This case is an ideal vehicle for providing the clarification the patent and investment community require. At issue is how to determine whether something is a product of nature under 35 U.S.C. § 101.
A conflict exists between the incentive to invent, provided for by the U.S. Constitution and patent law, and the breadth of patent-eligible subject matter under 35 U.S.C. § 101. It has become difficult to recognize the line between patentable subject matter and non-patentable products of nature. The Supreme Court has made conflicting statements regarding that line in its rulings in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). It is time for the Court to resolve these inconsistencies.
There is an essential tension between Funk Bros. and Myriad. Funk Bros. requires, for patent-eligibility, that more than a “simple step” separates the claimed subject matter from a product of nature. Thus, in Funk Bros., a non-naturally-occurring mixture of naturally-occurring bacteria was found non-patent-eligible. See Funk Bros., 333 U.S. at 132 (reasoning that “the state of the art made the production of a mixed inoculant a simple step”). In contrast, Myriad requires no more than that the claimed subject matter is not identical to a product of nature. In Myriad, non-naturally-occurring cDNA was held patent-eligible simply because it was not found in nature, even though no more than a routine, conventional, and simple step was required to prepare cDNA from naturally-occurring RNA, and even though the genetic information contained in the cDNA did not differ from the genetic information found in nature. See Myriad, 569 U.S. at 594 (reasoning that “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring”). It therefore remains unclear, under Supreme Court precedent, whether more than a simple step must separate claimed subject matter from something that is found in nature. Funk Bros. answers “yes” to this question; Myriad answers “no.”
I have recently filed a petition for a writ of certiorari that raises this issue on behalf of Urvashi Bhagat, a solo inventor of new and useful lipid compositions that have the potential to improve the health of millions of Americans who suffer from chronic illness. Yet she is being denied a patent that would support her in bringing these beneficial inventions to market, frustrating the purpose of the U.S. patent system. I hope that her story will inspire others similarly frustrated with the current state of patent-eligibility in the United States to file amici briefs to support her petition. Amici briefs are due by September 29, 2018.
In addition to requesting resolution of the conflict between Funk Bros. and Myriad, Ms. Bhagat’s petition asks the Court to hold the federal courts accountable in properly reviewing agency decisions. Specifically, the petition asksthe Supreme Court to consider whether the Federal Circuit failed to apply “meaningful review,” as the Administrative Procedure Act requires, in affirming the USPTO’s decisions under 35 U.S.C. §§ 101 and 102(b).
Some of the facts that underlie the case are set forth below essentially as laid out in the petition. The full petition and appendix are available here.
This case presents an instance in which an inventor has made and disclosed valuable inventions that apply new and useful discoveries to the solving of long-felt and critical public health problems. Chronic diseases affect millions of Americans. Petitioner, the inventor of U.S. Patent Application 12/426,034 (which claims priority to an April 21, 2008 filing date), has developed formulations that have the potential to ameliorate or alleviate the symptoms of many who suffer from chronic diseases. Nevertheless, petitioner has been denied the patent reward that this country’s founders enabled to encourage and foster innovation.
The rejection of the claims pending in the ’034 application, at issue here, appears to be, in part, a consequence of uncertainty in the proper application of 35 U.S.C. § 101. This case merits review to clarify the scope of patentable subject matter under 35 U.S.C. § 101 and of the incentive to innovate and to invest in and disclose innovations. Review of this case will also resolve some of the substantial doubt that uncertainty surrounding § 101 has cast on the validity and value of such patents.
In this case, Urvashi Bhagat, motivated by the illness, suffering and premature death of her own mother, devoted herself to researching the relationship between diet and chronic illness. She focused on the role of lipids in health and disease. Lipids are a diverse class of over 100 distinct chemical compounds that are ubiquitous in nature and include, for example, fatty acids, cholesterol, steroids and certain vitamins. Lipids play many important biological roles, including being crucial cell membrane components, providing a source of energy to the organism, affecting protein function and involvement in gene regulation. Lipids affect the activity of each other and their derivatives function as important hormones and chemical messengers that affect a broad range of physiological functions.
Bhagat’s research focused on two subsets of lipids, the omega-6 and omega-3 families of fatty acids. Linoleic acid (LA) is the precursor of the omega-6 family, and alpha-linolenic acid (ALA) is the precursor of the omega-3 family. The bodies of mammals, including humans, cannot synthesize LA and ALA, but can synthesize the other omega-6 and omega-3 fatty acids from dietary LA and ALA. Mammals must obtain LA and ALA from dietary sources.
