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The Silent Treatment: The EPO’s Approach To Non-therapeutic Methods Encompassing Therapeutic Effects – Patent


Methods for treatment of the human or animal body by therapy (or
surgery) are excluded from patent protection at the EPO under
Article 53(c) EPC. The purpose of the exclusion is to avoid
restricting the activities of medical and veterinary practitioners.
In contrast, purely non-therapeutic methods of treatment, e.g.
purely cosmetic methods, are permitted.

On face value, the EPO’s approach seems clear and navigable.
However, in practice the waters are murkier. The “treatment by
therapy” exclusion of Article 53(c) EPC, often described as a
narrow exclusion, is applied quite broadly in practice.
Furthermore, certain method inventions can fall between the claim
formats permitted by the EPO, meaning that protection may not be
available without careful drafting at the outset.

“Therapeutic” treatments

As in most jurisdictions, the EPO considers that therapeutic
treatments include prophylactic treatments as well as curative
treatments (EPO Board of Appeal Decision T 19/86). Additionally,
the term “therapy” is considered to include not only
treatment of diseases, but also the alleviation of the general
symptoms of pain and suffering (T 144/83). The pain or suffering
need not actually result from a disease; methods of treating pain
or suffering are excluded even if the pain/suffering is caused by
natural circumstances such as age, pregnancy, menstruation,
atmospheric conditions (e.g. temperature), etc. (T 81/84).

In contrast, treating discomfort of normal and healthy
subjects might not be considered therapy. It is not immediately
clear where discomfort (treatment permitted) ends and suffering
(treatment excluded) begins. It is not sufficient to rely
solely on a distinction between treating healthy and unhealthy
subjects, since treatment of suffering caused by e.g. age or
pregnancy, even in healthy subjects, is excluded. The key
determining factor is whether the subjects are in, or are at risk
of developing, a pathological state in the absence of treatment. If
so, then the treatment is likely to be considered therapeutic
rather than merely the non-therapeutic alleviation of discomfort (T
385/09).

Hidden (encompassed) therapeutic methods

A commonly encountered situation is when a claim reciting a
non-therapeutic method nevertheless encompasses a
therapeutic method. The EPO is particularly rigorous in spotting
and objecting to such hidden therapeutic effects.

T 1635/09 provides a useful example. Methods of pharmaceutical
contraception are not considered by the EPO to be methods of
treatment by therapy because pregnancy is not a disease (see e.g. T
820/92 and T 74/93). In T 1635/09, the claims concerned uses of
oral dosage forms comprising low doses of certain
oestrogen compounds for contraception. Despite reciting
contraceptive uses, and being entirely silent on any therapeutic
treatment, the claim was deemed to fall foul of the Article 53(c)
exclusion. This was because the claim was still considered to
encompass an excluded therapeutic method within its scope.
Specifically, the application taught that the low doses of
oestrogen resulted in a reduction of harmful side-effects as
compared to higher oestrogen dosages. This reduction/ prevention of
harm was considered to be prophylactic therapy.

The risk of Article 53(c) objections on the basis of therapeutic
methods that are not recited in a claim, but are nevertheless
encompassed by it, is encountered frequently by cosmetic method
claims. Methods for purely cosmetic treatments are
straightforwardly patentable (see G1/07, affirming T 383/03).
However, many cosmetic methods inherently comprise a therapeutic
effect; positive superficial changes often go hand-in-hand with
genuine health improvements.

For instance, in the well-known case T 290/86, the claim at
issue was directed to a method of cleaning plaque and/or stains
from human teeth. Although this method was intended to be cosmetic
in nature, it was deemed to have the inevitable therapeutic effect
of preventing tooth decay, and was therefore refused.

