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An extension to the life of pharmaceutical patents?

Natasha Rao
28/11/2019

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United Kingdom

Yesterday the Labour party claimed to have uncovered documents concerning talks on the NHS between UK and US officials. Pertinently, these are alleged to include discussions about lengthening the life of pharmaceutical patents.

But how would this work within the current UK legal framework? And what ramifications would this have for the UK as a whole? 

Current legal framework – UK and US  

At present pharmaceutical (and indeed all) patents have a life of 20 years in the UK from their filing date, as elsewhere in the EEA. 

However, it is possible to obtain a Supplementary Protection Certificate (SPC) under the SPC Regulation (EC) No 469/2009 to extend the life of a pharmaceutical patent by up to five years after expiry of the patent or 15 years from the first marketing authorisation (MA) in the EU, whichever is the shorter. An SPC is designed to compensate for the time lost between the grant of the patent and the grant of MA (namely, the regulatory approval required for the drug to be marketed in the EEA). A 6-month extension can be granted to the term of the SPC if appropriate research is conducted into how the drug performs in paediatric populations. 

A similar system is operated by the US Patent and Trademarks Office (USPTO) in the US: pharmaceutical patents have a life of 20 years from their filing date, with the potential for a 5-year extension to compensate for FDA delay in granting marketing approval for the drug (under the Hatch-Waxman Act). A similar 6-month extension can also be granted for paediatric research, although this is an extension to the term of the patent rather than the SPC. 

Notably, the 5-year 'SPC-type' extension in the US applies to the entire patent. In contrast, in the EEA, the scope of the SPC is narrower and granted in respect of the active ingredient or combination of active ingredients in the patent. 

Impact of lengthening patent protection 

An increase in the life of pharmaceutical patents in the UK (or US) would bring their patent protection systems out of line with Europe as a whole, where 20 year-protection is the norm. It also raises questions as to how the SPC system would continue to function in the UK if the protection term for pharmaceutical patents is increased (assuming that the UK is still able to benefit from the SPC regime after Brexit). 

It is possible that the proposed UK-specific 'SPC' regime coming into effect after Brexit (see our earlier blog, No-deal patents and SPCs: latest government guidance) could be designed to allow for an extended patent term for pharmaceutical patents in the UK. However, given that current SPCs are expected to remain in effect after exit day, such a change would likely create inconsistency in patent terms at least until all SPCs granted under the EEA system have expired. 

The question of how to determine the appropriate term of protection for pharmaceutical patents is controversial given its implications for the medical sector and for public health. Whether the 20-year period continues to be considered to strike an adequate balance between the interests of pharmaceutical companies, generics, medical institutions and patients remains to be seen.

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