Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.
Last month, former Genentech employees were charged with conspiring to steal trade secrets to assist biosimilar developer JHL Biotech in developing its products. Last week, Genentech filed a motion in the United States district court for the Northern District of California, seeking an injunction to block JHL from making and selling potential biosimilars. Genentech says that the biosimilar company benefited from its proprietary information. A hearing is scheduled for December 13, 2018.
The company will request that the court block JHL from “making, testing, using, promoting, offering to sell, marketing, commercializing, or selling biologics, therapeutics, drugs, and/or products of any kind that utilize, embody, or were developed, in whole or in part, with the benefit or use of any of Genentech’s trade secret information."
Although not among the parties indicted for the alleged theft of trade secrets, JHL co-founder, co-chairman, president and CEO Racho Jordanov and co-founder, COO, and general manager Rose Lin were listed as defendants by Genentech.
On October 25, a federal grand jury indicted 3 former Genentech employees, Xanthe Lam, Allen Lam, and James Quach, as well as John Chan, a former JHL formulation scientist. The 4 allegedly stole trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).
According to the indictment, the stolen information includes proprietary analytical methods for ensuring drug safety and efficacy, processes for developing and testing products for quality purposes, and procedures and protocols for calibrating and maintaining manufacturing equipment and facilities.
Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, allegedly downloaded, collected, and transferred the proprietary information to her husband, Allen Lam, and others at JHL. She also allegedly secretly consulted for JHL while still employed at Genentech.
If the indicted defendants are found guilty, Xanthe Lam, Allen Lam, and Chan face as long as 10 years in prison. Quach could face as many as 5 years.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.