Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)

By Kevin E. Noonan --

Disaster survivors, and even people who just hear about a disaster, are often first overwhelmed by it; they can only rationally process its significance after some time.  During that time they overcome the initial visceral reaction and contemplate the effects the disaster will have on the future (and sometimes, develop remedies to avoid similar disasters in future).  Such is a reasonable reaction to the Federal Circuit's decision on June 12th in the Ariosa v. Sequenom case.

To recap, the technology at issue is non-invasive prenatal diagnosis of sex determination, blood typing, other genetic disorders (including Downs Syndrome) and detection of pre-eclampsia, using a simple blood test that reduces or eliminates the need for amniocentesis and chorionic villus sampling (which incur risks to both mother and child).  Sequenom Inc. is the exclusive licensee of U.S. Patent No. 6,258,540 originally obtained by Isis Inc.; three independent claims were attacked by Ariosa in a declaratory judgment action and asserted by Sequenom in its patent infringement counterclaims:

1.  A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
    amplifying a paternally inherited nucleic acid from the serum or plasma sample and
    detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

24.  A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises:
    removing all or substantially all nucleated and anucleated cell populations from the blood sample,
    amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally [sic] inherited fetal nucleic acid.

25.  A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises
    obtaining a non-cellular fraction of the blood sample
    amplifying a paternally inherited nucleic acid from the non-cellular fraction and
    performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

Ariosa (and co-declaratory judgment plaintiffs Natera Inc. and Diagnostic Center, Inc.) filed a declaratory judgment action against Sequenom on these claims, and the District Court denied Sequenom's motion for preliminary injunction (in July 2012), based on a substantial question of invalidity under Section 101 (this was before the Supreme Court's Myriad decision, and under prevailing Federal Circuit law where both genomic and cDNA was patent eligible).  The Federal Circuit then vacated the District Court's denial of Sequenom's preliminary injunction motion for reconsideration under the Myriad decision.

On remand, the District Court granted Ariosa's summary judgment motion for invalidity on the grounds that the claims were patent ineligible (and denied Sequenom's cross-motion for summary judgment of infringement).  Ariosa's argument was simple:  the claims at issue did not "add enough" to a natural phenomenon (the existence of paternally derived cell-free fetal DNA in maternal blood) to render the claims patent eligible.  Because the additional limitations "either apply well-understood, routine, and conventional activity to the natural phenomenon or limit the natural phenomenon to specific types of the natural phenomenon, which are also unpatentable" the claims do not recited patent eligible subject matter according to Ariosa.

The District Court agreed, providing as its analysis that cffDNA was a natural product that was itself patent ineligible, and that amplifying and detecting DNA from plasma or serum was well known at the time the invention was made, based on "evidence" in the specification.  (This interpretation seems to be a misreading of the specification, which states that amplification was achieved using standard techniques, not that amplifying DNA from plasma or serum was itself a standard technique.)  The prosecution history was cited for the same point with regard to methods for detecting cffDNA, and Sequenom's expert "acknowledged that others before the inventors had amplified and detected nucleic acid in plasma or serum."  The District Court based its decision on a combination of the AMP v. Myriad and Parker v. Flook decisions, concluding that to be patent eligible, Sequenom needed to invent novel ways of detecting cffDNA ("[s]imilarly, had the inventors of the '540 patent created an innovative method of performing DNA detection while searching for paternally inherited cffDNA, such as a new method of amplification or fractionation, those claims would be patentable"), based on dicta from the Myriad case.

Taking its turn, the Federal Circuit first provided its understanding of the proceedings below, in an opinion by Judge Reyna joined by Judge Wallach with Judge Linn concurring.  According to the opinion, the Court appreciated that the inventors had found cell-free fetal DNA (cffDNA) in maternal plasma or serum "that other researchers had previously discarded as medical waste" (emphasis added).  Foreshadowing their reasoning, the panel then state that "[a]pplying a combination of known laboratory techniques to their discovery, Drs. Lo and Wainscoat implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender" (by which the opinion avoids the more significant uses such as detecting Downs syndrome and other fetal genetic defects).  And more foreshadowing occurs when they characterize the development of this test as being a "discovery."