In many major cosmetic areas, claims intended to be directed to
cosmetic methods risk encompassing therapeutic methods:
















Cosmetic area

Cosmetic Method

Example of therapeutic Method Potentially
Encompassed

Anti-ageing (and cosmetic UV protection)

Reduction of fine lines/ wrinkles

Prevention of UV-induced skin damage/ cancer

Hair / scalp treatment

Cosmetic prevention of hair loss

Treatment of alopecia

Oral care

Plaque removal

Prevention of tooth decay

Weight loss methods

Cosmetic weight loss

Treatment of obesity

Skincare

Cosmetic treatment of acne

Treatment of bacterial infection

Deodorant methods

Prevention / reduction of body odour

Prevention of microbial infection

Inseparable associations

It has become established EPO practice to ask the key question
of whether a claimed non-therapeutic (e.g. cosmetic) method can be
clearly distinguished from any therapeutic effects that happen to
result from that method. If so, then the claim will be deemed to
encompass only non-therapeutic methods, and so avoid the Article
53(c) exclusion. But if the non-therapeutic method is
“inseparably associated”, or “inextricably
linked”, with a therapeutic effect, then the method will fall
within the Article 53(c) exclusion.

The assessment of how tightly associated the non-therapeutic and
therapeutic aspects are will of course need to be determined by the
technical realities of the case in question. However, some useful
insights are available from case law.

In T 469/94, the claim at issue was directed to the application
of certain compounds to reduce the perception of fatigue in a
person about to participate in major exercise, or in a person
having completed major exercise. The claim recited that this was
achieved by the compound raising the person’s bloodstream
choline level. This is a non-therapeutic application; the
perception of fatigue is not a disease. However, the same steps
were known to lead to the therapeutic treatment of muscular
disease, muscular injury and epilepsy.

In this case, the Board considered the claimed non-therapeutic
method to be clearly distinguishable from the therapeutic effect
for two reasons. First, the recipients in either case would be
different since the non-therapeutic method would be performed on
healthy subjects, whereas the therapeutic effect would apply only
to those with a muscular disease, muscular injury or epilepsy.
Secondly, the two treatments would be effective over different
timeframes: minutes/hours for the non-therapeutic effect in
contrast to days for the therapeutic effect. The two effects were
therefore not considered to be inseparably associated, and
the claim was permitted.

T 385/09 (mentioned above) concerned a non-therapeutic
method of cooling cows in a milking stall in order to motivate the
cows to go there spontaneously; the desire to be made more
comfortable by cooling thereby leading to increased milking. The
method could also be used for the therapeutic treatment of a cow
suffering from overheating. The Board considered the two effects
were sufficiently separate given that they would be practiced on
different groups of animals, i.e. healthy cows vs. those suffering
from heat stress.

In T 1916/19, the claim at issue recited a
non-therapeutic method of providing an anti-microbial
effect to skin, the method comprising the steps of applying a
particular composition thereto. This resulted in the reduction of
unpleasant body odour, i.e. a cosmetic effect. The Examining
Division had refused the claim under Article 53(c) EPC because the
anti-microbial treatment was considered also to encompass
prevention of several diseases (e.g. microbial infection). On
Appeal, the Board disagreed, finding that removal of pathogenic
bacteria from healthy skin is not necessarily prophylactic
because a healthy individual is notlikely to develop a pathological
state merely because of the presence of such bacteria. As the Board
put it: “Not disinfecting one’s armpits or feet may have
unpleasant consequences, but will not, as such, lead to a
pathological condition”.

There is clearly some similarity between T 469/94, T 385/09 and
T 1619/19. The non-therapeutic methods in these cases concerned
application to healthy individuals, which is clearly not a
curative treatment (which requires an unhealthy patient as
a starting point). However, T 1916/19 teaches that consideration
also needs to be given to the likelihood of the healthy individual
developing a disease. If convincing arguments can be
presented that a healthy individual is unlikely to develop a
pathological condition without the claimed treatment, then it
follows that the treatment of that individual is also not
prophylactic in nature.

Precisely how unlikely the risk of developing a
pathological state needs to be to pass this test is not
well-established, and will most likely remain an issue to be
determined on a case-by-case basis. There are however some cosmetic
areas where the EPO’s position is staunch, and not favourable
to patentees. Methods comprising the application of UV sunscreen
agents to the skin, and methods of oral cleaning/ care, are almost
always objected to by the EPO for covering therapeutic methods,
even if the claimed method is intended to be cosmetic. The EPO
views methods involving the application of sunscreen to the skin to
be therapeutic due to the prophylactic effect against sunburn that
inherently and unavoidably occurs. Methods of oral cleaning/ care
are almost always considered therapeutic due to the resulting
effect on tooth decay, gum disease, etc.

