Scott v. Finney
34 F.3d 1058 (1994)
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Rule of Law:
The extent of testing required to establish an invention's reduction to practice depends on the complexity of the invention and the problem it solves, requiring only a reasonable showing, through a common-sense lens, that the invention will work for its intended purpose beyond a probability of failure.
Facts:
- Dr. F. Brantley Scott invented a self-contained, inflatable penile implant.
- The device consisted of two internal reservoirs connected by a valve, designed to be manipulated through the skin to shift fluid and simulate an erection or flaccidity.
- To test a prototype, a surgeon temporarily implanted a single unit of the device into an anesthetized patient.
- The procedure, which was videotaped, showed the surgeon successfully operating the valve through the skin multiple times, causing the device to create an erection and then return to a flaccid state.
- An expert urologist, Dr. Drogo K. Montague, viewed the videotape and testified that the device demonstrated sufficient rigidity for intercourse.
- After the successful demonstration of its function, the surgeon removed the prototype from the patient.
Procedural Posture:
- Dr. Finney filed a patent application for a penile implant on May 15, 1980, making him the 'senior party' in the dispute.
- Dr. Scott and John H. Burton filed a competing application on May 15, 1981, making them the 'junior party'.
- A patent interference proceeding was initiated before the Board of Patent Appeals and Interferences to determine who invented the device first.
- The Board found that Dr. Scott's evidence of a videotaped surgical test was insufficient to establish reduction to practice because the device was not tested under actual use conditions for an appropriate period of time.
- Consequently, the Board awarded priority of invention to Dr. Finney.
- Dr. Scott (appellant) appealed the Board's decision to the U.S. Court of Appeals for the Federal Circuit, with Dr. Finney as the appellee.
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Issue:
Does the temporary surgical implantation of a novel penile prosthesis into an anesthetized patient, which successfully demonstrates the device's essential mechanical functions on videotape, constitute a sufficient reduction to practice to establish priority of invention?
Opinions:
Majority - Rader, Circuit Judge
Yes. The temporary implantation and successful demonstration of the device's mechanical functions was sufficient to constitute a reduction to practice. To establish reduction to practice, an inventor must show the invention is suitable for its intended purpose, but the necessary level of testing is guided by a common-sense approach that considers the invention's complexity and what is truly novel about it. Here, the underlying materials and concept of an inflatable prosthesis were already established in the prior art. The key novelty was the self-contained hydraulic system with its manipulable valve. The videotaped test sufficiently demonstrated the workability of this novel aspect, showing it could be operated through the skin to produce the necessary rigidity. The Board erred by imposing an overly strict standard requiring testing under actual use conditions (intercourse) or for a prolonged duration. Such extensive safety and efficacy testing is the province of the Food and Drug Administration (FDA), not a prerequisite for establishing priority of invention before the Patent and Trademark Office (PTO).
Analysis:
This decision clarifies the standard for reduction to practice in patent law, particularly for medical devices. By adopting a flexible, 'common sense' approach, the court lowers the evidentiary bar for inventors, allowing testing that demonstrates the workability of the novel aspects of an invention without requiring exhaustive, real-world trials. The case significantly distinguishes the role of the PTO (determining workability for patentability) from the role of the FDA (determining safety and efficacy for commercial sale). This precedent allows inventors to secure patent priority with laboratory or limited clinical testing, reducing the burden of proof and potentially accelerating innovation by protecting inventions earlier in the development process.
