T 0699/19 - Novelty of 2nd medical use claims

Key points

• The issue is whether the 2nd medical use claim at issue is novel over D3. D3 is WO 2004/096122 and is a prior right. Incidentally, some European patents were granted in the patent family of D3.
• The Board: "In line with established case law, a disclosure destroys novelty only if its teaching is reproducible, i.e. is disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (see e.g. Case Law of the Boards of Appeal of the European Patent Office, 10th edition 2022, I.C.4.11). A second medical use claim is sufficiently disclosed only if the disclosure in the prior art document [*] makes it credible that the therapeutic effect on which the disclosed treatment relies can be achieved (see decision T 609/02, Reasons 9). Therefore, document D3 is only novelty destroying to the claimed subject-matter if it discloses that an anti-NGF antagonist antibody is indeed suitable for the treatment of osteoarthritis pain." 
• [*] - sufficient disclosure of a patent claim is assessed in view of the application as filed, not in view of "the prior art document", of course. On the other hand, the Board is correct that the principle of enablement applies equally for a claim (under Art.83) and for the validity of prior art documents as "effective disclosure". 
• D3:  "[0036] The methods and compositions of the present invention are useful for the treatment of pain of any etiology, including acute and chronic pain, any pain with an inflammatory component, and any pain in which an opioid analgesic is usually prescribed. Examples of pain include post-surgical pain, post-operative pain (including dental pain), migraine, headache and trigeminal neuralgia, pain associated with burn, wound or kidney stone, pain associated with trauma (including traumatic head injury), neuropathic pain, pain associated with musculo-skeletal disorders such as rheumatoid arthritis, osteoarthritis, cystitis, pancreatitis, inflammatory bowel disease, ankylosing spondylitis, sero-negative (non-rheumatoid) arthropathies, non- articular rheumatism and peri-articular disorders, and pain associated with cancer (including "break-through pain" and pain associated with terminal cancer), peripheral neuropathy and post-herpetic neuralgia." 
•  "Document D3 investigated the effect of an anti-NGF antagonist antibody on post-surgical resting pain based on a local inflammation in a rat animal model. The local inflammation was caused by an incision through skin and fascia in the hind paw of the rat (see Example 1 on pages 54 to 57). The post-surgical pain experienced in this animal model is therefore caused by an injury to soft tissue and an associated inflammation. [] In contrast, osteoarthritis is a chronic disease which affects the joints. " 
• "Document D3 therefore does not contain any experimental evidence for the treatment recited in the claim." 
• "The opponents considered that paragraphs [0007] and [0008] of document D3 disclosed a plausible technical concept for the claimed therapeutic effect." 
• The Board:  "paragraphs [0007] and [0008] of document D3 only disclose a plausible concept for rheumatoid arthritis as a condition associated with inflammation and elevated NGF levels. Unlike the disclosure in document D1 (see points 40. to 43. below), there is no information on osteoarthritis, a disease with an aetiology different from that of rheumatoid arthritis. " 
• " The opponents did not submit any evidence of common general knowledge which would support the notion that the skilled person, taking note of the disclosure in document D3, would accept that osteoarthritis pain could be treated with an anti-NGF antagonist antibody." 
• As a comment, provided that the required level of technical support (plausibility) is the same for enablement of D3 as prior art and D3 as patent application under examination, the case law could be consistent. There could be some tension if "ab initio plausibility" is the threshold for D3 to be effective as prior art and "ab initio implausibility" would be the threshold for D3 as the application from which a European patent is granted (by submitting some post-filed evidence showing that the compound is actually therapeutically effective). 
  
  
• General burden of proof on appellant?
• The Board, on the burden of proof: "[The opponents/appellants] argued that the patent proprietor had not provided any prior art raising reasonable doubts, substantiated by verifiable facts, that the treatment disclosed in document D3 could not be carried out, asserting also that the patent proprietor itself had acknowledged that osteoarthritis had an inflammatory component. However, the opposition division had decided that document D3 did not contain an enabling disclosure of treating osteoarthritis pain with an anti-NGF antagonist antibody. The opponents challenged this finding [as appellants in appeal, it may be added]. It was therefore on the opponents to demonstrate that the opposition division's decision was incorrect, and why; it was not down to the patent proprietor to raise additional doubts.  The opponents did not submit any further evidence or arguments, e.g. to the effect that the skilled person, on the basis of their common general knowledge, would have considered the claimed therapeutic effect plausible at the effective filing date of document D3."
• Here the Board sets the burden of proof (or the burden of persuasion) on the appellants (incidentally being the opponents).  
  
