Combining Law and Science; Making Technology Understandable in Patent Cases

         Combining law and science; making technology understandable in patent cases

 Phil McGarrigle† & John DiMattero††

Introduction

In the U.S. Supreme Court case Association for Molecular Pathology v. Myriad Genetics 569 U.S.  (2013), quite a few different analogies, metaphors, hypotheticals and examples were used to explain the science and to compare the facts to other case law. Even though popular culture includes references to     aspects of DNA (on multiple TV dramas where forensics are featured in criminal investigations, for example) the technology in the case was still difficult to explain to a lay person. In fact, much of the oral argument transcript shows attempts to explain the science and less time directed to the policy arguments that one would expect at the Supreme Court.

Confusion about the technology at the heart of a legal dispute makes it difficult to apply the relevant case and statutory law. In fact, In Myraid, understanding the science was such a key point that Justice Scalia did not join the majority with respect to explaining the science as he did not “affirm those details on my own knowledge or even my own belief”. While it is understandable that the litigants wanted to reduce the technology to simple terms in order to focus on the legal issues, such simplification carries the risk that the legal decision is not based on accurate science.

Analogies can be misleading if they are too simple to convey subtleties and may not illuminate the critical issues for decision making. Justice Alito commented on overly simple analogies by saying, “You keep making the hypotheticals easier than they’re intended to be.” Oral Argument 7, lines 21-22. Also, in response to Justice Sotomayor’s analogy about baking a cookie, Mr. Castanias, representing Myriad, commented on the analogy by saying “that’s the problem with using the really simplistic analogies” page 36, lines 18-19.

Robert Merges discusses the concept of using analogies which simplify technology to make it understandable (http://www.scotusblog.com/?p=158953). He suggests that reducing most technologies to their essentials in patent cases can blur the line as to whether the patent claims the idea (not patentable) or the application of the idea (patentable). When the analogy presents the claimed invention as more of an idea, this can lead the justices into a metaphysical discussion about the patentability of the claims. In effect, the analysis can turn into what Merges calls the “freshman seminar effect”, which describes the endless string of hypotheticals used to test the viability of various metaphysical principles.

Trial lawyers make use of analogies because they can explain complicated concepts of law or science to lay judges or juries. However, their use can be a double edged sword. If the analogy does not quite fit the purpose for which it is proffered, it can be challenged to the detriment of the proponent.

In Myriad, the Supreme Court did not adopt analogies by either side in the opinion. Perhaps this was because analogies failed to express the true debate in the case in that they did not describe how a compound can exist in nature, well integrated into its surroundings, but still not be patentable as the information it carries is not any different from the claimed subject matter. It could be that in simplifying the science, the physical aspects of DNA were lost and all that remained was the information carried by the DNA. To some extent, one could assert that this is a feature of all molecules, and that DNA simply has less of a structural element than other molecules.

Did the Court understand the science enough to make good law in this case? Superficially, the discussion in the opinion was accurate at one level, but it is less clear if the implications of the science were understood by the justices in the fullest sense. The amount of discussion at the oral argument and     the number of analogies brought up suggests that the science was a struggle to overcome.

The Litigator’s Viewpoint

John DiMatteo of Wilkie Farr & Gallagher LLP was involved on the peripheries of the Myriad case. He assisted Dan Ravicher of the Public Patent Foundation and Chris Hansen of the ACLU to prepare for oral argument in the Southern District of New York, before the Court of Appeals of the Federal Circuit , and before the Supreme Court. He, along with Willkie summer associate Cristina Quiñones-Betancourt offer some thoughts on the use of analogies via a question and answer format below.

1. What categories of analogies did you see in Myriad?

There were multiple categories of analogies, such as those focused on separation, purification/isolation/extraction, visualization, and those based on human intervention. See below.

