|Title:||Intellectual Property and Product Development Public/Private Partnerships|
|Author(s):||Merz, J. F.|
|Citation:||Merz, J. F. (2005). Intellectual Property and Product Development Public/Private Partnerships. Intellectual Property and Product Development Public/Private Partnerships.|
|Link(s):||Definitive , Open Access|
|Key Related Studies:|
|About the Data|
|Data Description:||Between December 2004 and mid-May, 2005, interviews were sought with a total of 30 individuals, using phone calls and email, and 24 interviews were held with representatives of all 14 PDPPPs in the census as well as 5 other organizations.|
|Data Type:||Primary data|
|Secondary Data Sources:|
|Data Collection Methods:|
|Data Analysis Methods:|
|Cross Country Study?:||No|
|Government or policy study?:||Yes|
|Time Period(s) of Collection:||
This is the final report of an interview study of US-based product development public/private partnerships (PDPPPs) focused on the development of new drugs, vaccines, and other products for diseases that disproportionately affect developing countries. PDPPPs are nonprofit entities that sponsor others to perform or directly perform themselves at least one of the following R&D activities: basic research (such as target identification, validation and proof of concept), animal, preclinical and clinical testing, licensing, and manufacturing. The successful PDPPP may also be responsible for distribution. PDPPPs are distinguished from Access PPPs, which are nonprofit entities concerned primarily with expanding access by pulling together manufacturers, funding agencies (such as GAVI, USAID) and developing countries to enable the purchase and distribution of existing drugs, vaccines, and other medical products.
Main Results of the Study
- The author asked Respondents about problems they have had related to IP, and several related cases in which patents presented problems, both for the science as well as the business of their organizations. One Respondent stated that “a few times” patent holders have refused to license patents on key antigens or antibodies, where the PDPPP was compelled to either focus development efforts on countries where no patents had been secured or to use alternative, “less effective” targets. A different Respondent associated with the same organization reported a case, perhaps one of those discussed above, of an affiliated academic scientist who avoided use of a patented antigen, choosing instead a less scientifically preferred alternative. One major concern about patents is that they may block development of products for use in markets that can not afford to pay patent rents. Few Respondents reported cases in which they were unable to secure licenses.
- One major concern about patents is that they may block development of products for use in markets that can not afford to pay patent rents. Few Respondents reported cases in which they were unable to secure licenses. Two Respondents reported that their organizations had approached firms that held exclusive NIH licenses on, in one case, a potentially blocking patent, and in another, a desirable technology, and in each case licenses were outright refused. In the latter case, the PDPPP was able to invent around the technology. A third Respondent reported that a company had refused to grant a license for an “enabling technology” even though it was for a different field of use, and the PDPPP was able to use other technologies to fill the gap. A fourth Respondent related a case in which a vaccine was exclusively licensed by the NIH with worldwide rights to a large pharmaceutical firm, which had no intention to market in the developing world; the NIH was heavily – and successfully -- lobbied to get them to alter their licensing strategy in subsequent technology transfer agreements.
- Overall, most Respondents did not perceive IP issues to be insurmountable, but they clearly are requiring substantial efforts in time and money to manage. As one Respondent put it, his “day job is to work around tough IP issues.” Several Respondents mentioned the high costs of patents, maintenance fees, freedom to operate studies, and legal services related to contract negotiations, the costs of which they would prefer to spend on their science.
Policy Implications as Stated By Author
The PDPPPs studied here can be characterized as a fledgling “industry”; just over half of the organizations are less than 5 years old, and only 2 predate 1990. On a microscale, these entities are dealing with fundamental questions about the relationship between intellectual property and drug and vaccine development and access that face policy makers at national and international levels. From all of this experimentation may emerge new models for addressing public health needs in the developing world, as well as new insights about patents and pharmaceuticals. It is too early to tell which, if any, models work better than others, and particularly whether aggressive patenting and ownership strategies will help PDPPPs achieve their charitable goals more effectively than alternative strategies.
Coverage of Study
|Level of aggregation:||Individual|
|Period of material under study:||2004-2005|