The "inventive Concept" After Mayo: Where Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (fed. Cir. 2015), Went Wrong

• Publication year: 2021
• Citation: Vol. 96

96 Nebraska L. Rev. 221. The "Inventive Concept" After Mayo: Where Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), Went Wrong

The "Inventive Concept" After Mayo: Where Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), Went Wrong(fn*)

Jared Koch

TABLE OF CONTENTS

I. Introduction .......................................... 222

II. Background ........................................... 223
A. Development of § 101 .............................. 224
1. Laws of Nature, Natural Phenomena, and Abstract Ideas ................................. 224
2. The "Inventive Concept" ....................... 226
B. Mayo Collaborative Services v. Prometheus Laboratories, Inc ................................... 228
1. Facts .......................................... 228
2. The Mayo Test ................................ 230
C. Alice Corp v. CLS Bank International .............. 231
D. Ariosa Diagnostics, Inc. v. Sequenom, Inc ........... 232
1. Facts .......................................... 232
2. The Federal Circuit's Decision ................. 234

III. Analysis .............................................. 236
A. The Inventive Concept After Mayo ................. 237
B. Discovery as an Inventive Concept ................. 238
1. Conformity with the Inventive Concept Framework .................................... 238
2. Addressing the Federal Circuit's Concerns ...... 240
3. Public Policy .................................. 241
C. Implications for Patentability ...................... 245

IV. Conclusion ............................................ 246

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I. INTRODUCTION

The U.S. Constitution provides that "[t]he Congress shall have Power . . . To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."(fn1) Under this authority, Congress has stated that a patent may be obtained for the invention or discovery of "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."(fn2) However, the Supreme Court has long held that laws of nature, natural phenomena, and abstract ideas are not patentable.(fn3) For example, a newly discovered mineral or plant could not be patented.(fn4) Nor could Einstein's law that E = mc2 or Newton's law of gravity.(fn5) These categories are not patentable because they are "the basic tools of scientific and technological work,"(fn6) and granting a patent of these tools might "tend to impede innovation more than it would tend to promote it."(fn7) At the same time, courts are hesitant to construe these exclusions too broadly because lack of patent protection might just as easily hamper innovation.(fn8)

The courts have always toed the line between incentivizing innovation and allowing public access to innovations as inspiration for future inventions.(fn9) The Supreme Court continued to toe this line in Mayo Collaborative Services v. Prometheus Laboratories, Inc.,(fn10) balancing the categories of patent-ineligible subject matter with inventive concepts that might transform them into patentable inventions.(fn11) Nonetheless, in Ariosa Diagnostics, Inc. v. Sequenom, Inc.,(fn12) the Federal

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Circuit definitively tipped the scales in favor of public access, effectively eliminating any incentive to innovate in the life sciences.(fn13) By implementing an overwhelmingly strict standard for inventive concepts, the Federal Circuit expanded Mayo to be as broad as the justices feared its "sweeping language" to be.(fn14) After Ariosa, the Federal Circuit leaves life sciences innovation in dire straits, the consequences of which are yet to be fully realized.

This Note explores the inventive concept as revitalized by Mayo and attempts to refute the Federal Circuit's misunderstanding of Mayo. Part II.A lays out the relevant background, outlining the traditional understanding of patentable subject matter under § 101 and the inventive concept. The discussion then turns to the Mayo test, with the remainder of Part II endeavoring to navigate the murky waters of Mayo and subsequent application of the Mayo standard by the courts. In response to the Federal Circuit's understanding of the inventive concept in Ariosa, Part III discusses how-if at all-Mayo changed the inventive concept, and why discovery of a law of nature must satisfy it. Finally, this Note concludes with an examination of the consequences and aftermath of Ariosa's restrictive interpretation of the inventive concept.

