The 10 principles

The core purpose of biopharmaceutical innovation is to save and improve the lives of patients.

As innovative biopharmaceutical companies, it is our mission to make a positive contribution to patients’ lives and advance modern medicine by researching, inventing, developing and delivering innovative medicines and vaccines to all patients who need them.

We believe that intellectual property is a key facilitator of medical progress and we are committed to patient and societal benefit as guiding principles in our IP practices

We support the patent system’s central goal of incentivizing innovation in all its forms to promote scientific, technological and human progress and enhance social welfare.

We also support the longstanding internationally recognized standards developed in furtherance of that goal, which require that all inventions demonstrate novelty, inventive step, and utility in order to be entitled to a patent. We further supportinitiatives to ensure patent quality through measures that aim to provide patent offices and examiners with sufficient resources and capabilities to correctly apply these requirements.

With this in mind, we seek and enforce patents for inventions that we, in good faith, believe meet these standards.

We believe that successful global partnerships and collaboration among different stakeholders facilitate our shared goal of improving the lives of patients worldwide.

We rely on IP rights regularly as a tool to create dialogue and advance these relationships and objectives. IP helps to bring together the right parties with the right assets, and share their experience and expertise to address a given challenge. It further provides legal certainty, thus creating the conditions necessary for contributors to confidently share their technologies, know-how and other intellectual assets to the maximum extent possible, without compromising their ability to continue to invest in future innovation and collaboration.

We believe a robust patent system encourages effective and fair competition between innovators, which incentivizes innovation and delivers more choices for patients.

We commit to continually acting in a responsible and proportionate way when protecting our inventions and resolving our patent disputes, recognizing benefits to patients in the availability of different innovative medical treatment options.

We believe that society benefits from the disclosure and dissemination of the information contained in patents and patent applications. Patent information is an important contributor to our common scientific and technological knowledge; it teaches others how to practice inventions in the field and promotes the further advancement of technology.

We further believe that information about the patent status of medicines helps to make their procurement more efficient and certain, facilitating access to medicines for patients.

To help advance these goals, we commit to support voluntary and meaningful initiatives that make information about patented medicines more easily available and accessible, and improve the public understanding of the global patent status of approved medicines. We work with relevant partners to promote the use of patent information for the benefit of humankind.

We believe believe that patent disputes should be resolved without undue delay, and in ways that provide enhanced legal, market and business certainty for the parties involved. This ultimately benefits regulators, national health systems, and patients.

We commit to continue acting responsibly, ethically and professionally during the course of all proceedings concerning the securing, enforcement and defense of patents.

We believe that generic and biosimilar medicines play an important role in the sustainability of health systems and the promotion of a healthy innovation lifecycle.

To that purpose, commit to continue supporting appropriate exemptions from patent infringement for activities related to seeking regulatory approval, that facilitate efficient approval while preserving the integrity and function of the patent and regulatory review systems.

We embrace the patent system’s goal of promoting scientific, technological and social progress. We believe that goal is substantially achieved through the disclosure and publication of scientific and technical knowledge in patent documents, and through the role that the system plays in incentivizing research, development and dissemination of patented technologies that improve lives, including innovative medicines and vaccines.

We support well-defined exemptions from patent infringement for activities that constitute solely bona fide experimental use and preserve the integrity and function of the patent system, and are consistent with international agreements.

We believe that a strong IP system advances public health. We know from experience that it does so not only by incentivizing the development of new medicines and vaccines, but also by enabling our companies to invest in local communities and health infrastructures, for instance by conducting local clinical trials and partnering with local companies, which facilitates access to medicines and enables improved health outcomes.

We recognize the importance of our contributions to global health and we are committed to using our expertise, capabilities and innovative capacity to deliver treatments that save and improve lives.

We further believe in the importance of partnering with each other, governments and other stakeholders to tackle global health challenges. This includes companies’ consideration of mechanisms such as voluntary licensing and non-assert policies, when and where these add value for patients. There may also be extraordinary circumstances, such as during pandemics, where our role is even more critical. In those circumstances, we are fully committed to intensifying our efforts and our collaboration with all stakeholders to address these urgent challenges.

We believe believe that all countries, including Least Developed Countries (LDCs), stand to benefit from the implementation of the TRIPS Agreement and effective IP regimes.

However, we recognize the unique level of economic development and specific socio-economic challenges faced by these countries. Therefore, we support a time-based transition period for LDCs to meet the TRIPS standards while they focus on overcoming these structural challenges and work towards implementing the necessary framework to protect and enforce IP.

We will also continue to engage in approaches to IP in Least Developed Countries that take into account their unique challenges. These may include voluntary licensing, non-assert policies or selective approaches to filing, in addition to supporting capacity-building initiatives which can foster a dynamic local innovation ecosystem.