Patents and intellectual property

0081599_man_sheet

Vital to encourage innovation

Innovation is the key driving force at Roche. And it will remain essential if we are to continue the fight against the many diseases that are still incurable, including cancer, Alzheimer’s disease, multiple sclerosis, amongst others. Like all research-based companies, Roche needs patent protection to be able to recoup its long-term investments in research into new medical solutions and to pursue further innovations. Without patents and pricing that encourages real progress, innovation is impossible.

It takes between 8 and 12 years and costs an average of about 1 billion Swiss francs to bring a new drug to market. With so much investment required, and only one in every 1,000 compounds making it to market, developing new medicines is a high-risk business. By being the sole manufacturer of a medicine for a specified period, companies can generate revenue from sales and recoup some of the substantial cost of development. However, patents are normally registered when a molecule is in early development, which may be many years before a drug reaches a patient. As a result, the length of time from approval when development costs can be recouped is around 8-12 years.

However, after the patent expires, the intellectual property related to the drug is publicly available and the drug can freely be produced by any interested manufacturer. This is another way that innovative healthcare companies can give something back to society.

Roche is aware that patents — and the level of drug prices required to sustain economic development in the industrialised world — can present one of the many barriers to providing basic medical care in the world’s poorest countries. That is why we have adopted patent policies for the Least Developed Countries that are designed to give their populations better access to our medicines.

Biosimilars

Patient Safety the central concern

Unlike traditional medicines which contain small molecules produced by chemical synthesis, biological medical products have complex molecular structures. They are produced from living systems using sophisticated manufacturing processes that are difficult to reproduce. Copies of a biological product are therefore similar but not identical to the original. These ‘biosimilar’ products cannot be considered generic medicines, or approved based on the limited dataset most regulatory bodies accept for generics.

Because of the complexity of biotechnology-derived products, this new category of drugsrequires a high level of quality and control over the manufacturing process of the active substance and the finished product, as well as clinical safety and efficacy data for their registration and evaluation. We support the development of a clear regulatory framework for the approval of biosimilar products, which compares them with the original drug. Industry has been contributing to the development of sensible standards and a regulatory pathway for biosimilars in the European Union and the US. The challenge remains in the countries and regions where a regulatory framework has not been defined and where these products can be marketed and used without being approved in accordance with an approved set of regulatory requirements. For these countries, we believe that regulatory authorities should follow the World Health Organization (WHO) Guidelines on Evaluation of Similar Biotherapeutic Products, where a comparison with an original biological product is required to establish similarity.

Patient safety must be the central concern when dealing with biosimilars. In view of this, Roche continues to work with key stakeholders to help establish a proper regulatory framework for these products, and at the same time, maintain efforts on quality, safety and efficacy in order for the patients to benefit from new and better therapies targeting severe diseases.