consideration of intellectual property strategies. This article provides strategic considerations for obtaining patent protection for new uses for old drugs such as GLP-1RAs.
The Extended Lifespan of GLP-1 Receptor Agonist Drugs from the Discovery of Pleiotropic Effects
Glucagon-like peptide-1 (GLP-1) was first discovered in the 1980s as a regulator of glucose levels. Further research led to the creation of a stabilized GLP-1RA called semaglutide, the active ingredient in Ozempic®, a successful diabetes treatment, and in Wegovy®, a revolutionary body weight management drug. Moreover, recent clinical studies and real-world clinical data have revealed broader pleiotropic effects of these drugs, opening doors for repurposing and extending the commercial lifespan of these drugs. For example, a recent study published in Nature Medicine (Jan. 20, 2025) used clinical data to analyze the primary intended effects of GLP-1RAs and secondary effects across multiple health conditions. This study uncovered potential applications of GLP-1RAs in reducing the risks of neurocognitive disorders, gastrointestinal issues, hypotension, syncope, interstitial nephritis, and drug-induced pancreatitis. In addition, a clinical trial published on Feb. 12, 2025, in JAMA Psychiatry, found that semaglutide can significantly reduce alcohol craving.
Discovering new clinical approaches for existing and approved drugs provides opportunities to extend the lifespan and market potential of the existing drugs, as shown for GLP-1RAs and other pleiotropic drugs. In the case of GLP-1RAs, patent protection has been successfully obtained for new uses and formulations based on discoveries of new clinical effects. In fact, many patents covering GLP-1RAs are drug-device combination patents or formulations adapted for particular administration routes, such as oral or subcutaneous formulations.
As shown for GLP-1RAs, the discovery of pleiotropic effects can effectively extend the lifespan and markets of drugs by facilitating repurposing. However, patenting repurposed drugs can be challenging and requires careful consideration of patent prosecution strategies.
Patent Prosecution Strategies for Repurposed Drugs
Patenting a new use for existing drugs can be challenging because the claimed new use may be implied or considered obvious based on the known characteristics and mechanisms of the existing drug. See, e.g., In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (stating “[i]t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.”) A new use can also be found obvious if prior art discusses similar uses of related drugs. Still, the new use can be patented if the prior art does not mention using the same active agent for the same clinical indication, as explained in Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, No. 20-1747 (Fed. Cir. 2021).
Below are considerations and strategies for overcoming challenges in patenting existing drugs and turning the discovery of pleiotropic drug effects into patentable claims.
Discoveries of clinical benefits or their underlying mechanisms are not patentable but may suggest patentable uses or formulations.
The Federal Circuit has found that claims directed to new results obtained with a known method are inherently anticipated and, therefore, unpatentable if practicing the known method would necessarily produce the claimed results. See In re Woodruff and King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275−76 (Fed. Cir. 2010). In King, the challenged patent claims were directed to beneficially increase the bioavailability of a drug when the drug was ingested with food. However, the prior art contained instructions for taking the same drug with food. Accordingly, the Court in King found that the claims relating to increasing bioavailability by food ingestion were inherently anticipated and invalid. The Court in King also clarified that the inventor’s ability to describe the underlying scientific principles or mechanisms, which was admittedly unknown or undisclosed in the prior art, does not confer patentability. Id. at 1328.
Moreover, it is usually unnecessary to disclose mechanisms’ underlying claimed inventions because understanding the principles underlying a claimed invention is not necessary. For example, Eames v. Andrews (The Driven-Well Cases), 122 US 40, 55–56 (1887) held that even though “the inventor did not know what the scientific principle was . . . . [t]hat does not vitiate the patent.” See also Radiator Specialty Co. v. Buhot, 39 F.2d 373, 376 (3d Cir. 1930) (explaining that “[i]t is with the inventive concept, the thing achieved, not with the manner of its achievement or the quality of the mind which gave it birth, that the patent law concerns itself.”). Hence, it may be beneficial not to disclose mechanisms’ underlying claimed inventions because mechanisms could be used to explain why the invention is obvious in some cases.
Thus, stakeholders should carefully consider if the discovery of new mechanisms or effects implies new method steps (e.g., specific administration routes), formulations, dosages, and treatments of different indications or patient populations to ensure the discovery can be covered by patentable claims as further discussed below.
Discoveries of new formulations or devices for delivering an existing drug can be eligible for patenting.
The Federal Circuit found a patent for a new formulation containing an existing drug valid in Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., 894 F.3d 1374 (Fed. Cir. 2018). For example, many patents covering the GLP-1RAs claim a combination of a delivery device and an active agent. In other cases, a new formulation adapted for different administration routes, such as subcutaneous or oral administration, can be sufficient to obtain a new patent.
