What Happened
2023's biggest patent story was the Supreme Court's Amgen decision, which reinforced that patent claims must be enabled by the specification. Beyond that, the UPC launched in Europe, venue battles continued in the U.S., and Section 101 reform remained stuck in Congress.
Why It Matters
Amgen's impact on biotech patenting is already visible. Applicants are disclosing more species, claiming more narrowly, and being more careful about genus claiming. Existing patents with broad functional claims face new vulnerability. This will shape biotech innovation and investment for years.
The UPC's first year showed promise and challenges. Several hundred cases were filed. Thousands of patents were opted out. Early decisions are starting to emerge. The court is functioning, but it's still proving itself. Patent owners are watching closely before committing fully.
In the U.S., Waco remained popular despite Federal Circuit scrutiny. The PTAB continued to be a powerful validity challenge forum. And eligibility uncertainty persisted—software and diagnostic patents still face unpredictable Section 101 hurdles.
What You Should Know
For 2024, watch how Amgen gets applied in lower courts and at the USPTO. Watch whether the UPC gains credibility and caseload. Watch whether Congress finally acts on eligibility reform (possible but still uncertain). And watch whether Waco's filing surge moderates under continued Federal Circuit oversight.
The practical advice remains consistent: disclose adequately, choose venue thoughtfully, consider PTAB challenges early, draft with eligibility in mind, and maintain flexibility through continuation practice.
The fundamentals haven't changed, even as the details keep evolving.