EP 3 389 691 B1 relates to cyclic NTCP targeting peptides which are preS-derived peptides of hepatitis B virus (HBV). It also relates to medical uses of said cyclic peptides and the pharmaceutical compositions, such as in the diagnosis, prevention and/or treatment of a liver disease or condition, and/or in the inhibition of HBV and/or HDV infection.
Brief outline of the case
The patent was maintained according to AR2 and the opponent appealed.
Claim 10 as maintained reads:
“The cyclic peptide of any of claims 1 to 8 or the pharmaceutical composition of claim 9 for use as in vitro HBV and/or HDV entry inhibitors.”
In claim 10 as maintained the feature “in vitro” was added. Claim 10 as maintained corresponds to claim 10 as granted.
For the board this addition infringed Art 123(2). As the other AR were not admitted under Art 12(6) RPBA, the patent was revoked.
The opponent’s point of view
The application as filed did not include the term “in vitro“. Claim 10 was directed to a product, and therefore this term was not used to disclaim unpatentable subject-matter. The assay disclosed in the example in the application as filed could not serve as a basis for the generalisation in claim 10.
The proprietor’s point of view
Peptides for use as in vitro HBV and/or HDV entry inhibitors were directly and unambiguously derivable from the application as filed for a skilled person.
Claim 11 as filed was not a broad generic disclosure but instead disclosed only two alternative embodiments: in vivo and in vitro. Claim 11 did not explicitly define the use to be an in vivo use and therefore at least implicitly related to both in vitro and in vivo uses. Subject-matter implicitly disclosed to the skilled person was part of the content of the application as filed.
The proprietor further relied on claim 11 in combination with page 39 and Figure 8.
The board’s decision
Claim 11 of the application as filed is drafted in the form of a purpose-limited product claim, pursuant to Art 54(5), and is directed to a cyclic peptide for use in the inhibition of HBV or HDV infection, prevention of primary infections with HBV or HDV, and as an inhibitor of HBV and/or HDV entry.
The absence of a feature, in vivo, does not amount to the direct and unambiguous disclosure of an alternative feature, in vitro.
For the board, an in vitro use is not necessarily implied by the patent application as a whole. Page 39 and Figure 8 concern the same in vitro inhibition assay described in point 4 of the example.
Even if the example describes an assay for the inhibitory activity of the peptides, it cannot from this assay, carried out under specific conditions, be inferred that the invention concerns in vitro assays as generally defined in claim 10.
Moreover, in the board’s view, an in vitro use is not implied by the application as filed when read as a whole since it relates solely to peptides for medical uses, in particular concerning HBV infection, liver diseases and cardiovascular diseases.
Comments
The position of the board might look severe at a glance, but it is in full line with the valid case law on added matter as exemplified in G 2/10.
The two alternatives here, in vivo and in vitro, can prima facie be considered as implicitly disclosed. However, the in vitro assay defined in the description was very specific, and could therefore not be generalised. The in vivo use, as a medicine, was however disclosed in a general manner.
The proprietor also banked on the “highly positive preliminary opinion of the OD”, and waited the communication of the board under Art 15(1) RPBA to file further AR, in which claim 10 as granted was deleted. Such a late filing is rarely admissible. It can also not come as a surprise that the board might have a different position than that of the OD.
Loosing a patent for added-matter is always bitter, as then a discussion on novelty or added matter is not taking place.
Waiting the communication of the board in order to file further AR, is generally doomed to fail. This was already the case under the previous RPBA.
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