EP 3 167 888 B1 relates to the treatment of paroxysmal nocturnal hemoglobinuria patients with an inhibitor of complement component 5.
Claim 2 reads:
“A pharmaceutical composition comprising the antibody of claim 1.”
Claim 1 reads
“An antibody that binds C5 comprising a heavy chain consisting of SEQ ID NO: 2
and a light chain consisting of SEQ ID NO:4.”
According to the description SEQ ID NO: 2 represents the eculizumab heavy chain and SEQ ID NO:4 represents the eculizumab light chain.
Eculizumab is a humanized monoclonal antibody directed against the terminal complement protein C5.
Brief outline of the case
EP 3 167 888 B1 is a divisional application of EP 2 359 834 and of EP 2 001 490. The decision to grant has been issued on 05.04.2024. The time limit for filing a statement of grounds of opposition has not yet expired.
EP 2 001 490 A1 has been refused by the ED and the appeal withdrawn.
EP 2 359 834 B1 has been revoked and the revocation was upheld by the BA.
It is interesting to note that
- a first opposition has been filed at the EPO by Samsung Bioepis NL B.V. The grounds of opposition raised are Art 100(c), i.e. Art 76(1)/123(2), Art 100(a), Art 54/56 and Art 100(b), Art 83. The statement of grounds of opposition has not yet been filed.
- a second opposition has also been filed at the EPO by one of the companies of the Amgen group. The only ground of opposition raised is Art 100(b), Art 83. The second opponent “reserved the right” to file further grounds of opposition. Acceleration of the opposition proceedings has been requested.
The proprietor requested a PI before of the Hamburg LD of the UPC. The Hamburg LD issued two decisions, one with respect to a single defendant, Samsung Bioepis NL B.V; the second with respect to a series of defendants belonging to the same group of companies, Amgen.
The request for PI has been rejected by the Hamburg LD.
The PI requester’s point of view
The PI requester’s=the applicant for a PI is of the opinion that the patent is valid as
- the refusal of the ED has been set aside by a BA.
- the claimed subject-matter is directly and unambiguously disclosed in the divisional application EP 3 167 888 A1, in the parent application EP 2 359 834 A1 and in the grand parent filed under the PCT as WO 2007/106585.
- the invention is sufficiently disclosed to be carried out by a skilled person. The antibody is defined by its sequences and the sequences are specified in the patent, just like common preparation methods.
- the subject-matter of the patent is also novel. The claimed sequence is not disclosed in the prior art. The subject matter of the patent in suit involves an IS, as assessed in the first and second instance examination proceedings.
The defendants’ point of view
The Defendants argue that the requests for PI must be denied.
They disagree on the construction of claim 2. They are of the opinion that the sequence of the antibody claimed in the patent in suit is not the sequence of eculizumab.
The claims of the patent in suit have been granted by the TBA on the basis of AR5, in the explicit understanding that it protects a different antibody than the products of the parties.
The TBA considered that an antibody with SEQ ID NO: 2 and SEQ ID NO: 4 of the patent in suit was not the same antibody as eculizumab. While the name “eculizumab” was referred to in the specification of the patent, the eculizumab antibody itself (i.e. its sequence) was not sufficiently disclosed. The TBA denied the attempts of the requester to correct the sequence in the description under R 139.
The Defendants further contended that the patent as granted is invalid. The EPO will revoke the patent in the opposition proceedings. The assumption of the TBA that an antibody with an amino acid sequence such as SEQ ID NO. 4 can be used as a pharmaceutical composition, i.e. binds C5, is no longer justified because the requester himself submited that the signal peptide would hinder the interaction with C5.
The claims of the patent as granted are also insufficient for various reasons not explored at the EPO (not reproducible; extending to undisclosed subject matter). Accordingly, there is no sufficient degree of certainty with respect to the validity of the patent in suit.
The LD’s decision
The LD first considered that on summary examination, the defendants’ embodiments make direct and literal use of the technical teaching of the patent protected by claim 2.
Interpretation of the claim
Referring to Art 69(1) EPC and to Art 1 of the Protocol on interpretation, the description and the drawings must always be taken into account as explanatory aids for the interpretation of the patent claim and not only be used to clarify any ambiguities in the patent claim.
At the priority date, the skilled person would have recognized that the sequence ID NO: 4 of the light chain is not correctly reproduced.
In view of the knowledge available to the skilled person, it would have tried to resolve his initial suspicion that SEQ ID No.:4 is erroneous by verifying the sequence of eculizumab in the CAS Database registry for Eculizumab.
