With the advent of biotechnology, the human community stands on the threshold of an extraordinary revolution having profound implications for man and his relationship with other creatures1. Advances in the revolutionary technology are transforming industrial process and management landscape2, with far-reaching impacts on healthcare, agriculture and environment protection.
The success story of modern biotechnology industry is closely linked with the evolution of modern patent law, and patents are pillars of biotechnology industry3. To protect adequately biotechnological inventions, what is required is effective harmonizing legislation as regards patentability criteria4. Although harmonization at the international level is in progress, due to territoriality, distinct policy goals and cultural backgrounds of each nation, patent laws are inherently diverse5 and the worldwide patent scene is a mosaic of different requirements of procedures6 . Therefore, it is still necessary to be familiar with the domestic requirements before filing a patent application in certain countries.
The recent decisions of Myriad7 and Prometheus8 aroused the rethinking of an essential issue: patent-eligible subject matter9 in biotechnology, especially gene-based inventions. Through the comparison of patent-eligible subject matters related to biotechnology in the U.S., Europe, Japan and China, this study will be of assistance for a patent practitioner in this art to have an overview of the diverse doctrines in these countries or regions and to effectively design patent drafting and filing strategies.
II. Legal Statutes and/or Case Law
1. TRIPS: the “Umbrella”
TRIPS is a dramatic turning point in recent phases of IP development10 and the most comprehensive multilateral agreement on intellectual property up to date. TRIPS established the minimum standards for patentability. Article 27.2 and 27.3 of TRIPS provide the possibility, but not obligation, to exclude certain inventions from patentability, for instance, inventions contrary to ordre public or morality, diagnostic, therapeutic and surgical methods for the treatment of humans or animals, plants and animals as well as essentially biological processes for the production of plants or animals. As analyzed below, the principles and standards of TRIPS are reflected and implemented in individual patent laws to different extent.
2. the U.S.
In the U.S., “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor”.11 However, “[t]his is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable”.12
As early as 1948, in Funk Brothers Seed Co. v. Kalo Inoculat Co., the Supreme Court held that an inoculant13 comprising a plurality of selected mutually noninhibitive strains of root-nodule bacteria was not patent eligible.14 It was ruled that the discovery of properties of the bacteria is “no more than the discovery of some of the handiwork of nature”; and the aggregation of the selected strains into one product is “hardly more than an advance in the packaging of the inoculants”.15
From 1970s till early 1980s, the Supreme Court made several decisions regarding the issue of patent eligibility. In this period, a landmark case in the field of biotechnology is Diamond v. Chakrabarty 16. In contrast to Funk Brothers Seed Co. v. Kalo Inoculat Co., in this case, the Supreme Court considered that an oil-eating bacterium comprising at least two stable energy-generating plasmids “qualifies as patentable subject matter” since it is “a nonnatually occurring manufacture of composition of matter” .17
The holding of Diamond v. Chakrabarty set out “the framework for deciding the patent eligibility of isolated DNA moledules18” and gene patents have been deemed as patent eligible for around 30 years. This status quo, however, was called into question by the district court’s holding in Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (Myriad I).19
On May 12, 2009, the Association for Molecular Pathology, physicians, researchers, genetic counselors and patients brought suit in the Southern District of New York against the United States Patent and Trademark Office (PTO) and Myriad Genetics (Myriad), challenging the validity of fifteen claims from Myriad’s seven patents related to BRCA genes, mutations in which correlate with an increased risk of breast and ovarian cancer.20 The District Court held that all of the challenged claims were invalid under 35 U.S.C. §101.21 Specifically, isolated DNA was deemed as an unpatentable product of nature because the unaltered information-encoding function of DNA is also central to the utility of DNA in its isolated form.22 The Federal Circuit reversed the district court regarding the nine composition claims, holding that the composition claims related to isolated DNAs were patent eligible under 35 U.S.C. §10123. In the meantime, the Federal Circuit affirmed the district court regarding the five method claims and concluded that the claims to “comparing” or “analyzing” two gene sequences fall outside the scope of § 101 because they claim “only abstract mental processes”.24 The Federal Circuit reasoned to its conclusion through comparisons with the decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.25, in which it held that methods for optimizing the dosage of thiopurine drugs administered to patients with gastrointestinal disorders were patent eligible under § 101.
However, in the decision of the Supreme Court Mayo Collaborative Services v. Prometheus Laboratories, Inc., it was held that “Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm”.26 Following this decision, the Supreme Court vacated the judgment of “Myriad II” and remanded the case to the 3rd Federal Circuit for further proceedings in light of the Supreme Court’s decision in Prometheus. Around five months later, the Federal Circuit reaffirmed its ground and ruled in favor of Myriad Genetics27. Upon the petition by the American Civil Liberties Union and the Public Patent Foundation, a certiorari was granted by the Supreme Court and oral arguments are scheduled before the Supreme Court on April 15, 2013.
In addition, according to the existing policy of USPTO, human organisms are not patent-eligible subject matter. This policy has been codified into Section 33 of the Leahy-Smith America Invents Act, stating that “notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism”.