The discovery of a new patient population to be treated by an existing drug can be patentable.
The Federal Circuit explained in Sanofi v. Watson Labs Inc., Case Nos. 16-2722; -2726 (Fed. Cir., Nov. 9, 2017) that the asserted prior art did not provide the required “reasonable expectation of success” for treating the claimed patient population. Therefore, if a drug’s discovered effects or mechanisms indicate that an existing drug could be used to treat a novel patient population, this particular patient population could contribute to the novelty and non-obviousness of the patent claims for the new use.
The discovery of a new administration route or dosing schedule for an existing drug can be patentable.
The challenge of inherent disclosure can be overcome by adopting a different method of drug administration for the new use. The Federal Circuit found in Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378–79 (Fed. Cir. 2005) the prior art use did not teach the “topical application to skin sunburn” required by the claimed new use. In Perricone, the patent claims at issue were directed to treating skin sunburn or damaged skin by topically applying a composition that was known in the prior art to the skin. However, the prior art did not disclose topical application to the sunburned or damaged skin, so the Federal Circuit found the prior art did not inherently anticipate the claims. Accordingly, identification of specific new ways of administering the drugs or dosing schedules may provide options for addressing inherent anticipation of new uses for existing drugs.
Conclusion
The recent dramatic success of GLP-1RAs in weight management and the reports of numerous beneficial pleiotropic effects of this class of drugs highlight the immense potential for repurposing drugs to extend lifespan and markets of drugs. Maximizing the value of GLP-1RAs and next-generation pleiotropic drugs will demand effective navigation of data management and analysis, deals and licensing, regulatory exclusivity, and strategic patent prosecution.
With the rise of AI-driven clinical data analysis, stakeholders have unprecedented opportunities to detect pleiotropic effects and new uses for existing drugs to extend their lifespan and market. Securing robust and timely patent protection for new uses will be critical to extend the commercial lifespan of existing drugs.
Dewberry Group, Inc. v. Dewberry Engineers Inc. (No. 23-900)
The federal Lanham Act provides that a plaintiff who prevails in a trademark infringement suit is sometimes entitled to recover the “defendant’s profits” derived from the infringement. But does the “defendant’s profits” look only to the named defendant, or can it consider the profits of separately incorporated affiliates that were not parties to the lawsuit? In Dewberry Group, Inc. v. Dewberry Engineers Inc. (No 23-900), a unanimous Supreme Court held that district courts may “award only profits properly ascribable to the defendant itself” absent some legal basis (like veil piercing) for looking beyond the named defendant to related entities.
The case began with a trademark infringement suit between two real-estate companies: Dewberry Engineers and Dewberry Group. (As the Court’s opinion acknowledged, any summary of the facts was itself likely to create confusion because there were “too darn many Dewberrys.”) After Dewberry Engineers emerged victorious, it sought to recover the “defendant’s profits,” as authorized by the Lanham Act. But the only named defendant was Dewberry Group. Unfortunately for Dewberry Engineers, Dewberry Group has no profits: It provides various business services at below-market rates to separately incorporated companies also owned by Dewberry Group’s owner, thus operating at a significant loss. And while those affiliates earn millions of dollars in profits, those profits go to the books of the affiliates alone, not back to Dewberry Group. No matter, said the District Court: It would look to the “economic reality” of the situation and treat the affiliates and Dewberry Group “as a single corporate entity” for purposes of calculating the “defendant’s profits.” It therefore awarded $43 million to Dewberry Engineers, an award (and methodology for calculating it) that the Fourth Circuit affirmed.
In a unanimous opinion by Justice Kagan, the Supreme Court held that the District Court and Fourth Circuit had erred by including the affiliates’ profits in the calculation of the “defendant’s profits.” Kagan began by noting that the ordinary legal meaning of the term “defendant” refers only to the entity actually sued—here, Dewberry Group alone. And while Dewberry Engineers could have added the affiliates as defendants, for whatever reason, it hadn’t. Kagan then turned to “background principles of corporate law,” which generally prohibit courts from treating separately incorporated affiliates as a single legal entity absent some recognized exception. Piercing the corporate veil is one such exception, but Dewberry Engineers had never tried to establish the facts required to pierce Dewberry Group’s corporate veil and reach its affiliates. For these reasons, the lower courts “were wrong to treat Dewberry Group and its affiliates as a single entity in calculating the ‘defendant’s profits.’”
