This website uses cookies to ensure you have the best experience. Learn more

Biotechnology And The Law: Case Studies Pset

1148 words - 5 pages

1. While organisms from nature are not inherently patentable, “human-made microorganisms with markedly different characteristics from any found in nature can be patented as long as the other patent requirements are met” (Bhatia “Patenting” 19). To be patentable, an invention must be new, non-obvious, unique, and useful. Thus, following the conclusion of the case Diamond v. Chakrabarty, which states that as long as the invention meets the above patenting requirements, and that “anything under the sun that is made by man” is patentable, this newly engineered yeast cell is indeed patentable (Bhatia “More” 1). The literature search proved that it was a novel idea, since no previous patents ...view middle of the document...

Also, since the production and clinical trials of the reference drug, drug treatment practices may have changed, clinical trial endpoints may have been modified, and varied patient trial groups may affect clinical trial outcomes. Thus, despite inherent similarities, there may be underlying differences in effectiveness that only thorough new clinical trials would reveal (Suh). Biosimilars are complex topics with specific scientific and regulatory challenges, because they require reference products, quality markers, non-clinical and clinical data and trials, and special requirements for interchangeability with preexisting drugs (Bogaert). Currently in the United States, an application for a biosimilar patent “must include data derived from a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate condition of use for which the reference product is licensed and intended to be used. The purpose of these data is to help demonstrate that the product is biosimilar to a reference product” (Bogaert). Only once this similarity is proven can the new rituximab product can be considered an effective and licensed biosimilar product.
3. With the extension of a patent, the government also reserves the right to “’march in’ and compel the granting of a license (or grant one itself) to a ‘responsible applicant or applicants’ if the patent owner is not holding up its end of the agreement to use the invention for the benefit of the public” (Conley). The existence of “march-in rights” has the potential to be extremely helpful in dire times, but if misused, to override the free market and wreak havoc on pharmaceutical business, thereby “distorting the pharmaceuticals market” (Conley). The ruling effectively gives the government the authority and ability to take over a pharmaceutical company if the company is not performing according to the government’s wishes. While this could have proven beneficial to patients with Fabry disease in 2009, and it can be argued that patient lives should have overruled pharmaceutical freedom, the precedent that would have been set by government intervention could have proven disastrous. Had the government intervened, the company would have essentially undergone a government takeover. Considering the emphasis America places on the importance and value of the free market, this radical decision could have had rippling effects. If government takeovers became a feasible option, pharmaceutical companies could become hesitant to invest large amounts of time and money into products, only to see their products confiscated by the government. Also, perhaps more importantly, if...

Find Another Essay On Biotechnology and the Law: Case Studies Pset

Bankruptcy and Insurance Case Studies Essay

1045 words - 5 pages insured to answer questions that will result in lower rates (Sentell) (Twomey & Jennings, 2014, p. 778). Case law and statutory law revolves around the issue of the materiality of the misrepresentation made by the insured in the bad faith refusals of underwriters to pay claims (Sentell). Williams v. Tennessee Farmers Life Reassurance Co., No. M2011-01946- COA-R3-CV (Tenn. Ct. App. July 31, 2012) exemplifies this in that “Ms. Williams' failure

Boeing and Walmart Case Studies Essay

1231 words - 5 pages , they are using switching costs as an isolating mechanism to sustain their competitive advantage. True – Buyers will end up incurring significant switching costs if they change to another supplier. The Onecard is a loyalty program that offers customer’s points, discounts and rewards and they will face switching costs if they chose to shop at another grocery store. 2. Referring to the Wal-Mart case study provided, answer the following

The pros and cons of Biotechnology

780 words - 3 pages not -what genes are involved in what kind of behavior. Rather it is HOW do the different sequences of genes biologically affect certain type of behavior. In chapter 1, Rifkin introduces the readers to the positive and negative consequences of the ambitious development of the biotechnology in the first chapter. Although Rifkin explains how the biotechnology is boon to the public health, the tone he carries throughout seems to be actually

The Sociological Impact of Nanotechnology and Biotechnology

2028 words - 8 pages I elected to do my term paper on the sociological impact of nanotechnology and biotechnology (commonly called “bionics”) because of the vast potential for advances in medicine, space exploration and technology. These are but a few of the areas which will surely be affected by the development of new and never before imagined processes and engineered materials which have the power to change the way every aspect of one’s life is lived. I will

