When the Lawyer Draws the Product

Contents

This paper is written in the role of in-house counsel and takes the form of a report to the board of Siemens Healthcare AB. Its starting point is two assignments that meet in the same product: the next generation of the SOMATOM X.cite CT platform with the AI-driven workflow assistant myExam Companion, and a proposed out-licensing of a US X-ray tube patent with associated know-how to an external party seeking to enter the non-destructive testing market.

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The first strand shows how a single product decision simultaneously triggers the MDR, the AI Act, the GDPR, NIS2 and cybersecurity regulation – and why compliance therefore cannot be an ex post check, but must be built into product development itself. The second strand builds a licence agreement clause by clause, on the premise that what is commercially most valuable is rarely the patent but the unwritten knowledge that cannot be recalled once it has been disclosed, and places each clause in relation to the framework of competition law (TTBER). The third strand draws the conclusion: in-house counsel is no longer an adviser consulted after the fact, but an architect who shapes the legal subjects, legal objects and legal relationships through which the technology can be developed, commercialised and controlled at all.

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For anyone who wants to see how regulatory compliance, intellectual property law and contract design merge in a technology-driven business, the text offers a sustained application rather than a discussion of principle.

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