Exact Sciences' Legal Battle Takes a Turn: Cologuard Rivalry Continues

Published in Science and Technology on Friday, August 22nd 2025 at 11:33 GMT by Seeking Alpha
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The ongoing legal saga between Exact Sciences and Guardant Health has taken another unexpected turn, with Exact Sciences withdrawing its request for an injunction against Guardant’s ctD-Lung test. This move, while seemingly a retreat from the aggressive litigation initially pursued, doesn't signal the end of the dispute; rather, it highlights the complexities surrounding intellectual property in the rapidly evolving field of cancer diagnostics and the strategic considerations driving both companies.

The core of the conflict revolves around Exact Sciences’ claims that Guardant’s ctD-Lung test infringes on patents related to Exact Science’s Cologuard colorectal cancer screening test. Specifically, Exact Sciences alleges that Guardant's technology utilizes methods described in their patents concerning biomarker detection and analysis – techniques initially developed for Cologuard but potentially applicable across various cancers. The initial lawsuit, filed in December 2023, sought to prevent Guardant from continuing to offer the ctD-Lung test until the patent infringement claims were resolved.

However, Exact Sciences’ recent decision to withdraw the injunction request suggests a reassessment of their legal strategy. While the company maintains its belief that Guardant is infringing on its patents, pursuing an immediate injunction proved challenging. Obtaining an injunction requires demonstrating not only patent infringement but also irreparable harm – meaning the plaintiff must prove they are suffering ongoing and significant damage directly attributable to the defendant’s actions. This is a high bar to clear, and Exact Sciences likely faced difficulties in definitively proving such harm in this particular case.

Guardant Health has consistently denied any wrongdoing, arguing that their ctD-Lung test does not infringe on Exact Science's patents. They have also emphasized the importance of continued innovation and access to cancer diagnostics for patients. The company’s legal team has actively fought against the injunction request, highlighting its potential to disrupt patient care and stifle competition in a critical area of healthcare.

The withdrawal doesn't mean the underlying patent infringement lawsuit is dismissed. Exact Sciences will continue to pursue their claims through standard litigation proceedings. This means the case will proceed towards discovery (the process of gathering evidence) and potentially a trial, where a judge or jury will ultimately decide whether Guardant has indeed infringed on Exact Science’s patents.

The Broader Context: A Competitive Landscape & Patent Thickets

This legal battle is playing out against a backdrop of intense competition in the liquid biopsy market – a field focused on detecting cancer biomarkers from blood samples, offering less invasive alternatives to traditional tissue biopsies. Both Exact Sciences and Guardant Health are major players vying for dominance in this space. Cologuard has established Exact Sciences as a leader in non-invasive screening, while Guardant’s ctDNA tests are gaining traction in both early detection and monitoring of cancer progression.

The legal dispute underscores the complexities surrounding intellectual property protection in biotechnology. Patents are crucial for incentivizing innovation, but they can also create barriers to entry and stifle competition. The fact that Exact Sciences initially sought to apply patents developed for colorectal cancer screening to a lung cancer diagnostic highlights the potential for broad patent claims and the challenges of defining the boundaries of intellectual property rights.

What’s Next?

The withdrawal of the injunction request marks a temporary pause in the most aggressive phase of the legal battle, but it's far from a resolution. Here are some key things to watch:

Discovery Phase: The upcoming discovery phase will be critical. Both companies will attempt to gather evidence supporting their respective positions. This could reveal more details about the technical similarities and differences between Cologuard and ctD-Lung, potentially influencing the outcome of the case.
Patent Validity Challenges: Guardant may challenge the validity of Exact Sciences’ patents, arguing that they are not novel or non-obvious – a common tactic in patent litigation.
Settlement Negotiations: While unlikely at this stage, settlement negotiations could emerge as both companies assess their legal risks and potential costs.
Impact on Innovation: The outcome of the lawsuit will have broader implications for the biotechnology industry, potentially shaping how patents are interpreted and enforced in the future. The legal battle between Exact Sciences and Guardant Health is a microcosm of the larger challenges facing the healthcare industry – balancing innovation with competition, protecting intellectual property while ensuring patient access to cutting-edge diagnostics. While the injunction request has been withdrawn, the underlying dispute remains unresolved, promising further developments in this high-stakes legal drama.

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Exact Sciences' Legal Battle Takes a Turn: Cologuard Rivalry Continues