Reply: PSMA-Targeted Therapeutics: A Tale About Law and Economics

REPLY: I thank Dr. Notni for his recent letter in which he provides his perspective on one part of the success story of PSMA-targeted theranostics. Success stories often come with conflicts and intellectual ownership discussions.

Dr. Notni makes important points. He acknowledges the pivotal role of the inventors of ¹⁷⁷Lu-PSMA I&T in shaping the field (1). He also emphasizes our obvious responsibility to honor patent protection. I would like to highlight that both patented and unpatented compounds can be successful and become market drivers. It is important to allow free market forces to compete for business. For instance, one company is currently initiating a phase 3 clinical trial with the nonpatented compound ¹⁷⁷Lu-PSMA I&T in patients with castration-resistant prostate cancer (2). As another example, the U.S. Food and Drug Administration recently granted a new-drug application for the non–patent-protected ⁶⁸Ga-PSMA-11 for a wide range of indications in patients with prostate cancer (3). This development further establishes the high clinical relevance and impact of PSMA-targeted PET imaging in the care of prostate cancer patients (4). Reimbursement will set the stage and prepare the market for several soon-to-be-approved compounds with comparable diagnostic performance. Then the market will decide which ones are most conveniently used clinically. It is thus important to recognize that both patented and nonpatented compounds can address unmet clinical needs, improve patient outcomes, and create significant revenues while following very different business models. I would, however, urge caution regarding exploiting the lack of patent protection for rebranding long-established compounds. Such measures would simply create market and customer confusion.

Theranostics are rapidly growing and have generated substantial interest from industry. Both protected and unprotected compounds will have their place in the clinic and in research. Non–patent-protected compounds could greatly facilitate translational research, addressing (independent of Big Pharma) resistance to PSMA-targeted therapeutics, for instance.

Protected and nonprotected compounds will give rise to larger and smaller companies, all aiming to become fiscally solid despite very different business models.

They all are part of the new nuclear medicine ecosystem, make important contributions to patient care, and will shape the further development of our discipline. We should therefore appropriately appreciate the outstanding contributions that have given nuclear medicine an immense boost over the past 15 years.

• © 2021 by the Society of Nuclear Medicine and Molecular Imaging.

• Revision received May 10, 2021.
• Accepted for publication May 10, 2021.