A nullity suit is not inadmissible for abuse of law merely because the nullity plaintiff, who was one of several co-defendants of a parallel infringement suit, did not join an earlier nullity suit of one of his co-defendants but waited for the result of this earlier nullity suit.

The scope of the disclosure of a document can include steps/features which the patent claim and the description do not explicitly mention but which, from the point of view of the person skilled in the art, are evidently necessary for implementing the claimed teaching of the patent and which therefore do not need to be separately disclosed but are “read along”. However, the inclusion of evident steps/features does not allow supplementing the disclosure with the common knowledge of the person skilled in the art, but merely serves to determine the complete meaning of the disclosure, i.e. the technical information which the skilled reader derives from the document on the basis of his common knowledge.

The case at hand concerns the European patent EP 359 593 (hereinafter “the Patent”) which discloses an improved process for separating proteins from human or animal blood plasma, and in particular a process for separating the protein factor VIII which is necessary for the treatment of Haemophilia A (factor VIII deficiency). The claimed process allows producing the protein factor VIII in highly concentrated form on industrial scale.

The proprietor of the patent filed several suits for patent infringement in Germany against Octapharma AG (hereinafter “Octapharma”), its managing director and two of its affiliates. As a reaction to the infringement suits, Octapharma filed a first nullity suit (3 Ni 5/04) against the Patent. As in prior (but unsuccessful) opposition proceedings, Octapharma argued that the Patent lacked novelty over EP 0 343 275 B1 (hereinafter “EP ‘275”).

EP ‘275 was filed before the priority date of the Patent but published after this date. According to Article 54 (3) EPC, such “post published” prior art can be the basis of a lack of novelty objection, but not for a lack of inventive step objection.

Contrary to the Boards of Appeal (see T-292/02), the German Federal Patent Court came to the conclusion that EP ‘275 explicitly disclosed all features of claim 1 and therefore anticipated the claims of the Patent as granted. As a reaction, the Patentee amended claim 1 of the Patent by supplementing claim 1 with an additional feature from the description of the Patent. According to this feature, the factor VIII solution resulting from the steps of the process of claim 1 is freeze-dried.

The Federal Patent Court held that this additional step of freeze drying was neither explicitly described in EP ‘275 nor implicitly disclosed since the step was not necessary for obtaining the sought after factor VIII solution (see 3 Ni 5/04) Therefore, the Federal Patent Court upheld the patent in its amended form. In the appeal proceedings of the first nullity suit, the Federal Supreme Court affirmed this decision (see Xa ZR 10/07).

After the decision of the Federal Supreme Court, the affiliates and the managing director of Octapharma filed a second nullity suit. The nullity plaintiffs once again argued that the Patent lacked novelty over EP ’275 and presented additional evidence that the step of “freeze drying” was the only well-known process for making protein solutions durable at the priority day. The nullity plaintiffs also presented evidence that the so achieved durability was indispensable for turning the factor VIII solution into a tradable therapeutic product.

The patentee argued that the affiliates and the managing director of Octapharma could have joined the first nullity suit, that the subsequent filing of two nullity suits based on the same prior art increased the patentees cost risk, and that the second nullity suit should therefore be held inadmissible for abuse of law.

In its decision on the second nullity suit, the Federal Patent Court held the second nullity suit to be admissible but confirmed that the Patent – in its amended form – was novel over EP ‘275 and dismissed the nullity suit (see 3 Ni 32/10). In the appeal proceedings, the Federal Supreme Court again confirmed the admissibility of the second nullity suit but held all claims of the Patent invalid for lack of novelty over EP ‘275.

What regards the admissibility, the Federal Supreme Court explained that, under German law, everybody is entitled to file a nullity suit against a patent which is in force in Germany at any time and that German law does not provide for any rule forcing a defendant to file a nullity suit within a certain time period. Therefore a co-defendant of an infringement suit is entitled to wait for the outcome of a nullity suit filed by another co-defendant before filing his own nullity suit.

What regards the lack of novelty objection on the basis of EP ‘275, the Federal Supreme Court decided that the freeze-drying feature was implicitly disclosed and therefore anticipated by EP ‘275. According to the Federal Supreme Court, the skilled reader understood that the method disclosed in EP ‘275 was intended to provide factor VIII not only for laboratory or short-term therapeutic uses but also for large scale therapeutic uses. Since it was not in dispute that such large scale therapeutic use required a certain degree of durability of the factor VIII solution and that freeze-drying was the only way for achieving the necessary durability at the priority date, the Federal Supreme Court concluded that the step was “read along” by the skilled reader analyzing EP ‘275.

The decision shows that the filing of successive nullity suits by several members of a company group is admissible and can enhance the chances of success of an invalidity attack. The decision also clarifies the standard for the implicit disclosure of features which are not mentioned in a document but which are part of the common knowledge at the priority date. According to this standard, the skilled person reflects about the purpose of a disclosure and “reads along” features which are (very) well known to the person skilled in the art and which are evidently necessary for realizing the objective of the disclosure.