In a victory to US biopharmaceutical company Gilead Sciences, India’s patent office on Monday granted an Indian patent to Cobicistat, marketed under trade name Tybost, a licensed drug for use in the treatment of HIV and AIDS.
The patent office in Delhi granted it to Gilead after rejecting the pre-grant opposition filed by a patient group named Uttar Pradesh Welfare for People Living with HIV/AIDS Society (UPNPplus), a community-based, non-profit organisation. According to industry reports, Cobicistat is a component of three four-drug, fixed-dose combination for HIV treatment and being marketed in the US.
According to Gilead, the compound has advantages such as improving the effectiveness of a medicine – an antiretroviral drug – administered along with it, without showing any major biological activity on its own. As per Gilead’s argument, Cobicistat is a novel compound or new chemical entity (NCE), which acts as a pharmacokinetic enhancer for enhancing the levels of HIV inhibitors in plasma, when co-administered together.
The patent office, while rejecting the pre-grant opposition, said that none of the grounds raised was found to be valid. Apart from the issues of novelty and obviousness, the opponent has raised objection to granting the patent on lack of sufficient and clear description of the invention. UPNPplus pointed out that the present application does not give a specific technical guidance to arrive at Cobicistat as claimed in the claims. Therefore, the present application should be rejected for the lack of clarity and insufficient disclosure, they submitted.
The opponent stated that Cobicistat is a mere modification of Ritonavir and the applicant has not placed any evidence on record to show therapeutic efficacy of Cobicistat. The patient group alleged that the claimed application does not involve any inventive step, it is not an invention within the meaning of the Patents Act, and it is a mere admixture resulting only in the aggregation of the properties of the components. The group argued that application should be refused since the drug is a derivative of Ritonavir, another anti-ritroviral medication used in combination to treat HIV/AIDS, and is not patentable under Section 3(d) of the Patents Act.
The assistant controller of patents and designs, Delhi, after considering both the arguments, said that the claims involve inventive step and it was not barred from patentability under Section 3(d) of the Act and the opponent failed to prove that the claimed compound is mere structural analogs of Ritonavir, under this section. Considering various other arguments, the official rejected the pre-grant representation as none of the grounds raised was found to be valid.