Espicom View: Boston Scientific is no longer ranked first in the drug-eluting stent market, so the injunction will provide another blow and could overshadow the recent approval of the Promius Premier stent in the EU. If the company is unable to get the injunction overturned, this will impact its position in the drug-eluting stent market even further, allowing OrbusNeich to gain ground.
OrbusNeich has fulfilled all the requirements established by the Dusseldorf Regional Court, including posting of a performance bond and service to Counsel for the Defendants, and is today enforcing the preliminary injunction issued by the Court on 30th April 2013 against Boston Scientific and its German subsidiary.
The preliminary injunction prohibits the importation, distribution, sales and marketing of certain products by Boston Scientific or any other subsidiary of Boston Scientific in or into Germany. Included in the prohibited products are the Boston Scientific cardiac stents sold under the names of Promus Element, Promus Element Plus, Omega, Taxus Element, Synergy and Promus Premier, each in the Small Vessel, Small Workhorse and Workhorse diameter ranges. Boston Scientific would also breach the injunction if it causes other affiliated companies to sell the products in Germany. The preliminary injunction provides for significant economic penalties for violation of its terms and restrictions.
Boston Scientific has appealed the preliminary injunction. However, until the appeal is decided, which OrbusNeich expects will be in six to nine months, the injunction remains in force. OrbusNeich believes that the injunctive relief is justified and will defend the appeal along with vigorously prosecuting its patent infringement claims in the principal case filed in the Dusseldorf Court. OrbusNeich has stated that it expects the principle patent infringement case to be heard in May 2014.
In February 2013, OrbusNeich received a favourable ruling from the European Patent Office (EPO) in connection with its European Patent EP1 341 482. The '482 patent covers certain novel stents with helical structures. It was issued by the EPO to OrbusNeich in October 2010, and does not expire until December 2021. In July 2011, Boston Scientific and Terumo filed oppositions asking the EPO to revoke the '482 patent, asserting that the patent was invalid. In response, OrbusNeich amended the claim of the '482 patent to more clearly identify the scope of its novel, helical stents. During oral proceedings held on 11th February 2013 in The Hague, the EPO upheld the claim of the '482 patent as amended. Later that month, OrbusNeich submitted patent infrigment claims against Boston Scientific in Germany and the Netherlands, and in March 2013, claims were filed in Ireland.
OrbusNeich's current products include the Genous Stent, as well as other stents and balloons marketed under the names of Azule, R stent, Scoreflex, Sapphire, Sapphire II and Sapphire NC. If Boston Scientific is taken out of the running in the German stent market, it would create a large gap that OrbusNeich could potentially take advantage of. Futhermore, if OrbusNeich manages to uphold this patent in other regions and wins infringement claims, it would open the market opportunity for OrbusNeich even further.
In 2012, sales of Boston Scientific's coronary stent systems, including bare-metal stent systems and drug-eluting stents (DESs), of US$1,363 million, represented approximately 18.8 per cent of the company's consolidated net sales in 2012. The decline of 15.9 per cent was primarily due to competitor product launches and pricing pressures. Bare-metal stent systems saw the largest decline, falling by 22.5 per cent worldwide, to US$86 million. This class of stent saw revenues decrease in the US and International markets. DESs also declined worldwide, falling by 15.4 per cent to US$1,277 million. Boston Scientific has recently had its Promus Premier stent approved in the EU; however, the company may not feel the full benefits of this with the injunction in Germany.