On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit.

What is exhaustion?

As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from using that right to stop the importation of a product into an EU country where it has been lawfully placed on the market in another country in the European Economic Area (EEA). In other words, an IP holder cannot use its IP rights to prevent parallel import (sometimes called grey imports) of goods from within the EEA. Unless the law is changed, this will not apply after Brexit, because the UK will no longer be part of the EEA. The proposed legislation seeks to change this so that exhaustion still applies to any goods brought into the UK, provided they have been placed on an EEA market with the IP owner’s consent. This will apply irrespective of whether there is a Brexit deal or not, and it is intended that this comes into effect on Brexit-day, if approved by Parliament.

Continue Reading Brexhaustion: IP Rights and Exhaustion Post-Brexit

On 14 November, the Supreme Court handed down its judgment on the validity and infringement of the second medical use patent that protected Pfizer’s Lyrica® (pregabalin) for the treatment of various types of pain. In Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor [2018] UKSC 56, the Court decided that the patent held by Warner-Lambert (a company in the Pfizer group) was invalid for insufficiency, because it did not render it plausible that pregabalin would be effective to treat all of the claimed types of pain. The Court also held that, had the claims been valid, they would not have been infringed by a “skinny label” generic version of pregabalin that had the protected indications carved out. However, the five judges of the Court were not in agreement on several key points.

Continue Reading UK Supreme Court rules on validity and infringement of second medical use patents

Yesterday, a new global medicines patent database, the Patent Information Initiative for Medicines (Pat-INFORMED), was launched by WIPO and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

Pat-INFORMED is designed to help procurement agencies better understand the global patent status of medicines, for example to anticipate generic launch and to design tenders. It includes a free open access database of patent information, and a platform where procurement agencies can make direct enquiries to companies. Continue Reading New global database for drug patent information

On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead’s combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product “is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically.” It is for the English High Court, as the referring court, to determine whether that test is met by Gilead’s patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead’s patent.

Continue Reading CJEU rules on SPCs for combination products

The UK Supreme Court has overturned existing case law to, for the first time, formally recognise a “doctrine of equivalents”, resulting in a broader scope of patent protection under UK law. This new approach is more patentee-friendly and brings the UK into closer alignment with courts elsewhere in Europe and in the US.

Continue Reading UK Supreme Court broadens patent protection