Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Today, we review the brief submitted by the Wisconsin Alumni Research Foundation (WARF), the Marshfield Clinic and MCIS, Inc.

In the brief's Statement of Interest, the WARF amicus states that it is "a non-profit organization that supports and promotes scientific research at the University of Wisconsin–Madison by patenting inventions and discoveries of university researchers and licensing them for commercial use."  The Marshfield Clinic is "a non-profit clinic whose mission is to serve patients through research and education as well as providing accessible, high-quality care," and MCIS (a Marshfield Clinic affiliate) "produces medical information products and services that enable effective, efficient practice of medicine at an affordable cost."

These amici assert "a strong interest [] in the patent-eligibility question this case presents because they have commercialized other ground-breaking medical therapies and products and aim to continue doing so for the benefit of both their institutions and the public they serve."

The brief makes three arguments in favor of en banc reconsideration:  first, that the Supreme Court's precedents in Mayo and Alice v. CLS Bank is limited ("no more and no less") to preventing patenting of natural phenomena, laws of nature and abstract ideas.  Second, this precedent is not intended and does not require invalidation of claims to applications of natural phenomena that do not monopolize the phenomenon per se.  Finally, they argue that the panel erred by misinterpreting Sequenom's claims when it found isolation, amplification and analysis of cffDNA from maternal blood and other fluids to be conventional.

In making their first argument, the brief cites Justice Thomas's Myriad opinion for the proposition that "practical applications and variations of natural phenomena, laws of nature, and abstract ideas are patent-eligible" (emphasis in the brief), as well as Diamond v. Diehr, Diamond v Chakrabarty, Mackay Radio & Tel. Co. v. Radio Corp of Am., and LeRoy v. Tatham.  Mayo did not overturn this prior precedent, and amici argue that the Mayo opinion (as explained in Alice) was intended to prevent the "clever draftsman" from "avoid[ing] the exceptions to patent-eligibility by gussying up the claims with extra verbiage or trivial additional elements."  But the brief argues that the use of the concepts of "conventionality" and "transformation" in the Mayo/Alice decisions was not intended to require an analysis of the claims with regard to those concepts "for their own sake":  "[i]nstead, the critical question is whether a patent impermissibly claims and prevents others from using a natural phenomenon, law of nature, or abstract idea itself, or instead permissibly claims a practical application of one of those things" they argue.  The brief illustrates this argument by citing the comparison in the Mayo opinion itself between the Prometheus claims (which were invalidated because "they 'effectively claim[ed] the underlying laws of nature themselves'") and Diehr's claims to transformative methods for curing rubber (which "did not 'seek to pre-empt the use of [the Arrhenius] equation' but instead 'transformed the process into an inventive application of the formula' and sought 'only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process'".

Having set the stage with this argument, the brief then goes on to state what the Mayo/Alice opinions do not do:  preclude patenting of applications of natural phenomena, laws of nature or abstract ideas.  These amici argue that the Myriad opinion stated that while "isolated naturally occurring DNA is not patent-eligible, innovative methods of isolating or manipulating DNA may be" and that "practical applications of knowledge about gene sequences may be patentable even though the sequences themselves are not."  Extending this analysis to Sequenom's claims, they acknowledge that Isis (the patent owner) could not have patented the mere discovery that cffDNA was present in maternal blood (the natural phenomenon) or the cffDNA itself (the natural product that would be invalid under Myriad).  But if Sequenom had invented "innovative methods of isolating cffDNA in maternal fluids" that would have been patent eligible, and likewise what the inventors of Sequenom's asserted claims had invented should also be patent eligible as a practical application of the discovery of cffDNA in maternal blood.  And these amici remind the Court that the inventors did not attempt to patent either the cffDNA or claim all practical uses of their discovery:  indeed, the claims are directed to detecting only paternally derived cffDNA, which the brief characterizes as only "one fraction of the naturally occurring cffDNA."  And the brief argues that there existed "practical alternative detection methods that do not involve fractionation and amplification of the cffDNA" and thus (sub silencio) that the claims do not preempt every use of the discovery that cffDNA (both maternally as well as paternally derived) can be found in maternal blood of a pregnant woman.

