Two Newly Issued Meganuclease Patents Immediately Challenged by Cellectis in Declaratory Judgment Action

In an earlier post, I reported on patent infringement litigation between Cellectis and Precision BioSciences, two companies commercializing engineered I-CreI meganucleases as tools for specifically cleaving a targeted recognition site in double-stranded DNA.

On February 21, the patent office issued two new patents directed towards modified I-CreI meganucleases (8,119,361 and 8,119,381), and on the same day Cellectis filed declaratory judgment action against Precision seeking to establish that these patents are invalid and not infringed. These patents are continuations of 8,021,867, which is the subject of another declaratory judgment action filed by Cellectis last year. On their face, the patents indicate that they are assigned to Duke University, but Cellectis alleges that Precision is the actual owner of the patents. The infringement litigation between the parties began when Cellectis sued Precision for allegedly infringing Cellectis’s patent 7,897,372. The lawsuits have all been filed in Delaware District Court.

On Feb 21, Precision also filed a case in the Eastern District of North Carolina asserting the two newly issued patents against Cellectis.

Based on a quick reading of the claims, it appears that both the Cellectis patent and the Duke/Precision patents are directed towards rationally engineered variants of the I-CreI meganuclease with altered target specificity. The Cellectis and Duke/Precision claims focus on modification at different amino acid residues in protein, but it looks as though there would be substantial overlap in the claim coverage of the Precision and Duke/Precision claims. In particular, the claims all recite “at least” one amino acid substitution as specified by the claim, but all are written to encompass I-CreI meganucleases with additional amino acid modifications, so a I-CreI meganuclease modified at several locations in the amino acid chain could fall within the scope of patents owned by both parties.

Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not

Last August I posted a draft article debunking the myth that 20% of genes are patented, and explaining that the widespread concern that human gene patents will impede whole genome sequencing is largely based on a misreading of the empirical evidence. I have continued to work on the project, and have just posted a follow-up article on SSRN entitled "Will Gene Patents Derail the Next Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not.”. I plan to present some of the results at the USPTO hearings on gene patents and genetic testing to be held at the University San Diego on March 9. A brief abstract summarizing the article is provided below, the full article can be accessed here.

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents “present a significant obstacle to the next generation of innovation in genetic medicine—multiplex tests and whole-genome sequencing.” His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single "Policy Perspective" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as "covering" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.