Friday, 3 August 2018

T 2145/13 - 2nd medical use (too) broadly claimed?


In this opposition appeal, the Opposition Division (OD) previously upheld the patent in amended form. Claim 1 as upheld by the OD reads as follows (this claim also being maintained by the patent proprietor as part of the main request during the subsequent appeal proceedings):

"1. An anti-NGF antibody for use in the treatment of post-surgical pain".

Several prior art documents, which were already introduced during the opposition proceedings, described the use of anti-NGF antibodies for use in the treatment of neuropathic pain.

The appeal proceedings focuses on the claim construction of the term "post-surgical pain" and whether this term has been interpreted too narrowly by the OD by considering it to exclude neuropathic pain. In other words, is the use of an anti-NGF antibody for the treatment of post-surgical pain indeed novel in view of its known use for the treatment of neuropathic pain?

Of further interest is that during the oral proceedings, the proprietor withdrew all pending auxiliary requests and filed a new first auxiliary request:

"1. An anti-NGF antibody for use in the treatment of post-surgical pain, wherein the anti-NGF antibody is for use in suppressing or ameliorating resting pain."

To briefly summarize the proceedings: the BoA considers the normal meaning of the term "post-surgical pain" to include any pain after surgery, including neuropathic pain (after surgery). The proprietor however argues that the term has a more limited meaning in the relevant art and submits, inter alia, an expert opinion. However, the appellant (naturally) disagrees and provides a counter expert opinion. The BoA then considers the patent's description and finds that its definition does not exclude neuropathic pain caused by surgery. The main request is thus considered to lack novelty. The auxiliary request is not admitted into the proceedings as this possible construction of the phrase "post-surgical pain" was deemed to be foreseeable by the respondent (proprietor).

Reasons for the Decision
Admission of third party observations and of document A30 into the proceedings - Article 13(1) RPBA

1. The issue of admission of the third party observations need not be decided on, since neither of the parties relied on them in their submissions and the board has not relied on them in reaching its decision.

2. The appellant did not object to the admission of document A30 into the proceedings. The board decided to admit the document.

Main request - Claim 1

Novelty - Article 54 EPC

3. The claim is for an anti-NGF antibody for use in the treatment of post-surgical pain.

4. Documents A2, A3, A17 and A19 all disclose studies involving the administration of an anti-NGF antibody to rats which have undergone a surgical procedure in which the spinal chord or spinal nerves are severed (see documents A2, A17 - see page 101, left column), constricted (CCI) or ligated (SNL) (document A3 - see page 838, left column, document A19 - see page 266, right column). In each case, pain experienced by the rats was ameliorated by the administration of the anti-NGF antibody.

5. The above assessment of the prior art was common ground between the parties. There was however disagreement about whether the pain treated by anti-NGF antibody administration, was "post-surgical" within the meaning of term as used in the patent.

6. The appellant was of the view that any pain, including neuropathic pain, that was a result of a surgical procedure should be regarded as "post-surgical" pain. By contrast, the respondent took the view that each of the above mentioned documents related to the treatment of neuropathic pain, which was known in the art as being a distinct and different category of pain, distinguished from post-surgical pain, inter alia, by site and duration (time-course) and indeed measured using a different experimental model.

7. In deciding on the novelty of the claimed subject-matter, the question to be answered is therefore whether nor not the term "post-surgical pain" encompasses neuropathic pain caused by surgery.

8. Terms used in patent documents should be given their normal meaning (cf. Case Law of the Boards of Appeal of the European Patent Office, 8th edition, II.A.6.3.3). The normal meaning of the terms "post-surgical" and "pain" are "after surgery" and "pain of any type", respectively. Adopting this interpretation would mean that neuropathic pain caused by surgery must be encompassed by the expression "post-surgical pain".

