Mayo v Prometheus - Gwu - George Washington University

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514 European Intellectual Property Review For example, if use of an invention offends public policy, even a machine 95 or transformation 96 cannot be patented. Moreover, if an improvement is clearly not within the "useful Arts" to which the US Constitution limits congressional patent power, the improvement cannot be patented. 97 It warrants emphasis that the machine-or-transformation test is not a policy in its own right. It is merely instrumental, a means for judging the pre-emptiveness of a principle-implementing claim. The machine-or-transformation test is not a positive test that if satisfied confers patent-eligibility on a claim; it is a negative test that if not satisfied typically leads to patent-ineligibility, so that ,satisfying the machine-or-transformation test is not a sufficient condition for patent-eligibility. More impmtant, as Prometheus tells us: "[A] process that focuses upon the use of a natural law [must] also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." 98 That statement hints at a positive test of patent-eligibility but does not explicitly disclose it by telling us in so many words how to recognise when a claim "amounts to significantly more than a patent upon the natural law itself''. But Prometheus's harmonisation ofthe case law gives us ample and powerful clues: we can examine its view through rose-tinted lenses of Neilson and Diehr and look at the opposite side of the patent-ineligibility holdings in Benson and Flook. By doing that we discern how to recognise when a claim goes beyond a mere statement of a natural principle. What Prometheus instructs is this: The implementation of the principle must add to the principle more than just the conventional expedients that scientists or mtisans in the relevant field know and use, or the implementation should at least purport to do so (the lessons of Prometheus and Flook). A novel apparatus helps (Neilson redux). Novel co-operation or co-action is very helpful (Diehr redux). The claims should not be open-ended and exceed what the inventor has taught the public to do to exploit the principle (Morse). That is how Prometheus teaches us to recognise when a claim "amounts to significantly more than a patent upon the natural law itself''. The war between section 101 and sections 102-1 03 Finally, it was argued that "virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable application sufficient to satisfy§ 101 's demands" and all remaining screening functions should be performed by §§ 102 (novelty), 103 (obviousness), and 112 (enablement and definite description). 99 The comt emphatically rejected this view as conosive of the patent system. This approach, the court protested, would make the accumulated law of§ 101 and its predecessor provisions dating back tO the firSt US patent ad 00 a "dead letter". 101 The case law dating back to the 19th century against patenting ideas, principles of nature and the like is not codified in§§ 102, 103, or 112, and therefore would be abrogated by this proposal. Only § 101 addresses such doctrines, by limiting the grant of a patent to a person who "invents or discovers" a new "process, machine, 95 E.g. a machine or article of manufacture for poisoning people. See Lowell v Lewis , 15 F. Cas. 1018, I 019 (C.C.D. Mass. 1817) ("For instance, a new invention to poison people, or to promote debauchety, or to facilitate private assassination, is not a patentable invention") (Story J.); a process for deceiving consumers into believing a product is of higher quality than it actually is-see Rickard v Du Bon 103 F. 868 (2d Cir. 1900) (patent on process for making cigars appear to be made from more expensive tobacco held invalid since its only utility was to deceive customers). In the altemative, these machines or processes can be deemed not "useful", as the statute requires them to be. But they are useful, in any ordinary sense of the term, to those who desire to use them (consider the B01·gias ). It is just that some courts have disapproved of that utility. (More recent authority tends to retreat from Lowell and Rickard. See Juicy Whip Inc v Orange Bang Inc 185 F. 3d 1364, 1367-1368 (Fed. Cir. 1999).) Perhaps a better question to have asked in the Lowell case would have been whether poisoning people, promoting debauchery and facilitating private assassination are within the "useful At1s", as that term was understood at the time of adoption of the Constitution. 96 E.g. a process addicting consumers to smoking cigarettes by adding to cigarette tobacco an addictive substance such as additional nicotine, which alters (transfonns) brain dopamin:e pathways. See "Making the Decision to Quit Tobacco: Nicotine Addiction", New York Times, http:/lhealth.nytimes.com!health/guides/specialtopic/smoking-and -smokeless-tobacco/nicotine-addiction.html [Accessed June 5, 2012]. The same utility considerations apply here as apply in the preceding note. 97 Article I §8 cl.8 of the Constitution authorises Congress to grant patents in order to "promote the Progress of ... useful Arts". See generally Richard H. Stern, "Being Within the useful Arts as a Fm1her Constitutional Requirement for US Patent-Eligibility" [2009] E. I. P.R. 6. 98 Prometheus 132 S. Ct. 1289, 1294 (2012) (citing Flook 437 U.S. 584, 594 (1978)). 99 Prometheus, 132 S. Ct. 1289, 1303 (quoting the amicus curiae brief of the Govemment). Like the "considered as a whole" argument, this one has been taken up by the patent bar. An argument of this type was made against Flook shortly after that decision, in the late 1970s, when the court vacated and remanded several judgments of patent-eligibility for reconsideration in the light of that decision. See In re Bergy 596 F. 2d 952 (Ct Cus. & Pat. Apps 1979). In his dissent in Diehr, Justice Stevens commented caustically on the Bergy opinion in particular and the general refusal of the Court of Customs and Patent Appeals to follow the guidance of Supreme Court opinions on patent-eligibility, culminating in its judgment in the Diehr case: "In my judgment, this reading of F/ook-although entirely consistent with the lower court's expansive approach to§ 101 during the past 12 years-trivializes the holding in Flook, the principle that underlies Benson, and the settled line of authority reviewed in those opinions." Diehr 450 U.S. 175, 205 (1981). 100 Patent Act of 1790, Ch. 7, I Stat. I 09, § l (authorising patent grants to applicants who "have invented or discovered any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used"). 101 Prometheus, 132 S. Ct. 1289, 1303 (2012). [2012] E.I.P.R., Issue 8 © 2012 Thomson Reuters (Professional) Uk Limited and Contributors
