The BRCA case pitted a private corporation intent on patenting DNA sequences against a publicly funded effort that forgoes such practices, while simultaneously revealing gene patenting as one of genomics’ biggest business stories. Furthermore, it produced two new R&D strategies from Randall Scott at Incyte and Craig Venter at Human Genome Sciences; both focused on sequencing protein-coding genes for patenting purposes.
Patents
Genomic science emerged during an era of growing government and nonprofit research funding as well as huge investments by biotechnology and pharmaceutical firms. Patents on DNA technologies became a central feature in this story, reflecting shifting norms about what should and shouldn’t be patentable as well as patent law’s attempts (or lack thereof) at keeping pace with emerging technologies.
Early DNA patents related to particular amino acid sequences associated with disease (e.g. insulin or growth hormone) or methods of sequencing DNA molecules – commonly referred to as gene patents; however, most DNA patents do not make such claims. Patents on other DNA inventions included technological improvements on existing laboratory instruments, such as the Polymerase Chain Reaction (PCR) method for rapid replication and amplification of DNA molecules conceived at around the same time by Maxam and Gilbert at Harvard, Fredrick Sanger and Coulson in Cambridge UK and Ray Rodriguez and Fernando Bolivar at UCSF; Cetus firm secured a patent on heat-stable reagents such as Taq polymerase used with thermocycler instruments in performing PCR reactions.
By the late 1990s, these and other patent innovations had helped drive the expansion of start-up firms such as Affymetrix and Illumina. Both firms took advantage of classic Bayh-Dole stories involving federally funded university research producing patents licensed exclusively to start-up companies that built instruments designed for use in academic and industrial laboratories.
These technologies were often utilized in the research and development of therapeutic proteins, followed by clinical trials to test their safety and efficacy. This process often costs thousands of dollars and takes years. Patents on such proteins often serve to incentivize investments in engineering product development by providing their inventors with control of intellectual property rights for products they create.
The US Supreme Court’s Myriad decision of 2003 brought about significant change. In this landmark ruling, they declared Myriad’s BRCA1 and BRCA2 gene patents invalid due to the “nonobviousness” requirement based on CAFC decisions dating back to 1995. Though the ruling didn’t overturn them as such, it rendered them unenforceable based on “nonobviousness.”
Licensing
Myriad’s patenting decision had four effects. First, it raised questions of who owns and controls patent rights from federally funded inventions; it led to the development of a novel licensing strategy which generated $246 Million; it altered molecular biology by showing patenting methods central to genome sequencing is possible and profitable; it altered molecular biology norms by showing patenting genome sequencing methods can be profitable; and finally it indicated the need for greater cooperation between researchers and their institutional leaders – as proteomics/genomics researchers rank patents among their list of impediments to innovation (218).
Myriad’s attempt at aggression in Canada was met with resistance by Industry Canada, who instead encouraged Myriad to license its rights to MDS (Multi Diagnostic Screening Ltd), a private firm which would enable provincial health ministries to conduct BRCA testing (183). Myriad did not pursue this same strategy in Australia.
Commercialization
Scholars have often looked to research as an indicator of anticommons effects; however, researchers should understand that stronger impacts may occur further downstream, through forgoing investment in innovations requiring patent protection as inputs.
TIGR and Human Genome Sciences (HGS), two companies dedicated to sequencing-for-profit, were both founded as a result of the EST patent dispute. Furthermore, small start-ups Incyte and 23andMe used capillary gel sequencing instruments from ABI that consumed less DNA while producing results faster than Prism 377 instrument. Both companies utilized sequencing protein-coding genes before filing patents or licensing rights from them for products or licensing rights development – similar strategies were pursued by University of California which launched spinoff company Affymetrix which produced DNA microarrays for licensing rights development by University.
