Patent Eligibility of Diagnostic Tools: Utility as the Key to Unlocking Section 101

By N. Scott Pierce
October 27, 2019

“Long before eligibility, novelty, and obviousness were distinct provisions under any patent act, broad preemption on one hand and bare novelty on the other were dueling concerns in patent law, and the jurisprudence surrounding notions of utility resolved the conflict.”

A petition for certiorari was filed on October 1 in the case of Athena Diagnostics v. Mayo Collaborative Services asking the question:

Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

unlock-Depositphotos_66997577_xl-2015 copyThe claims at issue are directed to a “method for diagnosing neurotransmission or developmental disorders related to [MuSK] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK],” and includes several steps that involve labeling the MuSK, such as by iodinization, “immunoprecipitating a…complex,” and ultimately “monitoring” for the label, the “presence” of which is “indicative … that said mammal is suffering from said neurotransmitter or developmental disorder related to [MuSK]” [Athena Diagnostics, Inc. et al. v. Mayo Collaborative Services, LLC, 915 F.3d 743 (Fed. Cir. 2019); reh’g and reh’g en banc denied, 927 F.3d 1333 (Fed. Cir. 2019), petition for cert. filed (U.S. October 1, 2019) (No. 19-430)]. The developmental disorder is Myasthenia gravis (MG), an autoimmune disease that causes muscular weakness.

Benefit as a Policy Argument

As suggested by the question posed to the Supreme Court, the petitioners rely on the fact that the labeled MuSK does not occur in nature, is novel, and is employed in specific steps. As a consequence, according to the petitioners, the claimed methods are “not ‘directed to’ a natural law.”  Rather, “they are directed to a particular chemical process for detecting a previously unused biomarker and diagnosing illness.” For the petitioners, the novelty of the labeled components employed and the specificity of the steps in the method set the “patent claims here … a world apart from the claims invalidated in Mayo.” Athena’s position is supported by Judge Stoll’s dissent to the denial for rehearing where she stated that “[c]ertain diagnostic claims, such as the ones at issue in this case, are so narrowly tailored that preemption is not a reasonable concern.” Accordingly, if, in the two-step test for eligibility promulgated in Alice Corp. v. CLS Bank International [134 S. Ct. 2347, 573 U.S. 208 (2014)] the claims are sufficiently narrow to not be “directed to” one of the exceptions to patent eligibility, then the second and, in this case, potentially more problematic step of identifying the presence of “invention” is effectively mooted, at least with respect to patent eligibility.

The petitioners hinge their argument throughout the brief on the novel beneficial utility of their claimed method, relying heavily on recitals in the eight concurring and dissenting opinions that accompanied the denial of rehearing and rehearing en banc by the Court of Appeals for the Federal Circuit. Summarizing, the petitioners conclude that the “members of the en banc Federal Circuit agreed with Athena that sufficiently specific diagnostic methods with proven utility like the ones here should be patent eligible.” As stated by the petitioners, “[n]umerous government officials, practitioners, and scholars have echoed and amplified the message that the law of patent-eligible subject matter is in a state of turmoil and there is no more important question.”

However, benefit has not always carried the day in recent eligibility analyses. For example, the Supreme Court stated in Ass’n for Molecular Pathology v. Myriad Genetics, Inc. [133 S. Ct. 2107, 2117 (2013)] with respect to isolated genes, that “Myriad did not create anything. To be sure, it found an important and useful gene, but separating the gene from its surrounding genetic material is not an act of invention.”  Moreover, benefit as a policy argument can fall on deaf ears given the refrain in Funk Bros. Seed Co. v. Kalo Inoculant Co. [333 U.S. 127,132 (1948)] that “the application of this newly-discovered natural principle…may well have been an important commercial advance…. But once nature’s secret…was discovered, the state of the art made…production…a simple step. Even though it may have been the product of skill, it certainly was not the product of invention.”  The Court in Myriad, relying on Funk Bros., concluded that “[g]round breaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”  In other words, “preemption” as mentioned by petitioners, is “‘the concern that drives,’ the judicially-created exceptions to Section 101,” and often has overridden the significance of benefits provided by advancements in technology, such as in the field of diagnostics.

Unlocking Eligibility with Utility

Nevertheless, and ironically, Athena v. Mayo may provide the vehicle for revamping the “unending chaos” and “mess” that is the current state of patent eligibility. The benefits recited by the petitioners and unanimously echoed by the judges are not just policy arguments; they reflect a view of eligibility and non-obviousness that is rooted in precedent and which obviates the crippling effects of preemption doctrine. That precedent is the jurisprudence of “utility,” and provides the long-overlooked key to unlocking eligibility by bridging patent eligibility and patentable distinction.

