Untangling SPCs in Sweden and Europe

By Ellen Setreus, Ylva Skoglosa and Camilla Liden of Valea

During the last decade, ever increasing attention has been paid to the apparent differences in interest between national health care budgets and the pricing of products in the pharmaceutical sector.

To compensate for the long and costly process of obtaining a market authorisation for a new medical product, and the fact that crucial medical research is actually driven, or at least financed to a large extent, by the originator companies, and not by the generic providers, EC 1768/92 (later codified in Regulation EC 469/2009), EC 1610/96 and Regulation EC 1901/2006, were introduced into the European Community, forming the legal basis for obtaining supplementary protection certificates (SPCs).

However, in the last couple of years, the legal situation concerning SPCs in Europe has become increasingly complex, due primarily to the large, and, at least for the legislators, unforeseen interest for obtaining them. Adding to the complexity, the national views on these issues differ greatly between European jurisdictions, increasing the demand for harmonisation. Applicants for SPCs commonly end up receiving protection in some countries while losing out in others. The legal intricacy increases when it comes to determining the scope of protection that is actually obtained by a granted SPC.

The problems are mainly due to the wording of EC 1768/92, which leaves legal gaps concerning the interpretation of certain terms, such as “active ingredient”, “combination of active ingredients” of Article 1(b), “protected by a basic patent” (Article 1(c) and 3(a)), and the “product” which has been the “subject” of a certificate (Article 3(c)).

This has led to frequent referrals to the Court of Justice of the EU (CJ) to settle national disputes.

The European perspective

To set the scene, previous decisions from the CJ have established that second medical uses of a product do not form an integral part of their definition (C-202/05, Yissum). Furthermore, the concept of the term “product” in Article 1(b) has been a specifically frequent issue of discussion, with earlier decisions of the CJ confirming that products that only differ in the proportion of the active chemical compound must be regarded as the same product, with C-258/99 (BASF) and C-431/04 (MIT) stating that combination products comprising several ingredients, only one of which has a therapeutic effect, should be considered to be the same product.

An often cited case is C-392/97 (Farmitalia), which clarified that an SPC is capable of covering the product in any of the forms enjoying the protection of the basic patent, such as salts and esters – in other words a seemingly favourable interpretation of Article 3(a) for the applicant, whilst still establishing legal praxis for others to protect derivatives of a product which were not the literal subject matter of a basic patent.

At this moment, both the originator and generic community are holding their breath on whether or not the CJ decides to take Advocate General Trstenjak’s recent opinion in the much discussed joined cases C-322/10 and C-422/10 (Medeva/Georgetown University).

The background to the Medeva/Georgetown cases resides in earlier national (UK) decisions of Takeda (EP0174726), Gilead Sciences (EP0915894), and Astellas (EP0634408). In Astellas and Takeda, the applicants used the “infringement test” for support for the products of their SPCs being protected by the basic patent (Article 1(c)), but this was not allowed. Gilead, on the other hand, was rejected by the UKIPO but later allowed on appeal, due to having a claim for “optionally other therapeutic ingredients”.

The basic patent, on which the SPC applications from Medeva were based, comprised a claimed combination of the two antigens pertactin and FHA (filamentous haemagglutinin). However, the market authorisations and SPCs filed by Medeva were directed to multiple disease vaccines.

The questions that are raised in the referral in essence concern how the content of the basic patent and authorisation are to be reflected in the application for an SPC, and how well they need to correspond to each other. The Attorney General interprets Article 1(b) to the extent that all active ingredients of a market authorization need not be a part of the SPC. The Attorney General further interprets the wording of Article 1(c) “basic patent means a patent which protects a product as such” as to refer to the subject matter of the patent, thereby taking a stand against the protective approach (the “infringement test”) for determining the extent of the basic patent. This is an interpretation which is slightly surprising, as the term “protect” is actually used in Article 1(c), and it is not clear how this can be equated to “subject matter”. Once more, the Attorney General leaves the door wide open for national interpretation of the “subject matter of the patent” by referring to that which is decisive namely “the rules governing the basic patent”.

In this respect, the outcome of the referral to the CJ from Daiichi Sankyo (C-6/11) will hopefully shed light on how specific the language needs to be for a further active ingredient in a combination product.

Other equally important issues discussed in the Medeva/Georgetown opinion are whether or not only one SPC is to be granted from a basic patent, as well as for each active ingredient. If only one SPC were to be granted, the first SPC would then exhaust the right for any other SPC directed even partly to such a product, or to another product protected by the same basic patent.

