Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is Resolved; Plaintiff OFA Appeals
On March 5, 2025, one U.S. District Court ruled unequivocally in FDA’s favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at *15 (N.D. Tex. Mar. 5 2025), denying plaintiffs’ motion for (1) a preliminary injunction (PI) prohibiting the Food & Drug Administration (FDA) from taking action against Outsourcing Facilities Association (OFA) members and FarmaKeio based on their compounding of the drug ingredient tirzepatide pending final judgment in the case and (2) a stay pending conclusion of the review proceedings in response to FDA’s declaration that the shortage of the diabetes and weight-loss tirzepatide products has been resolved.
Background
Based on unprecedented demand and Eli Lilly’s inability to meet this demand, the tirzepatide products at issue, Mounjaro® and Zepbound®, whose marketing applications were approved in 2022 and 2023 respectively, were placed on the drug shortage list in December 2022.
The Food Drug, and Cosmetic Act (FDCA) defines “shortage” as “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” 21 U.S.C.§ 356c. When a drug is placed on the FDA’s shortage list, Congress permits 503A compounders, those operating under state board of pharmacy oversight and issuing patient specific prescriptions, to compound copies of the drug and 503B outsourcing facilities which are those compounders who are registered and regulated by FDA and who manufacture large batches of sterile compounded medications for health care entities, to compound from that drug’s active ingredient—which is otherwise prohibited—including by compounding drugs that are “essentially a copy” of an approved drug. See 21 U.S.C.§§ 353b(a)(2)(A)(ii), (a)(5), (d)(2)(A). Thus, compounding copies of a drug is only permitted while a shortage exists.
Current Status for Compounders
Consistent with FDA’s February 11, 2025 update, which remains in effect given the Court’s denial of the PI and stay, FDA’s approach to compounders is as follows:
For a state-licensed pharmacy or physician compounding under section 503A of the FDCA, the period of enforcement discretion described below has ended.
For outsourcing facilities under section 503B, FDA does not intend to take action against compounders for violations of the FDCA arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list until March 19, 2025.
Future State
On March 10, 2025, OFA filed a notice of interlocutory appeal signaling their intention to appeal the March 5, 2025 decision in FDA’s favor to the United States Court of Appeals for the Fifth Circuit. The appeal notwithstanding, we will watch for developments on certain GLP-1 products that continue to be compounded by 503A pharmacies under the rationale that certain compounded products are required to meet the individual needs of patients. There are a number of different strengths, different dosage forms, and combination of ingredients being compounded or contemplated. While FDA has not yet taken a position with respect to these types of modified compounded products, it will be interesting to see whether FDA agrees that such modifications are determined to be needed to meet the individual needs of patients and are clinically relevant or whether such products are considered to be essentially a copy of a commercially available product. If so and barring judicial intervention, 503A pharmacies must stop compounding tirzepatide, and 503B pharmacies may only continue compounding tirzepatide until March 19, 2025.
Want To Learn More? See our prior blogs.
FDA Targets GLP-1 Providers with Warning Letters
GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (semaglutide injection) from its Drug Shortage List
GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding
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.
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.
Georgia Legislature Considering Substantial Overhaul to Medical Marijuana, Hemp Laws
I’ve had Georgia on my mind these days. I needed to get that out immediately because otherwise I would have been hearing that song in my head the entire time I was writing.
As is the case in many capitals around the country during legislative sessions, there’s cannabis reform afoot in Georgia. Before we dig into it, perhaps a brief vocabulary lesson is in order. “Cannabis” is essentially a scientific term that refers to the cannabis plant. “Marijuana” and “hemp” are legal terms distinguishing between strains of the cannabis plant. At the federal level, for example, “hemp” has been defined as a strain of the cannabis plant containing less than 0.3% delta-9 THC on a dry weight basis.
One more background fact. Marijuana is, for the moment, a Schedule I substance under the federal Controlled Substances Act. That means the manufacture, possession, and sale of marijuana is illegal in every state. There is an effort underway to reschedule marijuana to Schedule III, which would have interesting potential implications to marijuana operations. Still, as of the time if this writing, marijuana remains Schedule I.
Despite that, a plurality of states has adopted laws allowing for the medical (and in many instances) recreational use of marijuana. Instead of cracking down on activity that seems to clearly conflict with federal law, the federal law has for more than a decade gone to great lengths to demonstrate that it would not interfere with state marijuana regimes.
With that in mind, we turn to Georgia. Georgia adopted a “low THC oil program” in 2015. The rollout of that program was, to be charitable, not without bumps. But there may be a new regime on the horizon.
Three bills changing the way Georgia regulates hemp and medical cannabis have cleared the Senate ahead of Thursday’s Crossover Day deadline. The votes on the bills are some of the only ones this session that didn’t fall cleanly along party lines, with Senate Republicans divided over expanding medical access to cannabis and members of both parties split over new regulations on recreational hemp products.
