Supplementary protection certificates in Europe

Supplementary protection certificates (SPCs) extend the protection conferred by a patent to an approved medicinal product by up to five years (plus a further six months if a paediatric extension is granted). Article 3 of the SPC Regulation (469/2009) sets out the conditions to obtain an SPC, which are granted nationally. However, the number of national references made to the European Court of Justice (ECJ) still shows divergence as to how the legislation is interpreted.

In 2020, the ECJ sought to resolve some of this uncertainty. It issued judgments in Royalty Pharma (functionally defined products) and Santen (second medical use products), while national courts have applied the ECJ’s Teva v Gilead test relating to combination product SPCs.

Combination products

For any product to be entitled to an SPC, it must be “protected by a basic patent in force” under Article 3(a) of the SPC Regulation.

The test for assessing this criterion for a combination of active ingredients was set out by the ECJ in Teva v Gilead (Case C 121/17) (Pinsent Masons acted for Teva), a reference from the UK High Court ([2017] EWHC 13 (Pat)). Gilead had an SPC for its Truvada product, comprising tenofovir disproxil (TD) and emtricitabine. Claim 27 of the basic patent claimed TD “and optionally other therapeutic ingredients”. The debate related to whether this language covered the combination of TD and emtricitabine.

In July 2018, the ECJ set out a two-limb test:

• the combination of the active ingredients must necessarily, in light of the description and drawings of that patent, fall under the invention covered by that patent; and
• each of those active ingredients must be specifically identifiable, in light of all the information disclosed by that patent.

However, the ruling left questions unanswered. In particular, the ECJ failed to clarify whether this test applies to single as well as combination products.

Further, the ECJ did not clarify whether the product must reflect the core inventive advance of the basic patent. This concept had been introduced previously (Actavis v Sanofi, C-443/12; Actavis v Boehringer, C-577/13), where the ECJ held that an SPC would not be granted for a combination product where the ‘core inventive advance’ of the basic patent related to a single active ingredient which had already been the subject of an SPC and therefore did not comply with Article 3(c) of the SPC Regulation, which requires that “the product has not already been the subject of a certificate”.

Finally, the ECJ said that the product must be specifically identifiable by the person skilled in the art in light of the description and drawings of the patent, and “the prior art as at filing date or the priority date of that patent”. It is unclear whether the ECJ meant that the skilled person’s relevant knowledge is the ‘common general knowledge’, rather than the prior art or a combination of both. This has been left to the national courts to interpret.

National implementation

National courts have attempted to implement the Teva v Gilead test with differing results. In addition to the United Kingdom, proceedings in relation to Gilead’s Truvada SPC took place in other European jurisdictions. The courts in all of those jurisdictions found the SPC to be invalid, but for different reasons. While it is perhaps disappointing, it is not necessarily surprising that since the ECJ’s rejection of the infringement test in Medeva there is still no Article 3(a) test that provides absolute clarity.

When the case returned to the High Court of Justice (EWHC [2018] 2416 (Pat)), Arnold J held that the first limb of the ECJ’s test was not satisfied, as there was no basis for the skilled person to understand that the combination of TD and emtricitabine embodied the patent’s “core inventive advance”. He also found that it did not satisfy the second limb, as emtricitabine was not specifically identifiable in the claims or anywhere in the patent. He held the SPC to be invalid.

In addition to the foreseeable differences in application by different EU member states, the test has even been applied in two different ways by UK patent judges, albeit with the same outcome, as the Court of Appeal (England and Wales) ([2019] EWCA Civ 2272) upheld the High Court’s decision but used different reasoning. It rejected the ‘core inventive advance’ principle, and stated that the first limb of the test is simply an extension of that established in Eli Lilly v Human Genome Sciences (C-493/12) in which the court had confirmed that the claims should relate ‘necessarily’ to the active ingredient. Extending that test to combination products, the Court of Appeal said that “to protect a combination product, a claim must require the presence of two compounds, not just one”. Claim 27 did not satisfy this because the second ingredient is optional. Having decided that Gilead’s SPC did not satisfy the first limb, the court did not consider the second limb.

