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With Key RNAi Patent In Hand, PBL Aims to Make Technology Widely Available

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By Doug Macron

Having secured a fundamental RNAi-related US patent earlier this year, UK-based technology management firm Plant Bioscience Limited has begun the process of hammering out deals with organizations interested in licensing the intellectual property.

The patent, which broadly covers the use of small RNAs to trigger post-transcriptional gene silencing, could potentially hamstring the efforts of those in the business of RNAi therapeutics and research tools, but the company aims to make it non-exclusively available to as many parties as possible, a PBL official told Gene Silencing News this week.

Within the RNAi field, freedom to operate remains a hotly contested subject, with companies such as Alnylam Pharmaceuticals (GSN 11/9/2006) and Benitec Biopharma (GSN 1/30/2004) having publicly asserted control over key IP while making claims about being able to block the work of others in the sector.

“Some IP in this space … gets used in a tactical way,” PBL Managing Director Jan Chojecki conceded. “There is a lot to play for. It's an extremely valuable space and a lot is at stake.”

However, “we don't want to get involved in a strategic standoff,” he said. “We'd like to be in control of what we do ourselves.”

As such, Norwich, UK-based PBL aims to make the patent widely available on a non-exclusive basis, Chojecki said, although he added that limited exclusively could be negotiated depending on the situation.

“Generally … we will give exclusivity in some areas where it makes business sense … but in this case it's mostly not essential,” he said. “We don't want to get swept up into some strategic play by the different parties” working in the field.

PBL's patent, No. 8,097,710, is entitled “Gene Silencing,” and claims a “method to silence genes in cells by post-transcriptional gene silencing [using] ... short RNA molecules” that are between 20 and 24 nucleotides long. The molecules are specifically comprised of a short antisense strand “complementary to the region of a target RNA transcribed from a gene to be silenced,” and a short sense strand corresponding to the sequence of the target RNA, according to the patent's abstract.

The patent lists the Sainsbury Laboratory researchers David Baulcombe and Andrew Hamilton as inventors, and stems from their seminal work in plants. PBL is jointly owned by the Sainsbury Laboratory, the John Innes Center, and the UK's Biotechnology and Biological Sciences Research Council.

According to Chojecki, the first patent in the '710 patent family was issued in 2004 and covers methods for detecting gene silencing in plants. The second was issued in early 2010, and claims the detection of gene silencing in mammals.

“The significant next step was … '710, [which covers] methods of inducing gene silencing,” he said, adding that additional composition-of-matter patent applications are pending at the US Patent and Trademark Office.

Chojecki noted that the '710 patent is definitely “broad,” and extends into therapeutic, diagnostic, and research applications of siRNAs. He said that PBL also views bio-agriculture and white biotechology as falling within its scope.

In those five areas, he said, the company anticipates issuing licenses related to in-house drug-discovery research, the provision of contract research services, the use and sale of reagents and life science tools, and the development of therapeutics.

Overall, PBL expects to primarily issue non-exclusive licenses, in keeping with its goal of making the patented technology widely available. Still, he said, “we could look at exclusivity on a product-by-product basis.”

For the time being, PBL is taking a wait-and-see approach on finding licensees for the '710 patent, according to Chojecki.

“It's for individual companies and organizations to interpret the claims against what they are doing,” he said. “We're responding to [their] inquiries and we go from there.”

A number of licenses have already been granted, Chojecki added. Though none relate to RNAi-based therapeutics, discussions with several players in this area are currently ongoing, he said.

Chojecki said that, at some point, PBL may begin reaching out to organizations it believes need a license to the IP, but that this is not something the firm typically does.

“We generally find that, in the areas we've worked in over many years, the responsible organizations come forward and ask for a license sooner or later,” he said.

“If we have to be more proactive, we'll look into that, but we're a long way off [from] doing that,” he said.

Chojecki noted that since its establishment in 1994, PBL has never needed to file a patent-infringement lawsuit.

“We've done a lot of successful licensing in all the life science sectors, and we feel we do know what people are prepared to pay and the terms they're prepared to accept,” he said. “We're pretty flexible about things, so generally we reach a mutually agreeable situation, and that's how we intend to play it.”

The exact nature of the licenses to the '710 patent are worked out with the potential licensee, and cost structures are not publicly disclosed, Chojecki said, although he did say that they typically involve upfront payments and downstream value sharing.

“We might well publish standard rates later on, but we're not going to do that now,” he said.


Have topics you'd like to see covered in Gene Silencing News? Contact the editor
at dmacron [at] genomeweb [.] com.

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