Patents and intellectual property

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 and AIDS.  Like all research-based companies, Roche needs patent protection to be able to recoup its huge 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. 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.

It costs an average of about 1 billion Swiss francs and takes between 8 and 12 years to bring a new drug to market. Long-term reliable conditions are therefore a requirement for research and development. Appropriate protection of intellectual property is crucially important. When an invention is patented, information about it becomes publicly available, and the inventor acquires the right to make exclusive use of the invention for a specified period. Since patent protection starts the moment a patent is granted, and not when an invention reaches the market, the period of market exclusivity (unlike trademark exclusivity, for instance) is fairly limited. Patent protection for a new drug is generally limited to 20 years and typically expires 8 to 12 years after the drug is launched. Patents ensure that the market can operate, that the process of innovation is not interrupted and that new and improved products continue to reach the market.

Counterfeiting of pharmaceutical and diagnostics products on one hand is an infringement of intellectual property rights. But above all, it presents an obvious danger to human health. They can cause serious illness or kill with harmful ingredients or by depriving patients of proper treatment.

While estimates of the scale of the problem vary widely, trafficking in counterfeit medicinal products (including medical devices and diagnostics) is widespread and affects both developing and developed countries.   As counterfeit medicines are often indistinguishable from authentic versions, counterfeiting is difficult to detect, particularly for customers.

The World Health Organization (WHO) has identified counterfeiting as a growing, often underestimated danger, citing, in particular, the problems of product toxicity, instability and ineffectiveness. Guidelines issued by the WHO in 1999 provide guidance for all stakeholders on measures that can and should be taken to combat counterfeit drugs.

Responsibility for preventing and controlling drug counterfeiting rests primarily with national governments and international organisations. Roche cooperates at both the national and the international level with regulators and law enforcement and customs officials. Internally the Group is also doing everything it can to address this problem. The company reviewed its internal Anti-Counterfeiting Policy in 2004 to ensure that adequate measures are in place. The goal is to support local authorities, international organisations and trade associations in their efforts to prevent negative impacts on public health caused by counterfeit medicinal products.

Patient Safety the central concern

Several innovative biological medicines have started to go off patent and are facing the introduction of a wave of products claiming to be similar to the originals, so called "Biosimilars" or "FOBs" (follow-on-biologics). Because of the complexity of biotechnology-derived products, this new category of drugs requires 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.

Drafting regulatory requirements to address the complexity of biotech development and production has been an on-going challenge. Industry has been contributing to the development of sensible standards and a regulatory pathway for biosimilars in the European Union. 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.

Patient safety must be the central concern when dealing with biosimilars. In view of this, Roche continues to be successful in promoting the establishment of a proper regulatory framework for these products, and at the same time maintains its efforts on quality, safety and efficacy in order for the patients to benefit from new and better therapies targeting severe diseases under individual features, which allows to improve the benefit/risk balance of such products and focus on new therapies.