A cure for resistance? How ultra-long patent terms may entice pharma to address the antimicrobial resistance crisis

A cure for resistance?  How ultra-long patent terms may entice pharma to address the antimicrobial resistance crisis

Antimicrobial resistance (AMR) is a rapidly emerging crisis, and it is already estimated that antibiotic resistance alone caused 1.27 million deaths and contributed to 4.95 million deaths in 2019 (more deaths than HIV/AIDS or malaria) [1].  This is only set to increase as our use of existing antimicrobials accelerates in response to population, environmental, and healthcare pressures.

And it is not just antibiotic resistance to common bacterial pathogens that poses the greatest challenge, although this is undoubtedly huge.  Resistance emerging in viruses, parasites, and fungi are threatening global progress towards eradicating major complex diseases such as HIV/AIDS and malaria.

So how can this be addressed?  The World Health Organisation has rightly highlighted AMR as one of the top 10 global public health threats facing humanity.  However, addressing AMR will require concerted investment and policy change from government and healthcare organisations.  It will also require pharmaceutical companies, which have the infrastructure and expertise to scale up antimicrobial research, to pivot towards research and development of new antimicrobials.  This has historically been difficult, as pharmaceutical companies move away from antimicrobials towards more profitable therapeutics and biologics.  The development of new vaccines against key pathogens, e.g. TB, malaria, and HIV, could also help alleviate some of the AMR burden.

Patents are of course a major factor in the profitability of a new drug, and extending the lifespan of a patent in its final years (which often coincides with the first few years a drug is on the market) is key for maximising profitability to recoup high R&D costs.

One incentive that has been proposed by the industry is granting pharmaceutical companies patent term extensions beyond those already available to allow them to recoup more costs by maintaining longer exclusivity.  In this way, a new antimicrobial could eventually become profitable, despite prescribing practices which seek to minimise use of ‘last resort’ antimicrobials.  The extension could be applied either to the patents covering new antimicrobials themselves, or to other patents already held for more profitable drugs. 

In Europe, such extensions could potentially be applied within existing legislative frameworks to extend the patent lifespan for drugs through Supplementary Protection Certificates (SPCs) and paediatric extensions, which may simplify legislative changes needed for further extensions. 

How long the further extensions should be is another topic for debate, as anything considered to be “ultra-long” (e.g. up to 70 years) would likely be fiercely opposed by generics manufacturers.  Other arguments against ultra-long extensions include increased costs for healthcare providers and patients, and lack of accessibility of new drugs in less profitable markets.  Pharmaceutical companies also already commonly apply “evergreening” strategies to extend the patent lifespan of therapeutics, and so there is an argument that further formal extensions are not equitable on top of this practice.

Whatever the position on patent terms for new antimicrobials, there is no question that increased investment in development is desperately needed to prevent millions more deaths associated with AMR, and all strategies to encourage development of new drugs should be considered.

[1] Antimicrobial Resistance Collaborators, Lancet, 2022; 399: 629-655

Introduction to Potter Clarkson

Leading European intellectual property law firm, Potter Clarkson, helps companies, organisations and individuals across all areas of technology, including in the life sciences and medtech sectors, to understand, create, protect and defend the commercial value of their innovations anywhere in the world through IP rights.  Recognised as a top tier firm, it is known for its deep technical expertise and clarity of advice.

We will be attending the BioInfect conference on 1 February, and are looking forward to meeting other BioNow members there!