Issue of the Case:
This month's case is unusual in that it involves an appeal from the US Patent and Trademark Office rejecting the plaintiff's patent application. The Court of Appeals for the Federal Circuit was asked whether an invention for automatically distributing drugs to patients was patentable because it eliminated the role of pharmacists.
Facts of the Case:
The plaintiff's patent application claimed methods for automatically distributing drugs to the holder of a pre-encoded portable medical data carrier. Under the claims of the patent, the physician would encode a patient's prescription onto a data carrier, such as a creditcard-sized integrated circuit card.
The data carrier includes identification, prescription, and financial data. During the encoding process, the prescription is safety-checked for items such as contraindications, maximum approved dosages, and adverse drug interactions. After the safety check, the data carrier is given to the patient. The patient then presents the data carrier to a drug-dispensing machine.
The dispensing machine verifies the patient's identification by means similar to the manner in which a bank ATM card might be validated, such as a memorized code or the patient's physical features (fingerprint, etc). The machine then delivers the prescribed drug to the patient. The data carrier is re-encoded to reflect the dispensing transaction and is returned to the patient.
The Court's Ruling:
The patent examiner rejected the plaintiff's application because it was obviously based on a number of previously issued patents for drug-dispensing systems. The plaintiff argued that his technology was unique because all the previous inventions required professional supervision?usually by a pharmacist. The court affirmed the rejection of the patent application. It ruled that the elimination of the need for a pharmacist did not make the invention patentable.
The Court's Reasoning:
Patent law requires that every new invention be novel, useful, and non-obvious. The plaintiff contended that his invention was novel because it eliminated the supervision of a pharmacist. To support his case, the plaintiff maintained that eliminating a pharmacist would have 3 new effects: dispensing accuracy of near-zero error, homogeneity of dispensing results, and privacy in dispensing drugs.
The court rejected the plaintiff's arguments. It noted that previously issued patents already recognized that automation of the dispensing function could increase accuracy. One system used in hospital pharmacies had dispensed more than 40 million medications with no reported errors.
The plaintiff's claim of a purported privacy advantage with his invention was found by the court to be illusory. The system in question makes records of each transaction, and those records are available for review purposes. The plaintiff argued, however, that even more privacy is provided with his invention because the patient need not have face-to-face contact with a pharmacist. The court found that, even if that were an important advantage, such a benefit was already provided through mail-order pharmacies.
The court went on to state that in the United States it is generally unlawful for prescription drugs to be dispensed without the participation of the prescriber or a pharmacist. Whereas legal requirements as to who may dispense prescription drugs do not control whether this invention is patentable or not, the fact that the previous inventions recognize the legal requirement for a licensed professional to participate in the drug-dispensing process does not mean that the elimination of the pharmacist's participation constitutes a patentable novelty.
Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.
Get to know RESPIMAT, the slow-moving mist inhaler from Boehringer Ingelheim Pharmaceuticals, Inc.
Watch the RESPIMAT video and test your knowledge with a short multiple-choice quiz. When you get all the answers right, you’ll receive a certificate naming you a RESPIMAT T.O.P. Performer. Why not check it out today?
Clinical features with downloadable PDFs