9. The respondent argued that the expression "post-surgical pain" had a particular meaning in the art which excluded neuropathic pain, even if it was caused by surgery. The skilled person distinguished between on the one hand, post-surgical, post-incisional or post traumatic pain and on the other hand, types of pain such as neuropathic pain and inflammatory pain. This was reflected in the use of specific models when testing agents for the treatment of the different types of pain. The examples in the patent used the Brennan model of incisional pain disclosed in document A20 rather than the model of inflammatory pain disclosed in document A1 or the model of neuropathic pain used in documents A2, A3, A17 and A19.

10. Both parties submitted expert declarations on the construction of the term "post-surgical pain". The appellant submitted document A26, a declaration of Professor Brennan (an author of, inter alia, document A20), while the respondent submitted document A25, a declaration of Dr Shelton (one of the inventors of the patent in suit). While agreeing that "post-surgical pain" referred to pain arising or resulting from an external trauma such as a cut, puncture, incision, tear, or wound into tissue of an individual, the experts disagreed on whether neuropathic pain resulting from a surgical procedure fell within the meaning of the term (cf. document A25, page 2, penultimate paragraph and document A26, paragraphs 7 and 8). This disagreement reflects that found in the parties' respective arguments.

11. In the board's view, the documents cited by the respondent disclose that the skilled person, at the effective date of the patent, was able to and did distinguish between pain caused by different mechanisms, such as inflammatory (cf. document A1), neuropathic (cf. paragraph [0010] of the patent). There is however no absolute definition of the term "post-surgical pain" in any of these documents that would lead the skilled reader to ascribe the term a meaning different to that set out in point 8. above. In other words, it is established that the skilled person knew about different types of pain and about the corresponding experimental animal models for these. This does not mean, however, that it is established that the skilled person would have understood that each of these types of pain could not be considered as pain arising as a result of surgery.

12. It is established case law of the boards that "the description and drawings are used to interpret the claims and identify the subject-matter, in particular in order to judge whether it is novel and not obvious" (see Case Law of the Boards of Appeal of the European Patent Office, 8th edition, II.A.6.3.1).

13. The patent defines "post-surgical pain" at paragraph [0011] and more extensively at paragraph [0065]. This latter paragraph reads as follows: ["post-surgical pain" is] "pain arising or resulting from an external trauma such as a cut, puncture, incision, tear, or wound into tissue of an individual (including that that arises from all surgical procedures, whether invasive or non-invasive). As used herein, "post-surgical pain" does not include pain that occurs without an external physical trauma. In some embodiments, post-surgical pain is internal or external pain, and the wound, cut, trauma, tear or incision may occur accidentally (as with a traumatic wound) or deliberately (as with a surgical incision). As used herein, "pain" includes nociception and the sensation of pain, and pain can be assessed objectively and subjectively, using pain scores and other methods well-known in the art. Post-surgical pain, as used herein, includes allodynia (i.e., increased response to a normally non-noxious stimulus) and hyperalgesia (i.e., increased response to a normally noxious or unpleasant stimulus), which can in turn, be thermal or mechanical (tactile) in nature. In some embodiments, the pain is characterized by thermal sensitivity, mechanical sensitivity and/or resting pain. In some embodiments, the post-surgical pain comprises mechanically-induced pain or resting pain. In other embodiments, the post-surgical pain comprises resting pain. The pain can be primary or secondary pain, as is well-known in the art".

14. The board notes that the above cited definition of "post-surgical pain" refers to pain in general arising from surgery and does not exclude any type of pain, in particular, it does not exclude neuropathic pain. Furthermore, there is no passage in the patent that excludes neuropathic pain caused by surgery from the intended meaning of "post-surgical pain". Indeed, it is explained that the term is understood to include pain resulting from accidental trauma, which could cause both tissue damage and nerve damage. Moreover, it is made clear that both primary (pain local to the site of injury) and secondary pain (pain at a site outside of the area of injury) are included in the meaning of the term. The board notes that neuropathic pain is often secondary pain (cf. document A3, page 838, "Behavioural testing").

15. Considering the prima facie meaning of the expression "post-surgical pain" and taking into account its definition in the description, the board can only conclude that said expression, as used in the patent, includes neuropathic pain caused by surgery or trauma.

