In a setback to Swiss pharma major Hoffmann-La Roche (Roche), the Chennai patent office has revoked a patent of the company for osteoporosis drug ibandronate sodium, marketed under the brand Boniva on a post-grant opposition filed by Cipla.
The drug, used to treat osteoporosis and metastasis-associated skeletal fractures in people with cancer, is being marketed as Boniva in the US, Bondronat in Europe and Bonviva in Asia.
Osteoporosis is a medical condition in which the bones become brittle and fragile from loss of tissue.
The patent office issued the revocation order after hearing the post-grant opposition by Cipla afresh on orders of Intellectual Property Appellate Board (IPAB) which remanded back the patent tussle acting on an appeal by Cipla.
IPAB had remanded the issue to the patent office setting aside the earlier order of the patent office, which refused Cipla’s post-grant opposition while granting the patent to Roche.
While setting aside the order, IPAB had observed that evidence of experts was not considered by the patent office and reasons for deviating from recommendations of the opposition board were not assigned by the controller of patents. The patent tribunal ordered the matter be considered afresh by affording opportunity to both parties to make submissions on the expert evidence and recommendations of the opposition board.
While there was no patent in India for the active compound ibandronate sodium, Roche had secured a patent for a pharmaceutical composition in solid unit dosage form consisting of the active ibandronate sodium.
After hearing the case afresh, the patent was revoked for being obvious and lacking inventive step and also that the subject matter was not patentable since it was a mere admixture of the components of the pharmaceutical composition.
KS Hariram, assistant controller of patents and designs, said, “Having considered all relevant documents, and pleadings of both parties, expert evidences, opposition board recommendations and in view of my own findings, the opponent (Cipla) has succeeded in the grounds under Section 25 (2) (e) and 25 (2) (f) of the Patents Act, 1970, and hence the granted patent is revoked.”
Earlier, the opposition board was also of the opinion that inventive step in Roche’s claim cannot be acknowledged. Following IPAB’s order, the patent office had constituted a supplementary opposition board to look at the expert evidence and give recommendation, as the members of the main opposition board were promoted to higher level or transferred to other branch offices. The supplementary opposition board also concluded that the claims lack in inventive step.
Ibandronate sodium is a bisphosphonate drug developed by Roche. It is indicated for treatment and prevention of osteoporosis in post-menopausal women.