Earlier in the month of November, Indian generic drug maker Cipla Ltd. had requested the Central government to revoke five patents held by Swiss firm Novartis AG on respiratory drug Indacetorol, used for the treatment of Chronic Obstructive Pulmonary Disease (COPD) under the brand name 'ONBREZ'. Cipla had filed a representation before the Department of Industrial Policy & Promotion (DIPP) to cancel the patents on the ground that the Swiss company had held them for six years without making the medicine locally or importing it in the quantity which is required.

The representation was filed under section 66 and section 92 of the Indian Patents Act, 1970.

Section 66 empowers Central Government to revoke a patent on the grounds of it being mischievous to the State or prejudicial to the public. The power given to the Government of India under section 66 of the Indian Patents Act has been exercised only twice so far. The first was when a process patent had been granted to Agracetus, a U.S. based company for genetically engineered cotton cell lines. This patent was revoked on the ground that it was against the public interest, cotton being an important source of India's national economy. The second case was when the Avesthagen patent for "synergistic ayurvedic/functional food bioactive composition" was revoked. On an application by the Traditional Knowledge Digital Library, this patent was revoked by the DIPP for "generally being prejudicial to the public". In the present case Cipla had applied for revocation on the ground of non-working of patent and sheer obviousness.

Section 66 of the Indian Patents Law acts as a correctional provision and the Government is considered as the adjudicating authority, which ensures that interest of public is given more priority than personal or commercial interests.

Under Section 92, the Central Government has the power to grant Compulsory License if it is satisfied that there is a circumstance of national emergency or of extreme urgency or in case of public non-commercial use. Cipla believed that COPD is one of the major causes of fatalities in India and therefore, proper treatment is essential. COPD has, in recent years, assumed epidemic proportions as it is prevalent in people residing in urban, semi-urban and rural areas. The causes of COPD are several and the sheer magnitude of the disease as per the publicly available data is sufficient for the Central Government to invoke the provisions of Section 92 and to treat it as an "epidemic" or a "public health crisis". Such exercise of power in the present case would be in consonance with the avowed purpose for which Section 92 has been enacted.

Cipla had already launched the generic version of Novartis' Indacetorol, under the brand name UNIBREZ.

However, Central Government after examining Cipla's petition considered it of minimal merit. The Health Ministry also suggested that Cipla's proposal for a compulsory license for the medicines under section 92 of the Patents Act a rarest of rare provision to be used in case of national emergency or in extreme urgency or for public non-commercial use may not be "fit" to pass legal scrutiny and if at all there is a chance for the grant of Compulsory License Cipla should opt for the route provided under section 84 of the Patents Act.

In a blow to Cipla, Novartis approached the Delhi High Court in a patent as well as trademark dispute in this regard.

Novartis filed a trademark suit on November 7, 2014 against Cipla for using the impugned mark UNIBREZ for pharmaceutical products which is deceptively similar to its mark ONBREZ used for pharma products. The Delhi High Court vide its order dated November 17, 2014 passed the order in favor of Novartis permanently restraining Cipla from using the impugned mark.

Novartis also petitioned before the Delhi High Court to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in India, claiming its patent rights and also sought damages and payment for infringing the patented pharmaceutical product.

Cipla stated in its reply the court that the drug sold by Novartis is way too expensive for the general public in India and is only available to government hospitals and this led Cipla to file a representation before the DIPP, to revoke exclusive patent rights granted to Novartis, claiming non-working of Novartis' patents in India.

After hearing the detailed arguments of both the parties, the Delhi High Court reserved its judgment.

Keeping in view the stand of the Health Ministry and the Delhi High Court in this issue, it is undoubtedly evident that a stringent approach is followed in matters relating to IP protection now, as the USTR had already blamed India for its lenient stand over approval to generic drug makers in regard to patented pharmaceutical products, posing serious challenges to the innovators.

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