Friday, August 03, 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).

Friday, December 11, 2015 T 2369/10 - Second medical use of products

Medical Instruments

The applicant found a new medical use for an existing product; namely treatment of substance addiction using a neurostimulator.
 
Normally a product is not made novel merely by identifying a new use for the product. Although, a use claim or a method claim may be possible, a purpose limitation for a product must imply technical differences in the product itself for it to be novel. 

However, if the new use is a medical one, the option of method and use claims are blocked by article 53(c) EPC, which forbids patenting of medical methods (see the articles for details). Fortunately for medical researchers, an exception is made to the general rule;  a new medical use for "any substance or composition" will provide novelty (articles 54(4), 54(5) EPC, G 5/83).

But what if someone invents a new medical use for a product which is not a substance or composition? The possibility of a method or use claim is blocked by article 53(c) EPC.  The lack of novel technical differences blocks the product claim. Although, article 54 does not explicitly allow the application to products which are not substance or composition, it is not forbidden either. 

The board declined the invitation though, and ruled that no novelty is obtained by a medical purpose limitation if the object is not a substance or composition. A request to  refer questions to the Enlarged board was denied. 

No Catchword or headnote is provided but reasons 8.1 give the following summary.

In the present case, the Board holds that, having regard to the wording of Article 54(4),(5) EPC, the ordinary meaning of this Article shall not be extended so as to include something which is not explicitly provided for.

Consequently the Board considers that there is no basis to contemplate that novelty may be conferred on products, other than substances and compositions, by virtue of the provisions of Article 54(4),(5) EPC.

Tuesday, September 01, 2015 T 943/13 - Not obvious as a food supplement

The opposition division revoked the following second medical use claim:

"1. A soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia, the dietary fibre comprising at least 30 wt.% of oligosaccharides having a chain length of 3-10 anhydromonose units."

I understand that document D12 appears to disclose a soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting which contains the required oligosaccharides. However, D12 does not disclose that the oligosaccharide prevents muscle wasting. On this basis the board finds the claim inventive. 

To be a bit pedantic, claim 1 does not actually say that it is the oligosaccharides that prevent the muscle wasting, but from the description this is clearly the purpose of including them. 

The board also devotes an interesting discussion to the sufficiency of this broad claim.

Tuesday, September 23, 2014 T 1616/09 - Different claims, different enablement

Enablement in pharmaceutical claims was central in this Examination appeal. The main request contained the following claims:

1. A pharmaceutical composition comprising a DNA methylation inhibitor; and an anti-neoplastic agent   (...)

20. A combination of a DNA methylation inhibitor and an anti-neoplastic agent (...), for use in a method of treating a disease associated with abnormal cell proliferation.

22. Use of a DNA methylation inhibitor for the preparation of a pharmaceutical composition for treatment of a disease associated with abnormal cell proliferation (...)

36. A kit for treating a disease associated with abnormal cell proliferation, comprising (...)

Based on a cited document the Examining division had concluded that it is unlikely that the combination of drugs had a synergistic effect. As the application did not detail how the combination provided an improvement, the application was refused under Art. 83 EPC and Rule 42(1)(e) EPC (Enablement).

The board did not agree with this application of enablement. The board's decision discusses the requirements for enablement for each of the claim categories. The following catchword was provided:

For the purposes of Article 83 EPC, the level of disclosure in the application which is required for claims directed to pharmaceutical compositions or kits is not the same as that which is required for medical-use claims. For claims directed to pharmaceutical compositions or kits it is in principle sufficient that the application provides information which allows the skilled person to produce the composition or kit, and that there are no substantiated doubts that it could indeed be used in therapy. For second-medical-use claims on the other hand it is required not only that the composition itself is disclosed in an enabling way but also that its suitability for the claimed treatment is plausibly disclosed in the application (Reasons 6).
In the case of a claim directed to a pharmaceutical composition comprising two classes of compounds which have both already been used in therapy in the prior art, there is a priori no reason to doubt that such a pharmaceutical composition can be produced; no specific functional effect has to be demonstrated (Reasons 6.1.1 and 6.1.2).
In the case of second-medical-use claims, if the claimed therapeutic effect was already known to the skilled person at the priority date, it is not necessary to demonstrate it in the application (Reasons 6.2.2).

