How the US-Mexico trade deal could impact the biologics market
BPR: Could you outline what has emerged from preliminary details of the potential US-Mexico trade deal?
JF: We don’t have a lot of detail, at this point, but what we do know, as it applies to pharma and biologics, the agreement includes data exclusivity provision specifically for biologics. Current Mexican law does not include any data exclusivity provided for anything, whether that is small molecule formulations, new data, and certainly nothing related to biologics. There has been some movement to propose exclusivity, similar to what we have in the US, for small molecules, and there is an argument that current NAFTA (North American Free Trade Agreement) provisions would override Mexican law, there’s been some litigation in that space. The question for the US-Meixoc Trade Agreement, as there is an express provision in there for biologics, is whether that scope would reach to small molecules.
BPR: What do the provisions for biologics exclusivity outline?
JF: The biologics data exclusivity currently in agreement, as far as we’ve been made aware, is a 10-year provision, which is a little bit less than what we currently have in the US. In the states, we have a 12-year period of no approval and the first four years of that approval are a ‘no review’ period, where the US Food and Drug Administration will not actually review any applications. Whether this provisional agreement functions in a similar way is not yet known, we assume, in terms of approval, it will work similarly but whether this includes a no review period is not yet known.
BPR: What has the reaction been to the news?
JF: The reaction has been what we would have expected: from the innovator side, they believe 10 years’ exclusivity is not enough because they didn’t believe, on the US side, that 12 years’ exclusivity was enough either. On the side of those who are advocating early access, they have suggested that the 10 year period is too long.
BPR: If you had to speculate, what would you estimate the timeframe for potential implementation?
JF: There is a desire to move things fairly quickly, considering our mid-term election timelines. I think that the participation, or lack of participation, with Canada may impact the timeline. Those individuals who are keen on pushing the deal through might say, “Canada, you can come later”, but that’s simply my speculation.
BPR: How does Canada influence the deal and what would you expect its reaction to be?
JF: It depends, it could be a case of everything arranged between the US and Mexico, and then Canada would have to agree or have a separate negotiation. In fact, just because NAFTA currently covers all of North America doesn’t necessarily mean that this new agreement will have to. In terms of conversation from the Canadian side, I’ve seen commentary wondering whether Canada should try to jump into the deal but at this stage, it is still unclear whether the deal might change to be better or worse for the country, in terms of length of exclusivity and which side of the fence you are on.
Jennifer Fox is a shareholder at Brinks Gilson & Lione, where she is co-chair of the firm’s biopharma practice group. With over two decades of experience in the pharmaceutical and biotechnology industries, her practice includes patent portfolio procurement and management, IP due diligence and transactional support, and post-grant proceedings.