T 0032/17 - Product-by-process feature and burden of proof

Kye points

• The Board, in this opposition appeal “Finally, where a process feature is the only feature allegedly conferring novelty to a product, the burden of proof for showing the fact that the process feature results in a distinct and identifiable characteristic of the product - i.e. in the present case in the chemical composition and/or the specific amino acid sequences of the claimed antibodies - is on the patent proprietor and not on the opponent(s) ” referring to T0179/03.
• I note that T0179/03 appears to not have been cited before. 
• Alternative positions are that the burden of proof of lack of novelty rests with the opponent or that the appellant has the burden of proof in opposition appeal. 
• A final option, also in view of the analysis below, is that under G3/14 r.55 the patentee has the burden of proof in case of improper product-by-process features.
• The Board in the headnote focuses on another aspect of the case, which however seems less broadly applicable. “The deposit of a hybridoma under Rule 31 EPC for compliance with the disclosure requirement of Article 83 EPC does not in itself convey any technical information about the molecular structure of the monoclonal antibody produced by said hybridoma, such as its amino acid sequence ”
• Addendum 10.05.2021: I think this headnote does not pertain to novelty. In particular, the Board does not comment on G1/92 hn. at all (“the chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition.”).
• The operative claim at issue reads: “Monoclonal antibody able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, characterised in that it is produced from a hybridoma  [...] deposited in the BCCM/LMBP under deposit number [...]”
• “The patent does not provide any information about the chemical composition or amino acid sequence of the antibodies produced by the deposited hybridomas either, e.g. in the form of a sequence listing (see also Rule 30 EPC).”
• As a comment, in principle, the deposit system of Rule 31 EPC is only relevant for Art.83 EPC, in that Rule 31 refers only to Article 83. The question may be raised whether implicitly a claim referring to a deposited sample under Rule 31 is also clear under Article 84. Of course, clarity is not a ground for opposition but under  G3/14, r.55: “A granted claim may turn out not to comply with Article 84 EPC but such non-compliance must be lived with. However, any lack of clarity of the claims may still be highly relevant in opposition proceedings in that it can influence the decisions on issues under Article 100 EPC []. For example the lack of clarity of a claim may have a profound effect on the outcome of the grounds for opposition according to (i) Article 100(b) / sufficiency ([], (ii) Article 100(a) EPC / novelty []  or Article 100(a) EPC / inventive step []. ” A question is whether this remark also applies when the patentee legitimately uses the system adopted under Rule 31 EPC. I note that the decision at issue at least not expressly discusses non-compliance or abuse of the deposit system under Rule 31 EPC.
• Counter arguments are certainly possible.
• A very interesting analysis was given by "Greg DeLassus" at Patently (here): “It is not that the standard for enablement of functional genus claims in the chem/bio arts has changed. It is that the technologies being claimed have changed.

  Back in the 80s and 90s (when many of these “antibody that binds [X]” claims were written), the sorts of antibodies that inventors were claiming were polyclonal antibodies. The way you make a polyclonal antibody is that you inject a mouse (or rabbit, or hamster, or goat, etc) with a particular antigen, and then a few weeks later you bleed the animal and collect the serum. The serum will be full of all sorts of antibodies, including a variety of different antibodies responsive to your antigen of interest. Even today, there is no technologically practical way to sequence the CDRs of all the target-responsive antibodies in that polyclonal serum. Therefore, if the CAFC had required that one claim the antibodies in those polyclonal sera according to CDR sequence, this would effectively have meant that there could be no patent protection for antibodies.

  Not only would this policy have been counterproductive to the ends that the patent system is intended to further, but it would not have even been consistent with the words of the statute, which merely require that the specification “contain a written description of the invention, and of the manner… of making… it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains… to make… the same… .” When you raise an antibody by injecting an animal, the important thing to describe with precision is the antigen used. If you can be precise enough about the details of the antigen, then other skilled artisans will be able to replicate your work, even without details about the CDRs of each antibody raised.

  Nowadays, however, almost no one is claiming polyclonal antibodies. Amgen and Sanofi, for example, are not fighting about who controls the IP around a polyclonal. Rather, they are fighting over a monoclonal antibody. In the same way that it would have been impossible to disclose CDR sequence data for polyclonal sera back in the day, it is almost trivially easy to describe CDR sequence data for monoclonals. Therefore, it makes sense for the CAFC to require such disclosure (and precision of claiming), even if it did not make sense to do so in older cases. Different technology requires different ways of describing in order for the skilled person to replicate.