Medical Cannabis
Senate Bill 220, also known as the “Putting Georgia’s Patients First Act,” passed in a contentious 39-17 vote after more than an hour of debate in the Senate. Like its counterpart in the other chamber, House Bill 227, the bill replaces the term “low-THC oil” with “medical cannabis,” in Georgia code, removes requirements that certain medical diagnoses like cancer or Parkinson’s disease be “severe or end stage,” and adds lupus to the list of qualifying health conditions.
Unlike the House version, SB 220 removes an existing prohibition against vaping cannabis oil and raises the percentage of THC that medical cannabis products may contain from 5% to 50%.
The bill was amended on the floor to include a provision allowing caregivers to pick up medical cannabis from pharmacies. Three other amendments aimed at reducing the amount of THC allowed in medical cannabis, removing the provision that allows for vaping, and removing PTSD and intractable pain from the list of approved diagnoses failed during a series of floor votes.
Hemp bills
Two bills aimed at strengthening hemp regulations in Georgia passed the Senate in decisive votes on Crossover Day, seeking to limit recreational use of marijuana as the chamber simultaneously eased restrictions for medical use.
Marietta Republican Sen. Kay Kirkpatrick’s SB 33 subjects chemical compounds like delta-8 THC, delta-10 THC, hexahydrocannabinol (HHC) and other cannabinoids to testing and labeling regulations that were added last year under Senate Bill 494. It passed in a 50-6 vote.
In her speech from the well, Kirkpatrick said her bill is aimed at cutting down on unregulated hemp products from China and other countries.
“This bill is not a ban,” Kirkpatrick said. “It’s a consumer protection bill that is not intended to impact processors that are already testing and labeling their products appropriately. It’s intended to make sure that consumers buying these products are clear on what they’re buying.”
Senate Bill 254, sponsored by Athens Republican Bill Cowsert, seeks to impose new limits on THC-infused products after the Georgia Department of Agriculture raised the maximum amount of THC that can be included in a single beverage from 5 mg to 10 mg.
Cowsert urged lawmakers to codify the original 5 mg serving size restrictions on THC-infused beverages, calling the higher-dose beverages a “loaded gun” and arguing that one 10 mg serving of THC was equivalent to four glasses of wine.
“Most states are limiting greatly the amount of THC that can be included in a beverage, or in a tincture, or any kind of lotions, or in gummies,” he said. “And the reason is to protect consumers — protect the public — from the psychoactive components of THC.”
Like SB 33, the bill includes new restrictions on cannabinoid variants like delta-8 THC and delta-10 THC. It was ultimately amended on the floor by a narrow 29-27 vote to ban all THC-infused beverages, and passed the Senate in a 42-14 vote.
One thing to consider is whether these proposals are all part of a big move by some interest group(s) to benefit one form of cannabis over another. Marijuana companies would obviously prefer a world where they didn’t have to compete with hemp companies. After all, hemp companies are not currently subject to the extraordinarily onerous regulations and taxes that stifle the growth of marijuana companies. On the other hand, cannabis politics make for strange bedfellows, where for example a marijuana operator may be lobbying in conjunction with anti-cannabis operators to lobby against hemp products. The enemy of my enemy…
It’s too early to tell how this will all play out. There are influential and well-heeled players in the hemp, marijuana, and alcohol industries on various sides of these issues. As always, we’ll monitor the situation so you don’t have to. Thanks for stopping by, and if you can do something to change Georgia’s absolutely nonsensical prohibition against attorneys advising state-legal cannabis companies, your author sure would appreciate it.
Reminder: FDA Does, In Fact, Review DOF
When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the “Letter”)[1] that was issued on February 3, 2025 to Edenbridge DBA Dexcel (“Dexcel”) over allegedly misleading promotional materials for the multiple myeloma drug Hemady® (dexamethasone) involving—you guessed it—a DOF reference. This marks OPDP’s first untitled letter of the year and the first under the new administration. The letter is relatively uninventive in terms of enforcement angles—leading with a garden-variety failure to present “any” safety information—but it does serve as a reminder that FDA can and will ask for DOF references, especially those that substantiate Consistent with FDA-Required Labeling (“CFL”) promotional materials. And of course, despite all the news about regulatory cuts affecting FDA, OPDP still appears alive and well.
Promotional Content
FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”)[2] for Hemady®, a drug indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. Specifically, FDA found the exhibit panel made false or misleading claims about the risks and efficacy of Hemady®. FDA does not make mention of the intended audience, but given the level of detail in the presentation of information, as well as the piece being part of an exhibit booth, we reasonably conclude the audience was intended to be healthcare professionals (“HCPs”).
