Patents Necessary to Incentivize R&D for New Drug Indications

Did you know that medicines can lead “double lives”? For example, zidovudine formed the backbone of global HIV treatment programs in the late 20th century. But, before extending and improving the lives of millions of HIV/AIDS patients, zidovudine was first conceived, decades prior, as a failed cancer drug. In a new report from Geneva Network, researchers explore the meaningful impact of identifying and developing additional indications for existing medicines, as in the case of zidovudine, and how that impact is made possible through the existence and protection of strong intellectual property rights – specifically patents.

The report’s key findings:

  • Repurposed medicines (i.e., with additional indications) have made demonstrable impact and hold great potential in addressing our most pressing health challenges.

There are many examples like zidovudine, and the future is just as promising. Researchers believe that repurposing existing medicines is the key to tackling growing health issue without effective treatment options , such as Alzheimer’s, as well as many of the roughly 8,000 rare diseases affecting patients worldwide.

  • Repurposed medicines benefit patients because they already have a known track record in other patient populations.

The safety profile, including potential side effects and drug interactions, of a repurposed drug is more well-known than that of an entirely new medicine. This real-world evidence helps patients and physicians alike make better informed treatment decisions.

  • Identifying a repurposed medicine, and bringing it to patients, requires a significant investment.

It is truly a myth that repurposing existing medicines is faster and less expensive than for “new” medicines. Repurposing medicines is almost always the result of extensive research and clinical trials, requiring significant time and resources. Conducting these trials can cost “tens or even hundreds of millions of dollars” and take years to complete.

  • Patents spur research and development of repurposed medicines.

The development process around repurposed medicines is incredibly risky, given there is a track record of little support on these therapies from government or other public agencies, and new forms, uses and indications are usually recognized long after initial patent protection on a product has been obtained. Additional patent protections on repurposed indications are critical to incentivizing companies to make the R&D investment required.

However, there are some potential barriers to fully supporting new innovations for patients. India and Indonesia, for example, do not offer patent protection for forms or new uses of known medicines because these medicines are not considered novel. That is why some Indian companies, such as Excelra and Dr. Reddy’s, are investing in foreign R&D on repurposed medicines – a missed opportunity for the Indian economy.

Supporting the development of repurposed medicines with a strong intellectual property ecosystem, including patent designations for new forms, new uses and new indications, can go a long way in not only recognizing the significant investment of these discoveries, but also delivering new therapies to patients who need them worldwide.