A 'Myriad' of controversy over the question of human gene patent eligibility: a comparison of the differing approaches in the United States and Australia.

Author:Robinson, Jill M.
 
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  1. INTRODUCTION II. BACKGROUND A. United States B. Australia III. REASONING OF THE COURTS A. Supreme Court of the United States B. The Federal Court of Australia IV. IMPLICATIONS OF PATENT ELIGIBILITY OR INELIGIBILITY OF HUMAN GENE SEQUENCES A. Proponents to Gene Sequence Patenting B. Opponents to Gene Sequence Patenting V. HUMAN GENE PATENT ELIGIBILITY DEBATE AS APPROACHED FROM OTHER COUNTRIES A. The European Union B. Canada C. Harmonization VI. CONCLUSION I. INTRODUCTION

    Next came the patent laws. These began in England in 1624, and in this country with the adoption of our Constitution. Before then any man [might] instantly use what another man had invented, so that the inventor had no special advantage from his own invention. The patent system changed this, secured to the inventor for a limited time exclusive use of his inventions, and thereby added the fuel of interest to the fire of genius in the discovery and production of new and useful things. (1) Lincoln's metaphor of patent law's exclusive rights "add[ing] the fuel of interest to the fire of genius," can be applied to the area of patents in another way besides to the "discovery and production of new and useful things." The incentive of exclusive rights has also fueled a wealth of debate over the proper subject matter for patent protection.

    The debate over whether human genes are eligible for patent protection has been prevalent for many years (2) and has come to the forefront once again. Currently, this issue is focused in the united states and Australia. in both countries, recent major decisions have shaken modern patent law.

    In the United States, the U. S. Patent and Trademark Office (USPTO) has granted patent claims relating to newly identified human genes that are linked to the predisposition for diseases. (3) Although the area of human genetics research is relatively new and evolving, patents on human gene sequences (4) have been issued in Australia without much judicial intervention. (5)

    The validity of gene patents held by the company Myriad Genetics has recently been challenged in both the United States and Australia. (6) The Supreme Court of the United States' decision to invalidate human gene sequence patents and the Federal Court of Australia's decision confirming their validity have ignited continued debate on the issue. (7)

    These decisions have far-reaching effects on medical research, patients seeking genetic therapies or testing, and the international character of patents as a whole. The impact of these decisions has sparked much debate from critics and proponents in the scientific, legal, public interest communities. (8) The major scientific and public interest arguments focus on incentivizing research and patient access. (9) Specifically, arguments critical of gene patents center around restraining genetic research and making genetic testing excessively expensive for the public. (10)

    This Comment examines the reasoning and policy implications of the two decisions, and suggests which decision yields the most favorable result. It then seeks to compare the approaches of the U.S. and Australian courts with other countries. It concludes by suggesting which approach produces the best outcome and proposes how and why gene patents should be regulated with international consistency.

  2. BACKGROUND

    In order to explain the arguments for and against the eligibility of human gene sequences for patenting, it is necessary to provide some background of the pertinent patent laws in the United States and Australia and the cases applying those laws in both jurisdictions. This section introduces a basic background of select United States and Australian patent law and the two major cases in the current controversy. Section A presents the law in controversy in the United States and a description of the case Association of Molecular Pathology v. Myriad Genetics, Inc. (11) Section B presents the law in controversy in Australia and a description of the case D'Arcy v. Myriad Genetics, Inc. (12)

    1. United States

      1. Pertinent Law

        Congressional power to make laws about patents stems from Article I, Section 8, Clause 8 of the United States Constitution, which gives Congress the power "[t]o promote the Progress of Science and useful Arts, be securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." (13) This grant of authority allowed Congress to enact the U.S. Patent Act, Title 35 of the United States Code.

