1 May 2010BiotechnologyCaroline Pallard

The risk of narrow protection

A peptide can be used, for example, as a vaccine, while an oligonucleotide can be used to silence a given gene whose expression product is involved in the development of a disease. Normally, biotechnology patent applications disclose a high number of peptides or oligonucleotides. The applicant usually follows this strategy in order to reduce the filing costs by gathering several peptides/oligonucleotides in a single application.

However, this is not without risk, since at the time of filing the application, the applicant may not yet know which peptides or oligonucleotides will prove to be the most promising. This article gives an overview of some of the problems encountered in Europe by this type of patent application.

Lack of unity

A lack of unity of invention decision is often formulated during the international phase of this kind of application, which means that each peptide/oligonucleotide needs to be seen as a single invention. As a consequence, each peptide/oligonucleotide can only be protected in one distinct divisional European patent application, which results in a dramatic increase in the patent cost for the applicant.

Filing a European application fulfilling the requirements of unity of invention is becoming ever more important in view of a change in European law that came into force on April 1, 2010. Before the change, an applicant was allowed to file a divisional application as long as a parent application was still pending.

From April 1, the time limit for filing a European divisional application will be drastically reduced to two years after the issuance of the first European office action. It is expected that this time limit may not be long enough to provide the applicant the opportunity to determine which peptides/oligonucleotides are the most attractive.

It is therefore crucial to try to file European patent applications fulfilling the unity requirements.

The Patent Cooperation Treaty (PCT) rules defining unity of invention are as follows:

Rule 13.1 PCT states that:

“The international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.”

Rule 13.2 PCT further defines the circumstances in which the requirements of unity of invention are considered to be met: there should be a technical relationship among those inventions involving one or more of the same or corresponding special technical features. In cases of peptides/oligonucleotides, the so-called Markush practice, which allows a group of alternative chemical compounds, applies, i.e. peptides/oligonucleotides are regarded as being unified where the following criteria are fulfilled:

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk