A hot area in medical technology for the past ten years has been minimally invasive surgery. Minimally invasive methods include various kinds of endoscopic surgery, e.g., laparoscopic, arthroscopic, and thoracoscopic surgery, as well as intravascular surgery and radioscopic techniques. Minimally invasive surgery represents the future, not only because the surgery reduces patient trauma but because of the potential reduction in costs due, for instance, to reduce hospital stays. Other kinds of medical apparatus and processes, such as risk management techniques, also serve to reduce costs.

Congress has recently passed a law exempting doctors, hospitals and other health care providers from liability for infringing medical method patents. This law will affect only a minute portion of medical patents for the reason that patentable medical methods generally require at least a modification or adaptation of medical instrumentation to enable performance of the methods. Although the modified medical instrumentation is likely to be unpatentable per se because of its similarity to conventional tools, marketing of the modified instrumentation is likely to infringe a medical method patent. A medical method patent is unenforceable against the physicians who directly infringe the patent claims, but the patent may nonetheless be enforced against instrument manufacturers who induce infringement by the physicians.

One hurdle encountered by medical patents which is not applicable to other kinds of technological advances, such as software and Internet business methods, is that imposed by the Food and Drug Administration. Medical devices and methods, like drugs, must be approved by the FDA. This approval process can be cumbersome and expensive and will frequently delay the launching of any company based solely on a new medical technology. A key to minimizing FDA-induced delay is to position the technology before the FDA so that the technology appears to be similar to existing approved techniques or instrumentation. Of course, on the patent side it is important to establish claims which are directed to patentable distinctions in the new medical technology without jeopardizing the FDA approval process.