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The Prometheus Decision: No Worries, No Problem

Written by Mary Beth Tung, Ph.D.
Davis Agnor Rapaport & Skalny, LLC
Posted: March 29, 2012 @ 2:24 pm

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The biotech community has been chattering ever since the Mayo Collaborative Services v. Prometheus Laboratories (“Prometheus”) ruling was issued by the U.S. Supreme Court March 20, 2012.  Biotech folks, unaccustomed to the flurry of appellate activity surrounding some recent biotech cases, including the July 2011 Federal Circuit decision, Assoc. for Molecular Pathology et al. v. U.S.P.T.O. and Myriad Genetics, 2010-1406 (2011), are understandably nervous and have been engaged in a parlor game of guessing the effects of the decision on the biotech industry.  The dinner discussions in my own household have centered on the subject (my kids think their parents are total nerds).  Several posts and the many comments on this august blog and on other blogs are indicators that the biotech patent bar has found itself thrust into the legal limelight in a series of decisions which many fear may seriously harm the biotechnology industry, still struggling in a slow economy.  In fact, the stock prices of several prominent biotech companies fell at the news of the Prometheus ruling, including Myriad’s stocks, which had fallen 9% at one point.  As many of my esteemed colleagues have and will continue to dissect the case, I will instead focus on the effect of the decision on the future of biotech patents.

Unlike many in the biotech community I do not think the Prometheus decision will break the biotech industry or even seriously affect it .  Much like the car mechanic in a small Caribbean island told me when my engine light came on in my rental car, “no worries, no problem!” (our car, in fact, never broke down, even on a mountain road with no shoulders).   I believe the holding in Prometheus prevents what could be a future legal quagmire, where overly-broad patents could serve to block entire fields of practice and create an enforcement nightmare in which ghosts of legal uncertainty and licensing ambiguities would haunt hospital hallways, R&D labs, boardrooms,  and investment entities throughout the country.  If the Prometheus decision would have gone the other way, it would not have been status quo, but rather been fairly harmful to future innovation.

The technology involved is a therapeutic method involving thiopurine treatment of persons with intestinal tract autoimmune disease.  Thiopurines are a class of pharmaceuticals called nucleoside analogs, which mimic naturally-occurring nucleosides, the subunits making up DNA or RNA – genetic material.  Nucleoside analogs include the well-known cancer drugs fluorouracil and ara-C, as well as HIV drug AZT (Retrovir) and the shingles drug, famcylcovir (Famvir), among many others.  A good review by Dr. William Plunkett’s group (MD Anderson Cancer Center at the University of Texas) is found here..  There are many patents which cover the products and methods of using these compounds and those patents will still be safely in place, with proper claims drafting.

The difference in Prometheus, in my humble opinion, is in the claim language itself and is a drafting problem, rather than a subject matter issue.  The claim(s) at issue include:

“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: a) administering a drug providing 6-thiopurine to a subject…, b) determining the level of 6-thioguanone in said subject…, and wherein the level of 6-thioguanine less than about… indicates a need to increase the amount of drug…”.

The “wherein” clause is considered by the Court as a separate method step.  The administering step was dismissed by the Court as merely identifying the artisan who would practice the invention.  The key step in the claim then, is the “determining” step.  This claim wording, with all due respect to the claim drafter, is so wrong on so many levels that it is hard to key in on any one aspect.  When I was an  Examiner, I would have rejected this claim as merely stating an inherent property of the drug metabolism – a rejection under 35 U.S.C. 101, as being non-statutory subject matter.  The drug is administered, which is an active step, but there really is nothing else in the claim.  The “determining” limitation is a mental step, and the “wherein” clause is even worse – because the limitation just indicates a need to increase the drug.  None of these steps do anything except describe a natural product whereby the body itself metabolizes a drug to a certain level.  In other words, an “administering” step does not rescue a method claim when the other steps consist of a mental step (“determining”) and a stated need to do something.

While I don’t disagree with the Court’s conclusions, the danger I think they created in this decision was that lower courts may start to hold all drug therapy claims invalid, because of course, all therapeutics are metabolized by the body without human intervention.  I would have liked to see more clarity from the court on the extent to which a claim might pass muster.

