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…
In a summary assessment of costs, where the parties had drawn up and agreed costs budgets prior to trial, the Court confirmed that each phase of the budget was to be considered separately and two phases could not be combined where one was overspent and the other was underspent. The budget was a guideline which…
In preliminary proceedings, the risk that a company will potentially suffer greatly as a result of the decision is a factor that has to be taken into account by the court. Case date: 28 December 2018 Case number: C/09/555970 / KG ZA 18-694 Court: Provisions Judge of the District Court of The Hague A full summary of this…
This recent decision from an EPO Board of Appeal is a rather satisfying development in how patentability (especially novelty) of purity claims is assessed at the EPO. This case may be seen as patentee-friendly, particularly for the pharmaceutical sector, as it likely extends protection for APIs. It will become especially important to review this case…
The much awaited decision T 1063/18 by Technical Board of Appeal 3.3.04 in a five-member composition has been published today. The patent application under appeal related to new pepper plants and fruits with improved nutritional value, and the decision did indeed turn out to be quite peppery, at least in regard to the EPO Administrative…
AstraZeneca tried to enjoin Hexal from marketing its Fulvestrant-medicament in main proceedings (after already having failed in PI-proceedings) due to alleged patent infringement of AstraZeneca’s Swiss-type claim patent. The Dusseldorf Court of Appeal, however, dismissed the appeal (docket-no I-2 U 29/18). To understand the implications of this case, one has to first step back and…
The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…
During the 2018 Mobile World Congress (“MWC”), Barcelona Commercial Court number 1 ordered a preliminary injunction preventing a company that was taking part in the Congress from continuing to market mobile phones that allegedly used antennas protected by patents owned by the applicant. The defendant lodged an appeal before the Barcelona Court of Appeal (Section…
In a recently published decision, the German Federal Patent Court outlines in detail which aspects they consider relevant to arrive at a royalty rate (ruling by the Federal Patent Court dated November 21st 2017, published in GRUR 2018, 803). It is one of the rare decisions where a German Court analyzes in detail which aspects…
For manufacturers of biologics and biosimilars facing potential patent litigation in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of disputes in federal district court. Biosimilar applicants who find themselves on the receiving end of a potential patent infringement complaint in district…
