Mayo v. Prometheus and Patent Eligibility

Christine Willgoos is of counsel in the Intellectual Property practice of Paul Hastings, New York. Ms. Willgoos's practice focuses on patent litigation in the fields of biotechnology, pharmaceuticals, and medical devices.

For more in-depth coverage of biotechnology patent issues, check out the Bloomberg BNA treatise, Biotechnology and the Federal Circuit, Second Edition.

On March 20, the U.S. Supreme Court unanimously decided Mayo Collaborative Services v. Prometheus Laboratories Inc. and held that Prometheus's patent claims, directed to methods for determining optimal dosages of certain drugs, were not patent-eligible.1 A few days later, the court granted certiorari, vacated, and remanded Association for Molecular Pathology v. Myriad Genetics Inc. to the Federal Circuit for reconsideration in view of Mayo.2 This article will explore the impact of Mayo on the inquiry conducted under 35 U.S.C. §101 for biotechnology inventions, including the isolated DNA sequences at issue in Myriad.

The Supreme Court Holds That, in Order to Be Patent Eligible, Method Claims Must ‘Add Enough' to Natural Laws

In June 2004, Prometheus brought suit against Mayo in the U.S. District Court for the Southern District of California for infringement of two patents. The patents are directed to methods of determining optimal dosages of thiopurine drugs to treat certain diseases by (1) administering, (2) determining the level of metabolites of the drug, and (3) comparing the metabolite levels to those set forth in the patent, wherein the comparison indicates a need to increase or decrease the dose of the drug.
The district court held on summary judgment that the patent claims were not patent-eligible under Section 101.3

On appeal, after reconsideration in view of Bilski,4 the Federal Circuit reversed the district court grant of summary judgment and held that the claims were patent-eligible under Section 101. Relying on the “important clue” provided by the “machine-or-transformation” test, the Federal Circuit held that Prometheus's claims were applications of natural law that did not preempt use of the natural law itself, i.e., that the claims did not preempt all use of the drug correlations and were, therefore, patent-eligible subject matter.5

The Supreme Court granted certiorari and reversed the Federal Circuit. The court framed the inquiry as follows: “Do the patent claims add enough to their statements of the correlations [i.e., the natural law] to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?”6 In answering that question “no,” the court held that Prometheus's patent claims were not patent-eligible because they did nothing more than recite a law of nature to a relevant audience and instruct the audience to apply it using conventional, routine activity already known in the art.7

Did the Supreme Court Provide Clarity or Did It Confound the §101 Inquiry With Novelty Issues?

“[A]ll inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”8 Starting from this basic truth, the court recognized that too broad an application of Section 101 “could eviscerate patent law.”9 But does the court's analysis in Mayo strike the appropriate balance? Does it provide clear guidance to lower courts, including the Federal Circuit, on how to apply the proper Section 101 inquiry to pharmaceutical and biotechnology inventions?

Certainly, some areas of the court's guidance are clear. For example, the court distinguished the claims at issue with “a typical patent on a new drug or new way of using an existing drug,” stating that the latter were particular applications of natural laws.10 Thus, under Mayo, “typical” claims to new drugs and new ways of using existing drugs pass muster under Section 101.

The court was clear that the machine-or-transformation test has little or no relevance to the Section 101 inquiry with respect to biological process claims. The court held that “transforming the human body by administering a [] drug” is “irrelevant,” because all that the claimed “administering step” did was target the relevant audience interested in applying the natural law.11

Similarly, the court held that “transforming the blood” by analyzing the metabolite levels was insufficient because it could be possible in the future to perform that step without such transformation.12

Although one may question the court's logic, particularly in that it suggests that a court must consider possible future, nonexistent technology in determining patent-eligibility, the Mayo decision clearly indicates that the machine-or-transformation test as applied to certain biotechnology process claims may have little or no relevance to the patent-eligibility of such claims.

Other aspects of the court's decision are far less clear and may serve to confuse, rather than clarify, the scope of the Section 101 inquiry. In particular, the court rejected the proposal that “any step beyond a statement of the law of nature itself should transform an unpatentable law of nature into a potentially patentable application sufficient to satisfy §101's demands.”13 Indeed, the court warned that not using Section 101 as a threshold step to the Sections 102, 103, and 112 inquiries would render Section 101 a “dead letter.”14 The court further stated that shifting the heavy lifting to Sections 102, 103, and 112 would require those sections to do “work that they are not equipped to do.”15

Yet, the court's own analysis confounds the Section 101 inquiry with Sections 102 and 103. The key holding of the Mayo case is stated as follows: To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons, we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.16

The italicized portions of the quote were added to designate what appears to be an importation of Section 102/103 issues into the Section 101 inquiry.

