Key points
- Claim 1 is directed to: ""1. A formulation comprising an exendin or exendin analog agonist, a biocompatible polymer and a sugar for use in a method of treating diabetes in a human, wherein said method comprises: (a) administering the formulation to the human once weekly; and (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of the exendin or exendin analog agonist of about 170 pg/ml to about 600 pg/ml for at least 1 month."
- Dependent claim 4 as granted recites: "A formulation for use according to any one of claims 1 to 3, wherein the exendin or exendin analog agonist is exendin-4."
- The patentee amends claim 1 in the main request to recite exendin-4.
- The Board: "The amendment of part (b) in claim 1 of the main request and auxiliary request 1 now "only" requires the sustained minimum plasma concentration of exendin-4 to be within the range of about 170 pg/ml to about 350 pg/ml. Thus, the amended claim defines only the range of the sustained minimum plasma concentration of exendin-4 alone, not that of all exendins comprised in the administered formulation. Accordingly, the claims now entail embodiments which were not within the scope of protection conferred by claim 1 or any other claim of the granted patent."
- As a supporting argument of the Board: " when reading the "comprising"-language of claim 1 [as granted], the skilled person would indeed also consider the presence of multiple exendins in the formulation. This implies that the total amount of all exendins or exendin analogue agonists, and not just the amount of exendin-4, administered with the formulation should result in the stated sustained minimum plasma concentration of about 170 pg/ml to about 350 pg/ml "
- T1360/11, headnote, frequently cited but not in the present decision, provided that “Where a granted claim directed to a composition defined in an open manner and including the presence of a component belonging to a class or list of compounds in a quantity defined by a range is later amended by limiting the definition of the class or list of compounds, a possible infringement of the requirements of Article 123(3) EPC may be avoided by including in the amended claim a quantitative condition on the limited class or list of compounds and an additional constraint on the total amount of compounds belonging to the broader class or list” (further referring to older decisions).
- The subclass-trap is not really a trap, of course, the patentee just needs to formulate the claims appropriately, assuming that there is basis under Art. 123(2) for the appropriate claim (using the "additional constraint")
- In the present case, patentee was still trapped: "Auxiliary requests 2 to 7 were filed by the appellants in response to the board's preliminary opinion (see section VIII.) provided in the communication under Article 15(1) RPBA. The requests constitute an amendment to the appellants' case to which Article 13(2) RPBA 2020 applies." The requests were not admitted.
- As a comment, I don't see claim 4 as granted separately argued in the decision. I'm not sure if patentee tried a restriction to claim 4 as granted verbatim with additionally a narrower range recited.
Main request and auxiliary request 1 - Claim 1
Extension of scope of protection - Article 123(3) EPC
2. Claim 1 of the patent as granted referred to "[a] formulation comprising an exendin or exendin analog agonist [...] (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of the exendin or exendin analog agonist of about 170 pg/ml to about 600 pg/ml for at least 1 month" (underling added by the board).
Dependent claim 4 limited the exendin or exendin analogue agonist to exendin 4.
3. Claim 1 of the main request refers to "[a] formulation comprising [deleted: an exendin ][deleted: or][deleted: exendin analog agonist] exendin-4 [...] (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of [deleted: the exendin or exendin analog agonist] exendin-4 of about 170 pg/ml to about [deleted: 600]350 pg/ml for at least 1 month" (amendments highlighted by the board).
Claim 1 of the auxiliary request 1 refers to "[a] formulation comprising microparticles containing [deleted: an exendin ][deleted: or][deleted: exendin analog agonist] exendin-4 [...] (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of [deleted: the exendin ][deleted: or][deleted: exendin analog agonist] exendin-4 of about 170 pg/ml to about [deleted: 600]350 pg/ml for at least 1 month" (amendments highlighted by the board).
4. The board notes that the articles "an" and "the" used in claims 1 and 4 of the patent as granted are no longer part of the claim wording (compare points 2. and 3. above). Moreover, the expression "comprising" used in claim 1 of the patent as granted to define the claimed formulation comprising an exendin or exendin analogue agonist, a biocompatible polymer and a sugar allows additional exendins to be co-administered as part of the formulation.
5. The amendment of part (b) in claim 1 of the main request and auxiliary request 1 now "only" requires the sustained minimum plasma concentration of exendin-4 to be within the range of about 170 pg/ml to about
350 pg/ml. Thus, the amended claim defines only the range of the sustained minimum plasma concentration of exendin-4 alone, not that of all exendins comprised in the administered formulation.
Accordingly, the claims now entail embodiments which were not within the scope of protection conferred by claim 1 or any other claim of the granted patent.
6. The appellants argued that due to the use of "an" and "the" exendin analogue agonist in claim 1 of the patent as granted, the word "exendin" was exclusively used in the singular. The formulation thus comprised only a single type of exendin. Hence, the minimum plasma concentration of the exendin or exendin analogue agonist measured in step (b) could only be the result of the administration of this specific exendin-4 when taking into consideration claim 4 of the patent as granted. None of exendin-3 or exendin analogue agonists, which were listed in paragraph [0037] of the patent as "additional embodiments", was claimed.
