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Friday 10 February 2012

MedImmune and Queensland: UK court wrestles with the meaning of Medeva and related referrals

The SPC Blog is delighted to have received this morning a three-headed note from Hugh Goodfellow, Daniel Wise and Edward Oates (Carpmaels & Ransford), who thought we might be interested in the local events which transpired in the Patents Court for England and Wales this morning, when that court had to grapple with some recent rulings from the Court of Justice of the European Union (CJEU). They write:
"The Patents Court had a busy morning applying the CJEU’s recent decisions in Medeva (C‑322/10) and the related Georgetown (C-422/10), Queensland (C-630/10), Yeda (C‑518/10) and Daiichi (C-6/11) referrals to real world SPC cases.  We now therefore have the UK judiciary’s first guidance as to how the CJEU’s rulings should be interpreted.

At 10 am, Mr Justice Arnold handed down a decision in the second leg of the MedImmune v Novartis Lucentis litigation [the ruling, in [2012] EWHC 181 (Pat), can be read in full here].  A key issue was whether MedImmune’s patent to 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 CJEU’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 CJEU to determine how much “specification” was required.  The Court had some sympathy for this argument:

53. In my view, counsel for MedImmune is also correct to say that the test laid down by the Court of Justice in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases. In particular, it is unclear precisely what is meant by “specified (or identified) in the wording of the claims”. Does this mean that it is sufficient for the product to fall within the scope of the claim on its true construction, or is something more required and if so what? For example, is it sufficient, say, for the claim to incorporate a Markush formula which covers a large number of compounds one of which is the product in respect of which an SPC is sought? Is it sufficient for the product to be defined in functional terms? Even in combination cases, it is not clear to me how the test enunciated by the Court should be applied in a case like Gilead. Regrettably, therefore, it is inevitable that there will have to be further references to the CJEU to obtain clarification of the test.

Despite this sympathy, the Court found that the patent did not contain an adequate level of “specification”.  Among other reasons, the Court said:

57. […] In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is 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 Arnold J should refer the matter in suit to the CJEU 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 already due to be heard by the Court of Appeal for England and Wales 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 indeed another EU national court (e.g. the German court which will be considering the same facts soon) -- decides that the CJEU needs to explain what it meant by its test.  The Court of Appeal in the Hague has already opined on the point in Lundbeck v Tiefenbacher (escitalopram), 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 practice of applying for SPCs based on unlicensed third party products.  Although this point was not taken up by the parties, it seems that SPCs based on third party marketing authorisations might now, in certain cases, be challenged by alleged infringers:

61.          As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay.

At 1030 am, the same judge heard Queensland v CSL and UK Intellectual Property Office, which he had himself referred to the CJEU in late 2010.  The CJEU issued its decision in this referral shortly after Medeva, and today marked the first time that any of the referred cases had been back before a British judge to apply the CJEU’s logic.  The parties agreed that the effect of the CJEU’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.  Granting an order for these applications to proceed to allowance, neither the Court nor the IPO raised the controversial “one SPC per patent” objection that some commentators have derived from the CJEU’s judgments.  It seems that in the UK, at least, the established practice that more than one SPC is allowable per patent provided that each SPC is directed towards a different active ingredient remains alive and well.  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 IPO suggested that this point will be raised by Medeva when its own referral gets back to the UK Court of Appeal later this year".
Disclosure of interest: Carpmaels & Ransford acts for Queensland/CSL in their SPC applications across the EU and is also leading the Neurim SPC referral at the CJEU, which raises further fundamental questions of SPC law.


Anonymous said...

I'm wondering: According to the German Patent Regaister, there is no pending nullity action regarding the ranibizumab basic patent/SPC in Germany, so there should be no "considering of the same facts" by a German court. Can you help me which case could be meant?

Anonymous said...

The Patent in suit is European Patent (UK) No. 2 055 777. You might like to look at the German equivalent of that.