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New challenges for the pharmaceutical industry

The strong competition which currently exists between the large pharmaceutical companies, and the growing use of generic medicines, are factors which force these companies not only to patent the results of their research projects, but also to do it in the best possible way and with a defined strategy.
As investment in research in this sector is usually very high, in these times of economic crisis R&D projects must be safeguarded. That is why the policy for protecting research results must be excellent and with the aim of obtaining an economic return on the investment carried out throughout the process.

That is why preliminary studies, such as intelligence and technological positioning reports, as well as previous research are indispensable before committing to new lines of research.

We should remember the case of Novartis, which after investing millions of dollars in decoding the genetic basis of type 2 diabetes, allowed free public access to its data.

The genomes of 1,500 patients with diabetes were compared with those of a similar number of people who did not suffer diabetes. 500,000 gene fragments were traced in which significant differences had been identified. Processing the enormous mass of data which was generated in the project requires resources which are inaccessible for any company.

Taking this success case as a reference, we should not forget that the data made public to third parties must be controlled. If disclosed through the companys website, it is important to draw up general conditions which specify how users may use and process that data, and the objectives for making that data available.

Consequently, controlled access to the companys data does not necessarily mean lack of protection for internal knowledge, or a risk for Intellectual Property rights.

Many of the large pharmaceutical companies are facing the expiry of the patents for their most profitable medicines. This means that they need to achieve excellence in their production processes and to maintain a high level of innovation if they want to continue being competitive once their patents expire.

The complex healthcare challenges faced by the poorest countries have led to business alliances among the large pharmaceutical companies and SMEs in the sector, thus promoting the concept of “open innovation”.

Some companies have taken on the role of major distributors of medicines, whose added value lies in the ability to bring together rights over the new procedures and medicines developed by pharmaceutical SMEs.

In this type of technological collaboration, it is essential to sign solid agreements with suitable clauses which regulate ownership of the results arising from the projects, nondisclosure etc.

Finally, it is worth pointing out the obvious role of trade marks in this scenario. A suitable policy for protecting distinctive signs, both of trademarks and of domain names, is essential for competing and achieving differentiation in a market in which technological transfer constantly flows among companies and laboratories of completely different sizes.

Carmen Sánchez-Puelles