Such a restrictive approach does not seem reasonable when considering a scenario in which the active ingredient, already part of an earlier SPC, together with an additional active ingredient, provides a new synergistic or therapeutic effect, hence providing a new “combination of active ingredients” according to Article 1(b). Also, applicants would then, once and for all, need to decide upon the central ingredient around which the SPC protection is to be formed. This, in turn, could result in applicants filing series of divisional applications, which does not seem like a good way forward. Therefore, the judgment of the CJ in the present case will be of utmost importance for further prosecution of applications within this field.

The Swedish perspective

The Swedish Court of Patent Appeals (PBR), on the other hand, has been curiously abstinent in referring cases to the ECJ, probably, in no small part, due to a lack of cases to decide upon, though most likely also due to the fact that the Swedish Supreme Administrative Court, already in 3248-96 (Hässle), decided that Regulation EC 1768/92, at least regarding “protected by a basic patent “(Article 1(c) and 3(a)), was acte claire. Previously, the PBR had rejected an SPC for a combination product of felodipin and metoprolol. The basic patent covered felodipin only, and no disclosure could be found in the basic patent relating to metoprolol. Further, the applicant had already obtained an SPC for felodipin. The court stated that, because of the earlier granted SPC, the purpose of SPCs was already fulfilled, as no one could sell or market a combination product comprising felodipin and metoprolol (96-052).

Nonetheless, even Sweden has begun to experience an increase in SPC applications. As can be seen from the 2010 PBR annual report, the appeals in SPC cases have been increasing considerably, following the trend in the rest of Europe.

For example in 03-018, Akzo Nobel applied for an SPC for the product desogestrel. The Swedish Patent and Registration Office (PRV) rejected the application, referring to an older certificate relating to a combination product comprising desogestrel and etinlestradiol (weight proposition 5:1). Akzo Nobel appealed the decision and PBR argued that a condition for granting an SPC according to Article 3(c) is that a product has not been the subject of a prior certificate, and also referred to case C-392/97 (Farmitalia). Furthermore, the applicant of the older patent and SPC had neither asked for, nor been granted, protection for an SPC covering only a combination product.

The Court therefore decided that the owner of the older patent had the sole right to a combination medicament, as well as a medicament comprising desogestrel as the only active substance, as it could have stopped the offering for sale of a medicament with only desogestrel.

In light of this reasoning, as well as the Swedish Supreme Administrative Court’s decision in 3248-96 (Hässle), one could easily have been misled into believing that the Court was in favour of applying the infringement test to decide whether or not a product is covered by a basic patent. To the contrary, though, in more recent rulings the PBR has not allowed anything other than the disclosure test.

The case 07-278 (Pharmacia & Upjohn Company), which was recently decided before the PBR, relates to an SPC application for the product “crystalline ceftiofur as a free acid”, which was rejected in first instance proceedings since an SPC for the active product had already been issued, even though this SPC covered ceftiofur as a sodium salt and no literal basis for crystalline ceftiofur as a free acid could be found in the basic patent of the earlier SPC.

The PBR ruled that this case was not relatable to C-392/97 (Farmitalia), but was instead about interpreting EC 469/2009 in combination with #14 of EC 1610/96, which led them to state that by the term “product” of Article 3(a) means the active ingredient in a medicament, at the same time defining the meaning of the word “medicament” in Article 3(c) to be the one used in common language, referring to C-431/04 (MIT). Consequently, minor changes to the medicinal product, such as a new dose, the use of a new salt or different pharmaceutical form, will not lead to the issuance of a certificate in Sweden. On the other hand, at the same time, the Court clarified that issuing one SPC does not prevent the issuing of another SPC and, thus, an SPC for an active ingredient not mentioned in the first basic patent, but in another, should be allowable in Sweden.

Further shedding light on the PBR’s interpretation of Article 3(a) are the cases 04-045 and 04-046 (Novo Nordisk), in which the Court clarified its obligations relating to the interpretation of the scope of the basic patent in relation to the protection of the product. In both cases, applications were rejected on the basis that the product (insulin glargin) did not fall under the given definition of the granted claims of the basic patent. PBR came to the conclusion that, where the basic patent gives a general product definition, or comprises something other than the product, the Court has the obligation to put to the test if the product is anyhow covered by the scope of protection according to Article 3(a). The Court reasoned that it has to employ a restrictive view towards granting SPCs for products not literally fulfilling the scope of the granted claims, because the act of granting an SPC could be conceived as being the same as stating that the product is covered by the basic patent.

