On 13 April 2018, the Barcelona Court of Appeal (Section 15) wrote a decision highly illustrative of the challenges that an “added matter” objection may raise in Spain, particularly in the context of preliminary injunction proceedings. The decision confirmed a ruling of 18 July 2017 from Barcelona Commercial Court number 4, which had lifted a preliminary injunction ordered against a manufacturer of generic medicaments, for considering that the patent was unlikely to overcome an “added matter” objection in the main proceedings.
The first question addressed by the Barcelona Court of Appeal (Section 15) was to what extent “nullity” may be raised as a defence in preliminary injunction proceedings, where life is very short. The Court reiterated, citing the case law stemming from its decisions of 4 January 2006 (amlodipine), that in the context of preliminary injunction proceedings the validity of a patent cannot be examined in depth. The patent will be deemed to be valid unless the defendant alleges “very clear and evident indicia” supporting nullity. After clarifying that the burden of proving these “very clear and evident indicia” lies with the defendant, the Court examined whether or not the arguments alleged to found the “added matter” objection in the case at hand were sufficiently robust as to lift the preliminary injunction, as the Court of First Instance had done.
In this regard, the Court wrote that “we cannot rule out that the allegation of added matter can be, at least in line of principle, a good reason to justify the assessment of nullity in the context of preliminary injunction proceedings, to the extent that its examination could raise issues less complex than those typical of patent law, such as the examination of novelty or inventive step “(paragraphs 12 to 17). It is fair to say that examining “added matter” is probably less complex than examining inventive step and, perhaps, novelty (although the “test” applied is normally similar) in the sense that it “only” requires comparing the claim with one document (i.e. the application as filed). However, as readers familiar with discussing “added matter” before the EPO’s Board of Appeal may attest, the examination of “added matter” is one of the most “technical” and, therefore, difficult aspects of patent law, in part due to the diversity of criteria and thresholds applied by various Boards of Appeal.
The case reported in this blog is a good example of this complexity. The Court of Appeal found that the specific grounds on which the Court of First Instance had founded the “added matter” objection were too complex to be discussed within the narrow contours of preliminary injunction proceedings. However, the Court of Appeal, following a precedent from the Munich Regional Court in a parallel case, came to the conclusion that there was a less complex argument that also led to the conclusion that the patent had an “added matter” problem. So, in the end, the Court confirmed the first instance decision that had lifted the preliminary injunction.
The teaching from this decision is clear: patentees should be aware of the risks raised by “added matter”, a relatively new actress on the Spanish litigation scene.
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Contrary to what is said in the blog, there is no diversity of criteria and thresholds applied by various Boards of Appeal when it comes to added subject-matter.
Examining “added matter” is in no way “less complex than examining novelty”. The test is not even similar, it is identical.
When deciding on novelty with respect to the prior art, it “only” requires comparing the subject-matter of the claim with prior art published before the effective date of the claim.
When deciding on added matter it “only” requires comparing the claim with the application as filed. If the subject-matter of the claim after amendment is new with respect to the subject-matter originally filed, then we are in presence of added subject-matter.
That means that the test to be applied is the “novelty” test.
In order to reduce to practice the question whether an application/patent contains added subject-matter case law of the Boards of Appeal of the EPO has developed a number of different concepts which can be considered as tools helping to assess the presence of added subject-matter, or in other words, to correctly apply the novelty test.
The concepts helping to correctly apply the novelty test are the following:
– the original application/patent is not a reservoir of features combinable at will;
– what is directly and unambiguously derivable from the original application/patent;
– the allowability of an amendment should be beyond any reasonable doubt.
The concept of “directly and unambiguously derivable from the original application/patent” is the most frequently used.
It is therefore not possible to claim that there exists a diversity of criteria and thresholds applied by various Boards of Appeal.
If the independent claim of a patent which should support an injunction comprises added subject-matter, there are good reasons to believe that the patent at stake has a very low survival rate.
The only case in which the survival rate is much better is if the claim as granted comprises an intermediate generalisation. Provided the proprietor is prepare to limit its claim so as there is no longer an intermediate generalisation, the patent can survive.
It is thus not a surprise if Spanish courts come to the conclusion that before granting an injunction, a quick look at added subject-matter might be worth it.
No EPC member state has adopted a stance as severe as the one of G 1/93 relating to the “inescapable trap”, but in good logic since after grant the scope of protection might not be extended, the conclusion should be the same at national level. Germany has even devised a mechanism trying to avoid the drastic consequence of G 1/93, cf. BGH X ZR 161/12 (Wound treatment device). During examination the situation is similar to that at the EPO, cf. BGH X ZB 5/16 (Phosphatidylcholine).
I wonder whether its is worth bothering filing a comment when it is superbly ignored
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