Court Strikes Down Agilent’s CRISPR Patents in Major IP Ruling

The dispute centers around Agilent’s U.S. Patents No. 10,337,001 and 10,900,034, which cover specific chemical modifications to CRISPR guide RNAs, particularly the incorporation of 2'-O-methyl (2'OMe) modifications. These alterations are designed to improve the stability and performance of guide RNAs used in CRISPR-Cas9 systems — a gene-editing tool that allows scientists to precisely alter DNA sequences.

The patents were challenged through inter partes review (IPR) by a competitor, who argued that the claimed inventions were neither novel nor non-obvious in light of prior art. The PTAB sided with the challenger, finding that the patent claims lacked the necessary inventive step. According to the Board, earlier disclosures — including scientific publications and patent documents — already described similar RNA modifications or rendered the claimed advances obvious to a skilled person in the field.

Agilent appealed the PTAB’s ruling to the Federal Circuit, asserting that the Board had misinterpreted key elements of the patents and failed to consider secondary factors such as commercial success and long-felt but unsolved needs. However, in its decision issued on June 11, 2025, the Federal Circuit rejected Agilent’s arguments. The court concluded that the PTAB had correctly assessed the evidence and applied the legal standards for obviousness.

In its opinion, the Federal Circuit emphasized that the use of 2'OMe modifications was well known in the field and that combining such modifications with guide RNAs for CRISPR applications would have been a logical step for researchers. The court also noted that there was insufficient evidence to establish that Agilent’s specific implementation of these modifications produced unexpected results.

The affirmation of the PTAB’s decision has significant implications. First, it removes potential barriers for companies and researchers developing CRISPR-based technologies. With Agilent’s patents invalidated, competitors may proceed without fear of infringing on these specific claims. Second, the ruling reinforces the effectiveness of the inter partes review system as a tool for challenging weak or overly broad patents, especially in fast-moving scientific fields.