Finally, the brief addresses what these amici (as well as the parties and other amici) identify as the panel's (and the District Court's) error:  determining that the isolation, amplification and sequencing steps are "conventional" and thus fail to satisfy the second step of the Mayo/Alice inquiry.  The first source of error was in "isolating the steps [recited in the method claims] rather than considering them as an 'ordered combination' as taught by Alice, [] Mayo, [[] and Diehr []."  And the brief makes the point argued by the parties and amici, both in the District Court and before the panel, that no matter how conventional the recited steps in these methods may be generically, it was not conventional to apply them to detecting cffDNA from maternal blood because (prior to the inventors' discovery) "no one thought cffDNA was present in maternal fluids."  This is in contrast to the circumstances involved in the Prometheus claims invalidated by the Court's Mayo opinion, where everything except the observed correlation between drug concentration in blood and therapeutic effect had been performed in the prior art.  The brief acknowledges the Supreme Court's importation of obviousness-type considerations into the patent eligibility analysis ("[f]or good or bad'), but cites In re Ochiai for the principle that a compound is not obvious when neither the starting materials nor the product are known in the prior art, even if the chemical reaction converting one to the other was "conventional."  71 F.3d 1565 (Fed. Cir. 1995).  This is analogous to the situation here, and thus the same conclusion should be reached.

The most idiosyncratic portion of the brief is the inclusion of a joke (which we would be remiss not to include in this post):

A physicist, a chemist, and an economist are stranded on a desert island.  A can of food washes ashore, but they but have no can opener.  The physicist devises an ingenious plan relying on leverage and gravity.  The chemist proposes a clever plan based on heat and pressure.  To which the economist responds, "Let's assume we have a can opener, and from there the solution is easy."

The lesson is that in reality (instead of the fantasy land that follows from some instances of how the Supreme Court's patent eligibility jurisprudence has been applied), the existence of the can opener cannot be assumed (just as a proper assessment of patent eligibility cannot assume the existence of paternally derived cffDNA in maternal blood and thus anything that is done with this unknown natural phenomenon cannot be "conventional."  In this regard the brief cites Justice Stevens' notion in dissent in Diehr that "a natural law (or phenomenon) should be 'treated for § 101 purposes as though it were a familiar part of the prior art.'"  But that is not the law, as the amici point out, because the Diehr majority rejected this rhetorical flourish, stating that "[i]t was inappropriate to dissect the claims into old and new elements and then ignore the presence of the old elements in the analysis."  And while the brief does not connect the dots in this way, can't it correctly be said that what the Diehr majority feared from the dissenters' approach has come to pass under Mayo/Alice ("the dissenters' approach 'would, if carried to its extreme, make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious'")?

These amici were represented by Michelle Umberger, Michael Osterhoff anf Dan Bagatell of Perkins Coie.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Comments

[The Memory Motel]

"can't it correctly be said that what the Diehr majority feared from the dissenters' approach has come to pass under Mayo/Alice"

Are you suggesting that claims like the one Prometheus asserted, i.e., gather data using old technology and think a non-obvious thought about the meaning of the data, should be eligible for patenting?

[The Memory Motel]

"To which the economist responds, "Let's assume we have a can opener, and from there the solution is easy."

The distinction between this "joke" and "reality", of course, is that (1) PCR was well-known when this application was filed; (2) it was well-known at the time the application was filed that PCR could be used to amplify and detect extraordinarily small concentrations of nucleic acid;(3) it was well known that DNA could be PCR'd from maternal serum (there's special about maternal serum that "blocks" the PCR reaction; (4) it was known as of the filing date that fetal cells and fetal cell debris existed in the maternal blood stream (5) it was well-known as of the filing date that where cells and cell debris can be found, there is an extremely high likelihood that PCR-detectable DNA can be found absent some special PCR-blocking circumstances (see (3) above).

