In a parallel post, Dennis summarized the numerous amicus briefs filed in support of Sequenom’s petition for rehearing en banc. Below, professors Jeffrey Lefstin (Hastings) and Peter Menell (Berkeley) discuss the core issues raised in their amicus brief.
Don’t Throw Out Fetal-Diagnostic Innovation with the Bathwater:
Why Ariosa v. Sequenom Is an Ideal Vehicle for Constructing a Sound Patent-Eligibility Framework
By Jeffrey A. Lefstin and Peter S. Menell
Over the past five years, the U.S. Supreme Court has reinvigorated patentable subject-matter limitations, issuing four significant decisions after nearly three decades of dormancy. These decisions reflect justifiable concerns about the patenting of abstract business methods and laws of nature. Just as importantly, they reveal internal inconsistencies and confusion about the scope of patentable subject matter and tension with the centuries-old fabric of patent-eligibility jurisprudence. As Justice Breyer remarked at the oral argument in Alice Corp. v. CLS Bank Int’l (2014), the Mayo (2012) decision did no more than “sketch an outer shell of the content” of the patent-eligibility test, leaving much of the substance to be developed by the patent bar in conjunction with the Federal Circuit.
Two of the Supreme Court’s recent patent-eligibility decisions (Bilski and Alice) involve non-technological business methods. Mayo glosses over several key issues, including how to reconcile prior discordant decisions (Flook and Diehr), and whether the requirement of “inventive concept” demands an unconventional application, or merely more than the generic instruction to “apply the law.” And Myriad departs from Mayo in a critical respect in that it authorizes patentability for a conventional transformation of a natural compound.
Unfortunately, the Federal Circuit’s panel decision in Ariosa v. Sequenom elides the critical questions. In view of Congress’s reluctance to weigh in on the scope of patentable subject matter and the Supreme Court’s signals to the patent bar and the Federal Circuit to bring coherence to these rough outlines, Ariosa v. Sequenom marks a critical juncture in the development of a modern patent-eligibility framework. Failure to vet these issues risks undermining the patent system’s role in promoting biomedical research. Beyond Supreme Court review, which is never guaranteed (consider the havoc wreaked by the Court’s passing on State Street Bank), or corrective legislation (which is even more speculative), en banc review by the Federal Circuit presents the last clear chance to avert potentially dire consequences.
Our amicus brief urges the Federal Circuit to grant en banc review in Ariosa v. Sequenom to ventilate the critical issues left unanswered by the Supreme Court’s patent-eligibility decisions. Although some language in Mayo could be interpreted to set forth unconventional or inventive application as a possible test for patent-eligibility, Mayo suggests two other possibilities for an “inventive concept”: non-preemptive application; and non-generic application – that is, more than a statement of a natural law coupled with an instruction to apply it. While the panel was correct to perceive that Mayo describes preemption as the underlying justification for the patent-eligibility doctrine, not the operative test, we believe that the panel was incorrect to conclude that Mayo dictates unconventional or inventive application.
Our brief further shows that the Ariosa panel decision conflicts with several strands of prior Supreme Court decisions. The panel decision jeopardizes valuable innovation in diagnostic research and other biomedical fields as unintended fallout of the Supreme Court’s justifiable desire to discard vague and non-technological business method patents. The primary responsibility for developing patent-eligibility doctrine now rests with the Federal Circuit and this case presents an ideal vehicle for explicating sensible jurisprudential boundaries.
Jeffrey A. Lefstin is Professor of Law at the University of California Hastings College of Law. Peter S. Menell is Koret Professor of Law and a Director of the Berkeley Center for Law & Technology at the University of California at Berkeley School of Law. Their amicus brief in support of en banc review in Ariosa v. Sequenom is available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2652452
Jeffrey Lefstin (Hastings) and Peter Menell (Berkeley)
Did either of these people write anything intelligent in the run-up to Prometheus v. Mayo? Any indication that they understood the facts and the issues and Prometheus’ theory of infringement of their claim to a method of thinking about a new correlation?
If so, I’d love to see a link.
I’d also like to know if either of these two individuals expressed any concern about “the bathwater” when State Street Bank was decided and the toxic sludge was dumped into the bath. If so, I’d love to see the links. I won’t hold my breath.
