Course: REGA 505-1 BIOTECHNOLOGY Professor: Peivand Pirouzi

GENE PATENTS

by Camille Thorpe Gihan Perera

Nov.8th, 2012 Humber College Regulatory Affairs Programme

Intellectual property (IP) describes the legal rights that result from intellectual activity in the industrial, scientific, literary, and artistic fields. Patents, industrial designs, copyrights, trademarks, and integrated circuit topography are all examples of IP 1. Patents have existed in some shape or form since the early 1400s. According to the United Kingdom Intellectual Property Office (UKIPO), the first recorded patent was granted in 1449 for the construction of stained-glass windows at Eton College 2. The Canadian Intellectual Property Office (CIPO) defines a patent as “a right, granted by government, to exclude others from making, using, or selling your invention in Canada” 3.

In general, patents are required to fulfill three main criteria: novelty (i.e. it should be the “first in the world”), utility (i.e. it should be functional, operative and useful), and ingenuity (i.e. it should be inventive and not obvious to someone skilled in that area) 1. A three-part test for a sound prediction of utility was prescribed by the Supreme Court and requires that, as of the Canadian filing date, the patentee have: (1) a factual basis for the prediction; (2) an articulable line of reasoning from the factual basis to the prediction; and (3) have made proper disclosure 4. Patents can only be granted to the physical embodiment of an idea, i.e. a patent cannot be granted for a computer program or a mathematical theorem. In other words, the patent must be able to produce something that is tangible.

The aim of the patent system is to encourage the production of inventions by ensuring their protection and utilization. This in turn helps promote innovation and facilitates the transfer and usage of new technologies. Patents guarantee exclusive property rights for the invention for which a patent has been granted, making it extremely valuable to an individual or a company.

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Patent rights are territorial and a patent granted in one country is not enforceable in other countries. Hence it is necessary for inventors and there assignees to file separate patent applications in different countries, in most cases, simultaneously. In addition, the patent application system varies from country to country. For instance in Canada, patents are granted to the first inventor to file an application, so it's strongly advisable to file as soon as possible after completing your invention. The patent system today remains a valuable resource for businesses, researchers, inventors, and academics as they actively innovate.

In order to understand the issues surrounding gene patents, it is helpful to know some basic information about genes. Genes are short pieces of deoxyribonucleic acid (DNA) that are arranged sequentially on chromosomes which encode instructions for building proteins 5. Chromosomes contain matching pairs of one copy of a specific gene which occurs in the same position on each chromosome 6. In females, one X chromosome gets its gene from the mother and the other X chromosome gets its gene from the father 6. In males, a single X chromosome comes from the mother and a non-matching Y chromosome comes from the father 6. Thus, genes are the basic unit of physical inheritance 5.

There are four main categories of gene patents 7: 

Therapeutic proteins. In this case, a certain sequence of DNA or messenger ribonucleic acid (mRNA) that codes for a specific protein (for example, insulin) is inserted into an organism so that it will produce that protein.

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Diagnosing disease. A gene sequence may be compared to specific variations of the sequence that are associated with disease (for example, tests for breast cancer-associated mutations).

Gene therapy. An engineered section of DNA may be introduced to replace or regulate a mutated sequence that is causing a disease.

Research tools. For example, fragments of DNA or RNA can be used to control other DNA in replication or transcription.

Since the 1990‟s, the biotechnology industry has experienced strong growth that has been mirrored by the higher than average growth rate for patent applications and patent grants that relate to biotechnology inventions 8. According to the Organisation for Economic Co-operation and Development (OECD), the number of patents granted in biotechnology rose 15% a year at the United States Patent and Trademark Office (USPTO) from 1990 to 2000, and 10.5% at the European Patent Office (EPO), compared to a 5% a year overall increase in patents 8. There are many reasons that patents are important to the biotechnology industry.