16. As discussed above, it was not disputed by the respondent that documents A2, A3, A17 and A19 all disclose an anti-NGF antibody for use in treating neuropathic pain resulting from surgery or trauma. The respondent did argue that, even if post-surgical pain were construed to include neuropathic pain caused by surgery or trauma, none of the cited documents disclosed the successful treatment of such pain by administration of an anti-NGF antibody. Instead, these documents reported that pain, remote from the surgical incision site, was ameliorated.

17. In the board's view this argument is essentially the same as the initial argument that "post-surgical pain" would not have been understood by the skilled person to include neuropathic pain caused by surgery, except that it concedes that incisional pain relatively local to the site of injury may have a neuropathic aspect. However, this is not the construction of the term "post-surgical pain" arrived at by the board and hence this argument must fail for the reasons set out in point 15., above.

18. Thus the subject-matter of claim 1 lacks novelty with respect to the disclosure in documents A2, A3, A17 and A19.

19. The board therefore holds that the appellant's appeal is allowable.

Admission of auxiliary request 1 into the proceedings -

Article 13(1) RPBA)

20. The filing of the claims of auxiliary request 1 by the respondent during the oral proceedings represents an amendment to their case. The admission of this request is therefore at the board's discretion (cf. Article 13(1) RPBA).

21. The claim request was presented at the oral proceedings and thus at a very late stage in the appeal proceedings. The respondent argued that the amendments were done specifically to address the board's finding under Article 54 EPC announced at the oral proceedings and were intended to qualify the type of treatment. They were also straightforward, being the amalgamation of subject-matter claims 1 and 2 of the granted patent. The appellant should have been prepared to deal with the claim request since its subject-matter had been present in the claims since the grant of the patent and raised no new issues.

22. However, the board notes that the objection under Article 54 EPC that led to the finding of lack of novelty was already raised by the appellant in the statement of grounds of appeal. The respondent was thus aware of that objection when filing the reply to said statement of grounds of appeal. That the board might agree with the appellant on the construction of the phrase "post-surgical pain" therefore cannot be considered as having been unforeseeable. Furthermore, no new objection was raised ex officio by the board and no new line of argument was raised by the appellant during the oral proceedings (see Case Law of the Boards of Appeal of the European Patent Office, 8th edition IV.E.4.4.12). Therefore, in the present case, the board cannot conclude that an unexpected development of the case occurred that could justify the late filing of auxiliary request 1.

23. Moreover, the amendments made raise issues of claim construction and inventive step, which have not been previously addressed in the appeal proceedings (see point XII., above). The admission of the claim request would therefore have added complexity to the case and would have led to a discussion of certain topics for the first time at the oral proceedings before the board.

24. In view of the above considerations, the board has not admitted auxiliary requests 1 into the proceedings (Article 13(1) RPBA).

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

This decision T 2154/13 (pdf) has European Case Law Identifier: ECLI:EP:BA:2018:T214513.20180412. The file wrapper can be found here. Photo "Pain" by Charles BERNELAS obtained via Flickr under CC BY 2.0 license (no changes made).

1 comment :

  1. An interesting point is that AR 1 which was not admitted consists of claims 1 and 2 as granted.

    It seems that the case law of the Boards is not very coherent in this matter.

    Some BA admit late filed requests consisting of a combination of granted claims, see for instance T 26/11, T 1105/14, T 1520/11, T 2600/12, T 1195/12 or T 173/14

    Other do not, as in the present case or for instance in T 569/08, T 1991/12, T 1202/11 or T 2145/13.

    In general a combination of 2 (1 independent + one dependent) claims as granted has more chances to be admitted, than a combination with more than 2 claims as granted, cf. T 569/08, T 879/15 although there are exceptions, cf. T 2387/10 or T 190/13.

    A late filed claim consisting of a combination of granted claims + features from the description has no real chance of being admitted in the procedure, e.g. T 2600/12.

    Filing in reply of a communication of a BA a claim consisting of a combination of granted claims, but without any justification or purpose a good chance of not being admitted, cf. T 122/13.

    ReplyDelete

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