New patent law has consequences for the pharmaceutical industry

On 13th December 2007 a revised version of the European Patent Convention (EPC) came into force. This new law, known as EPC2000, has a number of consequences for the pharmaceutical industry and the way in which patent applications are examined.

In addition to implementation of EPC2000, the London Agreement is expected to enter into force in the early part of 2008. Once in force, the London Agreement will greatly reduce the costs associated with validating a granted European patent in the designated states.

According to the European Patent Office (EPO) EPC2000 will bring the EPC up-to-date with the latest legal developments concerning patents internationally, will retain the time-tested structure and the high standards of quality for which the system in known and is intended to make the procedures before the EPO quicker, clearer and more efficient.

Format for Allowable Patent Claims

Under the old law, if an invention related to a new medical use for a known compound, it was necessary to formulate the claims into the so-called “Swiss-type” format, i.e. “Use of a substance or composition X in the manufacture of a medicament for therapeutic application Y”.

In contrast, under the new law, such a claim format is no longer necessary and for the first and each subsequent medical use of a compound or composition the more straightforward language of “Substance or composition X for use as a medicament” or “Substance or composition X for use in the treatment of Y” will be potentially allowable.

Missed deadlines

Under the old law, if a European patent application was refused or deemed withdrawn following failure to reply to an official letter, the application could be reinstated without a loss of rights by requesting ‘further processing’, paying a ‘further processing fee’ and completing the omitted act within the extended time period set by the EPO. However, further processing could only be requested in limited circumstances. In other circumstances, where rights were lost, but it was not possible to request further processing a complex and costly process for re-establishing rights exists, but it was necessary to provide by filing evidence supporting the fact that it was not possible to meet the deadlines despite all due care having been taken.

In contrast, under the new law it will be possible to request further processing in the majority of cases where a deadline has been missed. This will greatly simplify the procedure involved, reduce costs and provide more certainty for applicants.

Other notable changes include the relevance of ‘novelty only’ prior art documents in the designated states, the requirements for obtaining a valid filing date for a European patent application and the introduction of a post grant central limitation and revocation procedure.

Whilst implementation of the new law will provide many advantages for applicants in the pharmaceutical sector and elsewhere, there is at least one change that will be unfavourable.

“Multi-invention” applications

It is the established practice in most jurisdictions that a patent may only be granted for a single invention.

Under the old law, if an International patent application entered the European regional phase, and it related to more than one invention, it was possible to choose upon which invention future examination of the application should be based. This situation typically arose in a patent application relating to more than one gene sequence or protein where the EPO considered each gene sequence or protein to relate to a separate invention. The old law provided a convenient way for applicants to file a single patent application covering a large number of gene sequences or proteins and then to decide which gene sequences or proteins were the most important once further experiments had been performed.

Under the new law, if the EPO established the International Search Report (ISR), the resultant European patent application will automatically proceed on the basis of the first invention identified in the claims. If protection is required for other inventions included within the application, then it will be necessary to file one or more divisional applications, which can prove to be a costly exercise.

Accordingly, when preparing International patent applications which are to be examined by the EPO, it is advisable to decide upon the most important subject matter and to prepare the application so that this subject matter is the first subject matter identified in the claims.

If the EPO did not establish the ISR, then it will be possible to amend the claims on entry into the European regional phase to relate to the invention of choice.

Mark Sweetinburgh, a European Patent Attorney from Fry Heath Spence commented “In general, it appears that the changes to the law brought about by EPC2000 will be of benefit to applicants. However, it remains to be seen whether the benefits to those in the pharmaceutical industry will be outweighed by the restrictions imposed during the examination of multi-invention applications.”