Lack of Risk Information
First, FDA found that the panel made no mention at all of any risk information. The panel made beneficial claims such as “Hemady® reduces up to 80% of the number of tablets required for a therapeutic dose of dexamethasone for the treatment of adults with MM” and “Hemady® is a unique strength dexamethasone tablet bioequivalent to five 4 mg tablets of dexamethasone.” However, the panel did not present any information about side effects or other risks of the product, which, in FDA’s eyes, created a misleading impression about the product’s safety.
Misleading Claims of Efficacy
Second, FDA found that the panel information was misleading with regard to Hemady’s efficacy. FDA challenged a “Real-World Comparison” of adherence to Hemady® versus generic dexamethasone among patients with multiple myeloma. Crucially, FDA noted that while DOF was cited as support for the comparison, the associated “Adherence Study” did not support the conclusions regarding comparative adherence to Hemady® and generic dexamethasone. FDA specifically referenced issues with study design and methodology. Issues included: patients receiving Hemady® were not verified as having been diagnosed with multiple myeloma in the same way that patients receiving generic dexamethasone were; baseline characteristics were not controlled for across the patient populations; and the generic dexamethasone group had a significantly higher number of patients than the Hemady® group (3,775 versus 43). In light of these significant study limitations, FDA found the claim of Hemady’s efficacy over dexamethasone to be misleading.
Takeaways
This Letter was relatively short and less scathing than we have seen from FDA in previous untitled letters, but it raises interesting and significant points nonetheless. First, and perhaps most significant to FDA in deciding whether to issue the letter is the matter of risk presentation, or in this case, the complete lack thereof. While it is true that the exhibit panel did not contain any mention of safety information or risks associated with using Hemady®, it is possible that there were other materials at the exhibit booth that achieved this purpose. We wonder whether the offending piece was submitted on the Form 2253 alone, if it was submitted together with other pieces, or in either case, if the piece referenced other pieces. Alas, FDA makes no mention of other materials outside of the panel, nor does it make clear whether the exhibit booth was reviewed as a whole or if each piece making up the exhibit booth was evaluated for proper risk and efficacy presentation. Readers can draw their own conclusions. In any case, the Letter counsels that each piece of marketing material presented at conferences, symposia, and similar events should be evaluated on its own, as well as in concert with the pieces surrounding it.
CFL forms the basis for the second major issue raised by the Letter, and there are two takeaways resultant. First, FDA can and will scrutinize DOF references. We are no stranger to this and often suggest that clients prepare these references like scientific papers, including design methodologies, results, and conclusions, and having relevant scientific and/or technical experts either within the company or externally vet and sign-off. The level of detail and sophistication of the Adherence Study is unknown because FDA does not opine on it. So, we are left to conclude that regardless of its content, FDA at best wanted more contextual information (and maybe some disclaimers, which FDA loves) about the Adherence Study actually placed on the panel itself, or at worst disagreed entirely with the scientific merit of the Adherence Study and would have found it inappropriate to use, even if “explained/disclaimed-to-death.”
The second takeaway teed-up above is whether FDA would have still objected even in the face of additional contextual information and/or disclaimers. We view the FDA as saying that the study design and methodology do not match the manner in which the conclusions about benefit information are presented, and hence, the result misleads the audience. Without having reviewed the DOF, we will never know whether this is warranted, but it stands to reason that if we assume the exhibit panel contained no falsities in the conclusions presented (FDA never said there were), the DOF may have contained enough context for the HCP to understand that the study did contain various biases, and that the impact of the various factors on adherence should be interpreted with caution.
Readers of the blog will appreciate the extent to which we have discussed CFL in the past and will recall that we believe “context is key.” From a First Amendment protection perspective, the goal in CFL communications (provided you have met all the FDA guidance requirements) should be to provide enough context for the reader to fully understand and interpret the information and to be judicious about making conclusions. [3] The result on this piece may have been different if the CFL box was checked, but FDA already had its “no safety balance” hook, so it is unclear whether this would have made a difference from an enforcement perspective.
As noted at the open, the Letter marks the first major OPDP action under the new administration, suggesting that FDA staffing cuts, de-regulatory efforts, and all that has swirled around this new administration has not stopped OPDP from policing drug promotion. The Letter underscores the persistence of the FDA Bad Ad Program, which was how FDA received a complaint about the exhibit panel.
FOOTNOTES
[1] Untitled Letter available here: Hemady® Untitled Letter
[2] Promotional Content available here: Hemady® Promotional Material
[3] Contrary to popular opinion, we do not believe in the “when in doubt, disclaimer” approach. FDA may like disclaimers, but our marketing colleagues do not. So, finding a way to say what we want without hedging the message should be the goal.
