Article for life sciences autumn 2011 update

Amending chemical patent applications at the European Patent Amending chemical patent applications at the European Patent Office
An applicant may not amend a European patent application or patent to include subject matter that was not in the original application. However, whether an amendment adds new subject matter is a subjective test. A recent decision (T783/09) of the European Patent Office (EPO) Technical Boards of Appeal (TBA) addresses amendments to patent applications and patents for chemical inventions.

To assess if an amendment adds subject matter to the original application,
the EPO decides if a skil ed person would derive the proposed amendment
“directly and unambiguously” from the original text.
In chemistry cases, compounds are often described by a generic structural Where X = H, methyl, ethyl or propyl; and Y = Cl, Br, F or I. It is usually possible to shorten the lists for X and Y, as long as each list still contains more than one option. This is because the amendment stil covers a group of compounds, just a smal er group than originally disclosed. However, reducing the lists to a single option in each can add subject matter to the application, if the combination of options was not set out in the original application. Such an amendment singles out a specific compound, that was previously undisclosed. For example, if X is reduced to just H and Y to just Cl, the amendment wil add subject matter if the specific combination of H and Cl was not explicitly disclosed in the original application. Amending chemical patent applications at the European Patent Office The decision addressed the question of whether these rules also apply to patent applications for combination medicines, comprising “Drug A” and “Drug B”. Can the lists be shortened without adding subject matter?
The decision

The decision looked at a patent in which claim 1 was amended to
combination of a compound cal ed LAF237 with a second compound from a
list of pioglitazone, rosiglitazone or troglitazone. The original application
disclosed LAF237 in combination with 22 compounds, including al the three compounds of pioglitazone, rosiglitazone or troglitazone. The first question that the TBA addressed was whether the skil ed person could derive, directly and unambiguously from the original application, the combinations of LAF237 with just the three other compounds. Al of the 22 compounds were described as being “very preferred”. The TBA was satisfied that the original application disclosed the three claimed combinations from final claim 1 as part of a list of 22 disclosed combinations. However, the TBA also had to decide whether the original application also taught only the three claimed combinations from the list of “very preferred” 22 combinations, or whether their selection added subject matter. The TBA concluded that the application taught all 22 combinations as being of equal value –“very preferred embodiments”. The choice of the three combinations in amended claim 1 did not “single out” any specific subject matter that was not originally taught. Instead the amendment reduced the originally–disclosed group to a smal er group, which EPO practice al ows. The TBA decided that the amendment was acceptable.
The effect of the decision

The decision provides clear guidance for applicants having to amend
chemical claims by choose only some possibilities from two lists. Where an original application lists options, and the applicant wants to reduce the number of options in the list, this should be possible if the original application is clear that those options have equal value. We are of the opinion that this decision may also be applied to patent applications for chemical compounds. In the example given above if X is amended to be just H, this new decision would allow the applicant to amend Y to be Cl or Br, but not F or I, assuming that the original application taught


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