Genetics case has huge implications for N.J. biotech industry

Jessica Perry//April 16, 2013

Genetics case has huge implications for N.J. biotech industry

Jessica Perry//April 16, 2013

The Supreme Court heard arguments this week on whether products involving human genes can be patented, a landmark case that could impact New Jersey’s biotech industry.

Myriad Genetics Inc., a Salt Lake City-based molecular diagnostics company, argued Monday its ability to isolate DNA creates a new and useful molecule that had not previously existed. The genes, called BRCA1 and BRCA2, are used to diagnose breast and ovarian cancer and potentially other types of cancer.

Gerald Norton, a Princeton attorney who has represented biotech and pharmaceutical companies in New Jersey, is skeptical that the court will support Myriad’s argument, a conclusion he drew after reading transcripts from Monday’s session.

A decision is expected in June.

“We’re a little nervous, like cats in a room full of rocking chairs, for this decision to come out,” said Norton, who heads the intellectual property department at Fox Rothschild LLP. “It’s going to have a negative impact.”

Opponents in the case, listed as the Association of Molecular Pathology v. Myriad Genetics, argue that genes, like other products of nature, are not inventions and should not be patentable. Allowing such protection will slow future research and discourage lower-cost alternatives, opponents say.

But the justices appeared hesitant to take any action that would broadly invalidate patents, Norton said, fearful that a bold move could undermine incentives for research.

Norton said one outcome is a “split the baby” approach, where the court rules isolating genes are not patentable because they are products of nature, but synthetic molecules — known as cDNA, new products made by scientists — could be upheld.

“We don’t deny that you can’t put a patent on gravity,” Norton said. “But where human ingenuity is involved and you’ve made changes — and these are not trivial changes — then that rises to level of patent protection.”

The protection provided by patents generates critical revenue and draws investment for the life sciences industry, Norton said, leading to more research. He worries that invalidating Myriad’s patents could set a precedent that would challenge other industry patents that involve parts of nature.

Norton provided an analogy, which was argued by Myriad attorneys, that while a tree is a product of nature, making a baseball bat is an invention involving human creativity. But Supreme Court justices expressed skepticism that isolating DNA amounts to manufacturing a new product.

BioNJ, which advocates for life sciences companies in New Jersey, is watching the case closely. The industry group hopes that whatever the outcome, the court will clearly signal that it recognizes the value of innovative research and will not dampen incentives.

“We’re certainly following it,” BioNJ President Debbie Hart said. “We are not experts, but we’re hoping for a decision that enables innovation to move forward.”

Hart noted that it costs life science companies an average of $1.2 billion over 10 to 15 years to bring a drug to market.