AMS Spring 2023

Cellink-Organovo Lawsuit Over Bioprinting Patents is Far From Over

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In the highly competitive biotechnology and pharmaceutical industries, hardware manufacturers are under a lot of pressure to provide the best, most efficient, and fastest platforms for researchers. Bioprinting, in particular, is a unique niche within the 3D printing ecosystem, where an increasing number of startups are competing to position their systems in major drug companies, specialized biotechnology firms, academic institutions, government agencies, and private and public research centers. However, as in nearly every industry, this competition will lead to lawsuits.

The latest complaint filed by pioneering firm Organovo said several of the bioprinters made by biotech company Cellink infringe on patents for their technology. According to a grievance filed on July 27, 2021, in a federal court in Waco, Texas, the San Diego-based manufacturer is seeking cash compensation for the patents Cellink has allegedly infringed upon, as well as a court order blocking Cellink from using three of Organovo’s patents relating to the devices, systems, and methods of tissue fabrication (US9149952B2), improvements to bioprinting technology that facilitate automation of tissue and organ fabrication processes (US9315043B2), and a way for printing a 3D structure (US9855369B2). Additionally, the Swedish-based business is accused of infringing on a fourth patent owned by the University of Missouri and exclusively licensed to Organovo, entitled “Self-assembling cell aggregates and methods of making engineered tissue by organ printing” (US9752116B2).

As reflected in Organovo’s complaint, Cellink’s Bio X is accused of infringing three patents, and the Bio X6 is accused of infringing one. Cellink, however, claims the accusations are invalid. In fact, the company had filed two petitions on June 3, 2021, for Inter Partes Review (IPR), challenging the validity of two of Organovo’s patents that relate to its current bioprinting technology before the U.S. Patent and Trademark Office (USPTO).

Cellink's Bio X and Bio X6 bioprinters. Cellink’s Bio X and Bio X6 bioprinters. Image courtesy of Cellink.

A spokesperson for Cellink told 3DPrint.com that if those IPR proceedings were granted, they could lead to the cancellation of the challenged claims in Organovo’s patents. Organovo expects the USPTO to decide by December 2021 whether to institute Cellink’s IPRs. If it does, it will then conduct an administrative trial to determine the patentability of the patent claims challenged in the IPRs and issue a final determination within a year. However, if the USPTO declines to institute an IPR to a contested claim, then the decision is final and non-appealable.

Ultimately, if Cellink is successful in the IPR proceedings, Organovo may lose the IPR patents, limiting the company’s ability to stop others from using or commercializing products and technologies similar or identical to theirs.

“While Cellink respects valid intellectual property, we believe that Organovo’s patent claims at issue are invalid, not infringed, or both. Cellink remains steadfastly committed to evolving the future of medicine. As the world’s leading bio convergence company, we look forward to continuing to set the trends in the bio convergence space and collaborating with our industry peers to work toward solving the major health challenges we face as a society,” claimed Cellink’s source.

Also, as of June 7, 2021, Cellink filed for a declaratory judgment regarding non-infringement in the U.S. District Court in Delaware. The complaint was presented jointly with two recently acquired companies, MatTek Corporation, an in vitro technology firm founded by MIT professors in 1985, and Visikol, a spin-off startup out of Rutgers University specializing in advanced drug discovery solutions, including 3D cell culture assays.

The filing explains that the dispute over intellectual property dates as far back as 2019 when the two biotech companies reportedly had a dispute over the patents. At the time, Organovo sent a letter to Cellink stating that the company had used three of its patents to market its bioprinting technology. Several discussions followed until the two parties ceased any contact in March 2021, and just a month later, Cellink initiated legal proceedings.

3DPrint.com reached out to Organovo, and the company had this to say about the lawsuit: “Organovo is built upon a respect for intellectual property rights, and early on we licensed IP from top universities and then built our own patented innovations in house. Professional IP lawyers, as third parties, have been publicly recognizing that IP portfolio as broad and foundational since as far back as 2015, before Cellink announced its first printer.  Intellectual property laws exist to protect and promote innovation and they cover just this type of circumstance.  In a highly irregular move, Cellink started this fight by filing against Organovo, leading Organovo to conclude that Cellink must doubt its own freedom to operate. Organovo quite simply will not be bullied by a company with little track record of innovation that now wants to sue its way to clear sailing.  We are happy to teach Cellink to respect the intellectual property rights deriving from our own patents and those we license from the innovative professors who launched the field of bioprinting.”

Organovo's 3D bioprinting technology. Organovo’s 3D bioprinting technology. Image courtesy of Organovo.

Cellink and Organovo are two of the most renowned bioprinting companies in the industry. Recently rebranded as BICO, Cellink has been an active player since its inception in 2016 in Gothenburg, Sweden. BICO currency oversees 11 subsidiaries, including Cellink, and has a growing pipeline of upcoming acquisitions and bioconvergence technologies, not to mention dozens of partnerships with universities, public and private institutions, and researchers worldwide.

As for Organovo, the startup launched in 2007, is a pioneer and was one of the big driving forces behind bioprinting technology. Developer of the first 3D bioprinted liver tissue, Organovo had the potential to revolutionize medical research, but in 2017 Organovo Founder and CEO Keith Murphy left the company, and it was all downhill from there. In August 2019, company officials halted all research and development led programs and laid off 69% of its overall workforce to extend its cash runway as it explored available “strategic alternatives to generate value from its technology platform and intellectual property.” However, by September 2020, Murphy was back as the company’s newly appointed Executive Chairman of the Board, with a renewed team ready to develop regenerative medicine therapies to treat a range of severe liver diseases, which was part of Organovo’s original vision.

Inevitable or not, at some point or another, many businesses will face a legal dispute. In the world of 3D printing, several brands have undergone litigation, including Stratasys and MakerBot, Formlabs, Markforged, and many more. As for patent infringement cases, statistics reveal that between 95% and 97% of lawsuits are settled out of court. For now, Organovo and Cellink are each sure about their respective claims, and both companies are set on expanding their brand technologies, so we’ll have to follow this case as it unravels in the next two months.

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