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

Friday 21 May 2010

Infringement of SPCs by combination products

Philippe de Jong from Altius in Brussels has directed us to a couple of articles written for the EPLAW patent blog (http://www.eplawpatentblog.com/) relating to SPCs and combination products.
The articles are entitled:

Philippe also provides three recent decisions concerning losartan and SPCs, two of which are Belgian decisions (and for which he has provided English translations), and the third from the French courts. We'll put them onto the SPC resources page too.

English summaries of the 3 decisions are as follows:

Brussels court of appeal, 23 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (appeal) (English translation here)

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.

Pres. Brussels commercial court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance) (English translation here)

According to the President of the Brussels commercial court, the scope of protection of the SPC for the active ingredient losartan, whose duration had been extended pursuant to Article 36 of the Paediatric Regulation 1901/2006, 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). The main reason raised by the court is that, since the paediatric extension was applied for and granted only for the losartan-SPC and not for the separately obtained "losartan + HCTZ"-SPC, the combination product Cozaar Plus® could not benefit from the paediatric extension of the losartan-SPC. Consequently, generic versions of Cozaar Plus® could not fall under the scope of protection of the losartan-SPC either.

Pres. Paris district court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance)

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.

Friday 14 May 2010

More questions to the Court of Justice

A few months ago, we reported on Medeva's appeal against the UK IPO's decision to refuse an SPC application here

The SPC blog has found out that the Court of Appeal for England and Wales will be referring questions to the ECJ on the meaning of Article 3a and 3b of the SPC regulation, in the context of combination products. We haven't seen the questions, yet, but when we do you'll be the first to know.

Thursday 13 May 2010

More on active implantable medical devices..

Thanks to Alice de Pastors for more information on the fate of SPC applications on Yttrium-90 Glass Microsperes (see our post on 15th April here).

Alice tells us that the Dutch SPC 300226 was granted but then lapsed for non payment of annual fees. In other EU countries there were refusals in Belgium, Denmark, Italy, Sweden, and surrender in France.

Tuesday 11 May 2010

US Court of Appeals Decides Enantiomer Patent Term Extension Case

We don't usually report on US issues, but Jeffrey S. Boone, Vice President, Intellectual Property, for Covidien (Hazelwood, Missouri, US) has kindly sent us this update on patent term extensions in the US.

"In the United States, the Court of Appeals for the Federal Circuit (CAFC) today (2010 May 10) issued its decision in the case of Ortho-McNeil Pharmaceutical, Inc. v Lupin Pharmaceutical, Inc. The court decided that the previous approval of a racemic mixture does not prevent a patent term extension for a single isomer of the racemic mixture.

US 4,382,892 claims ofloxacin, an antibiotic which is a racemic mixture of equal amounts of two stereoisomers (enantiomers). The patent was granted in 1983 and the US FDA approved the commercial marketing of ofloxacin (FLOXIN®) in 1990. In 1991 a subsequent patent, US 5,053,407, was granted for levofloxacin, one of the enantiomers in ofloxacin. In 1996 the FDA granted marketing approval for levofloxacin, which has been sold under the proprietary name LEVAQUIN®.

The plaintiff submitted an application for a Hatch-Waxman patent term extension for the ‘407 patent, which claims the single enantiomer. With full knowledge that the racemic mixture had been previously granted marketing approval, the FDA decided that the marketing approval of levofloxacin (the single enantiomer), was the “first” permitted commercial marketing or use of the “product”, as defined under 35 USC 156(f)(1). Thus, the FDA decision, which was consistent with several similar prior cases, was essentially that the racemic mixture and the single enantiomer were not the same “product”, as defined by the statute.

In litigation that resulted from the defendant’s filing of an ANDA (an application for a generic version of LEVAQUIN), the defendant, Lupin, argued that an enantiomer is half of its racemate, and thus the enantiomer was a component of the previously approved drug. However, the district court declared on 2009 April 30 that the patent term extension was valid.

Now, the court of appeals has affirmed the district court. The court quoted one of the witnesses who stated “in each and every instance in which it has considered the question, the FDA has described a racemate as a single active ingredient, distinct from its enantiomers, and each enantiomer as a single active ingredient distinct from the other and from the racemate”."

You can read the case here.

Friday 7 May 2010

High Court upholds IPO's decision on Circadin

In December 2009, we reported that the Intellectual Property Office refused an SPC application for Circadin on the grounds that the application did not comply with Article 3(d) of the SPC Regulation.

The High Court has upheld the IPO's decision. Following a review of the provisions of Regulation 469/2009 and case law of the Court of Justice (Pharmacia, MIT and Yissum), Arnold J. held that "Yissum is fatal to Neurim's case on this appeal". He also considered that the interpretation of Article 3(d) is acte claire.

You can read the decision here.