Patent infringement : Delhi High Court restrains sale of generic drug Indacetrol by Indian pharma major Cipla till a decision on its compulsory licence application is taken

Delhi High Court, vide a judgment last week has upheld the patent infringement claim filed by Swiss drugmaker Novartis against Cipla, and granted an order of interim injunction restraining it from using Novartis' patent on respiratory drug Indacetrol (used for chronic obstructive pulmonary disease)

The Background: Novartis holds the patent for manufacture of the Indacaterol maleate salt as well as the manufacturing process for the drug, which is sold in India as an inhalation powder and inhaler under the trademark name of “Onbrez’ through Lupin since 2010.

In October last year, Cipla, India's fourth-largest drugmaker by revenue started manufacture and sale of Indacaterol powder and sale under the name “Unibrez”, citing urgent unmet need for the drug in India.

Novartis thereafter approached the Delhi High court to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in India. Novartis has also sought damages and payment for infringing the patented pharmaceutical product.

Cipla in its reply filed before the court had argued that the medicine sold by Novartis is too expensive and is sold only to government hospitals and is therefore not easily available to the public. Cipla also filed a representation before the ministry of commerce department of industrial policy and Promotion, to revoke the exclusive patent rights granted to Novartis, claiming that Novartis was not working the patent in India. Novartis argued that there was no obligation on the firm to manufacture the drug in India.

Judgment was reserved in the case by Justice Manmohan Desai on December 16, 2014.

The Judgment : In a 143-page long order, the Delhi High Court restrained Cipla from “using, manufacturing, importing, selling, offering for sale, exporting, directly or indirectly dealing in active pharmaceutical ingredient (API), pharmaceutical products, compund or formulation containing Indacaterol, specifically its Maleate set, namely Indacaterol maleate alone or in combination with any other compound or API or in any other form”, which may amount to an infringement of Novartis’ patent.

The Court said that statutory & monopoly rights of Novartis can’t be nullified until patent is held to be invalid, and that 'Public interest doctrine’ is an important consideration in patent cases, and Cipla should approach the appropriate forum while applying for compulsory licence application. Justice Desai also repelled the argument put forth by Cipla based on Article 21 of the Constitution, saying Article 21 cannot be pressed into service by an infringer seeking to justify the infringement of a valid patent.

The interim injunction has been granted till Cipla’s application for compulsory licensing of the drug is decided. The company has been allowed to sell its remaining stock. The Court further said that if such an application has indeed been filed by Cipla, the controller or the competent authority to decide the plea within six months from the filing of the application.