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Under High Pressure: New Mechanism of Action Can’t Save Drug Administration Claims

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board ruling that method claims reciting a mechanism of action triggered by the co-administration of two known antihypertensive agents were obvious over the cited prior art. In re Couvaras, Case No. 22-1489 (Fed. Cir. June 14, 2023) (Lourie, Dyk, Stoll, JJ.)

This case arose out of applicant John Couvaras’s prosecution of patent claims reciting a method of increasing prostacyclin release in the systemic blood vessels to improve vasodilation in a human with essential hypertension by co-administering two therapeutic agents. During prosecution, Couvaras conceded that the two claimed therapeutic agents had been known as essential hypertension treatments for many decades. The examiner agreed, citing 10 references as confirmation. The examiner further found that the physiological results of co-administering the two therapeutic agents were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.

Couvaras appealed to the Board, arguing that the increased prostacyclin release was unexpected and that objective indicia overcame any existing prima facie case of obviousness. The Board disagreed, ruling that the increased prostacyclin release was inherent in the obvious administration of the two known antihypertensive agents and that no evidence existed to support a finding of any objective indicia. Couvaras appealed.

Couvaras raised three arguments on appeal:

  1. The Board erred in affirming that a skilled artisan would have had motivation to combine the art.
  2. The claimed mechanism of action was unexpected, and the Board erred in discounting its patentable weight by deeming it inherent in the claimed method.
  3. The Board erred in weighing objective indicia of non-obviousness.

With respect to motivation to combine, the Federal Circuit agreed with the Board that the art supplied sufficient motivation to combine because the claimed therapeutic agents were known for decades to treat hypertension, finding the Board’s conclusion supported by substantial evidence. The Court found that Couvaras had forfeited a related argument for no reasonable expectation of success by failing to first raise that challenge to the Board.

The Federal Circuit also rejected Couvaras’s argument that the claimed mechanism of action was unexpected and therefore entitled to patentable weight. Couvaras argued that the Board downgraded the patentable weight of limitations drawn to the antihypertensive agents’ mechanism of action by deeming them to be merely inherent. According to Couvaras, even if the recited mechanism of action was inherent in the claimed administration of the two agents, that mechanism was unexpected because the increased prostacyclin release was unexpected and could not be dismissed as having no patentable weight due to inherency.

The Federal Circuit disagreed, explaining that Couvaras was attempting to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents and that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” The Court allowed that while mechanisms of action may not always meet the most rigid standards for inherency, “[r]eciting the mechanism for known compounds [...]

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If Prior Art Discloses Ingredients and How to Mix Them, the “Cake” Is Anticipated

The US Court of Appeals for the Federal Circuit affirmed that challenged claims were invalid as anticipated based on principles of inherency where the disclosed prior art formulations and processes necessarily met a disputed claim limitation. Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 20-1183 (Fed. Cir. April 11, 2023) (Reyna, Schall, Chen, JJ.)

Arbutus Biopharma owns a patent that matured from an application filed on March 9, 2015, that claims priority to a provisional application filed on June 30, 2010. The claimed invention provides stable nucleic acid-lipid particle (SNALP) formulations with a non-lamellar structure that function to increase the efficiency of nucleic acid entry into cells to promote the downregulation of gene expression. The non-lamellar morphology of a SNALP formulation was known to depend on two factors: the lipids incorporated into the SNALP formulation, and the process used to form the SNALPs. The patent disclosed five SNALP formulations of various compositions that can be used and incorporated by reference two US patent publications, which describe two methods that can be used to make SNALP formulations: the Direct Dilution Method (DDM) and the Stepwise Dilution Method (SDM). The representative independent claim recites a composition of SNALPs, wherein each particle in the plurality of SNALP particles comprises a nucleic acid and various lipid types. The claim also requires that at least 95% of the particles in the plurality of particles have a non-lamellar morphology (the Morphology Limitation).

Moderna filed a petition for inter partes review (IPR) asserting that all the claims of the Arbutus patent were anticipated by a prior art patent. The Patent Trial & Appeal Board found that although the Morphology Limitation was not expressly found in the prior art, the claims were anticipated. The Board determined that the Morphology Limitation was an inherent property (or natural result) of the prior art disclosures. On appeal, Arbutus challenged the Board’s inherent and express anticipation findings for many of the challenged claims, including for the Morphology Limitation.

A limitation is inherent if it is the natural result flowing from the prior art’s explicit disclosure. In other words, a limitation is inherent when the limitation is a property necessarily present in the invention and not actually an additional requirement imposed by the claims. In the IPR proceeding, Moderna argued that the Morphology Limitation was inherent because one skilled in the art would necessarily obtain formulations meeting this limitation by making formulations using the five formulations disclosed by the patent and using the DDM method (from the incorporated-by-reference disclosures) to prepare the formulations.

Both the challenged patent and the prior art disclosed five formulations that can be used to obtain the SNALP formulations. Evidence showed that any differences between the formulations disclosed in these patents would not impact the Morphology Limitation. The Federal Circuit found that substantial evidence supported a finding that the formulations disclosed in both the challenged patent and the prior art were the same or essentially the same.

The Federal Circuit further explained that both the challenged patent and the [...]

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.


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Inherency Can Be Used in Obviousness Analysis to Supply Missing Limitation

Finding that inherency can be used to show the presence of a missing claim limitation, the US Court of Appeals for the Federal Circuit affirmed a district court decision that asserted claims in pain management method patents were invalid as obvious. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361 (Fed. Cir., Dec. 27, 2019) (Reyna, J.).

Persion has US Food and Drug Administration (FDA) approval for its extended release hydrocodone product, Zohydro ER, and also owns two patents directed to methods of treating pain with extended release hydrocodone in patients with mild to moderate hepatic impairment. Persion sued Alvogen for infringement of certain claims in these two patents after Alvogen filed an Abbreviated New Drug Application (ANDA) requesting approval from the FDA to market a generic version of Zohydro ER. The asserted claims include: (i) non-adjustment claims directed to administering a dose of hydrocodone to patients with mild to moderate hepatic impairment without adjusting the dose relative to a healthy liver patient, and (ii) pharmacokinetic claims directed to pharmacokinetic parameters achieved after treatment with hydrocodone.


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