Jury Verdict Against Boston Scientific for $42 Million For Infringement of Patent on Biodegradable Drug-Releasing Implant
On January 31st, 2023, a jury awarded $42 million to medical device company TissueGen in a patent infringement case against Boston Scientific for infringement of U.S. Patent No. 6,596,296, titled “Biodegradable Drug-Releasing Implant.” The ’296 patent relates to a drug releasing biodegradable fiber implant which allows for controlled delivery of therapeutic agents.
The verdict comes after a five-year long dispute between the parties. The Board of Regents of the University of Texas System and TissueGen sued Boston Scientific for infringement of the ’296 patent in November 2017. TissueGen received an exclusive license to the ’296 patent from the University of Texas in 2003.
TissueGen’s infringement case concerned Boston Scientific’s SYNERGY™ technology. Boston Scientific reportedly previously received FDA approval for its SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System in 2015. The SYNERGY™ system is alleged to be absorbed shortly after drug elution is complete at three months to eliminate the long-term polymer exposure.
In the first phase of the trial, the jury found that the patent at issue was valid and that Boston Scientific had infringed the patent. In the second phase of the trial, the jury further found that Boston Scientific’s infringement was willful and awarded the plaintiffs $42 million in lost royalties.
Dr. Kevin Nelson, the founder of TissueGen, had allegedly met the Boston Scientific executives in a symposium in 2009 where he told them about the patented technology. Dr. Nelson is a named inventor on the ’296 patent and is reported to have invented the technology while he was an employee of the University of Texas.
TissueGen is a medical device company that reportedly has a portfolio of patents on drug delivery technology. It was founded in 2000. Boston Scientific is a worldwide medical device company founded in 1979. Boston Scientific recently announced that it generated net sales of $3.242 billion during the fourth quarter of 2022.
Biogen to Pay Forward $1.25 Billion in Settlement
Forward Pharma A/S (“Forward”) recently announced that a necessary super majority of its shareholders have approved a settlement of various patent disputes with two wholly-owned subsidiaries of Biogen Inc. (“Biogen”) in which Forward will receive USD $1.25 billion cash from Biogen. 77% of the voting shareholders voted in favor of accepting the settlement agreement.
Founded in 2005, Forward, a Danish biopharmaceutical company, develops pharmaceutical treatments for patients with neurological conditions such as multiple sclerosis. The company reports that it is currently conducting Phase 1 clinical trials for its formulation of dimethyl fumarate (DMF).
Boston, Massachusetts-based Biogen, founded in 1978, is also a biopharmaceutical company specializing in treatments for multiple sclerosis and other neurological conditions and rare genetic disorders. Biogen developed and now markets an oral multiple sclerosis medication (a DMF therapy) under the trade name TECFIDERA™ for which FDA approval was obtained in early 2013.
Forward and Biogen have been engaged in patent disputes before tribunals in the US and Europe since at least 2014. As exemplified by its suit for patent infringement brought in Germany, Forward alleges that Biogen infringes certain of Forward’s patents relating to oral DMF therapies for the treatment of multiple sclerosis. Forward has also brought an interference proceeding (seeking priority over Biogen’s patent to DMF therapy) in the U.S. Patent and Trademark Office (“USPTO”), and multiple opposition proceedings in the European Patent Office (“EPO”). Under the terms of the settlement agreement, one of the EPO oppositions and the patent infringement suit will be terminated, but the USPTO interference proceeding and the other EPO opposition will be allowed to continue to a final determination of patentability (appeals included).
In addition to the up-front cash payment it agreed to pay Forward, Biogen will pay royalties (10–20%) on U.S. and non-U.S. sales of its orally administered DMF products, but only if Forward successfully obtains patent rights covering those treatment methods as a result of the USPTO and EPO proceedings referenced above.
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