What can a business do if it wants to launch a product on the market but a competitor with patent application rights keeps evergreening those patent applications by abandoning and filing divisionals? In this way, it can be that some patent applications are never fully tested, but nevertheless can create uncertainty for competitors considering launching a new product. Such uncertainty can exist in any sector, but it tends to happen most frequently in the pharmaceutical field.
The British courts have long provided assistance to a would-be market entrant in such circumstances in the form of a so-called Arrow Declaration which takes its name from the case
"An Arrow declaration is a declaration that a product, process or use was lacking in novelty or obvious as at the priority date of a patent application. The point of such declaration is that it is in effect a declaration that the claimant will have a Gillette defence to any subsequent claim for patent infringement in relation to that product, process or use: see Gillette Safety Razor Co v
In the recent Teva v Novartis case the
- Novartis marketed a drug under the trade mark Gilenya for the treatment of relapsing-remitting multiple sclerosis. The market for Gilenya is valuable -
$2.8 billion worldwide, with annual sales in theU.K. alone of Ł46 million. -
Patent and regulatory protection for Gilenya finally expired on
22 March 2022 . - As is not uncommon in order to extend their exclusivity in Gilenya, Novartis had made patent applications for formulations of, and dosage regimes, including:
-
A European patent application EP 2 037 906 - filed
June 2007 - amendedMarch 2009 - withdrawnApril 2015 -
A first divisional EP 2 698 154 - filed
September 2013 - deemed withdrawnMay 2016 -
A second divisional EP 2 959 894 ("EP 894") - filed
July 2015 - grantedOctober 2022 - opposed by Teva and nine others. (Final determination of the opposition proceedings is not expected for many years.) -
A third divisional application EP 3 797 765 - filed
November 2020 February 2022 - Teva obtained marketing authorisation for its generic product and commenced an application for an Arrow Declaration so that it could launch on theU.K. market with certainty.March 2022 - Novartis commences a cross-claim for infringement under EP 894 and seeks an interim injunction. (At this time EP 894 had not formally been granted, but in view of the decision of the TechnicalBoard of Appeal at the EPO it was certain that it would be granted.)April 2022 - Novartis' application for an interim injunction was refused, but an injunction was ordered preventing the sale of the generic until determination of Novartis' application for permission to appeal.May 2022 - Novartis' application for permission to appeal was refused.August 2022 - Novartis stated that they were removing theU.K. designation from EP 894 (and EP 3 797 765) and applied to discontinue their infringement claim.September 2022 - Novartis applies to strike out Teva's claim for an Arrow Declaration. Meade J orders that the trial on Teva's claim for an Arrow declaration is confined to the issue of whether, as a matter of discretion, a declaration should be granted in circumstances where Novartis no longer have any relevant patent protection in theU.K. October 2022 - In theHigh Court Bacon J refused the application for an Arrow Declaration. Separately Novartis commences infringement claims and seeks interim injunctions in a number of European states including most importantlyGermany .December 2022 - The Court of Appeal upholds Bacon J's decision.
The judge noted that Novartis had declined to provide any explanation for dedesignating the
- Novartis' aggressive enforcement of EP 894, including the fact that it had obtained injunctive relief.
-
A declaration would provide clarity to Teva's customer in the
U.K. , theNHS . -
The inadequacy of Novartis' undertakings in dispelling the uncertainty on the
U.K. market. -
The potential utility of a
U.K. judgment to a decision inGermany on whether to grant a preliminary injunction against Teva. (Due to the bifurcated patent litigation system inGermany , a party often faces an injunction after an infringement trial for a year or so pending a decision on validity in a different court - the so-called "injunction gap". A decision from a respected Court on the same EP patent can be persuasive in deterring the German Court from granting an injunction in the injunction gap period.) -
Teva's supplies to the
U.K. transited through Country A (which country is confidential and not recorded in the Judgment), such that an injunction against Teva in that country would threaten that supply chain to theU.K. Accordingly, if a declaration of the English Court was influential on the Court in Country A the English Court should make the declaration in order to mitigate the risk of disruption to theU.K. market.
Teva accepted that the first of these five points was not a stand-alone reason for granting a declaration. The second and third reasons were held to lack merit.
As to the fourth point, Bacon J accepted that a German Court would undoubtedly take account of a declaration from the English Court and would give it such weight as considered appropriate, but went on to state:
"... the fundamental problem with this aspect of Teva's case is that the case-law ... consistently establishes that if the only or predominant purpose of the declaration sought is to use the judgment for a foreign court, this court will look carefully at the justification for the declaration. In such a case, a declaration is only likely to be granted in unusual cases where [there is] a very compelling justification for doing so."
And as to the fifth point, Bacon J concluded it was inevitable in a world of global supply chains that an injunction in one territory could be disruptive of the supply chain to the
The Court of Appeal agreed with Bacon J and her decisions, save for concluding that Bacon J fell into error in one respect, and in doing so was too favourable to Teva. Arnold LJ (who gave the leading Judgment) felt that once Bacon J had:
"... found that a declaration was not required in order to redress uncertainty in the
Accordingly, the
This case is perhaps to be contrasted with the decision last year in Advanced Bionics and another v
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Mr
One Financial Center Boston
MA 02111
© Mondaq Ltd, 2022 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source