Chapter §3.04 Compositions of Matter Within §101

• Jurisdiction: United States

§3.04 Compositions of Matter Within §101

[A] Definition of a Composition of Matter

A composition of matter is a mixture of substances such as a chemical composition or metallic alloy. The Supreme Court in Diamond v. Chakrabarty⁶⁸⁹ summarized its earlier decisions defining the phrase "composition of matter" as "consistent with its common usage to include 'all compositions of two or more substances and. . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids." '⁶⁹⁰ In the 21st century, the Supreme Court has considered whether claims directed to parts of the human genome can qualify as patent-eligible "composition[s] of matter" under 35 U.S.C. §101.⁶⁹¹

[B] Structure Versus Properties: Newly Discovered Properties of Known Compositions

If a composition of matter is claimed as such, it is the physical structure of the composition that must be novel, not merely its properties. The discovery or recognition of a composition's previously unappreciated property (e.g., the ability of aspirin to lessen the risk of heart attacks) will not impart patentability to that composition if its structure is already known. Such a discovery might merit patentability if claimed as a process, but not as a product.

For example, the inventors in Titanium Metals Corp. v. Banner⁶⁹² discovered that a titanium alloy made up of certain amounts of titanium, nickel, molybdenum, and iron exhibited exceptionally good corrosion resistance. They claimed the alloy as follows:

1. A titanium base alloy consisting essentially by weight of about 0.6% to 0.9% nickel, 0.2% to 0.4% molybdenum, up to 0.2% maximum iron, balance titanium, said alloy being characterized by good corrosion resistance in hot brine environments. ⁶⁹³

The prior art was a Russian printed publication that disclosed a particular alloy falling within the ranges recited in claim 1, but made no mention of any corrosion resistance property.

The Federal Circuit held that the Russian reference anticipated (i.e., destroyed the novelty of) the claimed alloy, despite the claim's inclusion of the corrosion resistance limitation. Whether or not the corrosion resistance property was inherent in the Russian alloy,⁶⁹⁴ and whether or not the authors of the Russian reference recognized this property, its recitation in the claim could not impart novelty to what was an otherwise old composition of matter.

The applicants might have obtained a patent by claiming a process for preventing corrosion in titanium alloys, but such a claim would be much narrower in scope and thus of less economic value than the product claim they sought (i.e., to the alloy itself).⁶⁹⁵ Nevertheless, the more limited scope of a process claim more closely corresponds to the inventors' contribution—the recognition of a previously unrecognized property of a known alloy.

[C] Products of Nature

[1] Purified Forms of Natural Products

The "product of nature" doctrine recognizes that potentially patentable subject matter must be created through human intervention. Patents are not available for the handiwork of nature. Thus, a newly discovered mineral or a plant found in the wild is not patentable subject matter under 35 U.S.C. §101. Those who make such discoveries or findings have certainly made an important contribution to society, but public policy demands that such advances remain freely available for all to use and build upon.

In contrast, so-called "purified forms" of natural products may be patentable if sufficiently different from the nonpurified (i.e., natural) forms so as to be novel and nonobvious. In fact, the USPTO has a long history of granting patents on purified forms of natural products; for example, the famous scientist Louis Pasteur was awarded a U.S. patent for purified yeast in 1873.⁶⁹⁶

Judge Learned Hand expressed the modern understanding of the patentability of purified forms of natural products in Parke-Davis & Co. v. H.K. Mulford Co.⁶⁹⁷ The patent in suit in that case was directed to a purified form of adrenaline, a naturally occurring hormone secreted by the suprarenal glands of animals and released into the bloodstream in situations of fear or stress. The inventor Takamine claimed "[a] substance possessing the herein-described physiological characteristics and reactions of the suprarenal glands in a stable and concentrated form, and practically free from inert and associated gland-tissue."⁶⁹⁸ Judge Hand rejected the accused infringer's challenge to the claim's validity. "Nor is the patent only for a degree of purity, and therefore not for a new 'composition of matter,' " he observed. Takamine was "the first to make it available for any use by removing it from the other gland-tissue in which it was found."⁶⁹⁹ While Hand conceded that it was "of course possible logically to call this a purification of the principle," the claimed composition "became for every practical purpose a new thing commercially and therapeutically." Hand considered that fact "a good ground for a patent."

