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…

The Court of Appeal upheld the first instance decision that the patent in suit lacked novelty and inventive step over the prior art. The Court confirmed, following Halliburton v Smith, that despite the fact the parties had reached a confidential settlement and Sony was not involved in the appeal, it was necessary to hear the…

Even though subject to a confidentiality agreement an internal newsletter may be deemed publicly available if the addressees would not consider the newsletter to be covered by the confidentiality agreement. Case date: 21 November 2018 Case number: C/09/472888 / HA ZA 14-1019 Court: District Court of The Hague A full summary of this case has been published on…

The Supreme Court confirmed that an unregistered patent licensee did have legal standing to file an infringement action in Spain when it filed such action as co-claimant to the patent holder. Case date: 08 February 2017 Case number: ATS 735/2017 Court: Supreme Court of Spain, First Civil Law Chamber A full summary of this case has been published…

The Court of Appeal upheld a decision of the Intellectual Property Enterprise Court that the patent in suit was novel and inventive over the prior art. In construing the numerical ranges of the patent, the Court of Appeal pointed out that the purpose of a comparative example is that identifies something outside the claimed invention…

As discussed in our blog of 30 May 2018, the EU Commission has proposed an amendment to Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (“SPC Regulation”) aimed at introducing a “manufacturing for export exception.” The purpose of the amendment is to allow the manufacture of generic and biosimilar medicines within the…