Digging deep into the maelstrom of intellectual property in pharma

One key issue that has emerged recently in UK and European patent law is the concept of ‘plausibility’.

The term has no explicit basis in statutory law but, over time, has developed as a minimum standard to be met by a patent disclosure, to prove an effect asserted for a claimed invention. The principle underlying the requirement is the prevention of purely speculative patent claims.

It can be particularly relevant to pharmaceutical patents, especially those for medical uses, where definitive proof of efficacy (i.e. clinical trial data) is typically not available when the earliest patent filings in a drug discovery programme are being considered.

The question of how much, and what, data is needed to make an asserted biological or clinical effect plausible then becomes a crucial strategic question.
At the European Patent Office, a referral to the Enlarged Board of Appeal (EBA) on the topic has been pending and has delayed ongoing cases, since any proceedings where plausibility seems likely to be decisive have been stayed.

Referred questions relate to the issue of what plausibility standard, if any, has to be met by a patent disclosure, in order for post-filing evidence to be considered when assessing inventive steps.

A decision now looks likely by the middle of next year. All stayed cases will then be reopened for the relevant appeal boards, opposition divisions and examiners to apply any conclusions reached by the EBA.

A preliminary opinion was issued in October, with the board apparently leaning toward a relatively lenient approach allowing a technical effect to be supported by post-filing evidence, provided that ‘no significant reasons to doubt it’ arise from the application as filed (an ‘an initio implausibility’ standard).

Although it is noted, however, that this is a non-binding opinion and could change following further submissions at the upcoming hearing.

Meanwhile, in the UK courts, a much harsher approach has been applied, with Bristol Myers Squibb (BMS) losing a patent for blockbuster anticoagulant drug, apixaban, which was found to be invalid based on lack of plausibility.

The judge conducted a detailed review of the law on obviousness and insufficiency in relation to plausibility, referring to both UK and EPO authorities, and held that BMS’s patent did not make it plausible that apixaban would have any useful degree of factor Xa binding.

In contrast to the EPO approach, the UK judge made it clear that post-filing evidence of effectiveness could not save the patent. BMS is, meanwhile, appealing the decision.

Perhaps one of the most challenging recent discussions about IP was at the World Trade Organization (WTO), about waiving IP associated with COVID-19 vaccines and treatments. South Africa and India proposed a broad patent waiver in October 2020, considering that patents were an impediment to the manufacture and distribution of COVID-19 vaccines.

Their position was reportedly backed by over 100 states, including the USA, but was opposed by others including the European Union and the UK.

There was also strong opposition from the pharmaceutical industry and many IP organisations, who argued that patents were a key driver of the innovation that had enabled the incredibly fast development and manufacture of the original COVID-19 vaccines and those developed against the emerging variants.

A compromise was reached in June 2022, with a decision being issued clarifying that a number of measures already included in the 1994 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to address cases of national emergency or other circumstances of extreme urgency are applicable to the COVID-19 pandemic.

In this regard the decision substantially maintained the status quo in relation to patent rights, by waiving the requirement to demonstrate that the COVID-19 pandemic represents a case of national emergency or other circumstances of extreme urgency for COVID-19 vaccines.

This allows countries to employ measures, such as compulsory licensing, more easily, to make COVID-19 vaccines available if the need for these vaccines is not being met. Discussions about whether the waiver should be extended to treatments and diagnostics are continuing.

The patent system is designed to encourage innovation. The rapid response of researchers to the COVID-19 pandemic can readily be seen by looking at the publication of patent applications over the last couple of years. The first patent application with COVID mentioned on the front pages was in July 2020, arising from the very early publication of an application filed in April 2020.

Low numbers of publications were seen until a noticeable upturn in August 2021, with the height of publications – 193 – occurring in October 2021. Since then, numbers have dropped off (below 50 applications a month in July 2022) but are still significant. We expect to see such applications being published for some time, given the normal 18-month period from filing to publication.

Finally, as we look forward, the main IP topic on everyone’s mind is the imminent (and long-awaited) arrival of the Unified Patents Court (UPC) and the EU Unitary Patent (UP). The expected start date is currently 1 April 2023, with the ‘sunrise period’ having commenced on 1 January 2023. Make no mistake, the European patent landscape is about to change dramatically.

The pharmaceutical field often sees relatively broad EP validation strategies, especially for patents covering approved products or clinical candidates.

The new unitary patent (UP), initially covering 17 EU countries (representing about 64% of total healthcare spend amongst EPC member states) is therefore, in principle, an attractive choice for pharmaceutical companies, especially smaller start-ups, since it offers extremely good ‘value for money’ (in terms of validation and renewal costs) compared to the classical ‘bundle’ of EP patents.

Choosing a UP inevitably beings the patent under the jurisdiction of the UPC. The new centralised court – initially at least – is an unknown entity for litigants. As a result, pharmaceutical patent owners who have invested heavily into years of R&D are likely to consider ‘opting out’ of the court’s jurisdiction during the sunrise period to be the lower risk strategy.

Indeed, it is widely expected that a majority of high value patents in the pharmaceutical sector will initially be opted out from the jurisdiction of the UPC, in order to avoid the threat of central revocation. In the longer term, however, it will be interesting to watch how the new system develops, especially on the key issue of supplementary protection certificates.

Julie Carlisle and Robert Watson are Partners at Mewburn Ellis.
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