Original molecule patent stands, but a new salt form is ‘not innovative’
India’s Intellectual Property Appellate Board has revoked one of two patents granted to GlaxoSmithKline for its cancer drug lapatinib. The board decided that, while developing lapatinib itself represents a viable invention, developing the ditosylate salt form (marketed as Tykerb) is an obvious development and therefore not patentable.
The two patents on the tyrosine kinase inhibitor were challenged by German generics company Fresenius Kabi Oncology. The decisions follow a string of similar rulings in which Indian authorities have revoked or refused to grant drug patents, in an effort to drive generic competition.