On
Sun filed an Abbreviated New Drug Application (ANDA) for a generic version of ZUBSOLV® before expiration of the ZUBSOLV® patents listed in the Orange Book, with Sun submitting a paragraph IV certification asserting that the patents are invalid, unenforceable, and/or will not be infringed by the activities in Sun's ANDA.
Unlike the first generic challenge, that came from Actavis and focussed its invalidity claim on obviousness, Sun also alleged that the patents are invalid on grounds of indefiniteness, written description and enablement. The Court ruled against Sun on all grounds and in favour of
Sun have appealed the decision, but Nikolaj Sřrensen, President and CEO of
The District Court's decision was very well motivated, and it clearly outlines the extensive flaws in Sun's claims regarding the patents' validity and infringement issue. We remain very confident about the strength of the Zubsolv patent portfolio and believe that the
From our perspective, it is good to see that, for a second time, the US courts have upheld the validity of our client's ZUBSOLV patents.
Recent trends have shown that, on top of more "traditional" lines of attack, such as lack of novelty and/or inventive step, generics are increasingly focussing their invalidity attacks on the more "formal" grounds of indefiniteness, written description and enablement. In order to avoid US patents being vulnerable to attack on these grounds, which are unrectifiable irrespective of how inventive the ultimate product that is covered is, it is vital that patent applications are well drafted and thought-through at the time of filing".
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