EPLAW Patent Blog

NL - Sanofi / Pharmachemie & Teva – Irbetasan & HCTZ

Sanofi S.A. v. Pharmachemie B.V. and Teva Pharma B.V. and Sanofi S.A. v. Teva Nederland B.V., District Court of the Hague, 14 September 2012, Case No's 425814 / KG ZA 12-905 and 426135 / KG ZA 12-928

This judgment follows the earlier provisional ruling of the District Court of the Hague granting Sanofi a provisional injunction against Pharmachemie and Teva to stop the defendants from putting onto the market, reselling, delivering or otherwise trading or offering for any such purpose any high blood pressure medication comprising irbetasan and HCTZ for the entire duration of the preliminary injunction proceedings.

Sanofi holds a combination-SPC for irbesartan, in the form of a salt and/or a hydrate and hydrochlorothiazide (also known as HCTZ), which SPC is in force until 14 October 2013. The SPC is based on EP 0 454 511 for “Dérivés hétérocycliques N-substitués, leur préparation, les compositions pharmaceutiques en contenant” (hereinafter “EP 511”). An earlier SPC for just irbetasan, referred to in these proceedings as the ‘Mono-SPC’ was also based on this patent, but lapsed in August 2012.

Teva argued that the combination SPC is invalid because:

HU - Focus increasing on balance of interests in preliminary injunction decisions

Metropolitan Appeal Court, Budapest, Hungary, 3 May 2012, Case No's 8.Pkf. 25. 635/2012/ 6. and 8.Pkf.25.634/2012/4, reported by Eszter Szakács

Recently a difficult preliminary injunction proceeding comprising several "rounds" has highlighted the complexity of judicial evaluation in pharmaceutical litigation. The decisions of the courts covered many aspects, however, the below report focuses only on issues emerged in connection with the balance of interests.

The case began at the end of 2010 when the patentee, a major pharmaceutical company, has filed preliminary injunction requests against two Hungarian companies. The patent in suit covered a pharmaceutical preparation comprising a combination of known  pharmaceutical active ingredients in a given proportion, one of which is in micronized form.

Read the entire contribution (in English) here.

DE - German Supreme Court "Pallet Container II"

German Supreme Court, 17 July 2012, docket no. X ZR 97/11 - "Palettenbehälter II"

The decision “Pallet Container II” deals with the important distinction between the permissible “repair” of a patented product and the impermissible “renewed-manufacturing” of this product. From a practical point of view, the decision addresses the legal boundaries to aftersales competition regarding “wear-and-tear-parts” and consumables (e.g. coffee pads or ink cartridges). As will be detailed below, in the future the “end customer’s perception and understanding” will play an important role in order to decide whether these boundaries are crossed or not.

Whereas in Germany a “repair” of a patented product is considered as its “intended use” and therefore warranted under the principle of exhaustion, the “renewed-manufacturing” is considered as a further commercial exploitation of the patented invention which is only permissible with the patentee’s consent.

NL - AGA v. Occlutech

Occlutech International AB v. AGA Medical Corporation, District Court The Hague, 12 September 2012, case/docket no. 407582 / HA ZA 11-2682
 
Occlutech seeks a declaratory judgment that its devices do not infringe AGA's patent for septal occluding devices. In short, the patent relates to a 'dumbbell' shaped device made from a tubular braid, in which at least one of the discs is cupped towards the other.
 
According to Occlutech it would be an essential feature of the invention that 'each end [of the device is] contained by means for securing each end'. Because this feature is not present in the granted claims, these would encompass added-subject matter. Since (i) the application would also disclose a device with only one end containing securing means (meaning that the feature would not be essential), (ii) the feature would not relate to the technical problem and (iii) because it can be removed without modification of other features, the court finds that the removal of this feature does not constitute added subject matter. These criteria are derived from the EPO Guidelines for Examination. Further added matter arguments of Occlutech are also rejected, as well as Occlutech's arguments in relation to insufficient disclosure and inventive step.
 
Most arguments of Occlutech in relation to public prior use are rejected because the concerned persons were bound by (implicit) confidentiality obligations or because people could not have derived the relevant features from such prior disclosure. However, Occlutech also offered to hear a physician from Bratislava in relation to the implantation of the devices in three patients in 1995 which would constitute public prior art. This offer is allowed and the court will proceed to hear said physician.
 
Occlutech also claimed that AGA should be ordered to provide documents in relation to the tests with the device before the priority date. The claim is largely rejected because it is not sufficiently specified, except for one invoice which is mentioned in one of the declaration submitted by AGA. AGA is ordered to produce this document.

Read the decision (in Dutch) here.

Head note: Paul van Dongen

UK - Eli Lily v. Human Genome Science

Eli Lilly and Company v. Human Genome Sciences, Court of Appeal, London, UK, 5 September 2012, with thanks to Penny Gilbert, Powell Gilbert, for sending in the case

"This follows on from the Supreme Court's finding that the HGS patent had industrial application, leaving the Court of Appeal to review issues on the law of sufficiency in relation to antibody claims and an issue of extension of protection.  The HGS appeal succeeded, and Lilly's Appeal was dismissed, so that all claims of the HGS patent were held valid."

Read the decision (in English) here.  

[Further head note follows]

NL - Sanofi v. Teva

Sanofi SA v. Pharmachemie B.V. and Teva Pharma B.V. and Sanofi SA v. Teva Nederland B.V., provisional judgment in preliminary injunction proceedings, District Court The Hague, The Netherlands, 3 September 2012, Case No.425814 / KG ZA 12-905 and 426135 / KG ZA 12-928

The Judge in interlocutory proceedings awarded a provisional injunction against Teva for the duration of the preliminary injunction proceedings.

Teva refused to promise to stay off the market for the duration of the preliminary injunction proceedings. The Judge ruled that Sanofi's claims did not appear to be unfounded and that Sanofi had a significant interest in maintaining the status quo (which is no trade in the generic irbesartan and HCTZ) until judgment is rendered.

Read the decision (in Dutch) here.