The opinion then acknowledges through the parties that the claims are not directed to cffDNA per se or paternally inherited species thereof.  In language that parallels Justice Thomas's language in Section III of his Myriad opinion, the opinion states that the '540 patent claims methods of using cffDNA and then sets forth the panel's understanding of the technical basis for the claimed methods and the procedural particulars of the case below.

The panel's analysis is best understood using the Court's own language, to better appreciate the basis for this decision:

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.  First, we determine whether the claims at issue are directed to a patent-ineligible concept.  Id. at 1297.  If the answer is yes, then we next consider the elements of each claim both individually and "as an ordered combination" to determine whether additional elements "transform the nature of the claim" into a patent-eligible application.  Id. at 1298.  The Supreme Court has described the second step of this analysis as a search for an "inventive concept" -- i.e., an element or combination of elements that is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself."  Id. at 1294; see also Digitech Image Techs., LLC v. Elecs. For Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014) ("Without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.").

Applying this understanding of the Supreme Court's teachings regarding diagnostic claims, the opinion states:

It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.  Sequenom does not contend that Drs. Lo and Wainscoat created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before Drs. Lo and Wainscoat found them.  The method ends with paternally inherited cffDNA, which is also a natural phenomenon.  The method therefore begins and ends with a natural phenomenon.  Thus, the claims are directed to matter that is naturally occurring.

Of course, what the claimed methods end with are amplified cffDNA and the diagnostic information that is discerned (but not claimed) using the method.

The opinion then takes isolated statements from the specification to support this conclusion (again, stating that cffDNA was "routinely" discarded) and that the inventors surprisingly found that detecting cffDNA could be used to render clinical diagnoses of fetal abnormalities non-invasively.

Of course, it is but a short analytical leap to find that the detection methods were simply "routine, conventional and well-understood" because the panel does not consider the claim as a whole but has broken its analysis into pieces (contrary to Supreme Court's Diamond v. Diehr decision).  Accordingly, the panel determines that there is no "inventive concept" in the claims (bizarrely, relying as did the District Court on Parker v. Flook).  (The applicability of that decision on life science inventions should have been firmly put to bed in Judge Rich's In re Bergy decision.)  The next portion of the opinion nicely sets out the logical and legal flaws in the panel's decision:

Like the patentee in Mayo, Sequenom contends that the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA.  Using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997.  The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA.  Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful.  The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.

Unlike the patentee in Mayo, the inventors of the claimed invention here did something not done before their invention (detecting cffDNA in maternal blood).  In contrast, every step in the methods claimed in Mayo had been performed in the prior art; the only inventive aspect in those claims was the therapeutic ratio, which the Court found to be a "natural law."  Accordingly, the Mayo claims did nothing more than recite the natural law.  That is not the case here.  Tragically, the remainder of this portion of the opinion recites the tedious evidence from the specification regarding known amplification and detection methods while ignoring that these methods had never been used to detect cffDNA in maternal blood.

The opinion then visits preemption (sadly, the Circuit Court responsible for interpreting patent law does not correctly state the standard, i.e., undue preemption; after all, all claims are preemptive in nature).  Fortunately, the panel does not follow the District Court through the looking glass of requiring for patent eligibility that every newly claimed method to recite not only a new method but that there be commercially viable, non-infringing alternatives available at the time an application is filed.  Instead, the Court considers the preemption question moot once claims have been determined to be patent ineligible.

Finally, the Court insulates itself from the negative consequences its decision has on innovation by citing language (dicta) in Myriad that "[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry," illustrated by the interpretation that "[t]he discovery of the BRCA1 and BRCA2 genes was a significant contribution to the medical field, but it was not patentable" (ignoring the fact acknowledged twelve pages prior in the opinion that the inventors were not claiming cffDNA).

Judge Linn's concurring opinion (which in a rational world would be a dissent) joins "only because [he is] bound by the sweeping language of the test set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  And he recognizes the consequences:  "[t]his case represents the consequence -- perhaps unintended -- of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain."  His soi-disant concurrence then sets out four ways to distinguish the case at bar from Mayo (although he does not avail himself of any of these grounds as a basis to dissent).  He states:

The Supreme Court's blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.  Indeed, the maternal plasma used to be "routinely discarded," '540 patent col.1 ll.50–53, because, as Dr. Evans testified, "nobody thought that fetal cell-free DNA would be present."

