Amgen, GSK, Regenxbio and others urge SCOTUS to review 'damaging' decision on biomedical patents
The Supreme Court should weigh in on a recent Federal Circuit decision that “defies history and precedent” and could upend the entire biopharma innovation ecosystem, a group of drugmakers and research institutions told SCOTUS in amici briefs this week, backing Bristol Myers Squibb’s bid to re-review a case against Gilead’s Kite Pharma.
The case in question centers on a CAR-T therapy patent first obtained by Memorial Sloan Kettering Cancer Center, which then commercially developed the therapy under an exclusive license to Juno, a company later bought by Celgene for $9 billion, and then acquired by BMS. But another, similar CAR-T therapy was developed without such a license by Kite.
Drugmakers and several research institutions are now backing BMS’ SCOTUS request, explaining how the Federal Circuit invalidated Sloan Kettering’s patent by applying an “unworkable ” standard that “strays from the statutory text.”
BMS asked SCOTUS last month to reinstate its $1.2 billion jury win against Kite, arguing that the Federal Circuit went too far in requiring that this “written description of the invention,” which it said must demonstrate the inventor’s “possession” of “the full scope of the claimed invention,” including all “known and unknown” variations of each component.
“The CAR technology at issue in this case is emblematic of the valuable lifesaving research coming out of academic research institutions, whose further development efforts may be stymied by the decision,” several research and academic centers wrote in support of BMS.
Amgen, GSK, Bavarian Nordic, Corning and others also supported BMS, explaining how this decision could make biomedical companies jump through new hoops and spend significant sums to meet this new “possession” requirement:
To even try to show that they have full ‘possession’ of their invention, innovators may have to expend tremendous resources producing an exhaustive catalogue of every variation of the inventive product. And when one considers the cumulative effort required for every inventor to perform that work for every patent application, the costs imposed on the industry are truly staggering. That wastes resources that could be spent on further innovation. And it adds nothing to the store of scientific knowledge
Regenxbio similarly called the Federal Circuit decision a “misapplication” that “lessens inventors’ likelihood of recouping the costly investments necessary for groundbreaking biotechnology and biomedical innovation, and it impedes the objective of the patent system to promote the progress of the useful arts.”
Biologics and other related inventions can often be modified in countless minor ways, the companies note, without affecting their function, which means they face special challenges in meeting this new written-description standard.
The drugmakers further note how this decision could create more of an already fervent me-too culture among the biopharma industry.
“Companies will increasingly eschew high risk research that addresses the most pressing and challenging medical problems in favor of chasing certain returns in the form of redundant therapeutics to known biological targets. But without any investment or appetite for innovation, the stock of new therapeutics to replicate will dry up,” the companies’ lawyers wrote.