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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
A report from Thomson Reuters claims the number of patent challenges in the US almost doubled between 2008 and 2009.
A report from Thomson Reuters claims the number of patent challenges in the US almost doubled between 2008 and 2009. According to the quarterly Movers and Shakers report, 2009 saw 61 molecules or combinations from various companies, including Sanofi Aventis and Pfizer, enduring patent challenges, compared with only 33 in 2008. Previously, the largest number of such challenges was 39 in 2007.
The report warns: "Companies can expect the barrage of challenges to continue now that many generic companies are beginning to screen intellectual property on potential Paragraph IV target products well before those drugs are approved and patents are listed in the Orange Book."
The most prolific filer of Abbreviated New Drug Applications (ANDA) that include patent challenges is Teva Pharmaceutical Industries, which, as of the end of 2009, had more than 146 patent challenges on record. Novartis was in second place with 73, closely followed by Mylan Laboratories.
According to the report, 2009 was a productive year for the US generic pharmaceutical industry despite the worldwide economic downturn. Companies from 15 countries received 448 ANDA approvals (a slight decrease from 463 approvals in 2008); however US companies, with 151 approvals, received more approvals than international companies, although Indian companies were not far behind with 139 approvals.