4.4. Surgical methods
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  8. 4.4. Surgical methods
  9. 4.4.4 "Treatment by surgery" in the case law since G 1/07
  10. f) Unpatentable claims for products that can only be produced in a surgical step
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4.4.4 "Treatment by surgery" in the case law since G 1/07

Overview

f) Unpatentable claims for products that can only be produced in a surgical step

Pursuant to the second clause of Art. 53(c) EPC, the exclusion from patentability "shall not apply to products, in particular substances or compositions, for use in any of these methods."

In G 1/07 it was found that a single surgical method step was enough to regard a multi-step method as being excluded from patentability. It was not a question of whether a medical practitioner would then infringe the claimed method. In decision T 775/97 this approach was transferred to particular products. The claim related to a new product which had been produced from two components, both known per se, by means of a surgical step in the human body. The board in T 775/97 held that no European patent could be granted with claims directed to a new and even possibly inventive way of using materials or devices, in particular endoprostheses, involving a treatment by surgery. This was held to be equally true for product claims defined by a construction which was only arrived at in the human or animal body following a surgical method step.

The board in T 1731/12 endorsed T 775/95 and continued its approach, holding that a device defined by a feature that could be arrived at only by a surgical or therapeutic step was excluded from patentability under Art. 53(c) EPC. It agreed with the thinking that a product defined by a surgical step could not exist without it, and thus that the surgical step was part of the claimed product. Moreover, the exclusion of such a product from patentability was not contrary to the second clause of Art. 53(c) EPC, which provided that products for use in therapeutic or surgical methods were patentable. Otherwise, medical and veterinary practitioners' freedom would be limited, as also discussed for example in G 1/07. The board saw a fundamental difference between the actions of "using" and "making" a product. Using patented subject-matter was generally allowed once that subject-matter had been duly purchased. To be allowed to make a patented product, by contrast, medical staff would need to purchase a licence for the process of making it; where that process involved a surgical or therapeutic method step, that would interfere precisely with the freedom of medical staff that the exclusion from patentability under Art. 53(c) EPC intended to protect. In T 1552/22 by contrast, the board held that while in T 1731/12 and T 775/97 surgical steps were required to reproduce the invention such that the apparatus/the device was excluded from patentability, in the present case no surgical step was required to reproduce the annuloplasty implant of claim 1.

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