This decision is also discussed on PatLit.

Reasons for the Decision


2. The examining division objected to the description as not meeting the requirements of Article 83 and Rule 42(1)(e) EPC.

3. Rule 42(1)(e) EPC states that "the description shall describe in detail at least one way of carrying out the invention claimed, using examples where appropriate and referring to the drawings, if any".
Article 83 EPC states that the patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. In other words, the teaching of the application as a whole must enable the skilled person to carry out, without undue burden, the invention which is defined in the claims.

4. In its decision, the examining division referred to the subject-matter not of the claims but of the description. For the purposes of Article 83 EPC as well as of Rule 42(1)(e) EPC, it is the invention, as defined by the claims, which has to be disclosed in the application in an enabling and detailed way. Examination of whether the description, as part of the application, provides such enablement and detail has thus to be done vis-à-vis the claimed subject-matter.

5. The present main request comprises product claims directed to pharmaceutical compositions (claims 1 to 19), as well as claims directed to medical uses, in the format of either purpose-restricted product claims (claims 20 and 21, and dependent claims) or Swiss-type medical-use claims (claims 22 and 23, and dependent claims), and product claims directed to kits (claims 36 to 39).

6. Clearly the level of disclosure which is required for these different categories of claims is not the same. For example, for claims directed to pharmaceutical compositions or kits - which are product claims, not restricted to any specific therapeutic effect - it is in principle sufficient that the application provides information which allows the skilled person to produce the composition or kit, and that there are no substantiated doubts that it could indeed be used in therapy. For second medical-use claims on the other hand it is required not only that the composition itself is disclosed in an enabling way but also that its suitability for the claimed treatment is plausibly disclosed in the application.

6.1 Independent claim 1: Pharmaceutical compositions

6.1.1 Claim 1 is directed to a pharmaceutical composition comprising a DNA methylation inhibitor and an anti-neoplastic agent, wherein the anti-neoplastic agent is further defined by a functional feature, namely that its activity is adversely affected by aberrant DNA methylation. As an example of DNA methylation inhibitors, cytidine analogs are mentioned and specifically decitabine (e.g. application page 7, lines 9 to 12), a compound whose use in therapy had already been disclosed in the prior art (e.g. Schwartsmann G. et al., Investigational New Drugs 18: 83-91, 2000, cited in the European search report). The application also provides a long list of available anti-neoplastic agents (page 1, line 15 to page 6, line 21), and further indicates which anti-neoplastic agents are part of the embodiments of the invention (page 7, line 13 to page 9, line 8); examples of combinations comprising specific groups of anti-neoplastic agents are also disclosed on page 17, line 26 to page 29, line 28. There is no reason to doubt that such products could be formulated as pharmaceutical compositions, since they were indeed individually available in the prior art as such and had also been used in combination (Schwartsmann et al., supra). The board thus considers that the application as filed, and in particular the description, contains sufficient information to enable the skilled person to produce the pharmaceutical compositions as claimed.

6.1.2 The arguments of the examining division were based on an alleged lack of evidence in the application showing that the technical problem as stated in the application - synergistic improvement of the effectiveness of anti-neoplastic agents - had indeed been solved, especially in view of all possible anti-neoplastic agents encompassed in the claims. Since enablement of claims conferring absolute protection for products does not require that any specific functional effect be demonstrated, but rather that the product can be produced, this argument fails. The board agrees that claim 1 has very broad limits, but these are well defined and the skilled person would know without undue burden which compounds were encompassed and which were not: all that is required is to test whether or not the anti-neoplastic activity of the anti-neoplastic agent is indeed impaired by aberrant DNA methylation (a phenomenon which is explained in the application e.g. at pages 12 and 13). The examining division has not provided any arguments, let alone substantiated by facts, that such testing would not be possible without undue burden.

