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Following a call for evidence in April 2022, the European Commission launched a public consultation in July 2022 seeking to revise the framework on compulsory licensing of patents in the EU. The general objective being to create a less fragmented and better-suited compulsory licensing system for EU-wide crises of a health, environmental, nuclear or industrial nature. Nevertheless, the consultation recognises that any system should remain exceptional and a last resort measure, applicable where voluntary agreements are not implemented, and bearing in mind that compulsory licensing may have a significant impact on IP holders.
Continue Reading European Commission launches public consultation on compulsory licensing of patents

The use of artificial intelligence (AI) and machine learning is growing at a significant pace and  spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind” is no longer limited to creations by a human being. These technological developments mean that the legal framework governing intellectual property (IP) rights such as patents and copyright, which protect “creations of the mind”, may need to be adjusted to address the changes and impacts brought about by the use of AI.

In line with the UK government’s ambition for the UK to be a leader in AI and to better understand the implications AI might have for IP policy, as well as the impact IP might have for AI in the short to medium term, the UK IPO conducted a public consultation at the end of 2020. The aim of the consultation was to seek responses on a range of questions relating to AI and IP rights. The UK IPO received 92 responses from a wide range of stakeholders, including IP rights holders, producers of AI technology and academia. The government’s response to the call for views on AI and IP was published in March 2021, under which reforms to patent and copyright law and policy were discussed.

In this blog, we summarise the UK government’s conclusions from the consultation before considering the potential impact to digital health applications and companies.Continue Reading AI and IP: Implications for digital health from possible reforms to UK IP law

On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In practice, this prevents the competent authorities from publishing a complete SmPC, showing all indications associated with the innovator product, on their website.

Today’s judgment will be welcomed by innovative companies seeking to ensure the effectiveness of their second medical use patents.Continue Reading CJEU decision on scope of skinny labels

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