The CDMO Surge and Potential IP Landmines in Outsourcing**

The CDMO Surge and Potential IP Landmines in Outsourcing**

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Biotech and pharma companies are increasingly outsourcing to CROs, CMOs, and CDMOs across all stages, from discovery to commercialization. With the CDMO market projected to exceed $300 billion within the next decade, this strategy offers critical benefits in expertise, speed, and capacity. However, it also brings unique IP challenges, particularly the risk of triggering the on-sale bar when contractors are paid to develop products and processes for these companies, and this is especially relevant for biologics, where process and manufacturing patents are key value drivers. The recent Federal Circuit decision in Celanese Intl. Corp. v. Intl. Trade Comm’n puts renewed focus on the issue, holding that pre-critical date sales of products made using secret processes can bar patentability.  In-house and external counsel must carefully navigate these outsourcing collaborations to safeguard innovations while managing potential on-sale bar issues.

Materials

Powerpoint: On Sale Bar

CAFC Affirms ITC’s Invalidation of Sweetener Patent Under On-Sale Bar, Citing Helsinn

Public-Use Bar: What Startups Need to Know

Lessons from Junker v. Medical Components, Inc. on Commercial Offers for Sale Invalidating a Patent

Supreme Court decides Helsinn v. Teva, Secret Sale Qualifies as Prior Art Under the AIA

Survey

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