6.2 Independent claims 20 to 23: Medical uses

6.2.1 Claims 20 to 23 are directed to medical uses of combinations of a DNA methylation inhibitor and an anti-neoplastic agent, wherein the medical use is for treating a disease associated with abnormal cell proliferation. By definition, attaining the claimed therapeutic effect is a functional technical feature of claims directed to medical uses. As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application (T 609/02, reasons 9).

6.2.2 As stated above, the therapeutic application as claimed is treatment of a disease associated with abnormal cell proliferation. Undisputedly, anti-neoplastic agents are, by definition, used to treat cancer, which is an example of a disorder associated with abnormal cell proliferation, and aim, either directly or indirectly and via different mechanisms, at controlling such abnormal cell proliferation: this was state of the art for the present application. Hence, even in the absence of any data in the application showing a therapeutic effect of these agents either on cancer or on other diseases associated with abnormal cell proliferation, there is no apparent reason to doubt that anti-neoplastic agents would have a role in controlling abnormal cell proliferation both in cancer and in other diseases not related to cancer. As such, it can be considered that said claimed therapeutic effect was already known to the skilled person at the priority date and that it therefore does not have to be demonstrated in the application. The fact that the compound to be used consists of a combination with a further substance, namely a DNA methylation inhibitor, does not change this conclusion, unless there were reasons, based on verifiable facts, to believe that this substance would interfere in a negative way with the activity of the anti-neoplastic agent. On the contrary, the teaching of the application is that this further compound may enhance the activity of the anti-neoplastic agent, and this is further supported by the post-published evidence submitted by the appellant with the grounds of appeal (documents D3.1, D3.2, D3.3, D5.10).

6.2.3 The arguments of the examining division concerning an improvement or synergistic effect (supra) are also not valid for these claims, as these claims do not require such an effect. Such an argument could be of relevance in the discussion of inventive step, but not of sufficiency of disclosure.

6.2.4 As regards D4.1, cited by the examining division as an example that one of the combinations falling within the limits of the claim (decitabine plus IFN-gamma) did not have an effect, the board follows the appellant's arguments that, in fact, this document further supports the concept underlying the invention. D4.1 discloses (page 5222, last paragraph and page 5223, first paragraph) that cell lines which are non-responsive to decitabine do not show a high up-regulation of gene expression in the same genes which are up-regulated in cells that are responsive to decitabine. According to D4.1, the cutaneous melanoma cell lines that are non-responsive to decitabine do not present a high enough up-regulation of gene expression in comparison to the uveal melanoma cell lines. Re-expression of silenced genes is an outcome of the hypomethylating activity of decitabine, and D4.1 regards this difference in re-expression as the reason behind the sensitisation of uveal melanoma cell lines, but not of cutaneous melanoma cell lines, to IFN-gamma by decitabine. Finally, D4.1 does demonstrate that decitabine and IFN-gamma (and also IFN-alpha) had an effect on uveal melanoma cells.

6.3 Independent claim 36: Kits

6.3.1 Although claim 36 is directed to a "kit for treating a disease...", thus raising doubts whether it is directed to a product with no purpose restrictions, or whether it has the scope of a purpose-restricted product claim (see also below), the same considerations as discussed above apply also to this claim. Hence, for the reasons given above, this claim is also considered to fulfil the requirements of Article 83 EPC.

