BIA welcomes legal confirmation that discoveries made through “routine” research can be patentable in ICOS vs Actavis ruling

In a ruling handed down today (27 March) by the UK Supreme Court, Lord Hodge has confirmed that discoveries made through well-established or routine research protocols can be inventive and rewarded with a patent.

The UK BioIndustry Association (BIA) has welcomed the clarity provided by the decision on principles of patent law that have a wider impact on the biotech sector beyond the parties in this particular case. The trade body intervened in the case to ask that the Supreme Court not provide a decision that could have unintended adverse consequences for 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. 

Responding to the BIA’s submission, the lead judge in the decision, Lord Hodge, said “I do not construe the judgments of the Court of Appeal as supporting any general proposition that the product of well-established or routine enquiries cannot be inventive… efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests.”

BIA Head of Policy and Public Affairs, Dr Martin Turner, said:

“The research and development of new medicines requires significant investment from companies so it is essential that they can protect the products of their investment through the patent system. This in turn incentivises further investment in medical research in a virtuous cycle that delivers improved treatments for patients.

“We welcome the Supreme Court’s clear statement that valuable medical discoveries made through clinical trials or other research that might be viewed as routine can be considered inventive and thus worthy of a patent. We are pleased that the Supreme Court has addressed the key points that we raised and provided this important clarity for the biotech community.

“Notwithstanding this, the application of the principles by the court in this particular case did not lead to the patent being found to be valid, so the individual facts of each case, as always, will have a significant influence on the court’s assessment.”

Nicole Jadeja, Partner of Fieldfisher and Vice-Chair of the BIA IP Advisory Committee, said:

"The Supreme Court has today provided members of the BIA with a lot of the clarity they were seeking in their intervention, giving guidance on the application of some key principles of patent law.  In a decision largely confined to the specific facts of the case, the Supreme Court has seemingly endeavored to determine the case in a way which will avoid unforeseen and far-reaching implications beyond the patentability of this particular dosage regimen patent."

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

Notes to editors:

• You can read the BIA’s Statement of Grounds for its intervention in the case here: https://www.bioindustry.org/resource-listing/statement-of-grounds---icos---anor-v--actavis-group-ptc-ehf---ors---7398----pdf.html
• The BIA wrote to the Supreme Court asking it to accept the case in March 2018, you can read the letter here: https://www.bioindustry.org/resource-listing/bia-icos-v-actavis-letter-to-the-supreme-court-pdf.html
• Further background on the case can be found in the BIA’s previous press release from 5 November here: https://www.bioindustry.org/news-listing/bia-given-permission-to-intervene-in-actavis-vs-icos-supreme-court-case.html
• The full title of the case is Actavis Group PTC EHF and others (Respondents) v ICOS Corporation and another (Appellants). It was heard on the 19th and 20th November. More information and the judgement can be found on the Supreme Court’s website: https://www.supremecourt.uk/cases/uksc-2017-0214.html  
• Patent EP (UK) 1,173,181 claims use of tadalafil in a low 5mg daily dose in the treatment of sexual dysfunction. 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. Cialis is a competitor (second in class) of the well-known drug Viagra for erectile disfunction
• The ruling of the Supreme Court in this case is that Patent EP (UK) 1,173,181 is invalid
• The BIA would like to make clear that none of the parties or their advisers were involved in the BIA’s decision or application to intervene in this case

Contact: Jack Fellows, BIA Communications Manager [email protected] 02076302196

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