BIA given permission to intervene in Actavis vs ICOS Supreme Court case

The UK BioIndustry Association (BIA) has been granted permission by the UK Supreme Court to intervene in a case that could have far-reaching impacts on the life sciences sector. The BIA is arguing that medical innovations should be patentable irrespective of how the invention is made.

The Supreme Court is reviewing Actavis vs ICOS, a case that addresses the patentability of a discovery made during the dosage regime testing stage of a clinical trial.

Generics pharmaceutical company Actavis, which is seeking to market its own version of the drug tadalafil, has challenged the patent owned by ICOS on the grounds that the discovery was obvious. Actavis claimed in the Court of Appeal that it would have been obvious starting from a prior publication to reach the patented discovery – a low effective dose of tadalafil that shows reduced side-effects – during routine pre-clinical and clinical trials, rendering it unpatentable. ICOS argued that it would not have been 'obvious to try' the 5mg daily dose because at the start of the development process the skilled team would have no idea whether or not such a dose would be safe and effective.

The Judge at first instance agreed with ICOS but the Court of Appeal overturned that decision. ICOS is now challenging the Court of Appeal’s decision in favour of Actavis.

The BIA highlights in its application to the Supreme Court that the design and conduct of clinical trials and other forms of biomedical research frequently involves the application of significant skill and complex decision making, despite often following a step-wise well-established path to ensure regulatory compliance. It submits that the assessment of obviousness should be based around the knowledge at the relevant time and not simply on the nature and type of research which led to the claimed invention.

The BIA also urges the Supreme Court not to make a decision in this case that could have unintended consequences for other patents for inventions made during the pre-clinical or clinical trial process, which would significantly raise the hurdle for companies to attract the investment needed to identify and develop new medical innovations.    

BIA CEO Steve Bates said: “Clinical trials are an important part of medical innovation and it is vital that companies can protect their discoveries regardless of what stage in the research process they are made. Without a strong and consistent patents regime that rewards innovation, UK bioscience companies will not be able to attract the investment they need to develop the life-saving drugs of tomorrow. We are delighted that the Supreme Court will give consideration to the arguments we are making on behalf of the UK bioscience sector.”

The BIA’s application was prepared by Fieldfisher LLP together with other members of the BIA’s Intellectual Property Advisory Committee.

Notes to editors:

Contact: Ed Sexton, BIA Communications Manager [email protected] 0207 630 2196

•        The BIA’s Statement of Grounds submitted to the Supreme Court as part of the application to intervene can be downloaded from: https://www.bioindustry.org/resource-listing/statement-of-grounds---icos---anor-v--actavis-group-ptc-ehf---ors---7398----pdf.html
•         The full title of the case is Actavis Group PTC EHF and others (Respondents) v ICOS Corporation and another (Appellants). It will be heard on the 19^th and 20^th November. More information can be found on the Supreme Court’s website: https://www.supremecourt.uk/cases/uksc-2017-0214.html 
•        Tadalafil is sold under the trade name Cialis by Eli Lilly, which is also a named party (Appellant) in the case and a member of the BIA.
•         The BIA would like to make clear that none of the parties or their advisers were involved in the BIA’s decision to apply to intervene in this case and are not involved in the application itself.
•         Patent EP (UK) 1,173,181 claims use of tadalafil in a low 5mg daily dose in the treatment of sexual dysfunction. Cialis is a competitor (second in class) of the well-known drug Viagra for erectile disfunction.

About the UK BioIndustry Association (BIA)

Established over 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.

For further information, please go to www.bioindustry.org and twitter.com/BIA_UK