The lengthy process of medicine development

In any type of research, major breakthroughs are the exception, while many small steps forward are the rule. This also applies to pharmaceutical research. It is the ongoing, incremental innovations over many years that lead to new therapies providing optimum benefit for patients. The pharmaceutical companies are in stiff global competition against each other to achieve small innovations in common diseases. They are competing with different substances aimed at the same pharmacological target. Yet the therapeutic success achieved by an individual medicine often does not become evident until it has been in use for some time. A wide variety of factors play a decisive role in success, among them efficacy, duration of action, interactions with other medicinal products, the existence of side effects, optimum availability of the active substance and optimum dosage forms.

Growing development effort

The effort that goes into research and development has increased greatly in recent decades, not least because of the stringent safety requirements embedded in the legislation. It now takes an average of 12 years to bring a new medicinal product to market. This work involves costs of around 2.6 billion dollars. Roughly two-thirds of this amount is spent before clinical trials even begin. Just ten out of every 10,000 substances that are investigated and tested in laboratories make it as far as clinical trials. Of these, only one single substance passes all the tests and comes onto the market as a medicine. The long development time means that the time available to the pharmaceutical companies to recoup their high development costs while their patent protection is active is continually decreasing.

Important patent protection for new active substances

On a global scale, a sum equivalent to around 20 percent of a pharmaceutical company’s turnover from prescription medicines is spent on research and development. This is one of the highest levels in any sector. Accordingly, research-based companies need to be sure that their discoveries will not be exploited commercially by third parties who have not shared in the cost of researching the products. A new active substance is granted protection by the state in the form of a patent. Statutory patent protection is limited to 20 years starting from the date the patent is submitted for registration, i.e. before preclinical studies in cell systems, for example, have even started. The usable period of patent protection has decreased as the safety requirements that a new medicinal product must meet have grown. Supplementary protection certificates were created to keep pace with this development. These certificates enable the patent protection for new medicinal products to be extended for a further 5 years, giving a maximum effective exploitable period of protection of 15 years.

Protection for submitted data as an incentive

The health authorities require the pharmaceutical industry to submit extensive data from preclinical and clinical studies before a medicinal product can be authorised. These data are required so that the quality, efficacy and safety of the medicine can be assessed. Pharmaceutical companies invest a great deal of time and money in preparing these data. The submitted data are protected (first applicant protection) to ensure that no other company can refer to or use them during the period of protection following the marketing authorisation of the product. First applicant protection provides an incentive for companies to allocate resources to research and development. It is an investment incentive that is independent of a product’s patent status. There are a number of reasons why a patent may not exist for a certain product in a specific country. In such cases, first applicant protection is the primary incentive for investment. This applies, for example, to the growing trend for companies to develop new indications on the basis of established active substances.