  Moreover, the ends which the patent law is meant to further are better served by requiring precise description of the antibody when one is claiming a monoclonal, just as they were better served by requiring precise description of the antigen back when one was claiming a polyclonal. It is the same statute and the same standards, but when one changes the technology to which they same statutes and standards are being applied, then it will necessarily follow that the spec and claims sufficient to capture each technology will look different.

  There really is no more than a superficial inconsistency between how the CAFC was handling these functional genus claims back then and how it is handling them now. Rather, at the deeper and more meaningful level, the CAFC’s handling is entirely consistent. The tech has simply moved on since then.” (underlining added)

  
   

• The present Board also recalls that: “ the Enlarged Board of Appeal held that "[f]or a product-by-process claim to be allowable it needs to be established that (a) it is impossible to define the claimed product other than in terms of a process of manufacture and (b) the claimed product itself meets the patentability requirements of Article 52(1) EPC. Thus, the specific process needed to obtain the claimed product should make it possible to distinguish the inevitable product of the product-by-process claim over the prior-art" (see decision G 2/12, OJ EPO 2016, 27, Reasons, point IV.(5)).”

• The Board on procedural matters: “After the board's final decision had been announced at oral proceedings, opponent 4 withdrew their opposition. As the final decision became effective immediately on its announcement, the above mentioned withdrawal did not change opponent 4's status as a party to the appeal proceedings.”

T 0032/17 

https://www.epo.org/law-practice/case-law-appeals/recent/t170032eu1.html

4. After the board's final decision had been announced at oral proceedings, opponent 4 withdrew their opposition. As the final decision became effective immediately on its announcement, the above mentioned withdrawal did not change opponent 4's status as a party to the appeal proceedings.

Main request - claim 2

The claimed subject-matter - claim construction

5. Claim 2 is drafted as a product-by-process claim. It is directed to a monoclonal antibody which is characterised by the functional feature "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3**(") and by the process feature "produced from a hybridoma selected from the group consisting of the hybridomas deposited in the BCCM/LMBP under deposit numbers LMBP 7011CB, LMBP 7012CB, LMBP 7013CB, LMBP 7204CB and LMBP 7205CB."

6. In the decision under appeal the opposition division held that, as a consequence of the process feature, the claimed antibodies were characterised by a unique amino acid sequence because "deposit numbers allow to identify specific hybridomas" and "each antibody produced by a different hybridoma will have a different sequence (heavy and light chains) which renders the antibody unique." (see decision under appeal, Reasons, point 4.10).

7. The appellant contested the opposition division's construction of the claim. They argued that the claimed antibodies were only characterised by the functional feature "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3" while the process feature did not confer any additional technical features on the claimed antibodies. The respondent disagreed and submitted that as a consequence of the process feature the specific amino acid sequence and indeed the entire chemical composition of the antibodies produced by the deposited hybridomas was a feature of the antibodies of claim 2.

8. According to the case law of the boards of appeal a process feature in a product-by-process claim only contributes to the novelty of a product claim insofar as it gives rise to a distinct and identifiable characteristic of the product (see e.g. decision T 179/03, Reasons, points 3.7 to 3.9). The skilled person following the teaching of the patent must inevitably achieve that characteristic and must be aware of that characteristic so that they can recognise the claimed product and discard any products not having it (see e.g. decision T 412/93, Reasons, point 33 and decision T 1120/00, Reasons, point 7). Furthermore, the Enlarged Board of Appeal held that "[f]or a product-by-process claim to be allowable it needs to be established that (a) it is impossible to define the claimed product other than in terms of a process of manufacture and (b) the claimed product itself meets the patentability requirements of Article 52(1) EPC. Thus, the specific process needed to obtain the claimed product should make it possible to distinguish the inevitable product of the product-by-process claim over the prior-art" (see decision G 2/12, OJ EPO 2016, 27, Reasons, point IV.(5)).

9. At issue in the present case is thus whether or not the process feature in claim 2 "produced from a hybridoma selected from the group consisting of the hybridomas deposited (...)" gives rise to the specific amino acid sequence and chemical composition of the claimed antibodies and furthermore, whether the skilled person is made aware of these structural characteristics of the antibodies by the teaching of the patent.

10. The deposit information recited in claim 2, see

point 5. above, informs the skilled person (i) about the depositary institution, i.e. "BCCM/LMBP" and

(ii) the deposit numbers assigned to the deposited hybridomas by the depositary institution, i.e. "LMBP 7011CB, LMBP 7012CB, LMBP 7013CB, LMBP 7204CB and LMBP 7205CB".

11. From the hybridomas' deposit information the skilled person derives that hybridomas producing the claimed antibodies have been deposited and have been assigned deposit numbers.

