Is a Medical Device a “Substance or Composition” Within the Meaning of Article 54(5) EPC

Is a Medical Device a “Substance or Composition” Within the Meaning of Article 54(5) EPC

In the medical field, patents routinely are directed to new compounds, compositions and medicines. In Europe, unlike U.S., there are limitations on what can be protected. Specifically, under European law, while medicines/compositions/devices can be patented, methods of treatment of the human body are excluded from patentability.

However, the exclusion can be circumvented by directing the claims of a patent application to the use of a particular “substance or composition” in a method of treatment. In this way, a new drug for use in the treatment of an ailment could be patentable.

As to new uses for known medicines, it is also possible to obtain patent protection in Europe. In Article 54(4) and (5) EPC it is respectively stated that Article 54(2) EPC: “shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.”

There is, however, currently a disconnect between the patentability of a known substance/composition versus a known medical device used in a new method of treatment. While current law makes it possible to protect a medicine when used in a new method of treatment, those same provisions may not apply to medical devices.

Most recently, Boards Of Appeal Of the European Patent Office (BAEPO), took up this disconnect in the case of EP1852136 “Use of a dialysis membrane for preparing a haemodialysis unit for reducing blood free light chain concentration.”

More particularly, the question was before the BAEPO was establishing “whether the claimed membrane should be considered a “substance or composition” within the meaning of Article 54(5) EPC.

The Board came to the conclusion that the scope of the term “substance or composition” in Article 54(5) EPC does not extend to all products for a specific use in a method referred to in Article 53(c) EPC. And as such the claims were held to be unpatentable.

Of note is the Board’s statement that, the claimed dialysis membrane does not contain any further substance or composition which may constitute an “active” ingredient according to decision T 2003/08, leaving the door open for consideration of devices which may include an active ingredient providing a specific therapeutic effect where the device simply served as a carrier for this active ingredient.