663Genomic information is now increasingly replacing self-reported race in medical-
and population-related research. With the availability of markers in population
genetics that are informative of ancestry and reveal genetic clues, the concept of
race is no longer useful in the context of this research.
Gene Patents and Personalized Medicine
Gene patents for therapeutics have often been subject of litigation but there is sur-
prisingly little publicity. In contrast, genetic diagnostics have been highly contro-
versial but rarely litigated until now. Problems do occur when patents are exclusively
licensed to a single provider and no alternative is available. Courts have been chang-
ing the thresholds for what can be patented, and how strongly patents can be
enforced. Technologies for sequencing, genotyping and gene expression profi ling
promise to guide clinical decisions in managing common chronic diseases and
infectious diseases, and will become an integral part of personalized medicine.
Developing such genomic tests may require exploring a complex landscape of intel-
lectual property and cutting through thickets of patented DNA sequences. A study
found that patent claims, if strictly enforced, might block the use of multi-gene tests
or full-genome sequence data (Chandrasekharan and Cook-Deegan 2009 ). With
availability of new technologies that reduce the costs of complete genomic sequenc-
ing to prices that are comparable to current genetic tests, policy makers and courts
are unlikely to allow intellectual property to obstruct such technological advance,
but prudent policy will depend on careful analysis and foresight.
In 1996, Myriad Genetics in the US began offering genetic diagnostic tests for
mutations in the genes BRCA1 and BRCA2, which are linked to hereditary breast
and ovarian cancer. Since that time, Myriad has been a forerunner in the fi eld of
personalized medicine through the use of effective commercialization strategies
which have been emulated by other commercial biotechnology companies. Myriad’s
strategies include patent acquisition and active enforcement, direct-to-consumer
advertising, diversifi cation, and trade secrets. These business models have raised
substantial ethical controversy and criticism, often related to the company’s focus
on market dominance and the potential confl ict between private sector profi tability
and the promotion of public health. However, these strategies have enabled Myriad
to survive the economic challenges that have affected the biotechnology sector and
to become fi nancially successful in the fi eld of personalized medicine. A critical
assessment of the legal, economic and ethical aspects of Myriad’s practices over this
period allows the identifi cation of the company’s more effective business models
(So and Joly 2013 ). The authors also discuss the consequences of implementing
economically viable models without fi rst carrying out broader refl ection on the
socio-cultural, ethical and political contexts in which they would apply.
On 13 June 2013, in “Association for Molecular Pathology vs Myriad Genetics
Inc”, the US Supreme Court unanimously ruled that naturally occurring genes cannot
be patented, but synthetic transcripts of genes can be. The case involved patent claims
Gene Patents and Personalized Medicine