by Professor Brook K. Baker, Senior Policy Analyst

Janssen Pharmaceutical Company, an affiliate of Johnson & Johnson, has just announced its intent "not to enforce its patent for quality, medically acceptable generic versions" of its protease inhibitor, darunavir (brandname Prezista) for sales in sub-Saharan Africa and in UN-defined Least Developed Countries.  That restriction gives this so-called "non-assert" commitment a geographical scope of just 64 countries. 

Janssen's publicity release is intended to give it a reputational boost on the eve of World AIDS Day, but there are multiple deficiencies and ambiguities in its announcement.  Although any increased access to generic darunavir of assured quality is desirable, Janssen has given far less than what is required:

1. The geographical scope is woefully inadequate because it excludes treatment-experienced patients in all non-African middle-income countries who are much more likely to need second- and third-line medicines – like darunavir – because they've developed treatment resistance to other regimens over time.  The vast majority of patients in developing countries who are treatment experienced and who need second- and third-line regimens live in middle-income countries in Latin America and Southeast Asia where patients first had government supported access to treatment, e.g., Brazil and Thailand.  Excluding these middle-income countries not only leaves poor patients in middle-income countries subject to the pricing whims of Janssen, but it also shrinks the market of darunavir-eligible patients.  Accordingly, the resulting consumer demand will be too small to incentivize robust generic competition and economies-of-scale will be much slower to develop – resulting in higher prices and fewer sources even in the covered territories.
   
   
2. The "generosity" of the geographical scope is misleading, because it appears that Janssen has no patent claims whatsoever in the vast majority of countries covered by the non-assert commitment.  A search of the Medicines Patent Pool patent database reveals a patent for a darunavir pseudopolymorph in ARIPO (Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Sierra Leone, Sudan, Swaziland, Uganda, United Republic of Tanzania, Zambia and Zimbabwe) and in South Africa only.  Of course, there may be additional patents that have been filed, but to date Janssen, like virtually every other Big Pharma company has been unwilling to publicly disclose their existing patent landscape in developing countries, making it very hard to generic competitors, governments, or other interested parties to ascertain patent status.
   
   
3. The prices currently charged in excluded, non-African middle-income countries can be quite outrageous.  According to MSF and Global Fund data available at http://www.theglobalfund.org/en/procurement/pqr/,  prices being paid by some excluded countries are as follows:
   Brazil:  USD 6,037 ppy
   Georgia: USD 8468 ppy
   Moldova: USD 9187 ppy
   Jamaica: USD 6570 ppy
   West Bank and Gaza: USD 5900 ppy
   Thailand: USD 4854 ppy 
   Of course, these prices are for one component of triple-therapy only, so the aggregate cost of a full second- or third-line regimen in these countries could be many times higher.
   
   
4. Janssen has not clarified whether the non-assert commitment is absolute and for the duration of any relevant patent claim or whether the commitment could be revoked.  In press coverage on the commitment, Janssen has already indicated that there are circumstances where it would assert its patent rights if - in its unilateral judgment - darunavir was being produced in sub-optimal formulations or dosages.  This would leave little incentive for generic companies to try to optimize chemical form, formulations or dosages since the rug could be pulled out from under it both with respect to the original investments needed to produce darunavir at all and with respect to the additional expenses incurred to "optimize" the medicine.
   
   
5. Janssen has not clarified whether it will permit co-formulation with other medicines, though as a protease inhibitor darunavir needs to be combined with a protease booster such as ritonavir.  In addition, darunavir should, if possible, be co-formulated with the other medicines to produce a fully potent fixed-dose combination.
   
   
6. Janssen has not clarified where the darunavir for covered countries can be lawfully produced.  There is a weak and opposed divisional claim for a combination with ritonavir in India and Janssen is pursuing an appeal of a denial of its patent for darunavir as a stand alone product.  Thus it is not completely clear in the long run that India companies could produce a darunavir standalone or a ritonavir/darunavir combo for export to SSA and LDCs.  Since the major generics of assured quality ARVs are India-based, it would be highly desirable if all generics producers of assured quality, including Indian, were permitted to produce for export.
   
   
7. Janssen has not taken adequate steps to ensure registration of darunavir in the covered territories despite ample time to do so.  The absence of such pre-existing registration negatively impact the cost, timeliness, and ease of registering a generic equivalent.  Many of the covered territories will allow fast-track registration of generic equivalents, but only if the originator's dossier has already been approved.  In the same vein, Janssen has failed to clarify whether it will assist in the generic registration process, and whether it will waive any data rights or patent-registration linkage rights in may have in any of the covered territories.
   
   
8. Janssen has not clarified what if any restrictions it might place on "qualified" generics, e.g., with respect to their right to oppose patent applications or challenge granted patents or to be licensees of compulsory licenses granted in non-territories.  There may well be other non-disclosed terms that are problematic.

The ideal voluntary license is one that is open to all qualified generic producers and has a territorial reach of all developing countries.  The closest to that ideal at present is the Medicines Patent Pool, which has the added advantage of transparency about licenses and efficiency in acting as a clearinghouse for multiple licenses on diverse products.  However, for the second time, Johnson & Johnson has tried to cover its tracks in boycotting the MPP by saying "we feel better doing it alone."  Indeed, J&J has stepped back from its earlier 2011 voluntary license because the geographical scope on this second commitment is smaller than what it promised a year ago for rilpirivine.   

In sum, the limitations on the Johnson & Johnson/Janssen non-assert commitment make it a gift box without the gift on the even of World AIDS Day.  Yes, over the long haul, as demand in the covered territories builds, a viable generic market may slowly develop and generic companies may get through the arduous registration process unassisted.  But, many other patients in middle-income countries and in underserved SSA and LD countries will go without the life-enhancing and life-saving benefits of darunavir in the meantime.  Scarce resources will be wasted on overpriced brandname Prezista or patients will go without.  This frankly is not good enough.