A Chinese Ebola Drug and IP Interplay
On June 11, 2015, the New York Times reported that a small Chinese company had produced 100 doses of an Ebola drug that closely mirrored a drug patented by a U.S. drug-maker and for which the U.S. government held a patent on one of the constituent antibodies. According to the article, a U.S. government official “expressed concern” that the Chinese company may have infringed the U.S. patent if it marketed the drug outside China without a prior agreement with the U.S. patent holder.
The question raised by this official, though on its face legitimate, must be set against the context in which the Chinese company chose to act. Ebola had already killed thousands of people, although a tiny handful given the U.S. drug had responded positively. If, as the Chinese company claimed, it had discovered a way to make the drug quickly and in larger amounts, wouldn’t this be a socially useful effort? In other words, in emergency situations, should the patent laws give way to saving lives?
The question is further complicated by the interplay of intellectual property rights and the need for randomized testing of drugs to insure that they are safe and effective. If drugs are rushed to market and administered to those who apparently need them – irrespective of the patent owners’ rights or wishes – does that interfere with drug testing protocols to such an extent that the action could be less useful than allowing science and IP rights to govern the outcome?
In a globalized world, where anybody’s problem can be addressed by anybody else; where problems cannot be localized; and where laws and protocols that seem right in one context may be less so in another, the type of questions raised by this U.S./China clash are inevitable. Sooner or later, countries will need to develop approaches to such quandaries so that “concerns” do not emerge or, worse, impede scientific or humanitarian objectives.
Notably, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides some guidance. It states that in a “national emergency or other circumstances of extreme urgency,” the subject matter of a patent can be used without prior authorization of the patent holder, provided that certain conditions are met. It seeks to balance the rights of the patent-holder with the interests of the public, and indicates the type of limitations on unlicensed use that should be applied. Such standards, while leaving considerable room for resolving disputes, could provide a basis for addressing acute humanitarian concerns.
In any case, the instant situation is already a heady brew of science, human need, intellectual property, and divergent national interests. Sorting it out will provide good practice for what is likely to be many more such cases.