First, biotechnology is a very research-intensive industry 8. The chemical and pharmaceutical industries have a ratio of research and development (R&D) expenditure to total revenues of approximately 5% and 13%, respectively 8. However, biotechnology companies may invest 4050% of their revenues in R&D 8. Thus, it is crucial for biotechnology companies to protect the results of their R&D efforts. Like other businesses, biotechnology companies must endeavor to provide investors with a return on their investments.

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Second, there are high costs for the development of new products and processes, but relatively low costs of imitation 8. Biotechnology research is high risk and it is difficult to predict whether investment in research will lead to innovations with a great market potential, or results that won‟t give the company any return on investment 8. It is relatively easy for competitors to reverseengineer products and processes, so protection of intellectual property is important to make the process of imitation as difficult as possible 8.

Third, there are close ties between the basic research performed in public sector institutions and the applied research done by private enterprises 8. Research performed in academic research institutions (for example, universities) and the resulting patents often form the basis for the establishment of small or medium-sized enterprises (SMEs) 8. These SMEs help to drive economic growth by promoting technological development and by creating biotechnologyrelated job opportunities.

Finally, patents may be the final product for some companies and may therefore be the companies‟ only real assets 8. These companies may develop innovative inventions, patent them, and then license them to larger companies with the resources to take the product to market 8. Without the ability to patent, these companies would have no basis for existing. As a result, there would be less of a driving force for continued innovation.

One of the arguments against the patentability of genes is that genes are discoveries and not true inventions. In this context, it is important to understand what exactly constitutes something as being „discovered‟, versus being „invented‟. The definition of a discovery is “something for
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which sight or knowledge has been obtained” 9, whereas an invention is “the discovery or production of some new or improved process or machine that is both useful and is not obvious to persons skilled in the particular field”10.

Genes by themselves are not new because they occur in nature, and gene sequences are representations of the genetic code (i.e. just information) that are translated into proteins. By this approach, genes can be argued to be simple discoveries and not patentable. The patentability of genes is determined by their utility. For instance, a gene that is isolated in a novel way, is mass produced, and is put into commercial operation is no longer a simple product of nature. The truly „inventive‟ step comes from isolating the gene, identifying its precise biological function, sequencing a few of its amino acids, and then applying it to a unique situation 11. It is this aspect of biotechnology that has allowed more than 20% of the human genome‟s 23,688 genes to be patented 12. In total, there are 4270 patents on file internationally within 3050 different patent families that are owned by 1156 different assignees 12.

To explore some of the current issues arising in the area of gene patents, the case of the BRCA genes will be discussed. BRCA1 and BRCA2 are human tumour suppressor genes whose mutations have been linked to hereditary breast and ovarian cancer 13. If a woman inherits a harmful BRCA1 or BRCA2 mutation, she is at increased risk of developing breast and/or ovarian cancer 13. If a man inherits a harmful BRCA1 or BRCA2 mutation, he is increased risk of developing breast cancer 13. Both men and women who have harmful BRCA1 or BRCA2 mutations may also be at increased risk of other cancers 13.

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Genetic tests developed by Myriad Genetics Inc. are available to check for BRCA1 and BRCA2 mutations at a cost of approximately $3000 14. Myriad Genetics Inc. controls all BRCA-related research and testing performed in the Unites States 15. Canadian women have about a 13% chance of developing breast cancer during their lifetime, with 5-10% of those who develop the disease having the genetic mutations at BRCA1 and BRCA2 16. Those who test positive may choose to increased surveillance via breast self-examination or mammography, or may choose to undergo surgical intervention (i.e. mastectomies) 17. There has previously been conflict between the company and non-U.S. governments and agencies because the company wants to exercise its patent rights internationally, which would prohibit all other tests for the BRCA1 and BRCA2 genes 16.

