This paper addresses the question of whether the patentability of signals is compatible with the law in Canada and attempts to develop a test for use in determining when a signal should be considered patentable subject matter. The hard-line position of the Canadian Intellectual Property Office, that signals are not patentable, is shown not to be supported in law. Canada’s domestic law is, in fact, compatible with the patentability of signals. Lessons are drawn from Europe, where signals are patentable and the United States, where they are not. Various international treaties are also examined for possible obligations concerning signals. Finally, an attempt is made to formulate a workable test for the patentability of signals that is compatible with Canadian legislation and case law.

This paper addresses the question of whether the patentability of signals is compatible with the law in Canada and attempts to develop a test for use in determining when a signal should be considered patentable subject matter. The hard-line position of the Canadian Intellectual Property Office, that signals are not patentable, is shown not to be supported in law. Canada’s domestic law is, in fact, compatible with the patentability of signals. Lessons are drawn from Europe, where signals are patentable and the United States, where they are not. Various international treaties are also examined for possible obligations concerning signals. Finally, an attempt is made to formulate a workable test for the patentability of signals that is compatible with Canadian legislation and case law.

Currently there are approximately 20,000 valid gene patents in the United States. The debate regarding biotechnology and patent law has reached a pinnacle over the patentability of genes. Biotech is fighting a patentability war on two fronts. The Court of Appeals for the Federal Circuit cannot agree regarding the touchstone of patentability for genes; two branches of the Executive are at odds over whether gene sequences qualify under 35 U.S.C. §101. Recent U.S. Supreme Court and Federal Circuit jurisprudence also undermine the patentability of genes as obvious. This thesis argues that the patentable subject matter debate fails to adequately address the goals of patent policy in fostering innovation. Looking to Canadian and U.K. jurisprudence, it is possible to hone an approach to obviousness that addresses the ethical and research concerns in the patentable subject matter debate while fostering investment and patent protection for non-obvious biotech discoveries.

Currently there are approximately 20,000 valid gene patents in the United States. The debate regarding biotechnology and patent law has reached a pinnacle over the patentability of genes. Biotech is fighting a patentability war on two fronts. The Court of Appeals for the Federal Circuit cannot agree regarding the touchstone of patentability for genes; two branches of the Executive are at odds over whether gene sequences qualify under 35 U.S.C. §101. Recent U.S. Supreme Court and Federal Circuit jurisprudence also undermine the patentability of genes as obvious. This thesis argues that the patentable subject matter debate fails to adequately address the goals of patent policy in fostering innovation. Looking to Canadian and U.K. jurisprudence, it is possible to hone an approach to obviousness that addresses the ethical and research concerns in the patentable subject matter debate while fostering investment and patent protection for non-obvious biotech discoveries.

Since 2000, digital technology and other technological advances such as 3D printing have improved non-traditional scientists’ participation in biotechnology and life science research and development. Non-traditional scientists, including amateur scientists, students and graduates from the life sciences, artists, programmers, engineers, and entrepreneurs, have rapidly increased under the Do-It-Yourself biotechnology (DIY bio) movement. These DIY biotechnologists or DIYers increase biotechnology research and life science inventions in society by encouraging open and cooperative development. Biotechnology research and development (R&D), especially in healthcare and agricultural biotechnology, suffers from patent proliferation with fragmented and overlapping rights that cover upstream research resources and research tools which can enable downstream developments. The proliferation of patents and related rights protecting upstream research can be detrimental to progress and citizens’ welfare because they can increase the cost of R&D, interfere with access to upstream research tools, and allow R&D to be concentrated around the issues found in developed nations. Many DIYers depend on self-funding and community resources to experiment with biotechnology. Proprietary research tools and equipment are harder to access. Some of them operate alongside proprietary R&D in a research area by building on off-patent technologies and inventing around patents. Some DIYers have made significant contributions in science that benefit other biotechnology researchers and developers, such as developing and manufacturing open source versions of proprietary research tools and equipment. Nonetheless, they can risk inadvertent patent infringement by working in competitive biotechnology research areas with heavy patent coverage. The presence of patent thickets in biotechnology can also discourage volunteers’ initial participation in open R&D. When third party patents develop around open and cumulative development, the risk of patent infringement increases for downstream development and commercial activities based on upstream open R&D. Alternative knowledge management strategies, such as open source patent licensing, clearinghouses and contract-based compensatory liability regimes, allow open innovation communities to create a protected commons of shared resources. However, these do not resolve problems in biotechnology patent law, such as fragmented and overlapping rights on cumulative technologies and strategic patent use. Government actions can address these problems, such as broadening outdated patent law exceptions, which can discourage unnecessary patenting and reduce the risk of infringement in alternative innovation environments.

美國最高法院於2013年6月13日，發佈自2010年起纏訟多年的 AMP v. USPTO & Myriad Genetics案判決，最高法院全體一致認為，與天然相同的DNA序列，即使經過單離（isolated）仍然不具有可專利性，但補償性的DNA（complementary DNA，簡稱cDNA），則為人為發明產物具有可專利性。 判決出來後，引發各界譁然，相關基因測試業者擔心，最高法院的見解，會使基因研發的投資意願大幅減少，反而會阻礙往後創新研發。但支持者認為基因本屬人類共有產物，且否准基因專利後，能夠讓其他更低價、更有效率的檢測方法進入市場，對社會有助益。在專利權人的私有利益與公共衛生利益激烈衝突下，各方都有鏗鏘有力的理由。 美國專利商標局（USPTO）從1980年代起，開始核發與基因有關之專利，並在2001年公布「實用性檢查指引」（Utility Examination Guidelines），認為單離的人類DNA或純化DNA分子，亦可賦予專利，透過賦予專利排他權，達鼓勵研發創新之目的。從過去三十年來，基因相關專利數量劇增，也因為專利排他的特性，對現有的科學研究產生阻礙，不僅如此，對於患者而言，因為專利權人積極行使權利，成為市場唯一壟斷者，使患者無法獲得其他醫療意見（second opinion）的權利，這也是Myriad案備受矚目的原因之一。 因此，本論文將藉由AMP v. USPTO & Myriad Genetics案，重新省思對於人體基因是否具有可專利性，並整理美國司法實務過往對於可專利標的、基因專利等重要判決進行分析，最後提出本文的見解，試圖提出一些可能的解決方案。

The primary objective of the thesis will be to focus on patent protection of software under the European Patent Convention, by analyzing the different approaches that the European Patent Office has taken into consideration since the mid-1980s. These approaches are derived from the different decisions that emanate from the Technical Boards of Appeal of the European Patent Office. The thesis will examine the most relevant decisions illustrating the juridical tendencies and basis that have been utilized to decide over the patentability of computer programs. The analysis will conclude with the latest approach taken by the Technical Board of the European Patent Office. The study will examine the patentability requirements of inventions in general established within the European Patent Convention. Sources that will be utilized to carry out this research will include case law, legislation, specialized legal commentary; journals and books. The present study sustains that computer programs may be patented as long as they comply with all the general requirements of an invention prescribed under the European Patent Convention together with the condition established by case law called the technical character requirement. Nevertheless, due to the fact that the Technical Boards of Appeal are not bound by previous case law, the current position could keep evolving as it relies on the stance of  the European Patent Office on patentability of computer programs which is seems to be influenced by the changes in the technological world