In his Pensées, Blaise Pascal noted:
“On what shall man found the order of the world which he would govern? Shall it be on the caprice of each individual? What confusion! Shall it be on justice? Man is ignorant of it. Certainly had he known it, he would not have established this maxim, the most general of all that obtain among men, that each should follow the custom of his own country. The glory of true equity would have brought all nations under subjection, and legislators would not have taken as their model the fancies and caprice of Persians and Germans instead of this unchanging justice. We should have seen it set up in all the States on earth and in all times; whereas we see neither justice nor injustice which does not change its nature with change in climate. Three degrees of latitude reverse all jurisprudence; a meridian decides the truth. Fundamental laws change after a few years of possession; right has its epochs; the entry of Saturn into the Lion marks to us the origin of such and such a crime. A strange justice that is bounded by a river! Truth on this side of the Pyrenees, error on the other side.”
The present decision shows that Pascal’s observation also holds true in patent law.
The Board had to decide on an appeal by the patent proprietors against the decision of the Opposition Division (OD) to maintain the opposed patent in amended form.
One of the core questions before the Board was whether the claims were entitled to the priority.
NB: All legal provisions refer to the EPC 1973.
[6] The assessment of inventive step hinges on the question whether or not document D3 constitutes prior art pursuant to A 54(2). In the decision under appeal it was held that it does, because the subject-matter of claim 1 cannot claim priority from the US application No. 835,799 […].
The board also comes to the conclusion that the subject-matter of claim 1 cannot claim priority from the US application No. 835,799, but by a line of reasoning which differs from that of the OD.
[7] A 87(1), inter alia, stipulates that the right to priority for the purpose of filing a European patent application can only be enjoyed insofar as the earlier application and the later European application disclose the “same invention”.
[8] In its decision G 2/93 [5] and particularly in decision G 2/98 [9] the Enlarged Board of Appeal (EBA) held that the expression the “same invention” means the “same subject-matter”. In G 2/98 [9] the EBA established further that – in agreement with the standard applied for determining the disclosure content of documents in the context of novelty and amendments in a European patent application or patent – “subject-matter” is considered as “disclosed” in an earlier application if the skilled person can derive it directly and unambiguously, using common general knowledge, from the earlier application as a whole.
[9] Furthermore, following the principle that a document must contain an “enabling” disclosure for it to be considered to be detrimental to the novelty of claimed subject-matter, it was also established by the case law that the requirement in A 87(1) that there be the “same invention” implies that the earlier application must disclose the invention claimed in the later European application in such a way that a skilled person can carry it out (see for example Case Law of the Boards of Appeal, 6th edition 2010, V.B.3).
[10] It follows from the considerations in points [8] and [9] above that for the purposes of determining the right to priority from an earlier application for a later European application, the assessment of the disclosure content of the earlier application is made in accordance with the EPC and its interpretation by the case law (see for example also EPÜ: Münchner Gemeinschaftskommentar, eds.: Beier, Haertel, Schricker; 15th edition, April 1991, Art. 53, Moufang, R., marginal note 151).
[11] Present claim 1 relates to “[a] soluble ligand which comprises at least a binding portion of an immunoglobulin molecule, in which the immunoglobulin molecule is capable of competitively inhibiting the binding of monoclonal antibody MR1 as produced by a hybridoma cell line deposited with the ATCC and assigned accession number HB 11048, to CD40CR molecule, [...].”
[12] The patent at issue discloses that for the generation of the immunoglobulin molecules, the binding portions of which are then to be used for generating the soluble ligands according to claim 1, the immunization is carried out with D1.6 cells, i.e. I-Ad-restricted, rabbit Ig-speific Th1 cells (paragraphs [0076] and [0087]). These cells have embedded in their membrane the CD40CR. Thus, the immunization results in immunoglobulins (antibodies) binding to membrane components of D1.6 cells including any immunoglobulins binding to the CD40CR, i.e. it results not in just those which are “capable of competitively inhibiting the binding of monoclonal antibody MR1 as produced by hybridoma cell line deposited with the ATCC and assigned accession number HB 11048”.