(Perhaps one basis for courts' seeming difficulty in applying Diehr properly is reliance on phrases like "conventional post-solution activity" from Flook; while this may make sense in claims to an alarm limit it is difficult to see how the methods steps recited in Sequenom's claims are properly characterized as such.  Cf, In re Bergy).  He then recites a list of what can only be considered to be secondary considerations (taking the Supreme Court's lead, incorporating concepts of obviousness into the patent-eligibility analysis) to establish how "groundbreaking" the claimed methods were.  And he states:

Unlike in Mayo, the '540 patent claims a new method that should be patent eligible.  While the instructions in the claims at issue in Mayo had been widely used by doctors -- they had been measuring metabolites and recalculating dosages based on toxicity/inefficacy limits for years -- here, the amplification and detection of cffDNA had never before been done.  The new use of the previously discarded maternal plasma to achieve such an advantageous result is deserving of patent protection.

Ironically, he relies upon Rebecca S. Eisenberg, Prometheus Rebound: Diagnostics, Nature, and Mathematical Algorithms, 122 Yale L.J. Online 341, 343–44 (2013) in support of these statements.

Judge Linn hoists the panel's decision on the petard of superior Supreme Court precedent:

In short, Sequenom's invention is nothing like the invention at issue in Mayo.  Sequenom "effectuate[d] a practical result and benefit not previously attained," so its patent would traditionally have been valid.  Le Roy v. Tatham, 63 U.S. 132, 135–36 (1859) (quoting Househill Coal & Iron Co. v. Neilson, Webster's Patent Case 673, 683 (House of Lords 1843)); Le Roy v. Tatham, 55 U.S. 156, 175 (1852) (same); see generally Jeffrey A. Lefstin, Inventive Application: a History, 67 Fla. L. Rev. (forthcoming 2015), available at http://ssrn.com/abstract=2398696 (last visited June 10, 2015) (analyzing traditional notions of patent eligibility of newly discovered laws of nature).

But while he says he sees no reason "in policy or statute" why these claims are not patent eligible, he believes he is bound by "the sweeping language in the Supreme Court's Mayo opinion" to concur.

It is clear that the Federal Circuit (or at least the members of this panel) believe that they are operating under a mandate from the Supreme Court regarding patent eligibility.  On the contrary, the Court itself has on many occasions made it clear that they view their role (in patent law and otherwise) as setting forth the broad contours of the law that they expect the inferior courts to use to develop the law properly.  In view of the lack of clarity in the Mayo opinion, a third year law student could distinguish this case from that one in arriving at the correct conclusion of patent eligibility.  Nothing more than Supreme Court precedent itself (specifically, the Diamond v. Diehr decision which the Court did not overturn in Mayo) is needed for the task.  The issue is not a lack of analytical and doctrinal tools but the will to employ them, which these members of the Federal Circuit do not seem to have had in rendering this decision.  But shielding the Court from the consequences of their bad decisions does them a disservice.  If the Court intended to exclude from patent eligibility all genetic (nay all types of) diagnostic methods, the Federal Circuit owes it to the Court to give them the opportunity to say so clearly and reap the political consequences.

Sequenom must now contemplate whether to seek en banc review (which is unlikely given the current composition of the Court, and equally fraught with risk for that same reason) or to petition for certiorari.  It is likely that the only way the Court will recognize the significance of this decision will be if that petition is widely and broadly supported by amici from industry, academia and the public through those patient groups who understand that failing to patent such tests today will lead inexorably to a future where all testing is proprietary and testing costs never decrease.  This is surely not what the Court had in mind when deciding Mayo; they deserve the opportunity to clarify the boundaries of patent eligibility with more care.

Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)
Panel: Circuit Judges Reyna, Linn, and Wallach
Opinion by Circuit Judge Reyna; concurring opinion by Circuit Judge Linn

Comments

[Dan Feigelson]

Excellent write-up and analysis, as usual. My quibble: "This is surely not what the Court had in mind when deciding Mayo; they deserve the opportunity to clarify the boundaries of patent eligibility with more care." As to the first part of that statement, I'm not convinced: this may be exactly what the Court wanted. And if it's not what the Court wanted, then I don't think "deserve the opportunity" is the right phrase here, unless you mean it in the sense of "deserve to be punished by hearing another one of these patent eligibility cases".

