The Burrill Report

Direct-to-consumer genetic testing company 23andMe has made no secret of its plans to leverage willing customers’ data to conduct research into the genetic basis of disease. So it was with some seeming pride that the company’s CEO Anne Wojcicki announced that the company was being issued its first patent on a gene variant related to Parkinson’s disease.

The announcement, made on the 23andMe blog, The Spittoon, May 29, was greeted instead with concern and criticism from 23andMe customers and triggered a robust discussion. The exchange between readers and the company led the company to make a “clarifying addendum” to the original post to address questions raised.

The controversy comes as the issue of gene patents continues to battle its way through the courts. What’s unclear is whether the whole back and forth between 23andMe and blog readers reflects a naiveté on the part of the company for thinking that the milestone would be celebrated without any examination of the broader implications or on the part of readers that a for-profit company would seek to protect intellectual property it developed and ensure it would have value to drug and diagnostics makers.

The patent (8,187,811), “Polymorphisms Associated With Parkinson’s Disease” relates to 23andMe’s discovery of a variant in the SGK1 gene that may be protective against Parkinson’s disease in individuals who carry the rare risk-associated LRRK2 G2019S mutation.

“We recognize that patents are complicated and can be controversial. Patents were created to protect innovation. Is discovering the function of a gene an innovation?” wrote Wojcicki. “The question of whether innovations related to genetics can be patented is in hot debate as evidenced by recent rulings related to Prometheus and Myriad patents.”

Some readers offered congratulations, some sought additional information about when certain details of their findings might be available, but several expressed concerns that the patent will be used to impede rather than foster research.

“I think 23andMe needs to come clean and say that their enterprise is a business, it is funded to eventually make money (it is not a non-profit) and reward its investors, management, and employees, and that the subscription model is not enough for this, but other sources such as patenting, and selling access to their database to Pharma companies wishing to find patients for clinical trials are necessary,” wrote one reader.

“I had assumed that 23andMe was against patenting genes and felt in total cahoots all along with you guys,” one customer posted. “If I’d known you might go that route with my data, I’m not sure I would have answered any surveys.”

In response to the comments, 23andMe posted an addendum to the original article on June 11 in the hopes of clarifying its position and quelling concerns. It stated it would not prevent others from accessing their genetic data or its interpretation specific to 23andMe patents. It reiterated that patents give drugmakers confidence that their significant investment will be commercially viable. “Developing new drugs and treatments costs time and money. A lot of time and money,” the company said. “Often the only way a company will even think about pursuing a drug lead is if they have assurance that they can recoup their investment. Having patent protection over the entire line of discovery gives a company confidence to invest in this resource-intensive process.”

23andMe is working with a new type of model made possible in an Internet age. It’s not just that they are providing genetic data directly to consumers, but they are also collaborating with their customers to allow them to participate in potentially important research about the relationship between genes and disease. This type of relationship may require additional thinking about ethical issues, and to what extent customers should shape policy. If there’s a lesson here it’s that consumers are happy to be research partners, but not silent partners.



June 01, 2012
http://www.burrillreport.com/article-23andme_patent_creates_concerns_with_customers.html