An important day for supplementary protection certificates
On 10th February 2012 the High Court had a busy morning applying recent decisions of the Court of Justice of the European Union (ECJ) in Medeva (C-322/10) and related referrals to real-world situations involving supplementary protection certificates (SPCs). In doing so, the High Court has shed some much-needed light on the situations in which SPCs will be available to extend patent terms. Although the judge considered the ECJ's decisions to be unclear – and did not shy away from saying so – he still held that the terms of Medimmune’s patent were not specific enough to allow it an SPC covering Lucentis, the treatment for wet AMD. On the other hand, in a separate case heard the same morning, CSL/University of Queensland’s patents were considered to be specific enough to cover components of the Gardasil HPV vaccine. Thus, the UK judiciary has issued its first guidance as to how the ECJ’s rulings should be interpreted.
At 10:00am, Mr Justice Arnold handed down a decision in the second leg of the MedImmune v Novartis Lucentis litigation. A key issue was whether MedImmune’s patent for a method for producing “a molecule with binding specificity for a particular target” included within its claims adequate “specification” of the active ingredient in Lucentis (the ranibizumab monoclonal antibody) to obtain an SPC for this product. MedImmune had argued that the ECJ’s requirement, set out in the Medeva judgment, for the active ingredient to be “specified in the wording of the claims” was unclear and required a further reference to the ECJ to determine how much “specification” was required. The court had some sympathy for this argument, even saying that it was “inevitable” that there will have to be further references to the ECJ to obtain clarification of the test. The judgment’s tone is quite strident and backs up the despair of many industry commentators, who have found the ECJ judgment too vague for national courts to draw clear lines around what is and is not allowable.
Despite expressing sympathy in those terms, the court then found that, in any event, the patent did not contain an adequate level of “specification” to cover Lucentis. The court’s principal reason was that there was “nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question”.
MedImmune had argued that the judge should refer the matter in suit to the ECJ for further consideration, but he declined to do so. The first leg of the litigation, in which MedImmune’s patent was found to be invalid and not infringed, is due to be heard by the Court of Appeal later this year, so the High Court felt that the higher court was better placed to order a reference should that become necessary to settle the dispute.
Although no referral was ordered in this case, many commentators have questioned the meaning of “specified in the wording of the claims” and time will tell whether the Court of Appeal or another EU national court (eg, the German court, which will be considering the same facts soon) decides that the ECJ must explain what it meant by its test. The Court of Appeal in the Hague has already opined on the point in the Lundbeck v Tiefenbacher escitalopram case, holding that although escitalopram oxalate was not explicitly recited in the claims, the reference in the claims to non-toxic acid addition salts was adequate “specification” of escitalopram oxalate to support an SPC for this product.
Of further concern to some will be the court’s questioning of the now-standard practice (following Biogen, C-181/95) of patentees applying for SPCs based on unlicensed third-party products. Although this point was not taken up by either party, the judge gave a good indication that he saw this practice as diverging from the original purpose of the regulation, so it may be that in due course, this point will be taken up by someone, probably an innovator pharmaceutical company that does not benefit from this practice.
At 10:30am on the same day, the same judge heard Queensland/CSL and the UK Intellectual Property Office (UKIPO) in the Queensland case, which he himself had referred to the ECJ in late 2010. The ECJ issued its decision in this referral shortly after the Medeva judgment, so this marked the first time that any of the referred cases had been back before a UK judge to apply the ECJ’s logic.
The parties agreed that the effect of the ECJ's decisions was that Queensland/CSL’s four SPC applications for the individual active ingredients in the Gardasil combination vaccine were allowable based on Queensland/CSL’s three basic patents, and so the court granted an order for these applications to proceed to allowance. Interestingly, the UKIPO did not object to the grant of multiple SPC applications on a single patent, despite the controversial “one SPC per patent” objection that some commentators have derived from the ECJ’s judgments. The judgment explicitly refers to the UKIPO’s view that the ECJ was not intending to change the existing law, which is generally understood to mean that there can be one SPC per product per patent. It therefore seems that in the United Kingdom at least, this established practice will continue. It will be interesting to see whether other countries take the same approach: initial comments from the Dutch Patent Office suggest that things may be seen differently elsewhere. Moreover, counsel for the UKIPO suggested that this point will be raised by Medeva when its own referral returns to the UK Court of Appeal later this year.
Of course, SPCs represent an extremely valuable form of intellectual property because they protect marketed medicinal products at the tail end of patent life, when sales volumes are likely to be high. Both these judgments should be welcomed, as they provide some useful guidance on how to apply the ECJ’s decisions, which are typically terse. While newly drafted patent applications can incorporate a selection of wording in the claims to maximise the chances of satisfying this branch of SPC law, it will be some time before these patent applications start to filter through the system. In the meantime, we suspect that many companies will continue to be vexed by this issue, and because of the value of these cases we can expect litigation to follow in this area for a considerable time.
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