SCOTUS *should* take up this case and clarify itself (but I'm pessimistic), as Sequenom is the reductio ad absurdum of the line of thinking in Mayo, Myriad and Alice. Sequenom is a case in which an absolutely novel and non-obvious invention is denied patenability because the Royal Nine couldn't be bothered to engage their brains and parse their words before they wrote the nonsense of that trio of decisions.

Then again, as you point out, this mess could also have been avoided had the judges on the CAFC engaged in some useful distinguishing - something we know they're still capable of doing, as they've done it exceedingly well following the SCOTUS Teva decision on claim construction.

Meanwhile, investment capital will continue to flow away from inventions like this one, leaving promising therapies and diagnostic methods on the shelf, and leaving the public to contend with a greater number of "untreatable" diseases than it should have to.

[Elizabeth Kubler Ross]

In summary ... the applicant tried to claim something un-protectable and failed to claim something protectable.

[EG]

Kevin,

I agree that this Federal Circuit could have been more bold and distinguished Mayo, especially given that both the majority opinion and Linn's concurring opinion acknowledged that Sequenom's diagnostic method as meritorious, yet patent-ineligible. But I'm not giving a pass to the Royal Nine and especially Breyer who should be castigated for writing that nonsensical opinion in Mayo that squarely led to this mess, only to be followed be equally nonsensical opinions in Myriad and Alice. The Federal Circuit is now "reaping the whirlwind" in this case of what Our Judicial Mount Olympus has unfortunately sown with its technological ignorance and unwillingness to follow the patent statutes, as written. Our High Court is truly an embarrassment.

[Paul F. Morgan]

EKR is right. The claims are so broad they covered the mere paternity test of one defendant.

[Skeptical]

Should I say "I told you so" now, or wait for Paul Cole to make a post...

[Kevin E. Noonan]

Elizabeth and Paul: overbreadth was not the basis of the decision. If it were, we might be having a different conversation. Would your opinion differ if the claims were limited to a specific disease (hemophilia, for example, which it (usually) inherited by males)? I don't think the court's decision would change under those circumstances. And as an aside, Paul, they may cover a paternity test but ironically that use would satisfy Judge Ilston's requirement that there be a commercially viable alternative at the filing date.

[Greg DeLassus]

I agree wholeheartedly with Dr. Noonan's take on the case. That said, I notice that he relies rather heavily on In re Bergy. It is probably worth pointing out that the CAFC regards Bergy as having been overruled. AMP v. USPTO, 653 F.3d 1329, 1352 n.7 (Fed. Cir. 2012).

I cannot agree with this conclusion. To my mind, when the SCotUS dismisses an appeal as moot, that leaves the lower court precedent in place. Nevertheless, it is clear that at least some CAFC judges regard Bergy as bad law, so it is no surprise that they do not arrive at the same conclusion as Dr. Noonan on the basis of Bergy.

[DeniseK]

Section 101 was created by the 1952 Patent Act. Accompanying the 1952 amendment is a very clear statement of Congressional intent and purpose for section 101, independent of the other sections. This intent found in the legislative history reproduced below:

SECTION 101-SECTION REVISED
Based on title 35 U.S.C.1946 ed., §31(R.S. 4886, amended (1) March.3, 1897, ch.391, §1, 29 Stat. 692(2) May 23, 1930, ch.312, §1, 46 Stat. 376 (3) Aug. 5, 1939, ch.450, §1, 53 Stat.1212).

The corresponding section of existing statute is split into two sections, section 101 relating to the subject matter for which patents may be obtained, and section 102 defining statutory novelty and stating other conditions for patentability.

"Process" has been used as its meaning is more readily grasped than "art" as interpreted, and the definition in section 100 (b) makes it clear that "process or method" is meant.

The remainder of the definition clarifies the status of processes or methods which involve merely the new use of a known process, machine, manufacture, composition of matter, or material; they are processes or methods under the statute and may be patented provided the conditions for patentability are satisfied. (34 J Patent Office Society 549 Full Report House Judiciary Committee May 12 1952)

How has this statute been shifted so far off its intended target?