It is clear that the Court zeroed in on their core concern – of tipping the balance from the exclusivity of a patent grant on one hand and the flow of information needed for future innovation on the other.  Whenever the Court mentions a “balance,” the patent bar should get nervous because invariably, “balancing tests” will soon find their way into future lower court decisions that bear little semblance to what (we think) the Court intended in the decision.

Since the Prometheus claims included two non-statutory components: a mental process, the “determining” step, and an inherent characteristic (metabolism by the body), if the Court would have issued a ruling with the opposite holding, I can envision a scenario where lower courts would start finding claims based on either mental processes or inherent characteristics as being patentable subject matter.  The problems are obvious – think thought police barging into a patient’s hospital room as her physician contemplates the correct dosing (“determining the level of…”) after reading the results of the serum drug level testing.  The scope of these future claims could bar whole areas of R&D, where the scope of the claims would so broad that normal medical decisions could be blocked by a patent.

The Court, in essence states as a question, that there is nothing more to the issue than a “drafting effort designed to monopolize the law of nature itself,” but sort of held on other grounds, namely a grounds based more on public policy (citing the Benson case): there is a “concern that patent law not inhibit further discovery by improperly tying up the future laws of nature.”  In the first respect, my position is similar to that of the Court: Prometheus highlights more of a drafting problem – not a subject matter problem.  The exclusivity vs. innovation debate has always been the center of the patent system, so the Court broke no new grounds in public policy.  The claims at the center of the decision needed no intervention on the part of the Supreme Court to be rejected, but needed to be invalidated nonetheless.  However, the fact that the Court chose to hear the case means that they determined that there were issues beyond drafting errors for which they felt needed to be addressed.  The efforts of the Court to force the biotech industry to tighten up their claim language to not include products of nature are needed, as evidenced by the issuance of the two Prometheus patents considered by the Court.

The decision in Prometheus centered on the particular claim language, not on biotech patents in general, as addressed by Justice Breyer: “The laws of nature at issue here are narrow laws that may have limited applications, but the patent claims that embody them nonetheless implicate this concern. They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe.”  (Emphasis added). Justice Breyer then states, “[t]he “determining” step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.”  Thus, the folks that are giddy about the possible Supreme Court overturn of all biotech patents based on the narrow confines of this decision are likely to be disappointed.

(Note: during the drafting of this post, the Supreme Court granted Cert. in the Myriad case and remanded the case back to the Federal Circuit to reconsider the case based upon the Prometheus decision.  566 U.S. __, 11-725, March 26, 2012)


About the Author

Mary Beth Tung, Ph.D. is a Registered Patent Attorney and handles intellectual property and related corporate and business matters for the Columbia, Maryland law firm, Davis Agnor Rapaport & Skalny, LLC. Mary’s patent practice includes biotech, pharmaceutical, and IT technology matters. As a former Biotechnology Patent Examiner at the U.S. Patent and Trademark Office, Mary examined patents related to immunology, autoimmune disease, diagnostics, and recombinant technologies.

In addition to her legal experience, Mary was an Assistant Professor at the University of Rochester’s School of Medicine and a Postdoctoral Associate at Yale University School of Medicine in the fields of cancer and anti-virus pharmacology. She is a member of the Maryland bar, a member of the Maryland State Bar Association and the American Intellectual Property Law Association. Mary is a graduate of the University of Maryland School of Law.

16 comments
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  1. Mary,

    Thanks for offering a different perspective on Mayo Collaborative Services. But I must respectfully disagree with your view that there being “no worries, no problems” with this decision. This case represents a potential debacle for any rational or objective determination of patent-eligibility of methods under 35 USC 101. I’ve said as much in my articles posted on this blog, as well as comments also posted on this blog.

    My “worry” starts with the followng from your article: “The “wherein” clause is considered by the Court as a separate method step.” Think about what that says: Breyer’s opinion characterizes the “wherein clauses” as a “step.” Any beginning prosecuting patent attorney or agent would understand that characterizing “wherein clauses” as a “step” is nonsense. When you can’t even correctly characterize basic claim terminology correctly, why are you surprised that patent law practitioners go ballistic, and have no respect for Breyer’s reasoning? And If Breyer can’t get the basic patent claim facts right, is it any wonder that the reasoning he provides won’t be accepted by patent law practitioners, notwithstanding the further disingenuous and nonsensical characterizaton of what that patent law is?

