Court Ruling Enables Exact Sciences to Proceed with Lawsuit against Geneoscopy

Rhea-AI Summary

Exact Sciences Corp. (Nasdaq: EXAS) announced that a judge has denied part of Geneoscopy's motion to dismiss a patent infringement lawsuit. This ruling allows Exact Sciences to move forward with its claims of patent infringement and false advertising. The lawsuit, first filed in November 2023, aims to protect Exact Sciences' Cologuard colorectal cancer screening test from Geneoscopy's alleged infringement and misleading advertising of its ColoSense test. A second complaint was filed by Exact Sciences in May 2024, asserting a new patent related to their sample collection technologies. The company expects the new case to follow a similar timeline to the existing one.

Positive

• Court ruling enables Exact Sciences to proceed with patent infringement lawsuit.
• Lawsuit aims to protect intellectual property central to Cologuard test.
• Company filed a new complaint in May 2024, asserting a new patent.
• New patent issuance (April 30, 2024) strengthens Exact Sciences' legal position.

Negative

• Ongoing litigation could result in legal expenses and resource allocation.
• Potential reputational risk associated with prolonged legal battles.
• No immediate financial gain from the legal proceedings.

Legal Expert

The recent court ruling allowing Exact Sciences to proceed with its lawsuit against Geneoscopy involves significant legal implications, particularly in the realm of intellectual property (IP) and patent infringement. Patent disputes are important in sectors like biotechnology, where innovations are tightly guarded. The legal battle underscores the value and strategic importance of Exact Sciences' intellectual property, specifically their patents for the Cologuard test. If Exact Sciences successfully proves infringement, they could potentially secure monetary damages and enforce injunctions to halt Geneoscopy's activities related to the contested technology. This could reinforce Exact Sciences' market position and potentially deter other competitors from similar attempts. However, prolonged litigation could also mean high legal costs and prolonged uncertainty.

In the short term, this ruling might bolster investor confidence, given that it supports Exact Sciences' position. Long-term impacts will become clearer as the case progresses and if any settlements or judgments are awarded in favor of Exact Sciences.

Market Research Analyst

From a market perspective, this court ruling favors Exact Sciences by potentially disrupting a competitor's operations. If Exact Sciences ultimately wins the lawsuit, they could limit Geneoscopy's ability to market their ColoSense test, directly benefiting Exact Sciences by reducing competitive pressure. This could also allow Exact Sciences to maintain or even increase its market share in colorectal cancer screening. The lawsuit emphasizes the importance of patent protection in maintaining a competitive edge, especially in the highly competitive healthcare and diagnostics industry.

For investors, this case highlights the strategic maneuvers companies use to safeguard their products and technologies. While the legal process is costly and can take time, the potential rewards in protecting market share and proprietary technology justify the efforts. Exact Sciences’ aggressive defense of their IP can be seen as a proactive step to protect their investment and innovation, which is typically viewed positively by the market.

Company asserts that Geneoscopy will infringe patented technology central to its Cologuard colorectal cancer screening test

MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that a District Court judge denied in part Geneoscopy’s (defendant) motion to dismiss a patent infringement lawsuit filed by Exact Sciences (plaintiff) in the United States District Court for the District of Delaware. This ruling paves the way for Exact Sciences to seek relief for Geneoscopy’s future infringement and false advertising.

Exact Sciences filed the lawsuit in November 2023 to prevent Geneoscopy from infringing upon Exact Sciences’ intellectual property central to its Cologuard® colorectal cancer screening test and to put an end to Geneoscopy’s false and misleading advertising and promotion about the alleged clinical performance and superiority of ColoSense. Rather than answer for its misconduct, Geneoscopy filed a motion to dismiss the case.

“Exact Sciences applauds the Court’s decision to permit our infringement and false advertising claims to proceed,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We will continue to vigorously protect and defend our extensive portfolio of patents from unlawful infringement, and we look forward to proceeding with our case against Geneoscopy.”

On May 15, 2024, Exact Sciences filed a second complaint against Geneoscopy to defend its intellectual property against infringement in the United States District Court for the District of Delaware. The case asserts a new patent, the ’746 patent, that was issued to Exact Sciences on April 30, 2024. Like the previously asserted ’781 patent, this patent relates to the novel sample collection technologies that have made Exact Sciences’ flagship Cologuard test so successful. When used according to Geneoscopy’s instructions, its ColoSense test infringes upon these same collection techniques. Exact Sciences expects its new case to proceed on a similar schedule as the existing case, given the overlapping issues.

About Cologuard

Results from Exact Sciences’ prospective, 90-site, point-in-time, 10,000-patient pivotal trial, DeeP-C, were published in The New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuard.com. Rx only.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240521661701/en/

Investor Contact:

Erik Holznecht

Exact Sciences Corp.

investorrelations@exactsciences.com

608-800-6605

Media Contact:

Morry Smulevitz

Exact Sciences Corp.

msmulevitz@exactsciences.com

608-345-8010

Source: Exact Sciences Corp.

FAQ

What was the recent court ruling involving Exact Sciences (EXAS) and Geneoscopy?

A judge denied part of Geneoscopy's motion to dismiss a patent infringement lawsuit filed by Exact Sciences.

When did Exact Sciences file the initial lawsuit against Geneoscopy?

Exact Sciences filed the initial lawsuit in November 2023.

What technology is at the center of the Exact Sciences lawsuit against Geneoscopy?

The technology central to the lawsuit is related to Exact Sciences' Cologuard colorectal cancer screening test.

When was the second complaint filed by Exact Sciences against Geneoscopy?

The second complaint was filed on May 15, 2024.

What is the new patent asserted by Exact Sciences in the latest complaint?

The new patent is the '746 patent, issued on April 30, 2024.