T 1045/16 - Budapest Treaty deposit

Key points

• The patent a melon plant “comprising an introgression from a plant of melon accession PI313970”. The patentee argues that these melons plants were publicly available and “ould be ordered directly from the website of the US National Plant Germplasm System”. The Board considers the invention to be insufficiently disclosed. 
• Rule 31 EPC specifies that “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 to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Article 83 if: [a valid deposit under the Budapest Treaty was made of a sample of the biological material”.
• The patentee does not dispute that the deposit with the US National Plant Germplasm System is not a deposit under the Budapest treaty as it is not a recognized institute. The patentee argues that the deposit makes the material available to the public in the sense of Rule 31 EPC.
• The Board does not accept this argument. “To be considered "available to the public" in the sense of Rule 31(1) EPC, a biological material must therefore be available in a manner that allows the skilled person to be certain that they can obtain it at least over the term of the patent. By way of illustration, examples of such biological material are brewers yeast and Escherichia coli in general, or indeed melon plants in general. Non-examples are specific, non-generic strains of microorganism or indeed accessions of plants only available from a non-Budapest Treaty institution.”
• I add from the decision that “It was common ground that, to carry out the invention in the sense of Article 83 EPC, the person skilled in the art required access to propagating material (e.g. seeds) containing the CYSDV-resistance-conferring QTL and marker, identical to or derived from melon accession PI313970 (the "relevant biological material"), see Section X., above. It was further not in dispute that there was no deposit of such material with a recognised depositary institution as set out in Rule 31(1)(a) EPC.”
  
  
• As a comment, I note that one opponent had submitted that PI313970 “originates from India ... the patent is a misappropriation of genetic material as provided by seed banks and originally stemming from India” (https://register.epo.org/application?documentId=ESSUE2GM3432900&number=EP06835672&lng=en&npl=false, p. 7, bottom). 
• The OD decision states, p.11, that PI313970 was originally isolated in India in 1961.
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T 1045/16 

https://www.epo.org/law-practice/case-law-appeals/recent/t161045eu1.html

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is admissible.

Admissibility of the opposition of opponent 2

2. In the board's view, the opponents comprised in the joint opposition are the legal and natural persons indicated in bold in the notice of opposition of opponent 2, dated 3 February 2012, at pages 1 to 2. It is apparent that Christoph Then, whose name is indicated in bold in the notice of opposition, is one of the joint opponents and, at the same time, the common representative of them. Therefore, the Board agrees with the assessment of the opposition division that the identity of the persons participating in the joint opposition is clear, and the opposition is admissible.

Main request - claim 1

Disclosure of the invention (Article 83 EPC/Rule 31 EPC)

3. The requirements of Article 83 EPC are met if the European patent discloses the claimed invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Special provision is made in Rule 31 EPC for inventions which involve the use of or concern 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 to be carried out by a person skilled in the art. In such cases, Rule 31(a) EPC provides that the invention is regarded as being disclosed as prescribed in Article 83 EPC only if a sample of the biological material has been deposited with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977 not later than the date of filing of the application.

4. It was common ground that, to carry out the invention in the sense of Article 83 EPC, the person skilled in the art required access to propagating material (e.g. seeds) containing the CYSDV-resistance-conferring QTL and marker, identical to or derived from melon accession PI313970 (the "relevant biological material"), see Section X., above. It was further not in dispute that there was no deposit of such material with a recognised depositary institution as set out in Rule 31(1)(a) EPC.

5. A deposit according to the Budapest Treaty is necessary under Rule 31(1)(a) EPC only in cases where the relevant biological material is not available to the public. Hence, it must be determined whether or not the relevant biological material in question was available to the public. This requires that the meaning of the expression "available to the public" in the context of Rule 31(1) EPC is first established.

6. According to decision G 2/93 of the Enlarged Board of Appeal, Rule 28(1) EPC 1973 [Rule 31(1) EPC 2000] refers to Article 83 EPC and serves to substantiate and to supplement the general requirements of that Article for a specific group of inventions for which a mere written description is not sufficient to enable a person skilled in the art to carry out the invention. Therefore, its provisions are subordinate to the requirements of Article 83 EPC (see Reasons, point 9).

7. It follows from the subordination of Rule 31 EPC to Article 83 EPC that the requirement that a biological material be "available to the public" in the sense of Rule 31(1) EPC serves to ensure that the person skilled in the art can carry out the invention.

8. It is also evident that the requirements of Article 83 EPC are not time limited. The skilled person must be able to carry out the invention at least over the entire term of the patent. This concept is fundamental to patent law: for example, the UK Supreme Court, in Warner-Lambert v Mylan & Actavis ([2018] UKSC 56, point 17) held that "the juridical basis on which patents are granted, [is] sometimes called the "patent bargain". [According to which] The inventor obtains a monopoly in return for disclosing the invention and dedicating it to the public for use after the monopoly has expired".

9. Thus, "available to the public" in Rule 31(1) EPC means available in a manner that guarantees that the skilled person can carry out the invention at least over the whole term of the patent.

10. To be considered "available to the public" in the sense of Rule 31(1) EPC, a biological material must therefore be available in a manner that allows the skilled person to be certain that they can obtain it at least over the term of the patent. By way of illustration, examples of such biological material are brewers yeast and Escherichia coli in general, or indeed melon plants in general. Non-examples are specific, non-generic strains of microorganism or indeed accessions of plants only available from a non-Budapest Treaty institution. Deposit with a non-Budapest Treaty institution cannot ensure availability to the public because Rule 31(1) EPC stipulates that biological material which is "not available to the public" is to be "deposited with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty".

11. Thus, in the the light of Rule 31(1) EPC, the availability of plants of the accession PI313970 from the US National Plant Germplasm System is not sufficient to ensure that the relevant person skilled in the art can practice the claimed invention during the term of the patent at issue.

12. According to the appellant, the mention of accession PI313970 in documents D1, D3 and D13 proves the availability of plants of the accession PI313970 to the public at the points in time of these publications. However, it follows from the considerations in point 7 above and from the established case law of the Boards of Appeal that the mention of the biological material in a scientific publication does not per se establish that said material is available to the public in the sense of Rule 31(1) EPC (see Case Law of the Boards of Appeal of the European Patent Office, 2019, 9th edition, I.C.3.2.5 and T 1338/12, Reasons, point 15.1).

13. In view of the above, the board concludes that the relevant biological material (plants of accession PI313970) was neither available to the public in the sense of Rule 31(1) EPC nor was a sample of the biological material deposited with a recognised depositary institution as provided for in Rule 31(1)(a) EPC. Thus, the claimed invention does not meet the requirements of Article 83 EPC.

Auxiliary requests 1 to 7

14. As was the case for claim 1 of the main request, claim 1 of each of these requests relates to an invention which requires that, in order to carry it out, the person skilled in the art has access to relevant propagating material (e.g. seeds) containing the CYSDV-resistance-conferring QTL and marker, identical to or derived from melon accession PI313970. It follows from the decision concerning the main request that none of these claims relate to an invention which meets the requirements of Article 83 EPC.

15. No claim request is allowable. The appeal must therefore be dismissed.

Order

For these reasons it is decided that:

The appeal is dismissed.