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UNITARY PATENT

In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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New, Quicker Option to Amend European Patent Application after Notice of Allowance

For many years, patent offices in Europe and the courts have sought to grant and uphold patent protection for inventions which are made through the discovery of the new use of a known drug. Such second medical uses can be valuable and sometimes life-saving. Research into new uses of known compounds can be as expensive as discovery of new molecules. Discovery of new molecules is becoming more and more rare, whereas the range of known drugs and their potential for undiscovered effects has expanded.
There is no question of awarding the inventor of a new use absolute protection for the substance itself. Nor can a patent be granted for a method of treatment using the compound in question. 
To circumvent these problems the Enlarged Board of Appeal of the European Patent Office has for many years granted claims for “the use of substance X for the preparation of a medicament (or pharmaceutical composition) for treating indication Y”. These are so-called “Swiss claims” because of their first use in the Swiss patent office. (See Eisai (Second medical indication) [1985] OJ EPO 64.)
A problem with the Swiss form of claim is that it is a process claim targeted at the manufacturer. It is difficult to make a case for contributory infringement, because this would require a downstream infringer, and there is generally no-one downstream of the manufacturer who is using the substance for preparation of a medicament. 
When the EPC was amended (renamed the “EPC 2000”), a different form of claim became permitted – simply “compound (or composition or substance) for use in a method of treatment of disease Y.”  The EPO has stopped granting claims in the Swiss form after the EPO Enlarged Board of Appeal decision G 2/08, but claims already granted in that form continue to have effect.

When filing amendments or corrections in response to a communication under Rule 71(3) EPC (notice of intention to grant), it is now possible to expressly waive the right to a further such communication.

Until recently, if an applicant for a European patent did not completely agree with the text intended for grant (“Druckexemplar”) and wanted to request further amendments, however minor, the only way to proceed was by issuance of a new Rule 71(3) communication with a new 4-month period for reply. There was inevitably a delay in issuing the new text and a cost in going through the approval procedure a second time. This was frustrating if there were mere typographical errors to be corrected.

As of 1 July 2015, the option of waiving a new Rule 71(3) communication is available. If taken, the EPO will consent to the waiver and proceed with the issuance of the decision to grant if:
–      the amendments or corrections requested are allowable and do not require resumption of substantive examination proceedings and
–     all formal requirements are fulfilled within the non-extendable period given in the communication (normally 4 months).
Any waiver expressed in response to a R71(3) communication is only effective in respect of the following R71(3) communication.
If the Examining Division does not consent to the waiver, the examination procedure will resume (e.g. when the amendments raise new issues), or a further Rule 71(3) communication will be sent (e.g. if further examiner amendments are necessitated by the applicant’s amendments).

Comment

This new option is proving attractive to clients who are faced with minor amendments or corrections in the final text and want to complete the grant process promptly and efficiently. It is also useful when we have instructions to proceed but the process of translating the claims (e.g. from English into French and German) shows up inconsistencies or ambiguities in the approved text.
On the other hand, requesting a second communication under Rule 71(3) is the wise approach if amendments are extensive. The text can be completely finalized before having to complete the formal requirements such as paying the grant fee and filing the required translations.

If we are to use this process, we need instructions to proceed in good time before the end of the 4-month period for response.  This is because we have to have the corrected/amended text translated into the other two languages and we need instructions to pay the grant and printing fees at that time. If we receive instructions close to the deadline such that translation of the claims is likely to incur urgency charges, we will typically file the amendments, request a further communication and use the new period to prepare the translated claims.

Waiving a further R71(3) communication means forgoing an opportunity to check the final text of the patent before grant, so it is a saving in time and money that carries a certain risk that the EPO will not implement the final changes correctly. It is not a process to be recommended if amendments are complex.