In February 2009 in a speech at Harvard Medical School, Andrew Witty, CEO of GlaxoSmithKline (GSK), described four commitments the company was taking to address improving global health, one of which was the creation of a licensable set of GSK patents relevant to neglected disease drug development (the “Least Developed Country Patent Pool”) (Witty Speech). While the other three commitments attracted less media attention (but warrant consideration), the formation of a patent pool, and invitation to other companies to contribute, caused quite a splash, probably a result of the public misunderstanding of the value of IP to research vs. product and market protection. A several months later in July, Alnylam, the iRNA company in Cambridge, MA, became the first contributor, adding about 1500 patents to the pool.
To their credit, GSK has made the process for obtaining a license fairly transparent, at least as described on the company website (GSK Terms). The grant has use and geographic limits: “The terms of the IP patent pool relate specifically to the development of medicines for the treatment of the identified diseases [the 16 identified as neglected by the US FDA] and only for use in least developed countries [as defined by the UN].” And will be cost/royalty-free with, I presume, the licensee assuming all liability. Apparently, GSK will also apply a means test to licensees, established companies likely preferred over one-person virtual outfits. Interested parties are to contact the pool’s administrator through an email link.
So what’s in this pool and how may it help accelerate the development of drugs for neglected diseases? The GSK portion of the pool is described by a list of marginally descriptive titles with country and number of filing, status, and application date (GSK Patent List). Although the number of pool members was touted in the media as 800, GSK points out on its website the pool comprises about 80 unique patent families. On initial read, the contents are promising in that all but one of the families covering compounds and formulations, some of which GSK notes are in unspecified stages of development as therapeutics. The rub is that with the limited data typically available in a patent application and without GSK’s data package from efficacy and toxicity testing, it’s difficult to know covered compounds’ value and utility. To start from scratch, one would need to resynthesize and test a sizable number of exemplar compounds, a major cost. Clearly it will be helpful if GSK includes technology/data transfer with a license. Even better, the company could provide testable quantities of the covered compounds to the many academic and PDP neglected disease screening programs (and even pay the for the screening). It is also possible, but unlikely, that the included compounds are already generally known as useful, e.g., an already-approved drug, greatly increasing the value of a license to the underlying IP.
The value of Alnylam’s contribution is less clear than that of GSK’s. As described in GSK’s press release (GSK-Alnylam PR), Alnylam contributed 1500 patents, but no listing is provided by either company. Presumably, the patents are from the company’s core IP holdings which are described on their website as:
- Fundamental IP required for all siRNA therapeutics;
- Chemistry IP required to introduce drug like properties;
- Delivery IP related to direct or systemic delivery of siRNA into diseased tissues;
- Target IP related to siRNAs for specific disease targets.
For company skilled in iRNA therapeutic development (I think there are about three), a license may be a windfall. But for anyone using Alnylam’s patents in target identification, having a license is nice but not having one is low risk. Any use of the IP for drug development likely requires substantial knowledge, investment, and possibly access to Anylam-proprietary know-how.
The bottom-line is that, while GSK is to be commended for starting the patent pool, and Alnylam for contributing to it, getting a license to IP in the pool is a small part of finding new treatments for the neglected diseases. What’s really needed is professionally-managed, industrial-strength R and D fired by academic innovation. I think GSK is moving in the right direction with its offer to consider for proposals for collaborations around the compounds (GSK Collaborations)- but a larger and better publicized effort would be greatly appreciated. Why the Big Three of the PDPs (TB Alliance, Medicines for Malaria, and Drugs for Neglected Diseases Initiative) haven’t jumped on this opportunity’s bandwagon is not known, at least to me.