Julian Klein contributed to this article.
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.
Leveraging USPTO Delays To Maximize Patent Term
Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications. With a hiring freeze in place, the current backlog at nearly 838,000 unexamined patent applications, and the wait for initial examination already over 20 months, applicants can expect the time required to obtain a patent to increase. While these delays may not be ideal, applicants can leverage them to their advantage by maximizing patent term through patent term adjustment (PTA) awards.
USPTO Examination Delays Result in PTA Awards
By statute, the USPTO must award patent term adjustment when it fails to meet certain examination timeline metrics, including issuing a first Office Action within 14 months and taking no more than three years to grant a patent. USPTO PTA statistics from January 2025 show that barely 30% of patent applications are being examined within 14 months, and the number of patents taking more than three years to grant is at a two-year high of over 20%. Assuming patent application filings maintain their current level or (more likely) increase, more patents could be eligible for longer PTA awards.
Avoiding PTA Deductions for Applicant Delay
Not all USPTO delays result in PTA awards. The final PTA calculation subtracts any “applicant delay” from USPTO delay. Applicants seeking to maximize patent term should take care to minimize PTA deductions, including by:
Ensuring a compliant Sequence Listing is filed within eight months of the application filing date or national stage commencement date
Avoiding filing a preliminary amendment or other preliminary paper more than eight months after the filing date (or national stage commencement date) and less than one month before the mailing of an Office Action
Understanding how Information Disclosure Statement (IDS) rules differ from PTA rules and timing IDS submissions to minimize PTA deductions
Currently, U.S. national stage applications (based on PCT applications) experience much longer early-stage processing delays than directly filed U.S. applications (on the order of months to years). If this trend continues, opting to pursue a U.S. patent via the PCT/national stage route could be another approach to earn significant PTA.
Avoiding Terminal Disclaimers That Override PTA
Even if a patent is awarded significant PTA, entitlement to that extended term could be in jeopardy if a terminal disclaimer is filed over a patent with a shorter term. To avoid leaving PTA on the table, applicants should consider portfolio development strategies that minimize the need for terminal disclaimers, such as by:
Including multiple independent claims in an original application to trigger restriction requirements
Responding to restriction and election of species requirements without traverse to preserve the right to file divisional applications
Filing true divisional applications entitled to the protections of 35 U.S.C. 121 against obviousness-type double patenting (OTDP), and invoking the safe harbor of 35 U.S.C. 121 as a defense to OTDP
Appealing weak rejections instead of filing RCEs to earn PTA from favorable appeal decisions and avoid the PTA implications of RCEs
Minimizing voluntary continuation applications that can raise OTDP issues
Understanding the contours of recent Federal Circuit decisions such as Cellect and Allergan on the interplay between OTDP, terminal disclaimers, and PTA
While USPTO examination delays may present challenges for stakeholders building their patent portfolios, they also present opportunities to maximize value through longer patent terms. By pursuing strategies that minimize PTA deductions and preserve PTA awards, applicants can significantly extend the life of their patents, potentially creating additional opportunities to capitalize on their innovations. As USPTO examination delays continue to grow, effectively leveraging them to maximize patent term could provide a competitive edge in the market, especially in industries such as biotechnology and pharmaceuticals, where long-term patent protection can be important.
SuperValu Wins False Claims Act Case with a “No Harm, No Foul” Jury Verdict
On March 5, 2025, SuperValu, Inc. (SuperValu), a grocery store chain that operates in-store pharmacies, was cleared of liability by a Central District of Illinois federal jury—finally quashing whistleblower claims that the company improperly over-billed the government and violated the False Claims Act (FCA). This jury verdict came after a long 14-year battle, which included a Supreme Court reversal of lower court decisions on the FCA’s scienter standard.
In 2006, SuperValu’s pharmacies began discounting generic drugs through a price-matching system (if a customer provided evidence of a cheaper price for certain drugs available at another pharmacy, SuperValu would match that price) and other loyalty programs. Many of SuperValu’s customers took advantage of these programs. However, when the company reported its “usual and customary” price to federal and state governments for reimbursement, SuperValu reported the much higher retail price of the drugs. After these programs ended, whistleblowers brought suit against SuperValu under the FCA’s qui tam provision. In the qui tam actions, plaintiffs alleged that SuperValu offered discounted pricing through these programs to so many customers that the discounted price was effectively their “usual and customary” price. As SuperValu did not offer the discounted pricing to Medicare and Medicaid, which were required by law to be charged the “usual and customary price,” the whistleblowers alleged SuperValu overcharged the government for years when seeking reimbursements for prescription drugs.
