In the area of life sciences, Laëtitia Bénard and Olivia Klimis of Allen & Overy consider the legal judgments of MEDEVA and GEORGETOWN by the Court of Justice of the European Union (CJEU).
EC Regulation No. 1768/92 of 18 June 1992 concerning the supplementary protection certificate (SPC) for medicinal products (as consolidated by EC Regulation No. 469/2009 of 6 May 2009, (the SPC Regulation)), applies to all SPCs granted in the European Union since 2 July 1993. It was adopted as an incentive for laboratories to invest in research related to medicinal products, so that they could efficiently recover the lost period of monopoly lapsed between a patent application and the first marketing authorisation allowing the launch of the medicine on the market.
Yet, 20 years after its adoption, many questions concerning the SPC regime remain unanswered. These uncertainties raised many arguments before the national courts and have recently led to six important judgments and orders of the Court of Justice of the European Union (CJEU). Further decisions on the SPC Regulation are expected in 2012, as other referrals are still pending.
The Medeva and Georgetown judgments of 24 November 2011 (C-322/10 and 422/10): conditions of grant of SPCs for several products
These referrals concerned the conditions of grant of SPCs set out in article 3(a) and (b) of the SPC Regulation.
According to article 3 of the SPC Regulation:
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted […];
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market.
In the Medeva case, the UK Patent Office had refused to grant SPCs for multi-disease vaccines (vaccines containing a combination of active ingredients) either on the ground that they relate to active ingredients which were not claimed in the basic patent, or on the ground that the marketing authorisation also contained other active ingredients.
Upon referral by the English Court of Appeal, the CJEU adopted a restrictive interpretation of when a basic patent is considered to protect a product under article 3(a):
Article 3(a) of Regulation (EC) No. 469/2009 […] must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.
The same preliminary ruling was adopted by the Yeda, Daiichi Sankyo and Queensland orders dated 25 November 2011 (C-518/10, C-6/11 C-630/10 and). In the Yeda decision, the CJEU further specified:
Article 3(a) […] must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.
Thus, the CJEU clearly ruled in favour of a very strict application of the disclosure test.
Such a test has the advantage to promote a uniform application of article 3(a) across Europe, as it should be independent from the national patent laws of the member sates. However, there remain many open questions that would probably lead to further referrals to the CJEU such as, in particular, the level of description of a product in the patent claim for it to be considered as “disclosed” under the CJEU ruling. In addition, the application of such a test does not protect the investment of pharmaceutical companies that developed an innovative combination medicinal product, in which only one or several active ingredients but not all the active ingredients contained in the combination medicinal product were disclosed in the basic patent. This interpretation of the SPC Regulation gives no incentive to further develop combination medicinal products where all the active ingredients were not disclosed in the basic patent.
The CJEU took a more liberal interpretation of what is considered as a valid authorisation to place a product on the market as a medicinal product under article 3(b):
Article 3(b) of Regulation No. 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.
This interpretation was confirmed in the Georgetown and Queensland cases, as to SPCs containing one active ingredient only.
In Yeda, the CJEU ruled in favour of innovative companies: SPCs may be granted for a smaller combination of active ingredients than those present in the marketing authorisation. This flexibility is essential to promote research in combination medicinal products such as multi-disease vaccines, which are in the interest of public health. It also takes into account that, for public health reasons, companies may be required to market multi-disease vaccines only.
In the framework of the Medeva and Georgetown referrals on the interpretation of article 3(b), the CJEU also made an additional finding on the subject matter and effects of an SPC under articles 4 and 5. Article 4 provides:
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
Article 5 specifies:
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
If one replaces the term “product” by its definition under article 1(b), namely the active ingredient being the subject matter of the marketing authorisation used as the basis for the medicinal product comprising such active ingredient, it can be derived from articles 4 and 5 that the subject matter of the certificate is the active ingredient and not the medicinal product that has been authorised, and that it extends to “any use” of the active ingredient, as a medicinal product, that could have been opposed by the patent holder.
