9 November 2018

T 0969/14 - Partial transfer of priority?

Key points

  • In this opposition appeal case, the question is whether the priority is valid. The priority application D16 was filed by Chiesi, the application that became the patent in suit was filed by Vectura. The question is therefore whether Vectura " owned the priority right resulting from D16" 
  • There is an assignment D22 from Chiesi to Vecture of " rights to the ownership of application 3 (D16)" . However, there is a further assignment D23 "in which Vectura re-assigned to Chiesi the right to claim priority from application 3 (D16) in worldwide patent applications insofar and only insofar as said worldwide patent applications shall claim the Programme 2 formulations." The "Programme 2 formulations" are embodiments of the invention.
  •  The Board first notes that in G1/15 the Enlarged Board has ruled that entitlement to partial priority may not be refused for a generic "OR"  claim. 
  • The Board: "Once it is acknowledged that partial priority rights exist, they must also be transferable separately. This, however, has consequences for the remaining priority right, because the assignor is left with a limited right." 
  • The patentee had argued that according to   T 15/01 there is no exhaustion of priority rights. The Board: "However, an applicant can only claim a right which he owns and this was not the case for the priority right concerning the Programme 2 formulations. An applicant cannot transfer a partial priority right and at the same time keep it for claiming it in a broader context." 
  • The Board finds that "Consequently, the subject-matter of claim 1 as granted encompasses embodiments for which the patent proprietor did not have the priority right and for which therefore the priority is not valid."  
  • The priority is therefore partially invalid.
  • Claim 1 is therefore not novel over D14, a prior right under Article 54(3). D14 validly claims priority of D16 and which discloses embodiments for which the priority of the claim 1 at issue is not valid. Consequently, the main request does not meet the requirements of Article 54(3) EPC.
  • As a comment, I think that the Board assumes too easily that "Once it is acknowledged that partial priority rights exist, they must also be transferable separately." Not everything that exists, can be transferred under law. For example, under Dutch law, claims of a patent can not be transferred:  a person can e.g. be owner of a 50% share of a patent or a patent application, but claim 1 and claim 2 can not have different owners (same for the EPO of course). The same applies to e.g. pedals of a bike under Dutch law. The pedals and the bike can have a different owner once the pedals are removed from the bike, but not as long as the pedals are part of the bike, the owner of the bike is owner of the entire bike. I can perfectly agree to with someone to sell to him the pedals, or to sell to him claim 2 of a patent, but such agreement is without effect as a matter of Dutch property law. Hence, the fact that "partial priority" exists as a matter of patent law, does not mean that it is separately transferable. The latter is a priori a matter of national law. If Dutch law is the applicable national law, it must be concluded that the assignment D22 is without effect as to the ownership of the priority right (under Dutch law, there is a strict distinction between agreements and ownership, as in German law). 
  • Auxiliary Request 4 adds a disclaimer to exclude the "Programme 2 formulations", the disclaimer feature was in claim 17 of the application as filed."The amendment brought to claim 1 of this request overcomes all issues as regards the validity of the priority and the relevance of D14 under Article 54(3) EPC." However, AR4 is not admitted because it was filed with the Statement of grounds. "The patent proprietor could have filed a request disclaiming the formulations for which the priority was not valid. He even had an express basis for this in claim 17 as filed and in claim 16 as granted to address this very issue." The request should have been filed before the OD.



EPO T0969/14 -  link


Reasons for the Decision
1. Validity of the priority
1.1 Pursuant to Article 87(1) EPC, a right of priority originates in the applicant of a first application. Therefore, in principle, the applicant has to be the same for the first application and for the subsequent application for which the right of priority is invoked. However, pursuant to Article 87(1) EPC, the right of priority may also be invoked by the "successor in title" of the person who has filed the first application. By reference to the "successor in title", it is recognised that the right of priority, being a legal right, may be transferred from the original applicant to a third person. It is generally accepted that the right of priority is transferable independently of the corresponding first application. The transfer must have occurred before the filing date of the subsequent application. This is well established jurisprudence of the Boards of Appeal (cf T 205/14 of 18 June 2015, with further references).


