Genentech v Comptroller General: Failure to pay fee loses two years of SPC protection
In an expedited appeal heard as a remote hearing shortly after the UK went into lockdown, the Court of Appeal rejected appeals by Genentech and its agent Master Data Center (MDC) which would have had the effect of allowing Genentech's SPC relating to Lucentis to continue in force for its maximum potential duration, i.e., until 23 January 2022. The background to the appeal was that, despite Genentech's instructions to MDC to apply for an SPC for the maximum duration, MDC had mistakenly only applied for a two-year SPC. As part of its evidence, MDC stated that there had been "several instances in the past" where the UKIPO had notified MDC of underpayments where it had mistakenly paid for a shorter term than the maximum, which it had then been able to rectify. On the basis of the renewal payment made by MDC, the SPC expired on 2 April 2020.
The Court of Appeal rejected MDC's submission that there is only one prescribed fee for an SPC, i.e. one appropriate to the maximum duration of the SPC as laid down in Article 13 of the SPC Regulation. The Court also rejected the submission that the UK SPC scheme does not permit an applicant to elect and pay for a shorter period of protection than the full term available.
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SPCs and combination products: Court of Appeal upholds invalidation of Gilead's Truvada SPC
At the end of 2019, the UK Court of Appeal in Teva & Ors v Gilead held that the UK Patents Court was correct in finding that the SPC for Truvada - a drug combining two antiretroviral medications (tenofovir disoproxil (TD) and emtricitabine) used to treat and prevent HIV infection – was invalid. The judgment followed 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 outcome in the Court of Appeal, together with the CJEU's judgment, confirms a clear approach for determining whether a product is "protected by a basic patent in force" under Article 3(a).
A number of generic pharmaceutical companies challenged the SPC on the basis that the "basic patent" did not protect the combination of TD and emtricitabine, and the SPC was therefore invalid under Article 3(a) of the SPC Regulation. Gilead maintained that the combination of TD and emtricitabine fell within the scope of claim 27 of the basic patent when construed in accordance with Article 69 of the European Patent Convention.
Following a referral to the CJEU, the Grand Chamber decided in July 2018 that a combination product will be protected by a basic patent within the terms of the SPC Regulation where, even though 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, falls 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 that, on the basis of the description, the drawings and the common general knowledge, 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.
The Court of Appeal agreed with the trial judge (Arnold J, as he then was) that Gilead's SPC was invalid. The Court made its decision based on the first limb of the CJEU test alone holding that a skilled person would not consider that the combination necessarily and specifically fell within the relevant claim. Gilead's application to the Supreme Court for permission to appeal was rejected in August 2020.
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Royalty Pharma: CJEU confirms 'core inventive advance' of the patent is not relevant
On 30 April 2020, the CJEU delivered its decision in a reference from the German court for interpretation of Article 3(a) of the SPC Regulation. The CJEU's decision followed the decision of the CJEU Grand Chamber in 2018 in Teva v Gilead which had also considered Article 3(a) of the SPC Regulation, and clarified certain aspects (see above).
The Court's conclusion was as follows:
- The concept of the 'core inventive advance' of the basic patent is not relevant under Article 3(a) of the SPC Regulation. In Teva v Gilead, the 'core inventive advance approach' had been rejected by the Advocate General, but had gained support in a number of territories. The UK Court of Appeal had said that the CJEU had "definitely set its face against the introduction of such a test", and this further clarification from the CJEU is therefore welcome.
- A product falling within a functional definition used in the claims of the basic patent, but which is not derivable from the patent as a specific embodiment in individualised form, may be protected by the basic patent under Article 3(a) where it is specifically identifiable by a person skilled in the art on the basis of all information disclosed in the patent, and their general knowledge in the field and the state of the art at the date of filing/priority date.
- A product will not be protected by a basic patent under Article 3(a) where, although it falls under the functional definition given in the claims of the patent, it was developed after the filing date following an independent inventive step.
Santen: CJEU rejects SPCs for second medical uses
The Grand Chamber of 13 judges of the CJEU concluded in July 2020 that SPCs should not be available for new applications of previously authorised products. In Santen, the CJEU decided that an SPC will not be available where the applicant relies on a marketing authorisation (MA) covering a new therapeutic application of an active ingredient or combination of active ingredients, where that active ingredient/combination has already been the subject of an MA for a different therapeutic application.
In its earlier Neurim decision, the CJEU had ruled that, under the SPC Regulation, the mere existence of an earlier MA, obtained in that case for a veterinary medicinal product, did not preclude the grant of an SPC for a 'different application' of the same product, provided that that application was 'within the limits of the protection conferred by the basic patent' relied upon.
In Santen the CJEU concluded that, under Article 3(d) of the SPC Regulation, the first MA for the product as a medicinal product means the first MA for a medicinal product incorporating the active ingredient/combination, irrespective of the therapeutic application of that active ingredient/combination for which that MA was obtained. Contrary to its earlier decision in Neurim, when defining the concept of first MA for the product as a medicinal product, there was no need to take into account the limits of the protection of the basic patent.
The CJEU's decision, in effect, to overturn its earlier (controversial) Neurim decision has been welcomed by generic pharmaceutical companies and opens up the possibility of challenges to other granted SPCs. This outcome was foreshadowed by the CJEU's decision in Abraxis in 2019 (discussed here), refusing SPC protection for new formulations of old active ingredients. However, whilst the CJEU said its decision accorded with the aims of the EU legislature for the SPC Regulation, it is worth noting the views of Lord Justice Jacob (as he then was) when referring questions in Neurim in the Court of Appeal in 2011: his view was that refusal of an SPC to Neurim would mean that the SPC Regulation had not "achieved its key objects for large areas of pharmaceutical research; it will not be fit for purpose". There may be interesting questions of interpretation relating to SPCs and retained EU case law now the Brexit transition period has ended.
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SPC Manufacturing Waiver in the UK
In July 2019, a new SPC manufacturing waiver took effect in the EU (discussed in more detail here). The waiver provides an exception to infringement of an SPC exempting the making of medicines in the EU for export to non-EU countries where protection has expired or does not exist, or for storing products in the six months period before expiry of the SPC for a Day One EU launch.
The introduction of the EU SPC manufacturing waiver coincided with the UK getting ready for its departure from the EU and so the Government issued a call for views before introducing a UK version of the waiver at the end of the Brexit transition period. Under the UK regime, third parties are able to rely on an exception to infringement in relation to making in the UK for export to countries outside of the UK and EU and, in the final six months of the SPC, to store in the UK for sale in the UK or EU on expiry. Originally, the Government had proposed to permit making for export to countries outside of the UK (i.e., including to the EU) but concerns were expressed during the consultation that this would have an adverse effect on innovators, particularly relating to EU accession sates.
The UK Government also decided against requiring a logo to replicate the 'EU Export' logo used for the EU manufacturing waiver, settling on the use of the words 'UK Export' alone (but with power to make additional labelling requirements if necessary).
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