Committee : Ethics and Society

Issue : The application of intellectual property concerning the patentability of living beings

Chair : Paula Duellmann

Introduction

Patenting, as part of the national laws, was formally introduced in 1623 in England, 1790 in the United States and 1791 in France. This led to the development of patent protection in many other countries during the 19th century. The main purpose of these patenting laws was to help innovators and investors to benefit from their invention and thus to encourage research and development (R&D). However,due to the ongoing evolution of science and innovation, there is a constant need to update and redefine these patenting laws as new issues arise. Such is the situation with patentability of living beings.

As man-made biological mutations of existing animals and plants, and new biotechnologies arrive on the international market, the ethical questions surrounding the subject, as well as the question of whether they fall under the umbrella of patentable objects has gained importance. Many examples exist such as the Harvard mouse or Oncomouse, a genetically modified laboratory mouse, which was patented in the mid 1980s in Europe, the United States and Japan, or the BRCA1 and BRCA2 genes, which are believed to be related to certain types of breast cancer, and in the United States patented by Myriad Genetics. These possible patents demonstrate the impact patentability can have on countries as well as individuals.

Parties involved and impacted by the possible patenting of living beings are national governments, agricultural, chemical and pharmaceutical companies as well as  public and private universities, nonprofit research organisations and even individuals, for instance in the case of medical treatments. The creation of an international treaty dealing with this issue would thus greatly benefit scientific advances in the future.

 

Key Terms:

Intellectual Property (IP)

The WIPO defines Intellectual Property as a creation of the human mind, that is to say everything from inventions, literary and artistic works to symbols, names and images used commercially. It can be divided into two categories which benefit from different kinds of protection by law:

industrial property, which may focus on one of the following categories: inventions, industrial designs and geographical indications etc..  and copyright, which protects art such as literature, films, music, architectural design etc..

 

Patent

Designed as a reward for human creativity and ingenuity, a patent is the exclusive right to an invention and therefore falls under the definition of Industrial Property. It protects products or processes that provide a new solution to an existing problem for a certain amount of time (varying by country legislation). This invention must be of practical use, contain an element of novelty for its particular field and an “inventive step” meaning that it isn’t the obvious solution. Furthermore, it must be regarded as “Patentable” by the particular country in which the applicant seeks patent protection;  scientific theories, mathematical methods, plants or animals, discoveries of natural substances, commercial methods or methods of medical treatments are often not regarded as patentable.

A patent also grants the patent holder certain rights, such as the decision of which parties may use the patented invention or the choice to sell the rights to this invention to a buyer, who then becomes the new patent holder.

        The Public domain

Once a patent or copyright expires, the invention or piece of art enters the public domain which makes it accessible to all. As the owner of the patent or copyright no longer holds an exclusive right, it is now available for commercial exploitation by others.

Living being

A living being is an organism which displays certain characteristic biological processes such as, but not limited to, the ability to grow and to reproduce.

Ethics

Ethics are sets of rules of conduct derived from moral values and beliefs. They differ greatly around the globe with regard to culture, society and religion and seek  to determine whether an action or a process is “good” or not.

Bioethics

Is the application of ethics to the scientific advances in the domain of biology and medicine and the fact of dealing with the issues posed. A good example for the issues that bioethics attempt to deal with is whether or not a foetus is regarded as a full living human, which, if it were,  would mean that abortion is equal to murder.

Biotechnology

Is the application of biological systems, living organisms or parts thereof, in technology in order to create certain products or for instance modify chemical processes.

 

General Overview

        The patenting of living beings is in many ways a polarizing issue, bringing a share of positive and negative consequences and opening many questions.

One of the reasons for this is that patenting living beings differs in certain aspects from patenting an object or a creation. First of all, the term ‘living being’ encompasses a great variety of creatures, plants and biological elements, for which there already exist different legislations. Human beings for instance are, by the Universal Declaration of Human Rights (UDHR) of 1948, born free and equal in dignity and rights”. As patenting is regarded by some as claiming ownership over an invention for a limited amount of time, most countries agree that human beings and most of their biological elements (such as cells) are thus not “patentable”.  This rule however does not apply to most animal species so in the case of patenting living beings, there can not be one single legislation for all, as is the case with objects or ideas. Secondly, a recurring problem is  that, by definition, all living beings (if not every single one of their biological elements on its own) can reproduce. Some scientists argue that this means that offspring of a generation of modified beings created in a laboratory “occurred naturally” which would in turn mean that by most countries standards the second generation would no longer be patentable.

However there are also issues in patenting living beings that are similar to patenting objects or ideas: for instance, the abuse by certain patent holders which can have devastating repercussions on scientific and medical R&D. If the patent holder chooses to keep his invention private or give very limited access  for the duration of the patent protection, he/she limits further research with or about the patented living being. This can result in some cases in the monopolisation of certain genes which can lead to an increase in difficulty in genetic diagnostics, and a decrease in  the competitivity in medical science to find better treatments.