Justice Kagan then turned to an alternative argument raised by Dewberry Engineers to defend the lower courts’ award: Another sentence of the Lanham Act provides that, “[i]f the court shall find that the amount of the recovery based on profits is either inadequate or excessive[,] the court may in its discretion enter judgment for such sum as the court shall find to be just, according to the circumstances.” Kagan rejected Dewberry Engineers’ reliance on that provision, observing that neither the District Court nor Fourth Circuit had based the award on this “just-sum provision.” Instead, the decisions below reasoned only that the courts could disregard the affiliates’ legally separate status. The Court therefore vacated and remanded the case back to the district court for a new award proceeding. Those new proceedings could include consideration of this “just-sum” provision. They could also involve an analysis of whether corporate-veil piercing was an available option. And the lower courts could take up the suggestion of the United States Government as amicus curiae that in calculating a the named defendant’s profits, courts can “look behind” the defendant’s books to identify “the defendant’s true financial gain,” i.e., that Dewberry Group may effectively be earning a profit on its infringing activities even if its books don’t say so.
Justice Sotomayor briefly concurred. She agreed that “principles of corporate separateness,” as well as the Lanham Act’s statutory text, “forbade the lower courts from attributing to Dewberry Group all the profits of its affiliates, absent veil piercing.” But she also noted that such legal principles “do not blind courts to economic realities” or “force courts to accept clever accounting, including efforts to obscure a defendant’s true financial gain through arrangements with affiliates.” She reasoned that there were still “myriad ways” by which courts could consider arrangements with affiliates when calculating the “defendant’s profits.” In particular, she opined that courts could take into account “a non-arm’s-length relationship with an affiliate that effectively assigns some portion of its revenues to the latter,” as well as “evidence that a company indirectly received compensation for infringing services through related corporate entities.”
Federal Circuit Affirms District Court’s Obviousness Judgment on ImmunoGen Patent Application
1. Background: ImmunoGen’s Patent Application & Dispute
In 2014, ImmunoGen, Inc. (Immunogen) filed U.S. Patent Application No. 14/509,809 (the ’809 application).1 The ’809 application has three independent claims, all of which are directed to methods of treating ovarian and peritoneal cancers by administering an antibody drug conjugate (ADC) known as IMGN853 (i.e., mirvetuximab soravtansine) according to certain dosing regimens. Specifically, the ’809 application claims administering the ADC “at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.”2
According to the specification, IMGN853 was found to cause ocular toxicity (i.e., blurred vision, keratitis, etc.) at certain doses.3 The inventors of the ’809 application discovered that “the high Cmax and initial AUC values are not required for efficacy” and developed “a therapeutically effective dosing regimen that results in minimal adverse effects.”4
The patent examiner, however, rejected the claims of the ’809 application on various grounds, including obviousness and obviousness-type double patenting. The Patent Trial and Appeal Board affirmed the examiner’s rejections and ImmunoGen filed suit in the Eastern District of Virginia seeking a judgment that it was entitled to a patent under 35 U.S.C. § 145.
After a three-day bench trial,5 the district court agreed with the Patent Office and determined that the claims of the ’809 application were obvious and were not patentably distinct from subject matter claimed in other patents owned by ImmunoGen (and thus were not patentable under the doctrine of obviousness-type double patenting).6, 7 ImmunoGen appealed, and on March 6, 2025, the Federal Circuit affirmed the district court’s judgment on obviousness in a precedential opinion.
2. The Federal Circuit’s Decision
The Federal Circuit began its obviousness analysis by explaining that “Immunogen first argues that the district court erred in its motivation-to-combine analysis because it was undisputed that at the time of the invention, a person of ordinary skill in the art would not have known that IMGN853 caused ocular toxicity in humans.”8 According to ImmunoGen, because the problem that the inventors aimed to solve was not known (i.e., that IMGN853 can cause ocular toxicity), the dosing regimen recited in the claims of the ’809 application could not have been obvious.
The Federal Circuit disagreed, explaining that “it does not follow that a claimed solution to an unknown problem is necessarily non-obvious.”9 And the Federal Circuit explained “that the specific problem the inventors of the ’809 application purported to solve via the claimed dosing regimen was unknown does not necessarily mean that the dosing regimen itself was not obvious.”10 In other words, the motivation provided by the prior art does not need to match the alleged motivation of the inventors—what matters is that a POSA would have been motivated by the prior art to arrive at the claimed dose, regardless of the reason, and would have had a reasonable expectation of success.