    As I also pointed out in my comments, what is also very unfortunate is that Breyer could have had his “cake,” and even gotten us patent practitioner’s (at least most of us) to “eat it” too if he had used the basic patent claim terminology correctly and had framed the applicable patent law issue appropriately. Characterizing Prometheus’ claimed method as not much more than patenting a “law of nature” was the absolutely worst way to go. As the late Chief Judge Markey basically said many years ago, every invention, be it composition, article, machine, or method/process is made up of elements and/or steps derived from “nature,” “laws of nature,” and/or “natural phenomena.” Going down the “law of nature” path suggested by Breyer eventually leads to a logical “cul-de-sac” from which you cannot escape.

    Even more alarming is the complete mishandling of binding precedent in Diehr. What Mayo Collaborative Services does repeatedly is what Diehr says in a paragraph I’ve quoted should not be done in an analysis of claimed methods under 35 USC 101. In fact, as another commenter (Anon) has astutely observed, what we now have is two different precedents that say the exact opposite on the same patent-eligibility issue. The litigators may enjoy having that choice, but it’s a potential recipe for utter precential “disaster” as we go forward with determining patent-eligibility under 35 USC 101 in further cases.

    Instead, Breyer could have gone down the path of Bilski and said that Prometheus’ claimed method is nothing more than an “abstraction” because it does’t achieve a “useful result” (i.e., simply providing numerical ranges of what dosages are too high or too low isn’t enough to reach the patent-eligibility zone). Even better, Breyer could have pointed to related U.S. Pat No. 6,987,097, and particularly Claims 1 and 13, and said “that’s what I mean by a ‘useful result’ that is more than an abstraction.” Prometheus would have been unhappy, and there might have been some grumbling by some patent practitioners, but such reasoning would have been accepted by the patent law bar at large (me included), and would have also given us meaningful guidance on how to craft method and process claims to reach the patent-eligibility zone. What could have been, but wasn’t.

    All is no lost either for I do see potential “light” in the currently “dark” patent-eligibility tunnel. That “light” and the way forward out of this Mayo Collaborative Services debacle is through the Classen Immunotherapies remand decision. Judge Newman’s opinion (joined by Chief Judge Rader) very astutely (and presciently) points to the “immunization step” in two of the patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the claims in the other ’283 patent missing this step did not. And Newman’s opinion primarily relies upon a legal basis other than the Federal Circuit’s “transformative” step reasoning that was reversed in Mayo Collaborative Services. (Judge Lourie’s convoluted “transformative” step reasoning has always bothered me.) I’ve written an article to discuss this path forward that should be posted soon on IPWatchdog. So stay tuned (and thanks again for offering a different perspective).

  2. Mary,

    With due respect (and BTW I’m no biotech guy), I don’t see how “determining” can be a purely mental step.

    Don’t you have to draw blood?

    And then run it through a physical analysis machine that is a particular machine for detecting concentration of a specific (particular) metabolite?

    Don’t tell me you can just sit in an ivory tower, imagine a specific patient in your head and then imagine what his or here metabolite concentrations are. That cannot be how one of ordinary skill would read the word “determining”

    sign me as –Confused

  3. Hat tip to Hansen IP blog for putting this up on the web:

    http://hanseniplaw.com/wp-content/uploads/downloads/2012/03/US6355623.pdf

    See for example, col. 2, line 40

  4. SB,

    Yep, the patent posted by Steven Hansen shows the way forward to rationality and sanity for patent-eligibility under 35 USC 101. And is the one I mentioned in my comment on this thread. If only Breyer would have looked at it . . . .

  5. If only Breyer would have looked at it . . . .

    Yeah, but all those chemical structures in Fig. 1, why that’s just the draftsman’s gobbledygook and this Court won’t be fooled by those sly crafty patent scriveners and their claim drafting trickery. Never mind the words, the drawings, the spec; those are just confusing facts that hide the “real” truth, namely that there are certain “Laws of Nature” and this document, whatever else it means, merely explains to an audience, a basic “Law of Nature”.
    /sarcasm

  6. EG,

    One thing seems to be clear, the Mayo v. Promo decision seems to be bringing out of the wood-works all manner of people who claim to understand what they are talking about when they sound off with noise-bites like “science” and “law of nature”.

