Releasing Unlocking IP: Principles for Responsible Negotiation

By Elizabeth West, Program Manager, FasterCures

Readers of the FasterCures blog are well aware of the importance of reducing cost, time, and inefficiency in the biomedical research system. One area consistently raised to us as having unnecessarily high transaction costs - both human and financial - is intellectual property (IP) negotiation.

We've long heard how IP can be a roadblock to innovation, but since it's a necessary and critical "cost" of doing business in drug development, we began to wonder if it might be possible to create an agreed-upon culture of responsibility in the practice of negotiating IP for medical research collaborations.

Last week we released Unlocking IP: Principles for Responsible Negotiation to serve as a set of guiding principles and points to consider when engaging in intellectual property negotiations involving biomedical R&D. The principles are a useful tool for all parties in biomedical research, in particular disease foundations, nonprofit disease groups, and philanthropists negotiating IP with academic, industrial, and nonprofit partners. The document includes principles for before, during, and after negotiations, for both new and seasoned organizations engaging in IP negotiations.

Some of the highlights include:

• Do not let fear paralyze you…If the desired result [of a deal] is based on research impact as well as monetary returns, not doing the deal or slowing progress is a far bigger loss to the patient and the public than lower potential economic return.
• Make sure you have the right people at the table at the right time…Think through which stakeholders are needed to  foster innovation, and only exclude a stakeholder group—especially nonprofits—after careful thought.
• Build in “use it or lose it” requirements (interruption licenses)….If you have invested in the IP and the owner is not exercising the rights to use the invention and make it widely available, or if they are using it in a way that impedes progress, ensure you have a way to take it to a party where its value can be maximized.

The principles emerged from a small, expert-led working group convened by FasterCures in July 2012. In addition to developing the principles, the group came to some broader conclusions regarding the intellectual property ecosystem. In particular, it found that there is a fundamentally new landscape in biomedical research resulting from the emergence of venture philanthropy and patient advocacy groups. These groups tend to want to enhance the freedom to operate, versus the limiting model more prevalent in the current environment.  A key conclusion of the working group is that an IP management system is needed that addresses this emerging ecosystem, not reflects the current one. We welcome all of your thoughts on the fundamentals of a forward-looking IP system.

The Webinar – directly from the experts

On Nov. 16, we continued the conversation on IP and the principles through the TRAIN (The Research Acceleration and Innovation Network) Webinar series. The Webinar (available to view here), moderated by Margaret Anderson, was led by an expert panel of individuals with in-depth experience in intellectual property negotiation from a variety of viewpoints.

Maria Freire, of the Foundation for the NIH, laid out the main findings of the working group and gave a detailed overview of the principles themselves, as well as spoke of the increased sense of urgency and interest of many groups in deals that “move towards the goal.” Robert Cook-Deegan of Duke University’s Institute for Genome Sciences and Policy provided the audience with the broader landscape of intellectual property negotiation successes and controversies, as well as analyzed the elements of success through an in-depth case study of Cystic Fibrosis Foundation and the CFTR gene patent. David Lubitz, of Schaner&Lubitz, PLLC, which provides council for many disease foundations, gave a thorough overview of the viewpoint of disease foundations and venture philanthropy groups, including funding goals, trends, and useful IP tools, including  interruption licenses. Many of the questions during the Q&A period focused on the replicability of the Cystic Fibrosis Foundation model, which the panelists agreed would require a foundation with financial resources, technical expertise, and potential commercial partners.

More on IP at Partnering for Cures

We will have more on this topic at our annual conference, Partnering for Cures, in New York City, Nov. 28-30. The IP-focused panel, License to drive (innovation): IP strategies to support, not slow, progress, will explore the evolving IP law and procedures, the IP implications of the movement toward more precompetitive collaboration in biology, examples of responsible IP management practices, and how IP decisions can impact follow-on innovation and patient access. We invite you to join us there!