December 22, 2014

There are analogies and there are analogies

A judge’s job can be simply described. Conduct a trial which generates a set of facts. Compare this fact pattern to those found in the caselaw. Then, simply follow the caselaw that contains the fact pattern most closely analogous to those before the court. But, of course, it’s not really that simple. All sorts of analogies can be drawn.  Attorneys for each party will draw an analogy that favors their side and so the judge rarely has only one analogy to consider.  The real job of a judge is to sift the wheat from the chaff; the principled, meaningful analogy from the superficial or even nonsensical.

In Biotechnology cases, distinguishing the principled argument from the superficially plausible—but really just nonsense—requires some understanding of molecular biology and the related sciences. Most of the time judges do a fine job even though they rarely have the appropriate technical degree. How?  In most cases both sides give the judge an accurate, if simplified, description of the relevant scientific principles and the intelligent judge is able to determine which argument is “most principled.” A judge once told me that either one side or the other will make a point that the other just doesn’t seem to get around to answering. You don’t need to be an expert in the field to notice that.

A problem can occur, however, when the judge decides to go it alone and make some factual finding or legal point that was argued by neither party. Why Courts think this is a good idea, God only knows. It presupposes that a liberal arts trained judge, spending a few hours reading the briefs, caught the “good argument” that was missed by technically trained parties that spent months on the case.

A classic example of a cringe-worthy moment is found in the Supreme Court decision, Sakraida v. Ag Pro, Inc. (1976). The invention at issue was a method of using flowing water to clean animal waste from barn floors. The case had plenty of prior art technical references covering the subject matter. The Supreme court, however, chose to add to the record: the Labors of Hercules, C. Witt, Classic Mythology 119-120 (1883). One can imagine Justice Brennan remembering a classics class from high school: “Hey, didn’t Hercules use a stream to clean the stables of Augeas? That’s just like this case and I’ll impress those patent geeks who didn’t think of that!” Right. And the next time a patent examiner reviews a Boeing aeronautical patent, he can reject it as invalid over Icarus, as applicant failed to disclaim “flying too close to the Sun.” What Justice Brennan did not realize is that patent law is, in part, a scientific, technical field. A reference to ancient mythology was laughably out of place.

Well, we have another cringe worthy moment, this time in the recent Federal Circuit decision, In re BRCA1– and BRCA2-based Hereditary Cancer Test Patent Litigation (2014). In this case the court once again reviewed patent claims owned by Myriad Genetics, for patent eligibility.  (In the first Myriad case, the Supreme Court declared certain claims to the BCRA gene patent ineligible.)  This second Myriad case addressed whether other claims owned by Myriad were also patent ineligible; claims to methods of detecting mutation associated with increased risk of breast cancer (the BCRA mutation).  The claims were drawn to two common techniques, DNA hybridization and DNA amplification.

The parties argued whether or not the case was controlled by Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Mayo”).  Then it happened. The Federal Circuit wrote . . .

We need not decide if Mayo is directly on point here because the method claims before us suffer from a separate infirmity: they recite abstract ideas.

. . . and you hold your breath because you realize that the Federal Circuit has decided to “go it alone” and decide the case on a point argued by neither party. They made an analogy to Alice Corp. v. CLS Bank (2014).  This case held that a business method (using mitigating settlement risk, the risk that only one party to a financial exchange will satisfy its obligation) is a patent ineligible abstract idea. In Alice Corp. the court used a two step analysis: one (1) it found that the steps of mitigating settlement risk are a patent ineligible “abstract idea.” Two (2) it found the remaining method steps, basic computer steps such as maintaining accounts, obtaining data, adjusting account balances etc. were merely applying the abstract idea to “some unspecified, generic computer.” These were not enough to transform the abstract idea into a patent-eligible invention. The Federal Circuit was deciding the case by reasoning that the fact pattern was analogous to the fact pattern of Alice Corp.

Now, why do I think that this is a bad analogy? I can understand a case like Alice Corp. in the context of business methods. Business methods make up a relatively new category of patent eligible subject matter and the settlement risk method seems an awful lot like two people made a deal and worry that the deal will fall through. That sounds like an abstract idea. Moreover, the computer steps merely do basic functions like saving data. So, in this context one can understand that (1) the method is merely and abstract idea and (2) the computer does not really change that.

But how much can you apply this sort of fact pattern to a biotechnology case dealing with DNA assays? Let’s look closely at the Federal Circuit’s analysis and see how well their analogy holds up. Right off the bat one must concede that, unlike business methods, biotechnology have been around for decades.

Is surviving breast cancer an abstract idea?

Lets look further.  Applying Alice Corp., the court found that comparing normal genes to mutant genes is an abstract idea. Really? Ask a patient who detected a BCRA mutation, and survived breast cancer because of that comparison, or had the relief of finding they did not carry the mutation.  Will that patient consider the comparison “abstract”? Is this analogy valid: two parties worried about a deal falling through is like a life changing cancer diagnosis?

Patented Nobel Prize methods become patent-ineligible–these methods are like using generic computers for business methods. Huh?

The courts second conclusion I found even more outrageous, that using generic computers in business methods is similar to DNA hybridization and DNA amplification in molecular biology experiments. And, because the former is “not enough” to convert abstract ideas to patent eligible inventions, neither is the latter.

Really? As I discussed in the previous post, these two methods are fundamental techniques of molecular biology. The principles of DNA hybridization are used to set up high stringency assay conditions that can detect a single base pair mutation in an entire human genome. Determining proper hybridization conditions is an essential step in virtually every experiment in the field. In DNA amplification one determines conditions under which amplification primers first hybridize to a template. Later, after “primer extension” different conditions are applied to free the template for hybridization to another primer. DNA amplification has been patented AND awarded the 1993 Nobel Prize in chemistry. Why did the court find these methods analogous to the use of a generic computer? Because they are “conventional!” A better word would have been indispensable.

A rhetorical flourish is often used in these patent eligibility cases:  one cannot, with drafting techniques, convert the patent ineligible into the patent eligible. Unfortunately, as a consequence of this decision, the court has found a way to transform, with a poorly reasoned analogy, the indisputably patent eligible into the patent ineligible.

Like other poorly reasoned analogies, this one has no underlying principle to keep it focused. Consequently, it applies, with equal force, to other examples with laughable results. Do you want to fly in a safe airplane? Consider a method of detecting stress fractures in airplane wings to keep planes aloft. Sorry, this method is no longer patentable. The reasoning is: one (1), comparing a fractured wing to a normal wing is just an abstract idea and two (2) the need for intact wings to keep a plane aloft is conventional, citing the Wright Brothers . . . and Icarus.