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.