mNEXSPIKE

Given that Moderna has allegedly “reaped billions of dollars from infringing GSK’s patents-in-suit,” GSK’s legal team is hoping “to recover a reasonable royalty for Moderna’s infringing sales.” A little less than a year after targeting Moderna in an mRNA vaccine patent lawsuit, GSK is widening the scope of its litigation by throwing its rival’s next-generation COVID-19 shot into the fold.In an amended complaint filed Thursday in Delaware federal court, GSK’s legal team said the company will also seek royalties on mNexspike after leveling initial patent infringement claims against Moderna’s first COVID vaccine, Spikevax, and its mRNA-based respiratory syncytial virus (RSV) shot mResvia last October.As in the original lawsuit, GSK’s legal complaint centers on claims that the British drugmaker holds U.S. patents on lipid mRNA vaccine formulation technology that was instrumental in the development of Moderna’s shots. Crucially, K asserts that research on the mRNA platform at the heart of the lawsuit was conducted “more than a decade before” the COVID pandemic began.GSK notes that it inherited the patents in 2015 when it purchased a “substantial portion” of Novartis’ vaccines business. The company’s lawyers said they are suing Moderna because the defendant has “consistently failed to acknowledge” its use of that mRNA research.Aside from purportedly incorporating “the full content of” GSK’s patents within its own intellectual property filings, Moderna also acquired “technical know-how” related to GSK’s mRNA platform by “hiring several former Novartis and GSK employees with first-hand knowledge” of the foundational research, the lawsuit alleges. As to why mNexspike is now involved in the proceedings, GSK argues that, like its predecessor Spikevax, the shot was made using “the same composition of mRNA, composition of lipid particles, and methods of manufacture” at issue in the original legal filing.Given that Moderna has allegedly “reaped billions of dollars from infringing GSK’s patents-in-suit,” GSK’s legal team is hoping “to recover a reasonable royalty for Moderna’s infringing sales.”Moderna plans to fight the claims, according to a spokesperson, who told Fierce Pharma that the company “remains confident in its legal positions across these matters.“We look forward to presenting our case and prevailing at the appropriate stages of each proceeding,” the spokesperson said in an emailed statement.GSK did not immediately respond to Fierce Pharma’s request for comment on the matter.The update to GSK’s case complicates an already tangled web of mRNA patent litigation, with a large swath of drugmakers who attempted to or succeeded at getting a COVID shot approved now involved in lawsuits at some level.Just looking at GSK, the company has also sued Pfizer and BioNTech on similar grounds to its Moderna case, likewise seeking royalties on sales of the partners’ coronavirus prophylactic Comirnaty. And last month, GSK netted $320 million upfront through the settlement of a separate mRNA lawsuit between CureVac and Pfizer-BioNTech.GSK initially partnered with CureVac on mRNA vaccine development in 2020 and restructured the alliance last July, although the relationship between the two companies has apparently soured since BioNTech moved to acquire CureVac earlier this summer.Elsewhere, Moderna has sued Pfizer and BioNTech for infringement, and several other non-commercial mRNA players, such as Alnylam, Acuitas Therapeutics and Arbutus BioPharma have gotten involved in the legal action as well. Meanwhile, Moderna’s latest COVID-19 vaccine, mNexspike, has been added to the patent litigation brouhaha some three months after scoring FDA approval for use in all adults aged 65 and older, as well as in people between the ages of 12 and 64 who have one or more underlying risk factors for severe COVID, such as asthma or diabetes.The shot was approved on non-inferiority data from a phase 3 trial pitting mNexspike against Moderna’s earlier vaccine Spikevax. The next generation shot demonstrated a 9.3% higher relative vaccine efficacy in patients 12 and older, and a 13.5% higher relative efficacy in a subgroup of study participants ages 65 and up.Moderna noted in June that it aimed to make the vaccine available for the upcoming 2025-26 respiratory virus season in the U.S. 

CBER Director Vinay Prasad is quietly dropping hints on how he may alter the way vaccines win approval, including larger immunogenicity trials as well as expanding the use of randomized trials for co-administered vaccines. In recent FDA decisional memos on the Covid-19 vaccine changes for Pfizer, Moderna and Novavax, Prasad outlined his thinking on what could be required for pre-approval trials and post-marketing commitments. They offer potential insight into how the agency’s standards are changing under Prasad, FDA Commissioner Marty Makary, and HHS Secretary Robert F. Kennedy Jr. For example, in a nine-page memo on Pfizer’s Covid-19 vaccine Comirnaty — building off other memos released last week — Prasad wrote that CBER “has a new evidence-based philosophy for allowing the sponsor to make claims about concurrent administration of vaccines.” While noting that concurrent vaccine administration “offers the theoretical benefit of increasing compliance with annual respiratory pathogen vaccination,” he also said that “the potential downside is that multiple vaccines administered together may interfere with efficacy” or could come with “new or higher rates of safety signals that would not have occurred with sequential vaccination.” The CDC has defended the safety of co-administering multiple vaccines, writing in a post last December — under the Biden administration — that “scientific data show that getting several vaccines at the same time does not cause any chronic health problems.” Under Prasad, however, the FDA seems to be calling that into question, building on a larger reconsideration of vaccine policy and requirements under Kennedy. Prasad wrote that CDER will referee safety questions and may require randomized controlled trials testing different vaccine administration practices against each other, including sequential and concurrent administration. He wrote that such trials could use “a hierarchical statistical design, testing first noninferiority and then superiority. The primary endpoint would be clinical, for instance: symptomatic RSV, COVID-19, and influenza.” To defend the new reasoning, Prasad cited former FDA Commissioner Rob Califf, who in January wrote in a JAMA commentary that “Covid vaccine uptake is now low enough that large RCTs are feasible to evaluate the efficacy and safety of new updated boosters.” In the memos for Moderna’s Spikevax and mNexspike, as well as Novavax’s Nuvaxovid, Prasad also explained why he’s requiring both companies to run much larger safety and immunogenicity studies as part of post-marketing commitments tied to their latest approvals. “The prior standard in CBER was acceptance of small immunogenicity studies using human sera, largely aimed at demonstrating numerical improvements in antibody formation against prevailing strains,” he wrote. “Now CBER will demand studies roughly 5 to 10 times larger than historically accepted.” FDA and Prasad didn’t immediately respond to a request for comment Tuesday on how large the trials might be, or if more official FDA guidance may be in the works. Prasad wrote that these post-market requirements for Moderna and Novavax can “improve vaccine regulation,” by potentially answering whether the vaccines might be less effective in immunocompromised people because they could fail to generate enough antibodies, or whether current Covid-19 vaccine policy is “doing justice for these Americans.”