EPLAW Patent Blog

UK - Hospira and Generics v Novartis

Hospira UK Limited and Generics (U.K.) Limited trading as Mylan v Novartis AG, UK Patents Court, 15 March 2013, [2013] EWHC 516 (Pat)

Hospira and Mylan commenced proceedings for revocation of European Patents (UK) Nos. 1296689 and 1591122.  Both concerned the administration of bisphosphonates, in particular, zoledronic acid or a salt – zoledronate – at intervals of at least six months for the treatment of osteoporosis.

It was accepted by Novartis that, if the patents were not entitled to one of their priority claims, then both patents would be invalid due to an intervening publication (Reid et al, “A single annual injection of the bisphosphonate …, Bone 28(5), S89 (2001)).  The judge (Arnold J) conducted a thorough analysis of the relevant priority document and concluded that none of the patent claims was entitled to the claimed priority.  For example, although the priority document disclosed a unit dose form of 1-10 mg, this was not linked to the other features of the claims.

Furthermore, several of the patent claims were also held to be invalid for insufficiency.  The claims in issue required the skilled team to carry out a substantial program of clinical trials to find out what doses and dosing intervals were efficacious – they were not enabled across their breadth and were therefore insufficient.

Read the decision (in English) here.

Head note: Graham Burnett-Hall

UK - Glenmark v. GSK (Malarone)

Glenmark Generics (Europe) Limited, Generics (UK) Limited (t/a Mylan) v. The Wellcome Foundation Limited, Glaxo Group Limited, High Court of Justice, Chancery Division, Patents Court, London, UK, 7 February 2013, [2013] EWHC 148 (Pat)

The Patents Court held that GSK’s patent for an anti-malarial drug was invalid.

Glenmark and Mylan applied to revoke GSK’s patent EP (UK) 0 670 719 relating to an anti-malarial pharmaceutical composition comprising a combination of atovaquone and proguanil in the ratio 5:2. The composition is sold by GSK under the trade mark Malarone and it is the most successful anti-malarial prophylactic in the UK. Glenmark and Mylan each planned to sell generic versions of Malarone and there was no dispute that the generic versions fell within the scope of the patent.

Glenmark and Mylan argued that the patent was invalid for obviousness in light of two items of prior art. One was a presentation and the other was an abstract relating to a lecture. The only difference between claim 1 of the patent and the presentation was that the presentation did not disclose the 5:2 ratio for atovaquone and proguanil. Mr Justice Arnold held that it would have been obvious to perform a larger version of the trial described in the presentation and that this would have led to the identification of the appropriate ratio. Mr Justice Arnold also held that the patent was obvious in view of the abstract which stated that a combination of atovaquone and proguanil had produced a cure rate of 100% for treating malaria and noted that the skilled team would have faced no technical obstacle in replicating the work reported in the abstract.

Read the judgment (in English) here.

Head note: Rob Fitt

UK - Novartis AG v Generics (UK) Limited (trading as Mylan)

Novartis AG v Generics (UK) Limited, Court of Appeal (Civil Division), London, UK, 12 December 2012Case No. A3/2011/2970

In this decision, the UK Court of Appeal confirmed that obviousness must be assessed by reference to the invention as described and claimed by a patentee.  In order to undertake that assessment, all the circumstances including, where appropriate, whether it was obvious to try a particular route with a reasonable or fair expectation of success, must be taken into account.  What is a reasonable or fair expectation of success will again depend upon all the circumstances, and is fact dependent.

Sometimes, it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. However, simply including something in a research project in the hope that something might turn up is unlikely to be enough.  The Court rejected that a finding of obviousness can only be made where it is manifest that a test ought to work.  Such a straightjacket upon the assessment of obviousness is not warranted by the statutory test and would, for example, preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable.

UK - Mylan v. Yeda

Generics [UK] Limited (trading as Mylan) v Yeda Research and Development Co. Ltd & Anor [2012] EWHC 1848 (Pat), 11 July 2012, Patents Court, Arnold J.

In this action the Claimant (“Mylan”) sought revocation of European Patent (UK) No. 0 762 888 (“the Patent”) and a declaration of non-infringement.  The First Defendant (“Yeda”) and the Second Defendant (“Teva”) were respectively the proprietor of, and the exclusive licensee under, the Patent. The Patent relates to a material known as copolymer-1, a polymer composed of amino acids alanine, glutamic acid, lysine and tyrosine in a particular ratio. The claims protect Copolymer 1 in a specified molecular weight range, and use of this for the treatment of multiple sclerosis (“MS”). Teva sells a product which it claims is protected by the Patent under the trade mark Copaxone (non-proprietary name glatiramer acetate) for the treatment of relapsing-remitting MS.

The action raised a large number of issues: whether the claims are entitled to the first claimed priority date; whether the Patent is invalid for obviousness over the prior art; whether the Patent is invalid for obviousness as making no technical contribution, but rather being an arbitrary selection from known copolymer-1 material; whether the Patent is invalid for insufficiency because the claims are ambiguous; whether the Patent is invalid for insufficiency on classical grounds; whether the Patent is invalid for insufficiency because it makes no technical contribution; whether the Patent is invalid for added matter; and whether the sale of Mylan’s glatiramer acetate product would infringe any of the claims of the Patent.