Otherwise it’s pretty transparent what’s going on here. Nobody is suggesting that all methods of fetal diagnosis are ineligible for patenting. That’s a strawman created to divert attention from the far more important issue which is abuse of the patent system to control information, including facts about human biology.
Subject matter eligibility problems come in different flavors. These professors know it. Jason knows it. Dennis knows it. Anybody who has read this blog for the past five or six years knows it. The different flavors arise from the various tricks that patent attorneys develop to draft “around” section 101.
For instance, Prometheus “discovered” a correlation. Correlations are ineligible for patenting. Prometheus’ trick was to throw in a preceding data-gathering step requiring a “transformation” before the “novel” step of “thinking about the data”. One major problem with that trick is that the data-gathering step was in the prior art so people practicing the prior art were turned into infringers merely for thinking about the data. The other major problem — an even bigger problem and the one that these professors are loathe to discuss — is that if you allow that trick to be played — and it certainly was allowed for years by the PTO — the patent system quickly loses its credibility. It becomes a breeding ground for grifters and parasites — you know, those rich entitled (and mostly Republican — surprise!) hypocrites who run blogs that do nothing but shill for their self-interests day in and day out, complaining about how the PTO isn’t granting patents fast enough for them (at the same time the grant rates are exploding) and, as a result, the US is turning into a third world country.
In this case Sequenom discovered a fact and they claimed the generic use of an old method to detect that fact. Such claims impermissibly prevent others using the prior art to study that fact. This is just another flavor of scrivening around 101. It’s exactly what Myriad tried to do with its broad sequence detection methods and it’s exactly why those method claims were shot down. As with Prometheus’ attempt to scriven around 101, Sequenom’s approach is one that will also be easily and widely abused by those looking to cash in. “I discovered ineligible X. I claim the use of old technology to detect X.” The Eastern District of Texas called. They look forward to your lawsuits!
Note the following because it’s extremely important: if Sequenom had discovered and claimed a specific serum isolation method, primers and conditions that worked surprisingly better than other tested methods for performing this test, we’d be having a very different discussion. But that’s not what happened here. Not even close.
Again, the failure of these academics to acknowledge these basic issues before engaging in ridiculous hyperbole about “throwing babies out with bathwater” is noteworthy. It’s noteworthy because we saw this willful ignorance in the run-up and aftermath of Prometheus v. Mayo.
Never underestimate the ability of conflicted or confused people to snatch defeat from the jaws of victory. Dredging the toxic waste from the slime pit that is the US patent system is going to take a lot of work and quite a bit of time. We all knew that. Leftsin and Menell aren’t helping. Please try harder, guys.
MM, good post.
MM, at least for the time being, the Federal Circuit is on board with common sense. I doubt if this case gets reheard en banc because most of the court knows that if they did, and held these claims patentable, the Supreme Court might have a fit. Anything could then happen, including the demise of the Federal Circuit as having the exclusive writ on patent law.
Reading their brief, I was struck by the studied absence of the text of the claim. Your post helps explain why.
From my understanding, the only thing new is the discovery of a fact.
How is that an invention?
“Their amicus brief in support of en banc review in Ariosa v. Sequenom is available at: link to papers.ssrn.com”
You have an unusual understanding of the word “available.”
Thanks, I’ve fixed it.
SSRN allows you to make a free account and access everything. No paywall.
Don’t Throw Out Bingo Management Innovation with the Bathwater:
How is it possible that this article fails to even discuss the fundamental issue that Prometheus v. Mayo addressed, or why that issue needed to be addressed?
Did these deep-thinking academics think everyone would forget exactly what Prometheus tried to do and why the Supreme Court shut them down?
Sheesh.
MM, I think Supreme Court was clear in Mayo that one cannot get a patent for discoveries of facts, but only for inventions.
… and that would be a wrong interpretation of Mayo
Well, MM, I tried twice to post a comment about the inaccuracies regarding Jefferson and the statutory history of 101 in the Noonan-Mosshoff brief over Gene’s site. They were not posted.
So, I guess what they say is true about Gene and his site.
Can somebody please tell me how the facts of this case are any different than those in Mayo?
Seems exactly the same to me.
Somebody discovers a correlation and then patents a method of implementing said correlation without adding any particular steps beyond merely applying the correlation.
