Tele-medicine patent for creating pharmaceuticals deemed obvious. BECTON v. BAXTER

Once a patent is granted, the patent is not immune from review. If a member of the public discovers prior art which would anticipate (35 U.S.C. §102) or render a patented invention obvious (35 U.S.C. §103), that member of the public can request an inter partes review (IPR). IPR is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims in a patent. The evidence that can be submitted in an IPR is limited to patents or printed publications which would qualify under §§ 102 or 103 and expert testimony to explain those publications. At the conclusion of an IPR the PTAB may invalidate all, some or none of the claims of the patent.

Obviousness under 35 U.S. Code § 103 is a question of law, based on underlying factual findings. Whether an invention is obvious is an objective test based on the prior art and a person having ordinary skill in that art. Prior art is the sum of all knowledge in a given field of technology. Research papers, granted patents, patent applications, and other forms of printed publications are all examples of prior art. The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.

Relevant underlying factual questions related obviousness include, whether a prior art reference teaches away, whether a skilled artisan would have been motivated to combine references, and a skilled artisan’s reasonable expectation of success in combining references.

BECTON, DICKINSON AND COMPANY v. BAXTER CORPORATION ENGLEWOOD, 20-1937 (C.A.F.C. 2021) is an example of a patent which was found to be obvious.

Baxter is the owner of U.S. Patent No. 8,554,579 (“the ’579 patent”), which is directed to “systems for preparing patient-specific doses and a method for telepharmacy in which data captured while following a protocol associated with each received drug order and specifying a set of steps to fill the drug order are provided to a remote site for review and approval by a pharmacist.”

Becton petitioned for inter partes review of the ’579 patent on the grounds that the patent was obvious in light of the prior art. Becton 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”).

Baxter claimed the ’579 patent was not obvious because there were two limitations the prior art did not disclose. The first is the “verification” limitation, which appears in claim 8 but not claim 1. The second is the “highlighting” limitation, which appears in both claims 1 and 8. The Patent Trial and Appeal Board determined that Alexander did not teach or render obvious the verification limitation and that combinations of Alexander, Liff, and Morrison did not teach or render obvious the highlighting limitation. Becton then appealed the PTAB’s decisionto the Court of Appeals of the Federal Circuit.

The Federal Circuit found that the PTAB’s decision was not supported by substantial evidence and reversed the decision. With respect to the verification limitation – Alexander disclosed that a pharmacist MAY verify each step when creating a drug. The ’579 patent claimed a system where a pharmacist MUST verify each step when creating a drug. The Federal Circuit found that while the claims of Alexander used the word may, the specification made it clear that each step of the process must be verified before a new step can be started. Therefore the PTAB’s finding there was a difference between Alexander and the ’579 patent was not supported by substantial evidence.

With respect to the highlighting limitation – Liff is directed to an automated drug dispensing system that contains prepackaged medications. Liff taught highlighting patient characteristics when dispensing a prepackaged medication. The PTAB found that there was no motivation to combine Alexander and Liff. The Federal Circuit found that the PTAB erred in looking to Liff as the only source a person of ordinary skill would consider for what “additional information might be relevant.” The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.

Because the Federal Circuit found that the PTAB’s decision was not supported by substantial evidence, the decision was reversed.

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