T 264/17 - Synthetic lubricant as a synovial fluid replacement

Art. 54(5) EPC provides for protecting the second or further medical indication for compounds which are otherwise (i.e., structurally) known. The proper claim format is the purpose-limited product claim format (e.g., "Compound X for use in medical method Y.", see G 2/08).

Traditionally the Boards have held that the  "substance or composition" of Art. 54(4) and (5) must be an "active agent or ingredient", in the sense of a pharmaceutically active agent. Chemicals which merely acted physically, such as injected collagen agents, were considered more a "device" rather than a "substance or composition" (see, e.g., T 1758/15). 

T 264/17 takes a different view on the issue.

The Board in T 264/17 now regarded a claim to the use of an inert lubricant as a replacement synovial fluid (fluid that reduces friction  in synovial joints, such as knees) allowable. The Board found it justified to award second medical use protection for the lubricant, because they considered it to act more like a chemical than like a device. For example, the inert lubricant did not rely on some sort of a 3-dimensional structure but had no defined 3-dimensional shape. The fact that the inert lubricant was not pharmaceutically active did not play a role. Specifically they said (in the German original):

"Der therapeutische Effekt wird auch unzweifelhaft von einer chemischen Zusammensetzung verursacht, nämlich von den in Anspruch definierten perfluorierten Polyethern. Ob diese im klassischen Sinn als "Aktivstoffe" bezeichnet werden oder nicht, ist dabei nebensächlich." (point 4.5.3 of the reasons)

The Board also mentioned decisions G 5/83, T 2003/08 and T 1758/15, in which the "substance or composition" of the second-medical use claim was a (pharmaceutically) "active compound", respectively. However, the Board in this case found that this was not a prerequisite for a second-medical-use claim.

I really like this decision. I always thought that a very narrow interpretation of the expression "substance or composition" in Art. 53(4) and (5) was more a result of successful lobbying of the pharmaceutical industry rather than making legal sense.

The text of the full decision can be accessed here.