Ever since the first patent settlements after the Drug Price Competition and Patent Terms Restoration Act was signed, many of us in the generic world (and now in the biosimilar world) have suggested that most patent settlements are pro-consumer as they can bring generic products (and now biosimilars as well) to market years before the patents expire on the brand-name drug products. I was an expert witness on the side of the generic manufacturer in one of the early cases involving a potassium supplement. The firm lost that case as it was decided that the settlement fell into one of the first so-called “pay for delay” decisions. However, the product could have come to market five years prior to patent expiration and would have saved consumers hundreds of millions of dollars. Well, I guess that is why I’m glad I never became a lawyer as that decision seemed so antithetical to the goal of the settlement agreement and the purpose of the Act.
Anyway, there is a further development in this area: “The Association for Accessible Medicines and its Biosimilars Council today released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent settlements in expediting patient access to lower-cost medicine. The analysis shows that patent settlements between brand and generic/biosimilar medicine manufacturers accelerated patient access to generic and biosimilar medicines to market by, on average, more than five years before patent expiration. Savings to the healthcare system from patent settlements since the FTC v. Actavis decision in 2013 total $423 billion, and the average savings to the healthcare system per molecule are $5 billion.” The results of the IQVIA study can be found here.
So, there appears to me to be a thin line between when a patent settlement is beneficial to consumers and when it is not but, when looking at the numbers, one wonders where that line might be drawn. Don’t blame me; I guess without a law degree I may never understand how or where the line is drawn! One of the great mysteries of generic drug life, I believe.