The CIPO granted Myriad Genetics Inc. three patents based on a patent application the company filed in 1995: two patents covering BRCA1 and mutations of BRCA1 were granted in 2000; one patent on the diagnostic test was granted in 2001 18. CIPO also granted Myriad a patent on BRCA2 in 2001 18. In 2001, the EPO granted Myriad patents covering any methods of diagnosing a predisposition for breast and ovarian cancer using the normal sequence of the BRCA1 gene 18. The EPO also granted patents relating to the mutated BRCA1 gene (34 mutations), the BRCA1 gene itself, and the BRCA2 gene 18. Myriad also obtained patents in Australia, New Zealand, and Japan 18.

In Canada, Myriad awarded MDS Laboratories (MDS), the exclusive right to market the BRCA tests in Canada 18. Myriad agreed to provide proband sequencing while MDS would arrange for individual mutation testing 18. In October 1998, Myriad invited a group of European researchers
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to visit its Salt Lake City laboratories to discuss the issue of patents and offered them a license 18. Because each country within Europe has a separate health care and laboratory system, Myriad pursued country by country negotiations 18.

Myriad was aggressive in asserting its patent rights, shown by the short amount of time it took to send a cease-and-desist letter to the University of Pennsylvania's Genetic Diagnostic Laboratory (GDL) after Myriad obtained its major patent 18. GDL suggested that Myriad was attempting to impede basic scientific research, although GDL did not publicize its own university's role in the BRCA patents as a co-owner of the BRCA2 patent 18. In accordance with Myriad‟s agreement with the National Cancer Institute, Myriad argued that GDL should obtain a license because it was not conducting its own research and was supplying testing services to outside researchers 18.

Several European research institutions launched opposition procedures to challenge the EPO‟s decision to grant Myriad's patents 18. The Institut Curie, the Assistance Publique-Hopitaux de Paris, the Institut Gustave Roussy, the Belgian Human Genetics Society, and German, Dutch, Czech, Austrian, Swiss, British, and Finnish genetic societies and patient associations participated in the challenge 18. Although Myriad‟s patents were not declared invalid, the patent claims were limited 18.

In 2010, a group of cancer patients and medical experts represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) of Yeshiva University`s Benjamin N. Cardozo School of Law in New York City challenged the validity of the BRCA1 and BRCA2 patents 17. The defendants named in the case were Myriad Genetics Inc., the

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University of Utah Research Corp. (which owns the patents), and the U.S. government 17. The U. S. government was included because the plaintiffs maintained that the patents should never have been granted and that by granting a monopoly on the BRCA genes, the Patent and Trademark Office violated every person‟s freedom of speech 17. Judge Robert Sweet of the federal district court in New York City that the BRCA1 and BRCA2 genes were not patentable inventions because they were not significantly different from native DNA as it exists in nature 17.

The decision was appealed, with the ACLU arguing that patents on human genes violate the First Amendment (i.e. freedom of speech) and patent law because genes are "products of nature" 19. However, in August 2012 a 2-1 panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C. affirmed Myriad‟s right to patent the BRCA genes 19. Circuit Judge Alan Lourie, writing for the court majority, said, "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature" 19. Myriad Genetics Inc. was not completely successful, however, as the court denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences 19.

In September 2012, the ACLU and PUBPAT filed a petition to the Supreme Court asking the court to reconsider the Court of Appeal‟s ruling on specific issues, particularly whether or not human genes are truly patentable substances 20. The petitioners do not simply want the claims of Myriad‟s patents to be limited – they want the patents declared completely invalid. The results of this case and others like it will have a profound effect on the biotechnology industry, and on society as a whole.

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In the post-genome era, companies in other areas related to biotechnology such as bioinformatics, have also sought out protection by applying for patents based on the utility of its algorithms and programs 22. These products have been instrumental in areas such as genome sequencing, location of drug targets, and methods of producing more efficient ways to cluster proteins.22

The subject of gene patents remains a very controversial topic in the fields of biotechnology, phamaceuticals, and healthcare in general. There is still debate as to whether there is truly any inventive step involved, or whether this is simply a loophole for inventors to patent what some people deem to be naturally occuring substances. From a legal standpoint, it may be necessary to further define the scope and breadth of a claim when applying for a gene patent to clearly illustrate its inventiveness 21. There are also moral and ethical problems created by gene patents, some of which have been granted so that companies hold the monopoly on the diagnosis and treatment of certain cancers and life threatening illnesses.