T 2275/18 is an interesting exception. The claim at issue was
directed to a non-therapeutic method of applying to human skin a
“personal care composition” [comprising certain UV
sunscreen agents]. During Opposition, in line with the usual EPO
practice, it was found that the application of UV sunscreen agents
resulted in a prophylactic effect against UV induced skin damage.
Indeed, the application disclosed such therapeutic uses of the
compositions. However, the application also disclosed situations in
which application was not therapeutic; specifically when the
personal care composition was a shampoo, hair conditioner, shower
gel, or other product used indoors, absent UV exposure. On Appeal,
the Board considered that sunscreen agents are active only when
exposed to UV radiation, and in cases where no prevention against
sunburn is needed, e.g. in the context of shower gels, applying the
composition to the skin cannot be considered as a prophylactic
therapeutic treatment. Since it was possible to carry out the
method on human skin without preventing the likely development of a
pathological state, the non-therapeutic and therapeutic aspects of
the method were considered distinguishable and the non-therapeutic
method claim was permitted.

Claims relating solely to methods of tooth whitening/ bleaching
can be permitted (see e.g. T 2468/11). However, it must be the case
that the method steps do not also result in any cleaning of the
teeth or oral cavity. Claims encompassing the application of a
bleaching agent in a standard toothpaste, mouthwash, etc. is likely
to lead to the exclusion of the claim under Article 53(c) EPC,
particularly if the description mentions generally positive effects
of such compositions on oral health (see e.g. T 2664/17).

Practical advice

Applicants attempting to claim non-therapeutic methods that
encompass a therapeutic effect certainly start on the back foot at
the EPO. However, viable strategies for navigating the exclusion
are available, as demonstrated in the cases discussed above.

A useful approach is to explain to the Examiner that there are
specific situations in which the claimed method steps
could be used without resulting in any therapeutic effect.
Those situations might arise by treatment of a specific group of
subjects (e.g. healthy individuals), treatment at a particular
time, location, anatomical site, etc. Markedly different timeframes
for non-therapeutic and therapeutic effects might also help to
illustrate that purely non-therapeutic scenarios exist. It is not
usually necessary to recite the specifics of the non-therapeutic
situations in the claim itself; it is usually sufficient just to
demonstrate that those situations do exist in reality, and are
clearly separate from situations where a therapeutic effect
results.

In this approach, if presenting situations based on the
treatment of healthy subjects as not yielding a therapeutic result,
it is also important to demonstrate convincingly that those
subjects are unlikely to develop a pathological condition without
the treatment.

It is worth remembering that under EPO practice, the claims are
interpreted in light of the description. Since disclosure of
therapeutic benefits in the description could undermine arguments
that a claimed method has only non-therapeutic effects (see e.g. T
1635/09, above), omission of such disclosures is worth considering.
Of course, this would not necessarily prevent therapeutic effects
from being identified by the EPO or third parties.

It is important to note how disclaimers should
be used in these claims. Applicants often try to present a claim
reciting that the claimed method is “non-therapeutic”.
The rationale is that if the claim expressly recites “A
non-therapeutic method…”, or “A non-therapeutic
cosmetic method…”, then it cannot be interpreted as being
directed to an excluded therapeutic method. Indeed, in many cases,
such a disclaimer is essential: if the method steps could
result in therapeutic effects in some scenarios, then it is
important to limit the claimed subject-matter to the
non-therapeutic methods. Such a disclaimer was essential in cases T
2275/18, T 1916/19 and T 385/09 above, and many others.

However, a “non-therapeutic” disclaimer might often be
necessary, but it is not sufficient, for avoiding the
objection in all cases. The presence of the disclaimer does not
achieve the desired limitation to a non-therapeutic use if, as a
matter of fact in practice, the non-therapeutic use is
still inseparable from one or more therapeutic effects. This was
demonstrated in T1635/09 (above), in which the contraceptive effect
was deemed to be inseparably associated with the therapeutic
reduction of harmful side-effects, and the presence of a
“non-therapeutic” disclaimer in the claim did not
overcome the objection. Likewise in T780/89, a claim to the use of
certain compounds for “non-therapeutic immunostimulation”
of non-human animals could not prevail because the administration
of the compounds still actually led to the health benefits of
immunostimulation. It was made clear by the Board in T 1077/93 that
if the therapeutic and non-therapeutic aspects are indivisible,
then the exclusion cannot be avoided by a purely formal rewording
of the claim.

