Method of treatment or diagnosis
Method of treatment or diagnosis
CJ Medical relied on section 4A(1) of the Patents Act 1977. It provides:
‘4A. (1) A patent shall not be granted for the invention of –
a method of treatment of the human or animal body by way of surgery or therapy, or
a method of diagnosis practised on the human or animal body.’
Section 4A is among those which must be interpreted, as nearly as practicable, in the same way as the corresponding provision in the European Patent Convention, art.53(c), which states:
‘European patents shall not be granted in respect of:
…
methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.’
The meaning of ‘a method of treatment of the human or animal body by way of surgery’ in art 53(c) was considered in detail by the Enlarged Board of Appeal of the European Patent Office in Case G1/07 MEDI-PHYSICS/Treatment by surgery [2010] EPOR 25. I need not explore that decision since Well Lead accepted CJ Medical’s contention that the method for using the device claimed set out in the Patent would amount to a treatment by surgery.
All the claims of the Patent are product claims. CJ Medical argued that the Patent nevertheless amounts to a patent for a method of treatment of the human body by way of surgery because the description sets out such a method. A surgeon carrying out that method would infringe the Patent.
Well Lead’s argument was simply that the application of s.4A(1) is confined to patents with method claims.
It was not established on the evidence that performing the method disclosed in the Patent would necessarily require the use of the device claimed. Even if it had been, I do not accept that the Patent falls within prohibition of s.4A(1)(a) of the 1977 Act and art.53(c) EPC. The words of art.53(c) reveal that the policy behind the provision is to prohibit only the patenting of certain kinds of methods, those identified. In my view there was no intent to place any restriction on the patenting of any sort of product. Although the expressly excluded products of art.53(c) are substances and compositions, they are stated to be exemplars.
With regard to CJ Medical’s point that a surgeon using the device of the Patent would infringe, it seems to me that the policy of art.53(c) is to accept such a possibility. For instance, a patent for a substance or composition suitable for use in a method of treatment of the human body by way of surgery would lead to exactly that result: a surgeon using the substance or composition in the course of the relevant treatment would infringe. However, it was apparently assumed by those who framed art.53(c), no doubt correctly, that any action for infringement would be directed against the party making or disposing of the product concerned, not the surgeon. This is to be contrasted with a claim for a method of treatment. In relation to such a claim it may be difficult to prove infringement by parties supplying a product used in the method, depending on the facts. The only clear infringer may be the surgeon.
I reject CJ Medical’s argument under s.4A(1)(a).
- Heading
- Judge Hacon
- The skilled person
- The expert witnesses
- Technical Background
- The Patent
- The claims
- Construction
- Claim 3 – a flexible, deflectable tip
- The prior art
- Soble and Russo
- The law on inventive step
- Inventive step over Soble
- Differences between claim 1 and Soble
- Sleeve v sheath
- No obturator in Soble
- A clamp in Soble instead of a flexible cap
- Conclusion on Soble and inventive step
- Wan
- Piercing stylus, obturator and trocar
- Inventive step of claim 1 over Wan
- Inventive step of claim 3 over Wan
- Added matter
- Method of treatment or diagnosis
- Infringement
- Normal construction
- Sizes 10-13 as equivalents
- Conclusions
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