Innovation and Access
Why intellectual property matters?
Intellectual Property Rights are at the heart of our biopharma industry innovation. They provide key incentives for research and development of new medicines and the improvement of existing ones.
Our industry plays a key role in providing the world with the medicines and vaccines that save and improve the lives of people around the world. A sound intellectual property environment is a key factor that attracts innovation because it provides innovators with a level of much-needed legal certainty.
The biopharmaceutical R&D process witnesses significant risks and costs because success is never guaranteed. On average, only 1 in 5 of our products ever get back their direct R&D investments. Intellectual property rights, whether patents, copyrights, trademarks, or trade secrets, help innovators to recover the sunk costs of research that did not make it to the market. Sound intellectual property protection allows inventors to focus on R&D with the promise they can enjoy the outcome of their labour.
The goal of most intellectual property is: to promote innovation through securing exclusive rights for a limited time, and to disseminate knowledge to the public through incentives for inventors to disclose their inventions. However, regulatory obligations, which apply, for example, to agro-chemicals and pharmaceuticals, often affect intellectual property terms. Thus, intellectual property policies should also reflect R&D and regulatory timelines. To a certain extent, data exclusivity alleviates some of this pressure, but in many circumstances a significant lead time between patent
filing and regulatory approval still exists. Recognizing this gap, some governments have provided mechanisms to retrieve time lost to delays. Restoration of patent terms due to regulatory delay, sometimes referred to as patent term extension (PTE), is one mechanism, applicable only for inventions that are subject to regulatory market approval.
The contemporary approach to biopharmaceutical research, through networks and partnerships, allows our companies to benefit from the expertise developed by various research groups. A specific R&D project can be sourced to a number of teams, working in-house or in other organizations. However, in and out licensing of technologies requires a certain level of economic and legal certainty. Sound intellectual property policies help alleviate some of this uncertainty.
Medical technologies that benefit patients and manufacturers alike are possible only with huge R&D investments and the protection of intellectual property that make those investments feasible. The key to sustaining continued access to new drugs relies therefore in sharing risks and rewards; the need for certainty comes from the long and risky R&D process that is an inherent part of our industry.
USD 141 Billion
what industry spent in 2015 for R&D
novel medicines approved by FDA alone in 2015
medicines in development for cancer