[Mike Stimson]

This isn't any surprise or anything the Federal Circuit didn't already do with the Myriad method claims (In re BRCA1- and BRCA2-Based Heredity Cancer Test Litigation). "The [claimed steps] do nothing more than spell out what practitioners already knew—how to compare gene sequences using routine, ordinary techniques. Nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences." The rule is that the eligible subject matter part of the claim needs to be patentable (new and non-obvious) separately from the ineligible part. Alice gets you there, and SCOTUS did that on purpose.

[Diana Cox]

Where are the bellows of outrage coupled with calls for statutory reform? What is the biotech and pharma industry waiting for? Surely it is clear that the courts have no interest in fixing this mess they have created, and in fact are making it worse with each decision - I see little point in trying to parse out the nuances and read the tea leaves in the decisions to find a path to what these courts would find to be patent-eligible, while at the same time commercially relevant. I submit that there is only one option, and it must be championed by the biotech/pharma lobby ASAP.

[Skeptical]

Greg,

In re Bergy CANNOT be overruled by the case you cite.

In re Bergy is properly referenced as sub nom Chakrabarty - a Supreme Court level case.

[Some Random Guy]

Point 1:
Next time I write an application, I will not say anything is "standard" or "routine" or "known in the art." The courts will hold it against me. I will say what was done in a very factual matter. The Background section - which is usually brief, just shrank even more.

Point 2:
I've read Section 101 numerous times, and I fail to find the phrase "inventive concept." I hate this importing of the obviousness considerations into the patentable subject matter analysis. I also detest the Supreme Court's usurping of Congress' job - and that is saying something, because I don't think much of Congress.

[Greg DeLassus]

Dear Skeptical,

To be clear, I am not saying that the CAFC purports to overturn Bergy in AMP v USPTO. Rather, Judge Lourie notes in his AMP (2012) opinion that he understands the Supreme Court to have overturned Bergy. He cites Parker v. Bergy, 444 U.S. 1028 (1980), which says (in relevant part) "Judgment as to In re Bergy et al. vacated and case remanded with directions to dismiss the appeal as moot." Therefore, Judge Lourie does not regard Bergy as binding precedent.

[Kevin E. Noonan]

Diana: You are correct and many groups are involved in calling for legislative reform. BUT the problem is that the Court has the power to make its version of subject matter eligibility the only one, based on its capacity to decide whether Congress has overstepped its exercise of one of the enumerated powers (think Commerce Clause cases from law school). So we need to move gently (much like Judge Rich and PJ Federico did in codifying obviousness) to prevent this outcome. I think the best way is to put into the statute the requirement that the claims be considered as a whole per Diehr (which Mayo did not overrule). But getting this through Congress will be difficult particularly because the Obama Administration is comfortable with the Court's circumscription of patent rights for political and financial reasons.

Thanks for the comment.

[Kevin E. Noonan]

Mike: While I agree there are some similarities I think this reading of the Court's precedent goes beyond what was said in Myriad III (but the sum of the CAFC judges involved in both decisions is one of the reasons why I think en banc review will not happen). Here the panel expressly recognized that the invention was groundbreaking etc. and still affirmed, and also argued that the claim "begins and ends with the natural phenomenon." There seemed to be some opportunity after Myriad III that a claim constructed "just so" might pass muster, but that hope is dashed by this opinion.

Thanks for the comment.

[Kevin E. Noonan]

Precedential or not, it is Judge Rich's application of the Flook decision to the facts that is illustrative of how concepts like "conventional post-solution activity" have no place in claims to life sciences inventions. Where is the "solution" in these claims? Flook was about an algorithm (which in pure form is an abstract idea), whereas the cffDNA and amplified versions thereof are tangible products of nature or human intervention, respectively. IF the inventors were trying to claim cffDNA per se the panel might have been on firmer ground in relying on Myriad, but the sad truth is that these claims are exactly the type of claims that Justice Thomas referenced in citing Judge Bryson's dissent in the second Myriad CAFC decision. The panel fell into the same trap that the district court did: applying Flook as if it answered the questions left by Mayo.

[Skeptical]

Benson and Flook were cabined by Diehr as explained in Bilski.

Unfortunately, there was a rather large (purposeful?) degree of misrepresentation after the Bilski case that sought to revive Benson and Flook as if those cases were not affected whatsoever by Diehr.

Thus, we have arrived at further case law that treats the decisions as "interchangeable" when the historical development clearly impugns otherwise.

When the Court itself simply feels that it can do whatever it wants, it does.