A comparison with the SEQ ID No. 4 in the patent in suit indicates that the first 22 amino acids are missing, which clarifies for the skilled person that the missing sequence is indeed a signal peptide.
The skilled person, who is taking the purpose of every patent claim into account, which is to provide the average person skilled in the art with a technical teaching which, when reworked, leads to the intended success of the invention, would conclude, that the light chain SEQ ID NO: 4 does not include the first 22 amino acids, the signal peptide. Otherwise, the technical teaching according to the patent would not provide a pharmaceutical composition that binds C5.
The LD held that the findings of the TBA, when it refused the correction, did not contradict its interpretation of claim 2. The interpretation of a patent claim is not dependent on a no doubt requirement. It is undisputed between the parties thatthe light chain SEQ ID NO: 4 is not able to bind to C5. The skilled person therefore would try to interpret the claim in such a way that it leads to the intended success of the invention, in this case the ability to bind C5 and function as a drug.
Insofar as the TBA has denied that a skilled person would be able to clearly identify the signal peptide of SEQ ID NO: 4, the contrary view of the court does not contradict this. The court reached its conclusion on the basis of the evidence of common general knowledge of the skilled person which has been submitted in the proceedings.
For the LD, the TBA decision was therefore based on different facts than the interpretation of the court, so that no inconsistency can be established.
Validity of the patent
The court has to form its own view on the validity of a patent in dispute. This is an independent review and based on the principles of the EPC. In preliminary measures proceedings, however, the court cannot base its decision solely on its own opinion if an opposition at the EPO against the patent in suit has been filed. If an opposition is pending, the UPC also has to consider the likelihood of a decision invalidating the patent by the EPO. The reason therefore is that the EPO has the competence to invalidate a patent for the EPC countries that cover the UPC territory as whole.
If the UPC regards a patent as valid, this decision would be overruled by an invalidity decision in the EPO opposition proceedings. Therefore, a decision on provisional measures cannot be based solely on the court’s view of the validity of the patent in suit, it is also sufficiently likely that in opposition the patent will be revoked.
In general, the own assessment of the court and the decision of the validity of the patent by the EPO should not be different, as both legal bodies apply the same legal standard, the EPC. There might be a difference, when the court interprets a patent claim differently than the EPO, so that the validity arguments are inevitably different.
Irrespective of the question whether the court considers the patent to be valid in light of the Defendant’s arguments concerning the validity of the patent in suit, it is the opinion of the court that it is reasonably likely that the EPO will revoke the patent due to lack of sufficient disclosure, Art. 83 EPC. The LD noted that the TBA only approved the “unusual” antibody with a light chain including the 22 amino acids.
The TBA concluded that the claimed antibody is sufficiently disclosed in the patent. However, this assumption can no longer be upheld in the present litigation as the requester itself is of the opinion that an antibody with the complete SEQ ID No. 4, i.e. in the presence of the signal peptide, is not functional.
Comments
Interpretation
It is interesting to note that the LD has a different interpretation of the claim than that of the TBA. The TBA refused the correction under R 139, the LD “read it” into its interpretation of the claim.
This is perfectly possible as in infringement Art 69(1) and, more importantly, Art 1 of the Protocol play a fundamental role.
On the other hand, the attitude brought to light is in direct line with, what is considered by lots of people, that the main job of the German Federal Court is to act as a patent reparation authority.
Validity
The LD was aware that a final decision of the EPO could overrule any validity decision of the UPC.
The LD acknowledged that there might be a difference, as the UPC interprets a patent claim differently than the EPO, so that the validity arguments are inevitably different.
The LD thus admitted that when applying Art 69(1) EPC and Art 1 of the Protocol, the results might be different.
This shows how important the answers in referral G 1/24 will be. Should the EPO follow the proposal in Reasons 6.2 and 6.3 of the referring decision, or having recourse to the description only in limited cases. It was for good reasons that the TBA refused the correction under R 139, as the correction would have infringed Art 123(2). The line of case law on the notion of “directly and unambiguously derivable, using common general knwoledge” should not be given up.
UPC_CFI_124/2024 – Samsung Bioepis NL B.V.
https://www.unified-patent-court.org/sites/default/files/files/api_order/2024-06-26%20LD%20Hamburg%20UPC_CFI_123-2024%20ORD_38059-2024%20ACT_13849-2024%20-anonymizid.pdf
UPC_CFI_124/2024 – Amgen
https://www.unified-patent-court.org/sites/default/files/files/api_order/2024-06-26%20LD%20Hamburg%20UPC_CFI_124-2024%20ORD_38032-2024%20ACT_13886-2024%20anonymizied.pdf
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