Georgetown Law, Class of 2017
3D printing presents myriad opportunities across many industries to produce goods quickly and efficiently. The biomedical industry in particular presents enormous potential. Companies in the field have already demonstrated that they are capable of using bio-ink to produce biological implants and tissues. In the future, they will likely be able to print fully functional organs.
The benefits of such technology are obvious: those in need of new organs will not have to spend eons on a waiting list until a matching organ is available for transplant; those with weak organs could have specific components repaired or replaced without having to undergo a full transplant or extensive drug therapy; research can be more widespread as access to biological material expands. The list goes on and on.
With so many potential benefits comes enormous profit potential, and with enormous profit potential comes a desire to protect the technology that enables it. The companies pioneering the space in the United States rely heavily on the existing intellectual property (IP) law framework to safeguard their technology. However, there are a number of potential problems that could make it difficult for the existing framework to safeguard the proprietary elements of the technology while still enabling the industry to grow.
There are two goals of IP law: (1) protect research and innovation from copycats, thieves, and accidental copiers, and (2) provide recourse for IP owners if there is a violation of their rights. Research and development costs are particularly expensive, and many companies are clamoring to be industry leaders, so there is a lot of money invested in the technology already.
The companies that have spent this money need to be able to protect their investments by retaining ownership of the IP. Ideally, from their perspective, the companies would have proprietary rights in the software used in the printing process, the bio-inks used, and other elements of the machine. Indeed, hundreds of patents have been filed, and likely many more are filed but obscured from the public while the companies work to perfect the inventions.
With ownership of those elements, the companies can control the market for the goods. They can set the price of the final product, which even if borne by insurance companies, would still be passed on to individual consumer, thus potentially limiting access. One perspective might be that the companies should be entitled to such ownership because they are spending the money to develop the technology and thus should reap the benefits if they produce the best results. However, given the natural elements of the product itself, many argue that IP law should not protect it.
Ultimately, the United States should allow for limited patent protection of certain elements of the bioprinting and copyright protection of the software. However, there should be no protection for the functional elements beyond that which patent law typically protects. In the case of a bioprinted organ, a utility patent would be appropriate. Utility patents protect unique machines and processes, and, if approved, allows the inventor to prevent others from using the same machine design or process for 20 years.
Such a patent could protect a company that has a unique method of, say, printing a kidney. However, the protection likely would not apply to any of the naturally occurring ingredients. A special compound the company developed to use as bio-ink may be sufficiently unique to acquire protection, especially given the Supreme Court’s ruling in Association for Molecular Pathology et al. v. Myriad Genetics (2013), which denied protection for naturally occurring genes, but approved patentability of synthetic DNA. Thus, it is conceivable that the formula for the bio-ink would be patentable, while the bio-ink itself would be more debatable.
On the copyright side, the key to determining the extent of protection will be the functionality determination. If a company develops software to perfectly print functional organs, that might be something society wants to be open to all developers. There are some protections for software developers creating derivative works built into the copyright law already, but those are geared toward research or other non-commercial uses. If the software is the best way to effectively print organs, perhaps everyone should be able to use it.
The United States could continue to use the existing IP law framework to facilitate protection of valuable processes and products currently in development in the bioprinting field. However, there are gray areas in the scheme when it relates to natural elements or functional elements. Companies may prefer something more predictable.
Another option could be to extend no IP protection to bioprinting because of the enormous social benefits, but to create significant barriers to entry into the marketplace. Thus, the companies spending millions on research and development could still retain the top position in the market to maximize profits, while outside researchers would be able to improve on elements of the processes without fear of violating IP rights. This would likely involve new legislation and significant input from the stakeholders, but it may be high time Congress thinks about how it will regulate IP in the 21st century.