Monday, April 15, 2013

Rethinking the Rule Against Patenting Products of Nature

By Mike Dorf

The Supreme Court hears oral argument today in Ass'n for Molecular Pathology v. Myriad Genetics.  The case presents the question of whether human genes are patentable.  As Lyle Denniston explains on ScotusBlog, that is an important question as a practical matter.  A ruling for Myriad that genes are patentable would potentially impede the ability of scientists to conduct basic research on such life-and-death matters as the "breast cancer genes."

Or perhaps not.  The PTO has been treating genes as patentable for years, without the Union collapsing. Lyle is one of the best SCOTUS reporters out there, but I think that his preview of the case is slanted for the petitioners.  Myriad would (and does) argue that recognizing patentability in genes gives incentives to companies like itself to develop new technology for studying (and potentially treating) disease, and that in a properly functioning market, such companies will license the new technology to other researchers.  Thus, in this view, a ruling against Myriad would potentially impede research.

I don't have a view about that fundamental question regarding all intellectual property: How much exclusivity is optimal to maximize innovation?  And while that question will certainly be in play in the case, it is not directly relevant.  Congress makes the judgment of how much IP protection to afford and implements that judgment through legal rules and standards.  The courts' job is to say what those rules and standards mean.  For judges and Justices who are not strict textualists, the background purposes of the laws are of course relevant to the determination of statutory meaning or construction, but the courts do not make an all-things-considered-judgement about the optimal level of IP protection.

The Supreme Court granted cert on one question: "Are human genes patentable?"  That question in turn invokes the following statutory language (codified at 35 U.S.C. sec. 101):
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.
Subsequent sections of the U.S. Code set out additional requirements for patentability--most notably that the invention must be novel and non-obvious, in light of the prior art.  But the issue in Myriad  is the threshold question of patentability under section 101.  (There is some debate over whether, and to what extent, the Court may take account of the other factors in making the threshold patentability determination.  Let's put that aside.)

So, are human genes patentable?  Before you indulge your intuition, it's important to understand that Myriad did not simply swab its CEO's mouth and go running to the patent office with a spit-soaked Q-tip. Instead, Myriad's patent is for genes that form a relatively small part of the chromosome on which they are found.  Specifying their location and isolating their sequence required considerable scientific work.

At this point, if you were to just read sec. 101, you'd probably say that the patent satisfies the test. After all, Myriad "discover[ed a] new . . . composition of matter."  But there is a substantial obstacle to that conclusion.  The courts have generally read the "discover" language as having no independent content.  It's not enough to discover something in nature, because a long line of cases say that no one can obtain a patent for a law of nature or for a product of nature.  Accordingly, patent protection is generally reserved for "inventions."

So now the case looks good for the petitioners.  After all, aren't the genes at issue products of nature?  The answer may depend on whether, and if so, how, the SCOTUS adopts a line of cases in the lower federal  courts--including a prominent 1911 opinion by Learned Hand--that say that merely isolating and purifying a naturally occurring substance does not qualify for patent protection.  The petitioners say that's all that Myriad did, but Myriad says that the isolated DNA sequence does not exist in nature.  Each side and their respective amici present interesting analogies that pull in opposite directions.

I find the question in this case genuinely difficult (and fascinating).  Rather than attempt to resolve it myself, let me offer a hypothetical question that I think clarifies what's at issue.

Suppose that Acme synthesizes a hitherto unknown chemical, X, which is very effective as a clotting agent.  Acme obtains a patent on X and sells it to treat hemophilia.  A year later, it comes to light that a hitherto unknown tribe in the remote Amazon has been using a paste made from the leaves of a hitherto unknown plant as a clotting agent for as long as anyone in the tribe can remember.  Chemical analysis  reveals that the active ingredient in the paste and the plant is identical to X.  Does it follow that Acme's patent is invalid under sec. 101?

Note what I'm not asking.  I'm not asking whether Acme can successfully sue the Amazonian tribe for infringing its patent when they use the paste.  I'm asking the threshold question facing the Supreme Court in Myriad: whether the patent is invalid under Section 101--and thus unenforceable against anybody--because X was a product of nature all along, even though nobody realized it.  Should it matter if it turns out that Acme's laboratory process for producing X is much cheaper than it would be to extract comparable quantities of X from the Amazonian plant?  Is Acme out of luck because Acme only sought and received a product patent rather than a process patent?

I think these are all hard questions because they show that the whole notion of a product of nature is ill-defined.  Everything is ultimately a product of nature--unless it is of supernatural origin.  So, if I were writing on a clean slate, I think I would either do away with or downplay the prohibition on patenting products of nature, while allowing some substitution of process patents for product patents as appropriate.  The Supreme Court, however, does not have those options.


N.B.  I became interested in this topic because I was dragooned by the Cornell LS Moot Court Board into judging a moot court round based on the case last week, so thanks for that!  Thanks also to my colleague Oskar Liivak for giving me a crash course in patent law.  It has been an interest of mine since I was a summer associate in 1988 at Fish & Neave, which was absorbed by Ropes & Gray in 2005.  But I lack any formal training in IP. 

