This ruling relates to an opposition against a patent application by Novartis for Panobinostat which is a hydroxamic acid that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.
The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.
Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.
Novartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.
Unipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.
The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »