T 2071/15 - Restoring pH is medical

Key points

• Claim 1 is directed to the use of a dental care product " for the purpose of restoring pH in the mouth, from a lower pH to neutral pH". The Board finds that this use excluded under Article 53(c).
• " The Board [] concludes that the activity carried out and/or the effect achieved in the course of the claimed use is the inhibition of growth of oral bacteria. [] It remains to be assessed whether this activity underlies a therapeutic effect in terms of the prevention or treatment of a disease." 
• "The product's capacity of preventing acid formation achieves the therapeutic effect of preventing [...] caries and tooth erosion. This capacity being the direct result of the product's activity of inhibiting the growth of oral bacteria [], it follows therefrom that this activity is inherently therapeutic, i.e. it underlies the therapeutic effect of preventing the aforementioned diseases."
• The Board concludes that " the use of claim 1 is based on the therapeutic mechanism of action of inhibition of growth of oral bacteria, and therefore constitutes a method of treatment of the human or animal body by therapy which is excluded from patentability under Article 53(c) EPC."

EPO T 2071/15 - link

2. Article 53(c) EPC - claim 1

2.1 Claim 1 is directed to the use of a dental care product comprising

(i) zinc ions in a certain amount, and
(ii) lactoperoxidase
for the purpose of restoring pH in the mouth, from a lower pH to neutral pH.

2.2 The opposition division held in point 4 of the reasons for its decision that claim 1 encompassed non-patentable subject-matter by virtue of Article 53(c) EPC in that it covered inter alia the prophylaxis of a medical condition such as caries. In this context the opposition division also observed that the cosmetic and pharmaceutical uses falling within the scope of this claim were inextricably linked by the underlying therapeutic mechanism of action of inhibition of oral bacteria.

2.3 In their statement setting out the grounds of appeal the appellants disputed the opposition division's negative finding on patentability under Article 53(c) EPC. In their view, the use of claim 1 simply related to the beneficial effect of zinc ions and lactoperoxidase in the environment of the mouth which did not involve any therapeutic method pursuant to Article 53(c) EPC.

2.4 Therefore, it needs to be assessed in the present case whether the claimed use constitutes a therapeutic method in accordance with Article 53(c) EPC. In this regard, the activities carried out and/or the effects achieved in the course of that use need to be determined (T 1635/09; OJ EPO 2011, 542; catchword 2).

2.4.1 Paragraph 0006 of the description of the patent in suit teaches that the dental care product of the invention inhibits oral bacteria occurring in plaque. These bacteria normally cause decay of food products, leading to the formation of acids which render the pH in the mouth acidic (see paragraph 0002 of the description of the patent in suit). Hence, by inhibiting these bacteria, the dental care product causes the pH of the saliva to become less acidic which, in turn, reduces the restoration time of the pH in the mouth (see paragraph 0006 of the description of the patent in suit as well as the experimental data contained in D1 to D4).

The Board therefore concludes that the activity carried out and/or the effect achieved in the course of the claimed use is the inhibition of growth of oral bacteria.

2.4.2 It remains to be assessed whether this activity underlies a therapeutic effect in terms of the prevention or treatment of a disease.

As already outlined in point 3.5 of its communication, the Board observes that paragraph 0001 of the description of the patent in suit defines the invention as relating to the use of a dental care product which has an improved capacity of preventing acid formation, e.g. in saliva, thereby preventing caries, tooth erosion and other affectations of the mouth caused by acidity. Hence, the product's capacity of preventing acid formation achieves the therapeutic effect of preventing the aforementioned diseases in the oral cavity including caries and tooth erosion. This capacity being the direct result of the product's activity of inhibiting the growth of oral bacteria (see point 2.4.1 above), it follows therefrom that this activity is inherently therapeutic, i.e. it underlies the therapeutic effect of preventing the aforementioned diseases.

2.4.3 The appellants did not submit any further written or oral arguments in response to the objections raised by the Board in its communication under Article 53(c) EPC.

2.4.4 Accordingly, the Board maintains its opinion expressed in its communication that the use of claim 1 is based on the therapeutic mechanism of action of inhibition of growth of oral bacteria, and therefore constitutes a method of treatment of the human or animal body by therapy which is excluded from patentability under Article 53(c) EPC.

Consequently, the main request is not allowable under Article 53(c) EPC.