The Case of Procedural and Substantive Law

2226 words - 9 pages 1. Define the terms takings as it relates to the environmental law and provide one example of a legally resolved taking case. Answer: Taking is a general term of an act of taking something. In an environmental point of view, the taking is ta process that involves taking something of an environmental assets, such as land, from an individual or organization. However, most cases, it involves government taking private property from owners when that

Biotechnology. An international biosafety protocol created to establish and maintain control over the products designed with biotechnology

1725 words - 7 pages OutlineThesis statement: An international biosafety protocol should be created to establish and maintain control over the products designed with biotechnology.I. The existing laws and regulations that govern the release of transgenic organisms are inadequate or nonexistent.A. The developed nations of the world are using regulations that were designed to control and monitor crops created with traditional technologies.B. Biotechnology is regulated

Statue and Case law Relationship

2013 words - 8 pages Employment laws are created to protect both the employer and the employee. The employer has to follow specific guidelines when hiring and firing employees. This paper will identify five discrimination cases with a brief summary of each as well as identify the statute or regulation interpreted in the case. Lastly, this paper will examine how the statute and/or regulations have evolved through case interpretation and how the cases influence the

Statute and Case Law Relationship

1030 words - 4 pages This paper provide a brief summary and identify the statute pertaining to race discrimination between Dayton, Police Department and Police Major Barbara Temple.This writer will provide a brief summary and identify the statue pertaining to race discrimination in this law case study. This writer will also explain and examine how the statue is related to this case study. Final this writer will deliver an outcome of the case involving Case #49

State and Case Law Relationship

2034 words - 8 pages State and Case Law Relationship Paper•EEOC v. Jillian's of Indianapolis, Inc., Jillian's Entertainment Holdings, Inc. & Jillian's Entertainment Corp., No. IP00-1452-C-B/G (S.D. Ind. Aug. 12, 2004)This case was brought under Title VII of the Civil Rights Act of 1964, which prohibits discrimination based on gender (or sex), as well as many other aspects of the employment relationship. It applies to most employers engaged in interstate

Analysis of the Case Law

3355 words - 13 pages Analysis of the Case Law "There is no prescribed constitutional relationship between the courts and the executive, but the judges assert their inherent power, derived from the rule of law, to review executive actions" The question starts off by giving us an element of the separation of powers when it says that there is no prescribed

Couselling, family and other issues in palliative - case studies

2611 words - 10 pages INTRODUCTIONThis assignment will take the format of case studies and it is aimed at examining my listening and understanding skills. The case studies I have chosen are ones that have impacted on my career in palliative care. Reflecting on a second possible interpretation within them I will be able to show how important it is to assess each situation thoroughly, as outcomes may be completely different if misinterpreted.CASE STUDY ONEBridget was a

Similar Essays

Biotechnology And The Modern World Essay

1030 words - 5 pages Advances in biotechnology can be looked at two ways; both positive and negative. People can also differ in what would qualify as positive and negative. Some may think that tinkering with Deoxyribonucleic acid also know as DNA, should not be allowed at all for any reason. Others believe that manipulating human DNA can have many different benefitial outcomes. Biotechnology or genetic engineering, can be be potentially misused and result in

Case Studies And The Design And Application Of Information Technology

2959 words - 12 pages Case studies play a significant role in the design and implementation of information technology. This is because of the fact that the global information technology industry is almost influenced by the same technological trends and it is feasible for them to share information regarding customization, upgrades and developments (Petrides 2000, 23). This paper will attempt to shed light on the manner in which case studies can inform in the design

Internet Censorship Two Case Studies: Australia And The United States

2829 words - 11 pages not ethical and internet users should decide for themselves what they can and cannot see. This paper will prove the ethical implications of internet censorship through two case studies: the United States' Communications Decency Act, and Australia's Broadcasting Services Amendment (Online Services) Act 1999. The United States and Australia have both taken two different approaches to internet censorship. However, both countries started out with

Amnesia In Singular Case Studies And The Experiments Developed Thereof

1570 words - 7 pages . His temporary memory seemed fine, though, and his IQ increased. HM retained a few memory functions, however. He could still learn complicated tasks, without realizing it. The only function of his memory that was severely damaged was his ability to turn short-term memories into long-term memories. Josh Foer writes "Given the horrific outcome of Scoville's surgery, everyone assumed HM would be a singular case study. EP shattered that