At a very high level, the United States, through the US Patent and Trademark Office, will issue patents to qualifying inventors in order to incentivize technological advancements.¹ These patents grant the patent owners the right to exclude others from making, using, selling, or offering to sell the invention for a period of time.² In effect, the patent owner is granted a significant financial incentive—a monopoly over the invention—in exchange for developing the invention and disclosing it to the public. The power to issue such patents stems from Congress’s Constitutional power “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”³

Importantly, the Constitution provides that the power to issue patents is limited to “promot[ing] the Progress of . . . useful Arts.”⁴ This intuitively means that certain inventions should not qualify for a patent, because the grant of a monopoly on that invention would not promote progress. For example, granting a patent—and thus a monopoly—for an old, widely used, publicly available machine would generally not promote progress.⁵

This also gives insight into the fundamental purpose of the patent law system as envisioned by the framers of the Constitution. The framers understood that the public benefits when technological advancements are made, and that this public benefit justifies the grant of a limited monopoly. In general, monopolies have a negative impact on the public because they decrease market competition and drive costs up. However, incentivizing the creation of beneficial inventions, or at least incentivizing faster development of such inventions, has been viewed as worth the cost. Because this cost has to be justified, patent rights are only available for those inventions that promote progress. In other words, the value of the patent is not determined by the time, effort, or labor that went into development but rather is determined by the results of that labor. The resulting innovation must be such that it promotes “progress” as defined by Congress and by the courts.

To protect this goal, Congress and the Judiciary have established specific criteria to determine which inventions qualify for a patent and which do not. The Congressional criteria for patentability, detailed in 35 U.S.C §§101-03, states that an invention must be novel, useful, and nonobvious.⁶ In addition to these requirements, the Judiciary requires that the invention not be classified as a law of nature, natural phenomenon, or abstract idea.⁷ As mentioned, the purpose of each of these criterion is to ensure that patents are granted only to inventions that “promote the Progress of . . . useful Arts.”

As new technologies emerge, it is unclear whether these judicially created criteria still serve that purpose or whether the criteria are overly expansive such that truly useful inventions are insufficiently incentivized. This Note looks specifically at 3D printed biomaterials—designed to replicate naturally occurring cells, tissues, and organs—to determine if this technology is patentable under the current system of judicially created exceptions, if it should be, and if there are better alternative forms of intellectual property protection such that a change to the current patent system is unnecessary. Part I discusses the relevant background of 3D printed biomaterials. Part II discusses judicial exceptions to patentability generally. Part III analyzes the patentability of 3D printed biomaterials under the current system of judicial exceptions. Part IV argues that judicial exceptions should be removed as they exist currently. Part V discusses the implications of such a change.