Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how the STRONGER Patents Act could affect biosimilars.
Could the STRONGER Patents Act impact biosimilars?
That's an interesting act, actually. My understanding is that the STRONGER patents act, among other things, proposes to harmonize the burdens and claim construction standards between PTAB, the Patent Trial and Appeal Board, that hears IPRs, and the district courts that hear district court litigations. In particular, the bill proposes to change the burden of proving invalidity in IPR and a related action, called a PGR, or a post-grant review, to the clear and convincing evidence standard and to use the narrower ordinary meaning claim construction standard that is used in litigation. In other words, it would change the burdens and standards to match what you see in litigation.
The bill would also limit standing to those who had been sued by the patent owner. So it kind of limits who would have standing as well to actually raise the IPR.
Another thing that it does is that it allows for appeal of an institution decision, which is something that you don’t have today. Today, an institution decision, whether [an IPR] is instituted or not is not appealable. So this would give you another shot at saying the PTAB was wrong in instituting an IPR. Given the estoppel provisions already associated with IPR and PGR, these changes could greatly reduce the popularity of these proceedings.
Although in a macro sense, it’s possible that having more restrictive paths to invalidating patents may mean that some biosimilars take longer to clear the necessary IP to launch risk-free, It’s unlikely that this legislation, the STRONGER Patents Act, would affect the ability of biosimilars to reach the market. In some ways, due to the size of most biologics patent portfolios, a biosimilar company may even prefer going to district court where they can challenge a number of patents all at the same time.