From about 1930 to about 1960, nutritional studies demonstrated that omega-6 fatty acids were active in growth and maintenance of skin health. Between 1964 and 1979, researchers developed awareness that arachidonic acid (AA) (an omega-6 fatty acid) metabolizes into prostaglandins and leukotrienes, involved in several disease processes associated with arthritis, asthma, atherosclerosis, thrombosis, tumor proliferation, and a variety of immune-inflammatory disorders. Therefore, high amounts of omega-6 were believed to promote pathophysiology. Ingestion of about 1% of daily calories as LA was considered to be optimal, and omega-3 fatty acids were believed to be beneficial and inhibit omega-6 activity by competitive metabolism.
Experts believed that, for LA and ALA to be equally competitive, their intake should be in the ratio of 14:1, but that equality of competition may not be the criterion for optimal function. The nutrition field recommended very low levels of omega-6 consumption (e.g. less than 6.67 grams/day for a 2000 kcal diet) and very low omega-6:omega-3 ratio of (e.g. 2:1). Numerous international scientists ratified the recommendation.
Petitioner recognized, through her research in the early to mid-2000s on people who suffered from certain chronic conditions, that the recommended dosages and ratios were too low and that the prior art had greatly misunderstood the dose-effect of omega-6 fatty acids. The prior art held that a stepwise increase in omega-6 intake is associated with adverse health, such as an increase in tumorigenesis when the intake is in the range of 0.5-4.4% of calories. Those skilled in the art therefore were not motivated to practice higher dosages of omega-6. Petitioner found, however, that higher intake of omega-6 was required to overcome adverse health conditions (for example, at least 11 grams per day or at least 5.82% of calories consumed).
Petitioner also discovered that the deficiency of omega-6 potentiates certain mechanisms, such that sudden increases in omega-6 have an overflow effect, which can lead to myocardial infarction, strokes, infections, and physiological disturbances.
Petitioner also determined that the optimal amounts and ratios of omega-6 and omega-3 intake depend upon a subject’s intake of other lipids such as, for example, antioxidants, phytochemicals, and other fatty acids and on a subject’s demographics. She devised formulations that embodied these ratios and amounts, and has pursued patents directed to such formulations. “[T]he ratio between [omega]-6-to-[omega]-3 of 15–17:1 in diets is not the problem, the problem is the other factors that influence the metabolism of [omega]-6 and [omega]-3.”
Petitioner’s claimed formulations, being mixtures of components from different sources, are formulated to provide certain amounts and ratios of certain components. At the same time, other components that are not desirable in large amounts or high concentrations become diluted as a consequence of mixing lipids from different sources. The formulations thus provide a dual advantage.
Subsequent to petitioner’s research and patent application filings, several public health organizations advised higher omega-6 intake based on experimental results. For example, the American Heart Association advised that the consumption of at least 5% to 10% of energy from omega-6 polyunsaturated fatty acids reduces the risk of chronic heart disease relative to lower intakes.
Therefore, prior to petitioner’s invention of the claimed lipid formulations, the person of ordinary skill in the art could not have determinedand practiced the claimed suitable ratios and dosages of total omega-6 and omega-3 fatty acids for a subject. Those of ordinary skill in the art have testified to this effect. Additionally, the public cannot solve this problem because lipids are unpredictable in their sources and less than 1% of Americans understand lipids. Thus, the claimed subject matter is directed to solving a poorly understood problem and meeting a critical and long-felt, unmet need. It has great potential to protect and improve public health.
Despite this, USPTO and the Federal Circuit have denied Urvashi Bhagat a patent.
This case is an ideal vehicle for providing the clarification the patent and investment community require. At issue is how to determine whether something is a product of nature under 35 U.S.C. § 101. This case embodies the need for further guidance because this application was rejected while patents that contain claims indistinguishable, on § 101 grounds, from the present case have issued previously. Clarification from the Court will enable the patent and investment communities to allocate their resources more efficiently by pursuing patents only on patent-eligible subject matter, and ensure that similarly situated inventors are treated similarly as required by the law.
Image Source: Photo provided by Urvashi Bhagat.
Updated at a 3:02pm EST September 7, 2018 to add the second paragraph, and to fix