Myriad Could Lead to More Trade Secrets

The U.S. Supreme Court ruling two weeks ago invalidating the patentability of isolated, naturally occurring DNA segments could lead more biotechnology firms to conceal their discoveries, rather than enter the patent process.

DNA shot

“A possible consequence is that some companies may consider keeping their discoveries as trade secrets rather than entering the patent process,” says Melanie Szweras, a patent lawyer at Bereskin & Parr in Toronto, “and that’s sort of the concern from an innovation perspective. Because if you can’t get a patent then you might choose not to disclose your invention.”

The Myriad ruling makes the United States an outlier jurisdiction when it comes to the patentability of natural DNA segments. David Schwartz, a patent lawyer at Smart & Biggar in Ottawa, says that the issue has not been addressed by the Canadian courts. “Isolated DNA is considered to be patentable, and the Canadian Patent Office has issued claims to isolated DNA for many years and will presumably continue to do so. Myriad, the decision of a foreign court, should not directly affect this.”

In Europe, meanwhile, Schwartz cites a 1998 directive that states that “an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”

While claims to isolated DNA segments remain patentable most everywhere, Szweras believes the U.S. ruling – brought by medical associations that felt restrained by Myriad’s patents – may prompt associations here to try their luck. “I’m sure there will be interest groups here that will want to try a similar challenge in Canada, but at this point the U.S. is on its own.”

In the short term, the ruling doesn’t mean all that much for the pharmaceutical and biotech industries. While DNA occurring in nature would seem to cover a broad swath of useful data, Szweras says that patents based on these molecules are only one weapon in a broad arsenal used to protect commercial inventions — for Myriad and other biotechs.

“There will definitely be some claims in U.S. patents that could be invalidated based on this ruling,” she says. “However, typically companies will have a variety of claims … which are unaffected by this decision.”

Perhaps most importantly, the Supreme Court ruling expressly states that synthetically altered or “complementary” DNA (cDNA) remains patentable. Schwartz says this is far more important, given that drug companies are (through recombinant protein technology) trying to develop “unnatural” molecules that produce decidedly unnatural effects on the human body (in the sense that fighting off a fatal disease can be considered unnatural).

The ruling isn’t without consequence, though. Schwartz says there’s a possibility, for instance, that biotech firms could use the discovery of an important DNA segment to produce a competing test or treatment. That test, however, would have to avoid infringing on various commercial patents — requiring entirely different methods.

David Dias

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