1.2 The application EP 00113608.4 (D16) was filed on 27 June 2000 in the name of Chiesi Farmaceutici SpA (in the following Chiesi), and the application which became the contested patent was filed in the name of Vectura Ltd (in the following Vectura) on 17 April 2001. Thus, it needs to be decided whether or not on the date of filing of the present application Vectura owned the priority right resulting from D16. As to this regard,the appellant has submitted documents D19, D20, D22, D23 and D24 to prove the transfer of the right of priority.
1.2.1 D19, the only assignment document filed before the opposition division, is a Confirmatory Assignment, confirming the transfer of the rights in application 3 (i.e. D16) effected by a Supplemental Agreement. From this it is not clear whether only the application or also the priority right had been transferred.
1.2.2 The Supplemental Agreement (D22) was only filed in appeal proceedings. In point 2 of it, Chiesi assigns to Vectura its rights to the ownership of application 3 (D16), but subject to the terms of this Supplemental Agreement. In point 4 it is specified that Chiesi agrees to file one or more applications taking priority from i.a. application 3 (D16) and relating to the specific Programme 2 formulations. For this purpose, Vectura will provide to Ciesi before 1 February 2001 a formal assignment of the right to claim priority for such applications from application 3 (D16). Point 5 contains that before 17 April 2001, Vectura will continue with a separate application based around the broader claims of application 3 (D16) but not including claims directed to the specific Programme 2 formulations.
In pursuance of this agreement, an assignment was executed on 13 April 2001 (D23), in which Vectura re-assigned to Chiesi the right to claim priority from application 3 (D16) in worldwide patent applications insofar and only insofar as said worldwide patent applications shall claim the Programme 2 formulations. From this it is clear that Vectura owned, at the date of filing of their patent application, the priority right from D16, with the exception of the priority right for the Programme 2 formulations. In Schedule 2 attached to D23, the Programme 2 formulations are identified to be formulations comprising magnesium stearate in combination with specific active agents, namely "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone". These formulations are the subject of application D14 which was filed by Chiesi, implementing the agreement with Vectura and for which Chiesi owned the priority right.
1.2.3 In decision G 1/15 (OJ EPO 2017, 82) the Enlarged Board of Appeal has ruled that entitlement to partial priority may not be refused for a claim encompassing alternative subject-matter by virtue of one or more generic expressions or otherwise (generic "OR"-claim) provided that said alternative subject-matter has been disclosed for the first time, directly, or at least implicitly, unambiguously and in an enabling manner in the priority document. In the present case, the so called Programme 2 formulations are explicitly disclosed in D16 (e.g. in claims 8 and 12) and thus can form a basis for a partial priority right. Once it is acknowledged that partial priority rights exist, they must also be transferable separately. This, however, has consequences for the remaining priority right, because the assignor is left with a limited right. The appellant (patent proprietor) referred to decision T 15/01 (OJ EPO 2006, 153) which ruled that the same priority right may be validly claimed in more than one European patent application and that there was no exhaustion of priority rights. Therefore, he was entitled to claim priority from D16 for the whole subject matter of his broader claim. However, an applicant can only claim a right which he owns and this was not the case for the priority right concerning the Programme 2 formulations. An applicant cannot transfer a partial priority right and at the same time keep it for claiming it in a broader context.
1.2.4 Therefore, the priority situation in the present case can be illustrated as follows:
FORMULA/TABLE/GRAPHIC
A is the priority right owned by Vectura and encompasses any formulations excluding the specific formulations B.
B is the priority right owned by Chiesi and relates to the specific "Programme 2 formulations" comprising magnesium stearate in combination with specific active agents, namely "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone".
The agreements between Chiesi and Vectura on the priority rights give therefore a respective partial priority right to each company corresponding to two alternatives clearly distinct and precisely defined.
1.3 The subject-matter of the claims as granted, namely the main request is broader than the subject-matter covered by the priority right owned by Vectura, encompassing any formulations excluding the specific formulations B.
The subject-matter of the claims as granted relates indeed to formulations without any restriction as to the nature of the active agents or of the excipient and additive, with a unique restriction regarding the preparation of the fraction of fine particle size, namely "a fraction of fine particle size constituted of a mixture prepared by co-micronising a physiologically acceptable excipient and an additive".
Hence, said claimed subject-matter covers explicitly also the specific formulations defined as "Programme 2 formulations" with "a fraction of fine particle size constituted of a mixture prepared by co-micronising a physiologically acceptable excipient and an additive".
The subject-matter of claim 1 of the claims as granted of the contested patent can thus be represented as follows:
FORMULA/TABLE/GRAPHIC
Wherein:
- A is the claimed subject-matter which encompasses any formulation comprising a co-micronised physiologically acceptable excipient and an additive, including specific formulations wherein magnesium stearate has been co-micronised with the excipient, and wherein the active agent may be "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone".
- B is the priority right owned by Chiesi and the subject-matter of the application D14 relating to the specific "Programme 2 formulations" comprising magnesium stearate in combination with specific active agents, namely "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone" and wherein magnesium stearate has been co-micronised with the excipient or not.
It appears clear that the subject-matter of claim 1 encompasses formulations for which there is no valid priority right, shown in black:
FORMULA/TABLE/GRAPHIC
This subject-matter relates to specific formulations of magnesium stearate with "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone" wherein magnesium stearate has been co-micronised with the excipient.