This has been confirmed by the CJEU in the Medeva case:
In accordance with Article 4 of Regulation No. 469/2009, [an] SPC is intended to protect the ‘product’ covered by the MA, not the medicinal product as such. […] In accordance with Article 5 of Regulation No. 469/2009, [an] SPC thus granted in connection with such a product confers, upon the expiry of the patent, the same rights as were conferred by the basic patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 of the regulation. Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate.
It results from this holding that the effects of the protection of SPCs covering one active ingredient extend to medicinal products that contain this active ingredient in combination with one or more active ingredients. This may explain the restrictive interpretation given by the CJEU to article 3(a): an SPC could not be granted for a combination medicinal product not claimed in the basic patent, but an SPC granted for a mono-medicinal product could be enforced against a combination medicinal product. This controversial question is the subject of referrals from the English High Court of Justice and the Düsseldorf Regional Court, which are still pending before the CJEU, although the CJEU appears to have clearly expressed its views in Medeva.
Finally, the CJEU made another ruling on the scope of article 3(c) of the Regulation. Referring to its preliminary ruling of 23 January 1997 in Biogen (C-181/95), it confirmed that:
where a patent protects a product, in accordance with article 3(c) of Regulation, only one certificate may be granted for that basic patent.
The Court did not specify how this rule must be applied where the basic patent protects several products. The majority of the national courts and offices consider that article 3(c) must be interpreted as allowing only one SPC per product per patent. This seems to respect the wording of article 3(c) and corresponds to industry practice in Europe.
In the Medeva and Georgetown cases, Advocate General Trstenjak defended a different opinion: she considered that only one SPC may be obtained per patent, even if the patent claims several active ingredients or combinations of active ingredients. So far, this opinion has – fortunately– not been followed by the CJEU.
The Queensland judgment: application of Medeva to SPCs based on products-by process claims
In Queensland, the CJEU confirmed the scope given to articles 3(a) and 5 of the SPC Regulation. In addition, it specified that the same solution applies in the case of a basic patent relating to a process by which a product is obtained, when the SPC concerns a product obtained by this process, but not claimed in the basic patent.
As to article 3(a), the CJEU concluded that:
Article 3(a) of Regulation No. 469/2009 precludes a supplementary protection certificate being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.
Again, the CJEU made an additional finding on article 5:
It is sufficient to point out that a patent protecting the process by which a “product” within the meaning of Regulation No. 469/2009 is obtained may, in accordance with Article 2 of the regulation, enable [an] SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the process by which the product is obtained (see Medeva, paragraph 32).
If the law applicable to such a patent so provides, [an] SPC granted on the basis of that patent will also extend the protection of the process by which the product is obtained to the product thus obtained (see, to that effect, Medeva, paragraph 32).
This judgment indicates that the interpretation of articles 3(a) and 5 provided in the Medeva case is not limited to SPCs granted for several products.
The Merck judgment of 8 December 2011 (C-125/10): obtaining a negative SPC
Two weeks after the Medeva judgment, the CJEU ruled on another hot topic concerning the relations between the SPC Regulation and the Regulation on paediatric extensions.
According to article 13 of the SPC Regulation, the SPC extends the effects of the basic patent for a time equal to the period that elapsed between the date the application for a basic patent was filed and the date of the first marketing authorisation to place the product on the market in the EU, reduced by five years, and that may not exceed five years.
The necessity to promote research in the field of paediatric treatments led to the adoption of the Regulation No. 1901/2006 of 12 December 2006 on medicinal products for paediatric use. Article 36 of the Regulation provides that where an application for a marketing authorisation includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or SPC shall be entitled to a six-month extension of the SPC period.
Following the adoption of the Regulation for paediatric extension, the question was raised whether article 13(1) of the SPC Regulation precludes the grant of an SPC where the period that has elapsed between the application for a basic patent being lodged and the first marketing authorisation in the EU is less than five years. While an SPC of negative or zero duration serves no purpose in itself, it may be useful to the patent holder wishing to obtain a paediatric extension.