The misrepresentations promoted by Sequenom and its amici are just as transparent and self-serving as those promoted by the supporters of Prometheus' claims and Myriad's claims not too long ago. For instance, I read somewhere where Sequenom's claimed subject matter "saved women's lives" because the alternative is amniocentesis. In fact, as of the filing date of Sequenom's claims it was known that you could isolate fetal cells from maternal blood. Moreover, the medical community doesn't consider amniocentesis to be a "dangerous" procedure; rather, it's considered to be safe and simple.

I think I also read somewhere that the Sequenom's named "inventors" were going to get a Noble Prize. Seriously? Has the bar for the Nobel Prize been dropped that low? Or are the folks out there who truly love Sequenom's patent reaching really high?

Lastly, I'd like to point out the astute comment from "Bruce" on an earlier thread: http://www.patentdocs.org/2014/09/ptab-decides-inter-partes-review-of-patent-at-issue-in-ariosa-v-sequenom.html#comments

These are the facts. You can try to ignore them all you want but they aren't going away. And a friendly reminder: ignoring the facts didn't work very well for the folks who loved Prometheus' and Myriads' junk claims either.

But please feel free to continue writing your self-serving press releases if you think that's going to work.

[Paul Cole]

I am reminded of a comment I made some years ago on this subject when the Mayo decision first came out.

A four year old child is given a CD on which is recorded some family videos not previously seen by members of the family. When the family player is empty, from the section 101 standpoint it is a patent-eligible machine but lacks novelty. When the disk is inserted the combination of player and CD is novel but is ineligible because the only novelty is in the ineligible recording on the disk.

The four-year old can have endless fun switching the player from an eligible/anticipated state to a novel/ineligible state and back again by inserting and removing the CD from the player.

Or perhaps there are more sensible and practical ways of applying the law.

[The Memory Motel]

September 18, 2015: Paul Cole comes *this* close to realizing that patent claims with different scope raise different legal issues.

[Paul Cole]

That chap Pharaoh was a complete idiot to be taken in by that con-man Joseph. As if there was any economic or practical value in the interpretation of dreams. Putting con-man Joseph in charge of his kingdom indeed, so that he was over everyone except Pharaoh! All that stuff in Genesis is complete tosh. Nobody should behave like Pharaoh did.

About three millennia later that fool Andrew Lloyd-Weber wrote a musical called Joseph and his Amazing Technicolor Dreamcoat about these events, deceiving generations of children about the value of interpretation.

We now know better. The Supreme Court has told us that interpretations are of no value, mere discoveries of natural phenomena that should be available to everyone with no reward to the discoverer. So there the law stands. We can be resistant to con-men who allege that they have performed a service by interpreting as blood test so that better but intrinsically hazardous drugs can be administered to needy patients. It should all be free. Why reward the discoverers?

[The Memory Motel]

September 18, 2015: Paul Cole demonstrates to the everyone that, in his view, the only meaningful rewards for scientific research come in the form of government-granted patent rights.

This will come as a great surprise to most intelligent scientists, very very few of whom Paul Cole appears to have ever met.

[Curious George]

"Memory Motel" = MM = Malcolm Mooney. A pity this blog is being infected like Patentlyo.

[Skeptical]

It's curious how transparent Malcolm's actions are, no matter which new sockpuppet he creates here.

It's also curious how venomous he is towards those selfsame "suckies" at Patently-O, yet how extensively he uses that rhetorical device (while claiming not to).

It is perhaps that he does not have a strong legal/factual basis of wanting the law to be aligned with his opinion/philosophy that compels him to act so.

As they say:
When you have the law, pound the law.
When you have the facts, pound the facts.
When you have neither, pound the table.

MM sure likes to pound the table.

Does he realize how weak and transparent that is?

I remain...

[EG]

Skeptical,

I fear you're correct that the Malcolm/MM "virus" has again infected Patent Docs.

[Kevin E. Noonan]

All: We welcome comments from all, so long as the comments remain civil and further the conversation. There are no worries about disagreements - we welcome them as it is the best way to get some measure of clarity.