Validity and enforcement of Supplementary Protection Certificates (SPCs) was another active area in 2018. Alongside yet more cases on interpretation of the SPC Regulation, the focus has also been on policy developments, including proposals to adopt a export manufacturing waiver. Meanwhile, consideration of other possible reforms of the EU SPC regime, including a unitary SPC, alongside a potential re-calibration of patent research exemptions, will await finalisation of the Commission’s ongoing analysis of pharmaceutical incentives.
And, of course, SPCs need to be considered in a Brexit context, with the UK government issuing draft Regulations to deal with their future treatment in the event that the UK leaves the EU with no agreement.
SPCs and combination products: Gilead’s Truvada SPC held invalid
In Teva & ors v Gilead, the UK Patents Court decided that the SPC for Truvada - a fixed-dose combination of two antiretroviral medications (tenofovir disoproxil (‘TD’) and emtricitabine) used to treat and prevent HIV infection – was invalid. The judgment followed the CJEU’s decision on questions referred by the Patents Court 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 Patents Court, together with the CJEU’s judgment, brought welcome clarity to the approach for determining whether a product is ‘protected by a basic patent in force’ under Article 3(a). In particular, it was welcome news to generics and healthcare providers seeking to bring this particular combination therapy for the prevention of HIV infection to the market.
Applying the CJEU’s two-stage test, the Court concluded that the Truvada SPC failed on both counts:
- From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, in the light of the description and drawings of the patent, the combination of active ingredients did not necessarily fall under the invention covered by that patent.
- From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, in the light of all the information disclosed by the patent, emtricitabine is not specifically identifiable (even though TD was).
Gilead has obtained permission to appeal.
Court of Appeal refers questions to CJEU on SPC Regulation in relation to Markush claim
The Court of Appeal has referred further questions on the meaning of Article 3(a) of the SPC Regulation to the CJEU in Sandoz v Searle (the date for the case to be heard is not yet in the CJEU diary). In doing so, the Court took a different approach to Arnold J who, having previously made a series of referrals to the CJEU on the meaning of Article 3(a) (including Teva v Gilead), concluded no reference was necessary.
The SPC (SPC/GB07/038) relates to darunavir (sold under the mark Prezista) and concerns a Markush claim, i.e., where a class of compounds is represented by means of a structural formula, thereby allowing large classes of compounds to be defined without being listed out. Arnold J decided that the product was specified or identified in the claims of the patent, even though it was not specifically identified by name or structure in the claims or anywhere in the specification and there was no teaching in the patent which pointed to darunavir and in particular its novel and unusual P1 group.
Floyd LJ reviewed the series of CJEU decisions on Article 3(a), and a recent German referral (Sitagliptin – the date of the hearing of this case is yet to be fixed) on functional claims. He identified the core question as being how specific must the claims be? He went on to express his provisional conclusion that darunavir was a product protected by the claims of the patent: in the case of a product with a single active ingredient and a patent with a claim which identifies a number of compounds by means of a Markush formula, where all those compounds embody the core inventive technical advance, the test should be whether the skilled person, considering the claims of the patent on the one hand and the structure of the product on the other, would immediately recognise that the active ingredient in question was one of those specified by the formula.
However, it was not clear that this was the correct approach in EU law, and so a reference to the CJEU was necessary.
Advocate General proposes return to literal interpretation of SPC Regulation in Abraxis case
On 13 December, Advocate General Saugmandsgaard ØE issued his Opinion in Abraxis Bioscience v Comptroller General of Patents, on the question of whether an SPC can be granted under Article 3(d) of the SPC Regulation where a product protected by a marketing authorisation is a new formulation of an active ingredient which is protected by an earlier marketing authorisation (as opposed to a new therapeutic use of an active ingredient, as in the Neurim case). We discussed the background to the case, a reference from Arnold J in January 2017, in our April 2017 edition. SPCs have been granted to Abraxis in nine Member States but rejected in Sweden and the UK, with other decisions pending.
The Advocate General suggests that this divergence may be as a result of differing interpretations of the CJEU’s Neurim decision. He proposes a move away from the teleological interpretation of Article 3(d) back to a literal interpretation in all situations, by abandoning the scope of protection of the patent test, given the restrictive meaning adopted by the Court in other cases of the concept of the ‘product’ within Article 1(b) of the SPC Regulation. Accordingly, in his view, there should be no SPC protection in this case as, whilst the marketing authorisation relied upon is the first to fall within the scope of the basic patent protecting the new formulation of a known active ingredient, it is not the first marketing authorisation for that active ingredient.
The CJEU’s decision will be significant as it will present the opportunity for the Court to re-examine the scope of the Neurim decision and its implications.
CJEU denies SPC protection for a substance which was an integral part of an authorised medical device
Finally on SPC decisions, in October 2018, adopting a strict interpretation of the SPC Regulation, the CJEU decided that an SPC could not be granted for paclitaxel (marketed under the name Taxol) on the basis of a patent relating to “use of Taxol for the preparation of a medicament to maintain an expanded vessel luminal area” and a CE conformity certificate issued for the medical device TAXUS, which is a paclitaxel-coated stent. Although Taxol had been the subject, as a medicinal product, of a marketing authorisation for the treatment of certain cancers, it had not been subject, as a medicinal product intended for the claimed use in the patent, to any formal authorisation procedure.
The CJEU concluded that the CE conformity certification procedure could not be regarded as an authorisation procedure equivalent to the marketing authorisation procedure laid down in the Directive for medicinal products, even though paclitaxel was subject, in respect of its use in the device, to an evaluation as a substance forming an integral part of the device.
The CJEU said that, where a medicinal product was an integral part of a device and performed on the body an ancillary action to the device, in respect of that use it could not be classified as a medicinal product, even if it would be classified as such if it were used separately. Further, the authorisation procedure to which it had been subject was not equivalent to that of a medicinal product. The CJEU noted that the EU legislature intended to reserve the grant of SPCs to medicinal products alone, and not to medical devices and substances used as adjuvant products of a medical device.
SPC Reform: Proposal for export manufacturing waiver
In May 2018, the EU Commission published a proposal for a ‘targeted amendment’ to the rules relating to supplementary protection certificates (SPCs) in the form of a ‘manufacturing export waiver’. This will allow EU-based manufacturers of generic and biosimilar products to manufacture those versions of an SPC-protected product during the term of the relevant SPC, provided it is done exclusively for the purpose of exporting to a non-EU market where protection has expired or has never existed.
The Commission considered that its proposal will address a competitive disadvantage for such companies, as compared to non-EU companies, and generate new opportunities, particularly as we approach the ‘patent cliff’ of 2020 when many blockbuster drugs will lose protection. Indeed, the Commission predicted that the waiver will generate at least €1 billion per year in net additional export sales in the EU pharmaceutical sector and create up to 25,000 extra highly skilled jobs over the next ten years.
The Commission recognised that there may be concerns for SPC-holders as to transparency and possible illicit diversion on to the EU market, but stressed that the core protection and enforcement of SPC rights will remain unaffected, in particular due to a number of safeguards.
In February 2019, EU negotiators reached agreement on the text of the draft Regulation. In addition to the manufacturing export waiver, agreement was reached allowing stockpiling of medicines for an ‘EU day one launch’ subject to certain disclosure and due diligence obligations. The text will now be subject to final approval.