Which bioengineered products are patentable?

What is patentable? This is defined under section 101 of the laws governing patents, which reads in whole:

"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."

But this is patent law, so of course it's not that simple. Keep in mind that I'm not a lawyer, so what I'm sharing here is for informational purposes only. I am a registered patent agent, though, so understanding issues around patentability is part of my job. And with my biology background, I take a special interest in genomics and bioengineering, which are the subjects of a recent important court decision.

The issue of what is patentable gets more complicated when people come up with a product that's similar to something found in nature. One of the most important precedents in patent law is Diamond v. Chakrabarty, in which inventors had genetically engineered a bacterium that could break down components of crude oil. The patent examiner rejected the application for a patent on this bacterium. At the time, living things were not considered to be patentable subject matter - they weren't seen as a process, machine, manufacture, or composition of matter. Further, the way that this new bacterium was genetically engineered was by inserting plasmids into its genome. Those plasmids were all naturally-occurring and taken from other bacteria. But the applicant appealed all the way up to the Supreme Court, where Chief Justice Berger held that genetically engineered bacteria like this one could be patented as either a "manufacture" or "composition of matter." It didn't matter that it was a living thing, it didn't matter that the components of this genetically engineered bacterium could all be found in nature. What mattered was that the composition as a whole - the genetically engineered bacterium - was new and had a function far beyond anything naturally occurring.

The relevance of Diamond v. Chakrabarty is timely because of a recent Federal Circuit court decision that reversed a Delaware district court's ruling regarding US Patent 10526617. That patent expired in 2022, but it was the subject of a lawsuit over past damages from potential infringement. The district court dismissed the lawsuit on the basis that the patent was invalid because it specified ineligible subject matter. What was the '617 patent about? It covers, among other things (per claim 1), "a cultured host cell containing a recombinant nucleic acid molecule." The cell genome covered by that patent is described as being recombinant because it includes at least some viral nucleic acid sequence, as well as host cell sequence. But the district court said that, because the nucleic acid sequences were found in nature - they were naturally occurring - it's not patentable subject matter under 101. The Circuit Court reminded the district court about the Diamond v. Chakrabarty ruling (among other things), and sent the case back for further consideration.

The important message for inventors is that a bioengineered invention may be patent eligible, even if it's living matter, and even if all of the components are naturally occurring. The product as a whole must be novel.

I'll keep an eye on this case to see where it goes from here.