Patents In Biomedicine And Biotechnology Biology Essay

Everyday a batch of new rational belongingss ( IP ) in biomedicine and biotechnology are deluging into to our universe. Although many such Information sciences are free and available to the populace, bulk of such IPs have commercial values to human wellness and our everyday life, and the proprietors of the IPs are often following different attacks such as trade secrets, hallmarks or service Markss, right of first publications and patents to protect their ownership and distribution rights over their IPs. In biomedicine and biotechnology, IPs include non merely biomaterials, and bioprocesses and devices to bring forth such biomaterials, but besides thoughts and the look of thoughts 13. In the yesteryear, patenting of IPs in biomedicine and biotechnology have drawn a batch of unfavorable judgments and debates 3-6,8,9,11,18,20,22-24,27,29-31,33,36,38-40,44,46-50,55,56,58,59,67,69-72,75,76,78.

In present paper, my treatment will be focused on the ethical analysis of the rights and patents of major IPs types such as genetically engineered plants/animals, root cells, curative genes/proteins, antibodies and vaccinums.

Intellectual Property Types and Rights in Biomedicine & A ; Biotechnology

1. Biomedical and Biotechnological Intellectual Property Types

As is good know, an rational belongings or IP is a alone merchandise or a creative activity of human mind/intellect with certain sum of commercial value. In the Fieldss of biomedicine and biotechnology, rational belongingss are chiefly intangible assets of finds, innovations, designs, and thoughts 12,13,30,33,62,73. Biomedical and biotechnological finds, innovations, and the related designs and thoughts can be classified into 3 major types or classs of rational belongingss as follows:

Biomedical and Biotechnological Materials. These may be genetically engineered beings such as transgenic workss 37,38,77, transgenic animate beings 21,28,60, genetically engineered viruses, bacteriums or yeast 26,41,42,61,64 ; some tissues or variety meats of a life being 5,67 ; some type of cells or cell lines 7,32,39,45,51,57 ; particular molecules from the cells of a populating being such as proteins and cistrons 14,17,25,35,65 ; or merchandises like antibodies and recombinant proteins made by an being or civilized cells or micro-organisms 26,37.

Bioprocesses. These may be any procedures adopted to bring forth any merchandises – such as the biomedical and biotechnological stuffs as described above, which are utile to human wellness or our everyday life. For illustration, a alone procedure to do high effectual human insulin for human type-1 diabetes, a alone procedure to bring forth a genetically modified viral vaccinum against terrible acute respiratory syndrome ( SARS ) 64, and a alone procedure to make familial testing ( test genes/mutations ) for cystic fibrosis, maturity-onset diabetes of the immature, long QT syndrome, and familial chest malignant neoplastic disease 50.

Biomedical and Biotechnological Devices. These may be any specific devices that may be used in health care, industry, scientific research or our everyday life ; or devices used to bring forth the biomedical and biotechnological stuffs as described above. For illustration, a particular agitation device to bring forth insulin by civilized bacteriums, an automatic insulin pump embedded subcutaneously for presenting insulin in diabetic patients, and the MedPulser Electroporation Therapy System for handling cancers1.

2. Biomedical and Biotechnological Intellectual Property Rights

It is good established that merely like a touchable belongings, the proprietor of an intelletual belongings or IP has the sole rights to command the usage of the IP ; the sole rights to do net income from the IP by leasing, merchandising, reassigning, and/or interchanging it ; the sole rights to destruct the IP ; and most critically the sole rights to except others from making these same actions involved with the IP.

An proprietor of a biomedical or biotechnological IP has all such rights of a regular IP as described above. However, such rights can be farther classified into two types: leagally protected rights ( i.e. , legal rights ) and lawfully unprotected rights ( i.e. non-legal rights ) . This is because in the Fieldss of biomedicine and biotechnology, two major signifiers of intangible assets exist – legal intangibles ( such as a particular design or expression to do a medical specialty for handling HIV/AIDS, a copyrighted publication, or a patented insulin pump ) , and competitory intangibles ( such as cognition activities or know-hows, coaction activities, purchase activities, or structural activities – which may impact a biomaedical or biotechnological company ‘s effectivity, productiveness, wastage, costs, grosss, client service, satisfaction, market value to bring forth a utile merchandise ) . Legal intangibles are undoutedly considered IPs or rational belongingss with legal IP rights – defensible in a tribunal of jurisprudence. However it is a contention whether or non competitory intangibles should be treated or regarded as rational belongings with legal rights – some people believe that they should be considered as IPs while others non – therefore with or without legal IP rights. For illustration, Kowalski et al 38 believed that IP rights involved in a genetically engineered harvest such as rice works, may include: ( a ) patent rights ; ( B ) rights of works assortment protection certifications ; ( degree Celsius ) rights of unpublished patent applications ; and ( vitamin D ) any innovations, betterments, and/or finds that may or may non be lawfully protectable, including know-how, trade secrets, research programs and precedences, research consequences and related studies, statistical theoretical accounts and computing machine plans and related studies, and market involvements and merchandise thoughts.

