Gene Therapy And US Patent Eligibility Update
The ground of “patent ineligibility” has been applied fairly widely in US patent practice. However, a recent decision of the Federal Circuit Court in REGENXBIO, Inc. v. Sarepta Therapeutics, Inc., No. 24-01408 (Fed. Cir. 2026) (“REGENXBIO v. Sarepta”) provides welcome relief for applicants seeking to protect biotech inventions in the USA. The Federal Circuit has held that the genetically engineered host cells for producing gene therapy products claimed in REGENXBIO’s U.S. Patent No. 10,526,617 (“the ‘617 patent”) are [...]