Thursday, December 20, 2012

Using IP Strategies to Break Down Barriers to Progress

Intellectual property (IP) protection is critical to driving investment in new products that can help patients as well as create economic value. Some maintain that IP protection can make scientific collaboration, technology transfer, and commercialization more challenging. At Partnering for Cures, five leaders in biotechnology, science, and intellectual property joined together to discuss how IP could aid the pace of innovation and technology to get to patients who most need it.

Moderator Maria Freire of the Foundation for the NIH began by pointing out that some people “go into panic attacks when having to deal with intellectual property … it seems like a big hurdle between basic science research done in universities or companies and getting it to the market.” However, this is not a new issue. The biggest change is that, within the last 10 years, new players have emerged: venture philanthropies. Freire referenced FasterCures’ newest publication, Unlocking Intellectual Property: Principles for Responsible Negotiation, which serves as a useful tool for all parties in biomedical research, in particular these new nonprofit disease groups and philanthropists.

In addition to the arrival of new players, Stephen Johnson of Kirkland & Ellis LLP and One Mind for Research emphasized that the IP landscape has changed due to the arrival of new technology. In the past, IP focus was on patents, but the “focus has moved away from patents and toward data,” he said. He used to see resistance to sharing data among pharmaceutical and biotechnology companies. Now, “there is acceptance of the pre-competitive space,” and companies increasingly embrace the opportunity to work together. “The future of creative collaborations will be balancing openness with incentives,” he suggested. Freire summarized that companies are more willing to share all data in the beginning, but once there is true innovation, they will then put protection around it. Johnson agreed with her assessment and advocated for processes that promote transparency. He said that one of the reasons that companies would be reluctant to share data is that they are worried that someone else who has access to the data is smarter than them.

Stephen Friend of Sage Bionetworks gave an example of another hindrance, stating that “many companies don’t feel like they can share what they’re talking about … and it’s hard to get things financed without a clear IP strategy. Many worry that someone else could come in, grab the idea, and take advantage of them.” He supported extending the pre-competitive space: “Too many post-docs think they are working on the next billion-dollar drug long before it is.” He cited the successful collaboration of Merck, Pfizer, and Lilly, who generated data in China and agreed that they would share the data among themselves for one year and then make the data publicly available.

Teresa Stanek Rea said that the U.S. Patent and Trademark Office also has a cooperative approach: “We are trying to collaborate with companies to find out what they need to do their job.” Like industry, the Patent and Trademark Office is trying to be more precise and more efficient in what they do and sees itself as the innovation agency in the U.S. government. “We are an agency in the throes of change, just as you are,” she said. Rea noted that the America Invents Act, puts forth “great provisions that help the user community because it takes a second look at issued patents, and whether the patent should have been granted.” Rea believes that the act should minimize litigation and not inhibit research.

Steven Tregay of FORMA Therapeutics brought the conversation back to venture philanthropies and emphasized the importance of being “cognizant of whether the patent that covers the product can actually be translated into treatment.” The key is helping people understand the value for society versus owning one possible combination that may be pertinent or may never be turned into a drug. He cited the success of the CoMMpass project of the Multiple Myeloma Research Foundation, a collaborative study that brought together a network to decide how IP will be shared and who has access to it. Tregay has also worked with the Leukemia & Lymphoma Society (LLS), which aggregates data from many organizations at once. LLS is concerned with creating value to patients and creating a path forward, and it shouldn’t be burdened with the “nightmare of bringing universities together,” he said. “That is the power of these disease foundations – that they are really laser sharp in their approach,” said Freire. “They don’t want to fix the world; they want to fix something for that indication. The traditional paradigm may not necessarily apply.”

Friend agreed that traditional ways of doing business may stymie dialogue and interaction. “We are at a spectacular time where we have tools, new approaches in order to innovate, and yet the way we have structured our incentives and our rewards around sharing, around who is getting credit, et cetera, is basically independent to that.” He cited the success of CommonMind, a public-private pre-competitive consortium that generates and analyzes large-scale genomic data from human subjects with neuropsychiatric disease and makes the data and results broadly available to the public. Friend said that university tech-transfer offices had a hard time at first agreeing to share data being generated, but that “the data required to build the models needed to develop the drugs had to be accessible in order to innovate.” The parties created collaboration agreements that allowed investigator data to be shared with others and not kept to themselves. “We must come up with incentives and rewards that allow the data to get out there,” he said.

Joseph DeSimone of the Frank Hawkins Kenan Institute of Private Enterprise at the University of North Carolina agreed that “partnerships are what work the best, and new connections should always be made,” but cautioned that “without really clear IP, it’s getting increasingly hard to get things financed. Having a really clear IP strategy and path to market is going to be increasingly important.” His university has a conflict of interest committee that meets with him and his students who start companies. He believes that transparency of partnerships makes it more successful: “If you are open to that kind of openness, it can be powerful to enable these kinds of connections.”

In closing, the panelists discussed the future of intellectual property protection with regards to innovation. There was a consensus that patenting had gotten more difficult, and Freire ended by saying “Let’s not rediscover wheels. If you can put something in a box, it’s a lot easier. If you want to think outside the box, just make sure that what you have already doesn’t fit in an existing box.”

Related resource:
Unlocking Intellectual Property: Principles for Responsible Negotiation

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