In going through my files, I came across an article from last year that asks a very basic but critical intellectual property (IP) question: “Are biosimilars patentable?” Sounds like a simple question, right? Well, the answer may not be straightforward, and relate to another question: “Exactly how different are they?”
In developing generic drugs, drug makers don’t seek to change the manufacturing process—they are attempting to provide an exact duplicate of the branded agent. This helps ensure that their product receives bioequivalency to the branded drug and an AB rating. Biosimilar agents are known to be inexact copies of the innovator product, and this can be the result of using a different cell line to produce the compound, or different processes to create a similar batch of biologic proteins or fragments. It would then make sense that biosimilar manufacturers would want to patent their proprietary process for manufacturing the drug, if it is in fact different than that used to create the originator biologic.
The authors, from a Toronto, Canada law firm, the University of Toronto, and an investment organization that promotes health innovation, point out that “the possibility that a biosimilar product could have meaningful patent protection arises from specific requirements for biosimilarity under the BPCIA, which account for the fact that manufacturing processes of biologics are inherently imprecise.”
They state, “The requirements for biosimilar approval may provide sufficient leeway to a biosimilar applicant to patent structural or formulation differences that provide non-clinical but business-relevant advantages over the reference molecule, such as improved shelf-life or ease of manufacture, without compromising clinical biosimilarity.”
Based on this analysis, it seems logical that a biosimilar manufacturing process should be patentable in its own right. This could pose a defense against other biosimilar developers. However, with so much patent litigation between originator and biosimilar manufacturers, could this add even more to lawsuits in defense of IP?
