TWO-STEPPING THROUGH ALICE'S WASTELAND OF PATENT-ELIGIBLE SUBJECT MATTER: WHY THE SUPREME COURT SHOULD REPLACE THE MAYO/ALICE TEST.

• Author: Lindhors, Rebecca

INTRODUCTION I. THE NEED FOR A STRONG U.S. PATENT SYSTEM II. THE DEVELOPMENT OF THE MODERN PATENT STATUTE III. JUDICIAL TREATMENT OF ELIGIBLE SUBJECT MATTER A. Funk Brothers Approach to Eligible Subject Matter B. Chakrabarty Approach to Eligible Subject Matter C. The Federal Circuit's Interpretation of Conflicting Supreme Court Precedent IV. THE MAYO/ALICE TWO-STEP V. TWO-STEPPING THROUGH THE PATENT-ELIGIBILITY WASTELAND VI. DETERMINING PATENT ELIGIBILITY ON A MOTION TO DISMISS VII. DRAFTING AROUND THE TWO-STEP VIII. CONSEQUENCES OF NOT REPLACING THE MAYO/ALICE TWO-STEP IX. CORRECTING THE MAYO/ALICE TWO-STEP THROUGH STATUTORY AMENDMENT CONCLUSION: REPLACING THE MAYO/ALICE TWO-STEP INTRODUCTION

An expectant mother jolts awake as a sharp pain rips through her stomach. She feels the warm sensation of blood spreading down her leg, her hands frantically grasp her stomach as another contraction tears through her. Her inhuman wail pierces the night air and tears stream down her face as she realizes her worst nightmare is coming true; she is having a miscarriage. (1) She has lost the child she has wanted for so long, less than forty-eight hours after having an amniocentesis to test for fetal abnormalities. (2)

Miscarriage is one of a multitude of serious complications expectant mothers must weigh when deciding if they should have an amniocentesis. (3) To determine if her child has any number of genetic abnormalities, an expectant mother would have a long needle inserted into her stomach, the needle would penetrate the uterus and amniotic sac, and extract amniotic fluid for testing. (4) This amniocentesis procedure carries serious risk of miscarriage, needle injury to the fetus, fetal infection, and other complications. (5)

Today, a revolutionary breakthrough in prenatal care means women no longer have to struggle to decide between important fetal testing and the catastrophic risks associated with amniocentesis. Drs. Lo and Wainscoat discovered that maternal plasma and serum, which had previously been discarded as medical waste, contained cell-free fetal DNA (cffDNA). (6) Lo and Wainscoat were able to develop a method to detect the small fraction of paternally inherited cffDNA in maternal plasma to determine fetal abnormalities. (7) This breakthrough has revolutionized prenatal care, offering women a safe alternative to high-risk, invasive testing; cffDNA testing is now offered in over ninety countries and is on track to be a first-tier prenatal screen for all pregnant women. (8)

There is no doubt that Lo and Wainscoat's invention has revolutionized prenatal care. (9) The Supreme Court's current patent eligibility test, the Mayo/Alice two-step, (10) however, threatens the future of such ground breaking inventions. The Mayo/Alice two-step analysis of patent eligibility first requires a determination of whether the claims at issue are directed to a law of nature, natural phenomenon, or abstract idea. (11) If the claims are directed to one of these patent-ineligible concepts, the second step of the analysis determines if there is an "inventive concept." (12) The Court described an inventive concept as "an element or combination of elements that 'is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'" (13)

The Mayo/Alice two-step has proven to be unworkable and has resulted in significant uncertainty in biotechnology. The test has been described as "being both indeterminate, as no one is certain how it will be applied in any particular case, and overly restrictive," as the test has been applied to invalidate a wide range of patents. (14) As a result of the Mayo/Alice test, a large number of life-saving, meritorious inventions are being rejected or invalidated for being directed towards patent-ineligible subject matter. (15) The uncertainty surrounding biotechnology patent protection has significantly contributed to the weakening of the U.S. patent system (16) and has led to one commentator calling the Mayo decision "the worst, most wrongly decided case by the Supreme Court in the patent field ever." (17) Without a change to the current Mayo/Alice two-step approach to determining patent-eligible subject matter, the Supreme Court risks hindering the development of innovations, the very thing the patent system seeks to protect. (18)

