For a patent to be valid the essential elements of an invention must be sufficiently disclosed. Is reference to a branded product with a structure and composition unknown to the public sufficient? The EPO appeals board recently considered it insufficient, as we discuss in this blog. (RADIOPHARMECEUTICAL PRODUCTS/GE Healthcare Ltd, T 0797/14, 13 July 2017).
The patent related to radioactive imaging agent in sealed containers. The stoppers, parts of the container in contact with the fluid, needed to be coated. The coating was described by reference to a known third-party commercial product, branded FlurotecTM.
Two oppositions were filed claiming that the patent failed to disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 100(b), EPC).
Opposition division decision
The EPO opposition division held that the patent was sufficiently disclosed. The evidence showed that FlurotecTM was known and available at the priority date and still available when the opposition was filed. It was held, that the skilled person would have no difficulty acquiring FlurotecTM and implementing the invention.
On appeal, the opponents argued that reliance on a branded product reduced the clarity of the claims and introduced a profound insufficiency. The fact that it was well known and widely available to a skilled person did not legitimise its use in the claims.
The precise formulation and method of production of FlurotecTM were not public knowledge. Therefore, the opponents argued that the sufficiency of the term was wholly reliant on a third party continuing to market FlurotecTM in its current form. It is after all well known that the formulations of branded products are changed from time-to-time (e.g. Heinz Beans). What would happen if the formulation of FlurotecTM were to be changed or its manufacture were to be ceased?
EPO appeals board decision
The appeals board dismissed the appeal finding that the stoppers, an essential element of the invention, were not sufficiently disclosed. The board accepted that the composition and method of the FlurotecTM product was not public knowledge. It noted that only the coating composition was disclosed in the claims.
The patentee did not (and presumably could not) provide any further information regarding the composition of FlurotecTM. The board held that the evidence provided by the third party, including commercial brochures and internet commercials, did not provide enough information for the skilled person to reliably determine the composition or structure of the product.
The board also accepted the opponents' argument that the availability of the branded product on the market did not mean that it had a stable and constant composition during that period. Availability was dependent on the manufacturer and demand.
There was no certainty that over the life of the patent the formulation of FlurotecTM might be changed, or manufacture ceased. In such circumstances the patent failed to disclose the sufficient information for it to be implemented.
It was therefore held to be insufficient and revoked.
At first glance this is a tough decision, as at the time of filing of the patent and at all times since, someone seeking to operate the patent would be able to acquire some FlurotecTM and operate the patent without difficulty, and there was no reason to anticipate that this would change. But things do change, and the fact that this might not always be the case was sufficient to render the patent invalid.
The lesson to learn from this decision is that if a branded product is needed in order to implement an invention not to refer in a patent to that branded product unless its precise formulation is known and can be reproduced. If that is not possible, the patentee will need to identify the key ingredient(s) that give the branded product the desired characteristics, and refer instead to those ingredient(s).
With thanks to trainee, Eleanor MacIntyre, co-author of this blog.