As a preliminary matter, one must remember that patent eligibility has been linked to what we now consider to be “preemption” since the 18th century cases of Boulton and Watt v. Bull [(1795) 126 Eng. Rep. 651 (C.P.); 2 H. Bl. 463] and Hornblower and Mayberly v. Boulton and Watt [(1799) 101 Eng. Rep. 1285 (K.B.); 8 T.R. 95]. Watt’s improved steam engine arguably was simply a different manner of using the well-known Newcomen engine (by condensing steam in a separate cylinder from that used for the power stroke). Lord Chief Justice Eyre famously stated in Boulton v. Bull that “principle alone [cannot] be the foundation of a patent.”  It is also important to understand that utility has been directly linked to the classes of invention eligible for patent protection since the first patent act in this country, enacted in 1790.  Aptly entitled, “An Act to promote the progress of useful Arts,” the 1790 act provided protection for “any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used” [Patent Act of 1790, ch. 7, 1 Stat. 109-12 (Apr. 10, 1790) (repealed 1793) (current version at 35 U.S.C. § 101 (2013) (emphasis added)]. The key is this: long before eligibility, novelty, and obviousness were distinct provisions under any patent act, broad preemption on one hand and bare novelty on the other were dueling concerns in patent law, and the jurisprudence surrounding notions of utility resolved the conflict. The historical role of utility in eligibility and patentable distinction obviates the problem of “preemption” and the current two-step prescription dictated by the Supreme Court in Mayo, Alice, and Myriad.

Positive and Comparative Utility Doctrines

Utility, as a concept, split during the nineteenth century into “positive utility,” which is now embraced in 35 U.S.C. § 101, and “comparative utility,” which was a test for a “substantial difference of structure or mode of operation” that would indicate patentable distinction [G. T. Curtis, A Treatise on the Law of patents for Useful Inventions (Little, Brown and Co., 4th ed., 1873) [hereinafter Curtis I]  at 110)]. “Positive utility” required only a “description of a class of inventions which can be the subject of valid patents.”  Under 35 U.S.C. § 101, “utility” has, of course, been overlaid with additional considerations by imposing “specific,” “substantial,” and “currently available” (or credible) criteria. [See, Brenner v. Manson, 383 U.S. 519 (1966)].The term “useful,” in the sense of “positive utility” under 35 U.S.C. § 101, however, has never included a test for “invention.”

“Comparative utility,” also referred to as “substantial novelty,” on the other hand, was an early test for invention beyond bare novelty of the eligible subject matter of the invention. The test for “comparative utility” was based on the statutory language of the 1790 act of “sufficiently useful and important,” and the 1793 act of “an improvement in the principle of a machine, or in the process of any composition of matter.”  “Comparative utility” required, at least implicitly, a “substantial difference of structure or mode of operation” that would be “useful and important” or “an improvement in the principle…or process” relative to what was known in the art. In short, to be an “invention,” comparative utility mandated a benefit over subject matter that is already in the public domain.

Echoes of that early test of invention still ring familiar to patent practitioners, such as the adage that, “provided the invention is substantially new, it is or no consequence whether a great or small amount of thought, ingenuity, skill, labor, or experiment has been expended, or whether it was discovered by accident” (G. T. Curtis, Treatise of the Law of Patents for Useful Inventions in the United States of America, Charles C. Little and James Brown, 1849 [Hereinafter Curtis II] at 5.) This language, of course, is reflected in the last paragraph of 35 U.S.C. 103, which reads: “Patentability shall not be negatived by the manner in which the invention was made.”

G.T. Curtis, an early commentator, inverted this reasoning as a corollary:

Still it is sometimes necessary to ascertain what bearing the amount of thought, design, or ingenuity that may have been expended, has upon the question of novelty. It may not be necessary that there should be positive evidence of design, thought, or ingenuity; but if it is necessary that the possibility of these qualities having been exercised should not be excluded by the character of the supposed invention, then such possibility becomes one test of the sufficiency of invention. [Curtis II, supra note 27, at 6.]

In essence, for the purpose of patentable distinction, the possibility of “design, thought, or ingenuity…becomes one test of the sufficiency of invention.”  The extension of this corollary being that, as stated by Curtis, because “a patent should be something that has not substantially existed before,” the lack of possibility of design or study in the “production” of an “alleged invention” is “proof” of “frivolousness.”

