EPLAW Patent Blog

UK - Teva v. LEO Pharma

Teva UK Ltd & Teva Pharmaceutical Industries Ltd v LEO Pharma A/s, England and Wales Court of Appeal (Sir Robin Jacob, Kitchin and King LJJ), London, UK, 28 July 2015, Neutral Citation Number: [2015] EWCA Civ 779

This is an appeal against Birss J’s finding that two LEO patents were invalid for lack of inventive step.  The key claims of the patents were for a combination of the active pharmaceutical ingredients calcipotriol and betamethasone, alongside the non-aqueous solvent Arlamol E.  The patents cover Leo’s Dovobet Ointment product, a dermal treatment for psoriasis.

The Court of Appeal held that Birss J had erred in his application of the law on the assessment of inventive step, thereby allowing the Court of Appeal to revisit the assessment de novo.  It is worth noting that in the absence of an error of principle, the English appellate Courts will be very cautious in differing from the first instance judge’s evaluation of the question of inventive step as it is considered a kind of jury question (see the House of Lords judgment in Biogen v Medeva at paragraph 54).  Sir Robin Jacob (with whom Kitchin and King LJJ agreed) returned to the bench for this appeal and delivered the leading judgment.

UK - Teva v Leo Pharma

Teva UK Ltd and Teva Pharmaceutical Industries Ltd v LEO Pharma A/S and LEO Laboratories Ltd (Third Party), Patents Court, 6 October 2014, [2014] EWHC 3096 (Pat), Birss J

The Patents Court held two Leo Pharma patents concerning a treatment for psoriasis invalid on the ground of obviousness.  The case is of interest not only for the unusual way in which the obviousness attack was structured but also due to the Court’s approach to regulatory considerations when assessing obviousness.

The two patents (EP 1,178,808 and EP 2,455,083) related to an ointment treatment for psoriasis comprising a combination of a corticosteroid and a vitamin D analogue with a particular solvent.  Leo Pharma has a successful product marketed in the UK as Dovobet Ointment, which is protected by both patents.  Its sales are substantial.  Teva wished to sell a generic version of that ointment.  Teva contended that Leo Pharma’s patents were invalid on three grounds: obviousness, insufficiency and added matter.  Leo Pharma applied to amend the claims of both patents and contended that the claims in their amended form were valid. Leo Pharma also contended that Teva’s proposed product would infringe the patents.

NL - LEO v. Sandoz

LEO Pharmaceutical ProductsLtd v. Sandoz B.V., Supreme Court of the Netherlands, The Hague, 3 October 2014, Case No. nr. 13/03763

The Dutch Supreme Court ruled that (contrary to LEO's arguments) in the problem solution approach, it is irrelevant whether the avergare man skilled in the art acknowledged the 'problem'. Decisive is whether having regard to the state of the art, the invention is not obvious to a person skilled in the art (Art. 6 DPA).

Read the entire decision (in Dutch) here.

UK - LEO Pharma v. Sandoz Limited / Appeal

LEO Pharma A/S and LEO Laboratories Limited v. Sandoz Limited, invalidity proceedings, High Court of Justice, Court of Appeal (Civil Division), UK, 17 November 2009, Docket No. No: A3/2009/131, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

Unusual obviousness attack (that is, where the skilled person would have come upon the invention without any expectation of successfully finding a better product) should be scrutinised with great care.

Referring to Biogen the Court of Appeal states about obviousness that "the Judge’s conclusion must be reached as an overall assessment of the relevant evidence, both technical and non-technical. If he has made such an assessment, weighing all the factors involved, then it will be difficult indeed to show that he has made an error of principle."

LEO Pharma's patent was upheld.

Read the judgment (in English) here.

Read the judgment in first instance (in English) here.

Read an extended summary here (provided by Marc Döring and Rowan Freeland who represented LEO Pharma).

UK - LEO Pharma v. Sandoz Limited / First instance

LEO Pharma A/S and LEO Laboratories Limited v. Sandoz Limited, invalidity proceedings, High Court of Justice, Chancery Division, Patents Court, UK, 15 May 2009, Docket No. HC08C00391, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

Sandoz unsuccessfully challenges Leo's patent on the basis that the claimed invasion is anticipated by and/or it is obvious in light of an earlier LEO patent application. None of the claims of the patent (for a new crystalline form of calcipotriol, calcipotriol monohydrate, used in the treatment of psoriasis) was found to be invalid. The infringement claim had been admitted by the defendant on the eve of trial and the counterclaim for revocation was dismissed.

Read the judgment (in English) here.

Read an extended summary of the case here (provided by Marc Döring and Rowan Freeland who represented LEO Pharma). 

Read the judgment on appeal (in English) here.