The road to increased patient access to a life-changing medicine hit a major curve this week with the US appeal court decision (link) upholding Amgen’s patents on a biologic medicine.
A quick reminder for those who haven’t been following the case: Sandoz’s biosimilar to this reference biologic, was approved by the US FDA in 2016. Amgen’s reference biologic was first sold in the US in 1998. In order to protect the reference biologic, Amgen has taken advantage of an apparent loophole in the law that has allowed it to acquire multiple patents on reference molecule itself. As a consequence, the reference biologic is protected by patents in the US until 2029. It’s well understood that the patent system is designed to provide a sufficient period of exclusivity to incentivize investment in innovation. But this is no ordinary case. This week’s appeal court decision, if it stands, means that Amgen’s exclusivity over this molecule itself will extend well beyond 30 years.
At Sandoz, we sincerely believe that valid intellectual property should be respected. However, in this extraordinary case, we believe with equal conviction that the patents are invalid and that Amgen should not be able to use them in this way to further extend exclusivity on the drug itself . You only have to read the dissent from Judge Reyna to see why Sandoz feels so strongly about this case. The stakes could hardly be higher: expert estimates suggest that introducing a biosimilar to the reference biologic could save the US healthcare system around USD 1 billion per year.
Of course, we’re used to these sorts of challenges as we continue our battle to improve patient access to medicines, and we will not let this temporary setback impact our long-term objectives. We are now evaluating our options, which may include further appeals.
Still, this is more than disappointing. In the topsy-turvy landscape of this bizarre case, I can sympathize for how Alice felt after emerging from that rabbit hole into a confusing world where things just didn’t make sense.
Unfortunately, we won’t just wake up and find this is all a bad dream – however I do still believe that the story of patient access to a biosimilar for this reference biologic will have a happy ending. We’ll certainly continue working to make that happen... I am proud to work for a company who is fighting to make our purpose become a reality around the world.