[13] Thus, in order to reproduce the invention characterized in claim 1, the antibody MR1 is indispensable for the skilled person to be able to select from all of the produced immunoglobulins those having the property of being “capable of competitively inhibiting the binding of monoclonal antibody MR1 as produced by hybridoma cell line deposited with the ATCC and assigned accession number HB 11048.”
[14] As to the question of whether or not the US application No. 835,799 provides an enabling disclosure for the subject-matter of claim 1, the appellants neither argue that this US application discloses itself a process by which a hybridoma cell line with the properties of the hybridoma cell line deposited with the ATCC and assigned accession number HB 11048 could be made, nor that such a process belonged to the common general knowledge, nor that the antibody MR1 or the hybridoma cell line “HB 11048” were publicly available at the date of filing the US application No. 835,799.
Thus, the “written” disclosure in the US application No. 835,799, even if supplemented by common general knowledge, would not enable the skilled person to carry out the invention characterized in claim 1.
[15] For inventions which use biological material and where a mere written description is not sufficient to enable a person skilled in the art to carry out the invention, the EPC foresees in R 28 that this deficiency can be made good by a valid deposit of the biological material at a recognized depositary institution.
[16] However, R 28 is concerned with the requirement of sufficiency of disclosure in relation to a European patent application.
It is stipulated in R 28(1):
“If an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention [...].” (emphasis added).
Thus – and this is also a view taken in the legal literature (see for example EPÜ: Münchner Gemeinschaftskommentar, eds.: Beier, Haertel, Schricker; 15th edition, April 1991, Art. 53, Moufang, R., marginal note 151) – there are no explicit provisions in the EPC as to when a deposit of biological material has to be made in relation to an earlier application in order to ensure that a later European patent application can enjoy the right to priority from that earlier application.
[17] However, the EBA has held that the requirement of sufficiency of disclosure must be complied with at the date of filing of the European application or – in relation to an earlier application from which priority is claimed – at the date of filing of that earlier application (see decision G 2/93 [10] and decision G 1/03 [2.5.3]).
In its decision G 1/03 [2.5.3] the EBA states:
“The same must apply if sufficiency of disclosure is at stake. When an application for a patent is filed, the process of making the invention has to be completed. The requirement of sufficiency of disclosure ensures that a patent is only granted if there is a corresponding contribution to the state of the art. Such a contribution is not present as long as the person skilled in the art is not able to carry out the invention. Therefore, the decisive date for fulfilling the requirement has to be the date of filing or priority, as the case may be. Deficiencies in this respect cannot be remedied during the proceedings before the EPO.” (emphasis added).
[18] Thus, the board judges that if the deposit of biological material is necessary for the requirement of sufficiency of disclosure to be fulfilled for a “priority application”, the deposit of this material must have been made no later than the date of filing of that earlier application.
[19] The above cited case law is reflected in the “Notice of the European Patent Office dated 18 July 1986 concerning European patent applications and European patents in which reference is made to microorganisms” (OJ 1986, 269). It is stated in point 8:
“Where a European patent application claims the priority of a previous application in accordance with A 87 to 89, the general conditions covering disclosure of the invention in the previous application apply to the micro-organism. In particular, if an invention, in order to be sufficiently disclosed, requires the deposit of a micro-organism culture to supplement the written description, the culture must have been deposited not later than the date of filing of the previous application. The depositary institution and the legal statute under which the micro-organism is deposited must comply with the requirements of the country in which the previous application has been filed. The previous application must also refer to this deposit in a manner enabling it to be identified.” (emphasis added).
[19.1] The position taken in this “Notice” from the year 1986 was later confirmed in relation to the EPC 2000 by a “Notice” of 7 July 2010 concerning the same subject (“Notice from the European Patent Office dated 7 July 2010 concerning inventions which involve the use of or concern biological material”, (OJ 2010, 498); see point 1.4).
[20] The view that, if a later European application claims the right of priority from an earlier application, the deposit of biological material has to have been made not later than the filing date of the earlier application is also endorsed in the legal literature (see for example EPÜ: Münchner Gemeinschaftskommentar, eds.: Beier, Haertel, Schricker; 15th edition, April 1991, Art. 53, Moufang, R., marginal note 150).
