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PA OPINION

CAR-T: Creating an effective IP strategy

The cell and gene therapies promised for years are finally becoming a reality. Personalised CAR-T treatments have been developed for leukaemia and lymphoma, offering new hope for patients with these notoriously tough to treat diseases.

But no one is yet fulfilling the potential of CAR-T. Not only can it treat acute lymphoblastic leukaemia (ALL), it should be able to target solid tumours such as melanoma, breast cancer and sarcoma, and even holds promise in treating other issues such as Alzheimer’s and auto-immune diseases. Considering this, it’s no surprise that CAR-T is a hot topic for the healthcare and pharmaceutical industries.

Of course, there are challenges associated with CAR-T from a scientific, manufacturing and business perspective. There needs to be research to mitigate dangerous side effects such as CRS (cytokine release syndrome). Pharmaceutical companies need to create an effective manufacturing strategy to meet rising demand. And the entire healthcare ecosystem must work together to overcome the extremely high treatment cost barrier ($650,000 per dose).

So, both incumbent companies and emerging players need an effective commercialisation strategy to stay competitive in the CAR-T space. To inform such a strategy, organisations can gather important insights by closely examining the rapidly evolving CAR-T patent landscape. This would include who has the best patents to invest in, which geographies are best to target and how to accelerate development of more effective manufacturing processes.

The rapid rise of CAR-T patents

Although young, innovation in CAR-T cell therapy has ramped up rapidly over the last decade. In 2009, there were less than 10 patent applications for CAR-T technology in total. In February 2019, there are 2,497 INPADOC families covering over 7,400 patent documents. There were 189 INPADOC families for CAR-T published in February 2019 alone. This rapid rise in patenting activity has had two major consequences.

First, few patents (seven per cent) are granted and active, meaning we’re currently sitting on an enormous backlog of patents, many of which will be granted soon.

Second, considering how quickly the patent landscape for CAR-T cell therapy has become crowded, it will become ever more challenging for companies to enter this exciting field.

What does this mean for your IP strategy?

Imagine a balloon. You can add air, increasing the concentration and activity of the gas within. To accommodate this influx, the balloon can grow, but it will inevitably become more and more difficult to add air.

Similarly, while the innovation landscape for CAR-T will continue to grow, it will become harder and harder for new players to enter the space without infringing existing patents. The CAR-T balloon is already relatively full, and the rapidly increasing number of patents that will be granted will make it even more challenging for new players.

As we fulfil the potential of CAR-T cell therapy and its applications become more widespread, the industry will become more valuable. When the value rises, so will the risks. Infringement will occur. Litigations will happen. For both start-ups and pharma giants, this may prove to be a difficult challenge to manage effectively.

Currently, the CAR-T space is crowded by academics and start-ups, and their IP will become highly valuable in the future. Incumbent pharma companies will need to strategize effectively to gain a strong footprint in the CAR-T space. They must avoid the risk of litigation and maximise the benefits of their technology by making sure they have access to the valuable IP that exists in this field. Before it gets too late. Before it becomes too valuable.

How can companies create an effective CAR-T IP strategy?

Major pharmaceutical players must find a path into the CAR-T space. But should they license from academics? Or do they buy start-ups and their IP portfolio? Both options could open huge opportunities. The only thing they must not do, is nothing. The key players are already at work.

Although Novartis faces many challenges with their product Kymriah, they are one of the leaders in the IP space for CAR-T technology. Celgene bought Juno Therapeutics, a newer player with a strong IP portfolio in the CAR-T space, in January 2018 for $9 billion. Then BMS bought Celgene for $7.4 billion in January 2019. In our view, this was most likely to gain access to Juno and Celgene’s valuable IP in the CAR-T space

Academics haven’t been sitting still either. Licensing deals between the key academic institutions have continually occurred over the last five years.

This is a crowded, valuable and rapidly growing landscape. To accelerate development and production, pharma companies may need to put in place patent cross-licensing deals, as is the case in the electronics and telecom industries. This will require companies to develop strategic patent portfolios to ensure they have the right size, geographical spread and quality to achieve success at the negotiation table. That means:

  • identifying strong IP portfolios from emerging players for potential acquisition
  • putting in place patent cross licensing deals
  • undergoing detailed patent landscaping to identify opportunities and effectively strategize IP portfolios.

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