In re Bergy further illustrates this principle.⁷⁰⁰ Patent applicant Bergy claimed a biologically pure culture of a microorganism that produced the antibiotic lincomycin.⁷⁰¹ The Federal Circuit's predecessor court, the CCPA, reversed the USPTO's rejection of Bergy's claim as, among other grounds, a mere product of nature. The court stressed that "[t]he biologically pure culture of claim 5 clearly does not exist in, is not found in, and is not a product of, 'nature.' It is man-made and can be produced only under carefully controlled laboratory conditions."⁷⁰² Indeed, "[t]he nature and commercial uses of biologically pure cultures of microorganisms like the one defined in claim 5 are much more akin to inanimate chemical compositions such as reactants, reagents, and catalysts than they are to horses and honeybees or raspberries and roses."⁷⁰³

[2] Genetic Materials

Realizing the limits on the product of nature doctrine helps explain why some human-based genetic materials have been patented, a point often discounted by those opposed to the granting of such patents. Admittedly, genes⁷⁰⁴ as they exist in the human body would, indeed, be considered products of nature outside the purview of 35 U.S.C. §101.⁷⁰⁵ But starting in the 1980s, the USPTO granted thousands of gene patents,⁷⁰⁶ taking the position that the discovery of a gene could be the basis for a patent on the gene as "isolated from its natural state and processed through purifying steps that separated the gene from other molecules naturally associated with it."⁷⁰⁷ Patent claims directed to such modified genes and gene fragments typically recite "a purified and isolated nucleic acid" comprising a particular nucleic acid sequence set forth in the patent application.⁷⁰⁸ The sequence of nucleotides⁷⁰⁹ encompassed by this type of claim arguably represented a significantly different composition or manufacture from the unpurified and unisolated DNA as it existed in the human body.⁷¹⁰

[a] Ass'n for Molecular Pathology v. Myriad Genetics (U.S. 2013)

In the 21st century, the topic of gene patents increasingly attracted heated public debate,⁷¹¹ eventually drawing the scrutiny of the U.S. Supreme Court. In 2013, the Court significantly limited the patentability of certain genetic materials in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. ("Myriad IV"),⁷¹² as detailed infra. Prior to the Court's decision in Myriad, the consensus view had been that "purified and isolated" DNA was not necessarily excluded from patentability under §101 as a "product of nature." The Supreme Court's Myriad IV decision rewrote the law and severely contracted the gene patenting landscape.⁷¹³

The Myriad saga entered the public consciousness when a New York federal district court in March 2010 granted summary judgment invalidating a number of biotechnology patents directed to the "BRCA1" and "BRCA2" human breast cancer genes.⁷¹⁴ One of the most highly publicized patent disputes in recent memory, Association for Molecular Pathology (AMP) v. United States Patent and Trademark Office (USPTO) and Myriad Genetics, Inc. ("Myriad I")⁷¹⁵ pitted patient care advocates against the patent-owning biotechnology industry.⁷¹⁶ The several patents in suit, owned by Myriad Genetics, Inc., included, inter alia,⁷¹⁷ numerous composition of matter claims directed to two human genes, known as BRCA1 and BRCA2. Myriad had identified the precise location and sequences of the BRCA genes in the 1990s, including certain mutations of the genes that correlated with an increased likelihood of developing breast or ovarian cancer. By testing for the presence of the mutations, doctors could determine whether a patient was at risk of developing these cancers.⁷¹⁸

The composition of matter claims in Myriad's patents were of two types: (1) claims to "isolated DNA" coding for the BRCA1 and BRCA2 breast cancer genes, the location and nucleotide sequence of which Myriad had identified;⁷¹⁹ and (2) claims to complimentary DNA ("cDNA"), which recited only the cDNA exons (i.e., those DNA nucleotides that code for amino acids) in the BRCA genes rather than their full DNA sequence containing both exons and introns (i.e., those DNA nucleotides that do not code for amino acids).⁷²⁰ After the district court held that the challenged composition claims (both the isolated DNA claims and the cDNA claims) were invalid because they covered patent-ineligible products of nature, Myriad appealed.

Prior to the appeal in Myriad in 2011, the Federal Circuit had upheld the validity of gene patents, but those challenges had been based on issues of compliance with the nonobviousness requirement of 35 U.S.C. §103 and the disclosure requirements of 35 U.S.C. §112 rather than §101 patent-eligibility grounds.⁷²¹ Thus the appellate court's decisions in the Myriad dispute were closely watched by the scientific and investment communities. The Federal Circuit issued its first of two merits...