T 0182/16 17-10-2019

Summary of Facts and Submissions

I. European patent No. 2 338 484 was granted with a set of twelve claims.

II. A notice of opposition was filed, objecting to the patent under Article 100(a), (b) and (c) EPC on the grounds that the claimed subject-matter lacked novelty and inventive step, was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art and extended beyond the content of the application as filed.

III. The patent proprietor's main request during the opposition proceedings was the rejection of the opposition. The patent proprietor also filed amended sets of claims as auxiliary requests.

IV. The documents cited in the opposition and appeal proceedings included the following:

D4: WO 2009/047 754 A2

D11: European Journal of Clinical Nutrition 56, 1242-1254 (2002)

D12: WO 2005/036 987 A1

V. The decision under appeal is the interlocutory decision of the opposition division, announced on 24 September 2015 and posted on 23 November 2015, rejecting the patent proprietor's main request and auxiliary requests 1 and 2 and finding that the patent as amended in the form of auxiliary request 3 filed on 24 September 2015 met the requirements of the EPC.

VI. Claim 1 of auxiliary request 3 deemed allowable by the opposition division reads as follows:

"1. A composition, said composition not being human milk, and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues for use in improving body composition, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass, and wherein the composition is an infant formula or growing up milk for toddlers."

VII. According to the decision under appeal:

(a) The subject-matter of the claims as granted (main request) and the claims of auxiliary requests 1 and 2, insofar as it related to reducing body fat and preventing obesity, was insufficiently disclosed (Article 83 EPC).

(b) Since the nutrition of a newborn had to be regarded as a therapeutic application, claim 1 of auxiliary request 3 related to a further medical use drafted in the claim format according to Article 54(5) EPC. As a consequence, the alleged technical effect had to be taken into account as a functional technical feature in the assessment of patentability. The claimed infant formula differed from any prior-art infant formula in the specified use of a composition enriched with sn-2 palmitic acid for improving body composition with regard to lean body mass and muscle mass and was therefore novel (Article 54 EPC).

(c) The subject-matter of auxiliary request 3 also involved an inventive step (Article 56 EPC).

VIII. The opponent and the patent proprietor each filed an appeal against this decision.

IX. In its statement setting out the grounds of appeal dated 16 March 2016, the opponent argued inter alia

(a) that infants and toddlers were not a patient group and the mere reference to infants did not imply a medical use (with reference to decision T 1278/12 of 28 April 2015, reasons 3.3.5),

(b) that the specified use "for use in improving body composition, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass"

related to the support of normal growth and was therefore non-therapeutic.

(c) Hence, claim 1 of auxiliary request 3 could not benefit from the legal fiction of Article 54(5) EPC, but simply defined a composition suitable for increasing lean body mass and/or muscle mass.

X. With its statement setting out the grounds of appeal dated 4 April 2016, the patent proprietor submitted three amended sets of claims as its new main request and auxiliary requests 1 and 2.

With its letter of reply (dated 2 August 2016) to the opponent's statement of grounds, the patent proprietor re-submitted the identical main request and auxiliary requests 1 and 2 and also filed two new sets of claims as auxiliary requests 3 and 4.

The wording of claim 1 of auxiliary request 2 was identical to that of claim 1 of former auxiliary request 3 deemed allowable by the opposition division.

XI. The board issued a summons to oral proceedings dated 12 June 2019.

In a communication annexed to the summons advising the parties of its preliminary opinion, the board observed inter alia that feeding an infant or toddler was not a therapeutic step and the purpose of "improving body composition" as defined in the claims covered non-therapeutic improvements in body composition. As a consequence, the claims presented by the patent proprietor could not be regarded as purpose-related product claims according to Article 54(5) EPC.

XII. In a letter dated 19 July 2019, the patent proprietor requested that the day for the oral proceedings, scheduled for 17 October 2019, be changed.

XIII. In a letter dated 9 August 2019, the board refused the patent proprietor's request to re-schedule.

XIV. With a letter dated 17 September 2019, the patent proprietor filed five new sets of amended claims as its main request and auxiliary requests 1 to 4. These requests involved a change of claim category as the independent claim of each request was directed to a "non-therapeutic method for improving body composition". On the condition that these requests were admitted into the proceedings, they were to replace the requests previously filed with the letter dated 2 August 2016.

XV. Oral proceedings before the board took place on 17 October 2019. During the oral proceedings the patent proprietor withdrew its requests of 17 September 2019 and filed further amended claim requests.

