Applying the so-called ‘Actavis Questions’ (further to the Supreme Court decision in Actavis v Eli Lilly), the Court of Appeal reached a different conclusion from the Patents Court on the issue of infringement. However, as the Court of Appeal upheld the first instance Court’s decision that the patent was invalid, this ultimately did not change…
The Court of Appeal overturned the Patent Court’s first instance decision concerning the validity of one of ICOS’s patents (licensed to Eli Lilly) covering a 1 to 5mg dosage form of tadalafil (Cialis®) for oral administration up to a maximum of 5mg per day for the treatment of sexual dysfunction. The Court held that the…
Early on Monday 10 December 2018, the Court of Justice of the European Union issued its judgment in Wightman et al v Secretary of State for Exiting the European Union (C-621/18), on whether the UK can unilaterally withdraw its Brexit notification. Although of course the judgment is strictly a legal reasoning, it also comes as…
Why would anyone want to have their own supplementary protection certificate (SPC) revoked? – The answer is, quite simply, Article 3(c). Under Article 3(c) of Regulation (EC) 469/2009 on SPCs for medicinal products (and, likewise, under Article 3(1)(c) of Regulation (EC) 1610/96 on SPCs for plant protection products), an SPC shall be granted only if…
(Corrected) The American Food Drug Administration (FDA) will follow the European Medicines Agency from London to Amsterdam because of the Brexit. That is clear from a report on the website of the FDA, describing its international activities. “Since the first foreign office opened in Beijing in November of 2008, FDA’s international presence has grown to…
The District Court of the Hague granted a provisional injunction against Sandoz’ generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which a provisional injunction was warranted, and the SPC appeared to be valid having been held so in the parallell procedure before the UK court….
Over the past few years the pan-European and parallel national patent litigation based on Eli Lilly’s pemetrexed patent has attracted considerable attention, as it has resulted in a number of diverse land mark decisions in relation to the doctrine of equivalence, as evidenced by the various posts on the Kluwer Patent Blog. By way of…
Whilst it is highly debatable whether the EU Withdrawal Agreement will get through the UK Parliament, the chances are that if any revised deal is struck later, the IP provisions will remain unchanged. (The Johnson brothers, and even Jacob Rees-Mogg are unlikely to be terribly exercised about matters such as the continued application post- 31…
Today, after nine months of waiting, the decision of the UK Supreme Court in the pregabalin litigation was handed down. Like Brexit and the nation, it is clear that the Supreme Court Judges were divided on several crucial issues. In this post, we will not attempt to give a detailed analysis of the decision but…
If a Brexit agreement is reached with the European Union, the UK can stay in the Unitary Patent system during the transitional period and likely be part of the system once this comes into effect. This was argued last week by Kevin Mooney of Simmons & Simmons, who is closely involved in the creation of…
