The genomics field is no stranger to IP lawsuits. But according to Lee Bromberg, cofounder of Bromberg & Sunstein and chair of the law firm’s litigation group, “We’re just seeing the beginning of these struggles in the biotech space.”
As the legal scene heats up, more and more scientists unfamiliar with terms like “equitable estoppel” may be taking crash courses in law or forking over hefty retainer fees for attorneys who understand patents and biosciences.
Bromberg visited the GT office this spring to discuss some of the main issues the field is likely to face. A major one stems from the American quirk of inventorship, he says. While most countries issue patents to companies, the US Patent and Trade Office assigns patents to individuals. With collaborations popping up throughout genomics — especially between academia and the private sector — it becomes “very hard to tease out inventorship,” Bromberg says. Expect to see more and more cases based on the “I invented that, they didn’t’” argument.
No surprise to this industry, Bromberg says the rash of gene-sequence patents issued before the clarified utility rule at the start of 2001 will no doubt mean more legal headaches. While he does predict that such patents will stand — challenges probably won’t overturn the patents, which were legitimately obtained at the time — he adds that it’s unlikely they’ll be enforced since they’re so broad and often don’t have listed uses. (The patent office came under such fire for the gene-sequence patents that there’s now a review protocol, almost like a buddy system, for patent application examiners, Bromberg notes.)
“We’re likely to see more continued filings and patents that claim a particular genome sequence, claim a particular use, or particular combinations of ways to do things,” as companies try to mold overly broad gene-sequence patents into something that could be enforced, Bromberg says.
Anyone in the genomics industry should be paying attention to landmark cases, he adds. Last year’s Festo decision, for instance, changed how courts look at amended claims in patent applications. And a strengthed doctrine of equivalence opened up infringement suits from the previous narrow definition of infringement (where it has to be an exact duplication of a patented idea) to situations where “it’s really close” but not exact, Bromberg says.