Patents and intellectual property
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Slides from the lecture on patents and intellectual property in Phil 133 ("Ethics in Science" at San Jose State University.
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This document discusses several issues relating to patents and intellectual property:
- There is a tension between the norm of open scientific knowledge and the concept of intellectual property ownership.
- Employers and universities often claim ownership over intellectual property created by employees and students. Patent law varies by jurisdiction on this issue.
- Patents provide a limited monopoly on inventions in exchange for publicly disclosing details that allow others to replicate the work once the patent expires. However, critics argue the patent system does not always encourage innovation or serve the public interest.
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This document discusses the ethical issues surrounding patenting human genes and how it affects scientific research and medical practice. While companies argue patents fuel research, evidence shows patents can slow research by requiring licensing fees and risk of infringement penalties. Patents on genes linked to diseases have limited further research identifying new mutations and made diagnosis only available through the patent holder. Surveys found many researchers limited projects or discontinued research due to patent risks. Withdrawing gene patents, like the Supreme Court did for BRCA1/2, can benefit research, innovation, healthcare costs and patients.
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Breast Cancer – Patents
Executive Summary
Introduction
Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are sought by innovators across various technological fields.
breast-cancer-ribbon
However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
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With a view to discuss implications of patents specifically related to breast cancer, we have researched and analyzed the breast cancer patent landscape in India and US, in light of latest legal developments, with special focus on Trastuzumab (a medicine which treats a form of breast cancer) and US Supreme Court judgement to overturn Myriad Genetics’ patents on the “breast cancer genes - BRCA1 and BRCA2”.
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As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
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Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held e
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- Patents provide a limited monopoly on inventions in exchange for publicly disclosing details that allow others to replicate the work once the patent expires. However, critics argue the patent system does not always encourage innovation or serve the public interest.
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This document discusses the ethical issues surrounding patenting human genes and how it affects scientific research and medical practice. While companies argue patents fuel research, evidence shows patents can slow research by requiring licensing fees and risk of infringement penalties. Patents on genes linked to diseases have limited further research identifying new mutations and made diagnosis only available through the patent holder. Surveys found many researchers limited projects or discontinued research due to patent risks. Withdrawing gene patents, like the Supreme Court did for BRCA1/2, can benefit research, innovation, healthcare costs and patients.
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However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
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As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
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In the field of biotechnology and healthcare, the cost of reparation is crucial, as the research in these fields is highly expensive. The financial investments can only be paid off if the companies can protect results by exclusive rights (patents) and gain the competitive advantage.
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Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held e
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- TRIPS established minimum global standards for intellectual property protection, including recognizing 7 types of IP rights like patents and copyright. It required countries to provide patent protection for inventions in all fields of technology.
- India initially only allowed process patents for food, drugs etc. TRIPS allowed India a 10 year transition period to implement product patents in all areas.
- The 2005 Patent Act Amendment in India fully complied with TRIPS by granting product patents for all inventions effective January 1, 2005. It also addressed issues like patentability criteria, opposition processes, and compulsory licensing.
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This document discusses the philosophical ideas of Duhem, Quine, and challenges in theory testing and scientific methodology. It addresses the concepts of underdetermination of theory by data, holism in testing, and meaning holism. It explains that scientific theories are tested as groups, not in isolation, and that changing one hypothesis can require changes throughout the theoretical framework. The document uses examples like Newton's laws of motion and predictions of planetary orbits to illustrate these concepts.
P160 Hempel, Hume, Deduction, and Induction
The document discusses Semmelweis' work in the 1840s to address childbed fever in Vienna hospitals. Semmelweis observed that the mortality rate from childbed fever was much higher in the first division ward staffed by doctors and medical students compared to the second division ward staffed by midwives. Through a process of elimination, Semmelweis hypothesized that cadaveric particles carried from autopsies to patients caused the disease. Reducing these particles by washing hands and instruments with chlorinated lime lowered the mortality rate, supporting his hypothesis. However, his conclusion could not be logically proven through the evidence, as other factors could also explain the outcome. The document also discusses the problem of induction in drawing conclusions about
Lect10 Human Subjects: History
The document discusses the history of human subjects research, including unethical experiments conducted by Nazi Germany scientists and the Tuskegee Syphilis Experiment conducted by the U.S. Public Health Service from 1932 to 1972. The Nazi experiments violated subjects' rights and caused extreme harm. The Tuskegee study intended to observe untreated syphilis in black men but became unscientific when subjects received some treatment and contributed no useful medical knowledge. It was later deemed unethical by modern standards for failing to obtain informed consent and exposing subjects to harm without benefit.
Lect11 Human Subjects: Regulations
The document discusses the historical evolution of ethics guidelines for research involving human subjects. It begins with the Hippocratic Oath from ancient Greece which established early standards of medical ethics. It then discusses the Nuremberg Code created after World War II which focused on informed consent and avoiding harming subjects. Finally, it examines the Declaration of Helsinki which recognized the need for institutional review and emphasized informed consent, assessing risks/benefits, and protecting subject well-being.
Lec12 Human Subjects:Global Issues
This document discusses several ethical issues regarding human subjects research, particularly in developing countries. It summarizes the Belmont Report's principles of respect for persons, beneficence, and justice. It then examines debates around the ethics of placebo-controlled trials in developing world contexts and whether local standards of care are acceptable for control groups. The tension between beneficence toward subjects and producing scientifically valid results that could benefit the population is also discussed.
Lec13 Scientific Papers and Communications
This document discusses scientific communication and the process of publishing scientific papers. It outlines the typical sections of a scientific paper, including the introduction, methods, results, and discussion. It also describes the role of peer review in evaluating papers before publication. While scientific papers aim to contribute to shared knowledge, they also serve as a way for scientists to establish priority and build their career records. This can complicate communication if it discourages sharing negative results or stretching the interpretation of findings. The document examines criticisms of the standard scientific paper format and considers other modes of scientific communication.