Regardless, the district court found that ocular toxicity was a known problem in the context of immunoconjugates like IMGN853 and thus a POSA would have known to monitor patients for those side effects when administering IMGN853. The district court also explained that pre-clinical studies were conducted in rabbits in which they were given IMGN853, but that ocular toxicity was not found to be a side effect in those studies. But experts on both sides agreed that pre-clinical animal studies do not always translate to humans, thus those rabbit studies would not have deterred a POSA from monitoring for those side effects in humans. The Federal Circuit found no clear error in the district court’s reasoning on these points.11
The district court also found that a POSA would have been motivated to reduce the toxicity of IMGN853 by experimenting with the dosing regimen and that AIBW was a known dosing methodology for that purpose.12 ImmunoGen took issue with the fact that the district court did not explain why a POSA would have been motivated to use AIBW specifically, as opposed to other known dosing methodologies.
The Federal Circuit again disagreed with ImmunoGen and found no clear error in the district court’s reasoning. Specifically, the Federal Circuit agreed with the district court that a POSA would have been motivated to select a 6 mg/kg AIBW dose with a reasonable expectation of success in view of a prior art reference that taught a dose of IMGN853 based on total body weight (TBW) dosing.13 The Federal Circuit acknowledged that TBW and AIBW are different types of weight-based dosing methodologies, but explained that the prior art reference’s 6 mg/kg TBW dose of IMGN853 would have also led to a 6 mg/kg AIBW dose of IMGN853 in certain situations. And the Federal Circuit explained that “[a] doctor dosing a patient at his or her IBW with IMGN853 at a dose of 6 mg/kg TBW would necessarily be dosing that patient at 6 mg/kg AIBW, as claimed. This would be true regardless of whether a doctor knew of AIBW dosing”14
Finally, ImmunoGen argued that the district court erred because a POSA would not have had a reasonable expectation of success with respect to using a 6 mg/kg AIBW dose to ameliorate ocular toxicity. The problem with ImmunoGen’s argument was that “the claims are silent as to any ocular toxicity problem,” and thus “ImmunoGen’s framing of the reasonable-expectation-of-success analysis is inapt.”15 Here, “[t]he inquiry merely required the district court to determine whether the evidence established that a person of ordinary skill in the art would have had a reasonable expectation that dosing a human at 6 mg/kg AIBW would have been effective in treating ovarian and peritoneal cancers, as claimed.”16 Because the prior art taught that dosing regimen, as claimed, the claims of the ’809 application were found to be unpatentable as obvious.17
Conclusions and Takeaways
The Federal Circuit’s opinion offers important guidance on obviousness issues in the context of “method of treatment” and dose-regimen patents. Namely, the fact that a dosing-related “problem” is not expressly known in the prior art may not save an otherwise obvious patent, particularly when the claims are “silent” on the dosing issues. In that case, a POSA can be motivated (and have a reasonable expectation of success) by the prior art for reasons distinct from what motivated the inventors to develop the claimed dosing-regimen.
Indeed, the Federal Circuit made clear that “the obviousness inquiry is generally agnostic to the particular motivation of the inventors,”18 and that “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.”19 Also, a dosing patent may be obvious even if the prior art does not expressly teach the specific nuances of how to arrive at the claimed dose or dosing methodology (e.g., where the TBW dose necessarily meant the same thing as the AIBW dose in at least some patients). Ultimately, the Federal Circuit’s opinion underscores the fact intensive nature of the motivation and reasonable expectation of success elements in the context of obviousness.
Footnotes
[1] The ’809 application claims priority to a provisional application filed on October 8, 2013.
[2] See, e.g., ’809 application, claim 1.
[3] See, e.g., id. at ¶ [0009].
[4] Id. at Abstract, ¶ [0009].
[5] Before this bench trial, the district court previously ruled in the patent office’s favor after a motion for summary judgment was filed. But the Federal Circuit vacated and remanded the district court’s summary judgment decision because “the district court resolved numerous factual disputes against” ImmunoGen.
[6] ImmunoGen, Inc. v. Vidal, 653 F. Supp. 3d 258, 307 (E.D. Va. 2023).
[7] The district court also found the claim term “adjusted ideal body weight (AIBW)” indefinite after trial, but the Federal Circuit did not address indefiniteness issues on appeal.
[8] ImmunoGen, Inc. v. Stewart, No. 2023-1762, 2025 WL 715996, at *3 (Fed. Cir. Mar. 6, 2025).
[9] Id.
[10] Id.
[11] Id.
[12] Id. at *4.
[13] Id. at *5.
[14] Id.
[15] Id.
[16] Id.
[17] The Federal Circuit also noted that “the government further challenged the patentability of the claims under the doctrine of obviousness-type double patenting,” but “[o]n appeal, the parties agree[d] that that issue rises and falls with the issue of obviousness,” and therefore double patenting was not addressed further by the Federal Circuit. Id., n. 3.
[18] Id. at *12, citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007)
[19] Id. at *7, citing KSR Int’l, 550 U.S. 420.