XVI. The parties' final requests were the following:

(a) The appellant - patent proprietor requested that the decision under appeal be set aside and that the patent be maintained in amended form on the basis of one of the following sets of claims:

- main request (filed as auxiliary request 2 on 17 October 2019)

- auxiliary request 1 (filed as auxiliary request 3 on 17 October 2019)

- auxiliary request 2 (filed as auxiliary request 4 on 17 October 2019)

- auxiliary request 3 (filed as auxiliary request 2 with the letter of 2 August 2016)

- auxiliary request 4 (filed as auxiliary request 3 with the letter of 2 August 2016)

- auxiliary request 5 (filed as auxiliary request 4 with the letter of 2 August 2016)

(b) The appellant - opponent requested that the decision under appeal be set aside and that the patent be revoked. Within the purview of this request, the opponent also requested that the main request and auxiliary requests 1, 2, 4 and 5 not be admitted into the proceedings.

XVII. Claim 1 of the main request reads as follows:

"1. A non-therapeutic method for improving body composition, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass, said method comprising administering to a human subject a composition, said composition not being human milk, and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues, and wherein the composition is an infant formula or growing up milk for toddlers."

Claim 1 of auxiliary request 1 reads as follows:

"1. A non-therapeutic method for improving body composition of a human subject when said human subject has an age above 5 years, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass, said method comprising administering to a human subject with an age between 0 and 36 months a composition, said composition not being human milk, and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues, and wherein the composition is an infant formula or growing up milk for toddlers."

Claim 1 of auxiliary request 2 reads as follows:

"1. A non-therapeutic method for improving body composition, the improvement of body composition being increased muscle mass, said method comprising administering to a human subject a composition that comprises lipid, said composition not being human milk, and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues, and wherein the composition is an infant formula or growing up milk for toddlers."

Claim 1 of auxiliary request 3 is identical to claim 1 of former auxiliary request 3 deemed allowable by the opposition division (see point VI above).

Claim 1 of auxiliary request 4 reads as follows:

"1. A composition, said composition not being human milk,

and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues for use in improving body composition of a human subject when said human subject has an age above 5 years, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass, and wherein the composition is an infant formula or growing up milk for toddlers and is fed to the human subject having an age between 0 and 36 months."

Claim 1 of auxiliary request 5 reads as follows:

"1. A composition, said composition not being human milk, and said composition comprising triglycerides comprising at least 10 wt.% of palmitic acid residues based on total fatty acid residues present in the triglycerides, and comprising at least 30 wt.% of the palmitic acid residues in the sn-2 position of the triglycerides based on total palmitic acid residues for use in improving body composition, the improvement of body composition being increased muscle mass, and wherein the composition is an infant formula or growing up milk for toddlers."

XVIII. The opponent's arguments may be summarised as follows:

Admission of the main request and auxiliary requests 1 and 2

These requests involved a change of claim category in comparison with earlier claim requests, in order to address the argument that the stated use of the claimed compositions did not qualify as therapeutic and could therefore limit the claimed scope only insofar as the claimed composition had to be suitable for said use.

Since this argument had been raised by the opponent as early as in the notice of opposition these requests - directed to a non-therapeutic method (or use) - should already have been filed during the proceedings at first instance, or at the latest, with the reply to the opponent's statement setting out the grounds of appeal.

With decision T 1278/12 of 28 April 2015, it had been established in EPO case law that enteral administration to an infant did not constitute a medical use. Both parties had been aware of that decision before they filed their appeals. The opponent had raised the issue once more in its statement setting out the grounds of appeal. Nevertheless, the patent proprietor had waited more than three years until one month before the oral proceedings to submit, for the first time in the course of the appeal proceedings, claim requests directed to a non-therapeutic method (namely the requests of 17 September 2019).

Since the board, in its written preliminary opinion of 12 June 2019, had simply agreed with the opponent's long-known argument, this could not be regarded as an unforeseeable procedural development justifying such a substantial change of the patent proprietor's case. Moreover, since oral proceedings had been scheduled to take place four months later, a delay of more than three months for filing new requests was not acceptable in any case. The opponent had only received the amended set of requests on 23 September 2019 and as a consequence had not had sufficient time to prepare its case. New issues were raised, such as whether the claimed method was indeed non-therapeutic, since it might well be argued that it inherently involved a prophylactic treatment against obesity (Article 53(c) EPC).