The Irish High Court (Gilead v Teva (2017) 6494P; and Gilead v Mylan (2017) 2984P) also found that, applying the Teva v Gilead test, Gilead’s SPC was invalid. In the court’s view the ECJ’s decision was invention-focused. Taking a similar approach to the core inventive advance principle, it found that there was no basis for the skilled person to understand that the combination of TD and emtricitabine “embodies the technical contribution of the patent”. The court also found the SPC invalid under the second limb of the test. However, the core inventive advance principle was rejected by the ECJ in relation to Article 3(a) in Royalty Pharma (C-650/17) in April 2020. A move away from the core inventive advance principle can be expected in future Irish cases following Royalty Pharma. However, this may not necessarily change the outcome of the Irish Gilead proceedings (currently under appeal), as the Irish High Court also found the SPC invalid under the second limb of the Teva v Gilead test, on the basis, inter alia, that emtricitabine was not specifically identifiable as a therapeutic ingredient at the priority date, whether from a document in the prior art, or the common general knowledge of the skilled person.

In France, the Paris Court of Appeal (Mylan v Gilead [18/15906]; and Biogaran v Gilead [18/15928]) has interpreted the Teva v Gilead test in a similar way to the Court of Appeal (England and Wales) but focused on the second limb. The court found that emtricitabine was not mentioned in the basic patent, and that Claim 27’s reference to ‘other therapeutic ingredients’ was simply too vague. The skilled person, on the basis of its common general knowledge at the priority date, would not automatically understand Claim 27’s general wording to refer to the combination of TD and emtricitabine. Gilead’s SPC was therefore invalid.

In Germany, the Federal Patent Court found Gilead’s SPC to be invalid (4 Ni 12/17). While the hearing took place before the ECJ decision in Teva, the written reasoning was handed down after and the court was clear in its judgment that Teva confirmed its view previously formed on the basis of Eli Lilly.

Despite the unanswered questions and differences in the application of the Teva v Gilead test, in Germany at least, the Dusseldorf Court of Appeal is of the view that the interpretation of Article 3(a) has finally been decided by the ECJ. The court’s comments came about in preliminary injunction (PI) proceedings in respect of the SPC for MSD’s combination product Inegy (I-2 U 61/18). The court found that the Teva v Gilead test, and therefore conditions of Article 3(a), were met in respect of this combination product.

However, unusually for PI proceedings regarding generic market entry, the PI was refused, with the court instead focusing on Article 3(c) and the core inventive advance principle espoused by the ECJ in Actavis v Sanofi and Actavis v Boehringer. The court stated that Teva related to Article 3(a), not Article 3(c), and therefore has no effect on the interpretation of those two decisions. The court also stated that a second SPC for a combination product may only be granted under Article 3(c) if the combination has its own inventive quality and is therefore more than a simple addition of two compounds. Whether such independent inventive quality exists must be determined by interpreting only the basic patent without considering later knowledge.

With regard to the Inegy SPC, the court held that the basic patent did not indicate that the combination is more than a simple addition of two compounds without unexpected effect. Therefore, the court found that the SPC is likely to be invalid and consequently dismissed the PI request. The court identified a number of areas where ECJ jurisprudence was unclear regarding the interpretation of Article 3(c), which may, therefore, be the basis for further ECJ referrals.

Functional definitions

In 2020 the ECJ issued its judgment in Royalty Pharma, a reference from the German Federal Patent Court relating to whether Article 3(a) is met in a claim where the product is covered by a functional, but not structural, definition.

Royalty Pharma sought an SPC for sitagliptin. The ECJ referred to the Teva v Gilead test, thereby confirming that it applies to single as well as combination products. It held that where a product is covered by a functional definition that the product is protected by a basic patent in force only if it necessarily forms part of the invention and that it can be specifically identified by a skilled person based on their general knowledge in the relevant field at the filing or priority date of the basic patent, taking account of the prior art at that date in light of all the information disclosed by the patent.

