Hi all,
Monoclonal antibody biosimilars are the monoclonal antibody produced from the same standards of pharmacutical quality as the original monoclonal antibody when the patent of the original expires. I noticed that the biosimilars are sometimes claimed by other companies who did not initially earn the patent.
What is the reason that the monoclonal antibody biosimilar is claimed by another company other than the company that claimed the patent for the original mAb?
Is there a patent law that prohibits this?
Otherwise, it is somewhat confusing as to why the original company does not claim it and own the patent for a longer time.
Thanks!
If this is related to a particular patent that you have, pleae consult with a registered IP lawyer for more guidance
Having said this, for US patent law the term biosimilar has its own definition in:
42 U.S.C. § 262(i)(2)
In a sense the biosimilar can infringe (as long as they are still in force) on the patent but according to the BPCIA they can resolve the dispute in a speedy fashion by identifying infringing parts (I take it that the process is similar but not identical and thats where the BPCIA comes in) and do the "patent dance"
For a review of this you can take a look at [1] page 141
the reason why the BPCIA exists is to try to slow down the price increase of treatments(see also [1] for the details and history of how it came to be).
Hope this helps
[1]https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1637&context=chtlj
Just to add something which influences the patent term: Supplementary protection certificates can extend the patent term with still 5 years as compensation for the clinical trials. This spc has to be granted based on the basic patent, the marketing authorisation in relation to the product (active substance). This can also give a different picture!
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