CRISPR votes for the CP to solve for disease over being caught in litigation under national jurisdiction

On Tuesday, May 7, the U.S. Court of Appeals for the Federal Circuit will hear argument in a long-awaited appeal addressing the inventorship of the Nobel Prize-winning CRISPR technology. The case is the latest in a continuing legal battle between two groups of innovators, each asserting patent rights to key aspects of the groundbreaking technology.

The facts on appeal are numerous, and the issues nuanced, covering questions of conception, reduction to practice, and written description (as well as cross-appeal issues). This article’s purpose is not to reiterate each side’s various legal positions, but to explore a narrower issue intertwined with the global CRISPR patent disputes: considerations of patent harmonization and the thus-far inconsistent patent outcomes.

The CRISPR Wars

“CRISPR” is an acronym for “Clustered Regularly Interspaced Short Palindromic Repeats.” As many readers know, CRISPR technology enables precision gene editing. The technology’s potential benefits are enormous, some of which are already being realized with the FDA’s approval of CRISPR-based therapies late last year.

Competing patents and applications have been awarded and filed in the United States and across the globe. On one side are Jennifer Doudna and Emmanuelle Charpentier (the two Nobel Prize winners), along with their research institutions, collectively known as the CVC appellants. On the other side are Feng Zhang and his colleagues at the Broad institute, MIT, and Harvard, collectively known as the Broad cross-appellants.

A basic aspect of the pending dispute is who first invented (to a satisfactory degree, under patent law) a CRISPR system that could work in eukaryotic cells. Recall from high school biology that prokaryotic cells do not have a nucleus, but eukaryotic cells do. The former are generally earlier on the evolutionary scale and thus less complex, but the two types of cells nonetheless have many common systems and features.

CVC filed its patent application describing the CRISPR-Cas9 complex and claiming its use in eukaryotic cells earlier than Broad, but Broad filed a patent application with experimental results in eukaryotes earlier than CVC. CVC also asserted an earlier invention date (through conception and reduction to practice). The case to be argued this week at the Federal Circuit concerns the Patent Trial and Appeal Board’s (PTAB’s) interference decision, which awarded priority of the invention’s use in eukaryotic cells to Broad. (Note that this is not the first CRISPR dispute to reach the Federal Circuit).

CVC’s CRISPR patents are being challenged in multiple patent tribunals, in the United States, Europe, Japan, and China. Intriguingly, the PTAB is the only patent office thus far to rule against CVC’s patents for the eukaryotic CRISPR system. As described below, the challenges in the other three fora have generally been in CVC’s favor.

The disparate outcomes may offer the Federal Circuit a reason to account for harmonization considerations when it hears oral argument. While harmonization is not front-and-center of the appeal—and was not expressly briefed by the parties—the Court may still want to ask why the PTAB was the apparent outlier as the only adjudicator thus far to rule against the Nobel Prize winners.