    Here is a sample:

    A scientifically-minded person would describe a natural law as something out of a physics textbook. A classic example would be the structure of an atom: a nucleus made out of protons and neutrons, surrounded by a cloud of electrons. …

    In plain English: whether or not a patient has the desired (not negative) reaction to a certain concentration of drug is both universal and natural. A test to determine the concentration of a drug in order to determine dosage just builds on that fact in a quantitative manner. Prometheus cannot patent such a test.

    What the … ? Do people actually think this way? Obviously yes.

    Source of the above sample is here:
    http://blog.liquidlitigation.com/2012/03/finding-balance-in-mayo-v-prometheus-ruling/
    but it is merely an example of many more similar understandings by others.
    (Sigh … decaying at standard rate raised to the 10th power.)

  7. “The “wherein” clause is considered by the Court as a separate method step. The administering step was dismissed by the Court as merely identifying the artisan who would practice the invention. The key step in the claim then, is the “determining” step.”

    So, accepting for the sake of argument that the determining step and the wherein clause embody a mental step and a law of nature, why does the administering step not make the claim patent eligible? Put another way, what if the claim had ONLY the administering step. Wouldn’t such a claim be clearly patent eligible? It would of course not be novel, but it should be patent eligible just like methods of treatment in general.

    Given this, how is it possible that ADDING limitiations turns a patent eligible process into a patent ineligible process. This makes no sense as a matter of patent law analysis, regardless of your views on the Prometheus claim. I think that this error is at the core of what is wrong with the Supreme Court’s patent eligibility jurisprudence–using the wrong tool for the job of invalidating claims that should not be patented.

  8. SB,

    Unfortunately, our patent world is starting to be ruled by the patent law uninformed and sometimes the scientific and technologically ignorant. First, the academic Lemley’s of the world, then certain portions of the scientific community that is patent law ignorant, as well hostile, next the ACLU who’ve decided patents are now a “first amendment” issue, finally the truly technologically-challenged and patent law-ignorant/hostile Supreme Court. In fact, the minute you, I, Gene, Anon, Blind Dogma, American Cowboy, Dale Hallng, or any other patent attorney dare to question the accuracy and/or informedness of the opinion expressed by one of these folks (and especially their patent law “credentials”), we’re immediately labeled and “demonized” as being indoctrinated, old school, biased, “greedy” (we’ve seen that one on this blog), self-serving, etc. I’m used to this sort of treatment from my days as a corporate patent attorney where we were viewed by the “real lawyers” as those “nerdy lawyers.” We just have to have a “thick intellectual skin,” push back as appropriate, and become more savvy about the PR game being played here.

  9. “So, accepting for the sake of argument that the determining step and the wherein clause embody a mental step and a law of nature, why does the administering step not make the claim patent eligible?”

    You bring up a very valid point about the “administering step,” one that my patent attorney brother Mark has raised. In fact, and this is yet another of the amazng inconsistencies in Breyer’s opinion, First, Breyer mischaracterizes what that “administering step” actually does (“simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs”). Breyer later says the following: “Unlike, say, atypical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.” A “new way of using an existing drug” is usually phrased in a method claim as “administering” that drug to treat a new disease state. Go figure.

    I would also be careful about characterizing the “determining step” and “wherein clauses” as either “mental steps” or a “law of nature.” Regarding the “mental step” issue, much has been said that Prometheus’ claimed method “patents thought.” When read correctly (and in its entirety as Diehr says correctly you should do), it does not because that would ignore the “administering step” and “determining step” (metabolite levels can’t be measured in someone’s “mind”). I know there’s been much said that Prometheus argued at trial that the doctor simply thinking about the result of the metabolite levels would infringe Prometheus’ claimed method. If Prometheus argued that, I’ll go on record as saying they were absolutely incorrect (and ill-advised) to take that position. Besides, this whole thing about doctor’s being impeded from “thinking’ or treating their patients is a complete canard (falsehood). 35 USC 287(c) makes such activites taken by the doctor absolutely immune from infringement. Do you sense some disingenuousness being perpetrated here by the Mayo, the amici who suggested this “doctor’s thought is being impeded” proposition, as well as Breyer’s opinion?

