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Andrea Stazi

In today’s technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inventions, with particular regard to patentability of life.
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Frederick M. Abbott and Graham Dukes

policy after 1945, to establish their own units for innovative research, and three decades of massive drug discovery followed. Chemists synthesized new substances, pharmacologists tested them in animal studies, pharmacists developed formulations and clinicians conducted investigations in human subjects. The result was the creation of entirely new classes of effective and relatively safe drugs, such as the modern diuretics, the benzodiazepine tranquilizers and treatments for psychosis and depression. Modifications of natural bodily agents, such as the corticosteroids

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Andrea Stazi

as that which is relative to an invention in the field of biology, the natural science regarding the study of life and living organisms. It may consist in a composition of matter, a method for obtaining or utilizing one or more of these, or a product which combines such elements. Contrarily, the hypothesis that a patent application may concern a naturally occurring biological substance in itself, regardless of whether it refers to a specific procedure or use associated with it, given that it has been sufficiently ‘isolated’ from its natural state, is one of the

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Burcu Kilic

: 4 SESS: 6 OUTPUT: Tue Jun 10 15:16:48 2014 36 Boosting pharmaceutical innovation in the post-TRIPS era Accountability Office revealed that between the years 1997 and 2005, the total spending on direct-to-consumer advertising grew at twice the rate of R&D spending.11 Such findings provide compelling evidence for the argument that the research-based pharmaceutical industry has a systematic tendency to overstate the cost of drug development.12 The potential magnitude of the overstatement remains unclear. The argument made here is highly important for one reason in

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Andrea Stazi

and human beings from patentability based on morality, for which patenting of said living organisms, including human genetic material, would violate ethical standards laid down by the Agreement. To the contrary, the supporters of the patentability of life noted that the ban on patentability concerns plants, animals and human beings but not non-natural plants or animals produced by man or those that are genetically modified, nor human genetic material which is isolated and purified into a non-natural form. On the other hand, no objections have been made regarding the

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Andrea Stazi

shall prevail over the sole interest of society or science’. 73 ‘Convention on Human Rights and Biomedicine’, art. 13. 74 Genomics is the branch of molecular biology which deals with the study of the genome of living organisms. 68 67 Columns Design XML Ltd / Job: Stazi-New_Directions_in_Patent_Law-x / Division: Stazi_Part_II /Pg. Position: 20 / Date: 17/3 JOBNAME: Stazi PAGE: 21 SESS: 4 OUTPUT: Thu Apr 23 10:11:20 2015 Interventions on human genetic material 69 UNESCO, ‘the human genome in its natural state shall not give rise to financial gains’. Article

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Frederick M. Abbott and Graham Dukes

, manufactured, distributed, used and assessed. The systems of innovation and regulation are integrated at various levels. We begin by examining global policy with respect to pharmaceutical innovation. Policies with respect to quality, safety and efficacy are no less important. However, throughout the past several years, policy makers, business leaders and public interest groups have expressed the most intense concern with suboptimal rates of medicines innovation, and with whether the mechanisms now used to promote innovation are unduly inhibiting public access to the

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Frederick M. Abbott and Graham Dukes

developing countries to interpret the TRIPS Agreement in the interest of their own populations. Linked to these problems is widespread discontent with the high level of drug prices, which can render products inaccessible to the poor but can also raise problems in affluent societies. A third source of tension is the increasing realization that useful pharmaceutical innovation has become a rare commodity. Continuing conflict sometimes seems to be an inevitable manifestation of a global system for the development and supply of pharmaceuticals that is dependent on the ability

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Burcu Kilic

–1150 (US 20 March 2012). ‘The Supreme Court invalidated the asserted patents’ process claims as not patent eligible subject matter under §101 of the patent statute. The Court decision is justified on three grounds: (1) the process claims were directed to ‘laws of nature, natural phenomena, and abstract ideas’; (2) the patent did not contain enough of an ‘inventive concept’ to ensure that it ‘amounts to significantly more than a patent upon the natural law itself’; and (3) the invention involved ‘well-understood, routine, conventional activity, previously engaged in by

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Burcu Kilic

$40 million in 1987 from $17 million at the time of its acquisition.9 Furthermore, the 1990s witnessed Teva’s continued rise in the global generic market. At this time, Teva continued to make aggressive investments in the areas of merger and acquisitions and R&D, as well as increasing its own production capacity. The acquisition of pharmaceutical companies in the US, followed by the acquisitions in Europe, saw the company’s business expand into France, Italy, the United Kingdom and Hungary. 8 Teva was bought out of W.R. Grace’s interest in the joint venture