Another SPC referral: will we get clarity or more questions?

Is there any piece of IP legislation which has given rise to so much uncertainty, for so little good reason, as the SPC Regulation? This Regulation must surely hold the record for the number of court cases taken and referrals made, relative to the modest number of rights actually granted under it.

Illustration not based on detailed analysis. Not even based on real data

The amount of litigation is even more astounding when you consider that unlike the laws on trade marks, patents and designs, there are no fine judgments to be made about issues like distinctiveness, obviousness or individual character. The entire SPC system is supposed to be completely administrative. Using a couple of easily determined dates, one should be able to plug them into a formula which returns an answer as to how many days (if any) extra protection should be granted to a patented pharmaceutical after the patent expires.

And yet, the Regulation has proved so unsuited to its purpose that national courts and patent offices still don’t know what the most basic criteria for SPC protection actually are, twenty years into the system's operation. This is not an exaggeration: just last month (as reported in the AdvoKat's post) Mr Justice Arnold’s pleaded with the Court of Justice (CJEU) to again clarify what is meant by the fundamental requirement for SPC eligibility contained in the phrase “the product is protected by a basic patent in force”. That question has been asked and answered before, but the CJEU's way of answering leaves patent lawyers, patent offices, and national courts scratching their collective heads and unable to apply the rulings in the real world.

Well, Arnold J has made another referral, in AstraZeneca AB v Comptroller-General [2012] EWHC 2840 (Pat).  To be fair to the legislators, this referral arises from a situation which was not easily foreseen, but on the other hand, it arises because of an alleged inconsistency between a number of earlier CJEU rulings on SPCs.

The facts

1.            AstraZeneca obtained a Swiss marketing authorisation (MA) in 2004 for their drug “Iressa”.

2.         This MA was also automatically valid in Liechtenstein (and hence the EEA). Under the SPC regime the date of the “first” MA, used to calculate if an SPC should be granted and for how long it should last, can be that of an authorisation to place the drug on the market in the EEA, not just in the EU.

Iressa a.k.a. gefitinib

3.         The Swiss MA in question was limited in duration and applied looser criteria than the EU authorities required under the relevant Directives. To remain in force, the Swiss authorities required better data within a time limit and when this did not appear the MA was withdrawn, terminating its effect in Liechtenstein also.  (The original data was also rejected by the EU authorities who refused to grant a corresponding MA).

4.            Following more clinical trials and better data AstraZeneca was ultimately granted a European MA in 2009 and a new Swiss one in 2010.

5.         It was therefore legal in 2004-2005 to market Iressa in Liechtenstein, but nowhere else in the EEA or EU. It was then illegal from 2005 until 2009 to market Iressa anywhere in the EU or EEA.Since 2009 the European MA has applied.

The questions referred

Which was the first MA?

The Comptroller regards the 2004 Swiss MA as the “first” authorisation (giving AstraZeneca an SPC term a few months shy of three years). This is in line with the CJEU decision in Novartis where the Court held that a Swiss MA could trigger the SPC provisions due to its effect in Liechtenstein and hence the EEA.

AstraZeneca argue that this MA did not trigger the SPC provisions because in the Hässle decision the CJEU had held that the only MA which will trigger an SPC is one granted in line with the relevant EU Directives (which the Swiss MA was not). Also, the Synthon decision stated that when a product is placed on the market without first having received an EU-compliant MA, the product is outside the SPC system. Accordingly, AstraZeneca argue, Novartis should be confined to its facts or was wrongly decided.

If AstraZeneca are correct, they say the 2009 MA is the triggering MA, giving them the maximum SPC term of five years.

Three questions: word them very carefully

Arnold J has therefore used his first two questions to address this point (rather like a hopeful castaway rubbing a genie's lamp and being granted three wishes which he wants to use to best effect and without being tricked by the genie) as follows:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?"

Arnold J has supplied the CJEU with his own suggested answers: (1) yes, the Swiss MA was the “first authorisation”, and (2) no, the circumstances make no difference.

In what the IPKat can only interpret as a frustration bred by hard experience, Arnold J makes a final plea to the CJEU given the argued conflict between earlier CJEU decisions: 

“If, however, the Court of Justice decides to overrule or qualify Novartis, I would request that it says so in clear and unambiguous terms, in order to avoid the need for yet another reference on this issue.”

Is the drug now disqualified entirely from SPC protection?

The Synthon decision mentioned earlier has a possible implication which could be very unhelpful to AstraZeneca. The Court held that where a product which had been marketed in the Community without first having undergone the testing and regulatory approval required under EU Directives, then not only did the SPC Regulation not apply, but any SPC granted for that product was invalid. A similar finding was made in the Generics decision.

The implication, the Comptroller argued, was that the compound in Iressa could now never be granted a valid SPC, having been marketed in the EEA without having first received an EU-compliant MA.

Arnold J. therefore used his final rub on the genie's lamp as follows:

“3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?"

Again, in case it helps, Mr Justice Arnold offers the CJEU his own view: yes, the product is ineligible for any SPC protection, in line with the CJEU’s decisions in Synthon and Generics but contrary to that in Neurim.

Final thoughts
Given the demonstrated inadequacy of many of the SPC Regulation’s provisions, and the fact that so many of the answers coming back from the CJEU simply beget more referrals, this Kat suggests a more radical approach is needed.

Perhaps the EU should simply repeal the SPC Regulation, preserving intact all rights granted to date, and rewrite the law to give the same protection as was intended previously, starting with a blank sheet of paper, a healthy measure of hindsight, and a thorough appreciation of the more common kinds of pharmaceutical patents, products, claiming methods and infringement problems. One suspects that secretly Mr Justice Arnold, along with many of his colleagues in the Courts and Patent Offices throughout Europe, would agree. Do the IPKat's readers agree, or is the Regulation good enough as it stands?