T 1057/22 - Fish oil and fruit juice for the treatment of cancer

Key points

•  Claim 1 is a second medical use claim and reads: "A composition comprising a combination of fish oil and juice [e.g. apple juice, claim 6] in an oil-in-water emulsion, for the use in treatment of cancer,
  wherein said fish oil is selected from fish oil having a totox value below 20 and omega-3 content above 10% by weight based on the total weight of the fish oil and wherein a suitable emulsifier is used to stabilize the emulsion,
  wherein the cancer types treated are selected from the group consisting of pancreatic cancer and neurological cancer."
• The Board, on sufficiency: " Decision T 609/02 was quoted in G 2/21 (see Reasons 75) and several other decisions of the boards. For therapeutic use claims, the boards have derived from T 609/02 the principle that for Article 83 EPC to be complied with, the suitability for the claimed therapeutic use, unless already known to the skilled person at the priority date, must be disclosed by the application (see T 609/02, Reasons 9 and the Case Law of the Boards of Appeal, 10th ed. II.C.7.2.1)."
• "it can be taken from example 4  [of the patent] that an increased apoptosis of pancreatic cancer cells by natural killer (NK) cells is achieved by Nutrifriend 2000 (a composition falling within the scope of claim 1) compared with the control and with the administration of the omega-3 fatty acid docosahexaenoic acid (DHA) alone (see Table 1 of the patent). However, Table 1 also shows that the omega-3 fatty acid DHA alone, which is a crucial ingredient of fish oil, leads to a slight increase in apoptosis of pancreatic cancer cells by NK cells. Under these circumstances, it is credible from the information given in the application as filed that also the claimed combination of fish oil and juice leads to the claimed therapeutic effects (see G 2/21, Reasons 74)."
• Example 4 is an in vitro example (https://patents.google.com/patent/EP2991507A1/) based on the co-culture of tumour cells with NK cells in the presence of the composition. 
• I'm no technical expert in the field, but perhaps the decision could have benefitted from a bit more explanation for the general audience as to how this in vitro example makes the therapeutic effect (sufficiently) credible.
• As Example 4 itself states: "Patients with pancreatic cancer have poor prognosis attributed to high potential for metastatic spread, protection by dense mesenchymal and inflammatory cell environment, and immune suppression with deactivation of natural killer (NK) cells by tumor cells." 
• "The therapeutic effect in connection with pancreatic cancer cells is further supported by evidence D27 [a declaration with evidence], which shows that fish oil alone (Denomega, the same fish oil as used in Nutrifriend 1100) and a combination of fish oil (Denomega) and a juice lead to a slight suppression of cell proliferation of pancreatic cancer cells, whereas a composition falling within claim 1 (Nutrifriend 1100) shows a significant suppression of pancreatic cancer cell proliferation. Evidence D27 filed after the filing date of the patent merely supplements the information provided in the application as filed (see example 4). D27 is not necessary to consider credible the claimed therapeutic effects (see G 2/21, Reasons 77), it only supports that conclusion."
• I'm puzzled as to why the Board refers to D27, given G 2/21 r.77. If the therapeutic effect is credible, Article 83 is met. Otherwise, it is not. Post-published evidence plays no role: "A lack in this respect cannot be remedied by post-published evidence". (G2/21, r.77)

EPO 

The link to the decision and an extract of it can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t221057eu1

3.2.7 The therapeutic effect in connection with pancreatic cancer cells is further supported by evidence D27, which shows that fish oil alone (Denomega, the same fish oil as used in Nutrifriend 1100) and a combination of fish oil (Denomega) and a juice lead to a slight suppression of cell proliferation of pancreatic cancer cells, whereas a composition falling within claim 1 (Nutrifriend 1100) shows a significant suppression of pancreatic cancer cell proliferation. Evidence D27 filed after the filing date of the patent merely supplements the information provided in the application as filed (see example 4). D27 is not necessary to consider credible the claimed therapeutic effects (see G 2/21, Reasons 77), it only supports that conclusion.