The latest round of negotations between the EU and India over a free-trade agreement was disrupted by protests over the way the IP clauses in the deal could affect access to medicines in developing countries. During the 12th India-EU summit in New Delhi on February 10, the two sides signed a declaration on research and innovation and agreed to intensify negotiations for a broad free-trade agreement. The meeting itself was preceded by protest marches that featured people suffering from HIV and AIDS and who are worried that any EU-India trade agreement will increase the price of life-saving medication. Médecins Sans Frontières highlighted three areas of concern: 1) that the enforcement measures it believes the EU is pushing could prevent generic medicines from leaving Indian ports to other developing countries if patent or trade mark infringement is alleged; 2) the investment part of the FTA would allow companies to sue the Indian government if it decided to issue a compulsory licence or otherwise control the price of drugs; and 3) that the EU may try to reintroduce data exclusivity rules into the agreements, despite agreeing earlier to keep them out. Biosimilar guidance released. The US Food and Drug Administration provided some long-awaited clarity last month for potential biosimilar applicants and innovator biologic companies. The agency released guidelines on how to demonstrate that a biological product is highly similar to or interchangeable with an FDA-licensed biological product and may therefore be approved under an abbreviated pathway similar to the process for small molecule generics. EPO signs Japanese patent translation deal. Patent applicants will find it easier to access Japanese patents after the heads of the EPO and JPO agreed a patent translation deal between the two offices. The agreement will add an automatic translation tool to Espacenet, the EPO’s public patent information service, allowing users to read machine translations of the documents in English, French and German. Enjoy innovation patents while they last. IP owners may want to make use of the innovation patent system before it is too late. The Australian Council on Intellectual Property says there are concerns that innovation patents are “overly difficult to invalidate and the remedies for infringement are overly generous”. Another concern is that they are being used to obtain a form of quick protection for higher level inventions while a standard patent is being pursued. Commission investigates Samsung. The European Commission has opened a formal investigation into whether Samsung breached EU competition law by enforcing standard-essential patents for 3G technology. The case was launched in late January and will be examined as a matter of priority. The Commission said it will examine whether this behaviour amounted to an abuse of a dominant position prohibited by Article 102 of the Treaty on the Functioning of the EU.