Utility v. Preemption

This basic distinction between “positive” and “comparative” utility is at the core of modern patent jurisprudence. While the fundamental exceptions to patent protection, namely laws of nature, naturally-occurring phenomena, and abstract ideas continued in American jurisprudence, they manifested themselves in the doctrines of new use and aggregation, which became defunct in the face of separate statutory provisions for novelty and non-obviousness introduced in the Patent Act of 1952.  With the new act, not only the notion of “invention,” but also the significance of the exceptions to patentability were placed under considerations of statutory novelty and non-obviousness.  As stated by Judge Learned Hand, for example, in Lyon v. Bausch & Lomb Optical shortly after passage of the 1952 Patent Act, the “definition of invention…[is]…now expressly embodied in § 103.” [224 F.2d 530, 550 (2d Cir. 1955)].  It wasn’t until the 1976 case of Gottschalk v. Benson (409 U.S. 63 [1972]) that confusion began to insert itself again by allowing overlap of criteria among the three statutory provisions of eligibility (101), novelty (102), and non-obviousness (103) in the form of “preemption.” By this reasoning, if “preemption,” as a doctrine, can be barred as a consideration in patent eligibility, thereby again limiting issues of laws of nature, naturally-occurring phenomena, and abstract ideas, as well as that of “invention” to statutory novelty and non-obviousness, then problems of patent eligibility, such as those presented in Athena v. Mayo, should fade.

In Athena v. Mayo, for example, by eliminating preemption as a consideration, Athena’s method claim for diagnosing neurotransmission or developmental disorders related to MuSK in a mammal would clearly meet the test for “positive utility” in that it is a “process” and, therefore, among the classes of invention which can be the subject of a valid patent. We will presume that the overlay of “specific,” “substantial,” and “credible” under Brenner v. Manson is also met and that, therefore, the only remaining criteria are novelty and non-obviousness under 35 U.S.C. §§ 102 and 103, respectively. Is the process novel? Yes, not simply because of the novelty of the labeled compound and intermediate complexes that form as a result of the claimed method, but also in the manipulative steps taken to enable the observation that, as discovered by the inventors, is indicative of a condition that could not be positively determined prior to existence of the claimed method. In other words, the method is a novel combination of steps that was conceived by the inventors as a consequence of a discovery made by those inventors. The method, being novel, does not preempt anything.

That being said, the remaining test would be that of non-obviousness and, using the alternative view of utility, comparative utility, the question is no longer one of whether the labeled compound is itself novel (since the compound itself is not being claimed as such). Nor is the question whether, having made the discovery of the association between MuSK autoantibodies and MG, that discovery is inventive in and of itself, but instead whether the claimed method allows for the possibility of “design, thought, or ingenuity….”  Again, Athena’s claimed method clearly does. Proof of this can be seen by considering the extension to Curtis’ corollary in that, if the claimed method did not permit the possibility of “design, thought, or ingenuity,” it would, by definition, have to be a combination of elements that is random. Combinations of elements, such as method steps, that are random must be frivolous. If they are not, then they must, at least conceptually, admit the possibility of “design, thought, or ingenuity.” Athena’s diagnostic method is not only useful, but has a novel benefit linked to the novelty of the combined steps. A novel benefit is evidence that, not only is Athena’s method not random, and therefore not “frivolous,” but also that it represents an improvement in principle or process that clearly would have met the earlier standard of “substantial novelty.” By this test, Athena’s diagnostic method is not only eligible and novel, but also patentably distinct.

Application Beyond Athena

This test applies not only to diagnostics, which seem to have confounded the Federal Circuit under the current two-step analysis articulated in Alice, but also to other areas. While exemplification of all possibilities is not possible here, one example would be the patentability of isolated genes, which are now barred from patentability under Myriad. Specifically, genes are nucleic acids composed of sequences of nucleotides. Sequences of nucleotides that encode functional proteins are not random, regardless of whatever evolutionary process resulted in each particular sequence. Genes, of course, occur in nature, but not in isolation. Isolated genes can have benefits that genes in their native environment do not. Although the entire genome of an animal can be mapped, such as has been done for humans, the function of any given gene making up that genome may not have been determined. Identification of the function of a gene, and determination of a beneficial use specific for that gene in isolation, means that the isolated sequence of nucleotides could be the product of “design, thought or ingenuity” and, therefore, would not be random. If the gene is novel in isolated form, it constitutes a “composition” that is new and useful within the meaning of 35 U.S.C. § 101.  It is also novel within the meaning of 35 U.S.C. § 102 and meets the criteria of non-obviousness under 35 U.S.C. § 103, at least from the point of view of “comparative utility.”

Application of concepts like “positive utility” and “comparative utility” may seem hopelessly anachronistic, but they have never been overturned or supplanted. Specifically, while “utility” as a doctrine has been overlaid with the criteria of “specific,” “substantial,” and “credible,” as mentioned above, the basic notion persists that “positive utility” under 35 U.S.C. § 101 ascribes membership among the enumerated categories of eligible subject matter. Likewise, the idea that patentable distinction extends beyond bare novelty to “comparative utility” also continues, although it too has been overlaid. Specifically, modern notions of criteria for patentable distinction now include possession of  “skill and ingenuity” beyond that of “an ordinary mechanic acquainted with the business,” which was introduced by the Supreme Court Hotchkiss v. Greenwood [52 U.S. (11 How.) 248 (1850)], and “obviousness,” a term that was considered by Judge Rich, one of the coauthors of the 1952 Patent Act, to be a “codification…and revision” of the judicial “invention” requirement.