It is also argued that in the field of biotechnology and gene patents, intellectual property is being granted and protected to such an extent that it is stifling innovation and new research 21. Overlicensing could deter researchers from carrying out investigative research out of fear of having to pay significant royalties. The business of patenting biotechnology has also changed the way many universities conduct research, many of which now have an associated commercialization department. Whether this will alter the focus of research done at universities from scientific innovation to profit-incentive based research is yet to be seen.

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One approach we believe would decrease the uncertainty currently surrounding gene patents is greater harominzation in patent law. First, the subject matter eligible for patent protection should be the same for all countries 23. Second, the way that “utility” is defined should be standardized so that the same types of inventions have the same degree of protection everywhere in the world
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. Third, the evidence that is sufficient in determining whether an invention is truly novel and

whether there is an inventive step should be standardized 23. Finally, patent offices should allow the same types of claims to simplify worldwide enforcement of patents 23.

There has already been some harmonization of patent laws. The Paris Convention was first signed in 1884 and now has been signed by every industrialized nation except Taiwan 23. This treaty allows an inventor in any signatory country to first file an application in his or her home country, and then to file corresponding applications within one year in any other signatory country 23. The filing date for the secondary applications is the date the patent was first filed in the original country and each applicant, regardless of which signatory country they are from, is to be treated like a resident citizen of the foreign country with respect to the patent prosecution process 23.

The Patent Cooperation Treaty (PCT) was signed in 1970 and currently has 146 contracting states 23,24. The PCT is administered by the World Intellectual Property Organization (WIPO) and its goal is to provide a common procedure for filing patent applications in each of its contracting states, so that one patent may be filed and examined in any PCT country 23,24. Other efforts at increased harmonization include General Agreements on Tariffs and Trade (GATT) patent agreements, the World Trade Organization‟s Trade Related Intellectual Property Rights
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(TRIPS) agreement, and the North American Free Trade Agreement (NAFTA) 23. In the United States, the American Inventors Protection Act of 1999 brought some aspects of U.S. patent law more in line with the patent laws of other countries 23. The was also harmonization via creation of regional patent offices like the EPO, so that different applications filed in each of the European countries may be judged by the same standards of patentability 23. In the future, creation of an EU patent could allow patents to be enforced throughout the EU without validation by individual countries 23. There have also been efforts by some of the former Soviet republics and countries in Africa to collaborate on regional patents via organizations such as the Eurasian Patent Organization (EAPO), the Organisation Africaine de la Proprie Intellectuelle (OAPI), and the African Regional Industrial Property Organisation (ARIPO) 23,25,26.

The issues surrounding gene patents are numerous. Fortunately a variety of international organisations exist to help align patent laws in various countries and plan for future challenges.

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References 1. Canadian Intellectual Property Office. Introduction to Intellectual Property. (2011) Retrieved October 24, 2012 from http://www.ic.gc.ca/eic/site/cipointernetinternetopic.nsf/eng/wr01988.html 2. UK International Property Office. November 30 2008. Retrieved November 5, 2012 from http://www.ipo.gov.uk/p-history.htm 3. Canadian Intellectual Property Office. What is a Patent? October 7, 2011. Retrieved September 24, 2012 from http://www.cipo.ic.gc.ca/eic/site/cipointernetinternetopic.nsf/eng/wr03300.html 4. Apotex Inc. v. Wellcome Foundation, (2002) S.C.J. No. 78 5. National Institutes of Health. National Human Genome Research Institute. Talking Glossary of Genetic Terms. Retrieved September 24, 2012 from http://www.genome.gov/glossary/ 6. U.S. National Library of Medicine. Genes. (2012) Retrieved November 5, 2012 from http://www.nlm.nih.gov/medlineplus/ency/article/002371.htm 7. Cleary, Thomas. Gene Patents: Should New Zealand Let the Gene Genie Out of the Patent Bottle? (2011) Dissertation - University of Otago. Retrieved November 5, 2012 from http://www.otago.ac.nz/law/oylr/2011/Tom%20Cleary%20%20LLB%20Honours%20Diss%202011.pdf 8. Burrone, E. Patents at the Core: the Biotech Business. (2006) World Intellectual Property Organization. Retrieved September 24, 2012 from http://www.wipo.int/sme/en/documents/patents_biotech.htm

