E cdip/15/inf/2 original: english date: january 8, 2015 Committee on Development and Intellectual Property (cdip) Fifteenth Session Geneva, April 20 to 24, 2015

VII. Conclusion

The objective of our study is to take a first look at patenting of pharmaceuticals in Chile, with a particular focus on the distinction of primary and secondary patents. We provide a number of descriptive findings that show that pharmaceutical patents associated with drugs that have received market approval are almost exclusively the domain of foreign originator companies. Chilean pharmaceutical companies have only recently begun to obtain market approval for a few patented drugs. Overall, we find that only a subset of drugs with market approval is protected by patents, a much larger number of products is protected by trademarks. Nevertheless, we also find a substantial number of ISP registrations that are not protected either by a patent or a trademark. When we take a closer look at ISP registrations protected by patents, we find that the majority is protected only by secondary patents. It would be interesting to explore to what extent this is due to the fact that the 1991 law did not allow companies to obtain patent protection in Chile for active ingredients that had been patented before abroad. This question is particularly interesting as we also provide some tentative evidence that among all patented active ingredients, Chilean pharmaceutical companies are more active in manufacturing of drugs that contain active ingredients that are associated only with secondary patents.

This study is only a first step towards a better understanding of pharmaceutical patents in Chile. We have assembled a dataset that combines pharmaceutical products, active ingredients, patents, trademarks, and information on the corresponding companies. These data enable us to substantially deepen our understanding of the impact of patents on the pharmaceutical industry in Chile. Still, our approach and data have a number of obvious limitations. Perhaps most importantly, we only observe whether a drug has obtained market approval, but we have no information on actual demand or prices. This limits our ability to account for the importance of different drugs other than through their therapeutic classes.
We plan to extend this work to assess the impact that the combined use of primary and secondary patents has had on the ability of Chilean companies to compete in the generics industry. Such analysis could produce relevant insights for the current debate on secondary patents.

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Appendix A: Data construction

This report is based on a linked database constructed from three separate sources:

1.The list of pharmaceutical products registered at the Chilean National Public Health Institute (ISP);

2.A database of all patent applications filed with the Chilean Patent Office (INAPI) between 1991 and 2010; and

3.A database of all trademark filings at the INAPI between 1991 and 2010.

Constructing the linked database required matching the active ingredients in the pharmaceutical products with the associated patent application(s) and matching the product names with the associated trademark filing(s). In both cases there is no easy reliable way to do the matching and a large part of it was done manually. We describe the data sources and the matching effort in more detail in this appendix.