Indeed, the court explicitly recognized that the Section 101 and 102 inquiries may “sometimes” overlap.17 Yet, while warning lower courts to keep these inquiries separate, the court itself determines that aspects of Prometheus's patent claims are not novel, but instead are “well-understood, routine, conventional activity engaged in by the scientific community.”

Just how or why the court came to make such a finding is unclear, as there is little discussion of what activity was known in the art with respect to the claimed methods. Similarly, the court's determination that the steps “add nothing significant beyond the sum of their parts taken separately” implies a Section 102/103 analysis was undertaken as part of the Section 101 analysis, yet none is described.

The court's use of language parroting the Section 102/103 inquiries as part of its Section 101 analysis may cause confusion in the lower courts as to the appropriate scope of the Section 101 analysis. Does a Section 101 analysis require a court to determine whether the activities recited in the claims are “routine” instead of “novel”?

Where does the Section 101 inquiry end and the Section 102/103 inquiry begin? The Mayo decision offers little guidance on this matter.

Perhaps the confusion results from the claims at issue in Mayo. By failing to state any means by which the “administering,” “determining,” and “comparing” steps were to be carried out, the court may have interpreted the claims to include only means which were known in the art, i.e., by failing to state specific means by which the steps were to be carried out, there was not “enough” to be passed through to a Section 102/103 inquiry.

Yet the court fails to clearly define what would be “enough.” Would the claims have been patent-eligible if, for example, they recited that the “administering” step was limited to a particular dosage form? Would it matter if the dosage form was already in the art or purportedly novel?

As another example, what if the claims included an additional step setting forth specific dosages by which the thiopurine drugs would be increased or decreased based on the metabolite levels determined?

Presumably, that would have been “enough” of an application to bring the invention within the scope of patentable subject matter. But what if the specified dosages were already routinely used in the art—is that an inquiry to be made under Section 101 or under Sections 102 and 103?

And if it is an inquiry to be made under Section 101, what is the standard to determine whether such methods are routine? Is it the same or different than the standard used under Sections 102 and 103?

Mayo does not clearly define where the boundary between Section 101 and other sections exists, and lower courts will likely struggle with such questions in attempting to apply the Section 101 inquiry going forward.

Implications of Mayo on Patentability of Isolated DNA Sequences and Methods of Use

One controversial application of the Mayo Section 101 standard is its anxiously awaited application in the Myriad case. On July 29, 2011, the Federal Circuit issued its Myriad decision and held, inter alia, that isolated deoxyribonucleic acid (DNA) sequences are patent-eligible subject matter under Section 101.18 The court also held that claims directed to “comparing” and “analyzing” such sequences were not patent-eligible, but that claims directed to a method of screening for mutations that may cause cancer were patent-eligible. Myriad filed a petition for certiorari, and on March 26, the Supreme Court remanded the case to the Federal Circuit for reconsideration in view of Mayo.19

As decided, the Supreme Court's Mayo decision does not directly address or implicate the patentability of isolated DNA sequences at issue in Myriad. Prometheus's patent claims in Mayo were limited to processes, and the court's decision was limited to the patent-eligibility of applications of natural laws, i.e, what “adds enough” to a process patent claim to make it a patentable application of a law of nature instead of a recitation of the law of nature itself. The isolated breast cancer DNA sequences at issue in Myriad, in contrast, are physical compounds and not attempts to claim processes that apply laws of nature.20 Thus, an appropriately narrow reading of Mayo may have little or no impact on the Federal Circuit's decision on remand of Myriad. Yet, those willing to search for clues in the Mayo decision will find that sections of the opinion may be read to support or dispute the patentability of isolated DNA sequences.

The Mayo court twice cites to Mackay Radio & Telegraph Co. v. Radio Corp. of America in distinguishing unpatentable “scientific truth” from patentable novel structures. The court states:
While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.21

This statement may support the basis for the Federal Circuit majority opinion in Myriad that isolated DNA is patent-eligible subject matter because isolated DNA molecules are “not the same molecules as DNA that exists in the body; human intervention in cleaving or synthesizing a portion of native chromosomal DNA imparts on that isolated DNA a distinctive chemical entity from that possessed by native DNA.”22 Thus, in the context of Mackay, the Federal Circuit essentially held that isolated DNA is patent-eligible because it is a novel and useful structure, not a scientific truth. Nothing in the Supreme Court's Mayo analysis directly contradicts or calls into question this finding.