Approachs of Protecting Intellectual Property in Biomedicine & A ; Biotechnology

IP impinges on about everything scientists in biomedicine or biotechnology do. As scientists are paid to come up with thoughts and aspire to patent and/or print their work, the protection of thoughts, innovations, finds, designs or written plants particularly should be of involvement and concern to all 13. Although many proprietors ( an single scientist or a group of scientists or an organisation or a group of organisations ) of an innovation, find, design, or thought in biomedicine and biotechnological Fieldss choose to allow the public straight use their Information science, some others, like the proprietors of IPs in Fieldss of music industry and film industry, may take to lawfully protect their IPs with different intents. Presently all 4 attacks have been used for protecting IPs in biomedicine and biotechnology country: patents, right of first publications, trademarks/service Markss, and trade secrets. A patent provides legal protection for a new innovation, an application of a new thought, find, or construct that is utile 13. Copyright provides legal protection from copying for any originative work, every bit good as concern and scientific publications, computing machine package, and digests of information 13. A hallmark or service grade provides rights to utilize symbols, peculiar words, Sons, or other markers that indicate the beginning of a merchandise or service 13. A farther method of profiting from an innovation is merely to maintain it secret, instead than to unwrap it – a trade secret 13.

Ethical motives of Protecting Biomedical and Biotechnological Intellectual Property by Patents

The scope of rational belongingss is really large, and patent protection is widely used in biomedicine and biotechnology. Therefore, I will concentrate my treatment on the moralss of patent protection of rational belongingss of the undermentioned hot countries: Genetically engineered plants/animals, root cells, curative genes/proteins, antibodies and vaccinums utilizing the feasible ethic theories -Kantianism, Act/Rule Utilitarianism and Social Contract Theory.

A. Critical Ethical Issues Derived from Patenting Some Hot Biomedical and Biotechnological IPs

1. Genetically engineered being ( workss or animate beings )

Genetically engineered ( GE ) being has particular use in our society and human life. Examples of GE workss are: ( 1 ) Planting immune cultivars is the most effectual and economical manner to command works virus diseases while a few genetically engineered ( GE ) virus immune ( VR ) harvests have been released in developed states for cultivation ( Note: works viruses cause terrible harvest losingss worldwide, conventional control schemes, such as cultural methods and biocide applications against arthropod, roundworm, and plasmodiophorid vectors, have limited success at extenuating the impact of works viruses ) 54 ; and ( 2 ) Significant possible advantages are associated with the production of vaccinums in transgenic workss by the collaborative attempts of both agricultural biotechnology sector and pharmaceutical sector although no commercial merchandise has been produced yet on the market 37. An illustration of GE animate being is assuring – transgenic animate beings as bioreactors to bring forth the need-growing curative recombinant proteins ( Note: The ability of transgenic animate beings to bring forth complex, biologically active recombinant proteins in an efficient and economic mode has stimulated a great trade of involvement in this country. As a consequence, genetically modified animate beings of several species, showing foreign proteins in assorted tissues, are presently being developed. ) 21.

Shall we patent GE beings? Many states have granted patents for GE beings while some other states still prevent patenting such beings. Therefore, the most critical ethical issue sing GE being is: Is it right or incorrect to protect the IP – GE being by patenting?

