In January this year, the White House launched the “Cancer Moonshot 2020” program - a new $1 billion effort to double the rate of progress towards cures for cancers. The aim is to achieve ten years’ worth of cancer research in the next five years through a variety of initiatives.
One such initiative is the recently-launched “Patents 4 Patients” program (also known as “The Cancer Immunotherapy Pilot Program”). This program allows patent applications relating to the treatment of cancer using immunotherapy to undergo accelerated examination at the US Patent and Trademark Office (USPTO).
Any applicant can apply to the program and there are no official fees. If the application meets the qualifying criteria, then it will be examined out of turn. The aim is for examination to be completed within twelve months (the USPTO doesn’t guarantee this, however).
The full qualifying requirements can be read here. The key points are:
1. The application must contain at least one claim to a method of treating cancer using immunotherapy;
2. The application must contain no more than 3 independent claims, no more than 20 claims in total and no multiple dependent claims.
But is speeding up the examination process actually appealing to patent applicants in the oncology field? Potentially, in some cases - USPTO prosecution times can be frustratingly long. But my first thought was that the major obstacle for many patent applications in this field is not the USPTO’s examination speed but their current approach to inventions perceived to relate to “natural products”.
The fallout from the notorious Mayo vs. Prometheus decision has led to an unsatisfactory situation where many claims to cancer treatments are considered by the USPTO to relate to new uses of “natural products”, and so are objected to for being ineligible for patent protection.
Much has been written about the poor logic underpinning these patent ineligibility objections and the uncertainty that they are causing in the field (see here for a summary of the current state of affairs).
The Patents 4 Patients program might therefore just serve to accelerate a patent application towards patent ineligibility objections! Many applicants might wish to avoid the program altogether and stay on the normal (slower) track while attempts are made to change US practice in relation to “natural products”.
This newly established program provides a fast-track review for cancer immunotherapy-related patent applications without the need for an applicant to pay an additional fee. The program, set to launch in July: Aims to cut the time it takes to review patent applications in cancer therapy in half (final decisions in 12 months or less). Is open to any applicant, including early stage bio-tech companies, universities and large pharmaceutical firms.