Engineering-side
life sciences.

What we see, day to day.

Services tuned to biotech.

Where this work lives.

Frequently asked questions about biotech IP.

• 01What IP issues are unique to biotech?

  Biotech IP work sits at the intersection of § 101 subject-matter eligibility (especially after Mayo for diagnostic-method eligibility), disclosure-vs-publication tension between academic founders and investors, freedom-to-operate at clinical milestones, and platform-vs-product claim strategy. Lynch LLP works on each of these in parallel: drafting that survives § 101 scrutiny, FTO scoped to the gates investors actually ask about, and continuation strategy that captures both the platform genus and the lead-asset species.
• 02How does Lynch LLP approach patent-filing timing in biotech?

  Filing strategy in biotech turns on the interaction between disclosure events, investor diligence gates, and FDA device milestones. Lynch LLP maps that interaction for medical-device, diagnostic, imaging, and digital-health companies and builds a 12–36 month roadmap around it, sequencing provisional, PCT, and continuation filings against the platform-and-product claim picture.

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• 03How do we approach freedom-to-operate analysis in biotech?

  Lynch LLP scopes FTO opinions to the questions that biotech stakeholders actually ask: pre-clinical FTO before Phase 1, clinical-asset FTO before Phase 3, and commercial FTO before launch. Each pass identifies blocking patents, evaluates design-around or licensing options, and is documented to a level appropriate for board, investor, or partner review without overshooting into expensive opinion-writing where it isn't needed.
• 04How does our experience in biotech differ from a general-practice firm?

  Three things distinguish our biotech work from a general-practice firm. First, our attorneys have engineering backgrounds — mechanical and electrical. That's the right depth for the device, instrumentation, and digital-health side of biotech, where claim drafting depends on understanding how the system is built. Second, the attorney you meet is the attorney doing the work. Strategic decisions happen with the lawyer you briefed at intake — not handed off to a junior staffer to execute somebody else's plan. Third, we coordinate U.S. and international filings as a single strategy. Biotech deployment markets — EU, Japan, China, Korea — vary by product line and regulatory pathway. Our 12-to-36-month patent roadmaps align with FDA 510(k) / De Novo / PMA milestones rather than treating prosecution as a series of disconnected actions.

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