Rapid Litigation: Biotech patent win

Cleaning up a legal mess
Rapid Litigation v Cellzdirect: Federal Circuit cleaning up a patent mess

In Rapid Litigation v Cellzdirect, the Federal Circuit has further cleaned up the 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.  Step 1 of this test is summarized 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. This, in turn, started to damage US biotech and software startups, which need patents to get funding, as well as for protection from larger competitors.

The Federal Circuit, one step below SCOTUS, and charged with cleaning-up patent law, waited several years for SCOTUS to correct itself, to no avail.  However, their recent (mid-2016) series of patent eligibility decisions, first Enfish, then Bascom, now Rapid Litigation (Celsis) v Cellzdirect suggest that the Federal Circuit is now getting serious about damage control.

“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, some Federal Circuit judges are STEM majors, and they have the power to do at least some damage control by providing official interpretations/clarifications of SCOTUS decisions. Here they clarified that in step 1, “directed to” is not the same thing as “involving”.

The patent in this case, 7,604,929, was about an improved method of freeze storing liver cells (cryopreservation of hepatocytes).  Before the patent, everyone in the field believed that freezing damages living cells, and that multiple freeze-thaw cycles should be avoided.  The inventors discovered that some hepatocytes were resistant to this problem, and used this discovery to invent an improved hepatocyte cryopreservation method.  This method first freeze-thawed the cells, then used a density gradient to select for the freezing resistant cells, and then refroze these resistant cells again, producing very freeze resistant hepatocytes.

An earlier court had ruled this patent invalid by arguing 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, because the ‘929 methods 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 biotech patents, at least in the most common cases where 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.

Prometheus bound (or at least distinguished)

Prometheus
Prometheus having a bad day

Mayo v Prometheus: In an ancient Greek myth, the Titan god Prometheus is chained to a mountain by the god of blacksmiths (Hephaestus/Vulcan). Why talk about ancient Greek myths?  Because the story suggests a way out of the recent (2012) unfortunate “Mayo Collaborative Services vs. Prometheus Laboratories, Inc.” holding.

This case involved two medical diagnostics patents (6,355,623 and 6,680,302), in which SCOTUS held that patents that incorporate “laws of nature” may not be patent eligible “unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations“.

Are there any inventions that don’t operate according to natural law?  What else is a patent claim but a drafting effort designed to monopolize a particular invention?  What exactly are “additional features” and “practical assurance”?  Here the Prometheus decision provides little or no guidance.

The decision’s use of “natural law”, as well as gratuitous citation of various examples from physics as well as medicine, is unfortunate for us scientifically trained types.  This is because the three dimensional nature of the universe, the forward direction of time, and everything else about the world are all based on laws of nature!

Thus unless read narrowly, this decision would produce an unconstitutional result (it would eliminate all patents, hence violating Article 1 section 8 of the constitution).  So the ruling must be read narrowly, because the SCOTUS upholds the constitution and is never wrong, right?

This will eventually get sorted out.  The Federal Circuit (Hephaestus/Vulcan), composed of judges who actually know something about laws of nature and patents, will step in.  Their job is to clean up problems like this.  Eventually they will likely “chain” the overly expansive Prometheus holding by various subsequent lower court holdings.  They can’t totally overturn Prometheus, but they can certainly bring some sense to it by nibbling away at the interpretation.  (Note added 4-10-16 — or maybe not, they are certainly taking their time!)

As one idea, the European Patent office (EPO) makes certain classes of medical methods that are practiced on the human body unpatentable.  Perhaps the Federal Circuit might draw on the EPO for inspiration, and produce rulings that narrow the scope of the Prometheus “natural law” holding to something more akin to present EPO practice.  This would still not be totally great for Biotech, but Biotech manages to survive in Europe nonetheless.

In the meantime, damage control is also underway at the USPTO.  Their July 3, 2012 guidelines state the USPTO’s expectation that Prometheus considerations will primarily impact patents that being examined by Technology Center 1600 – Organic chemistry, drug delivery, molecular biology, biotechnology, and the like. Perhaps they have been reading the EPO rules as well.  They further advise that examiners fully examine all applications, and reject on more than just patent eligibility issues.  This at least gives the applicant a chance to amend patent claims to try to overcome occasional random Prometheus rejections.