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9. Collins English Dictionary - Complete & Unabridged 10th Edition. HarperCollins Publishers. Retrieved September 24, 2012 from http://dictionary.reference.com/browse/invention 10. The Oxford Minidictionary, Third Edition. (1991) Oxford University Press. 11. Rutz, B. From bench to market: Life science patents in Europe. (2012) Biotechnol. J. 7(2):171-5. Retrieved September 24, 2012 from http://onlinelibrary.wiley.com/doi/10.1002/biot.201100110/pdf 12. Jensen, K and Murray, F. Intellectual Property Landscape of the Human Genome. (2005) Science. 310(5746):239-40. http://www.sciencemag.org/content/310/5746/239.full 13. National Institutes of Health. National Cancer Institute. BRCA1 and BRCA2: Cancer Risk and Genetic Testing. (2009) Retrieved October 29, 2012 from http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA 14. Gold, E R. BRCA Testing in Canada. Centre for Intellectual Property Policy. (2007) Retrieved November 5, 2012 from http://oba.od.nih.gov/oba/sacghs/meetings/July2007/Gold-BRCA.pdf 15. Cohn, M. Gene patent case could impact patients, research. The Baltimore Sun. September 22, 2012. Retrieved October 29, 2012 from http://articles.baltimoresun.com/2012-09-22/health/bs-hs-brca-patents20120922_1_myriad-genetics-patents-brca 16. Sherwin, S. BRCA testing: ethics lessons for the new genetics. (2004) Clin Invest Med. 27(1):19-22. 17. Marshall, E. Cancer Gene Patents Ruled Invalid. (2010) Science 328(5975):153

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18. Gold R, Carbone J. Myriad Genetics: In the eye of the policy storm. (2010) Genet Med. 12(4 Suppl): S39–S70. Retrieved November 19, 2012 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037261/ 19. Stempel, J. Myriad wins gene patent ruling from US appeals court. August 16, 2012. Reuters. Retrieved September 24, 2012 from http://www.reuters.com/article/2012/08/16/us-myriad-patent-idUSBRE87F12K20120816 20. Duke University Institute for Genome Sciences and Policy. BRCA Briefing Page. (2012) Retrieved October 29, 2012 from http://www.genome.duke.edu/centers/cpg/Myriad/ 21. World Intellectual Property Organization. Biotechnology. Retrieved September 24, 2012 from http://www.wipo.int/patent-law/en/developments/biotechnology.html 22. Wilson, A. Patents in the Bioinformatics Field: Releasing the Gene Genie. Bio-Science Law Review. (2002) Retrieved November 5, 2012 from http://pharmalicensing.com/public/articles/view/1034368662_3da73696212e0 23. Kaminski, M D. Patent harmonization. (2001) Modern Drug Discovery 4(1):36-37. Retrieved November 19, 2012 from http://pubs.acs.org/subscribe/archive/mdd/v04/i01/html/patents.html 24. World Intellectual Property Organization. PCT Resources. Retrieved November 19, 2012 from http://www.wipo.int/pct/en/ 25. James P. Regional Patent Systems in Africa. 5th FICPI Open Forum, Monte Carlo 1999. Retrieved November 19, 2012 from http://www.ficpi.org/library/montecarlo99/patentsafrica.html 26. EAPO. The Eurasian Patent Organization. (2012) Retrieved November 19, 2012 from http://www.eapo.org/eng/ea/

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