In 2020, the District Court granted SuperValu’s motion for summary judgment, holding that SuperValu had submitted false claims as defined under the FCA, but concluding that SuperValu did not possess the required scienter necessary to establish FCA liability. The government appealed to the Seventh Circuit, which affirmed the lower court’s decision. The Seventh Circuit applied a two-part test to determine if SuperValu knowingly or recklessly submitted false claims:
Was the defendant’s interpretation of law objectively reasonable (including not being ruled out by prior precedent); and
If the defendant’s interpretation was not objectively reasonable, did the defendant have a subjective belief the claims they were submitting were false?
If the defendant’s interpretation was not objectively reasonable, and the defendant had a subjective belief it was submitting false claims, the defendant knowingly or recklessly submitted false claims. The Seventh Circuit held that SuperValu’s interpretation of the law was objectively reasonable and, therefore, SuperValu did not possess the required scienter under the FCA.
In 2023, the Supreme Court reversed the Seventh Circuit, holding that, whether a defendant possessed scienter sufficient to satisfy the FCA requirements depended solely on that defendant’s subjective knowledge—doing away with the Seventh Circuit’s “objectiveness” test. Focusing on the plain language of the FCA, the Supreme Court held that, to prove a false claim, two elements must be satisfied: (1) the claim that was submitted was, in fact, false and (2) the defendant subjectively believed the claim was false.
Nearly fourteen years after its initial filing, the case returned to the District Court on remand from the Supreme Court for a jury trial. While the jury ultimately found that SuperValu did knowingly submit false claims under the Supreme Court’s scienter standard, the question of whether the jury would impose liability came down to whether the federal or state governments suffered damages due to SuperValu’s false claims. In a pre-trial motion, SuperValu argued that any evidence the plaintiffs offered of the alleged overpayments was evidence only of a gain to SuperValu—not a loss to the government. Because the government determines reimbursement rates under Medicare Part D plans, SuperValu argued that plaintiffs would have to prove that the alleged false claims changed the amount government actually paid and, thus, caused damages. It appears the jury accepted this argument. The jury unanimously decided the plaintiffs had not proved that either the federal or state governments suffered damages and, as a result, SuperValu was found “not liable.” After a long and tortured history, the whistleblowers’ claims were finally put to rest. The case ultimately ended with a “no harm, no foul” verdict, and SuperValu avoided liability under the FCA. The case suggests a potent line of defense for companies defending against FCA allegations.
Federal Appeals Court Rules Against Doctor Seeking to Use Mushrooms to Aide Terminal Patients: How We Learned to Question the Rationale of the Controlled Substances Act
It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as medicine, our goal was not to end up spending years covering the winding legal battle of a Washington physician to legally obtain psilocybin for terminally ill cancer patients to manage their pain.
But here we are. To be clear, while we’re certainly interested in the fate of Dr. Sunil Aggarwal’s efforts, we’ve been following the case closely because it’s one of a few legal cases to shed light onto what courts and federal agencies may do when faced with a medicinal demand for psychedelics outside of the research context.
In his efforts to be able to administer psilocybin to his patients, Aggarwal employed a two-fold approach: (1) he attacked the status of psilocybin as a Schedule I drug, and (2) he tried to get around statutory requirements governing a physician’s right to distribute Schedule I drugs outside of the research context. Neither has been successful (yet).
DEA Says No to Rescheduling, but the Court Keeps the Door Cracked
As a reminder, here’s what happened when Aggarwal petitioned the DEA to reschedule psilocybin:
Since at least 2021, Dr. Sunil Aggarwal has been working to legally obtain psilocybin for terminally ill cancer patients undergoing end-of-life care. Because psilocybin is a Schedule I drug under the Controlled Substance Act (CSA), obtaining the drug to treat his patients was “practically and legally difficult” according to his lawyers. Aggarwal turned to the DEA, petitioning the agency to transfer psilocybin from Schedule I to Schedule II. The DEA denied the petition in a four-sentence letter. Aggarwal then looked to the Ninth Circuit.
The Ninth Circuit Court of Appeals in Aggarwal v. U.S. DEA directed the U.S. Drug Enforcement Agency (DEA) to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II.
The Ninth Circuit sided with Aggarwal. The court held that the “DEA failed to provide sufficient analysis to allow its path to be reasonably discerned” and “failed to clearly indicate that it ha[d] considered the potential problem identified in the petition.” More specifically, the Ninth Circuit noted that the DEA failed to define “currently accepted medical use with severe restrictions,” which was the applicable standard for rescheduling on which Aggarwal relied. The court directed the DEA to clarify or reevaluate its position.
And, while the footsteps may not have been as swift as some would hope, we still stand by the predictions we made in 2023:
The Ninth Circuit’s refusal to accept the DEA’s out-of-hand dismissal of a petition to reschedule psilocybin is yet another step in what appears to be faster and faster footsteps towards the future. What that future holds is yet to be determined – though we will monitor closely – but whatever the future is it promises to be quite a ride.
