We recently blogged about the pending appeal of an IPR that upheld the patentability of the ‘405 patent covering Gilenya®. If Novartis ($NVS) prevails in that appeal, then that could potentially secure another seven years of exclusivity for Gilenya® without generic competition. Novartis, however, has a back-up plan. The Patent Office recently granted Novartis an additional patent (U.S. Patent No. 10,543,179) covering Gilenya®, which will also not expire until December 2027. Novartis has already commenced Hatch-Waxman suits against numerous generics to enforce the ‘179 patent. How strong is this patent?
Read MoreNovartis’ ($NVS) blockbuster drug, Gilenya®, is facing an onslaught of prospective generic competition. In response, Novartis has wielded one of its patents – the ‘405 patent. The patent survived an IPR challenge, and that decision has been appealed to the Federal Circuit. The appeal is fully briefed and heard oral argument earlier this year in January. If Novartis prevails in the appeal, that means it could potentially exclude generics until the ‘405 patent expires in 2027. What is the likelihood Novartis will prevail?
Read MoreUniqure ($QURE) and Spark Therapeutics ($ONCE) are squaring off over who will soon provide the best haemophilia B gene therapy. Meanwhile, the companies have acknowledged that intellectual property issues may be critical to which drug will come out on top. Will the patent issues cloud either drug’s commercial performance?
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