Court Reviews the "Usefulness" of Pharmacists

Pharmacy Times, Volume 0, 0

Issue of the Case:

This month's case is unusual in thatit involves an appeal from the USPatent and Trademark Office rejectingthe plaintiff's patent application. TheCourt of Appeals for the Federal Circuitwas asked whether an inventionfor automatically distributing drugs topatients was patentable because iteliminated the role of pharmacists.

Facts of the Case:

The plaintiff's patent applicationclaimed methods for automaticallydistributing drugs to theholder of a pre-encodedportable medical data carrier.Under the claims ofthe patent, the physicianwould encode a patient'sprescription onto a datacarrier, such as a creditcard-sized integrated circuitcard.

The data carrier includesidentification, prescription,and financialdata. During the encodingprocess, the prescription issafety-checked for itemssuch as contraindications,maximum approved dosages, andadverse drug interactions. After thesafety check, the data carrier is givento the patient. The patient then presentsthe data carrier to a drug-dispensingmachine.

The dispensing machine verifies thepatient's identification by means similarto the manner in which a bank ATMcard might be validated, such as a memorizedcode or the patient's physical features(fingerprint, etc). The machinethen delivers the prescribed drug to thepatient. The data carrier is re-encoded toreflect the dispensing transaction and isreturned to the patient.

The Court's Ruling:

The patent examiner rejected theplaintiff's application because it wasobviously based on a number of previouslyissued patents for drug-dispensingsystems. The plaintiff argued thathis technology was unique because allthe previous inventions required professionalsupervision?usually by apharmacist. The court affirmed therejection of the patent application. Itruled that the elimination of the needfor a pharmacist did not make theinvention patentable.

The Court's Reasoning:

Patent law requires that every newinvention be novel, useful, and non-obvious.The plaintiff contended that hisinvention was novel because it eliminatedthe supervision of a pharmacist.To support his case, the plaintiff maintainedthat eliminating a pharmacistwould have 3 new effects: dispensingaccuracy of near-zero error, homogeneityof dispensing results, and privacy indispensing drugs.

The court rejected the plaintiff'sarguments. It noted that previouslyissued patents already recognized thatautomation of the dispensing functioncould increase accuracy. One systemused in hospital pharmacies haddispensed more than 40 million medicationswith no reported errors.

The plaintiff's claim of a purportedprivacy advantage with his inventionwas found by the court to be illusory.The system in question makes recordsof each transaction, and those recordsare available for review purposes. Theplaintiff argued, however, that evenmore privacy is provided with hisinvention because the patient neednot have face-to-face contact with apharmacist. The courtfound that, even if thatwere an important advantage,such a benefit wasalready provided throughmail-order pharmacies.

The court went on tostate that in the UnitedStates it is generally unlawfulfor prescription drugs tobe dispensed without theparticipation of the prescriberor a pharmacist.Whereas legal requirementsas to who may dispenseprescription drugsdo not control whetherthis invention is patentable or not, thefact that the previous inventions recognizethe legal requirement for alicensed professional to participate inthe drug-dispensing process does notmean that the elimination of the pharmacist'sparticipation constitutes apatentable novelty.

Larry M. Simonsmeier isEmeritus Professor ofPharmacy Law atWashington State UniversityCollege of Pharmacy.