 Another relevant issue that applies to the patenting of objects but is far more present in the patenting of  living beings, is the question of whether the being is “sufficiently transformed” to be considered as novel. The answer to this issue differs from country to country; however many patent laws are considered to be too vague on this matter.

This last issue has sparked some speculation on whether life forms can even be considered as IP. Indeed, some argue that no matter how mutated or changed a living being is, it never truly becomes a “creation of the human mind”. This would mean that no living being or even biological element thereof would be patentable. Others, for instance the creators of such a species, often consider that the mutation or changing of the living being equates to inventing a new subspecies of that being.

        Another domain in which the patentability of living beings sparks heated discussion is of course the bioethical domain. Many issues arise from the patentability of living beings such as whether a patent equates to ownership over the element. These then become mixed with the ethical questions surrounding the living beings that are being patented, such as genetically modified  plants or transgenic animals.  For instance in the case of the Oncomouse, discussed later in this report, one of the more important questions that arose was whether it should be legal to mutate an animal in order to make it  genetically predisposed to a certain disease and thus suffering, in order to find a cure. This question, whilst highlighting the importance of the regulation of animal mutation, does not equate to an ethical question on the patenting of living beings in general.

Another issue specific to the patenting of human DNA sequences is for instance the human sense of dignity. The fact that a company or a private individual could own something so fundamental to the human body and thus  human identity is of concern, if not alarming, to many. There are, however,  those who argue that human beings should not be more protected than other species. Brian Cunningham the president of Rigel Pharmaceuticals argues "It seems to be okay to patent every animal in the zoo but us, a reflection of our need to believe that we are special.  These varying opinions on fundamental bioethical questions are  one of the reasons for the difficulty in coming to an international agreement.

        It is important to consider however that patenting of living beings also has very positive outcomes. Indeed, most inventions (living or not) require a great deal of effort and resources to create. Patenting helps reward this effort and thus gives the inventors new resources to further their R&D. It thus encourages R&D in private and public industries as well as providing opportunities for investment in this R&D. It is also important to consider that the patenting of a living being implies the full disclosure of the invention, which is then made accessible (if not usable) to the public. This encourages the publication of new inventions and encourages scientists to build upon each other innovation. Without patenting many fear that corporations would prefer to keep their new invention in the dark, which would also hinder the legislation of inventions greatly.

        All in all the patenting of living being is complicated on a legislative but also on an ethical and practical level. The creation of a universal understanding around this issue is thus of great importance to scientific and medical advances.

Case Studies:

        In order to understand some concrete problems, but also some positive consequences to the patenting of living beings, it is important to look at a few examples of more or less successful patenting of living beings.

The first micro-organism to be patented in the United States of America was a bacterium called ‘Pseudomonas putida’ that had been modified to be able to break down crude oil. Its inventor, genetic engineer Ananda Mohan Chakrabarty, filed for patenting in 1980. His bacterium showed great promise, in particular to help with oil spills, but it was denied patenting at first because the patent examiner considered that patent law, at the time, did not recognise living beings as patentable. After appealing to the United States supreme court, the patent was granted in 1981 after the United States Court of Customs and Patent Appeals stated that “The fact that [an organism is] alive is without legal significance for the purpose of patent law”. This became a fundamental argument for the many cases of patented living beings to come.

        Another interesting case of patenting living beings in the United States is the patenting of the BRCA1 and BRCA2 genes by Myriad Genetics Inc. in 1994 and 1995. The genes are highly associated with Hereditary Breast and Ovarian Cancer (HBOC) which represents about 5% of all breast cancers. By being able to regulate the research on these genes, Myriad Genetics Inc. created a monopoly for themselves, meaning that they were the only ones to research BRCA1 and BRCA2 and therefore create a diagnostic method for HBOC using these genes.  In order to create a revenue and pay back their investors, Myriad Genetics Inc. charged its customers up to the triple amount of what the procedures actually cost: $3,000 instead of $1,000. This was problematic, considering that a woman with the BRCA1 or BRCA2 mutation is five times more likely to get breast cancer and that breast cancer causes more deaths of women than any other cancer in the Western countries. In 2009, the Public Patent Foundation (PPF) and the American Civil Liberties Union (ACLU) brought on a lawsuit against U.S. Patent and Trademark Office and Myriad Genetics Inc. challenging the claims of Myriad on both patents, which was brought before the Supreme Court in 2011. The court ruled, in 2013, that if Myriad Genetics inc. had in any way created a new method of sequencing the BRCA1 and BRCA2 genes, there would have been the possibility of a method patent. However the way Myriad sequenced the BRCA genes were at the time already "well understood [and] widely used". As of 2014 the genes are thus no longer under any patent and may again be freely used in R&D.