According to Article 53 EPC 2000, the following inventions are not eligible for European patents: inventions the commercial exploitation of which would be contrary to “ordre public” or morality; plant or animal varieties; essentially biological processes for the production of plants or animals; methods for the treatment of the human or animal body by surgery or therapy; and diagnostic methods practiced on the human or animal body. It can be seen that the excluded subject matters are substantially consistent with those set forth in TRIPS.
Inventions the commercial exploitation of which would be contrary to “ordre public” or morality. Four types of such inventions are exemplified, namely: processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; use of human embryos for industrial or commercial purposes28 ; and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes29. Although use of human embryos for industrial or commercial purposes are not patent eligible, induced pluripotent stem cells (iPSC) may be allowable30.
Plant or animal varieties. Although plant or animal varieties are not patentable, however, if the technical feasibility of an invention concerning a plant or animal is not confined to a particular plant or animal variety, such an invention shall be patentable31. Therefore, a claim wherein specific plant varieties are not individually claimed is not excluded from patentability even though it may embrace plant varieties32. Also, the decision of T 19/90 (“Onco-mouse”) confirmed that a transgenic non-human mammalian animal does not fall within the scope of animal varieties under Article 53 EPC.
Inventions directed to the human body and its elements. Inventions as such are categorized into two forms: natural form and isolated form. On one hand, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions33. On the other hand, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.34
4. Japan Same as the U.S., laws of nature are not patent eligible in Japan. Further, an invention that is liable to injure public order, morality or public health shall not be patented.35
Methods of surgery, therapy or diagnosis of humans. Although methods of surgery, therapy or diagnosis of humans are not patentable in Japan, such methods practiced on non-human animals are not excluded from patent eligibility.
Plants and animals. In contrast to EPO, plant or animal varieties, essentially biological processes for the production of plants or animals including breeding methods are in general allowable in Japan36. Transgenic plants and animals are also patent eligible.
In addition, an isolated gene, a protein, a vector, a transformant and a fused cell are patent eligible in Japan.
In China, “any invention-creation that is contrary to the laws or social morality or that is detrimental to public interest” is not patent eligible37. In the field of biotechnology, such inventions include embryonic stem cells of human beings, human body at the various stages of its formation and development.38
Similar to Europe, scientific discoveries, methods for the diagnosis or treatment of diseases as well as plant and animal varieties, which are enumerated in Article 25 of Chinese Patent Law, are not patent eligible. “Methods for the diagnosis or treatment of diseases” are not limited to those practiced on human bodies, but encompass those practiced on animal bodies.
Plant and animal varieties. Not only a single plant, but also its reproductive materials, e.g., a seed, are generally deemed as “plant varieties”39. As for “animal varieties”, an embryonic stem cell of an animal, an animal at various stages of its formation and development, such as a germ cell, belong to animal varieties. It is worth noting that transgenic animals and plants are also construed as “animal and plant varieties” in current practice40.
Microorganisms and genes or DNA fragments existing in the nature are considered as scientific discoveries; however, they are eligible for patenting as an isolated form41.
This study provides an overview of the legal provisions regarding patent-eligible subject matter in view of recent cases. Under the “umbrella” of TRIPS, the provisions are harmonized to some extent, but the specific doctrines are still distinct in individual patent law. Compared with Europe, Japan and China, currently, patent-eligible subject matters are more extensive in the U.S..
Inventions contrary to public interest or morality are not patent eligible in Europe, Japan and China, which corresponds to the provision in Article 27.2 TRIPS. Embryonic stem cells of human beings are considered as inventions contrary to “ordre public” or morality and explicitly excluded from patent eligibility in Europe and China. In contrast, there is no such morality concern under the U.S. patent law currently, which was described as “Patent First, Ask Questions Later”42.
Corresponding to the provisions in Article 27.3 TRIPS, methods for the treatment or diagnosis of diseases are not patent eligible in Europe, Japan and China, although the specific criteria are not completely identical. In Europe and China, such methods practiced on a human or animal body are not patent eligible; in contrast, such methods practiced on a non-human animal body may be patent eligible in Japan.
Corresponding to the provisions in Article 27.3 TRIPS, plant and animal varieties are excluded from patent-eligible subject matters in Europe and China. However, in Europe, if the technical feasibility of an invention concerning a plant or animal is not confined to a particular plant or animal variety, such an invention shall be patentable. By contrast, transgenic plants or animals are deemed as plant or animal varieties and thus are not patent eligible in China.
Up to now, isolated genes are patent eligible under the four jurisdictions. Further update in the U.S. will await the decision of the Supreme Court in Myriad. Even though the debate regarding gene patents has been on-going and there is concern about the prospect of gene inventions, it appears that the filing of patent applications was not adversely affected in the U.S. in 2012. The amount of DNA patent applications in 2012 (9941) slightly increased compared with that in 2011 (9894)43. Considering the importance of biotechnology industry in the U.S., it is expected that isolated genes would continue to be patent eligible.