A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Tuesday, 22 February 2011

AstraZeneca v Commission: a reminder

Writing yesterday for the Law Times ("EU court fires warning on antitrust behaviour"), Julius Melnitzer talks about the "clear and perhaps startling message" of the General Court law summer in Case T-321/05 AstraZeneca v Commission (noted by The SPC Blog here) that even acting within the law was no guarantee that one is safe from allegations of abuse of a dominant position. Regarding SPCs, Melnitzer had this to say:

"... European rules also allowed patent holders to apply for a supplementary protection certificate extending the validity of their patents for five years. The term is limited to the lesser of five years from patent expiration and 15 years from the first European marketing authorization.

In its application for Losec, AstraZeneca claimed March 1988 as the first marketing authorization date, but the commission proved that France had issued an authorization in 1987.

“This resulted in [AstraZeneca] gaining an additional period of protection for Losec in some countries and excluded the possibility of generic competition for a period of several months longer than was justified under the [supplementary] system,” ...
Following complaints from two generic manufacturers in 1999, the commission began investigating AstraZeneca’s patent management strategies between 1993 and 2000. In 2005, it decided that both the deregistration of the marketing authorizations and the misrepresentation of the first authorization date constituted abuse of dominance and imposed fines totalling 60 million euros. ...

... [T]he mere fact that AstraZeneca applied for the supplementary certificates didn’t make its conduct abusive. But misleading regulators regarding the date of the “first marketing authorization” took the company’s conduct outside the realm of legitimate competition on the merits.

“The submission to the public authorities of misleading information liable to lead them into error and therefore to make possible the grant of an exclusive right to which an undertaking is not entitled, or to which it is entitled for a shorter period, constitutes a practice falling outside the scope of competition on the merits which may be particularly restrictive of competition,” the court stated.

... [T]he misrepresentation nor the withdrawal of the marketing authorizations, then, was in keeping with “the special responsibility of dominant companies not to impair, by methods falling outside the scope of competition on the merits, genuine undistorted competition.”

While the case arises in the context of the pharmaceutical market, it could well affect conduct in other regulated industries, particularly those in which innovation and patents are significant competitive factors. ...

AstraZeneca has appealed the matter to the European Court of Justice".
No date for hearing the appeal appears yet to have been fixed but, given the extreme length of the General Court's judgment (920 paragraphs), the complexity of the issues and the value of the outcome to the various sectors of the pharma industry, both the parties concerned and the Court of Justice will need a good deal of time to think.

Tuesday, 15 February 2011

Novartis v Actavis: preliminary injunction for Valsartan confirmed

The SPC Blog is grateful to David Por (Allen & Overy, Paris) for submitting the following note:
"Novartis v Actavis: French Court renders a preliminary injunction confirming the scope and effects of an SPC (Valsartan)

After the preliminary injunction rendered on 12 February 2010 enjoining Mylan and Qualimed from marketing a generic drug comprising Losartan and HCTZ on the basis of Du Pont's SPC granted for Losartan, the President of the Paris First Instance Court confirmed on 28 January 2011 that an SPC covering a compound (Valsartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Valsartan alone or in combination with another active ingredient.

The French Judge carried out a combined reading of Article 4 (subject-matter) and Article 5 (effects) in light of the definitions given in Article 1 of the SPC Regulation: 

“Within the limits of the protection conferred by the basic patent (EP No. 0 443 983), the protection conferred by an SPC (SPC No. 97C0050) shall extend only to the active ingredient that is to say valsartan covered by the corresponding MA, for any use of the product as a medicinal product that has been authorised before the expiry of the certificate”,

and added that

"while Article 4 of the Regulation provides some limits to the effects of an SPC, once these are defined, the SPC grants the same rights as those conferred by the basic patent".

Having held that SPC No. 97C0050 has for its subject-matter the sole active ingredient valsartan, the Judge ruled as follows:

"[O]nce this SPC No. 97C0050 is defined, the rights conferred to Novartis are the same as the rights conferred by the basic patent, such that Novartis can oppose to any use of this active ingredient for the treatment of hypertension, alone or in combination with another active ingredient.

Any marketing of a medicinal product containing valsartan as an active ingredient therefore obviously constitutes an infringement, since it infringes the rights that the claimants hold on this active ingredient until 13 November 2011.

The obviousness of the infringement that would result from the arrival of the pharmaceutical products “valsartan hydrochlorothiazide Actavis 80mg/12.5mg” and “valsartan hydrochlorothiazide Actavis 160mg/25mg” before 13 November 2011 is therefore demonstrated".

This decision can be appealed".
You can read the French decision here and the English translation here.

