Stem cells and cancer cells have enough molecular similarities that the former can be used to trigger immunity against the latter.
It’s never too early to start thinking about intellectual property rights—even for biologists doing basic research.
September 1, 2014|
© PETER HOEY COLLECTION/THEISPOT.COMFor the past two decades, Steven Dowdy, now a professor at the University of California, San Diego (UCSD), has been investigating how the cell cycle stops and starts, a question key to understanding cancer. Along the way, Dowdy hit upon an efficient method for delivering large molecules into cells. The technique turned out to be useful for his cell-cycle research, but its application wasn’t limited to basic science. After he filed two patent applications on his methods in 1998 and 2001 and published related work in Science (285:1569-72, 1999), biotech companies began asking him to give talks on the techniques and their application to drug delivery. His group has since published more than two dozen papers on ways to escort large molecules into cells, obtained an additional patent and applied for multiple others, and founded three start-up companies.
“Work on [the] cell cycle has literally taken me 20 years to resolve,” says Dowdy, who earlier this year published a paper that he says finally answers some of his first questions about early cell-cycle progression (eLife, e02872, 2014). “During that time, I kept my career alive” by developing new technologies, publishing and patenting them, and licensing the technology.
It’s very uncommon for institutions not to claim some kind of interest in work done using university resources.—James Grimmelmann,
University of Maryland, Baltimore
Academic scientists aren’t always so savvy about their intellectual property (IP) rights, and many are uninformed about the importance of securing IP during the course of basic research. Pursuing IP on the technology that one’s lab produces can earn researchers a welcome additional stream of income in the form of licensing royalties, or can even support the founding of a new company based on the technology, but companies or venture capitalists often will not invest in an idea without at least a patent application in the works. Patents not only protect products from competition, but also fend off lawsuits alleging infringement on existing patents. Extra cash aside, patents, while still not as important to career advancement as grants and papers, are increasingly a prestigious item to add to a resume, and many researchers take personal gratification from seeing their inventions leave the lab and make their way into the clinic or onto the market.
“If you really want any technology to be used by the public, that has to be supported financially,” says Richard Jordan, a patent attorney at the law firm Dickinson Wright in Washington, DC. “And so you really do need a sound business plan first, and then a patent strategy that supports your business plan.”
Here, The Scientist outlines how an academic scientist can successfully protect IP stemming from her research, and leverage it to commercialize her ideas—from what to look out for when reading a university contract on day one as a prospective graduate student or employee, to how thinking about IP in the course of basic research can boost one’s career.
© FURTAEV/ISTOCKPHOTO.COMGraduate students, postdocs, or new faculty members don’t generally choose their institution based on its IP policies. Factors such as salary or stipend, research strengths, and location will rightly take priority. But researchers should at least be aware of their university’s policies and reputation, says Joan Ellis, a patent attorney with a PhD in molecular biology who practices at Dickinson Wright. “When you sign that engagement letter, look beyond the salary lines and the insurance benefits and see what else is included.”
It’s standard for universities to claim ownership of an academic’s inventions, or to require that the researcher sign over any IP rights she obtains as a result of her employment. Universities require that researchers disclose any invention that might have commercial applications to their institution’s technology-transfer office. It’s important to do this before presenting the new technology at a conference or in a journal; inventions in the U.S. are patentable for only a year after they are publicly announced, and in other countries they often become unpatentable as soon as a researcher talks about them in public. The university tech-transfer office then decides whether to invest money in pursuing a patent and licensing opportunities for the invention. If the university is not interested in the invention or is unable to license it, it will sometimes return the IP rights to the inventor.
Researchers should also be aware of fine print when signing contracts to do consulting for businesses or when teaming up with other groups. It’s possible to inadvertently sign away one’s own right or the university’s rights to ideas generated using information obtained through collaborations or consulting work, and if these agreements are too broad, they can affect a researcher’s whole career, says James Grimmelmann, a professor of law at the University of Maryland, Baltimore, who specializes in IP. “Even fairly innocuous collaboration agreements can contain clauses that purport to assign [to others] all of your future patent rights in the work you do.”
It’s also important for researchers to realize that once the university pursues IP, the resulting patent will stay with that university, even if the researcher switches institutions. Researchers who move should stay in touch with their old university’s tech-transfer office for many years to complete unfinished applications, negotiate licenses, and cash in on royalty payments on technology they developed in their previous position.
When you sign that engagement letter, look beyond the salary lines and the insurance benefits and see what else is included.—Joan Ellis,
Dickinson Wright law firm
Dowdy says he got his impromptu business education doing consulting work for biotech firms and sitting on scientific advisory boards. The knowledge he gained from those meetings—ranging from the basic language of business and funding to what it takes to develop a molecule into a drug—were critical in his ability to launch three biotechs based on his technology, he says. “When I visited companies, I would learn at least [as much], if not more, from them as they would learn from me, and that really opened my eyes.”
© FURTAEV/ISTOCKPHOTO.COMOne very good thing about the university’s involvement in an academic’s IP is that the institution will foot the bill—and securing patents is not cheap. Fees to file the patent application and to issue the patent once it is approved can add up to more than a thousand dollars just in the U.S., and maintaining the patent after it has been granted costs thousands more. If you want to file in multiple countries, even more fees apply, including those for legal translators. And then there’s the expense of hiring a lawyer to write up the paperwork and to go back and forth with the patent office as it rejects claims. All told, a typical biotech patent in the U.S. costs around $30,000, according to Lisa Haile, a patent attorney and partner at the global law firm DLA Piper. Getting patents issued in a selection of key foreign countries can cost an additional $50,000 to $100,000.
