Key points
- The Board finds a crystalline form to be inventive.
- Claim 1 is directed to the compound ceritinib in free base form (i.e. not in the form of a salt).
- the subject-matter of claim 1 of the main request lacked inventive step starting from D1 as the closest prior art.
- the ceritinib HCl of example 7 of D1 is amorphous, and represents the disclosure in D1 which is structurally closest to the claimed crystalline ceritinib. This amorphous ceritinib HCl represents the starting point for the assessment of inventive step of the claimed crystalline ceritinib.
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the subject-matter of contested claim 1 is distinguished from this embodiment of D1 in that it concerns: - ceritinib in free base form, rather than as its HCl salt, - in crystalline, rather than in amorphous form.
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the board acknowledges that the patent - or the application as filed, respectively - does not comprise any data comparing the claimed crystalline ceritinib with the amorphous ceritinib HCl of D1 [.] The board nevertheless concludes that the technical effects mentioned below may be accepted as being credible on the basis of the information in the patent and the common general knowledge of the skilled person.
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", it is credible on the basis of this common general knowledge, which was known before the priority date of the claimed invention, that the effects of stability and ease of drying, demonstrated in the patent for crystalline ceritinib, represent improvements over the amorphous ceritinib HCl disclosed in D1. Therefore, an improvement over amorphous ceritinib HCl of D1 is acknowledged without taking the appellant's post-published evidence into account as proof of said improvement (supra). It follows also that case G 2/21 [still pending at the time of the decision], in which this issue is addressed, is not relevant to the present appeal case."
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The objective technical problem starting from the amorphous hydrochloride salt of D1 is hence the provision of a form of ceritinib having improved stability and ease of drying.
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"The appellant argued that the skilled person attempting to obtain a form of ceritinib with improved stability and ease of drying would have tried to prepare the ceritinib HCl known from example 7 of D1 in crystalline form. However, as set out in point 5 of D23, a declaration of a technical expert, any attempt to prepare ceritinib HCl only resulted in amorphous (i.e. non-crystalline) precipitates having chloride levels inconsistent with a stoichiometric salt.
The board agrees. Having failed to solve the above problem in the most obvious way by providing a crystalline ceritinib HCl, there would have been no reason for the skilled person to turn to ceritinib free base in the expectation that it would provide a solution. "
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- EPO
source http://justpatentlaw.blogspot.com/2023/05/t-182521-inventive-crystalline-form.html