Sadly, some do not see this as the problem that it is. Especially in regards to patent law, which is not a vehicle of common law. The Court indeed has usurped the role of the legislative branch. And Congress yawns.

[Greg DeLassus]

"Precedential or not,... Judge Rich's application of the Flook decision to the facts [in Bergy]... is illustrative of how concepts like 'conventional post-solution activity' have no place in claims to life sciences inventions."

I agree 100%. The Ariosa decision's recourse to the "conventional post-solution activity" trope rather misses the forest for the trees. Sure PCR was routine by the time the inventors filed their patent, but the use of PCR to detect congenital disease in a fetus without amniocentesis was not at all routine.

This decisions reads like a parody. It is a reductio ad absurdum of Mayo, and I am afraid that we have not yet seen absurdissimum to which we are presently reducentes.

[Diana Cox]

Kevin - I understand your concerns, but I think the correction needs to be more specific than asking giving SCOTUS the right to interpret "claim as a whole" - because they claim to have already considered the claim as a whole and STILL came up with (IMO) the wrong answer (see, e.g., Mayo).

Article I, Section 8:
"The Congress shall have power ... To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries."

35 USC, Section 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."

DISCOVERIES (which presumably many of us believe include specific uses of laws of nature that don't completely preempt the law itself, and natural products which are put into a useful form by the hand of man) appear to me to be subject matter explicitly enumerated and thus intended to be considered patent-eligible by the US Constitution, as well as by the statute. It is the definitions of Section 100 that may need to be made correspondingly more explicit, since SCOTUS seems to be struggling with this as a "judicially-created exception" (and thus THEY are acting unconstitutionally).

35 USC Section 100:
When used in this title unless the context otherwise indicates—
(a) The term “invention” means invention or discovery.
(b) The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material. ...

While this all looks pretty clear to me (has the 35 USC 100 argument been made in these cases?), how could 100 be amended to make it even more clear that discoveries that comprise useful forms of naturally occurring compositions of matter and application of laws of nature which don't preempt all uses of the law are patent eligible? For example:
- If the claim as a whole is directed to a natural product or a law of nature, but the natural product is materially changed by the hand of man into a product that is useful in any way that it would not be, but for the hand of man, including but not limited to level of purity or formulation that does not occur in nature, then it is patent eligible.
- If the claim as a whole is directed to a new use of a known process which uses a law of nature, but which does not preempt all uses of the law of nature itself, then it is patent eligible.

That is just off the top of my head, and I know better minds have already addressed these issues, but I'm not sure I understand why there is a Constitutional question involved that is at all within SCOTUS's purview, since this is a particular area that has clearly and specifically been enumerated and carved out as a power given to the Congress.

And Congress is NOT exactly controlled by Obama.

[Kevin E. Noonan]

No, Diane, but the Court asks for the Solicitor General's views often and the Administration can influence the debate. Is there any question that the Court in Myriad merely repackaged the "magic microscope" argument in rendering its decision?

I agree that Section 100 is another avenue to get the definitions we want but have no faith that anything short of an intense lobbying effort by the diagnostic equivalent of the genetic Pharma industry will get anything passed.

As for the Court, it always takes more seriously challenged to the enumerated powers of Congress; done improperly and only a Constitutional amendment will be able to undo the damage.

[Skeptical]

Greg - judgment was moot - the legal point, not so much.

Judge Lourie is wrong.

[EG]

Kevin,

With all due respect, I agree with Diane C.'s point of view, as well as that of Skeptical. The problem is that the Royal Nine doesn't constrain its constitutional role properly in interpreting the patent statutes, as written and enacted by Congress, and thus their decisions in the patent area become "arbitrary and capricious" where the doctrine of stare decisis, as illustrated by the Kimbel case, is invoked simply as an excuse to justify otherwise bad precedent, or ignored, as in the case of Diehr in Mayo and Alice, when it becomes inconvenient with their philosophical/political agenda. Also, as Professor Mossoff of George Mason has astutely observed, Our Judicial Mount Olympus ability to factually, correctly, and without revisionist "spin" articulate the history behind the Patent Clause is abysmal, as witnessed by the their reliance upon Thomas Jefferson in Graham when they should have relied upon James Madison who was actually at the Constitutional Convention and wrote about the respective IP Clauses in the Federalist Paper No. 43. (I also won't go into detail on how the Royal Nine have allowed the Commerce Clause to be "used and abused" either.)

