Legal and Regulatory

BICO licenses Organovo’s 3D bioprinting technology to end legal dispute

Bioconvergence specialistBICOhas signed a licensing agreement with 3D bioprinting firmOrganovoas a means of ending their long-running legal dispute.

Despite dismissingclaims it had contravened Organovo’s patentsas “invalid” under itsprevious guise as CELLINK, BICO has now agreed to license the technologies, in exchange for the legal proceedings being dropped. The move, according to the company, will only serve to fuel its drive to expand upon its product portfolio, and “further empower it to continue to advance” in the 3D bioprinting space.

“This will further enable an even more innovative and ground-breaking commercial agenda, speed up development for our customers, and enhance our market position; resulting in improved profitability in the long run,” explained BICO’s CEO Erik Gatenholm. “Onwards we will focus on strategic sales efforts to gain market share as well as our ambitious agenda for launching new instruments.”

A scientist using a CELLINK 3D bioprinter.
The BICO Group and Organovo have agreed to drop all claims against one another. Photo via the BICO Group.

Competing over bioprinting IP

BICO and Organovo’s dispute dates back to at least June 3, 2021, when the former actually filed a patent infringement suit against the latter under case number ‘1:21-cv-00832.’ While these proceedings didn’t become public knowledge for some time, due to a non-disclosure agreement (NDA) between the firms, once published, they made it clear BICO was alleging that five Organovo patents breached its own.

Filed under the legal documentsUS9149952B2,US9855369B2,US8931880B2,US9227339B2andUS9315043B2, these patents (like many) are broad in scope, and cover everything from multi-nozzle printing setups to tissue engineering methods.

At the time, BICO also alleged thatClemson University’sUS7051654B2patent regarding the “inkjet printing of viable cells,” andUniversity of Missouri’sUS9752116B2filing on “self assembling cell aggregates,” encroached upon its IP, but while neither institution commented publicly on proceedings, Organovo responded with a counterclaim of its own.

In the company’s claim,filedon July 27, 2021 in a federal court in Texas, it sought to challenge perceived infringements on three of its patents, which were reportedly relevant to theBIO X3D bioprinter. In addition to seeking cash compensation for the patents CELLINK was alleged to have infringed upon, it was said that Organovo requested a court order, which would block any further use of its IP.

A scientists experimenting using MatTek's in-vitro cellular technology.
The BICO Group has continually expanded its portfolio over the last year, acquiring the MatTek Corporation in March 2021. Photo via the MatTek Corporation.

From conflict to a commercial deal

According to statements issued by both firms, they’ve now agreed to resolve their dispute via a commercial licensing agreement. Through the deal, all civil actions concerning the validity of Organovo’s patents have been dismissed, with the companies also agreeing to drop any related demands, liabilities, and costs, in favor of finding a “beneficial and sustainable solution” to their legal conflict.

For BICO, this arrangement provides it with access to Organovo’s bioprinting technologies, effectively reinforcing its already-substantial portfolio. In exchange for access, the firm will have to pay around 1-2% of its total revenue for 2022, and while it has deemed this figure to be “non-material for the group,” the capital could prove vital to Organovo.

Following the unveiling of itsfirst 3D bioprinted kidney tissueback in 2015, the company went on to make a series of business and tech advances, taking part inregenerative muscle tissue research, after going public on the NASDAQ exchange.

However, Organovo announced that it had been forced into exploring “strategic alternatives” in 2019, when it discovered that itsliver tissue fabrication approachrequired significant redevelopment, and though it has since made significant efforts to minimize spending and seek funding to develop its technology, it has struggled to attract financing.

Organovo创始人和名誉主席Keith梅菲y (center right) hosts ringing the NASDAQ opening bell in October 2016. Photo via Organovo on Twitter
Organovo创始人和名誉主席Keith梅菲y (center right) hosts ringing the NASDAQ opening bell in October 2016. Photo via Organovo, Twitter.

During December that year, in an effort to revive its fortunes, the firm’s leadership agreed to merge withTarveda Therapeutics, but at the time its then-ex-CEO Murphy wrote aletterslamming the move, and it ultimately fell through. In the two years or so since, Organovo has sought to salvage its reputation in the courtroom, winning acaseagainst investor Georgi Dimitrov, yet further funding had eluded it.

With its BICO settlement, however, the company has finally established a fresh source of income. Although this comes as a small percentage of the BICO Group’s overall revenue, it represents a share in the spoils of one of the industry’s leading 3D bioprinting firms. As a result, Organovo’s shares climbed 52.6% to a high of $4.41 after the deal’s announcement, before dipping slightly on March 4, 2022.

“Organovo celebrates the success of CELLINK’s bioprinting product lines in opening up the horizons of 3D bioprinting to customers,” said Keith Murphy, Executive Chairman of Organovo. “We are proud to be a part of enabling CELLINK and BICO to grow these products and we look forward with excitement to their next generation of bioprinters.”

Bioprinting’s commercial potential

As is the case in many emerging fields, 3D bioprinting is awash with novel methodologies, and given their commercial potential, researchers are increasingly moving to patent their work in order to prevent it from being marketed elsewhere. Just last month,Trestle Biotherapeuticsgained a license for aHarvard-developed bioprintingapproach, said to enable the creation of functional kidney tissues.

Likewise, in January 2022, Israeli firmMatricelfsigned an exclusive licensing deal withTel Aviv Universitytech transfer companyRamot, for the use of anovel patent-pending 3D bioprintingprocess. Reportedly, the method, which involves utilizing patient stem cells and extracellular matrices to bioprint implants for regenerating damaged tissues, is undergoing patent approval in Europe and the US.

It’s also not unusual for 3D bioprinting firms to compare notes with one another, and share their research with the aim of developing more viable human tissues. In the past, for instance, both3D SystemsandCELLINKhave agreed to partner withCollPlant, as the two companies continue to target regenerative medicine use cases, including those aroundbioprinting tissues for cancer survivors.

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Featured image shows a scientist using the BIO X 3D bioprinter. Image via CELLINK.