Exelixis Announces Update on Second Patent Litigation Trial with MSN Laboratories

Rhea-AI Summary

Exelixis, Inc. (Nasdaq: EXEL) announced a favorable ruling in its patent litigation against MSN Laboratories. The U.S. District Court for the District of Delaware upheld the validity of three Orange Book-listed patents related to cabozantinib, rejecting MSN's challenge. These patents expire on January 15, 2030. The court also ruled that Exelixis' pharmaceutical composition patent is not invalid and not infringed by MSN's proposed ANDA product.

Previously, MSN had stipulated that its proposed generic cabozantinib product would infringe the patents in question. As a result of this ruling, the earliest MSN may launch its generic product in the U.S. is January 15, 2030, subject to appeals and regulatory exclusivity. Exelixis expressed confidence in its cabozantinib patent estate and commitment to defending its intellectual property rights.

Positive

• Court ruled in favor of Exelixis, upholding the validity of three key patents
• MSN's generic product launch delayed until at least January 15, 2030
• Strengthens Exelixis' intellectual property position for cabozantinib

Negative

• None.

Insights

Legal Expert

The court ruling in Exelixis' favor is a significant win for the company, upholding the validity of three key patents related to cabozantinib. This decision effectively protects Exelixis' market exclusivity for CABOMETYX® until at least January 15, 2030. The rejection of MSN's challenge to these Orange Book-listed patents strengthens Exelixis' intellectual property position and prevents potential generic competition for nearly seven more years.

Notably, the court also ruled that Exelixis' pharmaceutical composition patent (U.S. 11,298,349) is not invalid, further bolstering their patent portfolio. While this specific patent was found not to be infringed by MSN's proposed product, it remains a valuable asset for Exelixis against other potential competitors.

This outcome provides Exelixis with a clear runway for CABOMETYX® sales without generic competition, which is important for maintaining revenue streams and supporting ongoing research and development efforts. Investors should view this as a positive development for Exelixis' long-term market position and financial stability in the oncology space.

Financial Analyst

This legal victory has significant financial implications for Exelixis. CABOMETYX® is the company's flagship product, generating $1.42 billion in net product revenue in 2022, representing 27% year-over-year growth. Securing market exclusivity until 2030 provides a clear revenue projection for investors and allows Exelixis to continue investing in its pipeline without immediate threat from generic competition.

The extended exclusivity period also enhances Exelixis' attractiveness as a potential acquisition target or partnership opportunity. With a strong IP position and guaranteed market exclusivity, larger pharmaceutical companies may see Exelixis as a valuable addition to their oncology portfolios.

Investors should consider the potential for continued revenue growth from CABOMETYX® and the possibility of expanded indications. This legal win removes a significant risk factor and may lead to a re-evaluation of Exelixis' long-term value proposition in the market.

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) vs. MSN Laboratories Private Limited et al. (MSN), Civil Action No. 22-00228 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt); 11,091,440 (pharmaceutical compositions); and 11,098,015 (methods of treatment). The District Court’s decision in Exelixis’ favor on the validity of these patents follows an earlier Stipulation entered on June 21, 2022, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’439, ’440, and ’015 patents, which expire on January 15, 2030.

Additionally, the court ruled that Exelixis’ pharmaceutical composition patent (U.S. 11,298,349) is not invalid and not infringed by MSN’s proposed ANDA product.

“We are pleased with the court’s ruling, which upheld the validity of Exelixis’ ‘439, ‘440, ‘015 and ‘349 patents,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “We remain confident in the strength of the current and emerging cabozantinib patent estate. We will continue to pursue every available legal action to defend our intellectual property rights, which are crucial to safeguarding the scientific innovation that drives our mission to help cancer patients recover stronger and live longer.”

MSN is seeking approval for a product containing a different polymorphic form of cabozantinib (l)-malate than the form contained in Exelixis’ breakthrough CABOMETYX^® (cabozantinib) product. To Exelixis’ knowledge, the U.S. Food and Drug Administration (FDA) has not yet granted tentative approval of that potential product. If the FDA ultimately approves MSN’s ANDA, given today’s decision, the earliest that MSN may be permitted to commercially launch its proposed generic product in the U.S. is January 15, 2030, subject to any appeals or additional regulatory exclusivity.

About Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX^® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ confidence in the strength of the cabozantinib patent estate and plans to pursue every available legal action to defend its intellectual property rights; the potential timing for MSN to commercially launch its proposed generic product in the U.S.; Exelixis’ and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; the degree of market acceptance of CABOMETYX in the indications for which it is approved and in the territories where it is approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for this product; the effectiveness of CABOMETYX in comparison to competing products; Exelixis’ and its partners’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; Exelixis’ and its partners’ continuing compliance with applicable legal and regulatory requirements; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of cabozantinib; changes in economic and business conditions; and other factors detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241015378225/en/

Investors Contact:

Susan Hubbard

EVP, Public Affairs and

Investor Relations

Exelixis, Inc.

(650) 837-8194

shubbard@exelixis.com



Media Contact:

Claire McConnaughey

Senior Director, Public Affairs

Exelixis, Inc.

(650) 837-7052

cmcconn@exelixis.com

Source: Exelixis, Inc.

FAQ

What was the outcome of Exelixis' patent litigation against MSN Laboratories?

The U.S. District Court for the District of Delaware ruled in Exelixis' favor, upholding the validity of three Orange Book-listed patents related to cabozantinib and rejecting MSN's challenge.

When is the earliest date MSN can launch its generic cabozantinib product in the U.S.?

Based on the court's decision, the earliest MSN may launch its generic cabozantinib product in the U.S. is January 15, 2030, subject to appeals and additional regulatory exclusivity.

What patents were involved in the Exelixis (EXEL) vs. MSN Laboratories lawsuit?

The lawsuit involved U.S. Patents No. 11,091,439 (crystalline salt), 11,091,440 (pharmaceutical compositions), 11,098,015 (methods of treatment), and 11,298,349 (pharmaceutical composition).

How does this court ruling impact Exelixis' (EXEL) cabozantinib product CABOMETYX?

The ruling strengthens Exelixis' intellectual property position for CABOMETYX by upholding the validity of key patents and delaying potential generic competition until at least January 15, 2030.