In any given year, the U.S. Food and Drug Administration (FDA) grants marketing approval to new drugs. The most important category* are those classified as “new molecular entities” or NMEs. Chen Xingzhi has collected data on the 2010 NMEs included in the FDA Orange Book here: http://goo.gl/W78Tbk. Some of the data are summarized below:
- Among products listed in the FDA Orange Book in 2010, 15 were classified as NMEs.
- Among all of the NMEs, 43 patents were listed in the FDA Orange Book, covering 12 of the 15 products.
- None of the 43 Orange Book patents disclosed US government rights in the patents.
- US inventors were involved in 8 of the 43 patents, involving 4 products. In the 4 products that had a US inventor, three had 2 or more patents with foreign inventors, and only 1 had US inventors only.
- Patents assigned to US entities were involved in just two of the products.
- US companies were the sponsors of just three of the 15 products. In one of the three, the patents were in-licensed from Belgium. In the remaining two cases, the US company list Orange Book patents from US and foreign patent holders.
No one year of FDA approvals is necessarily typical for other years, and the percentage of US owned drugs is higher in other years we have examined. But for 2010, the role of US inventors, patent owners or companies was surprisingly small.
Note on Biologics: The FDA also reported approval of six new biologic drugs in 2010 that were not included in the FDA Orange Book, and for which there are no public disclosures of relevant patents. US firms sponsored 3 of the 6 biologic drugs. Of the remaining 3 biologic drugs, one each was sponsored by firms owned by Swiss, German and French businesses.
* The FDA taxonomy of NDA Chemical Types follows
Number Meaning
1 New molecular entity (NME)
2 New active ingredient
3 New dosage form
4 New combination
5 New formulation or new manufacturer
6 New indication
7 Drug already marketed without an approved NDA
8 OTC (over-the-counter) switch
10 New indication submitted as distinct NDA – not consolidated