Multinational drug-maker Mylan has hinted that it is willing to get its hands dirty in India, even if this meant pursuing “frivolous or invalid patents” to bring in less-expensive generic medicines.

“There is a clear distinction between large brand pharmaceutical multinationals and Mylan,” said President Rajiv Malik. Mylan is a multinational, but it is also a generic and specialty company focused on improving access to quality, affordable medicines, he clarifies.

And to enhance access, “we will pursue patents we believe are frivolous or invalid in order to bring generic versions of products to market sooner and create more affordable access to these products,” he said, adding that Mylan’s generic Herceptin programme is a case in point.

Malik was speaking to Business Line against the backdrop of Mylan’s Rs 5,168-crore acquisition of injectibles company Agila Specialties (a subsidiary of Bangalore-based Strides Arcolab). The deal cleared several filters, including the Cabinet Committee on Economic Affairs, last week.

Pursuing weak patents

The US-based Mylan’s indication that weak patents from big pharma will not be spared, comes even as the Indian patent landscape witnesses a similar situation. German healthcare company Fresenius Kabi has locked horns with British drug-maker GlaxoSmithKline over the latter’s patents on breast-cancer drug Tykerb and its salts.

Patients stand to benefit, when drug companies of all hues battle each other over patents and marketability. In the process, patent monopolies get over-turned (where patents are weak), paving the way for similar products to come into the market at lower prices. This gives patients a choice of product, besides improving access to the drug.

Malik pointed out, “Our generic Herceptin programme is one example of our efforts to bring more affordable medicines to the Indian market.”

Herceptin is the brand-name of Roche’s advanced breast-cancer drug Trastuzumab. The drug had attracted the attention of pro-health groups and the Government, for affordability and access reasons. Last month, Roche said, it would not pursue its patent on Herceptin. Meanwhile, Mylan is set to bring-in its version of Trastuzumab, and it has an agreement with Biocon on the drug.

Agila buy

Mylan’s acquisition of Agila comes even as there is much debate on whether buy-outs of local drug-companies by foreign firms need to be put through greater scrutiny.

Pro-health groups, for instance, fear that buy-outs of local companies have the potential to erode a country’s capacity to make medicines for itself, there by striking at the country’s health security.

Their concerns are valid, agrees Malik, adding that specialty companies operate differently from traditional big pharma, whose product pipelines have large, expensive patented medicines. Specialty drugs are niche, and target smaller patient groups.

As Agila gets integrated, Mylan is stepping-up its activity in oncology, Malik said, and more specialty drugs will be brought in, he added, without divulging details. Agila’s business in India is small, he said, allaying fears of the local market getting deprived of its products. Injectibles was a gap for Mylan, and the company would build on Agila’s strong product portfolio in the global market, he added.

Mylan’s research spends have increased from about Rs 50 crore in the early days to Rs 400 crore, he said. There would be more investments in Agila, he indicated, in both research and manufacturing.