Delaware Judge Dismisses Key Defenses in Moderna Patent Case
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy MRNA?
Source: seekingalpha
- Patent Defense Dismissed: Delaware Judge Joshua Wolson has dismissed two key defenses raised by Moderna in its ongoing patent litigation against Arbutus Biopharma, particularly the defense based on obviousness, stating that Moderna failed to raise these claims in prior inter partes review, thus barring them from asserting them in this case.
- Impact of IPR Estoppel: The judge emphasized that IPR estoppel prevents defendants from raising obviousness claims made in an IPR proceeding, which Moderna already lost, further weakening its position in the litigation.
- Issue Preclusion Defense Fails: Moderna's other defense, based on issue preclusion, argued that the patent subject matter was not actually invented by Arbutus; however, the judge noted that Moderna failed to demonstrate prior conception by another, with its own expert conceding that an Arbutus scientist encapsulated mRNA in lipid nanoparticles before Moderna did.
- Enablement Defense Allowed: Despite facing significant setbacks, the judge has allowed Moderna's enablement defense to proceed, asserting that enablement ensures adequate disclosure of the claimed invention and prevents claims broader than what is disclosed, potentially providing Moderna with a continued avenue for defense.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy MRNA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 46.600
Low
17.00
Averages
32.47
High
63.00
Current: 46.600
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company. The Company is advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a spectrum of diseases. The Company’s diverse development pipeline consists of 44 therapeutic and vaccine programs, 11 of which are in late-stage development. Its commercial products include Spikevax (its COVID vaccine) and mRESVIA (its respiratory syncytial virus (RSV) vaccine). Additionally, it has achieved four positive Phase III data readouts for its COVID vaccine (mRNA-1283), its RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), its seasonal flu+COVID vaccine (mRNA-1083), and its seasonal flu vaccine (mRNA-1010).
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Moderna's Share Performance: Moderna's shares have increased by 6.6% following a review by the FDA.
FDA Review Focus: The FDA's review pertains to the influenza vaccine developed by Moderna.
See More
- FDA Review Announcement: The U.S. Food and Drug Administration (FDA) will begin reviewing Moderna's investigational seasonal flu vaccine.
- Company Statement: Moderna announced the initiation of the review on Wednesday.
See More
- FDA Acceptance: The U.S. FDA has accepted Moderna's marketing application for mRNA-1010, marking a significant advancement in the company's vaccine development, with a target action date set for August 5, 2026, thereby laying the groundwork for future market expansion.
- Revised Application Pathway: During a Type A meeting with the FDA, Moderna proposed an amended biologics license application (BLA) that includes an age-dependent regulatory pathway and a post-marketing requirement for additional trials in older adults, demonstrating the company's commitment to regulatory compliance.
- Market Expectations: Moderna plans to launch mRNA-1010 for adults aged 50 and older in the 2026/2027 flu season, a strategy that not only addresses the demand for flu vaccines among the elderly but also has the potential to enhance the company's market share and brand influence.
- Stock Price Recovery: Following the FDA's acceptance of the application, Moderna's shares gained in premarket trading, reflecting investor optimism about the company's future growth potential, especially after facing pressure from last week's FDA refusal-to-file letter.
See More
- EU Marketing Authorization: Moderna's COVID-19 vaccine mNEXSPIKE has received marketing authorization from the European Commission for individuals aged 12 and older, marking the company's third product approved in the EU, thereby enhancing its competitive position in the global vaccine market.
- Clinical Trial Results: In a randomized, controlled Phase 3 trial involving approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Spikevax, with a 13.5% increase in adults aged 65 and older, providing strong support for its market launch.
- Safety Profile: The safety profile of mNEXSPIKE is comparable to Spikevax, with fewer local reactions and similar systemic reactions, and the most commonly reported adverse effects include injection site pain, fatigue, headache, and myalgia, indicating good tolerability.
- Market Outlook: Moderna has already secured regulatory approval for mNEXSPIKE in the U.S., Canada, and Australia, and is pursuing additional market authorizations worldwide, which is expected to drive future revenue growth for the company.
See More
- Portfolio Changes: Bridgewater Associates made significant adjustments to its investment portfolio in the fourth quarter.
- Exiting Investments: The hedge fund exited its position in a major wireless carrier as part of its strategy.
- Healthcare Holdings: Bridgewater also readjusted its investments in the healthcare sector.
- Market Position: As the largest hedge fund globally by assets under management, these changes reflect its ongoing strategy to optimize performance.
See More
- Guidance Miss: Walmart's latest earnings report projects adjusted EPS for the fiscal year between $2.75 and $2.85, falling short of Wall Street's $2.96 forecast, resulting in a premarket stock drop of over 2%.
- Challenges Under New CEO: With John Furner taking the helm amid intensifying market competition, investor focus on his strategic direction is increasing, which could impact stock performance.
- Market Performance Review: Despite a recent stock increase of over 21% and nearly 175% over the past five years, the lowered guidance may raise concerns about Walmart's future growth potential among investors.
- Industry Dynamics Impact: On the same day as Walmart's report, Wayfair posted its first annual sales gain, while Etsy's stock rose after beating earnings expectations, indicating a potential pressure on Walmart from the recovering retail sector.
See More










