Early win: Novartis wards off Indian Galvus contender
This article was originally published in Scrip
Novartis has managed to ward off an Indian generic challenger in a case concerning its DPP-4 inhibitor for diabetes, vildagliptin, with the latter undertaking not to manufacture the product or its combination until the product's patent is valid in India.
Novartis confirmed to Scrip that it had been granted a "permanent injunction" order prohibiting the Indian firm, Bajaj Healthcare, from commercializing its generic version of vildagliptin while the compound patent is in force.
Bajaj Healthcare, a relatively little-known local firm which manufactures active pharmaceutical ingredients, amino acids and nutritional supplements, had in its affidavit in the case in the Delhi High Court said that it had no objection if the suit was disposed of and a "decree of permanent injunction is passed in favor of the plaintiff [Novartis] during the currency of the plaintiff's patent".
While Bajaj Healthcare had obtained a license for the manufacture of pharmaceutical products containing vildagliptin, it clarified that it had to date not manufactured the drug or any formulation containing the drug and nor does it intend to manufacture any such drug or combination untll the patent as claimed by Novartis is valid.
In view of these developments, the Delhi High Court on 28 July disposed of the suit.
The case against Bajaj Healthcare forms part of a string of pre-emptive legal action by Novartis to defend its patent on vildagliptin In India.
In April Novartis filed infringement proceedings, seeking an injunction against Alembic Pharmaceuticals, Cadila Healthcare, Glenmark Generics and Bajaj Healthcare at the Delhi High Court for infringement of the Indian basic compound patent (expiry 2019) covering and claiming the novel molecule vildagliptin (scripintelligence.com 17 April 2014). Hearings in the cases concerning these other firms have been listed for later this year.
Novartis, which has been selling vildagliptin and vildagliptin in combination with metformin hydrochloride in India since 2008, previously blocked Wockhardt and later Biocon from going ahead with potential launch plans for their generic versions of the product in India (scripintelligence.com, 19 March 2014, 2 April 2014). The Swiss multinational has partnerships with USV, Emcure and Abbott for vildagliptin in India.
Wockhardt had filed a revocation petition against Novartis' vildagliptin patent in September 2013 before the Intellectual Property Appellate Board (IPAB). Novartis then sought information under the Right to Information Act in India and learnt that Wockhardt had been granted permission to manufacture and sell the product in May 2013, following which the Swiss company took legal action.
Novartis told Scrip that no decision had been taken in the case by Wockhardt before the IPAB. "Novartis will defend its patent in both the High Court and the IPAB, as necessary," it said.
Pre-emptive litigation has been on the rise in India and legal experts earlier said that it was probably a "ripple effect" from the fact that innovator firms found it difficult to get "ex parte injunctions" in India once a cut-price generic has been launched. They, however, cautioned that such cases also open up the possibility of a back door entry for patent linkage – which India does not recognize (scripintelligence.com 2 May 2014).
Indian laws also include a Bolar-type provision, wherein Section 107 (A) of India's Patent Act lists out certain acts that are not considered as infringement. This includes the act of "making, constructing, using or selling a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force in India or in a country other than India that regulates the manufacture, construction use or sale of any product".
India has recently witnessed pre-emptive legal action by firms such as Bayer concerning Xarelto (rivaroxaban) and AstraZeneca - Onglyza (saxagliptin) (scripintelligence.com, 20 April 2014, 4 April 2014).