Will the Right to Try Act Save Practitioners Who Don’t Conduct Research but Want to Administer Schedule I Drugs?
Perhaps realizing that convincing the DEA to reschedule psilocybin may be a tall task, Aggarwal tried his hand before the DEA and then the Ninth Circuit with another approach — trying to get around the Controlled Substance Act (CSA) by way of the Right to Try Act (RTT Act). Aggarwal challenged the DEA’s decision not to exempt him from registration under the CSA, but the FDA’s RTT Act didn’t turn out to be the rescuer he had hoped for.
Because it’s a Schedule I substance, the CSA dictates that psilocybin may only be produced, dispensed, or possessed in the context of a research protocol registered with the DEA and approved by the Secretary of Health and Human Services. In other words, psilocybin may only be dispensed by medical practitioners in the context of “bona fide research,” which requires the approval of the FDA (see21 U.S.C. § 823(g)(2)(A)). The DEA handles registration and “may, by regulation, waive the requirement for registration of certain…distributors, or dispensers if DEA finds it consistent with the public health and safety” (21 U.S.C. § 8222(d)).
The Food, Drug, and Cosmetic Act (FDCA) is even broader and “imposes restrictions on the…distribution of all drugs including but not limited to controlled substances” (21 U.S.C. § 331). Generally, before a new drug can be introduced to the market, it must go through the clinical trial process, but there are other ways. A patient, for instance, may attempt to access a new drug through the FDA’s expanded access program.
Where a prescription drug is a controlled substance, “the FDCA and CSA operate in tandem” and the person distributing the drug must comply with both statutes.
The FDA has also adopted the RTT Act, which is intended to expand access for eligible investigational drugs outside the clinical trail process. “The RTT Act exempts the drugs provided to eligible patients from specified statutory and regulatory requirements concerning drug labeling, marketing, clinical, testing and approval.” “To access an eligible investigational drug under the RTT Act,” an eligible patient’s physician applies directly to the drug’s sponsor, and the FDA is not involved in approving access.
Seeking psilocybin for his terminally ill patients, Aggarwal’s attorneys submitted a letter to the DEA asking the DEA “for authorization to access psilocybin for therapeutic use under state and federal RTT Acts and immunity from prosecution under the CSA.” His lawyers also asked that if it deemed registration was required under the CSA, that the registration requirement be waived.
The DEA said no dice and clung tight to the CSA. In so doing, the DEA made a few things clear:
“Practitioners who seek to dispense or possess [S]chedule I controlled substances must be properly registered as an approved researcher in accordance with the CSA and its implementing regulations.”
The RTT Act does “not provide any exemptions from the CSA or its implementing regulations.”
The RTT Act does “not give the DEA authority to waive CSA requirements.”
Doubling down, the DEA also declined Aggarwal’s request to initiate rulemaking to exempt him from the CSA’s registration requirement. The DEA provided the following as its reasoning:
The DEA could not fully assess Aggarwal’s proposal because it was lacking in detail.
Aggarwal’s desire to administer psilocybin to patients was not consistent with public health and safety. In making this particular finding, the DEA relied heavily on Congress’ determinations in designating psilocybin as a Schedule I drug that it has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
Aggarwal’s cited historical scenarios involving Schedule I controlled substances — including marijuana — were not persuasive.
The Ninth Circuit found in favor of the DEA, ruling that the DEA’s reasoning in blocking Aggarwal’s access to the DEA was not arbitrary and capricious. While the Ninth Circuit didn’t declare the following reasoning the rule of land even within the Ninth Circuit, it did make clear that the DEA’s reliance on this reasoning is not arbitrary and capricious:
“The CSA and FDCA together govern access to controlled substances for medicinal purpose.”
“Although the RTT Act itself does not require FDA approval for eligible patients to access eligible investigational drugs, it does not exempt such drugs from the FDA’s Attorney-General-delegated oversight pursuant to the CSA.” “So DEA’s continued enforcement of the CSA’s registration requirement does not affect, modify, repeal, or supersede the FDCA as amended by the RTT Act.”
The Ninth Circuit did not reject the DEA’s reliance on Congress’ determination, as codified in the CSA, that psilocybin has a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
So, What Does an Opinion Brushing Back One Physician on the West Coast Mean to the Psychedelics Industry More Broadly?
Proponents and physicians who are looking for easier access to psilocybin outside of the research context will see this as a significant step back. The DEA dealt a significant setback to the ability to rely on the RTT Act or to seek a waiver of registration. The Ninth Circuit didn’t really pull back the reigns. The DEA’s position that, even if a physician is able to obtain approval under the RTT, he or she still must obtain registration or a waiver under the CSA has now been approved (or at least not disapproved). And that position was pretty clear: The DEA is still in charge.
