G1/23 New Referral to the Enlarged Board of Appeal regarding whether a product was “made available to the public”

The Board in T 0438/19  (EP2626911) has referred the following questions to the Enlarged Board of Appeal for clarification regarding an alleged public prior use.

• Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date?
• If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date?
• If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?

In other words:

If the skilled person could not analyse and reproduce the composition or internal structure of a product without undue burden, is that product not prior art? (Q1)

• If “No”, then: is technical information about the product published before the filing date prior art? (Q2)

• Yes, then if technical information about the product published before the filing date is not necessarily prior art, which criteria apply to determining if the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person? (Q3)

Background

The referral concerns the interpretation of “made available to the public” within the context of Article 54(2) EPC and the standard set by G 1/92 for determining if a prior use of a product may be considered “state of the art”, namely:

• 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 same principle applies mutatis mutandis to any other product.

The issue in T0438/19 concerns whether the composition of the polymer ENGAGE® 8400 (i.e. the product) was “made available to the public” before the effective date of the patent.  ENGAGE® 8400 was accepted by the patentee to be commercially available but the patentee argued it had not been “made available to the public” because the skilled person was not able to produce exactly ENGAGE® 8400, without undue burden. The patentee submitted that reverse-engineering a commercial polymer without knowledge of the synthesis conditions, in particular the specific catalysts and reaction conditions would require an extensive research programme, i.e., would represent an undue burden.  The chemical composition of ENGAGE® 8400 was not therefore reproducible without undue burden.  In the patentee’s opinion, the product ENGAGE® 8400 could not therefore be considered enabled and could also not constitute prior art and so ENGAGE® 8400 could not be used as the closest prior art for inventive step.  This is significant because leaflets for ENGAGE® 8400 demonstrate that ENGAGE® 8400 meets all requirements of claim 1, except for the aluminium content.

In reviewing the case law, the Board in T 0438/19 considered there to be diverging case law regarding if the product itself was not state of the art because its composition or internal structure could not be analysed (T 370/02, r 8.8; T 2045/09, r 29 to 39; T 1833/14, r 1.9 and 1.10; T 23/11, r 2.5), or the composition or internal structure of the product was not state of the art (T 946/04, r 3.31 and T 1666/16, r 11).  The Board has therefore referred the above questions to the Enlarged Board of Appeal to clarify what constitutes the state of the art in relation to commercially available products.

We will continue to monitor the situation and provide insights.  At present, the Enlarged Board of Appeal has invited the President of the EPO to comment in writing by 30 November 2023.

Please contact your Venner Shipley contact if you have any questions on how this referral may impact your patents or applications.