Back to Basics

Patent eligibility, considered to be the most important question facing the patent system, poses insidious problems under current jurisprudence to some of the most beneficial cutting-edge technology available today. What is most curious, and the point here, is that this problem apparently can be solved simply by reaching back to the foundations of modern patent law and the underlying requirement that inventions be “useful,” a term that has been baked into the statutory provisions since the first patent act.

Image Source: Deposit Photos
Image ID: 66997577
Copyright: Sashkin7 

The Author

N. Scott Pierce

N. Scott Pierce is a partner at Foley Hoag LLP in Boston and an Adjunct Professor at Suffolk University School of Law. The opinions expressed herein are those of the author alone and do not necessarily represent those of his firm or any client of the firm.

For more information or to contact Mr. Pierce, please visit his Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 26 Comments comments. Join the discussion.

  1. Mark S Nowotarski October 27, 2019 1:32 pm

    Thanks for the great analysis. I always find it instructive to go back to the origins of patent law and view how they wrestled with very much the same problems we face today.

  2. TFCFM October 28, 2019 10:25 am

    Although Mr. Pierce’s is a noble (if wordy) effort, I think it misses the fundamental point that wishing away preemption* is unlikely to convince judges or Justices to ignore the preemption that patenting of a fundamental law of nature would cause.

    (* Mr. Pierce’s formulation: “In Athena v. Mayo, for example, by eliminating preemption as a consideration, Athena’s method claim for diagnosing neurotransmission or developmental disorders related to MuSK in a mammal would clearly meet the test for “positive utility”…)

    The patentee here merely discovered the pre-existing, fundamental natural law that occurrence of autoantibodies to MuSK is associated with one or more disorders (even the patentee seems uncertain which, beyond the few specified). This was so before the patentee discovered the law, it’s true now, and it will be true until and unless evolution “fixes” this defect in human organisms.

    Having discovered this association, any even-minimally-skilled molecular biologist can assay auto-antibodies to MuSK (or to any other “self” protein).

    The patentees claim obvious ways to detect MuSK auto-antibodies, and merely claim them in light of the new motivation to detect them (i.e., that the patentee has discovered a pre-existing association between them and one or more diseases).

    “Utility” is, simply put, not the issue. The claimed invention is clearly useful (and I don’t believe anyone involved in the matter disputes that.)

    The issue is, instead, whether discovery of a pre-existing natural law (that one or more of the diseases is associated with occurrence of a molecule) justifies patenting of one (or all) obvious methods of detecting that molecule (whether or not coupled with “thinking something” after performing the detection method).

  3. Anon October 28, 2019 11:03 am

    TFCFM,

    From a Congress-empowered and written statutory basis, what is your view of the writings of Sherry Knowles (for example, https://www.ipwatchdog.com/2019/01/16/sherry-knowles-scrutinizes-activist-supreme-court-unconstitutional-patent-eligibility/id=105228/ )…?

  4. Anon October 28, 2019 11:08 am

    TFCFM,

    Different author, but large overlap in viewpoint (and simple PowerPoint presentation to follow along):

    https://www.ipwatchdog.com/wp-content/uploads/2017/05/IIPCC-WDC-May-8th-2017-Professor-Lefstin-presentation.pdf

  5. EG October 28, 2019 11:37 am

    “Having discovered this association, any even-minimally-skilled molecular biologist can assay auto-antibodies to MuSK (or to any other “self” protein).”

    But that “discovery” is the whole point of why Athena Diagnostic’s method is unobvious, TCFCM. Are you going to suggest, as SCOTUS has improperly done, that the word “discovers” is not part of Section 101?

  6. concerned October 28, 2019 11:38 am

    Preemption is not the reality in my world. The only aim by the USPTO is to reject using any means.

    We argued lack of preemption. No counter response of preemption in the examiner’s response to our appeal. We were not preempting the routine and correct processing of Social Security benefits, my claims only kick in when mistakes and oversights occur by working professionals and/or family members in the application process. Our process and claims are crystal clear. Another convenient dodge by the examiner, like the many other dodges.

    I have 2 questions that I like to ask, none have received a response other than an opinion that was contrary to law as readily admitted by the person. A third question would be: Can a claim have preemption if it is correcting reoccurring human error?

    In addition, my claims were deemed abstract. That is too sad to be funny. With the hundreds of thousands of working professionals and experts come hundreds of thousands of brains, one brain for each persons. If mistakes by experts and professionals could be corrected or avoided via a mental process, there would be no oversights as there would be no auto accidents, no plane crashes, no human error, etc. We would just wish those tragic events away.

    It is understandable that authors, such as the one who wrote this article, want to share a new theory to save the patent day. Unfortunately, clarifying court decisions is not the apparent goal, hence all of the denied “certs” by SCOTUS.

