The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)¹, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. The accused infringing conduct at issue had multiple uses, leading to a complicated legal analysis with lessons for both patent owners and alleged infringers.

Plaintiff BlueAllele accused defendant Intellia of infringing three patents related to gene-editing technology. Gene-editing refers to methods where particular DNA sequences within a cell’s genome are targeted and modified for research or therapeutic purposes. Bi-directional insertion templates (BDITs) allow efficient DNA editing with minimal byproducts. BlueAllele alleged that Intellia used its patented BDITs in basic research and as research tools to identify and manufacture therapeutic candidates. It also alleged that Intellia used the BDITs for commercial purposes not related to approval by the Food and Drug Administration (FDA).

Pleading and burden of proof

Initially, the court reiterated that the Safe Harbor is an affirmative defense. Under the Safe Harbor², an alleged infringer must be “making, using, offering to sell, or selling a ‘patented invention’” and such conduct must be reasonably related “to the FDA approval process.” Since the complaint makes “adequate contrary allegations,” and “sufficiently alleges” that at least some of Intellia’s activities did not meet this standard, the court found that dismissal was inappropriate.

Basic research

BlueAllele alleged that Intellia used the patent products for basic research (i.e., for the “experimentation, identification, and development of in vivo therapeutics”), which is not protected by the Safe Harbor³. Accordingly, Intellia argued that it developed the accused products years before the asserted patents issued; thus, it argued that its conduct was “surely related to FDA submission and not basic research.” Although the court found that the argument seemed “fairly logical,” it refused to resolve this factual dispute on a motion to dismiss. Since BlueAllele “plausibly alleged” that at least some of Intellia’s conduct involved basic research, the motion to dismiss was denied.

Research tools

“Research tools” (i.e., laboratory devices or techniques that are not themselves subject to FDA approval and patent term extension under 35 U.S.C. § 156(a)) are not protected by the safe harbor.⁴

BlueAllele alleged that Intellia used the accused BDITs as research tools as part of the process to identify therapeutic candidates, used and made circular plasmids comprising BDITs for manufacturing of therapeutic candidates, and also used them in collaboration with other entities. According to the court, “[n]othing more is required to survive dismissal…” However, the court recognized that the accused products could become part of the therapeutic system. According to Intellia, the accused products were therefore “patented inventions” under the statute and thus subject to Safe Harbor protection even when used as research tools. The alleged distinction under the Safe Harbor between manufacturing uses and research tool uses required a complete factual record. But since at least some of BlueAllele’s allegations showed that the BDITs were not “patented inventions” and therefore not subject to Safe Harbor protection, the motion to dismiss was denied.

Experimental use defense

Although not directly related to Safe Harbor protection, recent developments may increase the scope of protected conduct. On June 28, 2024, the U.S. Patent and Trademark Office requested the public’s views on the experimental use defense and whether a statutory exception was warranted. Most of the numerous responses were positive.

Unlike European countries, the United States does not have an experimental use defense.⁵ However, the International Association for the Protection of Intellectual Property position allows experimentation to improve or advance a patented invention, but not for commercial exploitation. The scope of protection varies from country to country. For example, in Germany, quite possibly the country with the broadest protection, any experiment conducted to gain knowledge may be protected, even if the conduct ultimately has a commercial purpose. However, all countries, including the U.S., agree that the use of a research tool is not protected. (For more information about the experimental use defense in the U.S. and how it compares to other jurisdictions around the world, see our article “Should the Experimental Use Exception Be Broadened?”)

It is unclear whether the U.S. will enact a statutory experimental use defense, but it is worth considering how such a charge could affect decisions like BlueAllele, especially the aspects dealing with basic research.