Recent German court decisions have fundamentally shifted the risk landscape for generic and biosimilar companies facing second medical use patents.

The Östrogenblocker, Fulvestrant and Nilotinib cases establish that "skinny label" strategies—marketing products only for non-patented indications—are no longer sufficient to avoid infringement liability where substantial cross-label prescribing occurs.

Why this matters:

Generic manufacturers can now face direct infringement liability even without explicitly marketing for patented indications, if they:

• Know or should know about cross-label use for patented indications
• Exploit circumstances leading to such use (e.g. participating in statutory substitution mechanisms)
• Benefit commercially from prescribing patterns outside their approved label

The Nilotinib decision makes clear that passive compliance through label carve-outs is insufficient - active protective measures are now required, including restrictions on rebate contracts, database warnings and regular communications to prescribing physicians.

Read the full analysis here.

The article, linked above, was authored by Dr Andreas Obermeier, Partner, and Dr Anna Wolters-Höhne, Partner, in our Intellectual Property group.