Patent Challenges

We challenge applications for unmerited patents on antiretroviral drugs to stop companies from abusing the patent system. By filing cases, we demand companies to compete and reduce the price of their drugs.

Background

Commercial companies increasingly apply for patents on products that are not new or inventive – two legal requirements for a patent. Furthermore, they apply for multiple patents on the same drug to extend the coverage of the patent for several years.

Examining patent applications is complex work and requires a breadth of expert knowledge. With the increasing number of patent applications and dwindling public resources, patent offices around the world struggle to give each patent application the attention it deserves.

In recent years, serious concerns have been raised about the ability of examiners, even in the most well-resourced countries, to assess the quality of new patent applications adequately. The result is that companies secure unmerited patents for their products. Without market competition they can charge excessively high prices for their drugs.

One way to prevent poor quality patents is to challenge the patents, either by opposing the applications before, or revoking the patents after they have been granted. Generally speaking, challenging an application before it has been granted is less expensive and easier, especially for civil society.

Before a patent is granted, any person can present evidence and arguments to the patent office to show that a particular patent application does not meet the lawful criteria, and therefore should not be awarded a patent. These oppositions are of particular importance in countries where there are limited resources for patent examination. It helps the office to safeguard the quality of patents and prevent what is known as patent “evergreening”: applying for new patents on an old product to extend the years of coverage on a patent. See our animation to find out about evergreening.

In 2001, Thai activists were among the first to successfully challenge a patent on HIV drug, didanosine. In India, I-MAK and networks of people living with HIV successfully filed patent challenges between 2006 and 2007. These challenges enabled generic drug suppliers to produce three key antiretroviral drugs: lopinavir/ritonavir, abacavir, and nevirapine syrup.

After civil society set these precedents and trained generic drug manufacturers on how to file oppositions, companies began to file their own patent challenges on antiretroviral drugs. As India supplies generic drugs to most of the developing world, these patent oppositions have resulted in savings of over half a billion dollars in five years. The money saved by governments on the purchase of these medicines can be reinvested to treat more patients. Since 2007, patent challenges on antiretroviral drugs have been filed in Latin America, Asia, Europe and the United States.

Infographic showing the savings made on three drugs

In addition to preventing unmerited patents from being granted, there are other benefits to challenging patents:

  • Simply filing a challenge forces some companies to reduce the price of their drugs and/or to grant voluntary licenses (where the drug can be produced or sold for a lower price). For example, Gilead lowered its price for tenofovir after a challenge was filed in India.
  • It can compel companies to withdraw patent applications. GlaxoSmithKline withdrew its application for a patent on abacavir.

What we do

We challenge unmerited patents in our focus countries as an important part of our strategy to keep down the price of medicines. We have identified priority antiretroviral drugs that warrant patent challenges We have gathered legal and scientific evidence that will support patent offices to reject these unmerited applications. It is our hope that this will increase competition and drive down drug prices, resulting in increased access to affordable medicines for all people.

Find out more about the patent challenges filed by our consortium members.

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