patent prosecution Archives

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:

The Board erred in affirming that a skilled artisan would have had motivation to combine the art.
The claimed mechanism of action was unexpected, and the Board erred in discounting its patentable weight by deeming it inherent in the claimed method.
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 [...]

Continue Reading

Submarine Sunk: Patent Prosecution Laches Pops GATT Bubble

Addressing for the first time whether the US Patent & Trademark Office (PTO) can assert prosecution laches as a defense in a civil action brought under 35 U.S.C. §145, the US Court of Appeals for the Federal Circuit held that the PTO could assert prosecution laches as a defense against four patent applications in a case where the plaintiff delayed presenting the claims for these applications over a period of at least 10 years. Hyatt v. Hirshfeld, Case Nos. 2018-2390; -2391; -2392; 2019-1038; -1039; -1049; -1070 (Fed. Cir. June 1, 2021) (Reyna, J.)

Gilbert Hyatt is well known for having built a prolific patent application portfolio based on nearly 400 initial filings made just before the United States changed from an issuance-based patent exclusivity system to a filing-based patent exclusivity system under the Uruguay Round of the General Agreement on Tariffs and Trade (GATT). By 2003, those 400 initial filings had exploded into 45,000 independent claims. Hyatt’s applications were so labor intensive that the PTO developed a separate examining unit specifically dedicated to their review. Many of these applications have been rejected.

After the PTO finally rejected four of Hyatt’s computer software patent applications, in 2005 Hyatt filed a § 145 action in the district court. Throughout the litigation, the PTO argued that Hyatt had routinely delayed prosecuting his patent applications and never complied with his verbal agreement with the PTO to streamline each application to apply for only one invention. Ultimately, after a five-day bench trial, the district court found that the PTO failed to prove it had taken sufficient action to advance prosecution of Hyatt’s applications. The PTO appealed.

Resolving the threshold issue on appeal of whether prosecution laches is even available to the PTO in a § 145 action, the Federal Circuit explained that the right to assert laches as an affirmative defense flows naturally from the PTO’s rights to reject applications based on laches and defend such rejections on appeal in the Federal Circuit on the same grounds. Any other conclusion, the Court recognized, would create incongruence and undermine the PTO’s authority. Such a defense is available even if raised for the first time in the district court, as “§145 actions open the door to new evidence.”

The Court found significant errors in the district court’s application of prosecution laches law. First, the Federal Circuit held that the district court too narrowly focused on the PTO’s specific conduct without considering the totality of the circumstances, including delays caused by Hyatt’s sweeping amendments and prosecution of other patent applications, as well as the relative costs and burdens of examining Hyatt’s gargantuan application portfolio. The Court was particularly critical regarding the district court’s assignment of blame to the PTO in its attempts to manage the unwieldy task before it.

After reviewing the evidence presented by the PTO, the Federal Circuit found that the PTO had amassed significant evidence of Hyatt’s delay of prosecution of his applications—i.e., “patterns of prosecution conduct [that] created a perfect storm that overwhelmed the [...]

Continue Reading

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

Submarine Sunk: Patent Prosecution Laches Pops GATT Bubble

BLOG EDITORS

STAY CONNECTED

TOPICS

ARCHIVES

RECENT POSTS