Biotechnology patents

Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher
Practice notes

Biotechnology patents

Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher

Practice notes
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This Practice Note sets out which biotechnological inventions can and cannot be patented. It refers to Directive 98/44/EC (often known as the Biotechnology Directive) and Schedule A2 to the Patents Act 1977 (PA 1977), which permit biotechnological inventions to be patented but provide some important exceptions. These exceptions have been subject to interpretation by the Court of Justice in cases such as Oliver Brüstle v Greenpeace and Monsanto v Cefetra. This Practice Note also considers the exclusions to patentability under Article 52(b) of the European patent Convention (EPC) and the relevant European Patent Office (EPO) case law, Tomatoes I, Tomatoes II and Broccoli II. Finally, it considers the 2017 European Commission Notice on biotechnological inventions.

Patenting biotechnological inventions

Biotechnological inventions are, in principle, patentable. While there is no general exclusion against them in PA 1977 or the EPC, there are specific Rules governing the patentability of such inventions (see: The regulatory framework for biotechnology patents below).

Further, in practice, certain biotechnological inventions, while not necessarily specifically excluded, may fall foul

Nicole Jadeja
Nicole Jadeja

I am an IP litigator specialising in patent litigation in the life sciences sector. Having graduated with a science degree, I spent several years working in clinical trials in the pharmaceutical industry, before qualifying as a lawyer. Whilst I have litigated all types of IP, my experience in recent years has been litigating for pharmaceutical companies. As well as being an experienced litigator in the UK Courts and the European Patent Office, I have experience of litigating in the Court of Justice of the European Union having worked on two seminal cases which were referred to this Court, one concerning SPCs and one concerning counterfeit goods in transit. I frequently advise on multi-jurisdiction patent disputes, co-coordinating litigation in various European and other jurisdictions. I am Vice Chair of the IP Committee of the BioIndustry Association and a member of the Life Sciences Committee of the Chartered Institute of Patent Attorneys. I frequently speak at industry events, particularly on SPCs.

Christopher Leung
Christopher Leung

Solicitor, Fieldfisher


Christopher is an Associate in the IP Protection and EnforcementÌýGroup at Fieldfisher.ÌýHis experience spans a broad range of IP rights including patents and SPCs, trade marks, copyright, database rights and domain names.
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Christopher has a particular interest in litigation in the life sciences field and has experience of patent and SPC proceedings before the UK Intellectual Property Office, Patents Court, Court of Appeal and Court of Justice of the European Union, including acting as lead assistant in Sandoz Ltd & Anor v G.D. Searle LLC & Anor and Master Data Center, Inc. v The Comptroller General of Patents.
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Christopher also advises clients on the management of their global trade mark portfolios and the enforcement of their soft IP rights, and has acted in various high profile soft IP disputes including Karen Millen v Karen Millen Fashions Ltd & Anor (trade marks) and 77m Ltd v Ordnance Survey Ltd (copyright and database rights).

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Jurisdiction(s):
United Kingdom
Key definition:
European patent definition
What does European patent mean?

A European patent is a patent which is granted under the European Patent Convention.

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