Patent Protection for Medical Equipment and Diagnostics
Different countries have fairly uniform patent laws regarding novel medical equipment. The patent applicant is required to meet the usual criteria for patent approval – novelty, utility, and non-obviousness.
The situation is different for treatment methods in humans and animals.
Medical treatments in humans are not eligible for patents IN ISRAEL (Israeli Patent Law, section 7). This exception is firstly due to ethical considerations which dictate that the business interests of a patent-holder must not interfere with the treatment of a person in need of medical care. For example, an application for “plaster setting of internal human organs” would be rejected, although a similar method in use in animals is patentable in Israel.
Patent laws differ from country to country, so for example IN THE U.S. medical treatments are patentable for humans and animals.
The law IN EUROPE is similar to the Israeli law: “surgical, therapeutic, or diagnostic methods of treatment in humans or animals” may not be patented (section 53(c) of the European Patent Convention).
Stricter limits are maintained for a treatment method or system that involves existing (as opposed to original) medical equipment or a method that does not employ any equipment. In these cases the invention may not be patentable in any country.
What about diagnostics?
According to an interpretation of the Law for Human and Animal Treatment Methods dating from 2009, the European Patent Office ruled that a method or system for diagnosis of a sample taken from a human subject is patentable since it does not involve work on a living organ. The ruling excludes samples that are taken out and consequently returned to the body (for instance those made by a dialysis machine), or a method that involves taking samples from a living body.
Regarding diagnosis of medical conditions, it is worthwhile to consider the U.S. Supreme Court ruling on Bilski. Though the ruling dealt with patent eligibility for inventions in computer programming and business methods, the main argument centered on the patentability of “abstract” inventions. Because inventions in the medical diagnostic field often involve developments in computer programming to analyze data or information banks (and such analysis might be construed as abstract), the patentability of such inventions could strongly depend on the descriptive wording of the patent application.
Therefore, it is important to consult a licensed patent agent regarding options: whether to submit a patent application for the invention or to keep it as a trade secret. If patenting is opted for, professional editing and negotiation with the patent examiners in various countries are crucial to the future commercial success of the invention.