So, what does the opinion not mean? This opinion does not foreclose the efforts of physicians interested in conducting research blessed by the CSA and FDA. As we’ve previously reported, interest in researching psychedelics remains high and it appears capital does, too. Indeed, there are strong pushes for research in the federal, state, and private sectors with corresponding funding. There is no indication — and we have no expectation — that it will slow down any time soon, and the Ninth Circuit’s decision does nothing to change our thoughts on that point. Indeed, it appears to be, at least according to the DEA as approved by the Ninth Circuit, the clearest path forward.
EU Advocate General Recommends Overturning Decision Annulling Harmonized Classification and Labeling of Titanium Dioxide
On February 6, 2025, the European Union (EU) Advocate General (EU AG) recommended that the European Court of Justice (ECJ) overturn the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the European Commission’s (EC) decision to classify titanium dioxide as a suspected human carcinogen. The French government and the EC appealed the decision, arguing that the court exceeded the limits of permissible judicial review of an EC decision and that the court incorrectly interpreted the concept of “intrinsic properties” as it appears in the Classification, Labeling, and Packaging (CLP) Regulation.
According to the EU AG, “[i]n cases of scientific uncertainty relevant for the identification and classification of hazardous substances, the CLP Regulation bestows the role of final interpreter on the Commission, which in turn renders its decision on the basis of an assessment by the [Risk Assessment Committee (RAC)]. In other words, the Commission chooses the ‘correct’ interpretation of scientific data.” In the judgment under appeal, the court did not agree with the conclusion of the European Chemicals Agency’s (ECHA) RAC. The court “explained that taking into consideration the standard particle density value of titanium dioxide for the purposes of the Morrow overload calculation would be wrong; a lower density value should have been used in the circumstances at issue.” The EU AG concludes that “by going further than simply judging whether the administration was aware of and had assessed all of the aspects that current scientific knowledge required it to take into consideration,” the court exceeded the limit of its power of judicial review and annulled the EC’s decision “not because that institution did not take into account all of the relevant (scientific) factors, but because it disagreed with how the administration had assessed those factors.”
The lower court excluded the possibility that the carcinogenicity arising from the inhalation of titanium dioxide in powder form may be connected to its intrinsic properties because (1) carcinogenicity appears only if a certain quantity of that substance is inhaled and (2) carcinogenicity results only from inflammation in the lung due to the accumulation of titanium dioxide particles therein. The court concluded that these are properties that are extrinsic to the substance itself. The EU AG disagrees, stating that “in the light of the context and purpose of the CLP Regulation, the concept of ‘intrinsic properties’ must be interpreted broadly” and that the court “erred when attributing a narrow interpretation to the concept of ‘intrinsic properties.’”
The EU AG proposes that the ECJ:
Set aside the November 2022 judgment in CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, EU:T:2022:725);
Refer the case back to the General Court for the resolution of the remaining pleas in law; and
Order that the costs be reserved.
EU AGs assist the ECJ. They are responsible for presenting, with complete impartiality and independence, opinions in assigned cases. Their opinions are non-binding. The ECJ is expected to issue its decision later this year.
Appellate Court Paves Way for Launch of Alabama Medical Cannabis Program: Watch What Happens Now
It takes a big person to admit when they are wrong. But I’ll raise my hand and say I was wrong when I predicted that the Alabama Court of Civil Appeals would rule in favor of the Alabama Medical Cannabis Commission in late March or early April. That prediction was at least two weeks early, and I owe it to our handful of readers to own up to that mistake.
The Opinion
Last Friday, the Alabama Court of Civil Appeals ruled that the Montgomery County Circuit Court lacked jurisdiction to hear the complaints of Alabama Always – an applicant for a medical cannabis license that has not been awarded a license during any of the three rounds of awards – because Alabama Always (and, presumably by extension, any other disappointed applicant for an integrated facility license) had not exhausted its administrative remedies before filing suit. As a result, the Alabama Court of Civil Appeals instructed the circuit court to lift the injunction prohibiting the AMCC from issuing integrated licenses.
Because the court concluded that the circuit court did not have jurisdiction to hear Alabama Always’ claims, the court expressly declined to issue a holding as to whether the circuit court abused its discretion in various ways in entering the injunction. While as a general matter of judicial philosophy, I believe that the appellate court’s decision to resolve the case on jurisdictional grounds and not offer what would amount to dicta on other issues, the court’s decision to do so leaves open the possibility that Alabama Always and other disappointed applicants could seek additional relief on those grounds.
Why the Court of Civil Appeals’ Opinion Should Matter
I would be lying to you if I told you this decision was the definitive ruling that will allow integrated licenses to be issued in short order. I strongly suspect there will be requests for injunctive relief on separate grounds as soon as the current injunction is lifted.