In respect of these issues it was held: none of claims 2-3 and 5-12 is entitled to priority from the Priority Document; none of the claimed inventions is obvious in the light of the prior art, Teitelbaum 1971, Bornstein 1987 or Johnson 1994; the product claims are not obvious as being an arbitrary selection; the Patent is not insufficient in any of the ways alleged; none of the claims is invalid for added matter; and; the proposed glatiramer acetate product would infringe the Patent.

FR - Novartis v. Mylan and Qualimed

Court of appeal of Paris, 21 March 2012, Novartis v. Mylan and Qualimed: imminent infringement and  “clear the way”

The preliminary injunction granted by the court of appeal of Paris on 2 March 2012 in Novartis v. Mylan and Qualimed is interesting in two aspects:
1. it provides new guidance on the conditions for the infringement to be considered as imminent;
2. when assessing the likelihood of success of the invalidity grounds asserted by the defendants, it states that they could have cleared the way by bringing a nullity action before launching their products. To reach such result, not only the court of appeal reversed the first instance decision; it also took the opposite view of the English courts which decided that the corresponding patent/SPC was invalid.

BE - Supreme court upholds traditional Belgian prima facie validity test in PI proceedings

Novartis v. Mylan, Supreme Court (“Hof van Cassatie/Court de Cassation”), Belgium, 5 January 2012, Docket number C.11.0101.N,

The Belgian Supreme Court has confirmed an earlier decision of the Brussels court of appeal whereby Novartis saw its claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin granted. In doing so, the Supreme Court upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. This prima facie validity is not affected by a decision of the Opposition Division of the EPO against which an appeal has been lodged before the EPO Technical Board of Appeal, even if the patent concerned was revoked in its entirety by the Opposition Division. According to the Court, this directly ensues from the suspensive effect of such an appeal pursuant to Article 106(1) EPC.

Read the judgment (in Dutch) here.

Head note: Philippe de Jong

BE - Novartis v. Mylan / Fluvastatin

Novartis v. Mylan, Brussels court of appeal, Belgium, 26 October 2010, Docket number A.R. 2010/KR/175, with thanks to Philippe de Jong, Altius, for sending in the case and translation

The Brussels court of appeal has reversed a decision from the Brussels commercial court which had rejected Novartis’ claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin. In doing so, the Brussels court of appeal upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. According to the court, upon a proprer application of Article 106(1) EPC, it is irrelevant that the EPO Opposition Division revoked the patent, even in its entirety, since the appeal against that decision before the EPO Technical Board of Appeal has suspensive effect.

Read the decision (in Dutch) here.

Read the decision (in English) here.

Head note: Philippe de Jong


FR - Du Pont v. Mylan, Losartan SPC (first instance)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (first instance), Pres. Paris District Court, France, Docket No. 10/51453, 12 February 2010

*Now including the English translation*

According to the President of the Paris District Court, the basic patent for Losartan covers any product comprising Losartan, including a product comprising Losartan and another product such as a diuretic, like HCTZ.

Since pursuant to Article 5 of the SPC-Regulation, an SPC confers the same rights as the basic patent and since pursuant to the Article 4 of the SPC-Regulation the SPC protects any subsequently authorised use of the product as a medicinal product, the combination product Losartan+HCTZ falls under the scope of protection for the losartan-SPC. The fact that the paediatric extension was only granted for the Losartan SPC and not for SPC for the combination product, was not held to be relevant.  According to the court, the extended protection of the basic patent and the subsequent SPC, could only lead to the conclusion that any medicament containing Losartan as an active ingredient amounted to an infringement.

As to the prima facie validity of the SPC-extension, the court held, inter alia, that the relevant provisions of the SPC-Regulation and Regulation 1901/2006 do not specify that the MAs need to have been obtained at the time of the filing of the application. The paediatric MAs must have been applied for on the day of the filing of the application, but can be communicated whilst the application is under examination.

Read the decision (in French) here.

Read the decision (in English) here. Translation provided by Pierre Véron, Véron & Associés

ES - Eisai & Pfizer v. Mylan / Donepezil / Interim Injunction

Eisai Co. Ltd. & Pfizer S.A. v. Mylan Pharmaceuticals S.L., Commercial Court No. 5 of Barcelona, Spain, 29 December 2009, Docket No. 581/2009

Commercial Court No. 5 of Barcelona has confirmed its previous decision of 29 July 2009 pursuant to which it granted interim injunction inaudita parte against Mylan Pharmaceuticals (Mylan), which had been ordered to temporarily refrain from commercializing in Spain generic drugs with the active compound donepezil for the treatment of mild to moderate dementia caused by Alzheimer's disease.

BE – Du Pont et al. v. Mylan / Losartan SPC (Appeal)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (appeal), Brussels Court of Appeal, 23 February 2010, Case No. A.R. nr. 2010/KR/53

According to the Brussels Court of Appeal, the scope of protection of the SPC for the active ingredient Losartan does not, at first sight (“prima facie”), extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients Losartan and HCTZ) under Article 4 of the SPC-Regulation.  The main reason raised by the court is that, since the combination of Losartan and HCTZ was itself protected by an SPC, a medicinal product containing that combination could not infringe the SPC for Losartan alone.  According to the court, this would appear to run counter with Articles 3(c) and (d) of the SPC-Regulation.

Read the decision (in Dutch) here.
Read the decision (in English) here.