Last week, MIT and E8 Pharmaceuticals, a spinoff co-founded by professors at MIT and Harvard Medical School, filed a second patent infringement suit against Affymetrix‘s GeneChip genetic testing products and services. Last year, MIT sued Affymetrix itself. This time the defendant is Navigenics, a California-based direct-to-consumer genetic testing company. In February of this year, Navigenics acquired Affymetrix’s California CLIA-approved facility, including its microarray-based testing business. It’s possible that the acquisition was part of steps that Navigenics took to address potential compliance issues raised by the state of California with respect to its direct-to-consumer genetic testing services.
In a remarkably succinct (by the standards of patent lawyers) complaint, MIT claims that the GeneChip testing infringes what it calls a “pioneering” 2004 patent on a method of “accurate, reproducible and cost-effective genetic analysis, using minute amounts of sample DNA and a small number of reactants to generate results that were previously impossible.” MIT claims that the infringement is willful and knowing, as evidenced by references to the patent in the Navigenics-Affymetrix asset purchase agreement. Proof of willful infringement exposes the defendant to triple damages. MIT and E8 ask for unspecified damages, to be tripled, as well as attorneys’ fees and an injunction against further use of the patented technology, if Navigenics refuses to take a license. The complaint also references, as evidence of Navigenics’s willful infringement, “its insistence on certain contractual provisions regarding the ‘228 patent and this litigation,” which suggests that the parties have tried and failed to negotiate an agreement.
Since the completion of the Human Genome Project nearly a decade ago, technological and scientific progress in the fields of genomics and personalized medicine continues to accelerate, with the next generation of human genomic research seeking to untangle the complex relationship between genes and traits and realize the promise of personalized medicine. As these fields have grown, researchers, entrepreneurs and established companies have all enjoyed increasing public and media attention — along with the attention of politicians, regulators, and judges, who are bringing a new layer of complexity to an already complicated legal and regulatory framework.
To help make sense of the resulting confusion, Robinson, Bradshaw & Hinson proudly announces the launch of the Genomics Law Report. The Genomics Law Report focuses on the legal implications of important developments in the fields of genomics and personalized medicine — including key litigation, legislative, regulatory and policymaking activities — in order to facilitate understanding of the complicated and shifting legal landscape governing genomic and personalized medicine commerce and research.
We hope that the Genomics Law Report will enable you to follow these developments as we see them, from a legal perspective, and encourage the exchange of information and ideas within the genomics and personalized medicine communities.
If you’d like to learn more about the Genomics Law Report, would like to contribute or have a suggestion for what you’d like to see us cover, please feel free to send us a message at firstname.lastname@example.org. In the meantime, welcome and thank you!