II. BACKGROUND

As interpreted today, the Patent Act does not authorize patent protection for laws of nature, natural phenomena, or abstract ideas.(fn15) The Supreme Court has consistently recognized these exceptions to patentability for more than 150 years.(fn16) This Part begins with a discussion of how each exception is interpreted by the courts, carving out areas of unpatentable subject matter without crossing the line into removing incentives to invent. This Part goes on to discuss the framework laid out by Mayo(fn17) for analysis of patents directed at these traditionally unpatentable subject matters and the solidification of the Mayo framework in Alice Corp. v. CLS Bank International.(fn18) Finally, this Part relates the Federal Circuit's interpretation and application of the Mayo framework in Ariosa Diagnostics, Inc. v. Sequenom, Inc.(fn19)

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A. Development of § 101(fn20)

The development of § 101 jurisprudence began even before its passage in 1952. It took hundreds of years to mold the categories of patentable subject matter into what they are today, beginning with the Patent Act of 1793.(fn21) The 1793 Act identified invention of "any new and useful art, machine, manufacture or composition of matter, or any new and useful improvement on [the same], not known or used before application" as patentable subject matter.(fn22) Although the Patent Act has endured various iterations,(fn23) these original classes of patentable subject matter remain substantially similar in the text of § 101 today.(fn24)

1. Laws of Nature, Natural Phenomena, and Abstract Ideas

Over this great period of time, the Supreme Court has wrestled with how far patentability extends.(fn25) The journey began with Le Roy v. Tatham, in which the Court first excepted laws of nature from patentability:

A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right. Nor can an exclusive right exist to a new power, should one be discovered in addition to those already known.(fn26)

The Court expanded upon the invalidity of laws of nature the following year in O'Reilly v. Morse.(fn27) Morse dealt with the famous Samuel Morse, who obtained a patent for his invention of the telegraph.(fn28) In the reissued patent, Mr. Morse claimed "the use of . . . electro-magnetism, however developed for marking or printing intelligible characters, signs, or letters, at any distances . . . ."(fn29) Although the Court

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found the claim to be void on other grounds,(fn30) it stated that an invention that makes use of a principle such as electromagnetism is generally valid, so long as the patent does not claim the principle itself.(fn31) The Court later clarified that an invention that makes use of a principle need not be a machine but may be simply a process.(fn32)

Over time, the Court also recognized the ineligibility of natural phenomena for patent protection. This exception was first held in Funk Brothers Seed Co. v. Kalo Inoculant Co., in which the patent claimed a mixed culture of Rhizobia bacteria that were capable of inoculating various seeds.(fn33) The patentee did not invent the fact that various species of Rhizobium were capable of producing a mixed inoculant but rather discovered that natural phenomenon.(fn34) Since the Court could not allow a patent on "one of the ancient secrets of nature," it held the patent to be invalid.(fn35) The Court later limited this holding, noting that where a claim is to a "nonnaturally occurring manufacture or composition of matter-a product of human ingenuity 'having a distinctive name, character [and] use,'" patent protection is appropriate.(fn36)

The Supreme Court has also made clear that abstract ideas are not patent eligible.(fn37) In invalidating a patent on a mathematical formula for converting binary-coded decimal numerals into pure binary numerals, the Court specifically stated that "one may not patent an

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idea."(fn38) The Court went further, noting that even post-solution activity-such as adjustment of alarm limits based on the outcome of a formula-cannot be patent eligible.(fn39) At the same time, an application of an abstract idea is patentable, so long as the patent does not claim the idea itself.(fn40) Through well over a century of jurisprudence, the Supreme Court has properly concluded that patent protection is not appropriate when the invention is grounded in a law of nature, natural phenomenon, or abstract idea.

2. The "Inventive Concept"

While laws of nature, natural phenomena, and abstract ideas should generally be patent ineligible, the Supreme Court is also fearful that the exclusions might "swallow all of patent law."(fn41) Thus, where an invention falls in one of the three traditionally unpatentable areas of subject matter, the Supreme Court has sometimes upheld a patent that contains a sufficient "inventive concept."(fn42) The Court provided its first formulation of the inventive concept in Gottschalk v. Benson.(fn43) In Benson, the United States Patent and Trademark Office issued a patent for an invention related to "'the processing of data by program and more particularly to the programmed conversion of numerical information' in general-purpose digital...