Methods for treatment of the human or animal body are unpatentable
17.05.1998
According to Article L-611-10 of the Intellectual Property Code, "Inventions which are susceptible of industrial application, which are new and which involve an inventive step shall be patentable". According to Article L-611-16, "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions susceptible of industrial application whithin the meaning of Article L 611-10". According to Article L612-12, "a patent application shall be refused, in whole or in part, if ... its subject-matter is manifestly not to be regarded as an invention susceptible of industrial application within the meaning of Article L611-16"
We submit presently the facts and the decision of the French Patent Office about claims directed to a method for obtaining a biopsy of rigid tissue (such claims have been granted by the US Patent Office). In a first step, the French Patent Office has objected these claims - the French patent application included also claims concerning a device used for carrying out a biopsy - and asked the Applicant to remove these method claims taking account the provisions of Article L-611-16. The Applicant has presented observations mentioning that a biopsy is as sampling of a tissue fragment in order to carry out various tests, that this sampling allows to make the diagnosis and, consequently, the treatment, but is not, by itself, a treatment, and furthermore that the treatment is well defined in the jurisprudence, as a mean to cure or to prevent a desease (PIBD 176 356 III 251-253 and PIBD 176 356 III 253-254). In response, the French Patent Office indicates that he considers * that the "method" defines a well-ordered assembly of steps, allowing to obtain a result ; * that the "surgery" implies the intervention of the hand, naked or armed with instruments, on the human or animal body ; * that the "surgical treatment" can be defined in particular as a treatment including one or more incisions and modifications brought about to the organs (so called bloody treatments) (Larousse's dictionary of medicine) ; * that the term "surgery" encompasses interventions carried out on human body such as in particular endoscopy, punctures, injections, excisions, the opening of corporeal cavities or the fitting of catheters ... (Larousse and Petit Robert's dictionaries of medicine) ; * that the term "surgery" not only relates to preventive or curative treatments but rather indicates the nature of the treatment ; * that, moreover, Article L.611-16 of the Intellectual Property Code distinguishes the term "surgery" from the term "therapy" in excluding the methods of surgical or therapeutic treatment of human or animal body from the patentability ; * that the claims in question of the patent application relate to a method for obtaining a biopsy of rigid tissue ; * that in this process the steps of inserting a needle into the rigid tissue such that said needle contains a biopsy, inserting a plate into the needle, passing said plate along an internal surface of a tapered portion of said needle until the plate pushes the biopsy against an opposite internal surface of said needle, rotating said needle until the biopsy is separated from the rigid tissue, involve an intervention of the human body in the structure and constitute as much steps of a surgical nature ; * that the claimed process in the claims in question does constitute a method of surgical treatment of the human or animal body ; * that consequently, the subject-matter of the claims in question is manifestly not to be regarded as an invention susceptible of industrial application within the meaning of Article L.611-16 of the Intellectual Property Code.