You don't engender respect from the patent bar when you act in the manner that the Royal Nine does, including using their ignorance of the technology as an excuse to render decisions having no basis in the facts, invoking "policy concerns" (i.e., "patents may inhibit research") having no factual basis in the record before them, and generally impugning the reputation of the patent bar with snide comments like not letting the "draftsman's art" control claim construction when 35 USC 112, 2nd paragraph says otherwise. It also doesn't help when Our Judicial Mount Olympus continually "browbeats" the Federal Circuit which Congress, in 1982, created that Court to be the arbiter of patent law jurisprudence and with a not so subtle hint to the Royal Nine to "cease and desist" from doing so except in truly egregious cases. The ultimate insult is when the Royal Nine can't even characterize the majority holding of the Federal Circuit correctly, as embarrassingly happened with Alito's opinion in Akamai. How does that engender respect from the patent bar?

Sorry for the long diatribe, but in my opinion, it's the Royal Nine that has overreached its constitutional authority in the area of patent law. And we're paying and going to continue to pay a serious price in technology not being funded or developed, or being simply driven underground and protected as trade secrets because of this unconstitutional overreach. No one individual or group is above the law, and that includes the Royal Nine, whether they recognize or not.

[Skeptical]

Dr. Noonan,

The answer to your dilemma at 4:30 is to remove the Supreme Court from patent cases.

As long as some Article III court has review power, Marbury will remain satisfied, and patent cases are not within the original jurisdiction of the Supreme Court, so it is well within the authority of Congress to keep such cases away from the so-called Royal Nine.

Will this happen? Well, I remain...

[EG]

Kevin,

I concur in Skeptical's most recent comment. The only way to avoid the current mess we have with Royal Nine meddling in patent law jurisprudence is for Congress to remove its ability to hear appeals of patent cases. And as even Our Judicial Mount Olympus recognizes, Congress has the constitutional prerogative to do so.

[Kevin E. Noonan]

As much as we may think the Court to be an inefficient venue for deciding patent cases, unless amended the Constitution gives the Court the power to "check" the exercise by Congress of the patent clause. The Court might abdicate this responsibility under circumstances (such as a treaty) where signatories agree to be bound by a specialized patent court but I don't see that happening

Thanks for the comments

[Skeptical]

Dr. Noonan,

I disagree with your post at 12:25. ALL courts are of limited jurisdiction - even the Supreme Court. That same constitution that you mention also provides the power to Congress to set aside matters from that same Supreme Court. All that THAT action need to take into account - from a constitutional firmity point of view - is that said matter NOT be a matter of original jurisdiction of the Supreme Court.

Patent case appeals do not fall into the Supreme Court's original jurisdiction.

I threw the matter in of having at least an Article III Court in the loop for review in order to make sure that the case of Marbury does not open a back door to the Supreme Court. I would beckon you to review that case again, as nowhere in that case did the Court declare that it must be the Supreme Court that must have review, but rather, the Court's holding was that the Judicial Branch have the power of review. A lower court - still within the Judicial Branch - as set up by Congress (again, within the constitutional power of the Congress) meets this requirement.

The path I outline is FULLY constitutional and inoculates patent law from the Supreme Court effects.

Getting Congress to take up this matter is, well, where I remain...

[Kevin E. Noonan]

Well, Skeptical, we will need to agree to disagree. I think that patents being an enumerated power makes a difference and that the Court would declare unconstitutional any effort by Congress such as you propose. I am also skeptical that anything like this will ever pass Congress.

[Paul Cole]

I am currently working on a posting concerning this decision.

The same patent survived opposition in Europe, see Appeal Case T 146/07 of 13 December 2011. Surprisingly the CAFC decision does not even mention this, although the decision is accessible with only a few clicks on a web browser, and any knowledgeable person (including patent-experienced judges) would be likely to look at the EPO record as a matter of natural curiosity. Indeed, in the current state of web technology and the extraordinary generosity of the USPTO and the EPO in putting data online, it is arguable that the judges or their law clerks would be negligent if they failed to carry out this simple and straightforward cross-check.

