The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
Invitae Corp. continued its aggressive cost-cutting initiative with the sale of its reproductive health assets to Natera Inc. for $10 million in upfront cash and an additional $42.5 million in potential milestone payments and litigation credits. The assets include screening tests for carrier status and non-invasive prenatal screening.
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
On Dec. 1, a judge in the U.S. District Court for the District of Delaware granted Natera Inc. a permanent injunction in its patent infringement suit against Archerdx Inc. and its former parent company, Invitae Corp., adding another block to the intellectual property wall of protection around the market dominance of Signatera, Natera’s molecular residual disease (MRD) assay.
Ravgen Inc.’s patent litigation strategy could add another $100 million to the company’s coffers, assuming enhanced damages in its suit against Laboratory Corp. of American Holdings (Labcorp) awarded on May 12 are sustained on appeal. The additional damages are on top of the $272.5 million awarded in September for “egregious” violations of Ravgen’s patents on non-invasive prenatal testing methods.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91.
Natera Inc.’s personalized, tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, accurately and quickly predicted response to immunotherapy across 25 types of cancer, in a study published in Nature Cancer.