[21] In the present case – and this is undisputed – the hybridoma cell line producing the antibody MR1 has been deposited with the ATCC on 22 May 1992, i.e. only after the filing date of the US application No. 835,799.
[22] The appellants argue that it should be sufficient for ensuring a valid right to priority that the deposit of biological material is made at latest at the date of filing of the later European patent application in view of R 28(1) which explicitly refers to the “date of filing of the application”.
[22.1] However, the appellants’ reference to R 28 does not convince the board because this Rule lays down the requirements for a valid deposit in relation to European patent applications (see point [16] above).
[23] In a further line of argument the appellants refer, on the one hand, to A 87(2) stating that “every filing that is equivalent to a regular national filing [...] shall be recognized as giving rise to a right of priority” and, on the other hand, to case law in relation to US patent applications – “In re Lundak”, 773F.2d 1216 (Fed. Cir. 1985) – according to which “[t]he enablement requirement of §112, first paragraph does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of the access (...) prior to or during pendency of the application, so that, upon issuance of a U.S. patent on the application, the public will, in fact, receive something in return for the patent grant”.
The appellants therefore argue that, since a deposit in relation to a US application is not necessary at its date of filing, but must only be made at the latest before the grant of the corresponding patent, the US application No. 835,799 at issue here complies with the requirements of US patent law. It must therefore be considered as a regular national filing and thus, in accordance with A87(2), must give a right to priority.
[23.1] However, what A 87(2) and the complementing A 87(3) – which reads “[b]y a regular national filing is meant any filing that is sufficient to establish the date on which the application was filed, whatever may be the outcome of the application” – merely set out is that the date of filing of an application that may give rise to a right to priority under the EPC is accorded in accordance with national law for the purposes of A 87(1). It cannot be inferred from these provisions that the standards of national law are applied in relation to other requirements of a potential priority application, for example, in relation to criteria for determining the disclosure content of such an application. As observed in point [10] above, whether an earlier application and a subsequent European application disclose the “same invention” is assessed in accordance with the EPC and not, in respect of the earlier application, in accordance with the law of the state in which this earlier application is filed.
Therefore, the reference to A 87(2) does not convince the board either.
[23.2] In the light of the citation from the decision of the Federal Circuit “In re Lundak” (see point [22] above) the board accepts that, when it comes to the point in time when a deposit of biological material has to be made in order to fulfil the sufficiency-requirement according to the EPC and the enablement-requirement according to US patent law, the provisions according to the EPC were stricter than those of the US law.
[24] It is thus undeniable that in a situation where a deposit of biological material was necessary for a disclosure in an earlier application to be accepted as being “sufficient”, this had the consequence depicted by the appellants, namely that an applicant who filed an application at the US patent office had, already when drafting the US application, to take account of the requirements to be complied with in countries or regions that were eligible for filing subsequent applications claiming the priority of the first application. That may be inconvenient for applicants for European patents claiming priority from US applications, but it is the consequence of the distinct provisions of the two legal regimes.
[24.1] The board notes however that it was and is not uncommon when drafting potential priority applications that differences in the patent laws of different countries and/or their interpretation have to be taken into account. Another such example appears to be the different interpretation of the disclosure content of “closed ranges” of numerical parameters according to German and European patent law practice (although this may be harmonised if the principles developed by the German Federal Supreme Court in its decision “Olanzapin” (BGH X ZR 89/07) should be applied to “closed ranges”). While according to the present German jurisprudence the indication of a closed range by a start and an end point is considered as disclosing all intermediate points within this range (see Patentgesetz mit EPÜ, ed.: Schulte, R.; 8th edition, 2008; § 3, marginal note 104 and the decisions referred to therein by reference to foot note 232), this is not necessarily considered to be so according to the case law in relation to the EPC (see for example the decisions cited in Case Law, 6th edition 2010, I.C.4.2). If this difference is not taken into account when drafting and filing a German application, this may have the consequence that a later European application claiming only an intermediate point or intermediate part of the complete range disclosed in the earlier German application may not be allowed to rely on that earlier application for claiming priority.
