Court trial between Myriad and OncorMed: A brief case study

by: Benjamin Thimm

Summary

1. INTRODUCTION 3

2. DISCUSSION 4

2.1.1. Key dates of the case study between Myriad and OncorMed including its prehistory 4
2.1.2. Case history in brief 6

2.2. The criteria of patentability 7
2.3. Distinctions between patentable discoveries and inventions 7
2.4. Patentability of BRCA1 compared within the scope of the patent key features 8

2.4.1. Lack of Novelty 8
2.4.2. Lack of Inventive Step - Nonobviousness 9
2.4.3. Lack of Industrial Application and Utility 9
2.4.4. Lack of Description 10

3. CONCLUSION 10

4. REFERENCES 11

1. Introduction

For all of the time in which human beings have existed, they have been cursed with an abundance of life threatening, actually incurable diseases. Not until the last few generations did modern medicine finally develop to the stage where it could cure the most common ailments, thus improving the quality of life. But there are things even modern research can′t explain, and there are diseases that are still regarded as scourges of humanity. One of these scourges is cancer which appears in the form of mammary carcinoma. In this paper, I will consider the sequencing and patenting of the breast cancer gene.

By all accounts a woman′s breast is a phenomenon. It is a symbol of erotic love and a source of vital nourishment for the infant; on the other hand, as the root of one of the most prevalent tumours in women it is also a subject of fear. Even in the US male population, two thousand people suffer from breast cancer in their lives ^[1]. Altogether, 90 % to 95 % of these cases are acquired by complex interactions of endogenous and exogenous factors and are classified as sporadic tumours ^[2]. In about 5 % to 10 % of the cases a genetic disposition and a congenital acquisition of the disease does occur in successive generations, which classifies them as hereditary ^[3]. In this connection, cancer itself is not passed on in the broader sense, but the predisposition that increases the likelihood of the emergence of specific neoplasias. In 1990, Mary-Claire King′s research group (University of California) proved for the first time that in some families a single gene could be responsible for the development of breast cancer ^[4].

The cause of that genetic disposition was isolated in frequently occurring mammary and ovarian carcinomas in the form of mutations in two tumour suppressor genes, called BRCA 1 und BRCA 2 (BReast CAncer 1 und 2). Meanwhile, some 50 different hereditary cancer syndromes are known ^[5]. Thus, modern gene technology makes it possible to test family members genetically in advance, and to develop an individual preventative program.

After all, the risk of affection in carriers rises from 10% to 60% (with BRCA2) up to 80% (with BRCA1), and is reported often before the pre-menopausal age of 50 ^[6]. In spite of the new possibilities and successes, the discovery of these cancer predisposition genes has brought with it problems. Since a couple of years ago, the popularity of patenting genes has come to eclipse public research more and more, and threatens to degrade the mapping of the human genome into a mere subject of commerce. This problem exists in the debate about the breast cancer gene BRCA1. This paper shall point out the details of the battle over the BRCA1 gene patent, which has come between the fronts of two genetic testing companies. With this example, it shall be explained how the human genome has been perverted into a technical product in spite of existing regulations or patent criteria (or key features), which are supposed to prevent such perversions. These key features will be compared with the court case to draw possible juristic conclusions. Hence it can be determined whether the patent on BRCA1 has acquired legal status, and whether future gene patents can any longer be approved, or whether the patent law itself has to be redrafted to protect the human genome from privatisation.

2. Discussion

2.1.1 Following will list the key dates of the case study between Myriad and OncorMed including its prehistory ^[7]:

1989 A UK research group, initiated by the French researcher Gilbert Lenoir working at the Centre International de Recherche sur le Cancer (CIRC) in Lyon, establishes a consortium to search for the genetic basis of breast cancer, which over the next couple of years evolves into the Breast Cancer Linkage Consortium (BCLC) ^[8]. The BCLC consists of European wide researchers who have an interest in breast cancer. In addition to a series of European groups some other researchers in the US are also incorporated into the consortium. Funding for the BCLC comes primarily from the European Union but each member group within the consortium also obtains funding from their respective national governments ^[9].

1990 Mary-Clare King and her Consortium research group of the University of California reports the identification of a genetic locus on the long arm of chromosome 17 that is linked to a familial predisposition to breast cancer. So Mary-Clair King is the first scientist who reports that breast cancer susceptibility can be inherited.

1991 Myriad Genetics Inc., a medical genomics company, is founded by Mark Skolnick, a researcher at the University of Utah in Salt Lake City and a member of the Consortium.

[...]

[1] Marilyn A Roubidoux ; (2002) ; Breast Cancer Male; http://emedicine.com/radio/topic115.htm

[2] Christopher Benz; (no date); human Breast Carcinogenesis; http://bioeng.berkeley.edu/graduate/rotations/benz.html

[3] Lowe. T.; (2002); Cancer And Inherited Predisposition To Cancer http://fampra.oxfordjournals.org/cgi/reprint/16/1/71

[4] The American Physiological Society; (no date); Mary-Claire King; http://www.the-aps.org/education/k12curric/pdf/king.pdf

[5] FORCE; (2006); Hereditary cancer and cancer genetics http://www.facingourrisk.org/hereditary_cancer/hereditary_cancer_and_geneti cs.html

[6] The Susan G.; Komen Breast Cancer Foundation; (2001); BRCA1 or 2 Gene Mutations And Cancer Risk: Results From 5 Family-Based and 1 Population - Based Epidemiologic Studies http://www.komen.org/intradoccgi/ idc_cgi_isapi.dll?IdcService=SS_GET_PAGE&ssDocName=3-8-1-10

[7] L′lnstitut Curie; (2001); The Key Dates; http://www.curie.fr/upload/presse/keydates.pdf

[8] Devilee. P.; (2000); 13th General Meeting Of The Breast Cancer Linkage Consortium November 29 - December 1, 1999, Amsterdam. The Netherlands; http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=138778

[9] NSW Council for Civil Liberties Inc. (2003); A Brief History Of The Events Leading Up To The Patenting Of The BRCA1 http://www.nswccl.org.au/issues/breast_cancer.php