First published in Medical Design and Outsourcing
The COVID-19 pandemic has accelerated advancements in pharmaceutical, medical device and manufacturing technologies due to disrupted supply chains and new demands for treatments and materials. Among them is 3D bioprinting, which involves arranging encapsulated cells or other biological materials (bioinks) using a 3D printer to construct tissue, organs or biocompatible scaffolds that promote tissue growth.
3D bioprinting is decades old, and yet the past 12 months of the pandemic have yielded breakthroughs in treatment techniques and vaccinations in record time. Pandemic-related bioprinting appears to fall into three general categories:
- Modeling human tissue and organs to understand how SARS-CoV-2 affects the human body.
- Modeling the effects of therapeutic agents and techniques on human tissue and organs for combating the novel coronavirus.
- Developing tissue and organ replacements for treating those already affected.
It is easy to overlook intellectual property protection during a pandemic, but skipping the patenting process can mean forfeiting up to 20 years of IP protection. In the U.S., patent applications must be filed within one year of any public disclosure of the invention. Other countries and regions, such as Europe, require patent applications to be filed before any public disclosure. When an invention could have immediate worldwide value, the best way to ensure strong intellectual property coverage is to file at least a provisional patent application before even mentioning the invention to the public.
Provisional patent applications are a quick and inexpensive avenue for beginning the patenting process. If time is short, a provisional patent application can be as informal as a simple coversheet and a set of notes or a slide deck describing the invention. Patent applicants have 12 months to convert the provisional application to a nonprovisional one, providing time to decide whether to proceed with the full patenting process. Indeed, provisional applications are fast, inexpensive, and allow applicants to defer IP protection decisions.
After resolving the questions of when, where and how to file for patent protection, the inquiry turns to what can be patented. The answer, it turns out, is not simple. Machines, materials and methods are typically patentable — “anything under the sun made by man,” as the U.S. Supreme Court put it in 1980, quoting Congressional testimony from 1952 on the then-pending patent laws. But technology has come a long way since then, when the possibility of machine-made human tissue was science fiction.
Patent protection is widely available for bioprinting inventions aside from printed products. The process, materials and devices used to print the products can be patented. Examples of patentable inventions include bioprinter designs or functionality; bioink used in the printers, so long as the bioink is something different than purely natural material; cells encapsulated or modified to be suitable for printing; and even business methods involving bioprinting. The techniques for creating manmade biological structures using bioprinters will continue to be eligible for patent protection.
One of bioprinting’s overarching goals is to replicate and improve on parts of the human body, which puts bioprinting inventions in a grey area of patent-eligibility. Simply put, things that exist in nature are generally not patent-eligible, but the full analysis is more involved and case-specific. Due to the interplay between eligibility and other patentability requirements, available IP protection varies depending on the specific bioprinting innovation.
While replicating the human body can model the effects of the virus and treatments on the body, research may yield tissue structures that are better than natural counterparts for repairing the body. Enhanced tissues may stand the best chance of being easily distinguishable from natural tissue and therefore found to be patent-eligible, assuming the enhancements require different material structures or compositions. Although patent law will continue to develop, distinguishable bioprinted tissue will likely remain easier to patent than bioprinted tissue replicas.
Whether man-made tissues can be patented will be an ongoing patent law issue. At this time, patents are not granted for natural tissue. Eventually, bioprinting machines will print implantable tissue and organs. Patent eligibility may depend on whether the products are distinguishable from natural versions.
Many COVID-19-related bioprinting innovations are patent-eligible and will remain eligible for the foreseeable future. As many institutions are actively engaged in COVID-related research, delaying patent application filings would be a mistake. It could allow others to file competing applications first, blocking later filers on identical innovations. Provisional applications can be filed quickly and cheaply, securing a filing date with the patent office without tying up significant resources. Provisionals provide time to consider filing a nonprovisional application that could bestow exclusivity on use of the innovation for twenty years to come, and it is anyone’s guess what inventions will be useful in the years following this global pandemic.
As the race to prevent and treat COVID-19 continues, it is important to seek protection on the inventions that will protect the world, while sharing knowledge for the greater good. Unlike trade secrets, which must remain guarded, patents promote the dissemination of ideas in exchange for IP rights.