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At biopharmaceutical companies like Argenx, internal law departments play a crucial role in ensuring compliance with global frameworks. The pathway from laboratory discovery to approved immunology therapies, such as those in Argenx’s proprietary pipeline, requires adherence to Food and Drug Administration regulations in the US and European Medicines Agency in Europe. Compliance spans pre-clinical testing, clinical trial protocols, data integrity, adverse event reporting, and advertising limitations.
Seen through a variety of lenses, legal innovation at Argenx is helping the biopharma company continue impressive expansion.
Good News Brings More Complexity
Recent milestones at Argenx—like positive topline results from the ADAPT SERON study of VYVGART in patients with AChR-Ab seronegative gMG—trigger additional regulatory steps. Legal professionals must guide through data submission, labeling negotiations, and ongoing pharmacovigilance commitments. Moreover, as the science underlying autoimmune therapy advances, legal counsel must monitor shifting definitions and requirements for “first-in-class” and “differentiated” biological products in global markets.
The successful test results of VYVGART have encouraged the company to submit for FDA approval by the end of the year across all three subtypes of seronegative gMG. The company plans to unveil detailed results from the ADAPT SERON trial at an upcoming medical conference.
If the company is able to gain the seronegative gMG label, VYVGART would have the “broadest label of all FcRn antagonists approved in gMG,” William Blair analysts wrote to investors. The seronegative approval could add as many as eleven thousand new patients to VYVGART’s current US prescribing pool.
Although myasthenia gravis affects only 75,000-100,000 people in the US, the treatment space is filling up with competition, including Ultomiris (AstraZeneca), Rystiggo (UCB), and, most recently, Imaavy (Johnson and Johnson).
The Value of IP
Companies like Argenx are also deeply dependent on intellectual property protection. The “antibody innovation ecosystem” at Argenx is predicated on safeguarding unique discoveries (novel targets, disease pathways, and engineered antibodies) through patents, trade secrets, and know-how agreements. Each advance must be carefully patented to prevent infringement or misappropriation by competitors, particularly as the biopharmaceutical industry faces growing challenges from biosimilars and patent cliffs.
Legal oversight extends to freedom-to-operate analyses, due diligence in academic and commercial partnerships, and the prosecution of patent portfolios that can range from molecule composition to manufacturing methods. Lawyers are instrumental in drafting and enforcing confidentiality agreements, licenses, and collaboration contracts that define the terms of joint development with academic partners and external firms.
Argenx’s IP portfolio spans more than 300 patent families and around 1,200 patent applications worldwide, protecting innovations in antibody platforms, drug candidates, and specialty treatment modalities. The company’s proprietary SIMPLE Antibody platform has led to transformative therapies.
On the Cutting Edge
Providing legal support in biopharma means working on the frontlines of innovation. Counsel must be translators between scientists, executives, and external partners. Each collaboration agreement or technology licensing deal helps build the next pipeline milestone, opening new patient markets while ensuring the company’s interests are protected.
The space is high-stakes. Billions of dollars are in the line, and risk is everywhere. Regulatory disputes, patent challenges, aggressive competitors, and the pace of scientific change are all rocky waters that legal counsel must help navigate. In turn, counsel needs to be adept at anticipating problems, managing investigations, and guiding swift responses to new laws or emerging challenges. If you want to succeed in law in the biopharma space, living in the past isn’t an option.
Ultimately, the best counsel channels entrepreneurial savvy and deep scientific curiosity. They don’t just mitigate risk; they forge relationships that drive innovation forward. The best in-house lawyers do this by being clear and transparent, by building proactive compliance programs, and guiding executive choices with clarity and tact. Biopharma lawyers have to be true partners in innovation.
Valuable Partnerships
Innovation comes in many forms, like novel partnerships. Argenx’s partnership with Fujifilm Biotechnologies is one such example. The recently expanded agreement will see Fujifilm starting to manufacture the drug substance for efgartigimod at its Holly Springs, North Carolina facility beginning in 2028. Argenx is the first announced tenant of Fujifilm’s Phase II expansion at the high-tech site.
The partnership will empower Argenx with robust production capabilities to meet rising demand for efgartigimod in the United States and across global markets. Efgartigimod is the monoclonal antibody fragment that targets the neonatal Fc receptor. It is approved for treating gMG and chronic inflammatory demyelinating polyneuropathy. Both are chronic autoimmune neuromuscular conditions. The partnership with Fujifilm will ensure that consistent supply for clinical and commercial use is readily available.
The partnership serves as a blueprint for scalable, local-for-local supply of advanced biologics. Holly Springs will see its biomanufacturing capacity double. The agreement links Argenx to Fujifilm’s global kojoX network, a modular platform connecting facilities in the US, UK, Denmark, and Japan. It’s benchmarking partnerships like these that have continued to propel Argenx forward.
“As outside counsel for Argenx, we work with Brian on many projects in patents and trademarks. Brian is a creative thinker and has an energy and dynamism making it a pleasure to work with him.”
–Dr Joanna Peak, Partner
“Brian is among the finest in-house patent counsel I have worked with: creative and strategic, with the interpersonal skills to collaborate effectively with scientific, legal and executive teams. He is a pleasure to work with.”
–Andrew T. Wilkins, Ph.D., Partner