  • Separation
    • A Single Leaf (Oral Argument 6-8, 64)
      • One cannot get a patent on a leaf picked off of a plant.
    • Plants, rocks, etc. (Oral Argument 57)
      • “Everything is inside something else.” (J. Breyer)
    • Organs (kidneys and liver) (Oral Argument 55-56)
      • Removing an organ from the body and cutting off a piece of that organ does not make the cut piece patentable.
    • Plant in the Amazon (Oral Argument 43)
      • E.g., “It takes a lot of ingenuity and a lot of effort to actually find that plant, just as it takes a lot of effort and a lot of ingenuity to figure out where to snip on—on the genetic material.” (J. Roberts)
  • Purification or Isolation[1]
    • Gold (Oral Argument 4-5, 9)
      • Gold itself is not patentable because it is a natural product, however a new process for extracting or using gold is patentable because those patents would not create a monopoly on the underlying natural product.
    • Lithium (Fed. Cir. Op. 1702, 1711 fn.7)
      • Noting that although lithium is not free in nature, it is not patentable because it is an element. However, a lithium compound is not the same as elemental lithium.
    • Extract from Leaves of an Amazon Plant (Oral Argument 7)
      • If you simply pick a leaf off of the plant and eat it, you cannot receive a composition patent for merely discovering the plant. However if, for example, the extract is only useful in a concentrated form, then the concentrated form of the naturally occurring compound may be patentable because the extract has been physically transformed and has also been given a function.
    • Extraction of an Entire Amazon Plant from the Amazon Forest (Oral Argument 43-44, 49)
      • The plant itself cannot be patented because it is a thing of nature that has not been manipulated. Thus, there’s a distinction between something that has been extracted as a whole from something larger and something that has been extracted as a whole and then further manipulated.
  • Structure That is Not Isolated or Separated from Its Environs
    • Magic Microscope (Fed. Cir. Op. 1698, 1701, 1711), Super Microscope (Oral Argument 18)
    • “[I]f an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers ineligible subject matter.”    Id. at 1698 (government’s argument).
    • The court disagreed with the government because the test fails to regard molecules as separate chemical entities that may only be useful once they are no longer bonded to other genetic material. Id. at 1701.
    • Moreover, the court argued that a magic microscope would be unable to see the subject matter at issue because the chemical bonds, or ends, of an isolated DNA strand are different from those of an unisolated DNA strand. Id. at 1711.
  • Degree of Human Invention and Alteration
    • Chocolate Chip Cookie (Oral Argument 35)
      • A person can create a chocolate chip cookie with natural ingredients and can receive a patent for the finished product, but cannot receive a patent for each individual natural ingredient used. (J. Sotomayor)

2. How were analogies useful to understand the science in Myriad or were useful for reasoning through the problem?

No one analogy perfectly framed the issue, they were helpful in at least framing an argument or a point of contention. The reason why no one analogy was found to best fit the issue – as a matter of science, is “isolated DNA” markedly different than DNA in the body – relates to the fact that there are two ways to look at “isolated DNA”: (1) from the chemist’s end of the telescope where DNA in the body (a long complex molecule tightly bound with other molecules) looks “markedly different” from an isolated portion of DNA (simpler and free of many other molecules) and; (2) from the biologist’s end of the telescope where the genetic information encoded in DNA in the body is identical to that found in its isolated form. As such, no one was able to find an analogy that simultaneously correlated with the chemistry and biology of DNA.

Nevertheless, the analogies used at each stage of the case, from the district court through the Supreme Court argument, helped narrow the discussion. For example, commenting on Myriad’s baseball bat analogy, Justice Roberts noted during oral argument that isolated DNA is closer to “snipping” a section of wood from a tree while a baseball bat requires more. (Oral Argument 41). Further, the analogy of finding a rare plant in the Amazon was useful in expressing the idea that finding the BRCA 1 and 2 genes was a discovery, not an invention.

3. When are analogies ineffective?

1) When they do not apply to the facts of the case, such as the Magic microscope analogy which did not take into account that a magic microscope would be unable to see the subject matter at issue. (Fed. Cir. Op. 1698, 1701, 1711);

2) When they are oversimplified, such as the analogy of picking a leaf off of a plant and eating it does not include any manipulation other than picking the leaf, a process that would be very different from extracting something from the leaf that is not easily visible or ascertainable with the naked eye.(Oral Argument 7); and

3) When they are used improperly, such as Myriad’s attempted to liken the DNA at issue to a baseball bat, which begins as a tree and then needs to be cut out of the wood. The Court noted, however, that a baseball bat needs to be invented. In contrast, DNA merely needs to be cut. (Oral Argument 41).