[25] To sum up, the board comes to the conclusion that, due to the failure to deposit the hybridoma cell line producing the antibody MR1 no later than the filing date of the US application No. 835,799 (see point [21] above), this US application does not provide a disclosure which is sufficient for the skilled person to carry out the invention claimed in present claim 1. Therefore, the requirement of the “same invention” according to A 87(1) cannot be considered as being fulfilled (see point [9] above). Hence, claim 1 cannot enjoy the right of priority from the US application No. 835,799.
[26] In decision T 542/95 the opponent had objected to the right of priority based on the argument that a deposited hybridoma, that was referred to in the claims and that would be essential for carrying out the invention, had not been deposited at the priority date. The board dealing with that case acknowledged the claim to priority because the remaining features in the claim characterized the subject-matter in a unique manner such that feature relating to the hybridoma could “now be regarded as a mere surplus definition”. Thus, the circumstances of that case are different from those in the present one insofar as in the present case the hybridoma is considered as essential for carrying out the invention (see points [11] to [13] above).
[27] It follows from the foregoing observations that the relevant date for determining the state of the art pursuant to A 54(2) is the filing date of the European application. Hence, document D3 constitutes prior art in accordance with A 54(2).
The Board then found the claim to correspond to an arbitrary selection and, consequently, to lack inventive step.
The appeal was dismissed.
Should you wish to download the whole decision, just click here.
The file wrapper can be found here.
9 comments:
Quelle sublime érudition, Blaise comme compagnon de chevet!
Interesting case, even if it is a bit specialised.
An important decision for biotech, and one that may lead to the invalidation of many other patents. Good arguments for deciding either way, but of course the EPO decided against the inventor. Colour me shocked.
Well, Fly, you call it "a bit specialised" but the principle at stake here, and so usefully here reinforced and confirmed, is not "specialised" at all, is it. How thankful I am that the EPO treats the "disclosure" of a document always the same, irrespective whether is is under Art 54 or Art 123(2) or Art 87. Otherwise, there would be chaos in the house.
Max,
I used the word "specialised" because this decision is really only relevant for the field of biotech and its peculiar set of rules.
I, as a biotech dilettante, find it curious on a philosophical level that sufficiency of disclosure could be established by a (perishable) physical artifact. It reminds me somehow of the working models which had to be filed up at the USPTO up to the end of the nineteenth century.
It would have been surprising in anycase surprised that the outcome of this case would diverge from OJ 2010, p. 498:
The depository institution and the legal statute under which the biological material is deposited must comply with the requirements of the country in which the previous application was filed. The previous application must also refer to this deposit in a manner enabling it to be identified. For the purposes of disclosure of the invention in the European patent application claiming priority however, the requirements of Rule 31 EPC must be fulfilled, i.e. the deposit must have been effected with a recognised depository institution under the Budapest Treaty not later than the date of filing of the European patent application [...].
I have a problem with the general conditions under which biological material is made available to the public under the Budapest treaty. Even if the "expert solution" is not retained the applicant is informed of any third-party requests for samples. The wording of the declaration under Rule 32(2) is not limited either to designated EPC states, and seems to confer rights to the applicant extending beyond those strictly defined by the patent.
The OJ furthermore states:
3.3 Applicants are strongly advised to file the deposit receipt issued by the recognised depository institution in order to enable the EPO to ascertain whether the requirements laid down in Rule 31(1) EPC have been fulfilled.
This advice is provided in several forms, e.g. IIRC in the instructions for filling form 1200. There is no obligation for the applicant to actually provide proof that the deposit really occurred. If as a third party I were to investigate the matter, I see no other way but to make a real request to the deposit authority using EPO form 1140. Furthermore, technical information for maintaining the strain is held by the authority, but not necessarily part of the application.
I find it a bit surprising that the prosecution lasted the full term of the patent, considering that it is rather simple (straightforward examination, only one opponent, no procedural fireworks). The wrapper contains a measly 737 sheets. There was incidentally also arguments made concerning sample contamination, but it wasn't a factor in the decision.
Just thinking out loud here but is there not a difference between i) the sort of enablement that is needed in a document before it can be useful as a novelty destrover and ii) the sort of sufficiency in the description that is needed to satisfy Art 83 EPC in relation to any particular claim?
