In a press release, Johnson and Johnson “announced their intention not to enforce the patents they own and control on the antiretroviral (ARV) drug darunavir provided the darunavir product is medically acceptable and is used only in resource-limited settings,” which J&J defines as the 48 UN defined Least Developed Countries plus any other country in sub-Saharan Africa. This is the KEI statement on the J&J darunavir announcement.
According to James Love of KEI, “The Johnson and Johnson announcement expands the degree of competition for darunavir, which is potentially a useful drug to treat HIV/AIDS. Darunavir is normally dosed at 600 mg per day, boosted with 100 mg of ritonavir, and in combination with other drugs. A few observations can be made about the J&J policy. The announcement can be reasonably seen as motivated at least in part by the efforts of the Medicines Patent Pool (MPP) to obtain voluntary licenses. J&J hopes that its announcement to not sue for infringement in some countries will reduce the pressure to license to the MPP, and to the extent that the MPP influenced the decision, it shares some of the credit for the expanded competition. Another observation is that there is thin patent protection in the geographic areas covered by the announcement, so the decision is somewhat similar to Gilead’s license for tenofovir patents, another case where few patents existed in the geographic area of a license. In both cases using the product outside of a license to the patent pool will eliminate requirements to pay royalties. What we don’t know are some of the legal details and limitations of the decision, which apparently are not public, unlike the MPP licenses. Another issue with a non-assert unilateral announcement by a company is that the offer likely can be withdrawn. For example, when Pharmacia announced an open voluntary license to manufacture the AIDS drug delavirdine in some low income countries, the offer was eliminated after Pharmacia’s merger with Pfizer was finalized. A number of persons want to know if the J&J offer extends to the many combination patents they are filing in developing countries. Also, we note that patents for rilpivirine were not included in the announcement. Rilpivirine is normally dosed at 25 mg per day, and is potentially quite important as a drug that will be cheap to manufacturer.”