2. Root Cells

Stem cells have possible curative use in efficaciously handling human malignant neoplastic disease and human degenerative diseases such as Alzheimer ‘s disease ( AD ) , Parkinson ‘s disease ( PD ) and Age-related Macular Degeneration ( AMD ) . For illustration, human root cells have become peculiarly attractive campaigners non merely to replace damaged tissue in degenerative pathologies, but besides to present curative molecules in patients with disseminated metastatic malignant neoplastic disease, and across the worldwide at that place have been over 200 patent applications affecting human and non-human root cells – over one tierce of all root cell applications and one one-fourth of all embryologic root cell applications have been granted ( Note: Over the last decennary, betterments in malignant neoplastic disease therapies have prolonged the lives of malignant neoplastic disease patients. Despite dramatic progresss in imaging engineering, surgical techniques, and accessory radio- and chemotherapy, the overall forecast of this disease remains blue. In visible radiation of this, there is an pressing demand for the development of more effectual therapies that can aim residuary disseminated tumour load. Given the heterogeneousness of tumours in general, no 1 scheme is likely to supply a satisfactory intervention regimen. Until the center of the twentieth century, medical interventions were limited to options like drugs, surgery, antibiotics, and radiation. ) 45.

The United States Patent and Trademark Office has granted foundational patents, including a composing of affair ( or merchandise ) patent to the Wisconsin Alumni Research Foundation ( WARF ) , the University of Wisconsin-Madison ‘s rational belongings office. In contrast, the European Patent Office rejected the same WARF patent application for ethical grounds 10,15,19. The contention leads to the critical ethical issue here: Is it right or incorrect to patent the IP – root cells?

3. Curative Genes and Proteins

Curative cistrons and proteins are those cistrons and proteins that can be used to handle or bring around some specific diseases. One illustration of curative cistron is the cystic fibrosis ( CF ) transmembrane conductance regulator cistron ( CFTR ) , which can be engineered into a vector such as AAV to build the AAV-CFTR vector system for the possible intervention of CF by cistron therapy 66. One illustration of curative protein is insulin, which can be used to handle type-1 diabetes 74.

Although many states have granted the patenting of curative cistrons and proteins, many people still believe that cistrons or DNAs or proteins should non be patented 9,34,43,74. Therefore, the most critical ethical issue sing curative cistrons and proteins: Is it right or incorrect to patent curative cistrons and proteins?

4. Antibodies and Vaccines

Antibodies are immunoglobulin proteins that can respond with their corresponding specific antigens while vaccinums are specific antigens or immunizing agents that can bring on worlds or animate beings to bring forth specific antibodies and associated unsusceptibility. Both antibodies and vaccinums have widely used in scientific research involved with life things, and many bing antibodies and vaccinums have been widely used in naming, handling and forestalling diseases of life beings. One illustration of antibody used in human health care is the antibody of HIV, which is used widely to assist name AIDS and the pathogen type involved. One illustration of vaccinum used to forestall or even eradicate human diseases is poliovirus vaccinum, which has caused about 100 % obliteration of human infantile paralysis disease pandemic or endemic.

A big figure of antibodies and vaccinums have been granted patenting in the past decennaries while some people may believe that they should non be patented because of barricading the entree by patients that are hapless and in bad demand of them 2,18,26,32,35,52.. Therefore, the ethical issue sing antibodies and vaccinums still exists: Is it right or incorrect to patent antibody and vaccinum?

B. Solving the Critical Ethical Issues Derived from Patenting Hot Biomedical and Biotechnological IPs by Analysis Using Workable Ethical Theories

1. Analysis Using Kantianism

Over the past 20 decennaries, many patents have been claimed in the countries of cistrons, cistron merchandises like native or recombinant proteins, root cells, vaccinums and antibodies, engineered harvest species and animate beings every bit good as the proficient procedures or devices to engineer them 16,68,71. Such patent-debatable biomedical and biotechnological merchandises are non human being per Se. In other words, patenting genetically engineered workss, animate beings, root cells, curative cistrons and proteins, antibodies and vaccinums are non associated with handling people as “ merchandises ” , or handling people as agencies to an terminal. On the contrary, patenting such originative and utile bio-products will profit everyone in our society, i.e. , it treat others as terminals like handling ourselves in our society ( Note: this fits into the 2nd Categorical Imperative of Kantianism ) . Therefore, from the position of Kantianism, it is ethically right to patent biomaterials such as genetically engineered beings ( except human per Se ) , root cells, curative cistrons and proteins, antibodies and vaccinums.

