India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe.
The research was conducted using a software system that maps patent applications filed in specific sectors and territories. The results provide a retrospective analysis of pharmaceutical patents that have been first filed in India and Europe. In this case, first filings were used as an indication of the origin of innovation given that companies would often file their first patent application in their country of residence.
In India, first filings increased significantly between 2001 and 2011, from approximately 160 in 2001 to approximately 450 in 2011, which represented an average increase of 12% per year. On the contrary, first patent applications filed by companies in the UK, Germany, France and the European Patent Office have fallen since 2007, from approximately 8300 in 2007 to less than 5000 in 2011.
Withers & Rogers noted that the innovation growth in India is largely focused on lower-risk technologies such as manufacturing processes for existing drugs, new formulations and crystalline forms rather than the development of novel compounds. On average, it was estimated that less than 15% of pharmaceutical patent applications first filed in India over the past 12 years by relatively large players, such as CIPLA and Dr Reddy’s Laboratories, were directed toward novel compounds.
In Europe, the results were completely different. On average, approximately 35% of patent applications first filed by European pharmaceutical companies were for new compounds. According to Withers & Rogers, further research suggested that this focus on novel compounds has been steadily increasing during the past few years despite the decline in overall filings. In fact, in 2011, approximately 55% of pharmaceutical patents first filed in Europe were for new compounds.
“This research provides evidence of a flight to quality among European-based pharmaceutical innovators in recent years and this trend has become even more pronounced since 2007,” commented Dr Nicholas Jones, partner and patent attorney at Withers & Rogers, in a statement. “The economic downturn could be the primary reason for this as many pharmaceutical companies, like those in other sectors, have been forced to drive efficiencies where they can, which includes supporting and seeking intellectual property protection only for innovations that can demonstrate real commercial potential. This may explain why the proportion of patent applications originating in Europe that relate to new compounds seems to have increased from just over 30% in 2003 to around 55% in 2011.”
Jones added that Indian pharmaceutical companies, in contrast, have been filing patent applications at a rate of knots but their focus on lower-risk innovation suggests the strong dominance of the country’s generic drug market.
In India, there is fierce competition between new drug developers and generic producers. Withers & Rogers believe that this situation could possible lead to changes to India’s pro-generic legislation, such as the “compulsory licensing” laws, which require patent holders to relinquish market exclusivity for their patented products.
“Demand for generics is growing globally and their manufacture is becoming more complex, which means it represents a more value-added commercial opportunity for big pharma companies,” explained Jones. “Equally, Indian pharma companies are clearly seeing innovation and the development of their own patent portfolios as a strategic opportunity. As this happens, the Indian government will need to consider whether its current legislative approach, particularly with regard to compulsory licences, could shoot itself in the foot.”