Update (04/06/2020): After upholding four of Kymab’s patents addressing the production of antibody drugs earlier this year, the US Patent Trial and Appeal Board has rejected Regeneron’s attempt to invalidate a fifth patent regarding the same technology. So far, Regeneron has not requested a re-hearing from the Board regarding the decision to uphold Kymab’s first four patents, but it’s unlikely that the legal battle is over yet.
UK biotech Kymab has won the latest skirmish in its ongoing legal battle with the US giant Regeneron regarding patents protecting their rival antibody-producing technologies. The outcome of the battle could have big implications for biotech patenting as a whole.
In the latest clash, Regeneron challenged the validity of four of Kymab’s US patents named the ‘Bradley Patents,’ which address technology based on the production of human antibody therapeutics in mice.
The US heavyweight requested a post-grant review of these four patents by the US Patent and Trademark Office’s Patent Trial and Appeal Board. However, the Board declined to continue the proceedings, explaining that Regeneron “has not demonstrated that the Examiner materially erred” in the initial patent assessment. Kymab declined to comment on the latest decision.
Prior to this latest decision, relative newcomer Kymab had staved off challenges from the more established Regeneron regarding equivalent patents that it had protected in Europe and Japan.
But there remains much to play for. The two companies’ disputes have rumbled on for several years and the battle could end up shaping the way the patent system protects inventions in the biotechnology field.
In a separate skirmish happening on the other side of the pond, legal experts and the biotech industry are eagerly awaiting a potentially game-changing ruling on Regeneron patents by the UK Supreme Court. The patents at the center of the dispute are related to the genetic modification of mice to produce antibody drugs based on human antibodies.
In essence, mice can be genetically modified to produce human antibodies using human gene sequences, but this can also make the mice ‘immunologically sick,’ with poor immune responses and a reduced ability to produce antibodies.
Regeneron’s UK patents provide a potential answer to this issue: a reverse chimeric locus. This is a genetic modification that enables transgenic mice to make antibodies using a mix of human and mouse gene sequences. The mouse DNA section of the antibody can later be replaced by a human equivalent to make it safer for patients.
Kymab is challenging the validity of Regeneron’s UK patents and is attempting to overturn a previous UK Court of Appeal decision that upholds the validity of these patents. The UK biotech is arguing that Regeneron’s claims are too broad and that the patents do not contain enough information for the invention to be reproduced without undue burden on the ordinary skilled person.
Nicole Jadeja, a life sciences lawyer at Pinsent Masons, told me the hearing in the UK Supreme Court in February was well attended by industry as well as the legal and patent attorney profession and is being closely followed.
“In the biotech space and specifically in the antibody field, where innovative products and platforms are being developed, the dispute between Regeneron and Kymab raises important issues around how best, and when, to protect this type of innovation and how much work needs to be done to get a claim of commercially meaningful scope,” she said.
Neil Jenkins, who focuses on litigating patents at international law firm Bird & Bird, told me that if the Regeneron patents are upheld, it could arguably open the door to similarly broad product claims in other areas.
“On the one hand, the permissibility of broad claims could be said to reward research leading to ground-breaking advances in any given technology,” he said.
“On the other hand, it could also be said to encourage speculative claiming which in turn will make it difficult to determine whether there is the freedom to operate in the field of interest and… as such, has the potential to close off areas of research.”
The global therapeutic monoclonal antibody market alone is expected to generate in the region of €220bn by 2025 for indications ranging from cancer to rheumatoid arthritis, cardiovascular disease, and asthma. For this reason, successful innovations in the industry are likely to be highly lucrative.
The UK Supreme Court ruling is expected before the end of the summer.
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