On 12 June 2016, US President Barack Obama announced the “National Moonshot Initiative”, which aims to make more therapies available to more patients, provide early detection and double the rate of progress toward a cure for cancer.
In support of this important initiative, the US Patent and Trademark Office (USPTO) launched the "Patents 4 Patients" program, also known as the Cancer Immunotherapy Pilot Program. The pilot program will run until 29 June 2017 and offers an opportunity to accelerate examination of eligible patent applications for inventions directed to cancer immunotherapy. Eligible patent applications will have examination advanced, with the aim of having a final decision issued within 12 months.
Eligibility requirements for accelerated examination
To be eligible for accelerated examination under this pilot program, the patent application must:
- be a standard or utility patent application in the field of oncology;
- include at least one claim to a method of treating or preventing cancer in a human subject by immunotherapy;
- not contain more than three independent claims or 20 total claims, or any multiple dependent claims;
- not have been granted special status previously, either under this pilot program or otherwise (e.g. under the PPH or prioritised examination); and
- not be the subject of a non-publication request.
Immunotherapy would include the administration of cells, antibodies, proteins or nucleic acids to invoke an immune response against cancer, as well as the co-administration of biological adjuvants, such as interleukins, cytokines etc. along with conventional cancer treatment methods (chemotherapy, radiotherapy or surgery). The pilot program also covers in vivo, ex vivo and adoptive immunotherapies, including those that employ autologous and/or heterologous cells.
What are the advantages of accelerating a patent application to grant?
Patents play a critical role in attracting the investment necessary to enable biotechnology companies to develop effective immunotherapies that target life threatening conditions such as cancer. Bearing in mind the high costs of research and clinical development in this sector, the ability to prevent others exploiting a patent protected therapy for a limited period provides biotechnology companies or their licensees with an opportunity to recoup the investment made in developing immunotherapies and navigating the complex regulatory requirements as they bring such therapies to the patients who desperately need them.
By accelerating a patent application to grant, the value of a granted patent can be realised sooner by providing:
- increased certainty as to the scope of protection;
- leverage for attracting investment; and
- an opportunity to enforce granted rights against potential infringers.