In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners of original biologic products) in another. The result for Amgen and Sandoz is that Sandoz can start selling Zarxio™, its biosimilar version of Amgen’s Neupogen® (filgrastim) product, on September 2, 2015. The result for other biosimilar applicants is less clear, since the court’s decision leaves open more questions than it answers.
Technological innovation has left deep footprints on the evolution of International Law. In the mid-1960s, in his course at The Hague Academy of International Law, professor Mouton explained that every time inventors conceived a revolutionary invention, politicians had to devise an international organization to take care of it. A classic example is the establishment of the Central Commission for Navigation on the Rhine – the first international organization in history – created in 1815, following Robert Fulton’s invention of the steamboat. Technological innovation has also left footprints on the way the courts devise procedures to improve the administration of justice. A recent example c [...]
Summer is here and the anticipated (but not yet actually arrived in the author’s personal experience) slow-down in activity may provide many Kluwer Patent Blog readers with the chance to draw breath and catch up on the latest UPC developments. But how well do you know the UPC? Could you list the location of all the intended Local and Regional Divisions in reverse alphabetical order whilst building a sandcastle with a pair of enthusiastic toddlers? Could you summarise the Rules on Provisional Measures whilst erecting a beach tent in a 50km/h wind? If not, try the Kluwer Patent Blog Summer Quiz.
Here are the rules: give yourself 10 minutes and without peeking at the Agreement or the [...]
Competence of the Dutch courts is determined solely based on facts furnished by plaintiff. Jurisdiction for patent entitlement claims is governed by the Protocol on Recognition to the EPC, not by the Brussels I Regulation.
Conflicts between patents and generic medicaments are mandatorily solved by arbitration. Requests of authorization to introduce generic medicaments in the market (AIM) are published by the Portuguese Medicaments Office (INFARMED) and interested parties have a term of 30 days to oppose their industrial property rights. Upon the termination of the term, patents cannot be enforced against the holders of the AIM before arbitration or state courts.
The statute which provides that holders of industrial property rights can resort only to arbitration instead of directly resorting to state courts concerning provisional or interim measures (Article 2 of Law No 62/2011 of 12 December) is not contrary to the Portuguese constitution.
However, the statute according to which a patent cannot be enforced against the holder of an authorization to introduce in the market (AIM) or the applicant to an AIM beyond the term of 30 days after the publication by Infarmed of the request (Article 3(1) of Law 62/2011 of 12 December) is contrary to the constitution.