Biting hands that feed
Biotech companies fight with each other over the commercial rights to ideas and technology all the time. Patent lawsuits are as much a part of the business as lab work and clinical trials.
But those companies rarely go to court against big universities or scientific institutions, the source of talent and so many initial discoveries for the biotech industry. They don’t compete directly and, besides, do you really want to risk biting the hand that feeds you?
That’s partly why a lawsuit filed last week in Suffolk Superior Court is so extraordinary. The case involves a cast of world-renowned scientists and institutions in a dispute over key intellectual property rights in an emerging field that could change biotechnology, and possibly create vast fortunes.
Max Planck GmbH, a scientific society in Germany, and Alnylam Pharmaceuticals Inc. of Cambridge filed the suit against MIT, the prestigious Whitehead Institute for Biomedical Research in Cambridge, and the University of Massachusetts. They alleged important inventions were “misappropriated’’ by the three institutions.
That conflict is more personal than it sounds. Nobel prize-winner Philip Sharp, one of Alnylam’s founders and board members, is a professor at MIT. Another company founder, David Bartel, is both an MIT professor and a Whitehead member. Two other founders formerly taught at MIT. Researchers from Whitehead, MIT, and UMass sit on the company’s scientific advisory board.
They are fighting over rights in a hot new biotechnology field known as RNA interference, or RNAi in scientific shorthand. RNAi technology could potentially be used to turn off genes responsible for serious diseases. RNAi may be able to do as much good by turning on helpful but inactive genes.
RNAi technology got a big boost when UMass researcher Craig Mello and Stanford University colleague Andrew Fire won a Nobel prize in 2006 for their work in the field. Basic research continues in academic labs, but biotech companies are racing to create commercial drugs based on RNAi.
“It’s a potential game-changer,’’ says Warren Isabelle, president of Ironwood Capital Management in Boston. “You’re getting right to the heart of what makes biology work.’’
Whether RNAi will live up to that potential is hard to say. No approved medical products exist. The science works like clockwork in the lab, but everyone struggles to deliver it in humans without doing unintended damage.
“In a petri dish, this stuff is great,’’ says biotech stock analyst Steve Yoo, of Leerink Swann & Co. “But our bodies aren’t petri dishes. If they can solve the delivery problem, it’s off to the races, but it’s not an easy problem to solve.’’
Biotech companies are working on it, but are also stockpiling legal rights to RNAi inventions and discoveries. Alnylam asserts it has licensing rights to two key sets of discoveries that are intellectual cornerstones in RNAi technology. Competitors disagree. Those discoveries, both named after researcher Thomas Tuschl, are at the heart of the suit.
Tuschl and three other scientists advanced RNAi research with an initial set of discoveries that became known as Tuschl I in the 1990s. The researchers assigned rights to their respective institutions: Max Planck, MIT, Whitehead, and UMass. All four of the scientists were also founders of Alnylam.
Tuschl conducted further research with other scientists, all from Max Planck, that led to new discoveries known as Tuschl II.
Whitehead was responsible for securing Tuschl I patents that would be shared by the group, according to the suit. But patents for those discoveries have been awarded in just two countries, Australia and New Zealand. Max Planck was much more successful winning patents around the world for Tuschl II.
Alnylam and Max Planck claim data from the patented Tuschl II are being wrongly used in the still-pending Tuschl I patent application and want it stopped. That matters because Max Planck and Alnylam hold exclusive ownership and license rights to Tuschl II. They share Tuschl I with other institutions and biotech companies.
Officials at MIT and Whitehead declined to comment about the lawsuit. Officials at UMass Medical School did not return a call.
A court victory for Alnylam could weaken the intellectual property rights owned by competitors and strengthen its own hand. Whether the battle turns out to be worth it is an entirely different question.
Steven Syre is a Globe columnist. He can be reached at syre@globe.com. 
