3D-printed drugs raise new challenges for intellectual property

[Commentary] 3D printing will open the door to major improvements in a broad swath of industries. Take, for instance, the recent decision by the US Food and Drug Administration (FDA) to approve SPRITAM, an anti-epilepsy medication developed by Aprecia Pharmaceuticals, a Pennsylvania-based drug company. SPRITAM uses Aprecia’s “ZipDose” technology, which employs 3D printing methods to produce “a porous formulation that rapidly disintegrates with a sip of liquid.” Thought to be the first 3D-printed pharmaceutical on the American market, SPRITAM will allow epileptic patients with swallowing difficulties to medicate themselves appropriately. 3D printing will open the door to major improvements in a broad swath of industries. Take, for instance, the recent decision by the US Food and Drug Administration (FDA) to approve SPRITAM, an anti-epilepsy medication developed by Aprecia Pharmaceuticals, a Pennsylvania-based drug company. SPRITAM uses Aprecia’s “ZipDose” technology, which employs 3D printing methods to produce “a porous formulation that rapidly disintegrates with a sip of liquid.” Thought to be the first 3D-printed pharmaceutical on the American market, SPRITAM will allow epileptic patients with swallowing difficulties to medicate themselves appropriately. Most “branded” drugs are patented so that their manufacturers can recover the billions of research and development dollars they’ve invested.

After 20 years, their patents expire, and generic drugmakers can clone them to their heart’s content through a process overseen by the FDA. But empowering individual pharmacies or other tiny entities to copy these drugs through 3D printing techniques imperils those protections. The “cheap configurable chemical and formulation robot” that Cronin extols can be exploited to reverse engineer and clone existing drugs currently under patent protection. In addition, democratized drug manufacture raises issues of quality control and safety that the current, clunky FDA regulations are not well-equipped to handle; it’s far easier for regulators to inspect and certify massive, centralized manufacturing plants than individual pharmacies. So two cheers for these phenomenal scientific advances. We’ll reserve the third cheer for when these industries successfully navigate these difficult but not insuperable legal challenges.

[Michael Rosen is an adjunt professor of law a the University of San Diego School of Law]