A year ago in this column, I talked about Madey v. Duke, a case that sent shivers down the spines of people who relied on a traditional protection granted to academic and other researchers to use patented inventions for research purposes without worrying about needing a license to the technology. That protection, commonly known as the research exemption, is once again at the center of a major case.
This one focuses on a different angle of the research exemption — one granted to pharmas and biotechs, enabling them to use patented tools so long as it’s being done for the purpose of gathering information to send to the FDA. This case, Merck v. Integra LifeSciences, has been through federal and circuit courts — where judges sided with Integra, which sued Merck for infringing its peptide patents — and was scheduled to be heard by the Supreme Court in late April, with a decision expected in June.
Normally, cases about this particular statute are of interest primarily to those in late-stage pharma research — but this one has so many genomic tools companies up in arms that it’s worth checking out. Briefly: Merck researchers were using one or more peptides that were patented by Integra in a screen for drug candidates. Integra sued for patent infringement, and won both the original case and Merck’s first appeal. Merck maintains that it was protected by the safe harbor law, but courts ruled that the research being done was basic and early-stage, not solely to provide information to the FDA.
So what does all this have to do with tool manufacturers? Essentially, they fear that a decision in Merck’s favor could have the side effect of broadening the research exemption to cover all manner of technologies used in pharmas or biotechs.
Invitrogen led some of these in the filing of an amicus brief to the Supreme Court, joined by among others ALSSA, the tool manufacturers’ group Analytical and Life Science Systems Association. Their primary concern is actually not whether Merck wins this appeal, but to make sure the court is precise enough in the language it uses in its decision to prevent this from becoming precedent in the tools industry.
“Even if nobody intended this to cover tools,” says Dick Evans, corporate counsel for intellectual property at Agilent, “just by virtue of the absence of a statement” clearly indicating this case is not about tools, this “would give infringers [a possible defense] if they are even remotely involved in drug development.”
Alan Hammond, chief intellectual property counsel for Invitrogen, says the trickle-down effect of such a decision would be a drastic reduction in innovation among tools manufacturers. “At the end of the day, to have a legal ruling that could hurt … the innovation of tools — ultimately the scientists in the lab will not be able to have access to the tools that are made through those inventions.”
Meanwhile, another amicus brief was filed by the American Intellectual Property Law Association, arguing (like Invitrogen’s, on behalf of neither party) that the safe harbor protection should be interpreted broadly, including work further upstream and possibly research on drugs or compounds other than the one headed to the FDA.
ALSSA President Michael Duff says, “If the court is not careful, [this] could have a disastrous impact on this industry.” The life sciences sector was built on IP, he adds. “An awful lot of technology is developed by younger companies that have traditionally relied on venture capital funding. If there is some question about whether or not a company can assert and protect and enforce intellectual property protection of their technologies, are they going to get venture capital funding to build their businesses?”
All eyes will be on the Supreme Court next month for the decision. The tool manufacturers are genuinely worried, but is their fear founded in reality? It seems that only time — and the wording handed down by the Supremes — will tell.
Meredith Salisbury, editor of Genome Technology, can be reached at [email protected] Her Legal Probe column on legal and IP issues affecting the genomics industry appears bi-monthly.