Yet, the policy concerns that drove the Supreme Court's decision in Mayo are also implicated in the debate over patent-eligibility of isolated DNA sequences. In particular, the court expressed concern that applying too lax a standard under Section 101 could tie up “basic tools of scientific and technological work” and foreclose future innovation.23 These policy concerns are often expressed by those that oppose patentability of isolated DNA sequences, and formed part of the basis for Judge William C. Bryson's dissenting opinion in Myriad.24 Moreover, the Mayo court's analysis of Section 101 as excluding routine, well-understood, and conventional methods may raise the separate question of whether isolating DNA sequences “adds enough” to the scientific activity engaged in by researchers in the field to pass the bar of patent eligibility.

The two types of method claims at issue in Myriad may be easier to apply in the context of the Mayo decision. The Federal Circuit's determination that the “comparing-and-analyzing” claims25 are not patent eligible is consistent with Mayo and unlikely to change on remand. The claims directed to methods of screening for cancer susceptibility26 will likely be reanalyzed in the context of Mayo, particularly because the Federal Circuit analyzed them under the machine-or-transformation test27 that the Supreme Court called into question in Mayo.28 The court's analysis of these screening claims is likely to be most telling as to how the Federal Circuit will view and apply Mayo in the future.

Given the decades-old precedent in the Patent and Trademark Office and the courts that isolated DNA sequences are patent-eligible subject matter,29 it would be wise for the Federal Circuit and lower courts to tread carefully in applying Mayo. The Mayo decision arguably narrows the boundaries of patent-eligible subject matter, but does not bring about a wholesale change in law or expectations of the biotechnology and pharmaceutical industry.

In contrast, relying on Mayo to hold that isolated DNA sequences are not patent-eligible would be a significant extension of the Supreme Court's Mayo analysis and would upend reliance on long-standing precedent and the expectation that isolated genes and gene sequences are patentable. Indeed, both the majority and concurrence of Myriad agreed that such a drastic change in the expectation of patent-eligibility of isolated DNA sequences must come from Congress, not the courts.30

Conclusion

The Supreme Court's Mayo decision provides guidance in determining the patent-eligibility of biotechnology and pharmaceutical process inventions, but leaves many unanswered questions as to the boundaries of Section 101, particularly with respect to its interaction with Sections 102 and 103. The lower courts and the Federal Circuit, therefore, will be on the front line of clarifying the appropriate analysis under Section 101.

Given the potential implications of a broad application of the Mayo standard, courts should carefully and narrowly apply the Mayo analysis and beware of extending application of its holding to radically change the patent-eligibility of biotechnology and pharmaceutical inventions.

1 See Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (83 PTCJ 727, 3/23/12).
2 (83 PTCJ 761, 3/30/12). See http://www.supremecourt.gov/orders/courtorders/032612zor.pdf.
3 See Prometheus Laboratories Inc. v. Mayo Collaborative Services, No. 04-cv-1200, 86 USPQ2d 1705 (S.D. Cal., Mar. 28, 2008).
4 See Bilski v. Kappos, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010) (80 PTCJ 285, 7/2/10).
5 See Prometheus Laboratories Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010).
6 Mayo, slip op. at 8 (emphasis in original).
7 Id. at 10-11.
8 Id. at 2.
9 Id.
10 Id. at 18.
11 Id. at 19.
12 Id.
13 Id. at 20-21.
14 Id.
15 Id. at 21.
16 Id. at 11 (emphasis added).
17 Id. at 21.
18 See Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (82 PTCJ 449, 8/5/11).
19 Notably, there may be jurisdictional issues in the Federal Circuit taking up the case on remand. Under the Federal Circuit's analysis, its jurisdiction was based only on the case set forth by a single named plaintiff (see id. at 1342-48), who likely no longer meets the jurisdictional requirements set out by the court (see Federal Circuit, No. 2010-1406, docket entry 261). In its petition for cert, Myriad disputes the Federal Circuit's holding that there is no jurisdiction over other plaintiffs, but nothing in the Supreme Court's decision in Mayo implicates the jurisdictional question.
20 See Myriad, 653 F. 3d at 1334.
21 Mayo, slip op. at 2, 16.
22 Myriad, 653 F.3d at 1352.
23 See Mayo, slip op. at 17.
24 See Myriad, 653 F.3d at 1372, 1379-80.
25 See id. at 1334, 1355-57.
26 See id. at 1334-35, 1357-58.
27 See id.
28 Mayo, slip op. at 19-20.
29 See, e.g., Myriad, 653 F.3d at 1355.
30 See id. at 1355, 1370-71. But see also id. at 1381 (dissent).

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