        A patent that caused some ethical controversy in the United States is the Harvard mouse also called Oncomouse. It was created in the early 1980s as a type of laboratory mouse that had been genetically modified to carry a certain gene called the oncogene which made it a lot more susceptible to cancer, thus creating a valuable new way of researching cancer treatments. The patent was granted in 1988 by the United States Patent Office (USPO) specifying however, that the claim excluded humans in any way. The patent expired in 2005 and thus the Oncomouse is now free to be used in the United States. However this patent raised several ethical questions, not only regarding transgenic technology, but also the patenting of living beings; first was the question of whether patents should be granted for animals and especially higher-order animals such as mammals, and second whether the moral implications needed to be addressed in all cases of animal patenting.

Treaties and conventions:

There has been no international convention to directly address the patentability of life-forms, however the following treaties and conventions may be of indirect importance to the issue:

These treaties do not seek to override the national patent laws of the member countries, but, rather, to build a cooperation around them. More information about these treaties and more can be found on the WIPO website.

Affected Countries

        United States

        The United States general point of view concerning the patentability of living beings has already been explored during the case studies cited above.  

Canada

Allows only the patenting of lower life forms such as fungi, bacteria and cells from multicellular life forms. However in the case of higher life forms such as mammals plants and other multicellular life forms, the  Supreme Court decided in the  2002 case concerning The President and Fellows of Harvard College vs. the Commissioner of Patents that these are not in any way patentable.

Switzerland

Does not allow the patenting of animal breeds or plant varieties as underlined in 1995 by the Swiss supreme court. Furthermore, naturally occurring gene sequences and even  partial gene sequences of human origins or other may also not be patented.

India

Allows the patenting of DNA sequences with disclosed function, biochemical processes that do not result in the creation of a living being and micro organisms. The patenting of naturally occurring living beings is prohibited.

European Union

         The European Patent Office (EPO) states that it allows “patenting of certain elements of life forms providing they are novel, inventive, and industrially applicable, In the field of’ living matter, however, the patent system imposes two broad restrictions, namely the invention should not be contrary to ‘ public order and morality’, and should not cover plant nor animal varieties

        Australia

        Australia allows the patenting of genetically manipulated organisms, isolated bacteria and some biological materials such as peptides, if these have been isolated and synthetically produced. It strictly forbids the patenting of human beings, the biological processes or the genetic material thereof.

Possible ways to move forward:

 

Bibliography

Websites:

Bioethics:

https://en.wikipedia.org/wiki/Bioethics

The Convention on Biological Diversity:

https://www.cbd.int/convention/articles/default.shtml?a=cbd-02

The Universal Declaration of Human Rights:

http://www.un.org/en/universal-declaration-human-rights/

The Oncomouse:

https://en.wikipedia.org/wiki/Oncomouse

http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html

The Chakrabarty micro-organism case:

https://en.wikipedia.org/wiki/Diamond_v._Chakrabarty

The History of Patent Law:

https://en.wikipedia.org/wiki/History_of_patent_law

The WIPO treaties on intellectual property:

http://www.wipo.int/treaties/en/

WIPO Answers to intellectual property questions

http://www.wipo.int/patents/en/faq_patents.html

Patenting life forms in Canada:

http://kirbyip.com/patenting-life-forms-in-canada-challenges-and-opportunities/

Patenting life forms in Switzerland:

https://www.ige.ch/en/protecting-your-ip/patents/faqs.html

Patenting life forms in the United States:

https://en.wikipedia.org/wiki/Biological_patents_in_the_United_States

Patenting life forms in Australia:

https://www.ipaustralia.gov.au/patents/understanding-patents/types-patents/what-can-be-patented/patents-biological-inventions

Articles:

Intellectual property in general:

http://www.wipo.int/edocs/pubdocs/en/intproperty/450/wipo_pub_450.pdf

Patenting life in general:

http://www.newyorker.com/tech/elements/can-we-patent-life

http://www.nytimes.com/2007/02/13/opinion/13crichton.html

The application of patenting to animals:

http://onlinelibrary.wiley.com/doi/10.1002/3527600906.mcb.200400043/abstract

Against patents on life:

http://www.twn.my/title/pat-ch.htm

The impact of patenting on upstream science:

http://www.wipo.int/export/sites/www/meetings/en/2006/scp_of_ge_06/presentations/scp_of_ge_06_sulston2.pdf

International Patent Protection for Microorganisms, Plants and Animals:

https://www.princeton.edu/~ota/disk1/1989/8924/892412.PDF

Ethical issues encountered in gene patenting:

https://www.scu.edu/ethics/focus-areas/bioethics/resources/ethics-and-gene-patenting/

http://2012.igem.org/wiki/images/d/dc/Gene_Ethics.pdf

Slideshows:

Patenting of life forms:

https://www.slideshare.net/altacitglobal/patenting-of-life-forms

Patenting genes and microorganisms in India:

https://de.slideshare.net/TNAUgenomics/current-status-of-patenting-genes-and-microorganisms-in-india

images:

http://genome.jgi.doe.gov/psepu/psepu.home.html

https://www.preventovariancancer.ca/sites/default/files/pictures/BRCA12.jpg