Second medical use cases have been making their way through patent courts around the world. In the Novartis / Sun litigation the Hague Court of Appeal (PI decision) and District Court (interlocutory merits decision) already provided their thoughts on indirect infringement in 2015. The Court of Appeal concluded that Sun did indirectly infringe Novartis’ patent,…

On May 9, 2017, the Dutch-speaking Brussels court of commerce handed down its decision on the merits in the context of an infringement action initiated by Orion and its exclusive licensee Novartis against Belgian generic company Eurogenerics. The proceedings relate to Orion’s European patent EP 1 189 608, concerning an oral three-in-one solid composition of…

Pharmaceutical polymorph patents are regarded as effective means and important secondary pharmaceutical patents to extend the life cycle of pharmaceutical patent protection. However, the inventiveness evaluation criteria for pharmaceutical polymorph patents have become much stricter in China while the amount of patent application keeps soaring. The clinical research of pharmaceutical polymorphs commenced in 1950s internationally…

by Nicholas Round At the start of this month, the UK Supreme Court took a break from its recent post-Brexit work interpreting (and developing) constitutional principles to hear an intellectual property matter. This rare Supreme court foray for a patent produced a ripple of excitement across the UK IP litigation community not least because (uniquely…

The Federal Court of Australia has handed down its first detailed damages decision in a long time in a patent infringement claim against a generic pharmaceutical company. In doing so, it sets a new benchmark for damages claims by innovator companies whose products have been illegally copied. In Bayer Pharma Aktiengesellschaft v Generic Health Pty…

On 3 March 2017, the English Patents Court (Henry Carr J) issued a decision (here) in the joined claims filed by Fujifilm Kyowa Biologics (FKB) and Samsung Bioepis/Biogen (S/B) against AbbVie Biotechnology Limited (AbbVie) for so-called Arrow declarations in relation to dosage regimes of adalimumab (sold by AbbVie under the brand name Humira) for the…

In a judgment in preliminary proceedings the Bundespatentgericht (German Federal Patent Court) granted the pharmaceutical company Merck the right to use European patent EP 1 422 218 and to continue sales of the AIDS drug Isentress in Germany. It is the first time in its 55-year history that the Bundespatentgericht granted a compulsory patent license…

The Court of Appeal dismissed Boehringer Ingelheim’s application for permission to appeal the first instance Patents Court decision that EP (UK) 1,379,220 lacked inventive step.  The Court of Appeal also considered and overturned the existing judicial guidance on granting permission to appeal in patent matters. A full summary of this case has been published on…

Pharmaceuticals company Watson’s proposed generic version of competitor Shire’s brand-name mesalamine LIALDA® did not satisfy the requirements for a Markush group claimed by a Shire patent, the U.S. Court of Appeals for the Federal Circuit has held. A compound contained in the ANDA product—which was not present in the patent claim’s Markush group—structurally and functionally…

By decision no. 1651 of 14 October 2016 (publication reference: 24658/2016), the Italian Supreme Court put an end to the longstanding litigation between Bayer and the Italian company Industriale Chimica in relation to the production of drospirenone. This decision tackles both the issue of the patentability of chemical intermediates and that of infringement by equivalents….