Under EPO practice it is possible to add such a disclaimer to a
claim, even if the disclaimer is not disclosed in the application
as filed. However, it is important to do so cautiously and with
professional advice from a European attorney, because disclaiming
too much or too little subject-matter could be fatal for the
validity of the claim in post-grant proceedings.

Alternative claim formats are not always available

As mentioned, if a claimed non-therapeutic method is deemed to
be inseparably associated with a therapeutic effect, then the
method will fall within the exclusion of Article 53(c) EPC. In that
scenario, an applicant can attempt to change the claim format to
rescue some patentable subject-matter. Article 53 EPC states:

European patents shall not be granted in respect of: […]

(c) methods for treatment of the human or animal body by surgery
or therapy and diagnostic methods practised on the human or animal
body; this provision shall not apply to products, in particular
substances or compositions, for use in any of these
methods.

Therefore, purpose limited product claims are patentable when
the recited purpose is the use in a method which, if presented as a
method claim, would be excluded from patentability. So, if a claim
is deemed to encompass a therapeutic method, it can be re-cast in
the following use-limited product claim format:

Substance X [or composition comprising X] for use in a method of
treating Y.

This format provides for a therapeutic use-limited claim,
whereas the original intention of the method claim was to protect
non-therapeutic uses. This is clearly not ideal, but at least some
claim scope has been salvaged.

Unfortunately, at this point some cases fall into a trap, which
arises from the EPO’s established practice of requiring the
“method of treating Y” in the above therapeutic
use-limited product claim format to be a defined, real treatment of
a pathological condition (see e.g. T 241/95). Claims intended to cover
non-therapeutic methods are, quite naturally, often worded such
that they do not refer to a pathological condition. As a result,
when re-cast into this use-limited product claim format, the
recited use is not considered to be the defined, real treatment of
a pathological condition. In this event, such claims are then
objected to as being improperly formatted, and so are interpreted
as being directed to the substance/composition per
se
, often with associated prior art problems.

As an example, consider the claim:

A non-therapeutic method of reducing wrinkles on the skin of
a subject, the method comprising applying UVA-blocking agent X to
the skin.

This claim would most likely be excluded by Article 53(c) EPC
for encompassing inseparable methods of treatment by therapy, e.g.
prophylaxis of skin cancer. Re-casting the claim into the purpose
limited product claim format above would lead a claim such as:

UVA-blocking agent X for use in a method of reducing
wrinkles on the skin of a subject, wherein the method comprises
applying the UVA-blocking agent X to the skin.

Reducing wrinkles on the skin of a subject is not a defined,
real treatment of a pathological condition. This claim would
therefore be deemed improperly formatted, and so directed to
UVA-blocking agent X per se.

In this way, applicants can be trapped with neither the
non-therapeutic method claim, nor the therapeutic use-limited
product claim format, being achievable.

The applicant could try to present a claim in the therapeutic
use-limited product format specifying the treatment as the
prevention of skin cancer, UV-induced skin damage, or another
pathological condition. However, given the EPO’s strict
requirement for all claim amendments to find basis in the
application as filed (Article 123(2) EPC), this is only an option
if the application was drafted to include a disclosure of such
treatments.

For these reasons, particular care needs to be taken when
drafting applications to non-therapeutic methods that encompass
therapeutic effects. Decisions need to be taken at that stage
whether or not to include disclosures of therapeutic effects/
methods. On the one hand, such disclosures could undermine
arguments on the separable nature of the non-therapeutic method,
but on the other they could provide basis for a fall-back
therapeutic use-limited claim format. It is possible to include
both non-therapeutic method claims and therapeutic
use-limited product claims in the same claim set, provided that the
above-discussed requirements for both claim categories are met.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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