  
• " Consequently, on the basis of the arguments and evidence submitted by the opponents, the board is not persuaded that the opposition division's decision that document D3 did not sufficiently disclose that osteoarthritis pain could be treated with an anti-NGF antagonistic antibody was incorrect. As a consequence, in line with established case law (see point 26. above and decision T 1457/09, Reasons 36), the disclosure in document D3 is not prejudicial to the novelty of the claimed subject-matter (Article 54(3) EPC)." 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t190699eu1.html

Novelty (Article 54(3) EPC)

Document D3

26. In line with established case law, a disclosure destroys novelty only if its teaching is reproducible, i.e. is disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (see e.g. Case Law of the Boards of Appeal of the European Patent Office, 10th edition 2022, I.C.4.11). A second medical use claim is sufficiently disclosed only if the disclosure in the prior art document makes it credible that the therapeutic effect on which the disclosed treatment relies can be achieved (see decision T 609/02, Reasons 9). Therefore, document D3 is only novelty destroying to the claimed subject-matter if it discloses that an anti-NGF antagonist antibody is indeed suitable for the treatment of osteoarthritis pain.

27. In the decision under appeal, the opposition division considered that document D3 lacked any such disclosure because it contained data on treating post-surgical pain, but not osteoarthritis pain, with an anti-NGF antagonist antibody.

28. Document D3 investigated the effect of an anti-NGF antagonist antibody on post-surgical resting pain based on a local inflammation in a rat animal model. The local inflammation was caused by an incision through skin and fascia in the hind paw of the rat (see Example 1 on pages 54 to 57). The post-surgical pain experienced in this animal model is therefore caused by an injury to soft tissue and an associated inflammation.

29. In contrast, osteoarthritis is a chronic disease which affects the joints. Pain in the affected joint is one of the major symptoms, but it can have various possible sources (see e.g. the paragraph bridging pages 505 and 506 in the review article D49). Osteoarthritis pain therefore does not have a mechanism in common with the post-surgical pain experimentally induced in the animal model in document D3. Consequently, the data obtained in document D3 on the treatment of post-surgical pain does not provide any conclusions on the treatment of osteoarthritis pain with an anti-NGF antagonist antibody. Document D3 therefore does not contain any experimental evidence for the treatment recited in the claim.

30. Experimental results need not always be disclosed in an application in order to establish sufficiency. Therefore, a lack of experimental data as such is not a reason to conclude that a claimed invention is not sufficiently disclosed. Suitable evidence for a claimed therapeutic effect may also be derivable from the common general knowledge or a plausible technical concept disclosed in the application (see e.g. decision T 950/13, Reasons 3.2 and 3.6).

31. The opponents considered that paragraphs [0007] and [0008] of document D3 disclosed a plausible technical concept for the claimed therapeutic effect. These paragraphs disclose that a link between increased NGF levels and inflammatory conditions (including "a number of forms of arthritis") has been observed in the prior art. Paragraph [0008] then specifies that high levels of NGF were observed in the synovium of patients affected by rheumatoid arthritis and in rats with experimentally induced rheumatoid arthritis but not in non-inflamed synovium.

32. Hence, paragraphs [0007] and [0008] of document D3 only disclose a plausible concept for rheumatoid arthritis as a condition associated with inflammation and elevated NGF levels. Unlike the disclosure in document D1 (see points 40. to 43. below), there is no information on osteoarthritis, a disease with an aetiology different from that of rheumatoid arthritis. Therefore, the teaching in paragraphs [0007] and [0008] of document D3 does not on its own lead to any conclusions on a link between osteoarthritis and elevated NGF levels or inflammation. Consequently, document D3 does not disclose a technical concept which would plausibly show that osteoarthritis pain could be treated with an anti-NGF antagonist antibody.

33. The opponents did not submit any evidence of common general knowledge which would support the notion that the skilled person, taking note of the disclosure in document D3, would accept that osteoarthritis pain could be treated with an anti-NGF antagonist antibody. Instead, they argued that the patent proprietor had not provided any prior art raising reasonable doubts, substantiated by verifiable facts, that the treatment disclosed in document D3 could not be carried out, asserting also that the patent proprietor itself had acknowledged that osteoarthritis had an inflammatory component.

34. However, the opposition division had decided that document D3 did not contain an enabling disclosure of treating osteoarthritis pain with an anti-NGF antagonist antibody. The opponents challenged this finding. It was therefore on the opponents to demonstrate that the opposition division's decision was incorrect, and why; it was not down to the patent proprietor to raise additional doubts. The opponents did not submit any further evidence or arguments, e.g. to the effect that the skilled person, on the basis of their common general knowledge, would have considered the claimed therapeutic effect plausible at the effective filing date of document D3. Moreover, in order to assess whether or not the treatment of osteoarthritis pain with an anti-NGF antagonist antibody was sufficiently disclosed in document D3, the only relevant factor is what the skilled person understood from the disclosure in document D3 when reading it, and not what the patent proprietor may or may not have acknowledged in the course of the appeal proceedings.

35. Consequently, on the basis of the arguments and evidence submitted by the opponents, the board is not persuaded that the opposition division's decision that document D3 did not sufficiently disclose that osteoarthritis pain could be treated with an anti-NGF antagonistic antibody was incorrect. As a consequence, in line with established case law (see point 26. above and decision T 1457/09, Reasons 36), the disclosure in document D3 is not prejudicial to the novelty of the claimed subject-matter (Article 54(3) EPC).