    As I’ve also said elsewhere, the “law of nature” path is the absolute worst way to go and it isn’t even technically accurate to characterize Prometheus’s claimed method (or any step of it) as simply embodying a law of nature. What we have Prometheus’ claimed method is a man-made drug being administered with the metabolites generated being measured (determined) by humans (using human-made instruments), and with human-based evaluations/judgments being made that comprise the ranges recited in the wherein clauses. Even more significantly, as the late Chief Judge Markey basically said, every composition, article, machine, or method/process is based on elements and/or steps derived from “nature,” “laws of nature,” or “natural phenomena.” Going down the “law of nature” pathway eventually leads to a logical “cul-de-sac” from which you cannot escape (what we call in latin-legalspeak a “reducto absurdum”).

    Instead, Breyer could have had his “cake,” and even gotten us patent practitioner’s (at least most of us) to “eat it” too if he had framed the applicable patent law issue more appropriately. He could have (and should have) gone down the path of Bilski and said that Prometheus’ claimed method is nothing more than an “abstraction” because it does’t achieve a “useful result,” i.e., simply providing numerical ranges of what dosages are too high or too low isn’t enough to reach the patent-eligibility zone). Breyer (sorf of) goes down this path (but unfortunately incompletely) when he characterized Prometheus’ claimed method as “simply [telling] doctors to apply the law somehow when treating their patients. Even better, Breyer could have pointed to related U.S. Pat No. 6,987,097, and particularly Claims 1 and 13, and said “that’s what I mean by a ‘useful result’ that is more than an abstraction.” Prometheus would have been unhappy, and there might have been some grumbling by some patent practitioners, but such reasoning would have been accepted by the patent law bar at large (me included), and would have also given us meaningful guidance on how to craft method and process claims to reach the patent-eligibility zone.and as I’ve said elsewhere, Oh what could have been which would have avoided this utter debacle that the Mayo Collaborative Services decision is, including now leaving us “mere mortals” with two different lines of precedent (the other being Diehr) which are diametrically opposed and essentially irreconciable in terms of their approach to patent-eligibility issues (and I’ll also go on record as saying that the Diehr approach is the correct one).

  10. @EG and stepback,

    “What we have Prometheus’ claimed method is a man-made drug being administered with the metabolites generated being measured (determined) by humans (using human-made instruments), and with human-based evaluations/judgments being made that comprise the ranges recited in the wherein clauses.”

    and:

    Don’t you have to draw blood?

    And then run it through a physical analysis machine that is a particular machine for detecting concentration of a specific (particular) metabolite?

    But that is not what the claim recited. The claim didn’t recite instruments, ranges or any method of measurement. What is “determining?” In the broadest possible interpretation, it is a mental step – which is non-patentable subject matter. And what do you do with the measurements? Think about them? The whole claim rests on a non-patentable step under 101. IHMO. We all know what is supposed to take place under this claim, but in an effort to gain breadth, the drafter chose not to include any concrete steps and took the claim out of the patentable into 101 territory. There really are no steps in this claim, other than the first administering step. (And I do not believe the administering step merely identifies the artisan – I am really not sure where J. Breyer devined that one!).

    Just to set the record straight as to my background – I am not part of a “PR game being played here.” This is my subject matter – I did research in it, I examined it and I now write patents in this area. I am not “anti-patent” or “anti-biotech.” Far from it. If we are going to stand our ground on biotech patentability, this is not the case to do it. Myriad is where we need to concentrate our efforts – it is clear what the purpose of the ACLU and the justice department would like to do with their “magic microscopes on that one!”

    I would respectfully rather stick to legal arguments.

    @Bob Hodges,

    “what if the claim had ONLY the administering step. Wouldn’t such a claim be clearly patent eligible?” No – based on what? administering a drug to do what? Treatement? Experiment? Recreational? How much? An administering claim can be anything. There would certainly be 112 first issues – scope, enablement, written description, but what comes after the claim would be important in terms of 101. A good point is brought up here – for the sake of argument, if one step of the claim – “determining” is non-statutory subject matter, would the rest of the claim be non-statutory? My position is…. “it depends.” It depends on the claim taken as a whole. The Prometheus claim taken as a whole is a mental process and this is non-statutory.

  11. EG,

    Let me respectfully submit to you that your emotional rage over the senselessness of the MvP decision (and I share your angst) is blinding you and others here to some basic fundamentals of claim construction.