2. Analysis Using ( Act & A ; Rule ) Utilitarianism

Resnik in his paper of 2003 had evaluated the possible benefits and injuries of DNA patenting for biomedical research and medical pattern 56. He concluded that, all things considered, the benefits of patenting DNA outweigh the injuries, although societies should follow policies designed to forestall or extenuate the injuries associated with patenting – some of these policies include: ( 1 ) reenforcing the research freedom for academic research workers, ( 2 ) raising the “ saloon ” for the standards of patentability, ( 3 ) curtailing the range of patents, ( 4 ) unwraping struggles of involvement related to DNA patents, ( 5 ) sharing the economic benefits of patenting with patients, and ( 6 ) supplying insurance coverage for some types of familial trials 56. Therefore, from the Utilitarianism point of position, it is right to patent curative cistron and cistron merchandises ( proteins and antibodies, etc ) .

Resnik in his paper of 2002 55 argued that it costs a great trade of money to make research, to develop new merchandises, and to implement therapies involved human embryologic root ( ES ) cells ; and private companies, research workers, and wellness professionals require returns on investings and reimbursements for goods and services of human embryologic root cells. He held or defended the undermentioned points: ( 1 ) It should be legal to purchase and sell ES cells and merchandises. ( 2 ) It should be legal to patent ES cells, merchandises, and related engineerings. ( 3 ) It should non be legal to purchase, sell, or patent human embryos. ( 4 ) Patents on ES cells, merchandises, and related engineerings should non be overly wide. ( 5 ) Patents on ES cells, merchandises, and related engineerings should be granted merely when appliers province definite, plausible utilizations for their innovations. ( 6 ) There should be a research freedom in ES cell patenting to let academic scientists to carry on research in regenerative medical specialty. ( 7 ) It may be appropriate to take stairss to forestall companies from utilizing patents in ES cells, merchandises, and related engineerings merely to barricade rivals. ( 8 ) As the field of regenerative medical specialty continues to develop, societies should revisit issues associating to belongings rights on a go oning footing in order to develop policies and develop ordinances to maximise the societal, medical, economic, and scientific benefits of ES cell research and merchandise development 55. Therefore, from the Utilitarianism position, it is right to patent curative root cells including embryologic root cells for regenerative medical specialty.

Radder in his paper of 2004 discussed the patentability of cistrons of workss, animate beings, or worlds and of genetically modified ( parts of ) populating organisms 53. He argued that ( 1 ) patents of genetically engineered beings ( animate beings and workss ) or their cistrons are legitimate because they promote socially utile invention but it may besides halter instead than advance such invention ; ( 2 ) merchandise patents are non adequately based on existent technological innovations, as they should be harmonizing to the usual standard of patentability, and merchandise patents tend to honor patentees for innovations they have non truly made available 53. However, he failed to weigh the entire benefits and injuries of patenting genetically engineered animals/plants or their cistrons. If we add the benefits brought to the whole universe, whether to our everyday life or health care, by genetically engineered workss or animate beings, the entire benefits will outweigh its injuries. Therefore, from the Utilitarianism point of position, it is right to patent genetically engineered animate beings, workss and cistrons.

In add-on, past decennaries of patenting curative cistrons and proteins, vaccinums, antibodies, root cells, and engineered harvest species and animate beings, etc. , have demonstrated that such patenting has more benefits than injuries to our society. Therefore, from the point of Utilitarianism, it is ethically right to patent such biomedical and biotechnological stuffs.

3. Analysis Using Social Contract Theory

Shrader-Frechette ( 2005 ) argued that patents of genetically engineered seeds ( GES ) are sensible, but many patent policies are non – he outlined John Locke ‘s authoritative history of belongings rights, and argued that current patent policies must be revised to take history of Lockean ethical restraints 63. Everyone in our society have the moral rights to better life and health care but require the society to supply the resources. Patenting genetically engineered animals/plants, root cells, curative genes/proteins, and antibodies/vaccines, will greatly supply more such resources for such better life or health care rights. Therefore, from the Social Contract Theory position, it is ethically right to patent these biomedical and biotechnological merchandises.


Taken together, the above analysis utilizing Kantianism, Utilitarianism and Social Contract Theory has helped us to work out the critical ethical issues derived from patenting some critical biological and biomedical merchandises. That is, Kantianism Utilitarianism, and Social Contract Theory all told us that: It is a ethically right action to patent genetically engineered beings ( workss and animate beings but non worlds per Se ) , root cells, curative cistrons and proteins, and antibodies and vaccinums.

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