Consequently sticking to its acte claire approach to Article 3(a), in case 04-105 (Knoll), the PBR stated that Article 3(a) recites only that the product should be protected by the basic patent. Thus, although the marketing approval for methylbutylamine hydrochloride monohydrate had a therapeutic indication differing from the one mentioned in the basic patent, the SPC was granted.

In cases 07-277 and 10-086, Gilead had applied for an SPC for tenofovirdisoproxil in combination with other therapeutic ingredients, in particular emtricitabin. The applicant believed that the claim language to “optionally other therapeutic ingredients” adequately defined a combination product and referred to a granted SPC in the UK. The Court disagreed and referred to C-392/97 and to decisions 04-045 and 04-046, reasoning that, although in certain cases it may be possible to grant an SPC even if the product as such in not specifically mentioned in the basic patent, the disclosure in this case was too vague. Hence, for obtaining an SPC for a combination product comprising two or more active ingredients, in Sweden it is seemingly required that the ingredients are explicitly disclosed in the basic patent.

Thus, the Court clearly ruled that the Swedish SPC praxis is to take the disclosure approach instead of applying the infringement test. In view of their consistent approach to interpreting Article 3(a) in a strictly literal fashion, it is baffling how they can simultaneously arrive at the same interpretation as that of the Attorney General’s opinion in the Medeva/Georgetown case.

To summarise, we can only hope that patent offices will be as generous in evaluating inventive step as the courts are in applying the disclosure approach, as it seems that we are being pushed towards filing series of sibling applications with explicit disclosure for each and every potential new medicament that could become a future product worthy of extended protection.

Camilla Liden

Camilla Liden is a European patent attorney and Swedish authorised patent attorney and holds a Master of Science degree in molecular biology. She joined the patent profession in 2003, and prior to joining Valea, worked for three years at Karolinska Institutet Innovations looking at the commercialisation of life science inventions from academia. Camilla handles patent work for clients from small biotech start-up to large companies as well as technology transfer units. Camilla’s technical expertise is mainly within molecular biology, immunology, biochemistry, genetics, microbiology and pharmaceuticals, such as molecular biology tools, screening methods and protein chemistry. Her daily work involves dealing with pre-patenting investigations, drafting and prosecution of patent applications, performing freedom-to-operate and infringement investigations, and prosecuting applications for supplementary protection certificates. Camilla also works closely with clients on patent portfolio management and in identifying potential new inventions.

Ellen Setreus

Ellen Setreus is a European patent attorney and Swedish authorised patent attorney and has a Master of Science degree in chemical engineering. She joined the patent profession in 1998, starting at the Swedish Patent and Registration Office. She has also worked at the patent department of Pharmacia (three years) and at the patent department of AstraZeneca (six years). Ellen handles patent issues in the whole field of chemistry and she specialises in chemical and heath care inventions, such as organic chemistry, chemical processes, pharmaceutical formulations, polymers and coatings. She drafts, files and prosecutes patent applications in Europe and the rest of the world and deals with oppositions before the EPO as well as prosecuting applications for supplementary protection. Ellen works closely with companies on identifying inventions and proposing patent portfolio management. She also provides pre-patenting, infringement and validity investigations, freedom-to-operate analyses and due diligence work. Ellen also gives lectures and seminars relating to intellectual property, especially patents.

Ylva Skoglosa

Ylva Skoglosa is a European patent attorney and Swedish authorised patent attorney. Prior to joining Valea in 2002, Ylva gained a PhD in medical research at BMC in Uppsala. She has worked in IP since 1999, acquiring broad experience in patenting medical and biotechnological inventions such as medicaments, vaccines, diagnostics and medical or dental devices, biomaterials, and applied nanotechnology in these areas. Ylva is a sought-after specialist in handling large worldwide portfolios built on protein pharmaceuticals, including their formulation and production, as well as on patenting of transgenic animals and plants. She has solid expertise in the exceptions to patentability under the European Patent Convention, as well as in the patenting of new medical uses of known compounds. Ylva is a senior partner at Valea and is key account manager for a major company in the field of dental devices. She assists clients from small biotech start-ups to large companies and technology transfer units with devising patenting strategies, drafting and prosecuting applications worldwide, including applications for supplementary protection, freedom-to-operate evaluations, oppositions, litigations, due diligence and licensing issues.