Whats are the steps of ANYTHING when claiming things made out of electrons, protons, and neutrons?
Note – this is your logic being applied right back at you**
** here, both the Royal You and the personal you.
I would. But once again the author(s) have not provided even the patent number of the patent question, let alone the text of a claim.
It’s in the earlier post. The difference between claim 1 and claim 25 is interesting and perhaps worthy of discussion.
U.S. Patent No. 6,258,540.
I love how the claims themselves are never part of these 101 discussions.
I guess ideology comes before facts for many.
I’m a bit hung up on claim 25.
I think there is an argument to be made that claim 25 is patent eligible in light of mayo.
I say so too. Even if claim 1 goes down, claim 25 seems reasonable.
Yea claim 25 makes the case interesting IMHO.
If it was just claim 1 & 6 it would be Mayo all over again, which was my gut reaction.
When you glom onto the power to “Gist” away any old inconvenient claim element, the situation you refer to is unavoidable.
I agree with you.
35 USC 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.
You can still “discover” the correlation, but then you have to do something with the correlation for the claim to be patentable.
PatentBob, but the “invention” must be elsewhere in the claim, or the discovery must be applied in an inventive way.
I discover that cooked meat has no germs. Can I patent cooking meat? No, that is old. Can I patent cooking meat wherein the cooked met is germ-free? No. Can I patented cooking meat and then using that germ-free meat to seal battlefield wounds without infecting the wound? Probably.
Ned,
Can we please have a little inte11ectual honesty from you and have you recognize that the invention is the claim as a whole?
Congress thanks you.
Federico thanks you.
Your conscience thanks you.
anon, X is a law of nature — a fact. Which of the following is patentable?
1. I claim discovery X.
2. I claim discovery X, wherein discovery X is identified by use of conventional process Y.
3. I claim discovery X in a process that cures a specific disease. [Which cure was unknown prior to the disclosure in the application.]
Ned,
How do your questions answer my request?
Anon, they do, but only if you answer them.
No Ned, they do not.
I am looking for you to give a simple and direct answer to a simple and direct question.
Do you understand the question?
Ned –
I discover Crestor a composition of matter, a miracle drug that lowers HDL and saves lives.
Is it patentable?
Yes, of course it is.
What if there are 4 grams of it in a little naturally occurring clump orbiting the Sun in the Kuiper Belt, but nobody knows?
It it patentable now?
Les, how the frack can one discover something new?
Perversity of words — Discover used for invention, invention used for discover.
Stop it!
Once again, Ned, it is the words of Congress that you seem to mightily struggle with.
Don’t you think that your accusation of perversity is a bit unfounded here?
Go ahead: 35 USC 100(a) awaits your “wisdom.”
“Les, how the frack can one discover something new?”
Ned, in patent law, “new” means not previously “known or used by others.” And, I respectfully submit that “known” means “publicly known” and “others” means humans or at most, in its broadest sense, earthlings.
So, one can discover all sorts of “new” things.
Jerry has been hoping to discover a cure for M.S.
“Perversity of words — Discover used for invention, invention used for discover.”
Sorry Ned. I meant I invent Crestor and DISCOVER that it lowers HDL…
topce, I think you are right. Also consider Funk Bros, were trivial applications were not “enough.”
Patents are not for discoveries of facts, but for inventions.
You are older and wiser than I am Ned.– and more knowledgeable of the history of 101 What do you think of claim 25?
That appears to tailor the discovery to a specific method of use. Is that enough in your opinion?
Can somebody please tell me how the facts of this case are any different than those in Mayo?
Seems exactly the same to me.
See my post at 8. The facts are not “exactly the same”. But the eligibility issues presented are certainly similar.
“Failure to vet these issues risks undermining the patent system’s role in promoting biomedical research.”
Just two words for your assertion Professor: Bull Shit
Ariosa petitioners …
Scientific discovery …
Bags of money …
Delirious capitalists …
Patent henchmen …
FDA bagmen …
Great example of patent lawyers having a conniption fit because they can’t figure out a way to use the only tool in their bag to corner a lucrative market.
The biggest problem here is the notion of the Court having a “justifiable” concern – but only in someone else’s “backyard.”
You just don’t get to play the “divide and conquer” game with statutory law, as being written by the judicial branch.
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