Biologics and Biosimilars: Navigating Innovation, Competition, and Patent Strategy

The afternoon of the first day of the 2018 C5 Pharma & Biotech conference in Amsterdam saw a dynamic panel on biosimilars, chaired by Bristows partner Dom Adair. Joining him were Dr Corinna Sundermann (Senior Vice President, IP, Fresenius Kabi), Dr Lorenz Kallenbach (Corporate Patent Counsel, Merck), and Brian Coggio (Of Counsel, Fish & Richardson). All views expressed were personal.

The discussion opened with recent sales data underscoring that the majority of the world’s top‑selling drugs are now biologics. The panel then reviewed the breadth of biosimilar approvals by the European Medicines Agency, noting that the largest share of antibody approvals relates to Humira (adalimumab), the best‑selling drug worldwide.

A key theme was the balance of interests between originators and biosimilar entrants. Given the higher investment required for biosimilars compared with small‑molecule generics, the panel questioned whether they are more or less prone to litigation. Consensus emerged that certainty around IP rights is paramount; biosimilars will increasingly adopt early patent‑clearance strategies. However, this can backfire if regulatory approval is delayed, allowing a competitor to launch first. Dr Sundermann highlighted that litigation risk typically favors the patent holder, as damages awarded for a wrongful preliminary injunction are usually outweighed by the profits the owner accrues during the injunction period.

The conversation turned to the European proposal for a SPC manufacturing waiver. Dr Sundermann outlined the benefits: permitting EU manufacturing during the SPC term for export to non‑SPC markets would level the playing field with Asian manufacturers, protect skilled jobs, and enable biosimilar companies to launch on day one after expiry. He also argued that strict regulation controls any risk of reverse leakage into the EU. In contrast, Dr Kallenbach warned that a waiver could erode originator patent rights, undermine R&D investment, and complicate enforcement of SPCs. He pointed out that European generics often undercut originators in export markets, potentially reducing overall EU export value. A quick audience poll revealed a majority opposition to the waiver, though a sizable minority supported it.

Shifting to case law, the panel discussed the Arrow declarations framework and the UK’s Fujifilm v AbbVie decision. They debated whether biologics attract denser patent portfolios due to their inherent complexity or merely by chance. While AbbVie’s Humira patent estate complied with EPO rules, the panel explored whether those rules adequately protect innovation. Dr Sundermann advocated for tighter restrictions, whereas Dr Kallenbach defended legitimate use of divisional applications and suggested courts should tackle abusive conduct through Arrow declarations. The group acknowledged uncertainty about whether an Arrow declaration holds more sway than a revocation decision in foreign courts.

The session concluded with Mr Coggio’s concise overview of the US BPCIA patent‑dance procedure for biosimilar approvals, referencing recent case law including the Supreme Court’s Amgen v Sandoz ruling. He contrasted BPCIA with the established Hatch‑Waxman framework for small molecules, noting that BPCIA uniquely permits assertion of process patents—an aspect that could spur significant litigation given the sophisticated manufacturing processes behind biologic drugs.