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Originally Published MX May/June 2002

GOVERNMENTAL & LEGAL AFFAIRS

From Argument to Strategy

Medtech executives can draw several key lessons from the decision of the Supreme Court in the case of Pfaff v. Wells Electronics. Following are some areas that emerged in the argumentation of that case, and how medtech companies can devise strategies to protect their patent rights.

In Pfaff v. Wells Electronics, the crux of the issue was the idea’s stage of development. Offering an invention for sale is less likely to result in a loss of patent rights if untested features of the invention are included in the patent claims. If an inventor does not claim a feature in a patent, he or she will have a hard time later convincing a court that the invention was incomplete at the time of sale on the grounds that the feature was not tested.

Second, if a feature cannot be written into the patent claims, it should at least be written into the invention's specifications. In Pfaff v. Wells Electronics, neither the patent claims nor the invention’s specifications showed strong support for Pfaff’s assertion that durability—and therefore the time required to test for durability—was essential to the invention.

Third, the on-sale bar is more likely to prohibit the marketing of a simple invention than the marketing of a complex one. Inventors who have offered such simple inventions for sale in the past few months should expect that their patent rights will evaporate on the one-year anniversary of the offer. An offer of sale for a complex invention is less likely to be construed as a prohibited offer of sale, especially if the invention’s essential features are untested.

Finally, what is judged to be simple or complex varies with the type of invention—and specifically with the predictability of the type of invention. The functions of mechanical designs have historically been held to be predictable. Electrical inventions were thought to be less predictable, but this is changing with the growing ubiquity of electronics and software. The workability of untested chemical conceptions has always been held to be unpredictable; anyone can theorize a given polymer, but making it to industrial specifications is another matter. The functionality of biological inventions is considered the least predictable.

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