Pharmacyclics Inc, a Silicon Valley-based biopharmaceutical company and part of AbbVie, which itself is a spin-off from pharmaceutical giant Abbott, has lost a patent for its anti-cancer drug ibrutinib in India, following a post-grant objection raised by Andhra Pradesh-based Laurus Labs.
The Patent Office had, earlier this month revoked the patent observing that the claims made by Pharmacyclics are obvious to an ordinary person skilled in the art and that the drug lacks any inventive step that would make it superior to other existing formulations.
According to Pharmacyclics, ibrutinib is a small molecule that works by inhibiting an enzyme called protein kinase, which controls the rate at which certain cells multiply. It claims that the drug works differently from existing chemotherapy and immunotherapy solutions, and is sold in the US under the brand name Imbruvica. It is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor administered orally, and has been jointly developed and commercialised by Pharmacyclics and Janssen Biotech, Inc.
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.