Part I of this Note discusses why a strong U.S. patent system is crucial to the advancement of biotechnology and medical innovation. Parts II and III explore the development of the modern patent statute and the inconsistent judicial treatment of the eligible subject matter requirement. Parts IV and V describe the Mayo/Alice two-step and the effects of the test on patent eligibility. Part VI discusses the rise in the dismissal of claims based on motions to dismiss since the adoption of the Mayo/Alice two-step. Part VII compares the Vanda decision and the Mayo decision. Part VIII details the consequences of leaving the Mayo/Alice two-step intact. Part IX of this Note discusses the current push for overturning the Mayo/ Alice test through statutory amendment and details why this is not an adequate solution. Finally, the Conclusion develops a new test for determining what constitutes patent-eligible subject matter and highlights the benefits of the proposed test.

1. THE NEED FOR A STRONG U.S. PATENT SYSTEM

   Patents have been a driving force behind innovation in the United States since the country's founding. Patent rights, considered fundamental by the Framers, are recognized in the Intellectual Property Clause of the Constitution. (19) The Framers believed patent rights to be so critical to the success of the United States that the only mention of the word "right" in the original Constitution is found in that clause. (20) The original patent statute was passed in the Second Session of the First Congress. (21) Abraham Lincoln, a patent holder himself, recognized that " [t] he patent system... added the fuel of interest to the fire of genius, in the discovery and production of new and useful things." (22)

   Patent protection has played a major role in the development of some of the most prominent and ground-breaking inventions in the United States. (23) Patent rights are intended to "promote the Progress of Science and useful arts." (24) By granting an inventor a limited right of exclusion, patent law provides incentive for inventors to risk the enormous costs involved in developing new technologies. This incentive promotes the development of new technologies, and has a positive impact on society. (25) To obtain this limited right of exclusion, an inventor must provide an adequate disclosure of the claimed invention. (26) Patent law thus encourages inventors to disclose their inventions to the public, rather than maintain them in secret for their own benefit. Such public disclosure stimulates ideas and leads to the eventual development of further significant advances in technology. (27)

   In a strong patent system, patent rights are granted to particular inventions in a predictable manner, and patent infringement similarly is enforced in a predictable manner. A predictable patent system provides inventors with the ability to protect their rewards for successful inventions and to make educated decisions on where to allocate resources when developing new technologies. (28)

   The United States has long been considered to have the "gold standard" patent system and to be the world leader in securing patent protection for innovative, next-wave technologies. (29) The United States developed its "gold standard" patent system "precisely because it consistently secured legal protections for the fruits of inventors' labor." (30)

   In the 1980s, when other countries were hesitating to grant patent protection to cutting-edge innovations in the emerging, highly controversial field of biotechnology, the U.S. Supreme Court held that theses biotechnology innovations should be promoted and protected. (31) The Supreme Court's holding in Diamond v. Chakrabarty (32) recognized that the results of biotechnology research may be directed to eligible subject matter. (33) The Chakrabarty decision has been cited by commentators as a driving force behind revolutionary advances in life science technology and medical treatment. (34)

   After the Supreme Court's decision in Chakrabarty, Harvard College secured a patent on the oncomouse. (35) The oncomouse is a mouse that has been genetically modified to incorporate a cancer-promoting gene into its genome, (36) resulting in a multitude of opportunities to research cancer development and treatment. (37) While the United States issued a patent on the oncomouse approximately four years after the initial filing of the patent application, (38) other countries, such as Canada, rejected the application outright. The oncomouse patent was subject to a long series of rejections, court appeals, and remands before the European Patent Office ultimately granted the patent in 2004, nearly two decades after the issuance of the U.S. patent. (39) Europe's delay in granting patent protection gave the United States the edge in the biotechnology field. By securing patent rights in biotechnology inventions early on, the United States "became the birthplace of the biotech revolution" while Europe lost the "competitive and commercial edge in biotechnology." (40)

2. THE DEVELOPMENT OF THE MODERN PATENT STATUTE

   In order to obtain a patent, an inventor must file an application with the United States Patent and Trademark Office (USPTO) that meets several requirements. (41) The patent application is then examined by the USPTO to determine if the application meets the statutory requirements laid out in the patent statute. (42)

   The modern patent framework was adopted in the Patent Act of 1952. (43) Prior to the 1952 Patent Act, the statutory requirements for patentability were concise and grouped into only two statutory sections...