  7. Mark Nowotarski October 28, 2019 1:08 pm

    TFCFM @2

    “The issue is, instead, whether discovery of a pre-existing natural law (that one or more of the diseases is associated with occurrence of a molecule)…”

    I think one area where the judiciary has overreached is in the characterization of a discovery that a particular disease is associated with the occurrence of a particular molecule is a natural law. Natural laws, such as conservation of mass, are universal truths. They are not discovered. They are deduced and then tested to determine if they are true in all situations.

    A discovery of a disease marker, however, is specific. There is no known way to determine it from a natural law. They require work and investment.

    Discoveries, in my opinion, when applied to a useful end, should be patentable. It shouldn’t matter if the method of applying the discovery is known or not. The invention is in the discovery. The justification for patent protection is the encouragement of future searches for new discoveries that can be applied to useful ends.

  8. TFCFM October 29, 2019 11:38 am

    MN: “I think one area where the judiciary has overreached is in the characterization of a discovery that a particular disease is associated with the occurrence of a particular molecule is a natural law. Natural laws, such as conservation of mass, are universal truths. They are not discovered. They are deduced and then tested to determine if they are true in all situations.

    ???

    That a disease state is associated with condition X (e.g., production or change of a marker) seems to me no less a “universal truth” than conservation of mass. In each case, the “truth” is true and is discovered, whether through reasoning or screening (each of which requires deduction and testing before determining that “truth” has been discovered).

    Applying the view (from Chakrabarty) that patents ought to be offered for “anything under the sun that is made by man,” neither the truth of conservation of mass nor the truth of association of disease X with indicator Y ought to be patentable, because neither is “made by man.”

    A claim to a method of detecting indicator Y is no more (or less) inventive *after* the truth of Y’s association with disease X than the same method *before* that association is learnt to be true. (And the association itself is, of course, unchanged by its discovery).

    To the extent someone has discovered/invented a new, non-obvious method of detecting Y, that method should clearly be patentable. However, it seems to me that the step of thinking “Y means disease X” does not yield a separately-patentable method.

    This seems to be in accord with the Federal Circuit’s views (and perhaps the Supreme Court’s, but who can tell?), in that eligibility is found lacking when a method includes nothing inventive beyond “thinking Y means disease X,” while methods that include more (e.g., 1. detect Y 2. Think “Y means X” 3. Do something to treat X) are considered eligible.

    This seems correct to me:

    a) new Y-detection method seems clearly patent-worthy;

    b) old (non-patentable) Y-detection method + “think ___” seems not to be patent-worthy, in that mental steps are not patentable subject matter;

    c) new-or-old Y-detection method + think “disease” (non-eligible mental step) + do something useful, like treat disease also seems patent-worthy, assuming linkage of the Y-detection method with the something-useful method did not previously exist.

  9. Anon October 29, 2019 12:13 pm

    TFCFM,

    Any engagement on posts 3 and 4…?

    (I do not think that taking the Supreme Court view — even in Chakrabarty — avails you in a “words of Congress” if you are not going to take the words of Congress into account as to Discovery)

  10. TFCFM October 30, 2019 9:28 am

    Anon: “Any engagement on posts 3 and 4…?

    I haven’t read the material at either link and don’t plan to absent some good reason to do so. To the best of my knowledge, I’m not familiar with the writings/ideas of Ms. Knowles.

    If there’s some point you’d like to make, I’d prefer you identify the point, rather than posting links to who-knows-what.

  11. Anon October 30, 2019 12:48 pm

    and don’t plan to absent some good reason to do so.

    I would suppose understanding the law and an issue upon which you like to speak is good enough reason.

    Of course, this would take effort on your part (and probably more importantly, may take you actually engaging on an issue that is contrary to your typical narrative), so — like other times that you say that you are open to engage, but really have no inclination to do so — I will “set my expectations” accordingly.

  12. Anon October 30, 2019 12:58 pm

    TFCFM,

    Just realized that you had another excuse that should be called out as lame: the links are not “unrecognizable” links that one may hesitate to click through. Both are clearly links to IPWatchdog materials.

    It is also rather odd that you would prefer my paraphrase (to ‘get’ to the topic to be engaged) when you can obtain the direct point immediately. Seeing as your “game” has been largely one of dismissing anything that you do not agree with out of hand, I suppose that you might feel that it would be easier to dismiss my paraphrase than to dismiss the original source material.

    By this time, I should not be disappointed, but nonetheless, I was hoping for your views on the points enunciated at the links.

  13. Mark Nowotarski October 30, 2019 6:07 pm

    TFCFM @ 8

    I see your point, but I’m afraid I disagree. By your logic then instrumentation in general is not patentable. For example, suppose you discover that the intensity of infrared radiation is related to the temperature of an object. The only way to discover this is to already have an infrared detector. My position is that if your have made that discovery, you should be able to patent a method of measuring temperature by detecting infrared radiation, even if you use known infrared detectors. The reason I’m in favor of it is that it makes the risky investment worthwhile to find the relationship in the first place.