Monday, 14 February 2011

Antwerp court stops infringement of valsartan/HCTZ SPC based on patent claiming valsartan alone

From Philippe de Jong (Altius, Brussels) comes details of a fascinating recent decision from the Antwerp Court of Appeal in a case concerning SPCs for combination products. The case is Novartis v Teva, case 2010/RK/456, decided on 9 February 2011. Explains Philippe:
"The Antwerp Court of Appeal ordered Teva not to launch prematurely a generic version of Novartis’ blockbuster drug Co-Diovan. The product which Teva intended to launch on 12 February 2011 – the expiry date of Novartis’ basic patent for valsartan (EP 443 983 B1) – contained, like Co-Diovan, valsartan and hydrochlorothiazide or ‘HCTZ’ as its active ingredients. However, this combination of valsartan and HCTZ is protected until 25 September 2012 by a Belgian SPC. 
Teva launched a nullity action against this SPC before the Antwerp Commercial Court and also contested its prima facie validity in the summary proceedings which Novartis subsequently brought against Teva. 
The main argument raised by Teva in support of its nullity allegations was that the product valsartan+HCTZ was not protected by the basic patent within the meaning of Article 3(a) of SPC Regulation 469/2009 because the combination of valsartan and HCTZ was not specifically disclosed in the claims of the basic patent. Novartis argued that a product is protected by a patent if it infringes that patent. In view of the absolute protection for valsartan under the basic patent, any medicinal product containing valsartan, whether alone or in combination with other active ingredients, would infringe and thus be “protected by” the basic patent. 
The Court of Appeal followed Novartis’ reasoning, referring to the application of the “infringement test” in a number of European countries. The fact that in other countries a different test was applied could not affect the prima facie validity of the SPC. Particularly in view of the various pending references to the ECJ from the English courts about the correctness of this different test, the Court of Appeal concluded that the final word on which test to apply should be left for the full trial before the Antwerp Commercial Court, which will take place in April 2011. The preliminary injunction was therefore granted until a decision in the case on the merits is issued or until 31 May 2011, whichever is earlier".
Philippe has kindly provided both the Flemish original and an English translation.

Friday, 11 February 2011

Extending Patents to Medical Devices - an article

There isn't so much out there when it comes to an overview on SPCs and medical devices. However, the February 2011 issue of Intellectual Property and Technology Law Journal does contain an article by Sinan Uktu (Covington & Burling LLP) on that topic entitled "Extending Patents to Medical Devices in Europe".

A copy of the article can be obtained here.

Thursday, 10 February 2011

Synaptech: here comes the Hearing

Mark your diaries! Next Thursday, 17 February, is a big day for SPCs in the European Union. That's the day that the Court of Justice of the European Union is hearing Case C-427/09, Generics (UK) Ltd v Synaptech Inc, a reference for a preliminary ruling from Court of Appeal, England and Wales, on 28 October 2009.  The reference was made just days before Generics (UK) Ltd rebranded as Mylan.

The questions that the Court has been asked to give its ruling on are these:
"For the purposes of Article 13(1) of Council Regulation 1768/92 [concerning the creation of a supplementary protection certificate for medicinal products OJ L 182, p. 1], is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65 [on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products OJ 22, p. 369] (now replaced with Directive 2001/83 [on the Community code relating to medicinal products for human use OJ L 311, p. 67]) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

If, for the purposes of Article 13(1) of Council Regulation 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65 (now replaced with Directive 2001/83), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65) and that was never amended to comply with Directive 65/65 and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"
This blog notes that it has taken 18 months to get from the reference to the Hearing. In better times, by 18 months we might have expected to be well beyond that, taking delivery of the Advocate General's Opinion.

Thursday, 3 February 2011

"Patent box" tax incentives and SPCs in the UK

I've been reviewing the UK government's proposed "patent box" tax incentive this week (click here) with my tax colleagues and have found no mention of SPCs at all.

I am sure UK pharma and biotech have not overlooked the issue and would imagine that responses to the proposal, due this month, will pick this point up, but I am curious to know how SPCs are treated in other jurisdictions with patent box tax incentives...Belgium and the Netherlands to name two. All information gratefully received!

Tuesday, 1 February 2011

More on that Dutch Advair litigation

Further to The SPC Blog's post earlier today on GSK's loss of its Advair patent and SPC (here), thanks are owed to Peter Burgers (Brinkhof) for providing us with a full 21-page translation of the decision. You can read it here.

Peter has also drawn our attention to a note on this decision that was posted on the Kluwer Patent Blog here last Wednesday by his colleague Rik Lambers.

GSK reverse on Dutch Advair patent and SPC

Reuters reported last week ("GSK says considering appeal to a higher court") that GlaxoSmithKline lost a Dutch patent action last Wednesday which concerned its top-selling lung drug Advair, in what the report describes as "the latest in a series of legal battles across Europe over the inhaled medicine".  Advair, known as Seretide in most of Europe, attracted sales of £5 billion ($7.9 billion) last year, giving GSK 18 percent of group revenue.

GSK said in a statement that a court in The Hague had ruled in favour of joint claimants Novartis units Sandoz BV and Hexal AG, ruling that the Dutch part of the European patent for Advair, as well as its supplementary protection certificate, were invalid.  It is understood that the company is considering an appeal which, given the value of the product in the market, is understandable.  GSK has however previously suffered patent defeats on Advair in Britain, Ireland and Germany.

If any reader has more specific details of the court's decision, we'd love to hear about it.