I'm thinking that in the former case all I need is something enabled within the scope of the claim under attack whreeas in the latter case the sort of enablement I need is the sort that extends over the full scope of the claim.
But which of these two is needed under Art 87 EPC to take a claim back to a Paris priority date? The latter, I suppose.
Just thinking out loud here but is there not a difference between i) the sort of enablement that is needed in a document before it can be useful as a novelty destrover and ii) the sort of sufficiency in the description that is needed to satisfy Art 83 EPC in relation to any particular claim?
Your question sounds reminds of the old debate on whether the skilled person for Art. 56 is the same one for the assessment of Art. 83 compliance.
What pops into my mind on this subject are perpetual motion devices, or comparable impossible stuff that you will see in many fields. I already had problems with arguing a lack of inventive step for improbable gibberish. What kind of cr*p artist would constitute a person skilled in the science of nonsense?
When I think about this, I even begin having a problem with assessing novelty. An examiner will argue that the invention does not meet Art. 83, and will then for good measure cite a document for Art. 54(2), if she finds one. Usually it could be a paper or a book debunking the fallacy behind the alleged "invention". You will read into it the wording of the claim, but is it "enabling" in the sense of the Guidelines? These demand that the information given [in the document] to the skilled person is sufficient to enable him [...] to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at that time in the field to be expected of him [...]. But the document you cite argues exactly the opposite of "enablement".
Or, in a similar vein, the inventor was kind enough to publicly brag about his fairy-tale contraption before the filing date. Can you oppose this as prior art if the disclosure is as hare-brained as the application?
I do have some very specific cases in mind.
The general context: the EPO unfortunately grants patents to snake-oil peddlers, who then proceed to use this official "endorsement" in their advertising, like they also do with TÜV-certificates. (here is an example from a competitor, who markets a comparable magic contraption).
I'm thinking that in the former case all I need is something enabled within the scope of the claim under attack whreeas in the latter case the sort of enablement I need is the sort that extends over the full scope of the claim.
I don't really see a problem. If the claim as it stands is understandable and minimally enabled to the skilled person who reads it, then the same should probably apply to your prior art.
But which of these two is needed under Art 87 EPC to take a claim back to a Paris priority date? The latter, I suppose.
It would all depend, classically, on whether you represent the applicant/proprietor or opponent/infringer...
Just thinking out loud here but is there not a difference between i) the sort of enablement that is needed in a document before it can be useful as a novelty destrover and ii) the sort of sufficiency in the description that is needed to satisfy Art 83 EPC in relation to any particular claim?
I'm thinking that in the former case all I need is something enabled within the scope of the claim under attack whreeas in the latter case the sort of enablement I need is the sort that extends over the full scope of the claim.
This is a very fair and fine distinction, but the present case is not a matter of enablement over the whole scope of the claim. It is the novelty test which is not enabled here.
Present claim 1 relates to “[a] soluble ligand which comprises at least a binding portion of an immunoglobulin molecule, in which the immunoglobulin molecule is capable of competitively inhibiting the binding of monoclonal antibody MR1 as produced by a hybridoma cell line deposited with the ATCC and assigned accession number HB 11048, to CD40CR molecule, [...].”
While it could be that a previous antibody against CD40CR falls under the scope of claim 1, you simply cannot identify it without access to mAb MR1 to do a competition assay. Much less could you produce ANY SINGLE embodiment within the scope of the claim without MR1 or the corresponding hybridoma.
To allow such a claim would amount to accepting novelty of a product because the applicant has invented a new test (a new parameter) for it. This would be worse than patents on useless snake oil.
@MaxDrei:
But which of these two is needed under Art 87 EPC to take a claim back to a Paris priority date? The latter, I suppose.
I think so too. In my view,for an application to benefit from a priority claim, the priority document should already contain all the information that the patent application needs to contain, which includes the information needed to comply with Art. 83 (i.e. enablement over the full scope of the claimed subject-matter). If anything still needs to be added to the priority document, it is not fair to protect the applicant against intermediate disclosures.
Thanks for that, Myshkin. I think that's a nice way to express the core issue.
Post a Comment