Vol. 37, No. 1
Johnson & Johnson says no to patent pool
On December 19, 2011, Johnson & Johnson (J&J) informed the Medicines Patent Pool Foundation (MPP) that it would not enter into negotiations to license its patents for some of its HIV and AIDS medicines.
The Medicines Patent Pool is an initiative launched by UNITAID to streamline the licensing processes for the production of generic versions of patented HIV medicines, and allow generic pharmaceutical companies to develop new pediatric formulations, fixed-dose combinations, and heat-resistant formulations. (See NewsNotes November-December 2010).
The Pool has already concluded two licensing agreements with Gilead Sciences and the U.S. National Institutes of Health, and is in negotiations with five drug companies, including Bristol-Myers Squib and ViiV Healthcare (a joint venture of Glaxo SmithKline and Pfizer). Generic companies have begun to take licenses from the Pool allowing them to make lower cost versions of new HIV treatments for use in developing countries. The Gilead licenses are seen as a significant first step, although many civil society organizations have expressed dismay that the license agreements exclude a number of middle-income countries and limit manufacture of the new formulations to Indian generic companies.
NGOs and faith-based investors have been encouraging pharmaceutical companies, particularly Abbott, Merck and J&J, to join the Pool in order to increase access to affordable HIV and AIDS medicines. J&J had seemed the company that was most intently studying whether to enter into negotiations.
Will Stephens, vice president of Global Access and Partnerships at J&J's Janssen Global Services, explained the company's position in a statement on J&J's website: "Earlier this year, we responded to a formal invitation from the Medicines Patent Pool (MPP) to begin negotiations to grant licenses to the patents for our HIV medicines. We expressed confidence that our direct agreements with quality generic manufacturers were providing the best route to expand access to patients in need. After thorough deliberation and discussion, we continue to believe that this is the best approach to providing access to our HIV drugs today, so we have decided not to enter into negotiations with the MPP.
"Our access efforts are working. Through our nine licensing agreements with generic manufacturers we are effectively and responsibly meeting the needs for our HIV medicines in resource-limited countries; five of these agreements include the rights to develop fixed-dose combinations. And we are collaborating with researchers to study further how our medicines can be used best to help patients in developing countries and providing medical education to ensure our medicines are used appropriately in these settings."
Stephens noted that since J&J's AIDS medicines are not included in the World Health Organization's guidelines for HIV treatment in resource-poor settings, and the drugs in those countries are indicated for "third-line" or treatment-experienced patients, "we remain concerned that the model put forth by the MPP could foster more widespread use of inappropriate combinations of these drugs of 'last resort' that could adversely impact the future of HIV treatment globally."
The reaction to the decision was one of great disappointment. Doctors Without Borders (MSF) said: "In refusing to join the Medicines Patent Pool, Johnson & Johnson says there is no urgency for making these drugs widely available in developing countries. That's simply not true. MSF now provides treatment to more than 180,000 people living with HIV worldwide, and is beginning to witness the inevitable, natural phenomenon of treatment failure, whereby people develop resistance to the drugs they are taking and need to graduate to newer medicines.
"Rilpivirine, darunavir, and etravirine [the three J&J drugs] were identified among the key drug formulations needed for HIV treatment by the Medicines Patent Pool, UNITAID and the World Health Organization.
"Newer, better antiretrovirals are already used by patients in the U.S. and Europe, but aren't available to people in developing countries or are simply too expensive. People living with HIV need access to these newer treatments, so they have the best chance of keeping the virus from further weakening their immune system as they navigate this life–long disease."
Ellen 't Hoen, of the Medicines Patent Pool, told The Financial Times: "We are not concerned, but disappointed J&J came to the conclusion they are still not ready to make the jump." She said the Medicines Patent Pool would be stronger if every company participated, and she was expecting "good news" next year from others. She added the Medicines Patent Pool allowed negotiation on terms that could meet J&J's demands.