    I understand that your position and the Courts’ position is different because of preemption concern. I just happen to disagree.

  14. TFCFM October 31, 2019 9:55 am

    @ Anon: It’s really pretty simple. If you want to discuss an issue, raise the issue — don’t point to some web link and expect me to read whatever is there and to try to divine what issue you might be thinking you’d like to discuss.

  15. TFCFM October 31, 2019 10:25 am

    NM @#13: “For example, suppose you discover that the intensity of infrared radiation is related to the temperature of an object. The only way to discover this is to already have an infrared detector.

    I would have the same view of this example as I had of the one disputed in Athena Diagnostics. Namely:

    1) If all you have discovered/invented (the choice of word does not matter to me) is the naturally-occurring phenomenon that the intensity of IR radiation from a body corresponds to the temperature of the body, then the phenomenon alone ought not to be patent eligible.

    2) If an “old” (non-patentable) method can be employed to measure the phenomenon (e.g., an “old” IR detector), then a new method of “thinking about what an old IR measurement means” ought also not to be patentable (i.e., non-eligible natural phenomenon + non-patentable method + mental step).

    3) If something new, useful, and non-obvious is DONE WITH the newly-recognized correlation, however, that might yield a patentable method for the discoverer: For example, suppose you claim a method of using an IR detector as a temperature-sensor to set the level at which your spaceship’s air-cooling system operates. Assuming:
    – no one had previously used an IR detector for this purpose;
    – there was no reason other than the newly-discovered correlation for using an IR detector for this purpose; and
    – your claim is limited to IR detectors that are either known in the art or disclosed in your specification.
    This method claim seems eligible to me, even though it involves use of a newly-recognized/discovered/”invented” natural phenomenon. (And even if all elements of the claimed method other than use of an IR detector to determine temperature are “old,”)

    By contrast, the same claim would, in my opinion, be non-eligible if it recited a method of setting the level at which your spaceship’s air-cooling system should operate based on a temperature value “determined by measuring IR radiation” (i.e., using any known, unknown, or yet-to-be-invented device, method, or composition to measure IR radiation). In this latter case, the scope of the claimed “invention” is coextensive with the scope of the preexisting-albeit-newly-recognized correlation, which renders the claim directed to the correlation itself (or to a mere abstract idea, if you prefer that wording), rather than to what the applicant/patentee has actually invented.

    I also disagree with your apparent belief that no scientific discoveries will occur in the absence of the limited monopoly rights granted by a patent regime. The many advances which were made throughout human history serve as examples that this assumption is faulty. In the medical diagnostic field, for example, doctors and academics are not going to stop trying to better diagnose disease merely because their research might not make some diagnostic company executives and/or shareholders wealthy.

  16. Mark Nowotarski October 31, 2019 10:51 am

    TFCFM @ 15. Excellent answer. I think you’ve gotten to the crux of why we need a patent system.

    I agree that there will still be scientific discoveries in the absence of patents. That’s obvious because there were discoveries before patents.

    The real questions, however, are “What will people work on?”, “Who will pay for it?”, and “Why?”. Having worked in an industrial R&D lab for 20 years, I can tell you that the only reason we worked in a particular field was the anticipation of making a substantial profit off of our discoveries. The profit comes from the benefits we would bring to our customers with those discoveries. The profit has to be substantial since most of the investigations produce nothing. Without patents, the profit goes down, the incentive for the research goes away, researchers are laid off, and a discovery that could produce benefits for the public remains undiscovered.

  17. Anon October 31, 2019 2:18 pm

    TFCFM,

    Sorry, but I am going to call you out for B$ (yet again).

    The link is there to inform you of the direct positions. The “summarized issue” is already there in my earlier post as well:

    (I do not think that taking the Supreme Court view — even in Chakrabarty — avails you in a “words of Congress” if you are not going to take the words of Congress into account as to Discovery)

    Since you THEN go ahead and repeat the very same error at issue with “you have discovered/invented (</Ithe choice of word does not matter to me)” – it very much SHOULD matter to you. That is, if you had any interest in engaging (which is what you have claimed to have on multiple occasions).

  18. Ternary October 31, 2019 4:50 pm

    TFCFM, the patent system itself is an abstract idea. We can establish together what a patent is for and what it is not for. In some form in human history, patents were given on land, on the right to collect taxes, on the right to extract salt from sea-water, and even to “forgive” our sins. There is in fact no limit to what we can issue a patent on.

    The Founders suggested to provide patents to “promote the progress of science and useful arts.” There is nothing about abstract ideas, mathematical equations, and fundamental laws of nature. That type of nonsense was introduced by SCOTUS.

