Another Patent War?

by buildingpharmabrands

Close on the hells of the Supreme Court’s rejection of Glivec’s patent of the Swiss drug major, Novartis another patent, another international drug major, Merck Sharp and Dohme (Merck) moved the Delhi High Court against Mumbai-based Glenmark Pharmaceuticals, alleging violation of its patent for blockbuster anti-diabetes drugs Januvia and Janumet.

Glenmark recently launched its low-cost version of the drug has maintained that it launched Zita and Zita-Met, the branded-generic versions of Merck’s Januvia and Janumet after due diligence and research. Glenmark says that its product is non-infringing. Glenmark should certainly know that as the company itself aspires to become a research-based, global integrated pharmaceutical company. The company has launched its own drug discovery program about nine years ago and has received a total of about US $250 million in out-licensing deals with leading multinational drug companies such as Sanofi-Aventis, Lilly, Forest Labs and Teijin Pharma. Glenmark has considerable stakes in research and development and a rapidly progressing company.

An MSD spokes person spoke to Business Standard, “ We are disappointed with Glenmark’s decision to introduce products that directly infringe upon our intellectual property rights (IPR). We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend those.”

Patent wars till now have largely been restricted to exorbitantly priced lifesaving drugs for cancer and HIV. Now they seem to be extending to the chronic therapeutic segments like diabetes. This is likely to change the marketing dynamics of the rapidly growing US $13 billion Indian pharmaceutical market.

The key issue in this case is the price difference between the innovator drug and Glenmark’s branded-generic version as they put it is only about 30 per cent less, whereas in case of Glivec the price difference is a staggering 97 per cent.  This is because Merck followed an India-specific responsible pricing by pricing at a fifth of its US price when it launched Januvia and Janumet in 2008. A thirty per cent difference is not uncommon in India between a branded-generic and a generic-generic formulation and in some cases between two branded generic formulations.

Merck’s point of view clearly echoes the Research-based pharmaceutical industry when it said to the Business Standard, “Strong IPR protection is essential for growing India’s innovative capacity and economic growth. As an innovative pharma company, protection of our IPR is vital to ensuring we continue to assume the tremendous monetary risks associated with the discovery of innovative medicines.”