Having said that, I attended the oral argument, which totaled three hours – the longest I have personally witnessed – and I am confident that the Court of Civil Appeals would treat any effort to re-raise the issues raised in the arguments with similar thoughtful dismissiveness. There is absolutely nothing in the opinion – nor was there anything at oral argument – to suggest that the court will offer the type of relief sought by the disappointed applicants. In fact, there is every reason to believe otherwise.
Instead, I believe the appellate court’s opinion should (1) put an end to serious discussions of legislative intervention in the program and (2) motivate the trial court to move more quickly to dispose of the serial challenges being brought by disappointed applicants.
I’d be remiss not to offer this word of caution. There’s a great line in Mad Men when Don Draper, having been challenged by Conrad Hilton to make a pitch for the global Hilton advertising portfolio, responds: “There are snakes that go months without eating and then they finally catch something, but they’re so hungry that they suffocate while they’re eating. One step at a time.”
Friday was a big win for the AMCC, as the consequences for losing may have been existential. I would caution supporters of the opinion not to overstate the holding, which was expressly limited to jurisdiction, but to instead point to the substance and tone of the questions at oral argument and the language in the opinion strongly suggesting that further challenges along similar lines would receive an equally unwelcome reception.
Conclusion
I’ve used this one before and I hate to recycle content, but I will break tradition when it is on point and involves Tom Hanks and the late, great Philip Seymour Hoffman, at the conclusion of Charlie Wilson’s War.
As Hanks’ character celebrates the Afghan defeat of the Soviets, the hardened CIA analyst played by Hoffman offers this parable:
On his sixteenth birthday the boy gets a horse as a present. All of the people in the village say, “Oh, how wonderful!”
The Zen master says, “We’ll see.”
One day, the boy is riding and gets thrown off the horse and hurts his leg. He’s no longer able to walk, so all of the villagers say, “How terrible!”
The Zen master says, “We’ll see.”
Some time passes and the village goes to war. All of the other young men get sent off to fight, but this boy can’t fight because his leg is messed up. All of the villagers say, “How wonderful!”
The Zen master says, “We’ll see.”
Last week’s decision was a win for the AMCC and possibly for those seeking an efficient resolution to the years-long delay in launching Alabama’s medical cannabis program. But we’ll see. There are miles to go before we sleep.
And before I sleep, I’ll say a prayer that all involved will proceed with only the best of intentions and in furtherance of Alabama’s goal of getting medicine into the hands of people who need it.
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Healthcare Preview for the Week of: March 10, 2025 [Podcast]
(Slim Chance of) Shutdown Week
This Friday is the deadline to pass a budget or enter a government shutdown. The House released a continuing resolution (CR) over the weekend and is scheduled to be in session only until Wednesday. The House Rules Committee plans to meet today to consider the CR, which is expected on the House floor Tuesday.
While the proposed CR does not include several of the large funding cuts that have been discussed, it is not a clean CR. It would:
Fund federal agencies through the end of the fiscal year (September 30);
Limit spending in several, mainly domestic, areas; and
Provide increases for defense spending.
The proposed CR includes the same health extenders that were passed in the December 2024 CR. However, it does not address the scheduled Medicare physician payment cut or other healthcare policies that have been under discussion.
House Democratic leaders strongly oppose the CR, so Republicans likely will need near-complete support (217 votes) from their caucus. President Trump indicated strong support for the CR on social media and asked that no Republicans dissent.
If the CR passes the House, the struggle will move to the Senate, where 60 votes are needed to avert a filibuster. Senator Rand Paul (R-KY) is expected to oppose the CR, which would mean that Republicans need a minimum of eight Democrats to support it.
As with most key votes moving through the 119th Congress, we’ll have to watch to see what happens. While no one is advocating for a government shutdown, if the CR is unable to pass the House or Senate, that will be at least the short-term outcome.
The House will hold a few health-related hearings before Democrats head to their annual retreat at the end of the week. The Senate will hold nomination hearings to consider President Trump’s picks for key health agencies:
Mehmet Oz, MD, as the administrator of the Centers for Medicare and Medicaid Services;
David Weldon as the head of the Centers for Disease Control and Prevention;
Jayanta Bhattacharya as the director of the National Institutes of Health; and
Martin Makary as the commissioner of the US Food and Drug Administration.
These are the only hearings scheduled for these nominees, and they likely will be voted out of their respective committees and confirmed.
Today’s Podcast
In this week’s Healthcare Preview, Debbie Curtis and Rodney Whitlock join Maddie News to discuss the status of government funding and next steps to avoid a shutdown later this week, as House Republicans work to garner votes for their recently released continuing resolution.