Upon Further Review, Your Biotech Patent Is Invalid

A few Sundays ago, the Detroit Lions’ Golden Tate caught a quick slant pass in the final seconds of a game against Atlanta Falcons and landed in the end zone, securing what looked like a dramatic win.

Instead, the Lions and a boisterous Motown crowd suffered a crushing loss. The ruling on the field, a touchdown, was overturned—the referees said Tate’s knee hit the ground before the ball crossed the goal line.

That’s kind of how it goes for life sciences patent holders these days, government, industry, and legal players said at a Biotechnology Innovation Organization symposium Sept. 29. Applying the legal framework the Supreme Court established in its controversial 2012 Mayo decision, judicial referees are regularly invalidating biotech patents once thought secure.

It’s “the soul-crushing feeling of having a game-winning touchdown overturned by replay,” said Kwame Mensah, senior patent attorney and intellectual property lead with AstraZeneca and its MedImmune subsidiary. Mensah included a photo of Tate falling into the end zone in his slide presentation.

“The question is, how can we avoid this?” he said. “How can we guarantee our touchdowns stand?”

The Supreme Court says laws of nature, natural phenomena, and abstract ideas are not patentable without novel or useful application of them. Mayo provides a two-part test for determining whether these exceptions apply. The federal circuit’s 2015 Ariosa decision applied the test broadly, as patent holders had feared. Since Ariosa, which invalidated a patent on a breakthrough prenatal genetic testing method, courts have consistently struck down biotech patents—especially diagnostic ones—as covering ineligible subject matter.

Like incompletions under the NFL’s old tuck rule or its swelled catch rule, “I don’t know why these cases are decided the way they are,” said Hans Sauer, BIO’s deputy general counsel for IP. “I can, for every one of them, construct an alternative rationale that’s as logical and has as much support.”

A Hail Mary option for patent holders is amending 35 U.S.C. § 101, which sets forth patentable subject matters. The Intellectual Property Owners Association, American Intellectual Property Law Association, and the American Bar Association’s Intellectual Property section each released proposals this year after years of work. All three allow exceptions to patentable subject matter, but they specify them, Sauer noted. The current exceptions are judicially created.

“All three organizations reached the point of saying, ‘We can no longer leave this to the courts. This really, really ought to be addressed by Congress,’” Sauer said. “That to me was an important milestone.”

“It might not become law anytime soon,” he said, “but a hearing in the House or in the Senate on the matter, that’s maybe not too much to ask for.”

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