This content is from: European Union

HGS v Eli Lilly dispute explained

The UK’s Supreme Court will next week hear a case concerning whether the UK has correctly followed European patent law on industrial application

The case, Human Genome Sciences (HGS) v Eli Lilly, involves a split between the England & Wales Court of Appeal and the EPO Technical Board of Appeal (TBA).

In the case, the UK courts have revoked HGS's patent for the Neutrokine-α protein - even though the appellant's amended set of claims had been accepted by the TBA (decision T18/09).

The Maryland pharmaceutical company's patent covers the nucleotide and amino acid sequence of a specific cytokine protein ligand from the TNF (tissue necrosis factor) superfamily and antibodies to the ligand.

The protein was identified first by HGS, and later by others, in the 1990s using bioinformatics. Neutrokine-α is just one of a number of names given to the protein coded by the disclosed nucleotide sequence.

The patent was filed at the EPO in 1996 and granted in August 2005. Since filing the patent, HGS has been developing a monoclonal antibody to Neutrokine-α, which is in clinical trials.

Indianapolis-based pharmaceutical company Lilly has reportedly spent $50 million developing its own monoclonal antibody to Neutrokine-α and plans to spend another $250 million bringing it to the clinic.

In 2006, Lilly filed an opposition at the EPO, and a counter claim for revocation at the England & Wales High Court, essentially stating that the patent lacked an inventive step and constituted a claim to an arbitrary member of the TNF ligand superfamily without conceivable industrial applicability at the time of filing.

The case is thought to be one of the few examples where parallel litigation proceedings have been filed and cooperative procedures put in place to fast track the case through the EPO opposition procedure and the UK courts.

In 2008 at the High Court, Mr Justice Kitchin held that all claims in the patent were invalid on three grounds: they were not susceptible of industrial application, they were insufficiently disclosed and they were obvious because of a lack of technical contribution. He therefore revoked the patent.

The equivalent outcome was reached in 2008 following EPO oral proceedings. But in 2009, following the submission of more restrictive claims, the EPO's TBA held the patent valid (T18/09).

However, at the UK Court of appeal, three judges including Lord Justice Jacob ruled that the proposed uses for Neutrokine-α, as outlined in the patent, were not plausible at the time of filing and were ahead of a research programme to determine feasible industrial uses for the protein.

Consequently, despite the proposed amended claims, the patent was essentially deemed not to comply with Article 57 of the European Patent Convention (EPC), which states that the invention must be capable of industrial application.

Regarding the apparent clash of the ruling with decision T18/09 of the TBA, Jacob stated that the EPO was working with different evidence and that the UK courts were not bound to follow the TBA's findings of fact or give deference to them.

The Supreme Court has been asked to rule whether the Court of Appeal correctly applied the principles of law established by the EPO relating to Article 57 of the EPC and whether the amended claims are sufficient to maintain the patent under UK law.

The case is expected to last three days from July 18 to 20. Of the five Lord Justices allocated, Lord Justice Neuberger has the most experience with patent cases and is best known for his landmark ruling in the software patent case Symbian v UK-IPO in which the court ruled in favour of Symbian's software patent application.

In that ruling, Lord Neuberger stated that "it was desirable as far as possible to read the law so that the UK-IPO and the EPO came to similar decisions".

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