This collection examines patents, intellectual property and regulatory exclusivity in life sciences. Articles cover the Unified Patent Court, AI inventorship, employee inventions, licensed rights and parallel imports, alongside exclusivity rules affecting originators, generics and biosimilars.
These articles provide general information and are not legal advice.
Opt-outs under Art. 83 of the Agreement on a Unified Patent Court, made in 2023 before the Court had ruled, can now be tested against three years of its decisions. Withdrawal is not always open: a patent drawn into a national action since the Court opened stays outside it permanently.
AI-generated drug candidates raise unresolved inventorship questions. Patent offices require human inventors, but how much human contribution suffices?
Art. 332 of the Swiss code of obligations (OR) sorts employee inventions into three categories a standard US invention-assignment clause does not track, and one of them carries a statutory compensation claim the employment contract cannot waive.
A Swiss patent can block parallel imports of a price-regulated medicine even from the European Economic Area, but only while it and its supplementary protection last. Swiss antitrust law treats contract clauses barring such imports as hard-core restraints.
Since 1 May 2026 only the EU block exemption lists utility models as technology rights and only the UK's lists database rights. Switzerland has no block exemption. A licensed dataset can sit inside the safe harbor in one territory and outside it in another.
Two of the four 12-month extensions of EU market protection require the EU filing to come first or within 90 days of the first filing outside the Union. A US sponsor that files with the FDA first and in the EU more than 90 days later loses both.
EU orphan exclusivity will run on one clock per holder and active substance, and new orphan indications can extend it by a year at most twice. The two-year pediatric orphan reward will end, and earnouts keyed to orphan exclusivity will track a changed right.
Art. 85 of the EU Pharma Package Directive extends the Bolar exemption to health technology assessment, pricing and reimbursement, and tender filings. Generics and biosimilars can be launch-ready at patent expiry, so US originators may lose EU revenue sooner.
The transferable voucher adds a year of EU data protection, usable on another product only if its annual EU sales stayed within EUR 490 million in its first four years. For most US developers working on antimicrobial resistance (AMR) it is unlikely, alone, to reverse the build-or-abandon decision.
After the EU Pharma Package, a biosimilar entrant plans against an 8+1-year baseline whose added years depend on the originator's own applications, and a launch bar that can lift in one Member State. Switzerland runs a separate ten-year clock.
The proposed Biotech Act SPC year would depend on product innovation, efficacy trials in at least three EU states and eligible EU manufacturing. US and Swiss sponsors face unsettled conditions, timing and certificate questions.
The 2026 ICC Rules, PMAC and English-language courts in Bern and Germany change the choices for cross-border pharma disputes. Agreement dates, patent rights, urgent relief and the location of assets determine which procedure and enforcement route can work.
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