The Indian Patent Office has refused a patent to Vertex Pharma for its cystic fibrosis therapy Orkambi, saying the drug is not novel.
The rejection of the International Patent Application (No. PCT/US2008/085456) covers solid forms of lumacaftor one of the active ingredients in Orkambi which to date has been launched onto the market only in the US and Germany.
The ruling could mean that generic versions of Orkambi become available in India even as Vertex is still rolling out its product in other world markets.
Orkambi combines another Vertex CF treatment – Kalydeco (ivacaftor) – with lumacaftor in order to tackle two different genetic mutations in the disease.
Analysts have suggested it could eventually become a $5bn-a-year product, thanks to a list price of almost $260,000 a year. In 2015 Kalydeco and Orkambi brought in $632m and $351m, respectively.
India’s Kolkata Patent Office declined to approve the Indian version of this patent – first filed in 2008 – on the grounds that most of the claims are obvious and do not involve an inventive step. It also maintains that lumacaftor is a new form of a known substance.
According to consultancy TwoFour Insight, the patent office concluded that “the claimed polymorphic forms and process of preparation in the absence of better efficacy results are considered as mere new form and process respectively and thus, not patentable under section 3(d)”.
The patent office also concluded that better bioavailability does not necessarily lead to better efficacy, according to TwoFour.
Under India’s intellectual property law, Section 3(d) does not allow a new form of a drug such as a new crystal structure to be patented unless it confers a therapeutic advantage over the original substance.
The patent was opposed by the Indian Pharmaceutical Alliance (IPA), a trade organisation representing India’s larger pharmaceutical companies, including Cipla, Dr Reddy’s Labs, Lupin, Nicholas Piramal, Ranbaxy and Wockhardt.
CF is around four times less common in Indian people than Caucasians but – due to the size of the Indian population – it has been estimated that there are actually more patients with the disease than in Europe.