Consequently, the subject-matter of claim 1 as granted encompasses embodiments for which the patent proprietor did not have the priority right and for which therefore the priority is not valid.
1.4 Hence, the priority of the contested patent is not valid as far as a combination of magnesium stearate with "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone" as active ingredient is concerned (Article 87(1) EPC).
2. Main request - Novelty over D14
D14 claims a valid priority from application (D16), which is dated prior to the filing date of the contested patent, whose priority claim is not valid.
D14 discloses powder compositions comprising magnesium stearate as additive with an active ingredient selected from budesonise and its epimers, formoterol, TA 2005 and its stereoisomers, their salts and combinations; in D14, the excipient particles and magnesium stearate were also co-micronised to a size of less than 35 mym (see claims 1 and 10 and the examples).
Consequently, this document shows all features of claim 1 of the main request. This has not been contested by the appellant.
Consequently, the main request does not meet the requirements of Article 54(3) EPC.
3. Auxiliary request 1 - Validity of the priority and novelty over D14
The subject-matter of claim 1 of auxiliary request has been restricted by the feature "wherein the additive is magnesium stearate". This restriction has no incidence on the validity of the priority, since the claimed subject-matter still covers embodiments for which the priority is not valid, namely compositions comprising magnesium stearate and active ingredients selected from "formoterol alone, or in combination with beclomethasone or budesonide, and budesonide alone"; the restriction has also no incidence on the relevance of D14 since this document also discloses magnesium stearate as additive.
Hence, D14 is novelty destroying for auxiliary request 1 which therefore does not meet the requirements of Article 54(3) EPC.
4. Auxiliary request 2 - Validity of the priority and novelty over D14
The subject-matter of claim 1 of auxiliary request 2 corresponds to the subject-matter of the process claim 18 as granted with the product features of claim 1 as granted. As for the main request and auxiliary request 1 and for the same reasons, these amendments do not have any incidence as to the validity of the priority and the relevance of D14.
Hence, auxiliary request 2 does not meet the requirements of Article 54(3) EPC.
5. Auxiliary request 3 - Validity of the priority and novelty over D14
The subject-matter of claim 1 of auxiliary request has been restricted by the size of the carrier particles, which is the same than in D14 (see D14, page 12, 3rd par.). As for the main request and for auxiliary request 1 and for the same reasons, this amendment does not have any incidence as to the validity of the priority and the relevance of D14.
Hence, auxiliary request 3 does not meet the requirements of Article 54(3) EPC.
6. Auxiliary request 4 - Admission into the proceedings
6.1 The subject-matter of claim 1 of this request has been restricted by the disclaimer "wherein the additive is magnesium stearate and the active ingredient(s) is (are) not selected from budesonide and its epimers, formoterol, TA2005 and its stereoisomers, salts thereof, and combinations thereof", which was disclosed in claim 17 of the application as originally filed and in claim 16 of the patent as granted.
This request has not been submitted during the opposition proceedings, and has been filed for the first time with the statement of grounds of appeal.
The amendment brought to claim 1 of this request overcomes all issues as regards the validity of the priority and the relevance of D14 under Article 54(3) EPC.
6.2 According to Article 12(4) RPBA, the admission into the proceedings of a new request which could have been submitted by a party in the first instance proceedings is at the Board's discretion. When exercising its discretion the Board must take due account of the judicial nature of the appeal procedure and the interests of the parties concerned. Admission of a new request into the proceedings hinges on the question whether a party to appeal proceedings was in a position to make its submission earlier, and whether it could have been expected to do so under the circumstances (see e.g. T 301/11, T 23/10). In the present case the issue of validity of the priority and the resulting relevance of D14 was a point already raised in the notice of opposition by the opponent. In its summons to oral proceedings, the opposition division took the preliminary opinion that D14 was prior art pursuant to Article 54(3) EPC. The patentee was therefore fully aware of the relevance of this issue.
The patent proprietor could have filed a request disclaiming the formulations for which the priority was not valid. He even had an express basis for this in claim 17 as filed and in claim 16 as granted to address this very issue.
Even in the absence of documents D22 and D23 in the opposition proceedings, the introduction of the disclaimer would have de facto restored the priority right of the contested patent and would have excluded D14 from the relevant prior art; this introduction would have allowed the opposition division to take a complete decision on all grounds and points as regards the validity of the contested patent.
Moreover, the confidential status as such of D22 and D23 cannot be seen as a reason to not submit the subject-matter of auxiliary request 4 during the opposition proceedings since the patentee was aware of the partial priority right assigned to Chiesi.
6.3 The appeal procedure is a judicial procedure, separate from the preceding purely administrative opposition procedure, in which an administrative decision of an opposition division is reviewed by a judicial authority. Its function is mainly to give the losing party an opportunity to challenge the administrative decision against it and to obtain a judicial ruling on whether this decision is correct (G 10/91, OJ EPO 1993, 420, Reasons point 18). Since the appeal board, as a review instance, cannot be expected to deal with all the outstanding issues after the amendment of the appellant's case, admission of the auxiliary requests into the proceedings would give the appellant the opportunity to compel the board to remit the case. This would be contrary to a reliable and fair conduct of proceedings (T 301/11 of 3 February 2015). It follows from that that bringing an entirely fresh case is not in line with the purpose of the appeal proceedings.
6.4 Consequently, the Board exercises its discretionary power and decides to not admit auxiliary request 4 in the the appeal proceedings (Article 12(4) RPBA).
Order
For these reasons it is decided that:
The appeal is dismissed.

No comments:

Post a Comment

Do not use hyperlinks in comment text or user name. Comments are welcome, even though they are strictly moderated (no politics). Moderation can take some time.