7. As observed by the appellants and in line with established case law (see Case Law of the Boards of Appeal 9th edition, 2019 (CLBA), II.A.6.3.4, paragraph 3), a discrepancy between the claims and the description is not a valid reason for ignoring the literal content of a claim and interpreting it differently. The description cannot be used to give a different and narrower meaning to a claim which in itself imparted a clear, credible, technical teaching.
8. However, the term "exendin analog agonist" is not a scientific term directly known to the skilled person. To assess its correct meaning, the skilled person had to consult the description (see CLBA II.A.6.3.1.).
9. The appellant referred to paragraphs in the description, such as [0016], [0023], [0026] to [0032], [0039] and [0040], which mention that "preferably" or "in one embodiment" the exendin or exendin analogue agonist is exendin-4. This is in line with the subject-matter of claim 4 of the patent as granted, which is also restricted to exendin 4.
10. However, paragraph [0037] mentions that "[a]dditional embodiments provide that the exendin or exendin analog agonist is one or more of exendin-3, exendin-4 or an exendin analog agonist. In some embodiments, the exendin or exendin analog agonist is not exendin-3 or exendin-4".
Thus, when reading the "comprising"-language of claim 1, the skilled person would indeed also consider the presence of multiple exendins in the formulation.
This implies that the total amount of all exendins or exendin analogue agonists, and not just the amount of exendin-4, administered with the formulation should result in the stated sustained minimum plasma concentration of about 170 pg/ml to about 350 pg/ml (see part b) of claim 1 of the main request and auxiliary request 1).
11. The board therefore concludes that the amendments to claim 1 of the main request extend the scope of protection conferred by the patent and are not allowable under Article 123(3) EPC.
12. This applies mutatis mutandis to claim 1 of auxiliary request 1, which also refers to exendin-4.
Auxiliary requests 2 to 7 - Admittance into the proceedings (Article 13(2) RPBA 2020)
13. Auxiliary requests 2 to 7 were filed by the appellants in response to the board's preliminary opinion (see section VIII.) provided in the communication under Article 15(1) RPBA. The requests constitute an amendment to the appellants' case to which Article 13(2) RPBA 2020 applies.
14. The circumstance of two amendments in the sets of claims of these requests are of relevance for the admittance of these auxiliary requests.
15. First, the board agrees with the respondents that the objection under Article 123(3) EPC concerning the replacement of the wording "exendin-4" with "exendins or exendin analog agonists" in feature (b) of claim 1 of auxiliary requests 2 to 5 (compared to the sets of claims as filed with the statement of grounds of appeal, see sections IV. and XII.) had been raised by respondents I and VI in their respective replies to the statement of grounds of appeal (see section V.) when addressing the main request and auxiliary requests 1 to 3 (versions as filed with the statement of grounds of appeal; see section IV.).
16. Second, the board equally concurs with the respondents that arguments as to the lack of clarity of the feature "mean plasma level within the range of 170 to 290 pg/ml" as now featuring in part (b) of claim 1 of auxiliary requests 6 and 7 had been submitted by respondents I and VI in their respective replies to the appeal (see section V.) when addressing claim 1 of auxiliary request 3 filed with the statement of grounds of appeal (see section IV.).
17. An important aim of Articles 12 and 13 RPBA 2020 is that the parties' submissions are concentrated at the earliest possible stage of the proceedings so that the case is as complete as possible when the examination starts. Therefore, amendments to a party's case are to be filed at the earliest possible moment in the appeal proceedings. Article 13(2) RPBA 2020 applies to amendments to a party's appeal case made after notification of a summons to oral proceedings: such amendments "shall, in principle, not be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned."
17.1 This provision has two implications. It requires the party to a) explain what the "exceptional circumstances" are and b) provide cogent reasons both for the content and the timing of the amendment, i.e. why the amendment represents a justified response to the circumstances and why it was not possible to file the amendment earlier.
17.2 Auxiliary requests 2 to 7 were filed on 27 October 2020 (see section X.) after the parties had been summoned to oral proceedings (see section VIII.) and after the board had provided its preliminary opinion in a communication under Article 15(1) RPBA (see section IX.).
The appellants argued that the amendments in each of these auxiliary requests addressed issues under Articles 84 and 123(3) EPC which had been newly raised in the respondents' replies to the statement of grounds of appeal.
However, neither in their letter of 27 October 2020 nor later in the appeal proceedings have the appellants identified exceptional circumstances justifying why these requests were filed only after the board's preliminary opinion was issued.
18. For this reason, the board decided to not admit auxiliary requests 2 to 7 into the proceedings (Article 13(2) RPBA 2020).
Order
For these reasons it is decided that:
The appeal is dismissed.
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