PATENT FORMALITIES
Over the years, the novelty test has been applied increasingly strictly by EPO examiners. As a consequence, it appears that an amendment must be literally disclosed in the application as filed within a single embodiment to fulfil the requirements of Article 123(2) EPC.
This increasing stringency has, over the years, driven the EPO away from more liberal jurisdictions such as the requirements from the US Patent and Trademark Office. This has vast consequences for, eg, a Patent Cooperation Treaty (PCT) application written in US style without multiple dependencies that enters the EP regional phase. Suppose that claim 2 depends only from claim 1, and claim 3 also depends only from claim 1. Such application may have no problem in the US when limiting the claims to a preferred embodiment of the combined subject matter of claims 1 to 3 that has no verbatim basis in the application as filed.
However in EP, when limiting the claims, an embodiment of
the combined subject
matter of claims 1 to 3 would not be possible if there were no verbatim basis in the description. Suppose that claim 2 comprises 10 embodiments and claim 3 comprises 12 embodiments, a two-list situation occurs and the description should already depict 120 permutations to cover all combinations of single embodiments of each list. These exemplified lists are still relatively short, it is not uncommon in biotechnology applications
to have more than 100 embodiments per type
of claim (eg, antibodies, peptides,
oligonucleotides, proteins, disease conditions).
So in practice, the applicant is obligated to list all permutations of embodiments and their respective
fallback options. Consequently,
the description of the application in a field where inventions often comprise numerous embodiments, such as in biotechnology, grows to huge dimensions. The applicant is required to pay page fees not for providing extensive information on the invention, but merely to fulfil strict formal requirements.
It is therefore highly desirable that EPO examiners adopt a more liberal assessment of Article 123(2) EPC. In this respect, the recent decision G2/10 is quite relevant.
Caroline Pallard joined Nederlandsch Octrooibureau in 2006 after working as a Dutch and European patent attorney at DSM/Gist-brocades in Delft and a postdoctoral fellow at
the Dutch
Cancer Institute, where she specialised in immunology and biochemistry. She practises in biotechnology and in particular
molecular biology,
genomics, biochemistry, haematology and microbiology. Pallard has extensive experience of drafting and prosecuting complex patent
applications and
supporting complex licence negotiations, and she frequently advises biotech start- ups on their IP strategy.
In reason 4.3 of G2/10 (citing G3/89 and G11/91), the Enlarged Board of Appeal of the EPO reiterates the role of the person skilled in the art in the process of assessing whether an amendment fulfils the requirements of Article 123(2) EPC. The enlarged board states: “It follows that any amendment to the parts of a European patent application or of a European patent relating to the disclosure (the description, claims and drawings) is subject to the mandatory prohibition on extension laid down in Article 123(2) EPC and can therefore, irrespective of the context of the amendment made, only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of these documents as filed.”
24 Life Sciences Intellectual Property Review 2012
Peter ten Haaft joined Nederlandsch Octrooibureau in 2011, after working as a Dutch and European patent attorney at DSM/Gist-brocades in Delft, the Netherlands. He specialises in life sciences, particularly molecular biology, biotechnology, genomics, biochemistry, immunology and microbiology and has extensive experience of drafting and prosecuting complex biotech patent applications and handling IP licence negotiations. In his scientific career, ten Haaft worked in the research and development department of DSM/Gist- brocades and TNO/BPRC in Rijswijk.
Caroline Pallard is a partner at Nederlandsch Octrooibureau. She can be contacted at:
pallard@octrooibureau.nl
Peter ten Haaſt is a Dutch and European patent attorney at Nederlandsch Octrooibureau. He can be contacted at: tenhaaſ
t@octrooibureau.nl
“CONSEQUENTLY, THE DESCRIPTION OF THE APPLICATION IN A FIELD WHERE INVENTIONS OFTEN COMPRISE NUMEROUS EMBODIMENTS, SUCH AS IN
BIOTECHNOLOGY, GROWS TO HUGE DIMENSIONS.”
In this reasoning, the Enlarged Board of Appeal seems to proclaim the more liberal reading of Article 123(2) EPC by emphasising the role of the person skilled in the art in assessing the allowance of an amendment.
It will be interesting to monitor whether EPO examiners will broadly adopt the reasoning of G2/10 for assessment of Article 123(2) EPC.
The current practice of the EPO places an increasing demand on the skills of the European patent attorney with respect to these formal issues. In addition, early prosecution costs will dramatically increase since more and more of the description of the patent application is taken up for fallback options and/or more divisional applications may be filed.
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