On May 28, 2021, the Federal Circuit found obvious the claims of a patent directed to telepharmacy, describing a process allowing a pharmacist to remotely supervise and approve the work of non-pharmacists in filling drug orders. The court reversed the PTAB's decision to the contrary. Becton Dickinson and Co. v. Baxter Corp. Englewood, 998 F.3d 1337 (Fed. Cir. 2021). In reaching its conclusion, the court clarified that a prior art patent that has previously been invalidated still qualifies as prior art under pre-AIA 102(e). Id. at 1345.
Baxter's patent, U.S. 8,554,579, claims systems for the preparation of drug orders by a non-pharmacist where a pharmacist located remotely verifies each step of the preparation. Becton Dickinson ("BD") successfully petitioned the Board to institute an IPR, challenging the validity of certain claims of the patent. In asserting that the challenged claims were invalid, BD relied primarily on three prior art references: U.S. Patent No. 8,374,887 ("Alexander"), U.S. Patent No. 6,581,798 ("Liff"), and U.S. Patent Publication No. 2005/0080651 ("Morrison"). Id. at 1338. The Board found that BD had established that one of ordinary skill in the art would have been motivated to combine the references. And it determined that Baxter's "evidence of secondary considerations [was] weak." Id.
However, the Board found that the references did not teach or render obvious two claim limitations: 1) a verification limitation requiring a pharmacist to approve each step of the process before the next can be performed and 2) a highlighting limitation directed to the user interface that allows one to highlight particular information to get more detail. Id. at 1338-1339.
With respect to the verification limitation, Baxter argued that its claims required that the verification occur before the next step in filling the drug order could take place, while the Alexander prior art reference only disclosed that such verification "may occur." Id. Although the language of Alexander did use the word "may," the Federal Circuit found that, in the context of Alexander, "'may' does not mean 'occasionally,' but rather that one 'may' choose to systematically check each step. Id. at 1340. Specifically, Alexander explained "'[r]eceiving the pharmacist's verification may authorize the non-pharmacist to further process the work.'" Id. Baxter further argued that its claims include a mechanical prohibition on proceeding with work without verification, but the court found that the Board's claim construction did not require that. Id.
Turning to the highlighting limitation, the Liff reference "teaches that the user can highlight various inputs and information displayed on the screen" in the pharmacy context. Id. at 1342-43. The Board found "[BD's expert] fail[ed] to explain why Liff's teaching to highlight patient characteristics when dispensing a prepackaged medication would lead one of ordinary skill to highlight prompts in a drug formulation context to receive additional information relative to one particular step in that process, or even what additional information might be relevant." The Federal Circuit disagreed and found BD's expert provided uncontradicted testimony that "[a] person of ordinary skill in the art would have found it obvious to include in the user interface taught by Liff a tab for the prescription order and information regarding the prescription order that the operator was fulfilling." Id. at 1344. BD's expert further testified that "[a] person of ordinary skill in the art would have understood that additional information could be displayed on the tabs taught by Liff" and that "such information could have included the text of the order itself, information relating to who or how the order should be prepared, or where the order should be dispensed." Id. Based on such testimony, the court found that the claim would have been obvious to one of ordinary skill in the art.
Baxter also argued that Alexander did not qualify as pre-AIA 102(e) art because it had been canceled (invalidated) in a prior IPR. Because the statute requires a patent "granted" on an application, Baxter argued that the grant had been revoked and thus Alexander no longer qualified as prior art. Id. at 1345. The Board rejected this argument as contrary to public policy and unsupported by case law. The Federal Circuit likewise rejected the argument, noting little more than that the statute only requires that the patent "be granted," which had occurred here; the statute did not require that the patent be valid for its disclosure to qualify as prior art. Id. Because the Board's finding that Alexander did not disclose the verification limitation was not supported by substantial evidence, the Federal Circuit reversed.
The Federal Circuit reversed the Board's findings as to each limitation, concluding that BD had met its burden to invalidate the claims at issue. Accordingly, the court reversed the Board's decision.
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