        Section 101, Inventions patentable, of Title 35 describes what inventions and discoveries are eligible for patent protection. (14) Section 101 states, "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title." (15) The U.S. Supreme Court "has long held that this provision contains an important implicit exception. '[L]aws of nature, natural phenomena, and abstract ideas' are not patentable." (16) This exception for products of nature is central to the debate over the patent eligibility of isolated human gene sequences in the recent U.S. case Association of Molecular Pathology. (17)

      2. Association of Molecular Pathology v. Myriad Genetics, Inc.

        This case concerned the validity of patents held by Myriad Genetics on genes that correlate with an increased risk of breast and ovarian cancer. (18) This challenge was brought against Myriad by medical organizations, researchers, genetic counselors, and patients. (19)

        Myriad obtained several patents after discovering the precise location and DNA sequence of the BRCA1 and BRCA2 genes, (20) mutations of which can drastically increase the risk of breast and ovarian cancers. (21) The claims under attack in these patents are those covering isolated DNA coding sequences for each of the two genes and claims covering common mutations in the BRCA1 and BRCA2 sequences. (22)

        After Myriad's discovery, other organizations were isolating the BRCA genes for use in genetic testing. (23) Myriad wrote letters to some organizations asserting the genetic testing activity infringed Myriad's patents and filed patent infringement claims against others. All of the target organizations agreed to cease the allegedly infringing activity of isolating the BRCA1 and BRCA2 genes. (24) This solidified Myriad's position as the only entity providing genetic testing on the BRCA1 and BRCA2 genes. (25)

        The present case arose when Oster, along with medical patients, advocacy groups, and other doctors, filed suit seeking a declaration that Myriad's patents were invalid under Section 101 of Title 35 of the U. S. Code. (26) The District Court granted summary judgment based on its conclusion that Myriad's sequence claims were invalid for covering "products of nature." (27) The U.S. Court of Appeals for the Federal Circuit reversed, (28) and the Supreme Court of the United States granted certiorari.

        The Supreme Court held that isolated DNA involves a "naturally occurring segment of DNA, precluding patent eligibility"; however, the Court found that synthetically created DNA, known as complementary DNA (cDNA), is not naturally occurring and is, therefore, patent eligible. (29) The central dispute was whether the act of isolating the DNA sequences was an inventive act that entitles the individual who first isolates it to a patent on the sequence. (30) The reasoning behind the Supreme Court's decision will be discussed in Part III.

    2. Australia

      1. Pertinent Law

        Section 18 of the Patents Act 1990 describes which inventions are eligible for patent protection in Australia. (31) Contrary to the United States, there is no jurisprudential or statutory limitation to patent eligibility to exclude products of nature. (32)

        Section 18(1) of the Patents Act of 1990 sets out the eligibility requirements for obtaining a standard patent under Australian law. (33) This section states that an invention is patentable for the purposes of a standard patent if it is a "manner of manufacture," is "novel and involves an inventive step," and is "useful." (34) Furthermore, the patent can only be granted if the manner of manufacture "was not secretly used in the patent area before the priority date of that claim." (35)

        IP Australia, the Australian Government agency that administers rights and legislation related to intellectual property, (36) specifically lists in its guidelines for biological inventions that are patent eligible, "isolated DNA, RNA, chromosomes and genes (including human DNA and genes)."37 It also lists an isolated DNA coding sequence for a gene as an example of a patentable invention. (38)

        While Australia has its own patent laws, policies, and jurisprudence, the Australian courts have borrowed common law and reasoning from other jurisdictions. (39) Particularly, the Australian High Court, the highest court in the federal court hierarchy, has looked towards U.S. patent cases for guidance. (40) However concerning the patentability of human gene sequences, the Federal Court of Australia chose not to follow the lead of the United States, as evidenced in the decision in D'Arcy v. Myriad Genetics Inc. (41)

      2. D'Arcy v. Myriad Genetics Inc.

        This case also concerns the validity of a patent held by Myriad in Australia for the BRCA1 gene, for its claims covering sequence and mutation sequences. (42) Here, the Federal Court of Australia affirmed the February 2013 decision in favor of Myriad Genetics and the eligibility of human genes for patenting in Australia. (43)

        The case was brought by the patient advocacy group Cancer Voices Australia and Yvonne D'Arcy, a breast cancer survivor, against the U.S.-based Myriad Genetics. (44) Myriad holds the exclusive right to conduct tests for mutations in the BRCA1 gene in Australia as a result of owning the patent. (45)

        Cancer Voices Australia began legal action over patents associated with the BRCA1...

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