Biosimilars and Amgen's Dual Role

John is joined by Jonathan Graham, Executive Vice President and General Counsel and Secretary of Amgen, one of the world’s largest biotech companies and one of the pioneers of the industry. They discuss in-house legal leadership in major biotech companies and how science, intellectual property, and regulation shape strategy. Jonathan began his practice clerking for the Ninth Circuit Court of Appeals, then became a litigator for a large firm. Later, his career shifted in-house. He believes that litigation training develops useful skills, including rapid issue spotting across unfamiliar domains, crisp written and oral advocacy, and an ability to understand stakeholders’ incentives.

The biotech industry is unusually purpose-driven because the output is medicine that can extend life and restore quality of life. That mission creates urgency across functions, as delays can mean patients wait longer for needed therapies. The sector is also highly regulated and fast-moving, which elevates the importance of legal teams that operate as strategic partners rather than as a “department of no.”

Intellectual property is the economic lifeblood of biological drug development. Bringing a molecule to market often costs billions of dollars and requires years of lab work, clinical trials, and manufacturing scale-up. Without enforceable patents, competitors could free ride, undermining investment incentives. This reality drives frequent, high-stakes patent disputes that can be hard to settle because exclusivity is enormously valuable.

Patent doctrines often lag behind technology, forcing courts to fit new technologies into older legal frameworks. Artificial intelligence is potentially a powerful tool for discovery and analysis of molecules, but not a substitute for wet-lab validation or human inventorship. Regulators still require clinical evidence before any medicine is approved and likely will for the foreseeable future.

Biosimilars are currently a booming market with many parallels to generic drugs. A company may participate in the market as both innovator and biosimilar supplier by leveraging its research and manufacturing capabilities. Finally, government-driven drug pricing controls may slow innovation over time, even though scientific progress and therapeutic potential remain strong.

Podcast Link: Law-disrupted.fm
Host: John B. Quinn 
Producer: Alexis Hyde
Music and Editing by: Alexander Rossi