In Human Genome Sciences Inc v Eli Lilly & Co [2011] UKSC 51, the first patent decision since its formation in 2009, the UK Supreme Court has clarified the law on patentability and industrial application, in particular as its applies to the biotechnology sector. The Supreme Court has also reiterated that, as far as possible, UK patent law should be interpreted in light of the relevant jurisprudence of the European Patent Office.

Business Impact

As the Supreme Court Justices recognised, this decision is of considerable importance to the research-based biotechnology industry. It means that companies that discover a new protein which is likely to be biologically active (even if this is just an inference drawn from that molecule being a member of a class of compounds) can apply for a patent at an early stage of the R&D process and do not need to wait until they have fully demonstrated the use of the protein. It also emphasises that decisions of the European Patent Office's Boards of Appeal carry considerable weight, particularly where the Technical Board of Appeal has taken a consistent approach to a question of law.

An important factor in the Supreme Court's reasoning was the purpose of the patent system (namely to incentivise innovation by allowing a party to recoup research and development costs and make a profit) and whether this purpose would be served by making it harder to satisfy the requirement of industrial applicability. This was brought into sharp focus by the UK BioIndustry Association's submissions which explained the tension that exists between filing a patent application early without data showing the efficacy (and risking not obtaining a patent, but nonetheless disclosing the invention to the world at large), or waiting a couple of years before filing and running the risk that a competitor might file first.

Background

The proceedings concerned the patentability of a protein developed by Human Genome Sciences Inc ("HGS") called Neutrokine-α, antibodies to that protein, and the polynucleotide sequence encoding for it.

The HGS scientists had identified the gene sequence for Neutrokine-α by bioinformatics (computational biology) rather than the standard route of a lab-based technique. As a result, HGS were unable to determine the actual activity of Neutrokine-α. However, in order to preserve their position in a highly competitive area of research and protect their discovery, HGS filed an application for a patent including claims to the polypeptide, the gene sequence that encodes it, antibodies that specifically bind to it and corresponding claims to pharmaceutical and diagnostic compositions. HGS did not include any actual data as to the pharmaceutical activity of Neutrokine-α, but rather based their predictions on what was known about other members of the TNF superfamily.

HGS' patent was granted in August 2005. Subsequent to the patent application, the same protein as Neutrokine-α was discovered by two other research companies. Lilly, a major competitor in the area and itself running a research programme to bring Neutrokine-α to the clinic, brought opposition proceedings against the patent at the European Patent Office and launched revocation proceedings in the UK.

At first instance, Kitchin J held that simply identifying a protein was not necessarily sufficient to confer industrial application upon it. Kitchin J went further, stating that the patent contained an "astonishing range of diseases and conditions…and there is no data of any kind to support the claims made. The skilled person would consider it totally far-fetched that Neutrokine-α could be used in relation to them all and, as I have found, would be driven to the conclusion that the authors had no clear idea what the activities of the protein were and so included every possibility." Kitchin J distinguished this from the situation where the practical application of the gene or protein sequence is self-evident, e.g. insulin, erythropoietin or human growth hormone. Kitchin J's final observation was that use of the invention as a tool to carry out further research into its activities could not constitute a relevant industrial application.

Shortly after Kitchin J's decision, the Technical Board of Appeal (the "TBA") of the European Patent Office upheld the patent (in an amended form). It found that it was known in the art that all members of the TNF ligand superfamily exhibited certain biological properties. By identifying Neutrokine-α as a member of the TNF ligand superfamily (which had known shared properties) and providing technical data in line with the expected properties of a member of that superfamily, Neutrokine-α was plausibly shown to be usable and this was enough to satisfy the requirement of industrial applicability.

However, the Court of Appeal upheld Kitchin J's decision to revoke the Patent, rather than follow the TBA's decision to uphold it. The Court of Appeal endorsed Kitchin J's findings that the therapeutic and diagnostic applications suggested in the Patent were purely speculative.

The legislation

Although the UK Patents Act 1977 includes its own provisions for patentability and industrial application, in all three instances of this case being heard in the UK the courts have concentrated on the corresponding provisions of the European Patent Convention. Article 52 states that a patent will be granted for any invention, in any field of technology, provided that it is new, involves an inventive step, and is susceptible of industrial application. Article 57 provides that an invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry.

The appeal

In the Supreme Court, HGS contended that both Kitchin J and the Court of Appeal set too high a standard for industrial applicability in the context of a patent for biological material, and that the principles from the jurisprudence of the European Patent Office had not been followed.

Lord Neuberger, sitting as a Supreme Court judge and giving the leading judgment, undertook a careful and detailed analysis of the whole body of European Patent Office case law in relation to industrial application, which he concluded was consistent on the issue. Lord Neuberger also considered the earlier TBA decision in T0018/09 (Human Genome Sciences) which upheld the patent on the basis that the description delivered sufficient technical information to satisfy the requirement of disclosing the nature and purpose of the invention and how it can be used in industrial practice.

The role of EPO jurisprudence in the UK courts

In its previous incarnation as the House of Lords, the highest UK court has drawn attention to the importance of UK patent law aligning itself, as far as possible, with the jurisprudence of the EPO (e.g. Generics (UK) Ltd v H Lundbeck A/S [2009] RPC 13 and Conor v Angiotech [2008] RPC 28). Lord Neuberger reiterated this principle, and although he noted that decisions of the EPO should not be regarded as effectively binding on the UK courts, he stated that, where the TBA has adopted a consistent approach to an issue in a number of decisions, it would require very unusual facts to justify a national court not following that approach.

The relevant principles from the EPO jurisprudence

In his judgment, Lord Neuberger distilled the essence of the EPO's approach to the requirement of industrial applicability to a number of points, including the following general principles:

  • The patent must disclose a practical application and some profitable use for the claimed invention, so that the ensuing monopoly can be expected to lead to some commercial benefit.
  • A concrete benefit, namely the invention's use in industrial practice, must be derivable directly from the description coupled with the common general knowledge.
  • A vague and speculative indication of possible objectives that might or might not be achievable will not be sufficient.
  • The patent and common general knowledge must enable the skilled person to reproduce or exploit the claimed invention without undue burden or having to carry out a research programme.

Lord Neuberger also set out his view of the principles to apply to a patent disclosing a new protein and its encoding gene, and where the protein is a member of a family or superfamily. One key principle is that, if the disclosure in the specification is important to the pharmaceutical industry, the disclosure of the sequences of the protein and its gene may be sufficient, even though the protein's role has not been clearly defined.

Lord Neuberger then applied those principles to the patent for Neutrokine-α, and considered that the disclosure and existence of Neutrokine-α and its gene sequence, and its membership of the TNF superligand family should have been sufficient, along with the common general knowledge, to satisfy the requirement of industrial applicability in Article 57. Lord Neuberger therefore stated that he would allow the appeal.

Conclusion

Lord Neuberger added a final remark. As well as considering that the application of the legal principles reached the right result, he also considered that it was the right result on a wider, policy basis. He noted the fine balance between (i) allowing a patentee to have a monopoly over a particular biological molecule too early, as it risked shutting out the competition, and (ii) setting the hurdle for patentability too high, and negating the incentives of the patent protection system and scientific innovation. On the facts of this case, HGS' patent for Neutrokine-α sat on the right side of that line.