HGS made a patent application for the human protein Neutrokine-alpha and the discovery of its underlying gene sequence. Eli Lilly challenged the patent application in the High Court and the European Patent Office. The High Court upheld the opposition, whilst the EPO’s Technical Board of Appeal later decided that the patent gave sufficient information about its industrial use to justify the protection. A year later, the Court of Appeal upheld the High Court’s ruling and said that the patent was not susceptible of industrial application and therefore the patent should not be awarded. Under the European Union’s Biotech Directive, an element isolated from the human body can only be protected by patent if its industrial application is disclosed in the patent.
In this case, the Supreme Court ruled that it was sufficient to say that the protein was potentially useful for diagnosing, preventing or treating a large number of categories of disorders in the immune system, despite this assertion having been based on the protein’s membership of the TNF ligand superfamily of substances. This was because at the time of the patent application, the particular application of the individual protein was not known.
In following the EPO’s ruling, the Supreme Court said that it was important for UK patent law to be aligned as far as possible with EPO decisions. National courts could still come to its own rulings if it considers that the EPO has taken the law in an appropriate direction, misapplied a previous EPO ruling or not taken a particular argument into account. However, where the EPO had taken a consistent approach in several decisions, it would be unusual for the national court not to follow the EPO’s rulings.
On the type of patent application before the court in this case, the EPO had adopted a consistent approach, being:
- The patent had to disclose a practical application and profitable use which could be expected to lead to commercial benefit.
- The patent had to show a real possibility of exploitation.
- A skilled person had to be able to exploit the patent without undue burden.
- A concrete benefit had to be derived directly from the description and common general knowledge.
- Speculative use would not be sufficient, but plausible use could be.
- The plausible use could be assisted by later evidence.
- If all family or superfamily members of the protein had a role in controlling cells, it would be sufficient to assign a similar for the protein.
Paul Gershlick, a Partner at Matthew Arnold & Baldwin LLP and editor of Upload-IT, comments, “This case should give businesses in the pharmaceutical industry certainty. It will also act as encouragement for innovating businesses that discover a protein where the protein is a member of a wider family or superfamily that has a clear role.”