The variance in outcome raises, amongst other things, TRIPS compliance. Ignorance about TRIPS amongst even senior members of the US profession is profound, and it is possible for a European practitioner to raise the issue in a room full of leaders in the profession only to be met with expressions of utter indifference. Non-compliance with international treaties is a matter that SHOULD concern US practitioners, doubly so where the treaty concerned was initiated largely at the initiative of the US and with the objective of bringing other countries into line with what was then US practice.

Interestingly in Europe the problem addressed by the inventors was held to be the detection of foetal nucleic acids with improved sensitivity, or possibly the provision of an alternative source of foetal nucleic acid, and the claimed solution was held to be unobvious. It is interesting to consider how this finding fits with the claim wording in the EPO and in the US and what the implications for 35 USC 101/103 might be.

[Skeptical]

Dr. Noonan,

Can you tell me more about this "enumerated powers" angle?

As far as I can tell, that in and of itself will not (and cannot) be a deciding factor. Different perhaps - distinctive? I don't see it.

Also, I just don't see that aspect playing out with what is provided by the government's view: http://www.fjc.gov/history/home.nsf/page/jurisdiction_original_supreme.html

As to the actions of Congress, we align there. But that is merely because we lack a Churchill for our times. With continued erosion of its powers, the sleeper may yet awaken.

[EG]

Kevin,

I'm still with Skeptical on this one. Please note that initially there was no appeal from decisions by the former CCPA until later put in by statute. So providing no appeal in patent cases is not something that hasn't been done before by Congress.

Please also note that Article III, Section 2 gives Congress the authority to "make exceptions to and regulations of the appellate jurisdiction of the Supreme Court," including eliminating any such judicial review by the Supreme. The fact that the Patent Clause is an "enumerated power" as you note does not, in my opinion, affect Congress' ability to limit the scope of the Supreme Court's appellate jurisdiction.

Of course, Congress couldn't remove the Supreme Court's ability to rule on what is truly a constitutional question. But given that the Supreme Court has rarely questioned Congress' authority to enact legislation under the Commerce Clause (also an enumerated power in Article I), do you really think the Supreme Court, with a straight face, would argue that it's view of what "promotes progress" under the Patent Clause is superior to that of Congress? Also, how would you explain the exacting deference the Supreme Court gives to Congress under Copyright Clause as to what constitutes a "limited time" for copyright? Indeed, the differing standards that the Supreme Court seems to apply to the Patent Clause versus the Copyright Clause seems to be completely "arbitrary and capricious" to me.

[Kevin E. Noonan]

Dear Skeptical: I think I understand the misunderstanding. The link you posted with your comment above relates to the Court's original jurisdiction, which is limited to those times when the Court is essentially the trial court, mediating a dispute between the States as independent sovereigns.

What I am referring to is the more traditional appellate role stemming from Marbury v. Madison-the Court decides what the law is, where Congress makes those laws.

Here, the issue is how Congress is exercising the power to grant patents, which is a specifically enumerated power ( as opposed to powers to prevent discrimination in favor of locally produced apples, for example, under the Commerce clause due to the effects on interstate commerce that would occur if different states were permitted to raise barriers to sale of apples from other states).

As I see it, the Court is so focused on limiting patent-eligible subject matter because they believe that acting outside the scope of what the Court thinks is patent eligible would not promote progress and thus is outside the scope of Congress's power to do.

Whether we think their view if grounded in fantasy or reality is immaterial - we have the responsibility to do what we can to prevent the Court from rendering an opinion that raises the Constitutional stakes beyond those that Congress can remedy.

Thanks for giving me the opportunity to clarify.

[Skeptical]

I did mention that the Marbury case is satisfied by an Article III review. Nowhere in that case does it call for a Supreme Court review - I would posit that this is not a mere technicality, given that ANY Article III court is a part of the judicial branch and it was merely a branch to branch review that was at issue in that hallowed case.

[Skeptical]

I would also add that the Court's "fearfulness" over FUTURE merely possible (read that as conjectural) events is also problematic from the limitations on that body: the requirement for a PRESENT case or controversy and the restriction against advisory opinions.

If the Court is acting out of turn AND doing so for reasons clearly beyond the scope of THEIR authority then we have a duty to correct that situation, NOT shy away from the potential of a more difficult path or mere avoidance of conflict. This touches the meme of the Churchill versus Chamberlain comments.