However, the ECJ referred to the skilled addressee’s general knowledge in the relevant field, which is different to the wording in Teva. Should the skilled person’s knowledge be assessed based common general knowledge, prior art, a combination thereof, or something else altogether? Further clarification may be required.

The ECJ also found that a product which is the subject of an SPC and was developed after the application for the basic patent following an ‘independent inventive step’ cannot be covered by the basic patent even if it falls under a functional definition in the patent claims. Unfortunately, the ECJ did not provide guidance as to what constitutes an ‘independent inventive step’.

Importantly, the ECJ confirmed that while an SPC must be limited to the technical characteristics of the invention protected by the basic patent, there is no requirement that SPC applicants must overcome a ‘core inventive advance’ test to meet the criteria for eligibility, thereby finally rejecting this principle regarding Article 3(a). The clarification regarding the ‘core inventive advance’ test and the relevant date for assessing whether a product is protected by a basic patent should assist in the harmonisation of relevant future decisions in the national courts and authorities.

However, one further outstanding issue is whether the approach for functional claims applies to claims with Markush formulae. The advocate general’s non-binding opinion in Sandoz v Searle (C-114/18) was that the Teva v Gilead test should also apply to Markush claims. As the case was subsequently withdrawn, however, the ECJ did not address the question. This is frustrating, as Markush formulae are commonly used in pharmaceutical claims. Markush formulae are claims that encompass potentially millions of compounds sharing a common structural element, with substituents to be chosen within the class. These claims specifically disclose the chemical structure of only a very limited number of all the compounds that they intend to cover.

In France, the Paris Judiciary Court found Searle’s SPC likely to be valid in a PI application against Sandoz (Searle & Janssen v Sandoz [18/60334]). The judge found that the two-limb test was less relevant for Markush formulae, as these claims are of a structural (not functional) nature, and so it is easier for the skilled person to determine whether an active ingredient falls within their scope.

Second medical use

One controversial question has been whether an innovative use of a known product is entitled to an SPC. The ECJ has provided clarity on the interpretation of Article 3(d), which provides that the marketing authorisation serving as a basis for the SPC application must be “the first authorisation to place the product on the market as a medicinal product” in this regard. In Santen (C-673/18), the ECJ overruled its previous, controversial Neurim judgment (in which Neurim was entitled to retain its SPC relying on the first marketing authorisation for a human use of melatonin, although there had been a previous marketing authorisation for veterinary use), and held that SPCs are not available to cover existing authorised products for which new uses are found.

What about Brexit?

How will the UK courts approach SPCs when the Brexit transition period ends and they can no longer refer questions to the ECJ? The UK Ministry of Justice has recently opened a consultation on legislative proposals that may allow lower UK courts to depart from existing ECJ case law. The law applying to SPCs may become clearer in the United Kingdom quicker than elsewhere, with the United Kingdom’s ability post-Brexit to independently develop its jurisprudence and, if needed, amend its own national legislation.

Brexit is also expected to have a bearing on the United Kingdom’s implementation of the SPC Manufacturing Waiver (Regulation (EC) 2019/933). In July 2020 the results of a public consultation aimed at protecting the UK pharmaceutical industry’s access to the waiver following the transition period were published. The scope of the waiver is reduced, allowing only export prior to SPC expiry outside the European Union and the United Kingdom, not just outside the United Kingdom as originally proposed. However, in due course, the SPC Manufacturing Waiver legislation is also likely to lead to questions of interpretation.

What does the future hold?

The Teva v Gilead test has been implemented by national courts and, despite varied results, it is hoped that subsequent decisions (including Royalty Pharma) will refine its application to Article 3(a) and make steps towards the desired harmonisation across member states.

However, despite this, questions remain. The United Kingdom’s departure from the European Union will undoubtedly see differing decisions as to whether a given product is entitled to an SPC with important consequences for pharmaceutical manufacturers that supply both the EU and UK markets.