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Disclaimers in European Patent Claims

In brief: Lawyer Anthony Selleck examines a recent appeal of the European Patent Office decision to allow disclaimers within patent specification as a means to overcome prior art to obtain an European patent.

Disclaimers in European Patent Claims

The claims of a patent specification define the invention which the patentee may exclude others from exploiting. Usually, the invention is defined in 'positive' terms by specifying the 'technical' features of the invention that distinguish it from the prior art. In some cases, however, a patentee may have reason to limit the scope of the claims by expressly 'disclaiming' or excluding specific embodiments of the invention, typically in order to overcome some prior art.

In recent years, there have been a number of seemingly conflicting decisions relating to disclaimers from The Enlarged Board of Appeal of the European Patent Office (the Board). Recently, the Board held in a long awaited decision (Genetic Systems Corporation vs Roche Diagnostics GmbH; Dade Behring Marburg GmbH) that disclaimers in patent claims are allowable under certain circumstances, even where the disclaimer was not disclosed in the specification as originally filed.

The Board's recent decision should be welcomed by the biotechnology industry where disclaimers in patent claims can be particularly useful in obtaining an European patent.

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The Patent

Genetic Systems Corporation was granted a claim to a method of detecting the presence of the human immunodeficiency virus (HIV) in a sample involving contacting the sample with an assay medium containing particular peptides. The peptides were defined by reference to a range of contiguous amino acids, each of which was encoded by a specified part of the HIV genome.

After an opposition was filed by Roche Diagnostics GmbH and Dade Behring Marburg GmbH (the Opponents) against the grant of the patent and a new piece of prior art cited, Genetic Systems sought to limit its claim by expressly excluding (or 'disclaiming') a number of peptides that were originally encompassed in the peptide general formula of the claim. The Opponents objected to the amendment on the ground that as the specification only disclosed the general formula of the peptides and made no reference to any peptides that should be excluded from that formula, the disclaimer represented the impermissible addition of new subject matter to the patent specification after the filing date.

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New Matter Objection and the Board's Decision

The European Patent Office vigilantly examines patent applications to ensure that no new matter is added to a patent specification after the filing date. According to the Opponents, the disclaimer introduced new subject matter into the specification because neither the excluded individual peptides, nor the remaining members of the peptide group, were specifically mentioned in the specification.

The Opponents' argument was rejected by the Board, which held that the prohibition on addition of subject matter is only applicable where the amendment makes a technical contribution to the subject matter of the claimed invention. In circumstances where the effect of a disclaimer is merely to limit the scope of the patentee's exclusive rights, subject matter is not added to the specification and the disclaimer is allowable. In this context, the Board held that a disclaimer may be used to:

  • Avoid prior art which is relevant to novelty considerations only;
  • Avoid 'accidental anticipation'; and
  • Disclaim non-patentable subject matter.

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Novelty Prior Art

The disclosure of an European patent specification that was filed before a subsequent patent application, but only published after the subsequent application, is relevant in deciding whether the subsequent invention is novel. The earlier specification, however, can not be referred to when deciding whether the subsequent invention involves an inventive step.

In the case before the Board, the Opponents cited a prior filed, yet later-published, patent specification that disclosed some, but not all of the peptides encompassed by the general formula of the claim. The Board held that by disclaiming the disclosed peptides, Genetic Systems was not impermissibly adding new subject matter to its specification. Excluding individual members from a general formula had no bearing on the technical information of the specification and therefore did not result in the addition of new matter. Note, if the earlier specification had been published before the patentee's filing date, the issue would be one of whether excluding those members from the general formula involved an inventive step, which is a different consideration.

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Accidental Anticipation

An accidental anticipation occurs where an aspect of an invention is disclosed in the context of an unrelated technical field. An accidental anticipation is not relevant when considering inventive step because, from a technical point of view, it is so unrelated and remote that the person skilled in the art would never have taken it into consideration when working on the invention.

For example, an accidental anticipation could occur where a claimed invention is a large group of chemical compounds having certain properties which are advantageous for a specific use. One single compound falling within the group could turn out to be known for a completely different use. Thus, only properties that were completely irrelevant to the new use of the compound were truly known. Genetic Systems argued that in such situations, it is unfair that if, in the absence of a basis in the patent application as filed for a disclaimer excluding the known compound, that disclosure of the single compound should prevent an inventor from patenting the entire group.

The Board upheld the Genetic Systems' argument and held that a disclaimer is allowable to overcome an accidental anticipation in a completely unrelated technical field.

Moreover, a mere disclaimer excluding the subject matter of an accidental anticipation does not change the technical information in the application as filed. Therefore, according to the Board, such a disclaimer does not constitute the impermissible addition of new matter.

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Exceptions to Patentability

The European Patent Convention (EPC) expressly excludes certain subject matter from patent protection. For example, the EPC excludes methods of medical treatment and excludes inventions where the exploitation of which is contrary to public order or morality.

In some cases, a patent claim may be drafted in broad terms so that, whilst certain embodiments are allowable, other embodiments fall within one of the exceptions to patentability. The Board gave an example of a method for avoiding unwanted offspring having specified undesirable characteristics, such as sex, colour or health. Whilst such a method may be legitimate when applied to domestic animals, it could be contrary to public order or morality if applied to humans. In these circumstances, where the specification may include a broad teaching applicable to mammals in general, a disclaimer of humans from the scope of the claim would be allowable. This is because the disclaimer merely excludes from patent protection humans to which the teaching is theoretically workable. The declaimer has nothing to do with the technical teaching of the invention, so again no new matter is added to the specification by this disclaimer.

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Priority Applications

Importantly for applicants seeking European patents who claim priority from an earlier filed foreign application (such as an Australian application), the Board held that the insertion of a disclaimer in the circumstances set out above does not affect the ability to claim priority from the foreign application.

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Conclusion

The Board's decision is a clear endorsement of its earlier decisions in favour of allowing disclaimers and should benefit biotechnology applicants seeking patent protection in Europe. The option to include a disclaimer during the prosecution of an European patent application provides yet another means of overcoming certain prior art to obtain European patent protection for an invention.

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