Calcipotriol ointment for UK market (Leo pharm V/S Sandoz): Advantage Leo pharm

In a significant decision on Calcipotriol ointment (Leo Pharma v Sandoz), a decision of Justice Mann in the Chancery Division, England and Wales, on 17-3-2008 favored innovator Leo pharm.
Leo held a patent for Calcipotriol Monohydrate (EP0679154), a new crystalline form of Calcipotriol which was used in the treatment of the skin disease psoriaris. The patent claimed that the monohydrate form had technical and stability properties better than those of the existing anhydrate form and claims monohydrate form as product. On April 2007 Sandoz obtained market authorisation for a calcipotriol ointment, launching the product shortly thereafter. On 18 June, it obtained market authorisation for a cream.
Calcipotriol ((1R,3S)-5-[2-[(1R,3aR,7aS)-1-[(2S)-5-cyclopropyl-5-hydroxy-pent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexane-1,3-diol ) or calcipotriene is a synthetic derivative of calcitriol or Vitamin D. It is used in the treatment of psoriasis, marketed under the trade name Dovonex or Daivonex. Available as a cream, ointment or scalp solution (50mcg/mL), Calcipotriol is applied twice daily to plaque psoriasis on the body or scalp, but not the face. Improvement is usually detectable within 2 weeks. Most patients show some improvement, slightly more so than is seen with the use of corticosteroids alone.
Leo procured a sample of the ointment and, on testing it, found that it contained the monohydrate version of the calcipotriol molecule. In August Leo'informed Sandoz that the ointment infringed its patent EP0679154. When Leo requested for the samples, Sandoz refused the request for a sample on confidentiality grounds and challenged the reliability of Leo's testing procedures. Sandoz continued to refuse the request, which was repeated on several occasions, and failed to disabuse Leo of their mistaken belief as to the date of the cream's launch, which actually occurred on 31 October. Following a further request for a sample made in December, Sandoz told Leo that the cream had been on the market for some time, meaning they could obtain a sample from a third party. Having experienced difficulties in getting hold of a sample, Leo repeated the request and later told Sandoz that it would be bringing infringement proceedings. At this point Sandoz made samples available, the testing of which revealed the presence of the monohydrate molecule, which constituted 15% of the crystalline forms detected.At this point Leo applied for an interim injunction to stop Sandoz distributing the cream. Sandoz argued that there was no serious issue of infringement to be tried since, according to Leo's own tests, the presence of monohydrate crystals was so small that, as a matter of common sense, the beneficial effects referred to in the patent were not present. Questions also arose as to whether damages would be an adequate remedy for Leo if Sandoz were allowed to market the cream until trial, and as to the adequacy of any cross-undertaking in damages that Leo (whose own financial position was in doubt) would have to make in favour of Sandoz in the event that interim relief should not have been granted. Judge Mann J allowed Leo's application for interim relief. The judge concluded that It would be dangerous for a judge in an interim application to use common sense to determine what is ultimately likely to be a technical question that might require expert evidence. The balance of convenience and what could be taken to have been the status quo also pointed in favour of granting an injunction. So all parameters pointed towards granting injunction.