    Of course there are phenomena that are discovered and then applied. I see no reason not to give a patent on that. When somebody finds out that bark of a tree has a components that is effective against malaria, then a patent on quinine should be given to the first person who discovered that. There is no logical or physical rule (because its is a “universal truth”?) why such a discovery (and necessary follow-on steps) is undeserving of a patent. Only a made-up human rule determines that. The Founders, exponents of the Enlightenment, realized that there was much to discover and that such discoveries should be incentivized. Not anymore it seems to many who call themselves Constitutionalists.

    You do not define what a “universal truth” is. There are many physical phenomena, many still undiscovered, that when applied, will have great benefits, but that opponents may label a “universal truth.”

    The human eye always has had a limited bandwidth for movement (a universal truth?) A sequence of static image projected onto the eye within the limitations of the bandwidth of the eye gives the effect of a movie. A verifiable phenomenon. No inventor will claim the bandwidth of an eye, but you can claim the movie or the projector.

    An airfoil with camber will generate additional lift over a “barndoor shape” as one of my favorite websites on lift explains. Wings of birds have camber. A verifiable fact. Are new aircraft wings with camber (in which the camber may not even be directly visible) patent eligible. I say yes. Or perhaps a “universal truth?”

    The original infrared radiation detector was a prism and a thermometer held in the non-visible light area below red. It was discovered by William Herschel. As a verifiable phenomenon. A universal truth?

    Humans are often unable to directly determine a relationship between a physical phenomenon and its cause, let alone determine a quantification of those relationships. While we feel the heat of the sun (a universal truth again?), we did not know that IR was a possible cause. Only Herschel’s IR detector made that relationship a verifiable fact. An his instrument was a patentable invention, I find. But perhaps you find it a “universal truth” that is undeserving?

    I believe that patents are an incentive for doing inventions and discoveries (but not the only incentive.) To raise the bar on what is patent eligible is an ideological/political/economic issue. Not a scientific one.

    The introduction of undefined “universal truths” is not helpful in this discussion. It is unclear what a “universal truth” is compared to a physical phenomenon. And I certainly don’t want Courts or parties with a stake in the discussion to be the ones to define that (we know it when we see it.) A “universal truth” seems to be no more than a re-phrasing of “directed to an abstract idea.”

  19. Anon November 1, 2019 9:10 am

    Ternary,

    To your point of “You do not define what a “universal truth” is,” I would add two points that I have previously provided in that context:

    1) “This Is Not a Pipe”
    2) Flogisten, the Aether, and MANY other “universal truths” that — it turns out — were not.

  20. TFCFM November 1, 2019 10:40 am

    MN: “The real questions, however, are “What will people work on?”, “Who will pay for it?”, and “Why?”. Having worked in an industrial R&D lab for 20 years, I can tell you that the only reason we worked in a particular field was the anticipation of making a substantial profit off of our discoveries. The profit comes from the benefits we would bring to our customers with those discoveries. The profit has to be substantial since most of the investigations produce nothing. Without patents, the profit goes down, the incentive for the research goes away, researchers are laid off, and a discovery that could produce benefits for the public remains undiscovered.

    Having worked in, supervised, and thereafter been the patent attorney for R&D labs such as yours, I think we have a similar perspective.

    Certainly, SOME modern research follows profit only. Academic and other government-funded research, however, often does not. Even ignoring not-for-profit research, though, profit does not come from patents alone and even when patents contribute, the patents need not be for every abstract idea, natural phenomenon, or mathematical operation involved.

    By way of example, consider a (patent-eligible) therapeutic molecule or procedure for condition X. Patents on the molecule or the procedure are the profit source (and rightly so, since reducing X is the societal good to be promoted). Even if one successfully develops, manufactures, and patents such a molecule or method, that’s useless without customers (patients afflicted with X). Folks wanting to sell their (current or future) patented molecule/method have all the profit-motive in the world for developing (or encouraging others to develop) a method of diagnosing X, whether that diagnostic method is patentable or not.

    Indeed, continuing the example, if another party patents the only effective method of diagnosing X (or all such methods, if abstract-idea diagnostic claims are declared patent-eligible), then the therapeutic molecule’s/method’s developer entire investment can be held for ransom by the diagnostic developer. This has the perverse effect of *inhibiting* research on therapeutics until and unless diagnostic methods are either patented by the therapeutic developer or rendered unpatentable by public use or publication.

    (Also, if we now stop ignoring not-for-direct-profit research, we’ll further note that diagnostic methods are among the types of basic research that are often funded by non-profit and governmental sources.)

  21. TFCFM November 1, 2019 10:47 am

    Anon: “Sorry, but I am going to call you out for B$ (yet again).

    I’m equally sorry, but I still can’t understand any cognizable argument that you are attempting to make, other than, “I don’t like what you say. See, the Internet and the ‘words of Congress’.”

