In Rapid Litigation v Cellzdirect, the Federal Circuit further clarified a biotech patent eligibility mess caused by SCOTUS’s Alice and Mayo decisions.
In 2012 and 2014, the Supreme Court (SCOTUS), which wanted to invalidate a few pesky financial and medical diagnostics patents, decided to use legal “nuclear weapons” rather than legal “fly swatters“. The SCOTUS legal nuclear weapons were the now-infamous two-step “abstract material” patent eligibility test. You can see step 1 of the the SCOTUS test below:
Step 1) Determine if the patent is directed to “abstract” subject material. If not then congratulations, the patent passes this test and is patent-eligible.
SCOTUS refused to define “abstract material”. This allowed the USPTO and the lower courts to run amok and start randomly invalidating patents, including biotech patents. This, in turn, started to damage US biotech and software startups. These need patents to get funding, as well as for protection from larger competitors.
The Federal Circuit, one step below SCOTUS, is charged with cleaning-up patent law. They waited several years for SCOTUS to correct itself, to no avail. The Federal Circuit is itself confused about these issues, and their rulings largely depend on which judges hear a particular case. However, in mid-2016, they issued a series of patent eligibility decisions, first Enfish, then Bascom, now Rapid Litigation (Celsis) v Cellzdirect that suggest that at least some of the judges want to do some damage control. This decision was cited in the 2019 PEG, and is part of the present USPTO MPEP 2106.05(a) rules.
“Abstract” is just as undefined for biotech as it is for software. But for biotech, it seems have more of a “natural law-ish” flavor. Arguably a technologically illiterate approach since everything involves natural laws, but alas SCOTUS has no STEM majors.
Fortunately, a few Federal Circuit judges are STEM majors. They also had the power to do at least some damage control. They did this by providing official interpretations/clarifications of the SCOTUS decisions. Here they clarified that in step 1, “directed to” is not the same thing as “involving”.
MPEP 2106.05(a) Improvements to the functioning of a technical field
The patent in this case, 7,604,929, was about an improved method of freeze storing liver cells (cryopreservation of hepatocytes). Here, experts in the field previously believed that freezing damages living cells. They taught away from multiple freeze-thaw cycles. The inventors discovered that some hepatocytes were resistant to this problem. They used this discovery to invent an improved hepatocyte cryopreservation method. They first freeze-thawed the cells. Then they used a density gradient to select for the freezing resistant cells. Finally they refroze these resistant cells again, producing very freeze resistant hepatocytes.
An earlier court had ruled this patent invalid. They argued that discovering that some hepatocytes could survive multiple freeze-thaw cycles involved a “law of nature.” However, the Federal Circuit pointed out that “involved” isn’t enough grounds to invalidate a patent. This is because, the ‘929 patent also claimed other steps, such as using density gradients. So “directed to” is more than just “involves“.
This Federal Circuit decision makes it harder to invalidate a biotech patent. In particular, when the claims also have other steps in addition to the “natural law” steps. The fact that the ‘929 claims were relatively simple helps to further clarify the legal issues. MPEP 2106.05(a) now references this decision under “improvements to a technical field.”