FARGO — A biotechnology company and the University of Pennsylvania are suing Aldevron over claims the firm has infringed on a patent for making special materials used in gene therapy.
Regenxbio, based in Rockville, Md., and a customer of Aldevron’s, claims in a lawsuit filed in U.S. District Court in Fargo that Aldevron infringed on a patent it was given rights to by the University of Pennsylvania, where proprietary technologies were developed to use harmless viruses engineered to deliver therapeutic genes and other factors into cells to treat genetic diseases.
Aldevron makes products and offers services for biotechnology firms and research institutions around the world. It makes custom plasmid DNA — circular, double-stranded snippets of genetic material — as well as proteins and antibodies.
The lawsuit said Regenxbio obtained a patent for the technology in question on March 17 and claims Aldevron’s activities infringed its patent rights by “making available for use infringing cultured host cells through its long-term storage of infringing cultured host cells” enabled by Regenxbio’s patent.
An Aldevron spokeswoman said Monday, Sept. 21, the company takes intellectual property rights seriously.
“Aldevron expects other companies to respect the intellectual property that we have worked hard to develop, and we similarly respect the lawful rights of others,” spokeswoman Ellen Schafer said in a statement.
“We are confident that the court will find that we do not infringe any valid patent rights of Regenxbio or the University of Pennsylvania,” she said.
The lawsuit, filed Sept. 16, seeks to be designated a “special case” and asks for unspecified treble damages.
Beginning in the early 2000s, researchers at the University of Pennsylvania began developing a new suite of technologies to help make and use what are called viral vectors — harmless viruses that are engineered to carry therapeutic genes, antibodies or other factors to treat genetic diseases.
The lawsuit involves technologies to engineer host cells that produce a small, circular, double-stranded DNA molecule that can replicate in host cells containing a viral vector.
Developing the technologies, the Regenxbio lawsuit said, was “extraordinarily difficult” and involved a new strategy, resulting in identification of hundreds of new proteins that yielded higher gene transfer and longer-lasting gene expression with lower immune response and better manufacturing traits.
Regenxbio is a customer of Aldevron and has ordered custom materials from its labs in Fargo, providing a small amount of “starter material” containing its proprietary plasmids for Aldevron to replicate.
After replicating the material, Aldevron then returns it to Regenxbio.
Regenxbio’s lawsuit contends Aldevron made its proprietary material available to a handful of other firms not authorized to use its patented technologies.
In August, one of those firms filed documents with U.S. securities regulators outlining a method of inserting plasmid that makes use of Regenxbio’s patented methods, the lawsuit contends. A university in Germany similarly disclosed infringements allegedly tied to Aldevron against Regenxbio, according to the lawsuit.
Regenxbio claims Aldevron makes and uses cultured host cells using a recombinant nucleic acid molecule with adeno-associated virus that contains at least 95% of the same amino acids as its proprietary process.
Aldevron has not yet filed its formal answer to the lawsuit.