    If you’d like to make an actual point or argument, I’d be happy to try to reply. I don’t know what you expect me to do with nothing-but-fluff, however. For starters, I can’t even tell with which statement (of mine?) you’re attempting to take issue (let alone what that issue might be).

  22. Mark Nowotarski November 1, 2019 12:38 pm

    “then the therapeutic molecule’s/method’s developer entire investment can be held for ransom by the diagnostic developer.”

    If by “held for ransom”, you mean “have to get a license and pay a reasonable royalty”, I think that would be fine. That would encourage others to fund more development of diagnostic methods that would in turn lead to faster new drug development.

    If the diagnostic developer charged too high a price, that would encourage investors to fund the development of alternative diagnostic methods.

  23. Anon November 1, 2019 2:47 pm

    TFCFM,

    You are plainly dishonest. While the tagging in post 17 does have a flaw, it is clear that I disagree with your position shown with the bold tags of that post.

  24. Ternary November 1, 2019 9:44 pm

    Great Examples Anon. For the benefit of TFCFM, we should add “spontaneous generation.”

    “This has the perverse effect of *inhibiting* research on therapeutics until and unless diagnostic methods are either patented by the therapeutic developer or rendered unpatentable by public use or publication.”

    I believe this to be untrue. Much of basic research is done in academia and is not inhibited by patents. If and how therapeutics research gets from academia into production is another story. But I could find no documented example that a drug or therapy was not being researched because it was barred by a patent for a corresponding diagnostic test. Usually research is/was not funded into development because of limited market size or incumbent products. Not because of diagnostic patents. I found it such an interesting allegation (which by the way has nothing to do with “universal truths” or “abstract idea” but everything with economic interests) that I did some research, but could not find any data. But I am certainly open to being proven wrong.

    Furthermore, detection and quantification of an illness are a “sine qua non” for therapeutic action. In fact, both the providers of diagnostics as well as the therapeutics benefit enormously from our broken healthcare system, as both are taking a huge bite out of the reimbursement apple. I guess, that is the incentive for a patent.

  25. Anon November 2, 2019 10:31 am

    TFCFM @ 20: “Having worked in, supervised, and thereafter been the patent attorney for R&D labs such as yours

    Not believable. You show NO inclination for having an innovation protection mindset.

    Mark @ 22: “If by “held for ransom”, you mean “have to get a license and pay a reasonable royalty”, I think that would be fine. That would encourage others to fund more development of diagnostic methods that would in turn lead to faster new drug development.

    Very much in contrast, here Mark shows an appreciation of the “Stick” aspect of innovation protection.

    Patents are NOT just about the “carrot.” Having a “stick” is very much a manner of promoting innovation. TFCFM sounds in the camp that does not — that cannot — understand the basic nature of patents being a negative right (and exclusionary right) means that STOPPING others is NOT to be viewed as a detriment to progress, but instead is a spur to creativity.

    Ternary @ 24, you too (rather unsurprising) show an appreciation for the nature of patents and innovation protection through the “stick” aspect. Additionally, I add a ‘thank you’ for revealing the flaw in TFCFM’s anti-patent mantra, as patents are NOT in fact blocking to research (pure research, of the kind that TFCFM alludes to in non-patent efforts of academia or government). The moment you take that pure research and attempt to make money with it — THEN you venture into the patent infringement arena. If TFCFM were an actual registered patent attorney, he would have appreciated the actuality of the research exception. Instead, I imagine that he merely litigates and that litigation may involve patents. He continues to show a mindset lacking in the sense of actually protecting innovation.

    But Ternary, your last paragraph (bites of the reimbursement apple) bridges to a different concept that has earned my irritation: the financial aspects of the US/Transnational Pharma conglomerate and the byzantine (and quite frankly, lacking in sunshine) profit mechanisms of the entire health care industry. THESE mechanisms deserve a more critical eye. Ah, if only TFCFM spent his anti-patent energies on those mechanisms…

  26. TFCFM November 4, 2019 10:04 am

    MN @22: “If by “held for ransom”, you mean “have to get a license and pay a reasonable royalty”, I think that would be fine. That would encourage others to fund more development of diagnostic methods that would in turn lead to faster new drug development.

    This brings us full circle, back to the problem of patenting the natural phenomenon (“Y means X”) itself. One able to patent all means of detecting Y, and not just the means he has invented (assuming he has invented one at all, as opposed to using a well-known method to detect Y once the natural law is realized) can stop all treatments dead in their tracks by prohibiting all from diagnosing X.

    That’s entirely out-of-proportion to the diagnostic method discoverer’s/inventor’s contribution, which is why patents on abstract ideas and natural phenomena are prohibited to begin with (e.g., “use of the motive power of the electric or galvanic current … however developed for marking or printing intelligible characters, signs, or letters, at any distances“; Morse’s claim in the 1853 Supreme Court case, O’Reilly v. Morse).

Post a Comment

Respectfully add to the discussion.

Name *
Email *
Website