Patent Board rejects challenge to CSHL research

Traverse Biosciences founder Joseph Scaduto.
By GREGORY ZELLER //

A big win before the U.S. Patent Trial and Appeal Board will keep a versatile biomedical-research and drug-discovery tool in Cold Spring Harbor Laboratory’s possession.

The ruling means short hairpin RNA – invented by CSHL professor Gregory Hannon and his team – will remain the exclusive domain of Hairpin Technologies, a licensing agent spun out of the laboratory in 2015 to negotiate and execute shRNA licensing agreements with manufacturers and distributors.

The shRNA technology involves RNA sequences that make tight “hairpin” turns, which in turn create “RNA interference” – allowing researchers to effectively isolate and manipulate specific gene activity, a major step toward understanding the role of specific genes in certain diseases and identifying potential pharmaceutical targets.

In October 2015, four petitions for inter partes reviews – trials conducted by the Patent Trial and Appeal Board to review the actual “patentability” of a patent’s claims – were filed with the PTAB against four shRA-related patents held by Cold Spring Harbor Laboratory.

The petitions, filed by Benitec Biopharma Ltd – an Australian firm focused on gene-silencing therapies – claimed portions of the shRNA patents were “unpatentable.” According to Benitec, which also maintains research operations in California, the patents in questions claimed methods of using shRNA that weren’t exclusive to Hannon’s work.

But the PTAB disagreed, following the recommendations of attorneys from Massachusetts law firm Wolf Greenfield – Cold Spring Harbor Laboratory’s longtime patent and post-patent counsel – and dismissing the inter partes review requests.

bielski

Michael Bielski

Michael Bielski, Hairpin Technologies co-founder and managing partner, said the PTAB’s decision “clearly validates the strength of the shRNA intellectual property portfolio.”

A different decision by the PTAB could have been a mess for CSHL and that robust IP portfolio, which, thanks largely to Hairpin Technologies, has already been widely licensed. By January of this year, still within its first fiscal year of operation, Hairpin had already generated more than $1 million in shRNA licensing revenue, executing commercial distributor licenses with major-league multinational biotechnology firms including Sigma-Aldrich – which was acquired by German giant Merck for $17 billion in 2015 – and Life Technologies/Thermo-Fisher.

Hairpin Technologies has also negotiated commercial end-user licenses with GlaxoSmithKline, Johnson & Johnson and others.

With the PTAB reinforcing the patents, “We look forward to continuing to out-license this seminal technology to commercial distributors and end-users,” Bielski told Innovate LI.

Joseph Scaduto, another Hairpin Technologies co-founder and managing partner, referenced “about half-a-dozen” pending shRNA licensing agreements, including some that could be completed within weeks.

Scaduto, who’s also founder and CEO of Stony Brook-based pharmaceuticals-commercialization enterprise Traverse Biosciences, couldn’t say exactly where Hairpin’s revenue meter was pointing now. But with the patent dispute settled in CSHL’s favor, those pending deals and other new licensing arrangements should have “a significant impact on revenues,” he noted.

“Short hairpin RNA is being widely used in the pharmaceutical and biotechnology industries for commercial research purposes,” Scaduto said. “And it’s being used a lot for the development of new therapies to treat human diseases. The future is very bright.”

While his partners at Hairpin Technologies and others inside CSHL were “relatively confident” that Benitec Biopharma’s inter partes review requests would fall short, staffers did keep a close eye on the PTAB’s deliberations, according to Scaduto.

“We felt Cold Spring Harbor’s position would prevail,” he said. “But you never know what’s going to happen.”

Cold Spring Harbor Laboratory President and CEO Bruce Stillman agreed, noting CSHL administrators are “happy with the result, but not surprised.”

“Dr. Hannon and his team, through their pioneering work at CSHL, are recognized around the world for having developed shRNA to knock down gene expression in mammalian cells,” Stillman noted.


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