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Galderma Wins Important Victory in Fight Against Psoriasis Patent
| January 11, 2011
The PTO has issued a Right of Appeal Notice (RAN) to Leo Pharmaceutical Products in the inter partes reexamination of its U.S. Patent No. 6,753,013. The ‘013 patent claims a composition for “dermal use” comprising a vitamin D analogue, a corticosteroid, and a selected solvent for “once daily” application, as well as methods for treating various skin conditions with that composition. Galderma requested the reexamination in 2006 and has vigorously contested Leo’s assertions of validity.
Leo had tried to overcome several prior art rejections by incorporating the “once daily” limitation from certain dependent claims into the independent claims, and by citing a series of articles and declarations to show that the claimed composition gave unexpectedly superior treatment results. The examiner refused to enter the simple incorporation-type amendments because of the advanced stage of the reexamination, finding that the amendments should have been made earlier and would change the scope of other dependent claims – the amendments would require “more than a cursory review by the examiner, as further consideration is necessary and new issues may arise.” (Perhaps). The examiner was also skeptical of the “once daily” limitation as a patentable distinction over the prior art because the ‘013 specification does not indicate that it “is an essential feature of the claimed invention.”
As for Leo’s articles and declarations, the examiner concluded generally that they did not support a finding of unexpectedly superior properties. The declarations were unpersuasive, the examiner said, for a host of reasons, e.g., they “fail to compare the closest claimed composition with the closest prior art composition under the same conditions,” the inventive samples contained ingredients not recited in the claims, the inventive samples tested were not commensurate in scope with the claims, some of the declarants were employed by the ‘013 patent’s exclusive licensee.
The RAN is, of course, the last step in prosecution with the examiner, and Leo must now pursue an appeal at the Board. The news was not all bad for Leo since the examiner did withdraw two of the rejections. She also confirmed the validity of claim 11 for an ointment having a specific list of ingredients and found amended claim 12 reciting specific solvents to be patentable.
Galderma was also in the news recently for its law suit filed at the end of December, accusing Lupin of infringing its U.S. Patent No. 7,749,532. Lupin had filed an ANDA for a generic version of Galderma’s Oracea®.
