At a glance: In the present blog series a guide on patenting medical inventions is provided. Part 7 deals with treatments by therapy or therapeutic methods. The determination whether a treatment or a step is therapeutic must be based on correct and objective assessments.
The assessment of whether a certain procedure qualifies as a therapeutic step is based on specific criteria developed and evolved in case law over the years.
When trying to determine whether a method might be a therapeutic method and thus excluded from patent protection, it is important to apply the correct criteria to arrive at the right conclusion.
If you base your assessment on wrong assumptions, it might lead to the wrong conclusion and the claimed subject-matter might be excluded from patentability.
An objective determination of the nature of all involved method steps, is particularly important before drafting and filing a patent application for a medical invention including a possibly therapeutic step.
The following flowchart provides some guidance for assessing whether a medical invention is excluded from patentability. Each step of the flowchart will be discussed one by one in the present series of blog posts.
In one of the previous blog posts the distinction between surgical methods and therapeutic methods has been discussed (here). Therapeutic methods practised on the human or animal body are excluded from patent protection according to the German Patent Act (PatG) and the European Patent Convention (EPC)[1].
Just one therapeutic step suffices to qualify the method as a therapeutic method[2]. A therapeutic step may be any physical activity or action[3]. Consequently, a substantial physical intervention or health risk is not a prerequisite of a therapeutic step or method.
The term therapy as construed in view of the EPC includes treatments of diseases in general and curative treatments in the narrow sense[4]. Further, curative as well as prophylactic effects are covered by the term therapy or rather therapeutic effect[5].
Further, it is important to note that in general, the exclusion cannot be circumvented by claiming a method of treatment by therapy in form of a computer program (computer implemented invention, CII) which implements the very method of treatment by therapy[6], i.e., such CII does not fall under the exemption for medical products.
Claim 1 according to the main request read:
A method for determining airway pressure levels at which certain lung conditions of a lung ventilated by an artificial ventilator occur, comprising the steps of:
[…]
e) changing the airway pressure of the artificial ventilator, wherein from the observation of the resulting course of the plurality of calculated mean tracing values the airway pressure level at which alveolar opening or lung overdistension or lung open condition or alveolar closing occurs is automatically detected.
The applicant argued that the claimed method did not cure any particular disease and did therefore not qualify as therapy. Further, the applicant argued that the claimed method was only a “test phase”.
However, the Board of Appeal found that while the primary intention of the applicant was not to protect a method for treatment but a method for determining the relevant pressure levels, the presence of a single therapeutic or surgical step is sufficient to exclude the method from patentability. Here, the ventilation phase during which the claimed method is executed cannot be distinguished from the normal artificial ventilation applied to the patient. Further, the claimed method cannot be considered as a momentarily short change of the ventilation parameters without any influence on the ongoing therapy and according to the description of the specific embodiment the detection phase extends over several tens of breaths, so that this period of time is clearly not insignificant but part of the ongoing therapy time. Thus, there is a functional and indissociable link between the claimed method and any artificial ventilation practised on a connected patient. It is indisputable that artificial ventilation is a therapeutic method because it aims at keeping the patient alive.
Consequently, the method of claim 1 is a therapeutic method and excluded from patentability.
Using wrong assumptions and criteria for assessing a possible therapeutic method / step before filing an application might lead to the refusal of the respective method claims. Further, the claims and the description must be drafted such that no therapeutic step is explicitly or implicitly included.
Here you can download a summary of the above blog post for your quick review.
[1] Art. 53(c) sentence 1 EPC, § 2a Abs. 1 Nr. 2 sentence 1 PatG
[2] G 1/07, Reasons 3.2.5
[3] G 1/07, Reasons 3.2.5
[4] T 144/83; T 81/84; T 24/91; T 2420/13
[5] G 5/83; T 19/86; T 290/86; T 438/91; T 820/92; T 2071/15
[6] T 944/15