T 0797/14 - Commercially available but insufficiently disclosed

Key points:

• In this opposition appeal, claim 1 is directed to a container with a coating comprising an ethylene-tetrafluoroethylene copolymer . The copolymer is a key element of the claimed invention. This causes a problem with sufficiency of disclosure.
• " It appears however that the preferred and unique coating composition disclosed by the contested patent, namely the product Flurotec**(TM), has a composition and method of production which is not of public knowledge and is kept secret by the manufacturer".  Said Flurotec**(TM) coating is a known commercial product and is mentioned in several cited documents, such as the commercial brochures or Internet commercials [] but none of said documents brings further details as regards the structure and composition of the coating composition Flurotec**(TM)." 
• " The Board comes therefore to the conclusion that the essential element of the claimed invention, namely the coating composition Flurotec**(TM), is not of public knowledge and that there is also not enough information available to the skilled person for him to reliably determine the composition or structure of the product. The counterpart of a monopoly by a patent is however the disclosure of the invention, in particular of its essential elements, and not the provision or use of a commercial product which structure and composition are not public." 
• As a comment, this appears to be a patent of genuine user and buyer of the commercial polymer, not of the manufacturer.

EPO T 0797/14 - link

2. Main request - Article 100(b) EPC

2.1 Claim 1 is directed to a radiopharmaceutical composition supplied with a container sealed with a closure coated with a coating comprising an ethylene-tetrafluoroethylene copolymer (ETFE). Dependent claim 4 is directed to a specific closure coating made from the modified ETFE coating Flurotec**(TM). Said coated closure is the key element of the claimed invention, the selection of the claimed closures having an ETFE coating having indeed been shown to be particularly suitable for radiopharmaceuticals, since their purity and integrity composition is maintained during manufacture, transport and clinical use (see par. [0008], [0009], [0040] of the specification).

2.2 More precisely, the coating of the closures is made from a coating composition comprising an ethylene-tetrafluoroethylene copolymer, preferably a modified ETFE commercialised by Daikyo Seiko as Flurotec**(TM), as disclosed in the application as originally filed on page 13 (see also the specification in par. [0042]-[0044], [0050]). Said commercial product Flurotec**(TM) is the only coating composition disclosed in the description of the contested patent and all examples of the contested patent disclose closures coated exclusively with said Flurotec**(TM) coating.

2.3 It appears however that the preferred and unique coating composition disclosed by the contested patent, namely the product Flurotec**(TM), has a composition and method of production which is not of public knowledge and is kept secret by the manufacturer, Daikyo Seiko Ltd or its licensee Westpharma (see description of the contested patent par. [0050]).

The appellant did not provide any information as regards said composition during the opposition or during the appeal proceedings, though this point has been raised repeatedly by the respondents, as well as by the Board in its communication to which the appellant chose not to react on the substance . The description of the contested patent does also no provide more information as regards the structure and composition of the Flurotec**(TM) coating.

2.4 Said Flurotec**(TM) coating is a known commercial product and is mentioned in several cited documents, such as the commercial brochures or Internet commercials D1, D10, D13, D15 or D16 but none of said documents brings further details as regards the structure and composition of the coating composition Flurotec**(TM).

D19 is the only cited document giving an vague indication as to a modification possibly undergone by the ETFE polymer, namely by "incorporating 0.1-10 mol% of termonomers, such as perfluoro(alkylvinylethers) and perfluoroalkylethylenes, in the polymer backbone. Commercial reins are all modified in this way.". There is however no certainty that Flurotec**(TM) has been modified in this way.

2.5 There is also neither any certainty as to the availability as such or in a constant composition of the product Flurotec**(TM), nor as to the possibility that the Flurotec**(TM) can be analysed and reproduced by the skilled person.

2.5.1 As to the availability and accessibility of the product to the public, it is only apparent from the technical brochure D1 showing all Daikyo Flurotec® Closures, that stoppers coated with Flurotec**(TM) were available at least since 1992, and that said product Flurotec**(TM) was still available at the filing date of the contested patent, as shown by D16; according to the respondents, the product was still available in 2010.

This does however not mean that the product Flurotec**(TM) had a stable and constant composition before the filling date of the contested patent or will keep its composition stable and constant over time after the filing date, since there might be or have been continuous further developments leading to improved compositions from 1992 on.

This does also not mean that said Flurotec**(TM) product will remain available or accessible to the public after 2010, since this is dependent on the manufacturer and on the demand for said commercial product.

2.5.2 Given the complexity of a polymeric structure, there is also no certainty beyond a reasonable doubt that an accurate analysis of the product FlurotecTM is feasible. The process of preparation of the product being also unknown, the reproducibility of the product is also very questionable.

2.6 The Board comes therefore to the conclusion that the essential element of the claimed invention, namely the coating composition Flurotec**(TM), is not of public knowledge and that there is also not enough information available to the skilled person for him to reliably determine the composition or structure of the product. The counterpart of a monopoly by a patent is however the disclosure of the invention, in particular of its essential elements, and not the provision or use of a commercial product which structure and composition are not public.

For these reasons the Board concludes that the requirements of sufficiency of disclosure are not met (Article 100(b) EPC).