Patents, Open Source, and Open Insulin

5 min read

Three pharmaceutical companies control the patent rights for the majority of insulin products on the market. These companies have over the past decade raised the price of insulin egregiously. As a result, many diabetics and their families are struggling to afford this life-saving medicine and, in some cases, taking desperate actions to get the medicine their life depends on.

It is well documented that pharmaceutical companies regularly exploit the patent system in order to maintain exclusivity and thus increase their profits. Such tactics include pay-for-delay (also known as pay-to-play), evergreening, patent-thickets, product hopping, and large corporations draining smaller companies’ financial and legal resources during the strategy known as the “patent dance.”

In the insulin space, however, the main issue is not that these manufacturers have blatantly abused the patent system to reap their large profits, although there’s certainly some of that (see, for example, the 74 patents filed on Lantus); rather, the system is operating as it was intended. Newer, superior versions of insulin have been developed incrementally. This has led to a steady string of patents issued and no generics successfully launched until 2021, 100 years after insulin was discovered. Patents provide a mechanism to monopolize the market. This reduces or eliminates competition and allows manufacturers to price medicines at extraordinary costs to patients. A vial of Humalog (insulin lispro) in 1996 cost $21; in November 2020, the cost was over $350 without insurance.

Ultimately, patents reduce access to medicines by limiting who can manufacture and sell patented medicines. We see this playing out with COVID-19 vaccines and the unequal manufacturing and distribution across the world. Countries from the Global South formally requested patents be waived for COVID-19 vaccines in order to allow for more vaccines to be manufactured. The request was swiftly quashed by leaders in the Global North.

Recognizing the role patents play in driving up the cost of pharmaceuticals by allowing companies to continuously monopolize a resource and subsequently reduce access to life-saving medicines, Open Insulin Foundation (OIF) was founded with the goal of producing insulin using an open source framework.

OIF has been inspired by the open source (OS) software movement. OS pioneers saw software technology development as both a resource and a practice for public good. While definitions and practices vary, elements include transparency in the innovation process; free, unrestricted sharing of data, methods and ideas; modalities for wide participation in projects in real time; and shared ownership rooted in the public domain. OS operates as both a legal entity and a philosophical paradigm for facilitating widespread access.

The ethos of OIF follows that of the original OS software movement and other communal knowledge and commons-based movements: life-sustaining resources, such as insulin, should be organized through a model of collective ownership and stewardship. We reject the industry-touted idea that patents are the only or primary incentive that enables innovation in the pharmaceutical space. Through an open source model, we believe insulin, and other medicines, can be reconceptualized as a truly common resource for all.

Unfortunately, we operate not in a vacuum but in a particular social milieu that is entrenched in intellectual property regimes. As other OS pharma proponents have noted, the application of OS principles to the stages of pharmaceutical development — from drug R&D to making them safe and available to people — may likely vary with each step. Thus, from a practical standpoint, we are still researching the best way forward. This includes exploring options such as an open license that enables free and open use for public benefit purposes. We are looking to the precedents of the Defensive Patent License and the Peer Production License, and the Humanitarian Technology and Intellectual Property License Agreement.

French philosopher Michel Foucault offers an account of power within society as increasingly connected to knowledge. He found these realms so intertwined that he used the hyphenated term “power-knowledge” (French: savoir-pouvoir) as a way to convey their inseparability. Knowledge that is enclosed through “intellectual property” (as opposed to communal knowledge, for instance) offers a salient example of power-knowledge. The first word, “intellectual,” has a clear link to knowledge and the production of information. The second word, “property,” equates to power – economic power – in the form of enclosure and restricted use. Intellectual property laws institutionalize a prominent form of power-knowledge by privatizing information for economic benefit of certain individuals. As anthropologist Christopher Kelty points out, open source technology offers “a reorientation of knowledge and power with respect to the creation, dissemination, and authorization of knowledge” (Two Bits, pp. 2). Patents on life-sustaining medicine do more than drive up the cost; they offer a prominent form of power — power over life. Open source technology seeks to recognize and reconstitute this relationship.