To get the university tech-transfer office interested in your work and willing to invest in a patent, it is helpful to first understand what licensing opportunities are available in your field. Does your research feed into the agenda of an existing company that may license your patent? Or is your research relatively unique and free-standing—something that could be spun off into its own company and funded by venture capitalists?
“The first thing was to recognize that we were relatively ignorant of those things,” says MIT and Broad Institute synthetic biologist Timothy Lu, whose graduate advisor for his MD-PhD at the Harvard-MIT Health Sciences and Technology program encouraged him to pursue a patent for a bacteriophage engineered to express proteins that would break up biofilms.
Lu and his colleagues turned to business school professors for advice and got involved with MIT’s Venture Mentoring Service, a collection of more than 165 volunteer mentors who advise academics with nascent business plans. Lu’s innovations in phage engineering now underpin a broad set of synthetic viral technologies, ranging from systems for detecting pathogens in food to systems for fighting bacteria. In 2009, Lu cofounded a company that engineers phages to identify food-borne pathogens, now called Sample6, where he remains on the board of directors. “We filed IP that ended up being valuable,” says Lu. “It was an important asset to have to kind of convince investors that [phage bioengineering] could be a real thing.”
Grimmelmann emphasizes that it’s good to look into whether the institution has a policy of giving the researcher a say in how her ideas get licensed and commercialized and whether they give the researcher first priority if she wants to found her own company and license her own IP. “It’s very uncommon for [institutions] not to claim some kind of interest in work done using university resources, but good ones will have articulated a clear policy that brings the faculty back in as maker participants in any commercialization,” he said.
Lu credits a strong relationship with the tech-transfer offices for allowing him and his collaborators to license the technology to their own company. Otherwise, “they may just license it off to whoever puts an offer on the table, and you might find yourself unhappy a few years later,” he said. For instance, the university might license the technology to a company that has no interest in offering the researcher any input into its development. Or worse, it could go to a company that is developing a competing technology and has little intention of actually developing the researcher’s idea.
“If you have a vision for how [the IP] could be used, I think it’s really important to engage early and view the tech-licensing people as a partner rather than a bureaucratic office you’re dealing with,” says Lu.
© ALEX BELOMLINSKY/ISTOCKPHOTO.COMNot all inventions will get patented or licensed. A study published earlier this year in Nature (507:297-99, 2014) shows that, of 12,516 inventions disclosed to University of California tech-transfer offices between 1990 and 2005, just 25 percent had been patented by 2010, and even fewer had been licensed.
And even if a researcher does license his or her technology to a biotech startup, there’s no guarantee the bucks will start rolling in. That depends on the company’s success, which in the world of biotech can be a gamble. Dowdy’s first start-up company, Ansata Therapeutics, which focused on delivering peptide therapeutics into cells, folded in 2006, a result of the technology’s immaturity when the company started, according to Dowdy. His second company, Traversa Therapeutics, faced a similar fate. With technology for delivering small interfering RNAs (siRNAs) licensed from UCSD, the company aimed to capitalize on the process of RNA interference (RNAi), an inhibitory phenomenon now recognized for its potential clinical power (see “The Second Coming of RNAi,” The Scientist, September 2014). The technology initially failed to deliver high enough siRNA concentrations to work in the clinic, however, and in the midst of a mass pullout of RNAi investments by major pharmaceutical companies such as Roche, the company foundered.
If you have a vision for how the IP could be used, I think it’s really important to engage early and view the tech-licensing people as a partner rather than a bureaucratic office you’re dealing with.—Timothy Lu,
MIT and Broad Institute
“The failure at Traversa was we were always begging for money,” says Dowdy. “We could never do the experiments we wanted to do.” Before the company went bankrupt in 2012, it returned some of its licensed IP to UCSD, and after raising $18 million in initial funding last year, Dowdy launched a new RNA therapeutics company, Solstice Biologics, where Dowdy is on the board of directors. Based on the returned IP and some newer patent applications, Solstice also seeks to create RNAi therapeutics, but is using a different approach than Traversa.
The biotech dealings made news headlines in September 2013 when Hans Petersen, former chief executive officer of Traversa who had been forced out by the board in 2010, allegedly tried to kill Dowdy, shooting him straight through the lower abdomen. Petersen also fired at Dowdy’s wife but missed, and later that day, Petersen shot his estranged wife’s brother. He now faces attempted murder charges for all three shootings, along with other lesser charges.
Despite the drama, Dowdy is now almost fully recovered from his gunshot wound and is optimistic that Solstice will succeed where Traversa stumbled, and help bring RNAi to the clinic. His strategy going forward is to focus on developing the company’s technologies, and securing funding to make that happen. “It’s not your percent ownership that really matters,” he says. “It’s how well the company is funded to do what you intended it to do when you started it, which in this case was to treat patients.”
Lu adds that the business path can be as unpredictable as the scientific one. “Be kind of creative and ambitious in terms of the types of things you are thinking about. . . . Oftentimes you go into it not necessarily knowing the perfect direction, but as long as you have the energy and the willingness to really push for what you believe in, you can often find the resources you need.”