12 July 2018

SPC Update

Correction of expiry date following the Seattle Genetics Decision Genetics Decision

At the end of 2017, the CJEU handed down its decision in the Incyte case (C-492/16, EU:C:2017:995), which considered the fundamental issue of how the term of the Supplementary Protection Certificate (“SPC”) is to be calculated.

The calculation of the term of an SPC is based on the date of the first marketing authorisation (“MA”). However, in the 2015 case of Seattle Genetics (C471/14, EU:C:2015:659), the question arose whether that means the date that the decision of the first marketing authorisation was reached or the date the decision was communicated to the applicant. The CJEU ruled in favour of the second approach, namely the date the decision was communicated to the applicant. This meant that decisions of national administrative authorities had to be reviewed, and it allowed applicants to prolong the term of SPCs.

However, the Seattle Genetics decision led to a significant divergence in the practices of the national authorities granting SPCs, with only some offices correcting the expiry date of an SPC on request, and no office correcting the expiry date of its own motion.

Following the Seattle Genetics decision, Incyte requested a revision of the administrative decision relating to their Hungarian SPC for the pharmaceutical product ‘Jakavi’, asking for the originally granted SPC term expiring on 24 August 2027 to be extended to 28 August 2027. The request was initially refused on the ground that the requested change was not due to a clerical mistake or miscalculation and the deadline for appealing against the original administrative decision to grant the SPC had already expired. Considering the case, the Budapest High Court referred the following questions to the CJEU relating to the practical implementation of the Seattle Genetics decision:

  1. “Must Article 17(2) of Regulation … No 1610/96 … be interpreted as meaning that “the date of the first [MA] in the [European Union]” is incorrect in an application for a[n] [SPC], within the meaning of that regulation and of Regulation … No 469/2009, where that date was determined without taking account of the Court of Justice’s interpretation of the law in the judgment of 6 October 2015, Seattle Genetics (C471/14, EU:C:2015:659), with the result that it is appropriate to rectify the date of expiry of the [SPC] even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?
  2. Is the industrial property authority of a Member State which is entitled to grant a[n] [SPC] required to rectify, of its own motion, the date of expiry of that [SPC] in order to ensure that that certificate complies with the interpretation of the law set out in the judgment of 6 October 2015, Seattle Genetics (C471/14, EU:C:2015:659)?”

The CJEU decided that the authority responsible for granting the SPC enjoys no degree of discretion with regard to the duration of the period of effect of the SPC, indicating that the expiry date must be corrected  in the circumstances of the referred case. Thus, in essence, the adjustment of the date of SPC expiry by the authority represents the rectification of an erroneous date, rather than a review of the original decision, indicating that an incorrect expiry date of an SPC following the Seattle Genetics decision can be corrected at any time before expiry.

Sadly, the CJEU decision failed to address the second question of whether the administrative authority is required to rectify the term of the SPC in light of the Seattle Genetics decision of its own motion.

Only a Granted Marketing Authorisation may be used to apply for a Supplementary Protection Certificate

The question of what precisely constitutes a valid authorisation was raised in the case of Merck Sharp & Dohme Corporation v Comptroller General of  PatentsDesigns  and Trade Marks C-567/16. The SPC Regulation provides that at the date of application for an SPC a valid
authorisation to place the product on the market as a medicinal product has been granted.

Merck Sharp & Dohme (MSD) owned a European patent covering Atozet®, a drug used for the treatment of high cholesterol. They filed applications for marketing authorisation in a number of EU member states, including Germany and the UK. Subsequently, MSD filed an application for an SPC with the UK Intellectual Property Office (UKIPO) on the day before the patent expired. Rather than relying upon a UK marketing authorisation in the SPC application, MSD referred to an email from the German Medicine Products Agency described as the “end of procedure communication of approval”, which had been received just 3 days before the patent expired.

The UKIPO refused the application for an SPC on the ground that there was no UK marketing authorisation at the date of the application. When MSD appealed, the UK High Court referred the following questions to the CJEU:

  1. “Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
  2. If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?”

The CJEU ruled that an end- of-procedure notice issued in accordance with Article 28(4) before the expiry of the basic patent may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b), with the result that an SPC may not be obtained on the basis of such a notice.

New referrals to CJEU – to what extent must the patent identify the product?

In a referral to the CJEU from the German Court, the question of SPCs based upon claims defining products by means of functional features has been raised.

The case relates to an SPC application for a medicinal product (sitagliptin) used in the treatment of diabetes. Sitagliptin, a dipeptidylpeptidase IV inhibitor, is not specifically mentioned in the basic patent but it is covered by a functionally defined claim, which recites an “activity lowering effector of dipeptidylpeptidase IV (DP IV)-enzymatic activity for use in lowering the blood glucose level” in mammals.

The SPC application was initially rejected by the German Patent Office for not providing the specific active ingredient to the skilled person. Following an appeal to the Bundespatentgericht (German Federal Patents Court), the Court distinguished between the CJEU jurisprudence and the “inventive advance” test proposed by the UK Court. The German Court held that the requirements laid down by the CJEU in Medeva and Eli Lilly would only be met if the active ingredient in question is “specified in the claims in such a way that it can be identified as such and is actually provided to the skilled person”. Although the Bundespatentgericht agreed with the decision of the German Patent Office to refuse the SPC, they noted the fundamentally different approaches taken in the Member States with regard to Article 3(a) and referred the following questions to the CJEU:

  1. “Is a product protected by a basic patent in force according to Article 3(a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment?
  2. Is it therefore not sufficient for the requirements of Article 3(a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?
  3. Is a product not protected according by Article 3(a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?”

A second CJEU referral came from the UK Court of Appeal considering Sandoz v G.D. Searle [2018] EWCA Civ 49. Sandoz had sought to revoke Searle’s SPC for darunavir (Prezista®) in order to clear the way for the launch of their generic product. The “basic patent” for the SPC covered darunavir through a Markush claim, a type of claim that has yet to be considered by the CJEU in relation to Article 3(a). Once again, darunavir itself was not individually described within the patent. But was covered by the broad definition of the compounds claimed.

On appeal, Floyd LJ reviewed the case law relating to Article 3(a) and considered the various tests established by case law, as well as those proposed by the parties involved. He felt that the correct approach in EU law was not clear and so referred the following question to the CJEU:

1 “Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

It is hoped that these two recent referrals will bring some much needed clarity and consistency to this area of SPCs and we will provide updates when the decisions of the CJEU are available.