How Does Evergreening Restrict Access to Medicines?

The Trans-Pacific Partnership Agreement (TPP) is a regional trade agreement that will “set the standard for 21st-century trade agreements going forward.”

The TPP negotiations are being conducted in secret, but leaked drafts of the U.S. negotiating positions show that the U.S. is demanding aggressive intellectual property (IP) provisions that would roll back public health safeguards enshrined in international trade law in favor of offering enhanced patent and data protections to pharmaceutical companies, making it harder to gain access to affordable generic drugs and hindering needed innovation.

One of the U.S.’s demands involves broadening the scope of patentability; the U.S. wants to make it easier to patent minor modifications of old medicines, regardless of whether they offer any therapeutic efficacy for patients.

Currently, the TRIPS agreement includes important flexibilities for governments to decide what type of pharmaceutical products deserve to be protected by patents in a given country. Essential requirements such as ‘novelty,’ ‘inventive step,’ and ‘industrial applicability’ can be defined by lawmakers in different countries so they are appropriate within the context of national circumstances (i.e., public health needs).

The TRIPS agreement allows countries to set their own patentability standards, and therefore developing countries like India, Philippines and Argentina have started defining grounds for rejecting a patent, for instance if the pharmaceutical substance claimed is just a new form of a known substance.

This flexibility is important because it allows governments to prohibit so-called “evergreening,” the practice whereby pharmaceutical firms extend the patent life of a drug by obtaining additional 20-year patents for minor reformulations or other iterations of the drug, without necessarily increasing the therapeutic efficacy for patients.

The U.S. is seeking to erode this flexibility by requesting that TPP countries introduce new rules that would severely limit the ability of each country to define what is ‘patentable.’

 

For example, the USTR proposal for the TPP requests the patenting of a “new form, use or  method of using” and “new formulations” of an existing product – even if there is no increase in efficacy. This technique, known as “evergreening,” allows pharmaceutical companies to obtain or extend monopoly protection for old drugs simply by making minor modifications to existing formulations or dosages, or by identifying a new therapeutic use for an existing medicine.

Learn more: Trading Away Health: How the U.S.’s Intellectual Property Demands for the Trans-Pacific Partnership Agreement Threaten Access to Medicines