12 comments:

Paul Scott said...

Yes. They are out of luck. And should be.

Justin said...

Yes, unless one can tell the difference between the synthetic form of X and the natural form of X.

And among the *many* good reasons why, imagine the hypothetical enforcement of an in rem exclusion order by the International Trade Commission.


Michael C. Dorf said...

I still think this is harder than Paul and Justin do. During the actual oral argument today (transcript at tinyurl.com/yh4dqtd ) various Justices kept coming back to a hypo in which a patent is sought on a substance actually extracted from a plant in the Amazon. And one question was whether that could be said to be a product of nature if, say, it exists in the plant in much much lower concentrations than in the processed form. To my mind, this exposes the difficulty with the whole "product of nature" exception--although I realize the Justices seem committed to retaining that exception.

Justin said...
This comment has been removed by the author.
Justin said...

Michael,

Wouldn't your question that you highlight indicate the specific exception I note? If the synthetic form of X has properties not found in a "product of nature" - such as a level of concentration not attainable from public forms, then it is not necessarily within the proper scope of the "product of nature" test as that test is originally intended to apply.

Moreover, and I am not 100% sure of this, but I think your hypothetical conflates certain method patent issues not in the Myriad litigation. In the Myriad litigation, the method patents were invalid for reasons other than the product of nature test. But in your hypothetical, a method for creating the substance artificially might (this is where I am not 100% sure, since I am way outside my area of immediate expertise by now) be patentable, so the concern you are trying to "get at" might not exist.

Justin said...

Having thumbed through the oral argument, I now see that Mr. Hanson says pretty much the same thing I did on pages 7 and 8 of the transcript, so I apologize for any claim that you have conflated anything. But his answer on pages 7 and 8 is 100% correct; while I understand the judges have some basic philosophical concerns that tend to be in the forefront of Chicago School economics-based patent law, these concerns (to put it mildly) have overextended patent law already beyond what either good economics or fairness permit. Moreover, they seem to ignore Mr. Hanson's responses, which indicate that a method patent could, if the technology actually and in an innovating manner provides a real value, protect the economic development. Mr. Hanson also accurately explains that not all scientific research is done in search of a patent; indeed, most of the human genome project was done without patents in mind.

Michael C. Dorf said...

Two things (the first of which might be moot in light of Justin's follow-up):

1) I think that a much higher concentration of a product than exists in nature ought to qualify that product for being different from the natural product, but it is easy to read the lower court case law that the SCOTUS is being asked to endorse here as saying that "purification" does not generate patentability.

2) In my hypo, Acme didn't get a process patent because--not knowing about the naturally occuring plant--Acme thought that the product patent was enough. Maybe that's a reason to say tough luck on Acme but at least in my hypo, I have some sympathy for Acme. One way around this problem might be to expand the use of so-called "product by process" patents.

Finally (okay, that's a third thing), I want to be clear that I don't have strong views (or really any views) about the right outcome here. I just find the "product of nature" exception weird and therefore interesting.

Justin said...

Michael,

1) I should note that Mr. Hanson made the some concession at pp. 7-8.

2) Not sure this is all that compelling given the uniqueness of the hypothetical.

Shag from Brookline said...

I've long thought that the Constitution's patent/copyright clause, especially as impiemented by Congress over the years, as evidence of a living Constitution. How do today's originalists look upon the public meaning/understanding of"discoveries" back in 1789? The public meaning/understanding of science and evolution has changed quite a bit since then. The patent/copyright clause does not define "discoveries." Was this delegated to Congress? If so, how has Congress changed the definition over the years?

As I read through articles on oral arguments on Myriad, I thought of the Justices engaging in a judicial version of law office biotechnology. Alas, the Justices don't apply Daubert to their roles at oral arguments.

Jonathan said...

Does the Myriad case present a "Brand X" problem? Myriad's attorney focuses a lot on the USPTO's utility guidelines (promulgated after a notice-and-comment period) that specifically permit these types of patents. And the prohibition on natural products obviously goes back to the court's interpretation of the patent laws in Chakrabarty. Now, arguably, the Utility Guidelines contradict the decision in Chakrabarty because they permit patents for products of nature. So is there an argument that, under Brand X, the agency's interpretation trumps the court's interpretation and BRCA genes should be patentable?

(That the SG's office opposes the USPTO's view adds a possibly interesting twist -- does the Chevron paradigm still apply if the executive department is split on the interpretation, or do you follow the agency that has the expertise?)

Paul.K said...

But there is a substantial obstacle to that conclusion. The courts have generally read the "discover" language as having no independent content. It's not enough to discover something in nature, because a long line of cases say that no one can obtain a patent for a law of nature or for a product of nature. Accordingly, patent protection is generally reserved for "inventions."Cheapest Runescape Gold | billig World of Warcraft Gold

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