A low-profile biotech bests Regeneron in high-profile patent suit
For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.
Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.
The year before those suits, though, Regeneron alleged in the European High Court that Kymab had infringed on a patent they had filed in 2012 around ways of genetically modifying a mouse. It was the first of several different patent suits between the companies. Seven years later, that fight is still ongoing — a UK Supreme Court decision is pending — but Kymab has just won the latest salvo. The US Patent Trial and Appeal Board (PTAB) rejected in April Regeneron’s request to invalidate 4 Kymab patents, and today they rejected a fifth one.
The case could have impact both broadly on how biotechs choose to patent their inventions and specifically on Kymab, a company that, after raising over $220 million, is now in the early clinical stage and indicated its interest last year for a US IPO.
Kymab has its own name for their humanized mice: Kymouse. Spun out of the Wellcome Trust’s genetics-focused Sanger Institute, the company was founded in 2010 and their platform works similarly to Regeneron: infect a mouse with a virus, for instance, and instead of murine antibodies, the mouse will create human antibodies that in theory can then be given to a patient. The company unveiled the platform in a 2014 Nature Biotechnology paper.
By 2015, the two companies were in patent disputes in four different countries. At the center of the case were patents Regeneron had placed on a solution to a tricky problem making transgenic mice. Roughly, the first attempts to reap human antibodies from genetically modified mice had failed because when you give a mouse a fully human immune system, the mouse becomes “immunologically sick,” meaning it can’t mount as forceful an immune response and generate as many antibodies as a normal, mousified mouse would.
Regeneron figured out that you prevent this immunological shortfall by leaving certain mouse DNA sequences intact and swapping them out of the antibodies before you give them to patients. The technical term for this is a “reverse chimeric locus.” Kymab also uses reverse chimeric locus to create their antibodies.
While alleging Kymab infringed on their patents in Europe, in the US, Regeneron alleged that Kymab’s antibody patents should be thrown out on the grounds that they were an “obvious” extension of Regeneron’s work. In April, the PTAB upheld a previous ruling that 4 of Kymab’s patents were valid. Today’s ruling upheld the validity of the fifth and final patent in dispute.
With the Japan suit over and an Australian court recently ruling in favor of Kymab, the last domino is in the UK, where Regeneron argued that Kymab’s mice infringed on their patented strategy. Kymab argued that Regeneron’s patents did not give easy instruction for an expert to carry out the protected science – as patents must. A 2016 ruling sided with Kymab, a 2018 ruling with Regeneron, and in February, the UK Supreme Court heard the case. Both companies now await their verdict.