Food and Drug Administration/FDA Archives

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

by Lois D. Mermelstein | May 8, 2025 | Life Sciences

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However, under Supreme Court precedent, state unfair-competition laws that accurately mirror the relevant provisions of federal law are not subject to preemption. Zyla Life Sciences, LLC v. Wells Pharma of Houston, LLC, Case No. 23-20533 (5th Cir. April 10, 2025) (Oldham, Ho, Duncan, JJ.)

Under the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., no one may sell any new drug without prior approval from the US Food and Drug Administration (FDA). Because compounded drugs are not new but are merely remixed versions of existing drugs, registered compounding facilities are allowed to sell compounded drugs as long as they satisfy additional criteria specified in the FDCA. Six states mirror federal law by making it illegal to sell any new drug without FDA approval and provide for suit under traditional state unfair-competition law if a party sells drugs in violation of these state laws.

Zyla and Wells Pharma are competitors. Zyla sells FDA-approved suppositories containing indomethacin, a drug used to treat various ailments such as rheumatoid arthritis. Wells Pharma sells compounded indomethacin suppositories that are not FDA approved, but Wells Pharma is a registered compounding facility and thus satisfies at least one provision of the exemption. Zyla, seeking to enjoin Wells Pharma from manufacturing and selling its compounded suppositories in the six states mirroring the FDCA, filed suit under those states’ unfair-competition laws. Wells Pharma moved to dismiss under Fed. R. Civ. Pro. 12(b)(6), arguing that the state laws were preempted. After the district granted the motion, Zyla appealed.

The issue before the Fifth Circuit was whether the state laws conflict with the FDCA by incorporating it. As the Court explained, a state triggers implied “[o]bstacles-and-purposes preemption . . . when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Here, (quoting the California statute) the six state statutes at issue bar selling a “new drug” that has not been approved “under Section 505 of the [FDCA].” The Fifth Circuit, citing the 1949 Supreme Court decision in California v. Zook as controlling, concluded that where there is no conflict in statutory terms between the state and federal statutes, there is no preemption. Both a state and the federal government may regulate the same conduct – whether a state has provided an additional remedy in state law is irrelevant – and the FDCA itself permits states to regulate conduct related to drug safety and effectiveness concurrently with the federal government.

The Fifth Circuit reversed the district court’s order granting Wells Pharma’s motion to dismiss and remanded the case.

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

by Christopher M. Bruno | Apr 17, 2025 | Life Sciences, Patents

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

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Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

by Matthew J. Blaney | Apr 3, 2025 | Life Sciences

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code, entitling an abbreviated new drug application (ANDA) filer to deduct litigation expenses incurred defending against a patent infringement lawsuit. Actavis Labs. FL, Inc. v. United States, Case No. 23-1320 (Fed. Cir. Mar. 21, 2025) (Chen, Cunningham, Stark, JJ.)

Actavis filed ANDAs with the US Food and Drug Administration (FDA) seeking approval to market and sell a generic version of a drug already offered for sale in the United States. Per the Hatch-Waxman Act, filing an ANDA is an act of patent infringement where the ANDA holder seeks FDA approval prior to the expiration of the new drug application (NDA) holder’s patent. Following Actavis’s filing, the NDA holder brought a patent infringement lawsuit against Actavis.

Actavis subsequently treated litigation expenses incurred in defending the patent infringement lawsuit as ordinary and necessary expenses. Actavis deducted those litigation expenses on its tax returns for that year. However, the Internal Revenue Service (IRS) considered these expenses to be nondeductible capital expenditures since they were incurred “in pursuit of an intangible capital asset: namely, FDA approval to lawfully market a generic drug product in this country.”

Actavis eventually paid its tax liability but then sued the IRS in the Court of Federal Claims to recover what Actavis considered an overpayment of its taxes. The claims court agreed with Actavis, holding that Hatch-Waxman litigation expenses were deductible as ordinary and necessary business expenses. The IRS appealed.

The Federal Circuit affirmed. When determining whether Hatch-Waxman litigation expenses are deductible under Code § 162(a), the Federal Circuit uses two tests to settle the issue: the “origin of the claim” test and the “most significant benefit” test. However, as the Court emphasized, regardless of which test applied, Actavis prevailed.

The Federal Circuit first explained that Actavis prevailed under either test because patent infringement (not the FDA approval process) is what triggers incurring litigation expenses. Further evidence that the “origin of the claim rests in the patentholder’s decision to sue, and not in the ANDA filer’s decision to seek drug approval from the FDA, is the fact that infringement litigation cannot provide the ANDA filer what it wants – only the FDA can,” the Court stated.

Relying on the Third Circuit’s 2023 decision in Mylan v. Comm’r of Internal Revenue, the Federal Circuit delved into the fairness aspect of allowing Hatch-Waxman litigation expenses to be deductible. Citing Mylan, the Court explained that generic manufacturers defending against patent infringement suits “obtain no rights from a successful outcome. They acquire neither the intangible asset of a patent nor an FDA approval.” The Court also noted that brand-name drug companies in Hatch-Waxman lawsuits may deduct litigation expenses incurred while enforcing their patent rights. “[I]mposing very different tax treatment on the warring sides in an ANDA dispute, as the Commissioner advocates, is at odds with the careful statutory [...]

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