Conference call by the Working Group on Licences and Technical Contracts

At the beginning of July, the members of BIO Deutschland’s Working Group on Licences and Technical Contracts held a conference call to discuss current developments in the field of patent law. The agenda included the working group’s call for the introduction of a grace period in Europe, changes in US patent law, and various European initiatives.

With regard to the group’s call for the introduction of a grace period in Europe, the experts on patent law reported on the state of play on the talks on this topic. Talks have been held with the national associations of the pharmaceutical and biotechnology industry, while the first talks with policymakers have taken place. The topic has also been raised at the European level. In the coming months, the group plans to speak with ministries and policymakers, as well as with interlocutors at the European level.

On the topic of US patent law, the members of the working group reported on the Limelight ruling by the US Supreme Court and on the ruling’s impact on biotechnology patents. They also discussed the draft of new patent eligibility guidelines by the United States Patent and Trademark Office (USPTO). The Limelight case involved a dispute on whether direct patent infringement occurs if a supplier performs almost all the steps of a patented method, but the final step is performed by a user who does not have a direct economic link to the supplier. The US Supreme Court ruled that a method patent is not infringed in such cases. This ruling on a case from the IT sector could also be applied to biotechnology, as the process steps are distributed between the supplier and the final user, particularly in the case of diagnostic kits. In response to the Myriad ruling (see BIO Deutschland’s newsletter of June 2013), USPTO drew up new method guidelines, which are open for consultation until the end of July 2014. The working group discussed these guidelines and will take part in the consultation via BIO.

The working group experts also discussed the entry into force of the EU Regulation on Compliance Measures for Users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union. This regulation was published on 16 April 2014, but only enters into force when the Nagoya Protocol comes into effect. In accordance with Article 33 of the Protocol, the Protocol enters into force 90 days after the fiftieth ratification / recognition. On 11 July 2014, Switzerland became the fiftieth country to sign the Protocol. This means that the Protocol and the EU Regulation will enter into force on 9 October 2014.