In Law360, White & Case partner Kevin Adam discusses the potential impact on US patent litigation of the Affordable Prescriptions for Patients Act, which aims to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars.
The bill, which unanimously passed the US Senate earlier this month, would mandate that makers of biologic drugs could not assert more than 20 patents of particular types against a competing biosimilar manufacturer seeking to enter the market.
Some sponsors of the bill say it would "curb patent thickets," and will likely "protect competition and reduce prices at the pharmacy."
However, "Capping patents that can be included in a lawsuit is several steps removed from consumers paying lower prices," says Adam.
"In theory, the limit could incentivize makers of biologic drugs to assert their best patents, and fewer patents in lawsuits would mean lower-priced biosimilars would face lower hurdles to entering the market. But the link between a cap on patent assertions and costs seems a bit speculative," he notes.
Adam says that this this bill "could expedite the process, but it doesn’t necessarily mean that you’ll see more biosimilar entry [into the market], or that overall drug pricing will come down because of this change."Adam also noted that the final bill dropped a number of key provisions that existed in earlier versions, including the language on so-called "product hopping." That provision, Adam explained, would have made it difficult for branded drugmakers to decide whether to introduce important new drugs.
See the full Law360 article here.
Press contact
For more information please speak to your local media contact.
