Pharmacyclics filed a patent application of this inhibitors in 2009 and obtained a patent on September 25, 2014. Laurus filed a post-grant challenge on September 24, 2015 on several grounds such as lack of novelty and lack of inventive steps, among others.
Natco Pharma had reportedly launched a generic version of the drug in December 2019 and sources said Laurus Labs
has a tie up with Natco. The generic is priced significantly lower than the patented medicine.
Pharmacyclics had argued that experts of Laurus Lab had developed an incorrect structure and had made incorrect scientific represntations. It has also countered the arguments raised by Laurus.
The patent office, which heard the matter, said Laurus' allegation regarding lack of novelty is not maintainable. However, on the issue of lack of inventive step, it supported the arguments put forth by Laurus and abrogated the patent on the grounds that Pharmacyclics' drug wasn't an improvement over other existing drugs in the same space.
Pharmacyclic claims that the drug is now approved in 95 countries and has been used to treat more than 170,000 patients worldwide.