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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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The Best Option Is Obviously Not the Only Option

Following a jury verdict finding infringement of two patents and awarding $2.2 billion, the Patent Trial & Appeal Board issued a final written decision finding all claims in one of the asserted patents invalid. The Board explained that an asserted prior art combination only needs to be a suitable option, not the best option. Patent Quality Assurance, LLC v. VLSI Tech. LLC, Case No. IPR2021-01229 (June 13, 2023) (Giannetti, McNamara, Melvin, APJs).

In March 2021, a jury found that Intel infringed two patents owned by VLSI. On July 7, 2021, Patent Quality Assurance filed an inter partes review petition against all claims of one of the patents Intel was found to infringe. The Board instituted review. After institution, Intel filed an identical petition and motion for joinder, both of which were granted.

The challenged patent is directed to a method of determining the minimum operating voltage for integrated-circuit memory, storing the value of that voltage in nonvolatile memory, and using the value to determine when an alternative power-supply voltage may be switched to the memory to ensure that the minimum operating voltage is met. Intel challenged the claims of the patent based primarily on a combination of three prior art references.

VLSI raised numerous arguments for why the combination of prior art references did not teach the claimed invention. VLSI argued that a skilled artisan would not have had reason to regulate the power supply voltage of one reference with the voltage regulator of another. VLSI asserted that there would have been no need to use the switching mechanism if voltage regulation was available from the outset. The Board disagreed and quoted the US Court of Appeals for the Federal Circuit’s 2022 decision in Intel v. Qualcomm, which stated that “a petitioner is required to show only that there is something in the prior art as a whole to suggest the desirability of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available.”

The Board reiterated this theme in response to another of VLSI’s arguments. VLSI contended that a person of skill in the art would not have combined the prior art disclosure of a system for determining minimum operating voltages and storing them in nonvolatile memory with a reference that uses SRAM, a type of volatile memory commonly used as an alternative to nonvolatile memory. The Board again noted that “there is no requirement that an asserted combination is the best option, only that it be a suitable option.”

Given the jury’s verdict and damages award in the district court case, VLSI also argued that the jury’s verdict showed commercial success and was objective indicia of nonobviousness. As part of its analysis, the Board reiterated that the nexus between the alleged commercial success and the asserted patent claims must be both embodied by the commercial product and coextensive with them. The Board went on to find that “the record before [the Board] does [...]

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