Senior Pensions Consultant
Out-Law Analysis | 15 Nov 2019 | 3:41 pm | 4 min. read
The recent Chartered Institute of Patent Attorneys (CIPA) annual life sciences conference in Brighton offered an insight into what some of those changes are and pinpointed noteworthy differences, in particular, across the UK, the rest of Europe, the US and China.
we need to widen the debate on access to medicines and this is an issue that goes beyond the subject of intellectual property
Technology is more important than ever in helping to deliver new medicines and other innovation in life sciences, and is central to the personalisation of medicine we are witnessing.
The CIPA conference delegates were given an insight into some of the foremost technologies driving innovation in the sector. These include the CRISPR gene editing technology, the patent rights to which there is an ongoing dispute over. There was discussion too about the growing role of bioinformatics and artificial intelligence (AI) in health care.
The impact of AI spans the spectrum of the life cycle of a drug in the pharma sector and has already delivered demonstrated benefits in patient care in some areas.
At the early stages, AI is informing the drug discovery process, by enabling the identification of new molecules that can potentially be used as drugs, and new targets in the human body for treatment. Later in development, it is being used to accelerate clinical testing of prospective new medicines. For instance, AI can assist in the recruitment process for such trials, monitor patient compliance during the trials and identify side-effects experienced by patients.
A range of companies are also developing AI applications that track and monitor a person’s lifestyle or compliance in taking medicines, offer nutrition coaching and exercise plans.
On a broader level, programs such as IBM Watson are already being used by hospitals to support diagnosis and create management plans for oncology patients.
Further innovation is anticipated, but there remain questions over the patentability of inventions stemming from AI-based systems. There are also broader issues over how the patent system as a whole should support life sciences companies to overcome the combination of commercial, regulatory and political pressures the industry faces in light of pioneering development across the field.
As the CIPA conference heard, different responses to these challenges are emerging across jurisdictions.
In England and Wales, the courts have adopted a pragmatic and flexible approach when considering the scope of injunctions in pharma patent litigation, seemingly placing the needs of patients and public health issues more generally at the heart of their decisions.
Delegates were given an insight into the steps being taken by the European Patent Office (EPO) to help future-proof the European patent system. In this regard, the EPO has been training its patent examiners on the latest technology so that they are in a position to better assess whether patent applications for computer-implemented inventions, for example, meet the test for patentability. The EPO is also updating its procedures to try to speed up the time patent oppositions take in an effort to help companies get some certainty sooner.
In China, where criticism is sometimes levelled about the protection afforded to the IP of foreign companies, significant steps have been taken recently to bolster the patent framework in support of life sciences. A new IP Tribunal has been set up where experienced judges are in a position to deal with appeals in patent cases. The enforcement regime has also been strengthened, including with the introduction of a new offence of wilful infringement. This has the potential to increase the damages payments rights holders can obtain from infringers.
In the US, the courts are being less sympathetic to the challenges of industry. To the frustration of industry, and despite requests from lower courts to do so, the US Supreme Court has declined to clarify what kind of treatment claims pharma businesses can make while remaining within the boundaries of patent eligibility. In the absence of clear Supreme Court case law, the US Patent and Trademark Office has attempted to offer some guidance on the issue to help pharmaceutical manufacturers better understand the nature of claims they could include to ensure would-be patents are approved. A legislative solution is anticipated to clarify the issue, but to-date no draft legislation has been prepared.
On broader questions impacting the industry and society as a whole, a panel of experts, including CIPA president Julia Florence, acknowledged that there is a balance to be struck between opening up access to innovative treatments and doing so at a price that is both affordable to the taxpayer and which is sufficient to compensate pharmaceutical manufacturers for the time and resource it takes to develop those treatments.
This is a topic which attracts significant political attention and press commentary. As Julia Florence said, we need to widen the debate on access to medicines and this is an issue that goes beyond the subject of intellectual property.
As pressure builds on industry to develop new medicines to treat diseases, so society as a whole must join the debate as to what it wants from medicine, and what diseases it wants treated, who it wants to treat and when – under the current model it is not possible to incentivise and pay for it all. We need to give thought as to where resources should be prioritised and what models of incentives and reimbursement are needed.
With reflections on developments past and present, as well as a gaze into what the future holds for the life sciences sector, the 20th annual CIPA life sciences conference highlighted the evolution of different patent and court systems worldwide.
Nicole Jadeja, Tracey Roberts and Krishna Kakkaiyadi are life sciences experts at Pinsent Masons, the law firm behind Out-Law. Nicole Jadeja was one of the chairs of the CIPA life sciences conference this year and is a member of the CIPA life sciences committee.
11 Nov 2019
12 Sep 2019
Senior Pensions Consultant