In nullity proceedings initiated by Accord Healthcare (“Accord”) the District Court of The Hague has held Shire-NPS Pharmaceuticals’ (“NPS”) patent EP 1 203 761, the basic patent for an SPC covering cinacalcet, invalid for lack of inventive step and declared the SPC null. In short, the court considered that the (selection of) cinacalcet provided no…
Two recent decisions in the UK and Australia in the long-running pregabalin litigations demonstrate the different approaches in these jurisdictions to determine if a patent specification has sufficiently disclosed an invention. Readers will recall that the judgments concerned Warner-Lambert’s Swiss-style claims for the use of the compound pregabalin (marketed as Lyrica) in the treatment of…
In the Netherlands, Minister for Health Care Bruno Bruins clashed with Novartis last month about lutetium-octreotaat, after the Swiss pharma company had fivefolded the price of this cancer drug, an ‘orphan medicine’ for patients with neuroendocrine tumors. It is the latest of a series of controversies about medicine pricing. Kluwer IP Law discussed the case…
The Court of Appeal overturned the Patent Court’s first instance decision concerning the validity of one of ICOS’s patents (licensed to Eli Lilly) covering a 1 to 5mg dosage form of tadalafil (Cialis®) for oral administration up to a maximum of 5mg per day for the treatment of sexual dysfunction. The Court held that the…
Today, after nine months of waiting, the decision of the UK Supreme Court in the pregabalin litigation was handed down. Like Brexit and the nation, it is clear that the Supreme Court Judges were divided on several crucial issues. In this post, we will not attempt to give a detailed analysis of the decision but…
In a decision issued this summer, the Swiss Federal Patent Court had the opportunity to comment on the catalogue of grounds for invalidity which can be brought against a Swiss SPC. The Federal Patent Court issued a PI based on Genzyme Corporation’s Swiss SPC for sevelamer, although it was unclear whether the Swiss Institute of…
Concluding that the asserted claims of patents relating to dosing and administration of the drug Copaxone used to treat multiple sclerosis are obvious, the U.S. Court of Appeals the Federal Circuit has affirmed a decision by the federal district court in Delaware invalidating the patents, handing a major victory to generic drug manufacturers. The Federal…
The Court of Appeal dismissed an appeal filed by Cubist against the Patents Court decision that one of its patents relating to antibiotic daptomycin was invalid for obviousness. The Court of Appeal was satisfied that the first instance Judge had an ample evidential basis to find the claimed invention obvious, his finding was properly reasoned…
AstraZeneca had filed an application for interim relief based on two patents, DK/EP 1250138 T4 (“EP 138”) and DK/EP 2266573 T3 (“EP 573”) against Sandoz, which conceded that to the extent that the patents were valid, the Sandoz product “Fulvestrant Sandoz” infringed upon the two patents. Sandoz took the position, however, that the patents should…
A Markush claim is a type of claim commonly used in chemical and pharmaceutical fields. On December 20, 2017, in Beijing Winsunny Harmony Science & Technology Co., Ltd. v. Daiichi Sankyo Co., Ltd, (“Daiichi Sankyo Case”), the Supreme People’s Court (“SPC”) resolved a long standing-split among Chinese courts regarding the interpretation and amendment of Markush…