12. This deposit information however does not convey any technical information about the chemical composition or molecular structure of the antibodies produced by these hybridomas, such as their amino acid sequence, either explicitly or implicitly.

13. The patent does not provide any information about the chemical composition or amino acid sequence of the antibodies produced by the deposited hybridomas either, e.g. in the form of a sequence listing (see also Rule 30 EPC).

14. In view of the above considerations it is apparent that the chemical composition and/or the amino acid sequence of the antibodies produced by the deposited hybridomas cannot be inferred by the skilled person from the teaching of the patent in suit.

15. Finally, where a process feature is the only feature allegedly conferring novelty to a product, the burden of proof for showing the fact that the process feature results in a distinct and identifiable characteristic of the product - i.e. in the present case in the chemical composition and/or the specific amino acid sequences of the claimed antibodies - is on the patent proprietor and not on the opponent(s) (see also decision T 179/03, see points 3.9 and 3.14 of the Reasons).

16. The respondent's argument that the appellant could have determined the amino acid sequence of the antibodies produced by the deposited hybridomas can thus not succeed. The respondent has not discharged the burden of proof.

17. The board concludes from the above that the process feature does not impart any identifiable technical feature on the claimed subject-matter. The sole technical feature defining the monoclonal antibodies of claim 2 is thus the functional feature that they are "able to recognize 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3".

The public prior use of the antibodies disclosed in

document D32

18. Document D32, a sales catalogue, discloses, inter alia, an anti-25 Dihydroxy-Vitamin D3 antibody. Two catalogue numbers, A 1025.1 and A1025.2, are given for the antibody, relating to different concentrations, 10 myg and 100 myg, respectively (see page 3, lines 10 and 11).

19. Based on the submissions before it, the opposition division concluded that the antibodies designated as A1025.1 and A1025.2 in document D32 were one and the same antibody (sold at different concentrations), that these antibodies bind to 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, were available to the public and had been sold before the priority date of the opposed patent (see decision under appeal, Reasons, points 4.1 to 4.8).

20. In other words, the opposition division held that a public prior use of antibodies that fulfil the functional feature characterising the antibodies of claim 2, see point 17. above, had been established by the opponents.

21. Nevertheless, the opposition division acknowledged novelty of claim 2 because they considered that the claimed antibodies were further characterised by their amino acid sequence, see point 6. above, and "based on the evidence provided by the opponents the Opposition Division cannot conclude that the antibodies referred to in D32 are produced by the same hybridoma and have the same heavy and light chains" (see decision under appeal, Reasons, point 4.10).

22. However, in view of the claim construction adopted by the board, see point 17. above, the opposition division's reasoning, see previous point, cannot hold.

23. During the written appeal proceedings, the respondent submitted two lines of argument in support of novelty of claim 2, see section XXII. above. In the view of the claim construction set out in point 17. above, both of these lines of argument fail because neither the antibodies' amino acid sequence nor their potentially different cross-reactivity profile is a feature of the claimed antibodies.

24. As a third line of argument, submitted for the first time during the oral proceedings before the board, the respondent argued that is was doubtful that the antibody disclosed in document D32 was indeed bispecific. In support of this new allegation of fact, the respondent relied on document D13.

25. The opposition division's finding that the antibodies designated as A1025.1 and A1025.2 in document D32 were one and the same antibody that bound to

25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, see point 19. above, had not been contested, either expressly or implicitly, by the respondent during the appeal proceedings before. The third line of argument thus represented an amendment of the respondent's case at the oral proceedings and its admittance into the appeal proceedings was therefore considered by the board.

26. Admittance of the amendment to the respondent's case was governed by the provisions of

Article 13(1) RPBA 2007, see point 2. above.

27. Pursuant to Article 13(1) RPBA 2007, an amendment to a party's case after the filing of the statement of grounds of appeal or reply may be admitted and considered at the board's discretion. That discretion "shall be exercised in view of inter alia the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy".

28. The board considered that admittance of the new line of argument on the basis of document D13 would have raised issues not previously addressed in the appeal proceedings and thus extended the scope of discussion as determined by the grounds of appeal and the respondent's reply at a very late stage of the proceedings.

29. Such an amendment of the respondent's case would normally make remittal to the opposition division necessary and at the very least, would have meant adjourning the oral proceedings in order to give the appellant an opportunity to respond appropriately. Admittance of the new line of argument would thus also not have served the interest of procedural economy.

30. In view of these considerations, the board, in the exercise of its discretion, decided not to admit the respondent's third line of argument into the appeal proceedings.

Conclusion on novelty of claim 2 of the main request

31. Claim 2 of the main request lacks novelty over the public prior use of the antibodies disclosed in document D32.