The pending main request and auxiliary requests 1 and 2 of 17 October 2019, likewise directed to a non-thera­peutic method, were modified versions of the corresponding requests of 17 September 2019 and had been filed even later, namely on the day of the oral proceedings before the board, and only after the board had rejected the requests of 17 September 2019.

It was incumbent on the patent proprietor to define its own framework of requests and not just to react little by little, and belatedly, to external pressures.

Novelty - auxiliary request 3

Claim 1 of auxiliary request 3 referred to a use of the claimed composition which was non-therapeutic. Hence, the wording in question ("for use in improving body composition, the improvement of body composition being selected from the group consisting of increased lean body mass and increased muscle mass") limited the scope of claim 1 only insofar as the composition had to be suitable for achieving an increase in lean body mass or muscle mass. This criterion was met by any composition supporting normal growth in infants.

The subject-matter of claim 1 of auxiliary request 3 therefore lacked novelty relative to the disclosure of, inter alia, each of documents D4, D11 and D12, all of which disclosed infant formula products with triglycerides enriched with sn-2 palmitic acid as defined in claim 1 (D4: example 2 and Table 6; D11: Table 3 and Table 5; D12: example 4).

Admission of auxiliary requests 4 and 5

Identical requests had not been put forward during the proceedings before the opposition division. No reason had been given why these requests could not have been filed during the proceedings at first instance. Moreover, the requests were not prima facie allowable; in particular, they could not overcome the objections regarding lack of novelty.

Novelty - auxiliary requests 4 and 5

The same arguments applied as in the case of auxiliary request 3.

XIX. The patent proprietor's arguments may be summarised as follows:

Admission of the main request and auxiliary requests 1 and 2

At the time of the proceedings at first instance, it had been the usual practice of EPO examination and opposition divisions to regard the administration of a composition to infants, who constituted a particularly vulnerable and fragile target group, as a medical use referred to in Article 53(c) EPC. For that reason, the patent proprietor's initial requests had been drafted as claims for a further medical use, in the format according to Article 54(5) EPC ("composition for use").

While the amendments made to the pending main request and auxiliary requests 1 and 2 involved a change of claim category, this could not have come as a surprise to the opponent and to the board in view of the board's provisional opinion. At an early stage of the appeal proceedings, namely in the letter of 2 August 2016, the patent proprietor had moreover indicated its willingness to redraft the "composition for use" claims as claims directed to a method for improving body composition, in line with claim 2 of former auxiliary request 9 on file during the proceedings at first instance, should the board consider that improving body composition as defined in the claims did not constitute therapy.

The patent proprietor had also assumed that the board would grant its request to re-schedule the oral proceedings. When that request had been refused, the patent proprietor had presented its new claim requests of 17 September 2019 directed to a non-therapeutic method.

The technical features to be considered in the amended requests of 17 October 2019 were exactly the same as in the corresponding requests of 2 August 2016 previously produced in accordance with Article 12(1) and (2) RPBA. Additional features taken from the description - which were included in the previous set of requests of 17 September 2019 - had been removed. Thus the new requests were straightforward in that there was no change in substance regarding the technical features and issues to be discussed, in comparison with the initially filed requests of 2 August 2016.

Novelty - auxiliary request 3

It was conceded that the combination of technical features defining the claimed composition was indeed disclosed in the cited passages of documents D4, D11 and D12.

However, the subject-matter of claim 1 differed from the prior-art disclosures in the feature "for use in improving body composition", in terms of lean body mass and muscle mass.

The definition of claim 1 did not cover the normal growth of an infant or toddler. Since the claim was drafted in the format according to Article 54(5) EPC, it was intrinsically restricted to therapeutic improvements, including those of a prophylactic nature, e.g. reducing the chance of developing obesity and associated secondary disorders. Also, the term "increased lean body mass" would be understood by a person skilled in the art to refer not to an absolute increase, but to a relative increase based on total body mass.

Thus, the use stated in claim 1 had to be taken into account in the assessment of novelty as a functional technical feature, and not only to the extent that the claimed composition was suitable for such a use.

Admission of auxiliary requests 4 and 5

Auxiliary request 4 was in line with former auxiliary request 6 presented before the opposition division. Claim 1 of auxiliary request 5 corresponded largely to claim 1 of auxiliary request 3, as only the effect of "increased lean body mass" had been deleted.

Novelty - auxiliary requests 4 and 5

In support of the novelty of the subject-matter of auxiliary requests 4 and 5, the same arguments applied as in the case of auxiliary request 3.