Remittal to the first instance

7. The examining division's decision was based only on Article 83 EPC (in conjunction with Rule 42(1)(e) EPC). Novelty and inventive step thus still have to examined and the board notes that a number of documents have been cited in the search report as X. Moreover, there is no indication on file that other EPC requirements such as Article 123(2) EPC or Article 84 EPC have yet been assessed. In particular, it has to be examined whether all new combinations of features and new dependencies of claims do have a basis in the application as filed. Also some issues of lack of clarity are readily apparent, for example as mentioned above concerning the wording of claim 36, which raises doubts as to the claim category; a similar lack of clarity is also present in claim 19.

8. Although there is no absolute right to have an issue decided upon by two instances, it is also not the function of the board to consider and decide upon issues which have not been examined at all by the department of first instance. The board thus decides to exercise its discretion under Article 111(1) EPC and remit the case to the first instance for further prosecution.

Order
For these reasons it is decided that:
1. The decision is set aside.
2. The case is remitted to the first instance for further prosecution.
 

This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T161609.20140827. The whole decision can be found here. The file wrapper can be found here. Photo by  Lali Masriera obtained via Flickr.

Friday, September 12, 2014 T 879/12 - Again, no double patenting

This is an appeal against the decision of the examining division to refuse a European patent application, a second-generation divisional application. The examining division had held that the second-medical use claim in the purpose-limited format of Art.54(5) EPC related to the same subject-matter as the Swiss-type claims as granted with the grandparent application. The Board followed the argumentation of earlier T 1780/12 (taken by another board), and held the examining division to be wrong. Followers of our blog may find the differences with the conclusion in T 1570/09 interesting, where the Board denied the simultaneous presence of both claims in a single application (see e.g., T 1570/09, r.4.1 and r.4.8).

Summary of Facts and Submission
III. The applicant (appellant) submitted its statement of grounds of appeal and, in a further submission, referred to the identity of the legal issues in the present case and in decision T 1780/12 of 30 January 2014, taken by another board.

IV. Claim 1 of the request before the board, which is identical to the request before the examining division, reads as follows:
"1. An Apo-2 ligand for use in a method for treating cancer, wherein the Apo-2 ligand is:
(a) a polypeptide comprising amino acid residues 41-281 of Figure 1A (SEQ ID NO: 1);
(b) a polypeptide comprising amino acid residues 114-281 of Figure 1A (SEQ ID NO: 1);
(c) a polypeptide consisting of amino acid residues 114-281 of Figure 1A (SEQ ID NO: 1);
(d) a polypeptide consisting of amino acid residues 1-281 of Figure 1A (SEQ ID NO: 1); and
(e) a polypeptide which is a fragment of (a), (b), (c), or (d); and
wherein the cancer is squamous cell carcinoma, small cell lung carcinoma, non-small cell lung carcinoma, neuroblastoma, pancreatic cancer, glioblastoma multiforme, cervical cancer, stomach cancer, bladder cancer, hepatoma, breast cancer, colon carcinoma, head and neck cancer, prostate cancer or ovarian cancer and the Apo-2 ligand induces apoptosis in the cancer cells."
Dependent claims 2 to 8 refer to specific embodiments of the subject matter of claim 1.

V. Claim 1 of the grandparent application as granted reads:
"1. Use of an Apo-2 ligand for the preparation of a medicament for the treatment of cancer, wherein the Apo-2 ligand is:
(a) a polypeptide comprising amino acid residues 41-281 of Figure 1A (SEQ ID NO:1);
(b) a polypeptide comprising amino acid residues 114-281 of Figure 1A (SEQ ID NO:1);
(c) a polypeptide consisting of amino acid residues 114-281 of Figure 1A (SEQ ID NO:1);
(d) a polypeptide consisting of amino acid residues 1-281 of Figure 1A (SEQ ID NO:1); and
(e) a polypeptide which is a fragment of (a), (b), (c), or (d); and
wherein the cancer is squamous cell carcinoma, small cell lung carcinoma, non-small cell lung carcinoma, neuroblastoma, pancreatic cancer, glioblastoma multiforme, cervical cancer, stomach cancer, bladder cancer, hepatoma, breast cancer, colon carcinoma, head and neck cancer, prostate cancer or ovarian cancer and the Apo-2 ligand induces apoptosis in the cancer cells."

