Key points
- Claim 1 reads: "A solution with an effective amount of treprostinil sodium for use in a method of reducing the occurrence of a blood stream infection in a human suffering from pulmonary arterial hypertension and being treated with tresprostinil, said solution being obtainable by a process comprising diluting a starting solution of treprostinil sodium with a buffer comprising glycine and having a pH of greater than 10."
- "The appellants [=opponents] essentially argued that the method of reducing the occurrence of a blood stream infection in a human referred to in claim 1, was not a method of treatment within the meaning of Article 53(c) EPC because the antibacterial effect of the glycine occurred outside of the human body."
- The opponents: " It was apparent from the disclosure of the patent that the antibacterial effect of the glycine solution occurred outside of the human body. There was no teaching that the solution exerts an in vivo antibacterial effect."
- "The Board does not concur with the positions expressed by the appellants. The glycine-containing treprostinil solution of claim 1 is administered to humans suffering from PAH. This administration results in a therapeutic effect on the humans, namely the prevention of blood stream infection ... The method incorporated in claim 1 is therefore of therapeutic nature in the sense of Article 53(c) EPC and limits the scope of the claim in accordance with Article 54(5) EPC."
- However, "the subject-matter of claim 1 of auxiliary request 1 lacks an inventive step"
- The Board: "It follows that it was known to the skilled person that the use of a glycine buffer at a pH greater than 10 would have an effect on reducing the gram negative bacteria and inhibiting the growth of gram positive bacteria, and hence, an effect on reducing the occurrence of a blood stream infection when injected in a pharmaceutical solution."
- "The subject-matter of claim 1 of auxiliary request 2 has been reformulated as a method claim, namely a "method of reducing the occurrence of a blood stream infection in a human suffering from pulmonary arterial hypertension and being treated with treprostinil, wherein said method reduces the gram negative bacteria and inhibits the growth of gram positive bacteria, the method comprising administering a solution comprising treprostinil sodium in a concentration between 0.001 mg/mL and 1 mg/mL...", which corresponds to the medical indication originally claimed in claim 1 of the main request.
- "Based on the Board's conclusion that claim 1 of the main request was a purpose limited product claim under Article 54(5) EPC, it must be concluded that the method claim of auxiliary request 3 falls under the exclusion from patentability under Article 53(c) EPC. The reduction of the occurrence of blood stream infection relates indeed clearly to a method for treatment of the human or animal body by therapy, which is excluded from patentability by Article 53(c) EPC."
- As to the CPA, "The respondent [patentee] contested the choice of D1 as the closest prior art. Nonetheless, it failed to indicate in due time a suitable alternative document to be used as the closest prior art."
- "The Board recalls that the claimed subject-matter must involve an inventive step vis-Ã -vis each document of the prior art. If the person skilled in the art has a priori the choice between several documents of the state of the art as reasonable starting points, the inventive step can indeed only be effectively recognized after having applied the problem-solution approach to each of the options (T 967/97, T 21/08). If one of the options highlights the obviousness, then there is no inventive step. The problem-solution approach may thus need to be repeated for each of said options considered by those skilled in the art as reasonable starting points (T 710/97)."
EPO T 2411/18 -
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/03/t-241118-medical.html
