GSK Is First To Share Cancer Drug Patents With Poor Countries

GlaxoSmithKline to license its future cancer treatments for generic manufacturing in poor countries; access continues to be flagship issue for GSK's Witty, who also sits on recently formed UN access panel.

GlaxoSmithKline PLC intends to make a big splash in the Medicines Patent Pool as the first company to share its future cancer drug patents for development of generic drugs in least developed and low-income countries and certain middle-income countries.

The company announced on March 31 that it is committing its future portfolio of cancer treatments to patent pooling. Under the arrangement, patents would retain full protection in upper-income countries. GSK has two oncology compounds in Phase II trials and nine in Phase I development.

The initiative is among several steps GSK is taking to expand access to its medicines to people in the poorest countries. It also will no longer seek patents on its products in least-developed countries (LDCs) and low-income countries (LICs). And in lower-middle-income countries (LMICs), it will offer licenses to allow generic manufacturers to supply versions of its drugs for 10 years. There are about 85 countries that are least developed or low income.

Knowledge Ecology International, a nongovernmental organization focused on increasing access to medicines, is enthusiastic about GSK's decision to license patents on cancer drugs and the potential impact it will have on other drug makers.

"This is the first time we've heard anything significant from a company on the cancer front" with regard to access, said KEI Director James Love. "It's significant not just for products GSK has in its portfolio. It's important as to what it will lead to from other companies" with bigger oncology portfolios.

Love noted that Gilead Sciences Inc. initially was the only company to license its HIV products and now most HIV drugs are licensed through the Medicines Patent Pool (MPP). He added that MPP licenses are open and transparent and allow products manufactured under an MPP license to be exported to countries outside of the licensed territory, where there is no patent or where compulsory licensed have been issued.

MPP said it is in exploratory conversations with GSK and needs to look at the patent situation of the products and public need for them. "It's very good news for the access to medicines field," an MPP spokesperson said.

Since launching in 2010, the Medicines Patent Pool has signed licensing agreements with six pharmaceutical companies, which involve HIV drugs and one hepatitis C treatment, Bristol-Myers Squibb Co.'s Daklinza (daclatasvir). MPP has worked with GSK in licensing agreements with ViiV Healthcare, an HIV joint venture established by GSK, Pfizer Inc. and Shionogi & Co. Ltd., to increase access to Tivicay (dolutegravir) and Ziagen (abacavir).

Graduated Intellectual Property Protection

GSK's patent policies are implementing a graduated approach to intellectual property protection based on the economic situation of countries.

GSK said that it already does not apply for patents in the majority of least-developed countries and is now formalizing that position for least-developed and low-income countries and will not seek intellectual property protection for any current or future medicines in its portfolio. The company will continue to file and assert patents in the richer G20 countries.

"What we are trying to do here is to first of all streamline our approach and also unify it around a philosophy of making sure that we deploy intellectual property in a graduated manner basically in step with the economic maturity of the countries involved," GSK CEO Andrew Witty said in a press call.

He said the changes would "make it as clear and simple as possible for generic manufacturers to make and supply versions of GSK medicines" in least-developed, low-income and most lower-middle-income countries.

GSK is also publishing its intellectual property position worldwide in one location. Witty noted that the company sometimes hears from generic suppliers struggling to figure out whether or not GSK has a patent.

UN Panel On Access To Medicines Worries Industry

GSK's new patent policies are an extension of the company's efforts to expand access to medicines in developing countries, which include capping the price of patented drugs in least developed countries at no more than 25% of developed world prices and using a tiered pricing model for its vaccines in which high-income countries pay more than low-income countries.

Increasing access to medicines has been a focus of Witty, who will retire from the company in 2017. He sits on the United Nations High-Level Panel on Access to Medicines and announced the firm's new initiatives before the panel's March 31 meeting.

The proposed goal of the panel, which was launched by UN Secretary-General Ban Ki-moon in November, is to "review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies." The panel is scheduled to present a report to the UN Secretary-General in June.

The panel is apparently controversial for industry. The Biotechnology Innovation Organization and Pharmaceutical Research and Manufacturers of America were among the signatories to a Feb. 18 letter to Senate Finance Committee Chairman Orrin Hatch, R-Utah.

They said they are worried that initiatives at certain UN organizations could "degrade the global ecosystem for innovation." Specifically, they said they are concerned that the process of the UN High-Level Panel on Access to Medicines "will not provide for an informed, balanced, and inclusive dialogue that adequately incorporates the perspectives of innovators."

The letter cites concerns about the lack of transparency regarding the selection of the panel members and experts and "the limited scope of inquiry that specifically excludes the broader context needed to understand the complex issues impacting the development and deployment of health-related technologies."