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Alert 354 – United Kingdom - Court of Appeal issues important guidance on industrial applicability
The UK Court of Appeal in Eli Lily v Human Genome Sciences (HGS) has upheld a High Court decision which revoked HGS’ gene sequence patent for Neutrokine-α (see Alert 297). The judgment summarises and applies the principles governing industrial applicability in patent cases.
Background
A patent can only be granted if the invention is “susceptible of industrial application”.
HGS applied to patent the sequence for the Neutrokine-α protein, a novel member of the TNF ligand superfamily. The protein was identified as part of the superfamily because of its similarity to other genes which had been identified previously.
HGS filed a patent application before knowing whether Neutrokine-α would have any therapeutic activity. Instead, it predicted the protein’s uses by reference to characteristics of other TNF superfamily members, without any supporting data. At the time the application was filed, only one member of the superfamily had a known use, which did not appear to relate to the family’s common features.
The granted European Patent similarly claimed the protein, its sequence, antibodies to it and corresponding pharmaceutical compositions. The Opposition Division of the European Patent Office (EPO) found the patent invalid. The EPO’s Technical Board of Appeal (TBA) subsequently upheld the Patent on the basis of restricted claims, speeding up its decision at the request of the UK courts.
The Decision
Disagreeing with the EPO decision, the Court of Appeal held that the restricted claims were invalid in the UK for lack of industrial applicability. It did not consider any other issues in light of this important finding.
The court reviewed the principles to use in deciding whether an invention is susceptible of industrial application, established in a series of decisions by the TBAs. It is possible to patent a gene sequence, but only if the patent discloses the industrial application of the protein it encodes. No patent will be granted if it does not disclose how the protein can be used. It is not enough to say that the compound must have a biological function and therefore must be usable to treat a disease. How much disclosure is necessary depends on the facts of the case.
Patenting chemicals whose uses are unknown would prevent research, not encourage it. Any human protein could well have therapeutic potential which would be of interest to the pharmaceutical industry. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant. That might prevent further research in that area, and/or give the patentee unjustified control over others who are actively investigating in that area and who might eventually find actual ways to exploit it.
Having accepted the TBAs’ principles, the Court of Appeal applied them to the facts. HGS had disclosed that Neutrokine- α was structurally similar to TNF and was believed to have similar biological effects. That did not satisfy the requirement of industrial applicability. A skilled person reading this description would need to carry out a research program to identify possible uses of the protein.
The Court of Appeal carefully explained its reasons for reaching a different decision from the EPO. The principles applied were the same. However, the procedure for examining validity is much more intensive in UK Courts. In the EPO, there is no cross-examination or compulsory disclosure of documents. So, working on different evidence using a different procedure, the UK court was not bound to follow the TBA’s factual findings.
Our Comment
Neutrokine-α was independently identified by others soon after its discovery by HGS, which is common in fast-moving technologies. This case provides welcome guidance on the level of disclosure required for biotechnology patents, and the limits of the monopoly a patentee can expect to claim. It is also notable for the cooperation between the EPO and UK Courts.
Background
A patent can only be granted if the invention is “susceptible of industrial application”.
HGS applied to patent the sequence for the Neutrokine-α protein, a novel member of the TNF ligand superfamily. The protein was identified as part of the superfamily because of its similarity to other genes which had been identified previously.
HGS filed a patent application before knowing whether Neutrokine-α would have any therapeutic activity. Instead, it predicted the protein’s uses by reference to characteristics of other TNF superfamily members, without any supporting data. At the time the application was filed, only one member of the superfamily had a known use, which did not appear to relate to the family’s common features.
The granted European Patent similarly claimed the protein, its sequence, antibodies to it and corresponding pharmaceutical compositions. The Opposition Division of the European Patent Office (EPO) found the patent invalid. The EPO’s Technical Board of Appeal (TBA) subsequently upheld the Patent on the basis of restricted claims, speeding up its decision at the request of the UK courts.
The Decision
Disagreeing with the EPO decision, the Court of Appeal held that the restricted claims were invalid in the UK for lack of industrial applicability. It did not consider any other issues in light of this important finding.
The court reviewed the principles to use in deciding whether an invention is susceptible of industrial application, established in a series of decisions by the TBAs. It is possible to patent a gene sequence, but only if the patent discloses the industrial application of the protein it encodes. No patent will be granted if it does not disclose how the protein can be used. It is not enough to say that the compound must have a biological function and therefore must be usable to treat a disease. How much disclosure is necessary depends on the facts of the case.
Patenting chemicals whose uses are unknown would prevent research, not encourage it. Any human protein could well have therapeutic potential which would be of interest to the pharmaceutical industry. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant. That might prevent further research in that area, and/or give the patentee unjustified control over others who are actively investigating in that area and who might eventually find actual ways to exploit it.
Having accepted the TBAs’ principles, the Court of Appeal applied them to the facts. HGS had disclosed that Neutrokine- α was structurally similar to TNF and was believed to have similar biological effects. That did not satisfy the requirement of industrial applicability. A skilled person reading this description would need to carry out a research program to identify possible uses of the protein.
The Court of Appeal carefully explained its reasons for reaching a different decision from the EPO. The principles applied were the same. However, the procedure for examining validity is much more intensive in UK Courts. In the EPO, there is no cross-examination or compulsory disclosure of documents. So, working on different evidence using a different procedure, the UK court was not bound to follow the TBA’s factual findings.
Our Comment
Neutrokine-α was independently identified by others soon after its discovery by HGS, which is common in fast-moving technologies. This case provides welcome guidance on the level of disclosure required for biotechnology patents, and the limits of the monopoly a patentee can expect to claim. It is also notable for the cooperation between the EPO and UK Courts.
For more information, email dsternfeld@iprights.com.