    The word “determining” cannot be construed to mean any and every possible definition of that word taken in a vacuum (including for example, using a Ouija Board to “determine” whether your deceased Aunt Annie approves of your new girl friend).

    Instead per well established cannons of claim interpretation, the term’s meaning should be derived from the view point of one of ordinary skill in that art while taking all the other words in the claim into consideration as well as the rest of the patent application’s disclosure because the claims are an integral and inseparable part of the specification that “concludes” with said claims. (See 35 USC 112.)

    Moreover, unlike claim construction during prosecution before the USPTO, the broadest reasonable standard for interpretation does not apply and instead interpretation should be driven so as to preserve the patentability of the already issued claims. That is what is done in most litigations.

    But then again such claim construction rules apply only to the “little people”.
    The Supremes are above such low level and mundane ponderings.
    Given their supreme wisdom, they are stepping back to contemplate and see the “Big Picture”.
    (end of sarcastic last paragraph)

  12. @MBT
    Our posts crossed paths in the rush of the electronic dawn.

    No, not broadest interpretation, but rather “reasonable” and in light of the specification, (See my post above) ;-)

  13. SB,

    You’re correct that I still do have some “emotional rage” over Mayo Collaborative Services. But I am trying to not to let it blind me. Do check out my most recent article just posted on this blog for logical way out of this Mayo Collaborative Services debacle that certanly isn’t blinded by “emotional rage,” and which should apply to more than us “mere mortals.”

    MBT,

    We’re probably closer in agreement than your comment might suggest we are, at least to me. In fact, what you propose for Prometheus’ claimed method is what they appeared to have done in their European which was allowed. Also, Claims 1 and 13 of their ’097 patent that I’ve noted and Steve Hansen kindly pointed out should pass muster under 35 USC 101; if they don’t, we’re really in for a patent-eligibiltiy “nightmare.”

  14. EG – I just posted a comment on your Classen post where I agreed with you! :) I do think we are all really in agreement, as you said in that post – as to the result – these claims should have been thrown out for many reasons – but the devil is in the details as to what guidance the Court gave us – which again, I must agree with you – what they gave us wasn’t much and in fact probably set things back a bit. Notice, I spoke more about the effect on business, not dissecting the case in general, which you folks have been capably doing…. I think we’ll go through a period of confusion and adjustment – ok a LONG period of confusion, and then we’ll all draft around the problem – as you said they already did in Europe – and life goes on. Myriad scares me a lot more. And that is for a later post…

  15. MBT wrote:

    “what if the claim had ONLY the administering step. Wouldn’t such a claim be clearly patent eligible?” No – based on what? administering a drug to do what? Treatement? Experiment? Recreational? How much? An administering claim can be anything. There would certainly be 112 first issues – scope, enablement, written description, but what comes after the claim would be important in terms of 101. A good point is brought up here – for the sake of argument, if one step of the claim – “determining” is non-statutory subject matter, would the rest of the claim be non-statutory? My position is…. “it depends.” It depends on the claim taken as a whole. The Prometheus claim taken as a whole is a mental process and this is this is non-statutory.

    I think the above is really the most interesting and important set of issues that should have been resolved by the Court in Prometheus. In fact, when I first reviewed claim 1, I thought it was clearly patent ineligible under Section 101, because its last step was a “determining” step with no useful result. But now I’m less sure that Claim 1 should have been invalidated on 101 grounds, given that it does have a step of administering a drug to an individual which probably produces a useful result. I think there are a bunch of other reasons why Claim 1 should have been invalidated, but the real 101 issue is more complicated than I originally thought and is not addressed at all by the Supreme Court’s opinion. Which is a real shame.

    The nine justices of the Supreme Court really failed to do their jobs at even the most minimal level of competence in the Prometheus opinion. As others and I have pointed out, they didn’t even analyze the claim properly at a very basic level. Furthermore, Breyer seemed determined to apply his personal “natural law” theories of patent law to a case and a claim in which natural law is at most, a minor issue.

    Mark

  16. ‘Natural law’? How could you claim a ‘natural law’? Natural laws are universal, thus inherently lack novelty. What you can claim is specific novel applications of a natural law (new or old). What the Court didn’t understand was that S101 already prohibits patenting ‘natural laws’ – it doesn’t require any further judicial fiat.

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