Amgen vs Sandoz
This is an interesting and upcoming case revolving around Amgen's drug Enbrel. Sandoz is currently creating a biosimilar for Enbrel, and is in Phase 3 of drug trials. Next step is launch, but Amgen is utilizing its patent-protected Enbrel and method/manufacturing process to prevent Sandoz's biosimilar from launching in market.
Summary of Patents
- The ’182 patent is said to cover the etanercept fusion protein --> main protein in Enbrel
- The ’522 patent is said to cover constructs and methods of making the fusion protein.
- The other patents are said to “claim methods of using etanercept to treat psoriasis and/or psoriatic arthritis.”
Essentially, the case revolves around these patents owned by Immunex, which is a subsidiary of Amgen.
Why is this important?
Within the next 2-3 years, many large molecule drugs, will be coming off patent. As a result, many pharmaceutical companies are creating biosimilars (the equivalent of generics). These will provide patients with more options and end the monopoly some companies have due to their patents. Amgen is trying to block Sandoz from creating a biosimilar, by arguing that it has multiple patents on the drug and its manufacturing process. This is pertinent, because if it can show how Sandoz utilizes one of these patents, then it can have an injunction on Sandoz and prevent it from selling the biosimilar.
http://www.jdsupra.com/legalnews/amgen-launches-enbrel-biosimilar-patent-37046/
Hey Jaskirat,
ReplyDeleteGreat post! I enjoyed how you listed the patents and the summary of the patents in your post. I also enjoyed learning about the importance of Amgen's efforts to block Sandoz from creating a biosimilar drug of Amgen's Enbrel. To make this post better, I would talk about the specific claims of the patents.
Hey Jaskirat,
ReplyDeleteI really liked your explanation of what a bio-similar was and it's importance to not just pharma corps but to patients as well. More on the specific claims and the patent's uses would have made your post better. But overall, I really enjoyed your post and I look forward to reading more.