Cancer immunotherapy is an extremely promising area and it has been a game changer since the approval of the drug Yervoy© (ipilimumab) in 2011. Currently, 13 drugs have already been approved for immunotherapy for 16 different types of tumours.
Technological and business developments have grown hand in hand with patent protection. More than 450 patent applications were published in 2018 under the Patent Cooperation Treaty (PCT), against around 60 in 2014. Two technologies have undergone major development: ICIs (immune checkpoint inhibitors) and CAR-T cells (chimeric antigen receptor T cells).
More recently, a new class of therapies has emerged which use cells that are extracted from the patient’s own body and are genetically modified to recognise certain tumour cells, becoming super competent in combating the tumour. One of the most promising techniques uses CAR-T cells.
The class of ICIs essentially includes antibodies and CAR-T technology involves the use of genetically modified cells. Both represent a challenge for IP strategy, as the patentability of genes and methods of treatment is subject to limitations in various jurisdictions, particularly in Europe. Due care in the drafting of the patent, as well as careful planning of the underlying experimental trials, can help ensure the adequate protection of these patents.
ICIs are growing rapidly and have enormous potential to become blockbuster drugs in the near future. It is not surprising that the major players have already marked out their position, contributing to the intricate web of patents. However, patents for antibodies, which are defined by their genetic structure and/or by their functional characteristics, represent a fragile balance between legal uncertainty and the commercial exclusivity obtained that must be strategically evaluated.
CAR-T technology raises questions that are no less challenging. Instead of a mass-produced drug, the use of a patient’s own cells obscures the borderline between medicine and method of treatment. However, there are aspects of the process and product that are potentially patentable, namely genetically modified cells or DNA vectors used in the modification process.
In another approach, anti-tumour vaccines are showing themselves to be a promising form of immunotherapy that can help teach the immune system what tumour cells are like, making them easier to recognise and eliminate. There are two types of anti-cancer vaccines, preventive and therapeutic vaccines. Viral infections are responsible for the development of various types of cancer, such as cervical, head and neck cancer, caused by the human papillomavirus (HPV), and liver cancer, caused by the hepatitis B virus (HBV), and preventive vaccines play an important role in reducing the risk.
Therapeutic vaccines, in turn, contain tumour cells or parts of tumour cells, or pure antigens, and they increase the immune response against cancer cells that are already present in the body. However, since each tumour is unique and has its own distinctive antigens, particularly sophisticated approaches are needed. To date, only two therapeutic vaccines have been approved: Sipuleucel-T (Provenge®) for the treatment of prostate cancer, composed of the patient’s own stimulated dendritic cells, and Bacillus Calmette-Guérin (BCG), approved for the treatment of early-stage bladder cancer, which uses weakened bacteria to stimulate the immune system. Phase I and II trials are underway for the treatment of melanoma and kidney cancer. A phase I trial with mRNA encapsulated in liposomes for patients with advanced melanoma is also being conducted.
mRNA vaccines are emerging as a promising alternative to the traditional vaccine platforms, both for infectious diseases and for oncological application, as they can be manufactured quickly and adapted to a wide range of conditions. Various mRNA vaccines have been perfected and validated in immunogenicity and efficacy studies and, as a result, in the last 10 years, approximately 70% of patent families relating to mRNA vaccines have been registered by industry, with Moderna, CureVac, BioNTech and GSK holding almost half of the patent applications in this area.