The Patents (Amendment) (EU Exit) Regulations 2018

Jane Lambert

In Patents if there’s no Brexit Deal 3 Oct 2018, I discussed the government's guidance Patents if there's no Brexit Deal 24 Sept 2018.  I wrote:

"With regard to patents and SPCs, the guidance notes that few areas of patent law derive from EU legislation. Pharmaceutical and agrochemical products are important exceptions in that SPCs provide an additional period of protection for those inventions after their patents run out. There are also special provisions for biotechnological inventions, compulsory licences for patented medicines and limitations to the scope of a patent monopoly to permit trials and tests and other activities. The note states that s.2 of the European Union (Withdrawal) Act 2018 will preserve the relevant EU legislation and s.3 will incorporate it into our law."

Supplementary legislation to preserve rights subsisting under EU regulations has now been drafted. pursuant to s.8 of the European Union (Withdrawal) Act 2018,

The draft legislation is known as The Patents (Amendment) (EU Exit) Regulations 2018,  There are 69 of those regulations divided into 8 Parts:

• Part 1 (reg 1) Introduction (citation)
• Part 2 (regs 2 - 4) Amendments to the Patents Act 1977
• Part 3 (reg 5) Amendments to the Copyright Designs and Patents Act 1988
• Part 4 (regs 6 - 17) Amendments to The Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002
• Part 5 (reg 18) Amendments to the Patent Rules 2007
• Part 6 (regs 19 - 36) Supplementary Plant Protection Certificates - Amendments to Reg (EC) No 1610/96
• Part 7 (regs 37 - 50) Compulsory Licensing of Pharmaceutical Patents - Amendments to Reg (EC) No 816/2006, and
• Part 8 (regs 51 - 69) Supplementary Protection Certificates for Medicinal Products - Amendments to Reg (EC) No 469.2009. 

The Patents and Plant Variety Rights (Compulsory Licensing) Regulations2002 (SI 2002/247) implement parts of Directive 98/44/EC on the legal protection of biotechnological inventions. The EU regulations on supplementary protection certificates are directly effective.

SPC (supplementary protection certificates) extend the monopoly granted by a patent for up to 5 years after the patent's expiry to make up for the time needed to obtain regulatory approval for the distribution of the patented invention.   To make sure that SPCs continue to be available, the statutory instrument replaces references to the EU and its institutions or member states with references to the UK, the Intellectual Property Office and other British organizations.

I shall mention this draft legislation at the 11th Annual Forum on Pharma Biotech Patent Litigation in Amsterdam, 26 and 27 Feb 2019. Anyone wishing to discuss this article, the draft statutory instrument or patents and brexit generally should call me on 020 7404 5252 during office hours or sending me a message through my contact form. 

Brexit Briefing - January 2019

Jane Lambert

Although a lot has happened in Parliament since the last Brexit Briefing my view of te eventual outcome remains unchanged.  Any one of four things can happen between now and 29 March 2019:

• the Draft Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 14 Nov 2018 may be ratified in which case EU law will continue to apply to the UK until 31 Dec 2020 at the earliest;
• the notification dated 29 March 2017 by the Prime Minister to the President of the European Council of the British government's intention to withdraw from the European Union may be revoked in accordance with the Court of Justice's decision in C-621/18 Wightman and others v Secretary of State for Exiting the European Union  ECLI:EU:C:2018:999, [2018] EUECJ C-621/18, [2018] WLR(D) 747, [2018] 3 WLR 1965 in which case the UK will remain a member of the EU and Union law will continue to apply indefinitely;
• the two-year notification period may be extended in accordance with art 50 (3) of the Treaty on European Union in which case the EU law will continue to apply to the UK at least for the extension of the notification period; or
• nothing can happen at all in which case the UK will leave the EU at 23:00 on 29 March 2019 and the Treaty of European, the Treaty on the Functioning of the European Union and all regulations and directives made under those treaties since 1 Jan 1973 will cease to apply to the UK.

Businesses should apply for all eventualities including the last however many resolutions MPs may pass against British departure without a withdrawal agreement.

As the purpose of this blog is to provide legal discussion and not engage in controversy I shall not opine on which of those outcomes is most likely and which is more desirable.  All I will say is that businesses and individuals should keep a sense of proportion.   There may well be additional costs, delays at frontiers and other inconveniences if the UK leaves the EU without a withdrawal agreement but the prospect of civil unrest on such a scale that the Queen's safety would be at risk is improbable (see  Queen to be evacuated if Brexit turns ugly – reports 3 Feb 2019 The Guardian).  Brexit will not change geography or history or repeal the laws of economics.  We shall continue to do all kinds of business with our neighbours and commercial, cultural, security and personal relationships will not vanish overnight.  The UK will remain in the Council of Europe, the North Atlantic Treaty Organization, the World Trade Organization and other regional and global agreements such as the European Patent Convention.

Some of the additional costs, risks and uncertainties can be mitigated by forward planning and agreement for which specialist legal advice may be required.  Anybody wishing to discuss this article in general and their rights and liabilities, in particular, may call me on +44 (0)20 7404 5252 during office hours or send me send me a message through my contact page.