“On February 9, 2012, the FDA issued its draft guidance on biosimilar product development, starting the ball rolling on biosimilars in the United States. The guidance is intended to establish a pathway for drug makers to get approval for biologics based on existing drugs that have lost patent protection.” Finnegan partner
Sanya Sukduang “noted that the draft guidance doesn’t deal very much with IP issues. “The draft does give some indication of what the reference sponsors [holders of the original BLA applications] need to do to protect against infringement. There’s going to be leeway in the structure of the biosimilar’s amino acid structure versus that of the reference product. FDA has indicated that they want to look at this amino acid structure, but allow some variability and permit the abbreviated BLA to be biosimilar. It’s going to be interested to see how much variability FDA allows and still says, ‘It’s a biosimilar.’”” Mr. Sukduang also noted that “Innovator companies should go beyond looking at amino acid sequence and into other areas, when it comes to protecting against infringement: purification processes, manufacture, method of treatment, and the like. In the small molecule market, companies wouldn’t necessarily look at such aspects until they reach lifecycle management with a molecule. In biologics, it should be one of the first things you look at. As you look new indications, you claim patents for them, not just add them to the specifications, in order to add better infringement protection. Biopharma companies need to start broadening their view of patent portfolio.”