SPCs

SPCs continue to be a focus of regulatory and judicial development, though the CJEU refused to consider a reference from the UK court in Eli Lilly v Genentech on the question of whether an SPC should be granted to a patent owner that relies upon a third party’s marketing authorisation. The CJEU refused because the Patents Court had found the Patent in question invalid, and so the reference was speculative. The Patents Court had been concerned that it should make a reference to the CJEU, before any potential appeal on the invalidity decision to the Court of Appeal. Because of Brexit, that court may no longer be able to make a reference by the time the case is heard by the Court of Appeal (the substantive appeal is scheduled to be heard in January 2021).

SPC Case Law

Meanwhile, in Sandoz v Searle and Royalty Pharma, the Advocate General gave a joined Opinion considering SPCs based on active ingredients within the scope of a Markush formula or a functional definition, suggesting that they both can potentially meet the requirements of the SPC Regulation that a product which is the subject of an SPC is ‘protected by a basic patent’. This will be the case, according to the Advocate General, where the two-stage test the CJEU set out in Teva v Gilead concerning combination products is satisfied. The CJEU’s decision is awaited.

The Court of Appeal issued its decision in the Teva v Gilead case itself in December 2019, holding that the Patents Court was correct in finding that the SPC for Truvada – a drug combining two antiretroviral medications used to treat and prevent HIV infection, tenofovir disoproxil (TD) and emtricitabine – is invalid. The judgment follows an earlier reference from the UK Patents Court to the CJEU as to the criteria for deciding whether a product is “protected by a basic patent in force” under Article 3(a) of the SPC Regulation. The Grand Chamber of the CJEU gave its decision in July 2018. It held that a combination product will be protected by a basic patent within the terms of the SPC Regulation where, even if the combination of active ingredients is not expressly mentioned in the claims of the patent, those claims “relate necessarily and specifically to that combination”. This required an assessment of whether, from the point of view of a person skilled in the art and on the basis of the prior art at the filing/priority date of the patent:

The combination of those active ingredients necessarily, in the light of the description and drawings of the patent, fall under the invention covered by the patent. This requires more than that the product falls within the scope of the claim; the skilled person must understand, on the basis of the description, the drawings and the common general knowledge, that the combination product to which the claims of the patent relate embodies the technical contribution made by the patent.
Each of those active ingredients is specifically identifiable, in the light of all the information disclosed in the patent.

Gilead had appealed on the basis that Mr Justice Arnold in the Patents Court had interpreted and applied the CJEU’s two-limb test incorrectly.

The Court of Appeal concluded that Gilead’s SPC was invalid. The Court made its decision based on the first limb of the CJEU test alone that a skilled person would not consider that the combination of TD and emtricitabine necessarily and specifically fell within claim 27. In particular, there was nothing to suggest that the claim required the presence of another ingredient since it used the word “optionally”. The phrase “other therapeutic ingredients” was not limited to anti-viral agents, and the claim was not limited to a product containing TD for the treatment of HIV.

However, the Court of Appeal did expressly reject any role for the ‘inventive advance or technical contribution’ of the patent as proxy for assessing whether the product of the SPC fell within claim 27 (an approach which found favour with Mr Justice Arnold at the original trial of the action). Lord Justice Floyd – giving the judgment on behalf of the Court – held that the CJEU had “definitely set its face against the introduction of such a test”.

No protection for new formulation of old active ingredient

In Abraxis Bioscience v Comptroller of Patents, the CJEU adopted a narrow interpretation of Article 3(d) of the SPC Regulation, finding that a supplementary protection certificate cannot be granted where a product protected by a marketing authorisation is a new formulation of an active ingredient which is protected by an earlier marketing authorisation. In particular, the CJEU noted that the intention behind the SPC Regulation was not to protect all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but “to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”. An alternative finding would frustrate that objective, and would lead to legal uncertainty and inconsistencies.

The decision followed a reference by the Patents Court, following the UKIPO’s refusal to grant an SPC for a product described as “paclitaxel formulated as albumin bound nanoparticles” called nab-paclitaxel by Abraxis, and marketed under the trade mark Abraxane. Abraxane is indicated for the treatment of certain cancers, used alone or together with other anti-cancer treatments. Before the marketing authorisation for Abraxane had been obtained, paclitaxel had been marketed by other parties under earlier MAs. Whilst SPC protection was refused in the UK and Sweden, certificates were granted to Abraxis in nine Member States.

The CJEU’s decision could have been an opportunity to revisit its controversial Neurim decision but it did not do so, merely finding that Neurim did not call into question the interpretation it had reached. The opportunity to revisit Neurim will, however, come in a reference from the French courts, Santen with the Advocate General giving their Opinion on 23 January 2020.

SPC Reform: Manufacturing Export Waiver and EU Day One Launch

On the reform front, generic and biosimilars manufacturers will now find it easier and quicker to launch their products due to the introduction of the ‘SPC waiver’ which provides an exception to infringement of an SPC in certain circumstances.

The SPC waiver allows EU-based generic and biosimilars manufacturers to make a product in the EU for the purposes of exporting it to third countries where it may not be subject to protection. Significantly, it also allows them to make and stockpile medicines in the six months period before an SPC expires, to allow for a Day One EU launch on that expiry date. The EU anticipates that the waiver will generate over ten years additional annual export sales of more than EUR 1 billion, leading to 20000-25000 jobs.

The waiver applies to SPCs applied for on or after 1 July 2019. It will not apply to SPCs that take effect before 1 July 2019. However, where an SPC application was filed before 1 July 2019 but does not take effect until after 1 July 2019, it will apply after a period of three years, i.e., from 2 July 2022. There are some safeguards for SPC holders including an information obligation, labelling requirements and due diligence requirements. The UK government has issued a consultation on the retention of the SPC waiver legislation in UK law, at the end of the Brexit transition period.