T 0434/15 - Stem cell harvesting from blood

Key points

• This opposition appeal is about a method "to obtain progenitor and/or stem cells" from a patient, the method comprising a step of "harvesting said progenitor and/or stem cells". The Board concludes that the claim is directed to a surgical method because of this step, in view of G1/07.
• The Board first explains that "[a]pheresis is a method in which blood is removed from a person, passed through an apparatus for separating and collecting a particular constituent of the blood (in the present case, stem/progenitor cells) and re-transfused without the collected constituent."
• The Board concludes (based on a document D18) that "[apheresis] has to be carried out with extreme care to avoid damage to the remaining blood and to the stem/progenitor cells that are removed for further use."
• "Consequently, apheresis is a substantial physical intervention involving considerable health risks."
• The patentee had submitted a declaration of an expert stating that he worked in a hospital that "performed about 200 apheresis sessions a year. It was the second largest centre in the UK performing adult stem cell transplantation.".
• The Board: "the fact that a certain method is routine for a highly specialised centre cannot automatically lead to the conclusion that such a method would generally be a safe and routine technique."
• The Board concludes that "[t]here are considerable health risks involved. Furthermore, apheresis cannot be considered to be a generally safe, simple, routine procedure. Consequently, apheresis has to be seen as a method of surgery within the meaning of Article 53(c) EPC."

EPO T 0434/15 (Plerixafor ) - link

III. Independent claims 1 and 9 of the patent as granted read as follows:

"1. A method to obtain progenitor and/or stem cells from a subject, which method comprises
(a) administering to said subject an amount of a compound sufficient to mobilize said progenitor and/or stem cells into the peripheral blood of said subject, followed by
(b) harvesting said progenitor and/or stem cells,
wherein said compound is 1,1'-[1,4-phenylene-bis-(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane or a pharmaceutically acceptable salt or metal complex thereof."

 Reasons for the Decision

4.2 Methods for treatment by surgery (Article 53(c) EPC)

4.2.1 The following reasoning applies to methods according to claims 1 and 6, i.e. methods in which the progenitor/stem cells are harvested by apheresis.

4.2.2 Decision G 1/07 of the Enlarged Board of Appeal (see OJ EPO 2011, 134) has established a certain direction for the consideration of whether certain method steps are to be considered as methods of treatment of the human body by surgery. The exclusion of such methods from patentability should be justified on grounds of public health, the protection of patients and the freedom of the medical profession to apply the treatment of choice to its patients (see G 1/07, reasons, point 3.4.2.4, third paragraph).

4.2.3 The issue of protection of patients is tied to the health risk linked to the method under consideration.

Apheresis is a method in which blood is removed from a person, passed through an apparatus for separating and collecting a particular constituent of the blood (in the present case, stem/progenitor cells) and re-transfused without the collected constituent.

For the steps of removing and returning blood, cannulas are inserted into the person's veins. Depending on the vein chosen, different flow rates may be expected (see document (18), points 11 and 15). During the treatment, changes in blood volume occur (document (18), point 14), which might necessitate fluid replacement to keep the correct intravascular volume. The types of fluid used for replacement and the side effects/risks linked to this selection have not been discussed. The removed blood undergoes a separation step in the apheresis machine, where the stem/progenitor cells are removed. The method of apheresis thus includes a step in which blood, an important organ of the human body, is manipulated. The stem/progenitor cells which are removed play an important role in haematopoiesis. According to document (18), point 5, all mature blood cells such as leucocytes, erythrocytes and thrombocytes, i.e. cells that are indispensable for oxygen transport, immune response and injury management, are formed from these stem/progenitor cells. Apheresis thus has to be carried out with extreme care to avoid damage to the remaining blood and to the stem/progenitor cells that are removed for further use.

In addition to the health risks linked to the steps of removing and returning blood and any necessary fluid replacement, there are health risks linked to the handling of the manipulated blood, which is immediately returned to the person, and to the handling of the cells that are removed. Consequently, apheresis is a substantial physical intervention involving considerable health risks.

4.2.4 The patent proprietor has pointed to reasons 3.4.2.2 of G 1/07. In paragraph 5 of this point of the reasons, the Enlarged Board of Appeal states that excluding from patentability also such methods as make use of in principle safe routine techniques, even when of invasive nature, appears to go beyond the purpose of the exclusion of treatments by surgery from patentability in the interest of public health.

In his declaration (document (18)), Prof. Craddock claimed that he had the responsibility for the treatment and management of patients with haematological malignancies. He further pointed to the fact that he himself was not involved in the actual processes necessary to carry out the apheresis. These process steps were carried out by nursing staff (point 13). The Queen Elizabeth Hospital, where Prof. Craddock was based, performed about 200 apheresis sessions a year. It was the second largest centre in the UK performing adult stem cell transplantation.

However, the fact that a certain method is routine for a highly specialised centre cannot automatically lead to the conclusion that such a method would generally be a safe and routine technique.

4.2.5 Apheresis is thus a method using invasive techniques that allow for extra corporeal manipulation of an organ of the human body. There are considerable health risks involved. Furthermore, apheresis cannot be considered to be a generally safe, simple, routine procedure. Consequently, apheresis has to be seen as a method of surgery within the meaning of Article 53(c) EPC.

4.2.6 Having come to the conclusion that the step of harvesting, when carried out by apheresis, includes a method of surgery, it is not necessary to assess whether or not the claimed method is a method of therapy.

4.2.7 The subject-matter of claim 1 of auxiliary request 1 encompasses a method for treatment of the human body by surgery and is thus not allowable (Article 53(c) EPC).

5. Thus, neither the main request nor auxiliary request 1 meets the requirements of the EPC. Consequently, the patent is to be revoked.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.