Lec 14 Authorship Issues
This document discusses authorship standards and issues in scientific publishing. It outlines why author order and attribution matter for communicating who did the research and granting proper credit. It describes problematic authorship situations like ghost writers and guest authors that can mislead readers. The document also summarizes International Committee of Medical Journal Editors standards for authorship and calls for more explicit identification of author contributions to increase accountability. It raises some concerns about peer review being misused to delay competitors' work.
Lec16 International Strategies for Scientific Dialogue
International strategies for scientific dialogue discusses various cultural influences on scientific communities and how scientists navigate these differences. Some key points summarized:
1. Local cultures and institutions can influence how science is practiced differently than an idealized meritocratic model. Hierarchies form within communities based on factors like field of study or country of origin.
2. Japanese scientists aim to participate globally while maintaining their national identity, but risk being seen as "strange" if habits from abroad are acknowledged.
3. The Tsukuba Science City project departed from traditional Japanese models by focusing on a less prestigious field outside standard university channels. This lowered their status nationally but raised it internationally in that field.
Explanation classroomversion
The document discusses different types of scientific explanations and criteria for a good explanation. It presents the deductive-nomological model of explanation but notes some limitations, as not all good explanations fit this model and some arguments that fit the model may not be good explanations. Different examples are provided to illustrate explanations based on laws of nature, statistical generalizations, mechanisms, and pragmatic or contextual factors.
P160 antirealismclassroomversion
The document discusses various positions regarding scientific realism and antirealism. It presents an example from the 19th century of a scientist, Jones, developing a theory that an unobservable microbe called a "crobe" is responsible for transmitting disease in the same way that lice transmit diseases. While the theory is empirically successful, some argue we cannot know if crobes truly exist. The document explores arguments for scientific realism, antirealism, and a middle position of "entity realism," discussing what types of claims we can and cannot make regarding observable versus unobservable entities based on empirical evidence and scientific theories.
P160 naturalismclassroomlect
The document discusses several topics relating to naturalism as a philosophical approach:
1) Naturalism shifts the question from how to justify scientific methodology to how to adequately describe how knowledge and science work based on what science tells us.
2) A naturalist view is that science can describe the belief-forming mechanisms that humans use and philosophy can evaluate how good those mechanisms are for achieving different goals.
3) Several philosophers discussed apply scientific findings and methods to philosophical problems, including describing how social and reward structures within science help explain its success.
Feminist Critiques of Science
The document discusses feminist critiques of science, specifically examining how the exclusion of women from science may have been harmful. It explores how scientific theories in the past have promoted gender biases and stereotypes to justify excluding women. A key feminist critique is that excluding diverse perspectives, like those of women, reduces objectivity by limiting alternative viewpoints and questions that could be asked. The document argues that including more women in science can help address implicit biases and assumptions, leading to more rigorous and objective scientific research.
Indirect-table Analysis
The document discusses indirect truth table analysis for determining the validity of arguments. It provides examples of setting up truth tables to evaluate arguments by making the conclusion false and premises true without contradictions. The examples show both valid and invalid arguments based on whether a consistent truth assignment can be found.
Truth table analysis
The document discusses how truth tables can be used to determine the logical status of propositions and arguments. Truth tables assign truth values (True/False) to propositions based on the truth values of their component statements, allowing the logical status of single propositions and groups of propositions to be determined. The logical status can be tautology, contradiction, contingent, equivalent, satisfiable/consistent, or unsatisfiable/inconsistent depending on the truth values. Validity of arguments can also be determined from truth tables by checking if the conclusion is true in all rows where the premises are true. Examples of truth tables are provided to illustrate these concepts.
Translating English to Propositional Logic
The document discusses translating statements from English to propositional logic, including:
- Conjunction and disjunction are commutative but order matters for statements with mixed operators
- How to translate conditional statements like "if P then Q" and biconditionals like "P if and only if Q"
- Necessary and sufficient conditions and how they relate to conditionals
- Examples of translating various English language statements into propositional logic statements
P160 Kuhn classroom Lecture 2
The document discusses Thomas Kuhn's concept of scientific revolutions and paradigm shifts. It explains that normal science operates within a shared paradigm, but anomalies can lead to a crisis when the paradigm is unable to solve resistant puzzles. This forces scientists to consider alternatives. When comparing paradigms like Ptolemaic vs Copernican models of planetary motion, factors like how well each addresses unsolved puzzles, fits with other theories and observations, and aesthetic appeal influence which paradigm gains acceptance. However, paradigm choices are subjective since what we observe depends on the paradigm.
Propositional logic
The document discusses translating natural language statements into propositional logic by identifying logical structures like negation, conjunction, disjunction, etc. It provides examples of translating statements involving negation (e.g. "Bill does not own a car"), conjunction (e.g. "Jenny went to the park and Bill went to the park"), disjunction (e.g. "Either my roommate will bring the textbook or my lab partner will let me borrow hers"), and discusses how to properly capture meaning and logical relationships. Key concepts covered are using variables to represent propositions, appropriate use of logical operators, and handling collective subjects, temporal sequences, and additive comparisons.
Kuhn: Paradigms and Normal Science
Thomas Kuhn argues that science operates in two distinct modes: normal science and scientific revolution. During normal science, scientists work within a shared paradigm that provides the framework and assumptions for their research. The paradigm guides what phenomena can be explained, what problems are worth studying, and how research is conducted. However, over time anomalies and resistant problems emerge that the paradigm cannot resolve, leading to a crisis and eventual shift to a new paradigm during a period of scientific revolution.
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