LSIPR webinar: CAR-T trends show increased filing for narrower tech, says HGF partner

CAR-T cells have achieved hugely-positive outcomes in treating forms of cancer that are otherwise difficult to treat.

As a result, there has been a dramatic rise of patent filing in this area, as Iain Armstrong, partner at HGF discussed in a webinar hosted by LSIPR, CAR-T and other immunotherapies, yesterday, September 3.

CAR-T cells are a part of adopted immunotherapies, in which the body's own cells are removed and adapted outside of the body, and then returned. These adapted cells then facilitate the clearance of disease by binding to cancer cells and killing them,

As Armstrong explained, this is a complicated process which usually takes 22 days and comes with a high cost.

“CAR-T therapies have shown good results at a high level in blood cancers which are otherwise difficult to treat,” he said.

There are currently two CAR-T-based drugs which have been approved by the US Food and Drug Administration and the European Commission.

These are Kymriah, by Novartis, which costs $475,000 per treatment, and Yescarta by Gilead, which costs $373,000 per treatment.

But while the cost is high, Armstrong said that just one treatment should provide complete clearance of the cancer, as opposed to the ongoing cost of current therapies for cancers which are difficult to treat.

He said this is helping to ensure the market for CAR-T therapies is expected to expand to upwards of $3 billion by 2025.

And the market’s projected success directly collates with the rise of patent activity in the area.

“Filing numbers are increasing dramatically,” Armstrong said, adding that while there were around 60 PCT applications filed in the area in 2014, this rose to 450 applications in the year 2018.

Of those, most were filed by inventors in the US and China.

Importance of novelty

While earlier filing activity was for a smaller number of patents covering broader technologies, recent trends show that more applications are being filed covering narrower, incremental technologies, Armstrong said.

He added that while some of these filings may cover future blockbusters, others are likely to be for parts of products combining multiple patented technologies.

One reason for the change in patent strategy could be due to key patentability concepts.

The key requirements for a patent is novelty, which means the invention must be new; an inventive step, which means the patent must not be obvious in light of prior art; and the impact of data.

The “impact of data” means that the application must include data which demonstrates the effectiveness of the invention, and that the invention works as claimed by the patent.

“If you have limited supporting data that might mean you are limited to patent protection that fits around the limitations shown in the data,” Armstrong explained.

Using data when assessing the inventive step of an invention is particularly relevant in biotech and therapeutics, he added.

As more patents are filed in the area, it may become more difficult to prove that an invention is novel or has an inventive step, which is why patents are being filed for narrower technologies.

He said the areas where CAR-T patent filings are particularly high are for improved biological activities, directed to new targets, for use in solid tumours, and in non-tumour cells.

Listen to the webinar: CAR-T and other immunotherapies

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