Dependent claims 2 to 8 refer to specific embodiments of the subject matter of claim 1, specifying the same additional features as claims 2 to 8 of the request before the board.

Reasons for the Decision
Double patenting
2. The sole ground for refusal of the present patent application was the prohibition of double patenting.

3. Under the EPC 1973 a patent for a further medical application could, pursuant to a line of case law first set out in decision G 5/83 (OJ EPO 1985, 64), be granted for a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified therapeutic application (so called "Swiss-type claim") (cf. "Case Law of the Boards of Appeal of the EPO", 7th edition 2013, I.C.6.2.1, 144).
During the course of the revision of the EPC 2000, former Article 54(5) EPC 1973 ("first use in a medical method") was renumbered to become Article 54(4) EPC and a new Article 54(5) EPC was introduced to provide protection for second medical uses. The new Article 54(5) EPC eliminates any legal uncertainty on the patentability of further medical uses. It unambiguously permits purpose-restricted product protection for each further new medical use of a substance or composition already known as a medicine (cf. "Case Law of the Boards of Appeal of the EPO", ibid.).

4. Claim 1 of the present application is in the form of a purpose restricted product claim ("An Apo-2 ligand for use in a method for treating cancer"; cf. item IV above) according to Article 54(5) EPC 2000.
Claim 1 of the grandparent application was granted in the "Swiss-type" format ("Use of an Apo-2 ligand for the preparation of a medicament for the treatment of cancer"; cf. item V above) under the provisions of Article 54(5) EPC 1973.

5. The examining division stated in its decision that a claim directed to a second or further medical use claim under Article 54(5) EPC 2000 was considered to be directed to the same subject-matter as a "Swiss-type" claim directed to the same medical use, in the sense that both these claims concerned the same invention claimed in a different format.

6. The principle of the prohibition of double patenting is based on the idea that the applicant has no legitimate interest in proceedings that give rise to the grant of a second patent in respect of the same subject-matter for which he already holds a patent (cf. Reasons 13.4 of decision G 1/05, OJ EPO 2008, 271).

7. The decisive issue is therefore whether the subject matter of claim 1 of the present application is the same as the subject matter of claim 1 of the grandparent application.

8. The present case has much in common with the case underlying decision T 1780/12 of 30 January 2014.
The crucial issue for the main request underlying said decision was also whether the subject matter of a claim directed to a new medical use of a known compound was the same, irrespective of whether the claim was in the "Swiss-type" format or in the format according to Article 54(5) EPC 2000.
Furthermore, the board notes that points 1 and 3 to 8, and, with the exception of a single sentence, all of point 2, of the decision of the examining division underlying the present appeal (see item VI above) can be literally found in points 2 to 10 of the decision of the examining division underlying appeal case T 1780/12 (cf. item VII of decision T 1780/12).

9. Like in the present case, a parent application had been granted with claims in the "Swiss-type" format for the use of a composition comprising a biologically effective amount of an anti-aminophospholipid antibody, or antigen-binding region thereof, in the manufacture of a medicament for the treatment of cancer. A divisional application (underlying T 1780/12) had been filed with a main request comprising purpose-restricted product claims referring to a composition comprising a biologically effective amount of an anti-aminophospholipid antibody, or antigen-binding region thereof, for the treatment of cancer. Further claims, referring to features specifying a mechanism of action, were identical in both types of claims.
The examining division had refused the main request of the divisional application under Article 97(2) EPC in conjunction with Article 125 EPC because, in its view, claim 1 before it related to the same subject matter as granted claims 1, 24 and 25 of the parent application.

10. Regarding the issue of what constitutes the subject matter of a claim, the board in T 1780/12 concluded, by reference to decision G 2/88 (OJ EPO 1990, 93), that the category or type of claim and its technical features constitute its subject matter (cf. T 1780/12, Reasons 11 to 13). It was therefore necessary to establish whether or not the subject matter of the claims as defined by their categories in combination with their technical features was the same.