Mayo v Prometheus: No Patents on Conventional Implementations ofNatural Principles and Fundamental Truths 515 manufacture, or compos1t10n of matter", within the meaning that the case law gives those terms. 102 Although to some extent the § 101 inquiry may overlap with the others, they need not always do so and: "[T]o shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do." 103 The nutshell Prometheus resolves several related issues. First, it re-emphasises the quasi-jurisdictional impmtance of patent-eligibility as a threshold inqui1y that must be resolved in patent cases involving claims to implementations of: natural laws; phenomena of nature; equations of physics, chemistry, or mathematics; algorithms; and abstract ideas (collectively "principles"). Second, unwarranted pre-emption of the innovative efforts of other potential inventors remains an important policy consideration in judging patent-eligibility. Third, implementations of principles in a purely conventional or obvious manner are likely to be held patent-ineligible. In the same vein, conventional implementations of principles are now more likely to be judged pre-emptive under § 101 than relegated to an obviousness analysis under § 103. 104 Fourthly, the analytic dissection methodology appears to be in a stronger position than "considered as a whole" in determining patent-eligibility. But what's a natural principle? One issue that will doubtless generate more litigation is the scope and meaning of the terms natural principle and phenomenon of nature. One case testing that will probably come before the court in the next or following term-the Myriad case, allowing some gene patents. 105 The outer limits More generally, the outer limits of the concept of principle are not well defined. Clearly, principles of physics and chemistJy, such as the inverse square law for radiation and the law of mass action, qualify as natural principles. So, too, do empirical laws such as the effective dosage amount and toxic dosage amount of a given drug, which Prometheus involved. But what of more poorly understood inventions or principles? Very old inventions can illustrate this issue. For example, consider the canary in the coal mine or the fact that you can get clothes clean by submerging them on a rock in a stream and beating them with a stick. Are these natural principles? The objection may be raised that you cannot properly tell that something is a natural principle when you do not know what the principle is. Furthermore, is everything you cannot understand to be held a natural principle? That greatly expands the doctrine and collides with the legal rule that inventors are entitled to patents even if they do not know how or why their invention works. 106 Certainly, inventors who do not understand the underlying principle cannot very well submit claims that pre-empt the principle, so that the law need not penalise them in order to raise a fence against that risk. Those (such as the pharmaceutical industry) who fear or othe1wise disapprove of Prometheus's doctrine against patenting natural principles asse1i that the aftermath of Prometheus might be that the doctrine will expand to obliterate or at least threaten all patents, because ordinarily some principle is implemented to some extent in any patented invention. But one limit to such expansion is that the doctrine does not purpmi to obliterate inventive implementations of natural principles, as Morse's repeater apparatus was and as Prometheus says that Diehr's device was. Another limit is that inventors are not obliged to claim so pre-emptively that, as with Morse's claim 8, they exceed the bounds of what they have taught the 102 For example, "process" has a common sense everyday meaning that would embrace the processes that Benson, Flook and Bilski claimed. But that is not the statutmy meaning of the term, as the comi held in Flook 437 U.S. 584, 593 (1978) ("The rule that the discovery of a law of nature cannot be patented rests not on the notion that natnral phenomena are not processes, but rather on the more fundamental understanding that they are not the kind of 'discoveries' that the statnte was enacted to protect"). The case law "forecloses a purely literal reading of section I 01 ":Flook at (588]-[589]. 103 Prometheus, 132 S. Ct. 1289, 1304 (2012). 104 One consequence of that is that such secondary considerations as commercial success are likely to receive less weight, if any at all, under § 10 I than under§ 103. 105 In Association/or Molecular Patlwlogy v US Patent and Trademark Office 653 F. 3d 1329 (Fed. Cir. 2011) (known as the M:vriad ease), the Federal Circuit held isolated breast cancer related natnral DNA nucleotide sequences patent-ineligible and edited such DNA patent-eligible. The latter are fragments ofnatnral DNA with some gene sequences cut out because they are not functional in a manner desired. The case was co-pending with Prometheus, and after that ease was decided the Supreme Court vacated Myriad and remanded it to the Federal Circuit for reconsideration in the light of Prometheus. Like ideas, algorithms and natural principles, which are "the basic tools of scientific and technological work" (see Benson 409 U.S. 63, 67 (1972); Flook 437 U.S. 584, 589 (1978); Prometheus 132 S. Ct. 1289, 1302 (2012)), gene sequences are the basic tools of genetic technology work. The same legal principles may therefore apply. It may make a difference, however, whether the editing is conventional or trivial; it may also matter how pre-emptive the claim is-for example, would it pre-empt the breast cancer research of all other workers in the field? The Federal Circuit has set the remanded case for argument in July 2012. However the Federal Circuit decides Myriad, the large interests at stake arc sure to bring the case before the Supreme Court. 106 See Diamond Rubber Co v Consolidated Rubber Tire Co 220 U.S. 428, 435-436 (1911) ("it is certainly not necessmy that he understand or be able to state the scientific principles underlying his invention"); Newman v Quigg, 877 F. 2d 1575, 1581 (Fed. Cir. 1989) ("it is not a requirement of patentability that an inventor cmTectly set forth, or even know, how or why the invention works"). The inventor merely must teach the public what they must do to use the invention: Diamond at [ 436]. (2012] E.I.P.R., Issue 8 © 2012 Thomson Reuters (Professional) Uk Limited and Contributors
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Mayo v Prometheus - Gwu - George Washington University

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