13 June 2022

T 1598/16 - Bacteriophage for acne treatment

Key points

  •  Claim 1 is directed to: 'A bacteriophage (1) capable of lysing a P. acnes bacterium and incapable of lysing any bacterium which is not P. acnes, and which is incapable of sustaining lysogeny in a bacterium, (2) wherein the bacteriophage has (i) a genome having overall sequence identity of at least 88% with the genome of the bacteriophage deposited under Accession No. NCIMB 41349" (a few alternative deposits follow). [bold text added]
  •  " Claim 1 is directed to a bacteriophage defined both by functional features, namely that it is "capable of lysing a P. acnes bacterium and incapable of lysing any bacterium which is not P. acnes, and which is incapable of sustaining lysogeny in a bacterium", and by reference to the accession numbers given to the bacteriophages as deposited with a recognised depositary institution under the Budapest treaty." 
  • " The bacteriophages according to the invention are capable of lysing a P. acnes bacterium, incapable of lysing any bacterium which is not P. acnes and incapable of sustaining lysogeny in a bacterium (paragraph [0023]). " 
  • "  The opposition division considered document D8 the closest prior art, and no other documents have been put forward in the appeal proceedings. The board agrees that document D8, a meeting abstract disclosing the use of bacteriophages for treatment of acne, is a suitable starting point for the discussion of inventive step. Although D8 does not disclose any particular bacteriophage, it teaches that "Unlike antibiotics, phage are specific for one species of bacteria" and furthermore states that they have isolated several strains of phage which kill subsets of the strain bank comprising a large number of strains of P. acnes and that they "are currently isolating mutants of these phages with exclusively lytic capabilities and broad spectrum of virulence". D8 thus identifies the functional features as claimed, namely species specificity with a broad spectrum of virulence and exclusively lytic capabilities (i.e. no lysogenic capability) as being desirable properties for bacteriophages to be used in the treatment of acne." 
  • " The difference between D8 and the subject-matter claimed in claim 1 is that specific bacteriophages, identified by reference to their deposit numbers or by structural features, are not provided in D8. The technical problem can thus be formulated as the provision of bacteriophages which possess the desired characteristics as listed in D8 and are therefore suitable for use in the prevention and treatment of acne. The solution consists of the bacteriophages as claimed, and the board is satisfied that the problem has been solved." 
  • "the board considers that the solution involves an inventive step because there is no teaching in the prior art rendering obvious the provision of the three claimed bacteriophages, which are not merely further bacteriophages as they do have properties that render them particularly suitable for the aim of the patent, namely prevention and treatment of acne" 
  • As a comment, this decision appears to illustrate that naturally occurring micro-organisms can very well be patented under the EPC. 
EPO T 1598/16
The link to the decision is provided after the jump.

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