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At the close of ISSCR2013, I left Boston bathed in an ochre sunset, and settled on a plane to reflect on what my most unexpected learning had been.
James Bond or David Brindley?
My plane was bound not for home (London), but for Istanbul, where the TERMIS meeting was about to begin. As far as I’m aware, the last time a Brit was dispatched to Istanbul was James Bond in From Russia with Love. Physical differences (and minimal similarities) with James Bond aside, my mission on this occasion was also one of intelligence gathering and assassination – seeking novel approaches to remove intellectual property (IP) barriers to stem cell translation.
Perhaps it’s not a coincidence that my reflections on the ISSCR meeting led me to conclude that it wasn’t the stellar scientific advances that most impressed me, but the novel IP models employed to protect and, in some cases, facilitate access to crucial techniques in the translation of cell based products and services.
Historically, the pharmaceutical industry has had a formidable reputation for heavily protecting and aggressively enforcing claims to its intellectual property, elevating terms such as ‘patent thickets’ – describing aggressive IP strategies employed to deter the entry of a competitor into a given market – into the corporate vernacular. Latterly, however, such insular strategies have been touted as another key element of the industry’s business model that requires overhauling, amidst warnings of the potential financial impact of impending ‘patent cliffs’ – significant revenue declines for given companies as a result of a loss of market exclusivity following the expiration of key patents.
With such challenges in mind, what opportunities exist for the cell therapy industry 2027 to successfully negotiate the IP landscape and achieve its mission, as I have defined it, to deliver safe, efficacious and affordable cellular therapeutics to the patients it serves?
In From Russia with Love, the film’s protagonists fight over the finite resource of purified uranium. Today, a key challenge for the cell therapy industry is securing access to a limited number of techniques to derive and reprogram iPSCs – a significant proportion of which are controlled by Japanese innovators, including ISSCR2013’s keynote speaker Shinya Yamanaka.
Acutely aware of the strategic importance of such IP, the Japanese stem cell community formed iPS Academia Japan, an organization established to control and enable access to techniques and technologies pioneered by its innovators. Reassuringly, the remit of the organization is stated to be as follows: “to facilitate the prompt and broad application of iPS-cell related research for clinical use, and the resulting discoveries in a practical manner for the benefit of patients.” The organization clearly outlines a simple licensing structure with fees ($4k – $15k) payable depending on whether the protected technology is being utilized for “research tool(s)” or “therapeutic use;” and whether the potential licensee is a not-for-profit organization, academic institution or private sector organization. Canadian based MaRS Innovation employs a similar model. But is this enough?
To return to the Bond analogy, just as a sample of a radioactive compound is an essential building block for an atomic weapon, affordable and swift access to stem cell derivation and reprogramming technologies are essential building blocks towards a sustainable cell therapy industry 2027. And given the on-going and welcome trend towards open innovation – for example, the stipulation that Wellcome Trust funded research must be published in open access journals – surely it is only a matter of time until we see structures such as patent pooling, where key patents are made available for public access, in the cell therapy industry?
The successful implementation of such structures is a question of equipoise, in other words a mutually acceptable balance of interests between all industry stakeholders. This is something that I firmly believe can be achieved through a productive and sustained multi-stakeholder dialogue, to date admirably facilitated by organizations such as ISCT, ARM and GPI – helpfully lubricated by a few vodka martinis of course!
David Brindley
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Unfortunately, David, after more thought and research, I think you painted far too rosy a picture.
The costs for licensure from AJ run FROM $50K with “FROM” being the key word they use.
For example, hard numbers from a practical real world example of this is Cellular Dynamics, which has paid AJ $351,000 in license fees and royalties (see here: http://www.ipscell.com/2013/06/treasure-trove-cellular-dynamics-ipo-filing-big-money-ips-cell-ip-rights-and-trade-secrets/ ) just so far to date.
Those numbers are likely to go above a million in coming years.
This is not reassuring at all in my opinion.
Paul
Thanks, David, for the excellent piece. I’ve been researching the IP arena for iPS cells as well. One additional element that your readers might find interesting is that beyond Japan, many other entities collectively have hundreds or even thousands of iPS cell related patents as well. As much as Japan is in the driver’s seat on iPS IP, I think things could get very messy going forward. I did a post on this here: http://www.ipscell.com/2013/05/putting-the-ip-in-ips-cells-patent-war-looming/
Best,
Paul