11. The board stated that Swiss-type claims of the form "Use of X for the manufacture of a medicament for the treatment of Y" are construed as purpose-limited process claims while claims formatted in accordance with Article 54(5) EPC as "X for use in the treatment of Y" are construed as purpose-limited product claims. The categories of the claims are therefore different (cf. T 1780/12, Reasons 16).
Regarding the technical features, the board concluded that both sets of claims defined the same compound and the same therapeutic use, but that the Swiss-type claims comprised in addition the feature of manufacturing a medicament while the claims of the request before it did not (cf. T 1780/12, Reasons 17).
The board therefore decided that the subject matter of the claims of the main request before it was different from the subject matter of the Swiss-type claims of the parent application.

12. The board also dealt with the examining division's argument that "double patenting is concerned with the substantial identity of claimed subject matter and is not related to the (only potential) variance in granted protection".

13. In this respect, the board in case T 1780/12, agreed with the finding in decision T 1391/07 of 7 November 2008, that an applicant's lack of legitimate interest in patenting the same subject matter twice, invoked by the Enlarged Board in decision G 1/05 (cf. point 6, supra) could not be invoked in the case in which the scopes of protection only partially overlapped as there was no objective reason to deny the legitimate interest of an applicant in obtaining a protection different from that of the parent patent already granted (cf. T 1780/12, Reasons 19). Any potential variance in the scope of protection afforded by the claims was therefore crucial to the decision to be taken.
Based on point 3.3 of the Reasons of decision G 2/88, the board concluded that the category of a claim and its technical features constitute its subject matter and determine the protection conferred (cf. T 1780/12, Reasons 21). Thus, contrary to the examining division's view, the claimed subject matter and the scope of protection conferred by the claims are intrinsically linked.
Since the purpose limited process claim (Swiss-type claim) and the purpose-restricted product claim according to Article 54(5) EPC 2000 belonged to different categories and differed in at least one technical feature, they differed in the scope of protection afforded (cf. T 1780/12, Reasons 20 to 22).
There was no manifest objective reason to deny the legitimate interest of the appellant in pursuing claims drafted in accordance with Article 54(5) EPC 2000 and thereby obtaining protection different from - albeit partially overlapping - with that of "Swiss-type" claims of the parent application already granted (cf. T 1780/12, Reasons 25).

14. This board agrees with the legal assessment in decision T 1780/12 in that the scope of the claims in both cases is different, and considers its conclusions to be directly applicable to the present case.

15. In the present case, the claims of the patent application and the grandparent application define the same compound (an Apo-2 ligand defined by features (a) to (e)), and the same therapeutic use (the treatment of the same cancers, as specified in the claims (cf. items IV and V, above). But the subject matter of claim 1 is defined in the format of a purpose-restricted product claim, whereas the subject matter of claim 1 of the grandparent patent is defined in the Swiss-type format.
Since the categories of the claims are different and there is at least one difference in the technical features defining the claimed subject matter (the manufacture of a medicament), the subject matter defined by the claims and the scope of protection conferred by the claims are different.

16. The board therefore decides that granting a patent on the basis of claims 1 to 8 would not lead to double patenting.

17. Since the board does not uphold the decision under appeal, there is no need for oral proceedings (cf. item VIII, above).

18. As the decision under appeal is exclusively concerned with the issue of double patenting (cf. item II above) the Board decides to remit the case to the department of first instance for further prosecution (Article 111(1) EPC).

Order
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The case is remitted to the examining division for further prosecution on the basis of

claims 1 to 8, filed under cover of a letter dated 22 October 2009.


This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T087912.20140827. The whole decision can be found here. The file wrapper can be found here. Photo "Swiss flags" by Janet McKnight obtained via Flickr.