4. What was your favorite analogy and why?

I liked most the analogy of the plant that was discovered and uprooted from the Amazon. (Oral Argument 43-44, 49.) The analogy works in explaining the point that merely finding a gene for a particular disease is not an invention. Moreover, the analogy is easily extended to the concept of “isolated DNA”. Imagine that the botanist who discovered the plant used a well know enzyme extraction process to determine what enzymes are present in the plant. Once applied, the botanist discovers the specific plant enzyme that gives the plant a unique property, perhaps blue leaves. While an amazing discovery, the botanist cannot claim the blue leaf enzyme as an invention.

5. Are judges good at using analogies?

It all depends on the skill of the judge. In the Myriad case, the Supreme Court judges were good at determining which analogies did not work (e.g. the baseball bat) and which ones did (e.g. extracting a compound from a plant).

The Judge’s Perspective

Judge Whyte from the Northern District of California had a chance to comment on some aspects of analogies and their use in the courtroom. His responses to a series of questions are shown below.

1. How do judges handle technology issues?

I have had this discussion with some of my colleagues. There is a lot of reliance on law clerks for technical help. We generally tend to hire at least one technically trained law clerk at a time.

I also think that the judges depend heavily on tutorials from experts that are presented by the parties. I will decide what expert seems to make more sense and then I will apply the law to the facts that and hopefully I am more often right than wrong.

2. Do analogies help?

Yes. Tutorials can be at such a high level that I come out of it with just an overview, but not practical direction. It would be so helpful if a litigant can put something that I don’t understand into terms that I do. I often ask my law clerks to give me some real world example of the technology. Anything that helps me focus on the problem is welcome.

3. Do litigants use analogies effectively or are they overly simplified in favor of their position?

Analogies are very helpful unless you can see some basic flaw in them almost immediately. If so, it hurts their position because you assume the person has come up with the analogy is missing a step and therefore their position is not valid. So, I do think that analogies are very useful, but they have to be good because if they’re not, the other side is going to point out flaws in the argument which really hurts your position.

When presented with an analogy or other technical statement, I will try to take the attorney to a step beyond where they have gone to try to get them to say if this were the situation how they would analyze it. So often I get the answer that my facts are not the present case. The good attorneys will answer the question and are smart enough to realize that the new facts may make a difference to the result.

4. Do attorneys get tripped up using analogies.

Yes, they have to weigh the risk with the use of the analogy with its educational benefits. I would encourage analogies but I would probably test them with colleagues to make sure they have not missed something. Explaining technology is a struggle all the time.

5. Do attorneys use analogies in their presentations to the jury?

Claim construction is addressed by the judge, but juries need to make determinations that depend on some technical understanding. So, litigants may use analogies to educate them on the technology. I can’t tell you how many patent cases I have tried where part way through the case I finally understand the technology because of the presentation to the jury. Attorneys may presume the judge knows more than the jury, but I find these explanations helpful too.

Conclusion

The legal analysis of issues that are before a court in a patent case are complicated when they combine law and science. Scientific concepts can be difficult to explain to those who are not conversant with the particular science and problems arise when the parties overly simplify the technical descriptions using analogies. This oversimplification can distort the nature of underlying scientific principles and can lead to an incorrect understanding, ultimately producing a flawed result. Picking the correct analogies will benefit the court and lead to a better marriage of the science and the law.

Translating the science for non-scientists may become important as the Supreme Court continues to hear and decide cases having strong technology components. The victors may be the ones who can frame the issues using the right analogies.


[1]             Initial examples are aspirin and whooping cough vaccine. (Oral Argument 3-4).

†Phil McGarrigle (B.A. University of New Hampshire-Durham, J.D. Santa Clara University School of Law) is Senior IP Counsel at Jazz Pharmaceuticals and Lecturer at Law of Biotechnology at Santa Clara University School of Law

††Joe DiMatteo (B.A. Columbia University, J.D. Temple University) is the Chairman of IP at Holwell Shuster & Goldberg LLP