“A declaration pursuant toCPR 40.20 and/or the inherent jurisdiction of the Court that importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose of, and to keep for such sale or disposal in the United Kingdom, the Claimant’s products containing their biosimilar monoclonal antibody to the antibody adalimumab (Humira) for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every week by subcutaneous injection for: (a) rheumatoid arthritis would have been obvious and/or anticipated at the date from which EP (UK) 1,406,656 was entitled to claim priority whether or not co-administered with methotrexate (as would administration every week in the case of monotherapy in rheumatoid arthritis); and (b) psoriasis and/or psoriatic arthritis would have been obvious at the date from which EP (UK) 1,944,322 was entitled to claim priority (whether as an initial or continuing dosing regimen)”
“17 It is clear that this court could never have granted such declarations. They concern issues of validity which fall exclusively within the jurisdiction of other European courts in accordance with Article 22 (4) of Council Regulation (EC) No 44/2001, as Arrow has now accepted.”
“37 …Arrow seeks to contend that as of July 1997 it was obvious to the skilled person to use sodium alendronate trihydrate in the manufacture of a medicament in the form of a tablet containing about 70mg sodium alendronate trihydrate for oral administration for the treatment of osteoporosis in a human (in need of such treatment) according to a continuous schedule having a once-weekly dosing interval. Particulars are then provided of those matters which formed part of the art and which rendered such use obvious. It further seeks to contend that its product is a product having such characteristics. 38 In short, therefore, Arrow seeks a declaration that its own product was obvious at the priority date of the divisional applications. Such a declaration would give Arrow the security that dealing with its own alendronate product in this country will not give rise to any liability to Merck for infringement of any patent granted pursuant to the divisional applications or any further divisionals arising under them. It says this court has jurisdiction to grant such a declaration and that it is appropriate so to do because Merck has shown every intention of (a) pursuing and (b) relying upon the divisional applications against Arrow inter alia in the UK. There is therefore an issue between the parties and a real commercial need for the clarification sought.”
“I do not say that anyone could apply for declarations of the kind sought by Nokia. There would have to be real commercial reasons for the person seeking the declaration to have standing to do so. An interest in making 3G telephones which must therefore comply with the standard is clearly sufficient.”
“(1) Subject to the following provisions of this section, the validity of a patent may be put in issue— (a) by way of defence, in proceedings for infringement of the patent under section 61 above or proceedings under section 69 above for infringement of rights conferred by the publication of an application; (b) in proceedings under section 70 above; (c) in proceedings in which a declaration in relation to the patent is sought under section 71 above; (d) in proceedings before the court or the comptroller under section 72 above for the revocation of the patent; (e) in proceedings under section 58 above. (2) The validity of a patent may not be put in issue in any other proceedings and, in particular, no proceedings may be instituted (whether under this Act or otherwise) seeking only a declaration as to the validity or invalidity of a patent.”
“55 Arrow seeks a declaration as to its right to make and sell its own product. In my judgment clear words are required to exclude that right and section 74 should be interpreted no more widely than necessary to give effect to its purpose. What then is that purpose? I consider it must be to ensure that patents which are invalid are not merely declared to be invalid but are in fact revoked. But revocation proceedings cannot be commenced until a patent has been granted. Had it been intended that section 74 should exclude the right of a person to seek a declaration in relation to his own product, particularly in circumstances where the need to do so arises from the existence of a published application, then it could have said so in express terms. But it does not and in my judgment it should not be so construed. Section 69 supports this conclusion. It expressly deals with the provisions of the Act that are to take effect inrelation to a published application but contains no reference to section 74(2) or any equivalent prohibition.”
“It [Merck] says this court should not be making declarations in respect of the validity of patent applications because they are subject to examination by the EPO and their claims can change. For the court to start anticipating the examination process would be to usurp the function of the EPO and this is inconsistent with the framework of the EPC and the Act. I agree with all of these submissions. I find it hard to conceive of any circumstances in which it would be appropriate for this court to grant a declaration that no valid patent could be granted on a divisional application which is being prosecuted before the EPO. But that is not what is sought. Arrow only seeks declarations that its own product was obvious at the priority date. The existence of the divisional applications gives rise to the need and justification for seeking declaratory relief. Merck could withdraw the “GB” designations of the divisional applications or acknowledge that it can have no claim under them in this country in respect of a product having the specified characteristics of Arrow's product. If it did so then the commercial purpose of the declarations sought would likely fall away. But it has chosen not to take that course.”
“…in the unusual circumstances of this case I am not satisfied this court has no jurisdiction to grant the declarations sought in respect of Arrow's product. Nor am I satisfied this court would necessarily refuse such declarations in the exercise of its discretion. In my judgment these claims have a reasonable prospect of success and must be allowed to proceed”
“… that the tablets referred to in these proceedings of [various generic drugs companies] consisting of tablets that contain 70mg alendronate as active ingredient, which tablets are intended to be taken once a week for the treatment of osteoporosis, on July 22, 1997 followed from the state of the art in a way that was obvious to persons skilled in the art.”
“5.14 The Court furthermore holds that the statement requested… that the generic 70mg once-weekly dose of alendronate products is obvious, is capable of being allowed on the above grounds. There are more voluntary divisionals of Merck looming. Merck was unwilling to give its undertaking that it would not use those against the 70 mg once-weekly alendronate preparations of the Generics following the possible grant by the EPO. Be that as it may, based on the above the Court can accept the Gillette-type substantiation of the statement demanded by the Generics of obviousness of their 70 mg once-weekly alendronate medication for the treatment of osteoporosis. After all, for the same reasons that EP 904 lacksinventive step, said generic preparations follow in an obvious manner from the state-of-the-art on the oldest priority date… “5.15 That the Generics have an interest in the requested declaratory judgment, after having had to cancel 70mg alendronate once-weekly patents twice, the last time in the form of an unsuccessful Swiss-type use claim, requires little further explanation….”
“There is no statute or common law rule by which one court is bound to abide by the decision of another court of co-ordinate jurisdiction. Where, however, a judge of first instance after consideration has come to a definite decision on a matter arising out of a complicated and difficult enactment, the opinion has been expressed that a second judge of first instance of co-ordinate jurisdiction should follow that decision; and the modern practice is that a judge of first instance will as a matter of judicial comity usually follow the decision of another judge of first instance unless he is convinced that that judgment was wrong. Where there are conflicting decisions of courts of co-ordinate jurisdiction, the later decision is to be preferred if reached after full consideration of earlier decisions.”
“23 A procedure which allows disputes over patent rights to take in excess of a decade cannot meet the needs of industry, particularly in rapidly moving areas of technology. Although such a procedure may technically comply withArticle 6 of the European Convention on Human Rights , which guarantees a trial before an independent tribunal within a reasonable time, the opportunity for successive appeals and remittals means that there is in practice no final determination of the parties' rights for many years. Given their procedures, the Boards have a difficult task in seeking to achieve justice and finality”