This is precisely what Merck, the SPC applicant, was looking for in the case referred to the CJEU. Its SPC application concerning Sitagliptin, a pharmaceutical substance covered by the basic patent and used for the prevention or treatment of diabetes, had been refused by the German Patent Office on the basis of article 13(1).
Upon referral of the German Patent Court, the CJEU held that:
medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years.
In such a case, the paediatric extension will start to run:
from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.
The CJEU observed that a paediatric extension will be of use only if the negative duration of the SPC is less than six months. Accordingly, negative SPCs may be granted only if the first marketing authorisation in the EU was delivered between four-and-a-half years and five years after the patent application.
This ruling, which is consistent with the advocate general’s opinion, harmonises the law applicable to SPCs. Until the CJEU’s judgment, the question of negative SPCs had led to contradictory decisions in the member states.
The possibility to obtain SPCs of negative duration under article 13 is a supplementary incentive to carry out research in the field of paediatric treatments. Some innovative laboratories might yet be disappointed that the CJEU has not given to basic patent holders the right to a full six-month extension, starting from the expiry of the five-year period, even in the case of an SPC of negative duration.
The Novartis v Actavis referrals: the effects of SPCs granted for one single active ingredient
The interpretation of articles 4 and 5 in the Medeva and Georgetown judgments corresponds to the rationale of the SPC Regulation: an SPC is granted to the patent holder as a compensation for the lack of effective protection of the patent during the years necessary to obtain a marketing authorisation. It does not in any way constitute an additional reward for having placed a medicinal product on the market. As an extension of the basic patent, the SPC must then be granted the same protection as the basic patent, on the basis of the national rules governing that patent. This had already been acknowledged by the CJEU in the Farmitalia case (16 September 1999, C-382/97).
In view of the rules applicable to patent infringement in Europe, the scope of protection of SPCs covering one active ingredient should logically extend to medicinal products that contain this active ingredient in combination with one or more others. Many national courts in the European Union have already ruled in this way, in relation to the Losartan and Valsartan products (see Paris First Instance Court, 28 January 2011 (decision reversed on appeal on 16 September 2011) and 31 October 2011, Court of Düsseldorf, 8 March 2011, Court of Vienna, 6 June 2011 and Regional Court of Oslo 10 February 2011, in Valsartan; see also Paris First Instance Court, 12 February 2010 (confirmed on appeal by the Paris Court of Appeals, 15 March 2011) in Losartan).
Two preliminary questions, referred by the English High Court and the Düsseldorf District Court in the Valsartan case are still pending before the CJEU, and will lead it to specify its interpretation of articles 4 and 5 in relation to combi-medicinal products.
The question referred by the High Court is the following:
Where a supplementary protection certificate has been granted for a product as defined by Regulation (EC) No. 469/2009 for an active ingredient, are the rights conferred by that certificate pursuant to Article 5 of the Regulation in respect of the subject matter as defined in Article 4 of the Regulation infringed:
(i) by a medicinal product that contains that active ingredient (in this case valsartan) in combination with one or more other active ingredients (in this case hydrochlorothiazide); or
(ii) only by a medicinal product that contains that active ingredient (in this case valsartan) as the sole active ingredient?
The question referred by the Düsseldorf Regional Court is the following:
Should Articles 4 and 5 of Regulation (EC) No. 469/2009 be interpreted in such a way that the protection of a supplementary protection certificate, which has been granted for a single active ingredient (here: Valsartan), covers an embodiment comprising an combination of active ingredients (here: Valsartan + Hydrochlorothiazide) that contains such single active ingredient?
Choosing a positive answer to the above would meet the objective of the SPC Regulation and would be in line with the CJEU’s previous case law. Let’s wait for the CJEU to explicitly confirm the finding that can be inferred from the Medeva and Georgetown judgments as to combination medicinal products.