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Are gene sequences capable of Industrial Application?

In its first decision in a patent case, the UK's new Supreme Court (formerly the House of Lords) has handed down its judgement in the case Eli Lilly v HGS, overturning the decision of the lower courts that the patent in question lacked industrial applicability.

The Patent
Human Genome Sciences (HGS) had a European patent containing claims to the nucleotide sequence of the gene which encodes for the protein Neutrokine-α. 
At the time of filing the patent application, Neutrokine-α had been identified as a member of the TNF (Tumour Necrosis Factor) superfamily of proteins. Though displaying some diverse functions, members of this superfamily were all known to be involved in the immune system. Other than this, the patent application simply listed a large number of speculative uses for the protein.

Background to the case
Eli Lilly opposed the patent, bringing parallel proceedings at the European Patent Office (EPO) and in the UK courts. Among other things, they claimed that the patent fell foul of Articles 52 and 57 EPC which state that an invention cannot be patented unless it is "capable of industrial application", and that this is true "if it can be made or used in any kind of industry, including agriculture".

In Europe the patent was initially revoked, but this decision was overturned on appeal. It was considered that a person skilled in the art would, in the light of common general knowledge of the TNF superfamily and its properties, appreciate that Neutrokine-α would be involved in the immune system, and that this was sufficient to satisfy the requirement of industrial applicability.

In the UK courts, the patent was initially revoked, a decision which was upheld by the Court of Appeal. HGS then appealed to the Supreme Court.

In their arguments, Eli Lilly stated that membership of the TNF superfamily did not in itself provide any useful information about Neutrokine-α, and that no data had been provided to demonstrate that Neutrokine-α was involved in the immune system. On the other side, HGS argued that the predictions made in the patent were reasonable, and that subsequent research has shown Neutrokine-α to play an important role in the development of auto-immune diseases and B-cell cancers.
The BioIndustry Association (BIA) also submitted comments to the court pointing out that, after a gene has been discovered, it takes considerable research, time and investment to transform the discovery into a commercially exploitable product. Intellectual property is a key way of attracting investment, and making it more difficult to obtain patent protection for new discoveries would risk slowing early stage investment in the bioscience sector.

The Decision
As it was a European patent in issue, the Supreme Court looked to the corresponding European case and the principles of the European Patent Convention for guidance. In doing so, they summarised the following guidelines:

  • The patent in question must demonstrate a real possibility of commercial exploitation; merely identifying the structure of a protein without indicating any practical use is not sufficient.
  • A "plausible" or "reasonably credible" claimed use, or an "educated guess" can suffice. Such plausibility can be assisted by later evidence (though such evidence on its own is not enough).
  • If all known members of a family or superfamily have a common role, assigning a similar role to the protein may be sufficient.

Though the patent itself simply contained speculation as to potential uses of Neutrokine-α, the Court considered that the protein had nevertheless been plausibly identified as a member of the TNF superfamily. That family had known functionality, and the fact that further work was required in order to determine the therapeutic benefits of Neutrokine-α did not in itself render the patent invalid. This "plausible" use was enough to satisfy the requirements of Article 57 EPC.

In considering the issues raised by BIA, Lord Neuberger stated that: "Just as it would be undesirable to let someone have a monopoly over a particular biological molecule too early, because it risks closing down competition, so it would be wrong to set the hurdle for patentability too high".

What Next?
The case will now be returned to the Court of Appeal to deal with the remaining issues of obviousness and insufficiency.

Effect of the Decision
This decision has brought the UK courts into closer alignment with the EPO, providing greater legal certainty for those seeking to protect their discoveries. This decision means that, though there may be gene sequence patents which do not meet the requirements for industrial applicability, it will not be the default position that a claim to a newly discovered sequence will fall foul of this requirement. As this is the first case of a bioinformatics gene sequence patent being litigated in the UK, it sets a strong precedent for future rulings.

The bioscience sector can therefore breathe a collective sigh of relief. For legal practitioners, the case is also of interest because of the manner in which the judges were clearly influenced by policy considerations, and their evident misgivings in doing so. In his leading Judgement, Lord Neuberger clearly paid heed to the desirability of achieving harmonisation between the case law of the EPO's Boards of Appeal and the UK courts, and to the submissions of the BIA. He found in favour of the appellant, but commented "there is good sense in the contrary conclusion reached by the judge [at first instance] and the Court of Appeal". Lord Walker agreed with Lord Hope that "this is a difficult and troublesome case", but also noted that it is "an important case: not only for the parties, but also for the bioscience industry generally … and, in some measure, for the future course of patent law in the United Kingdom". He went on to say that "all my instincts … are for dismissing this appeal" but he was nonetheless persuaded "against my inclination, that this appeal must be allowed".
 

AdamsonJones

5 December 2011

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