Mapping the IP Landscape

The field of personalised medicine is diverse, and a dialogue with interested technology, patent and business experts needs to begin.

The US Food and Drug Administration’s Center for Drug Evaluation and Research has defined personalised medicine as “... using genetic or other biomarker information to make treatment decisions about patients”. The European Commission uses the term personalised medicine to refer to “a medical model using molecular profiling for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention”.

Using either definition, personalised medicine includes a broad range of processes and technologies, across aspects of diagnostics, data analysis, treatments, treatment monitoring and related areas. We have summarised selected personalised medicine areas and indicated some interrelationships between these areas in Figure 1. These areas feature the application of both pre-existing technologies and emerging innovations, all of which can be the subject of patent applications.

Partnerships in personalised medicine

Partnerships can be pivotal to securing value in personalised medicine, as might be expected in a technologically intense area where very diverse capabilities may be required to deliver effective solutions.

Drivers for partnerships in personalised medicine include:

•Capability gaps: personalised medicine players may lack internal capabilities spanning relevant technology and business requirements;

•Cost: capabilities can be costly to develop and maintain, making outsourcing certain capabilities a cost-effective option for even the largest of players; and

•Emerging ‘value chains’: new technologies open new opportunities to securing value (eg, new targets, more complex targets, optimised dosages), possibly increasing the complexity of commercialisation options.

Personalised medicine patent activity

Clear reference points and boundaries are essential to informing assessments of relative positions within an ‘IP Landscape’, a report that provides a snapshot of the patent situation of a specific technology. Defining personalised medicine and developing the axes on which to plot and interpret the vast amounts of data available are vital for useful IP Landscape mapping. For those who can draw an informative patent map and work out a good navigational route through complexity, there is an opportunity to gain significant competitive advantages.

To draw an analogy from Lewis Carroll’s The Hunting of the Snark, without boundaries, maps become meaningless plains which, while they may provide comfort, do not really improve understanding.

He had bought a large map representing the sea,

Without the least vestige of land:

And the crew were much pleased when they found it to be

A map they could all understand.

CambridgeIP conducted a snapshot of the IP Landscape of personalised medicine in May 2014. The snapshot is not comprehensive and serves to simply illustrate high-level trends and to identify most active players and commercial focus areas. It is important to note that many relevant technologies enabling personalised medicine solutions predate the emergence of ‘personalised medicine’ as well-known terminology.

Figure 2 illustrates patent family filing trends from our personalised medicine IP Landscape snapshot.

There are around 12,000 patents and patent applications in our IP Landscape snapshot, in more than 6,000 patent families—indicating a dynamic area, with a relatively high proportion of individual innovations given

the overall age of the area (as patent families can be considered as proxies for individual inventions).

As Figure 2 illustrates, there has been an appreciable increase in personalised medicine patent activity from around 2001 onwards. Patent activity in the area appears to have levelled from around 2006 at a relatively high level, possibly indicating sustained commercial interest in the overall area. Top patent owners (or assignees) in personalised medicine form a vibrant mix of pharmaceutical corporations and academic institutions.

Using comparative techniques, readers of IP Landscape maps can build up a detailed understanding of industry structures, trends in commercial research and development (R&D) interests, the relationships between technology components and relationships between entities active in the relevant areas.

“Using comparative techniques, readers of IP Landscape maps can build up a detailed understanding of industry structures, and trends in commercial research and development interests.”

Fact-based investment, business, IP and R&D strategies are enabled even in highly complex technology-market spaces. For the purposes of our IP Landscape snapshot we broadly divided personalised medicine patents into three high level areas: diagnostics, therapy and data processing using International Patent Classification (IPC) codes as quick proxies for the three areas (Figure 3).

Figure 3 illustrates patent activity trends over time in the three areas we defined for this IP Landscape snapshot.

Diagnostics accounts for most new patent activity in the area—perhaps reflecting the pre-existence of much therapy-related IP; and

Data processing is a theme that appears to be increasing steadily in importance since around 2000—one driver is improvements in sequencing technologies, which drive up data availability.

Case study: Myriad Genetics

Myriad Genetics, Inc is a US-based molecular diagnostics company, perhaps best known for its heriditary breast and ovarian cancer testing involving the BRCA1 and BRCA2 genes. Myriad Genetics also offers predictive tests for other cancers, including colorectal, uterine and pancreatic cancers.

Consideration of the Myriad Genetics’ patent portfolio enables us to identify several phases in the Myriad Genetics IP strategy, illustrated in Figure 5. These phases are:Myriad Genetics’ patent portfolio includes patents from the early 1990s to the present day. Figure 4 summarises Myriad Genetics’ patent activity over time. Spikes in patent activity in 2001, 2002 and 2007 are followed by what appears to be a decline in patent activity (even after accounting for a lag in the publication of patent applications).

A national phase, with mainly US patent filings and a ‘traditional’ patent-enforcement strategy;

An international roll-out phase, where the national patents and enforcement strategy are rolled out around the world and the company begins to make some patent acquisitions; and

A trade secret phase, where in more recent years Myriad Genetics begins to rely more heavily on trade secret protection—especially around ‘variants of known significance’ (VUS) data; and as older Myriad Genetics patents approach their expiry dates.

Conclusions

Co-dependences and strategic or practical reasons for relying on externally developed technologies may impact partnering and IP strategies in personalised medicine partnerships. Such co-dependencies and requirements for reliance on external parties’ developments in personalised medicine are often the result of the capability gaps mentioned above. To provide a simple example, a drug company may depend on a companion diagnostic for launch of the drug, while a diagnostics company depends on the drug’s success to sell the companion diagnostic to that drug.

In such cases, the focus of partners can dictate the value the partners place on particular components of a personalised medicine solution, and consequently the component-related IP they seek to own or control. For example, IP relating to diagnostics platforms will probably be of most interest to a diagnostics development company, whereas IP relating to drug products will probably be of most interest to a drug development company. This, coupled with co-dependencies, can lead to relatively balanced negotiating power between potential partners.

To continue with the simple example above, a companion diagnostic is of less value if it cannot be deployed in a drug’s key geographical market. As in other areas, personalised medicine IP-related partner selection criteria can include a Freedom to Operate (FTO) assessment of whether you and your potential partner have FTO around key developments and in key geographical markets.

Thorough IP Landscape research is often required to help identify and rank partners, as well as to inform negotiating positions and fact-based future IP strategies. As ever, do not forget to consider what happens if your partnership fails. Partnerships can end unexpectedly, and for unexpected reasons. Think through the implications of failture from the IP perspective. For example, who will own the IP created? And how will past and future IP-related costs be distributed?

The growing importance of data and of related technologies for storing, searching and analysing data in many personalised medicine solutions is interesting and may impact partnering and IP strategies. As more information is gathered in relation to individuals and their responses to treatments and other factors, data grow in size, becoming more detailed and more valuable.

Data and data protection appear to be an increasingly important aspect of the Myriad Genetics IP strategy, for example. It will be interesting to observe trends in this and other aspects of the personalised medicine IP Landscape over the next several years.

Quentin Tannock is the executive chairman of CambridgeIP, a research and analysis consultancy focusing on innovation and IP. He can be contacted at: quentin.tannock@cambridgeip.com

Anna Duch is a senior associate at CambridgeIP. She can be contacted at: anna.duch@cambridgeip.com