After having its adalimumab (Humira) trade secrets case against Alvotech dismissed by a court for lack of jurisdiction, AbbVie is trying again with a filing with the US International Trade Commission (ITC).
AbbVie maintains that Alvotech’s biosimilar candidate for adalimumab (AVT02), which has yet to receive US FDA approval, was developed with trade secrets solen by employees who once worked for AbbVie and then went to work for Alvotech.
“AVT02 will undercut Humira significantly on price and unfairly compete, leading to lower revenue, lower profits, reduced return on investment and, as a result, significant injury to the industry that AbbVie has invested in significantly to develop in the United States,” AbbVie writes in the complaint. The ITC has the authority to investigate and rule on alleged acts of product infringement.
Alvotech has stated it is innocent of any wrongful taking or use of AbbVie's trade secrets regarding the manufacture of adalimumab.
“This action by AbbVie–which repackages the meritless allegations from a case that was thrown out of court earlier this year–is a sign of AbbVie’s weakness and concern that Alvotech’s efforts to bring a lower-cost offering to market will expose AbbVie’s longstanding abuse of the patent/legal system," Alvotech said. "AbbVie’s abuse has improperly extended its monopoly.”
The employees AbbVie alleges to have stolen the manufacturing information are Rongzan Ho, Yi Li Tan, and Zhi Sheng Sheah. All three began working with Alvotech after resigning from AbbVie, the manufacturer alleges. AbbVie alleges that Ho, Tan, and Seah, were “were involved in setting up AbbVie’s Humira manufacturing plant in Singapore from the ground up” and so became intimately familiar with the company's secret processes for manufacturing adalimumab.
“These employees not only learned and had access to documents describing
AbbVie’s knowhow for running a high-quality manufacturing process for commercial -scale production of adalimumab, but also learned and had access to documents describing AbbVie’s knowhow for bringing a new adalimumab facility online and obtaining GMP certification of a new adalimumab facility,” the AbbVie complaint said.
In October 2021, Judge Harry D. Leinenweber of the US District Court for the Northern District of Illinois, declined to rule in the case because the alleged trade secret theft occurred abroad. Ho, for example, was based in Singapore and working at an AbbVie facility there when he allegedly took secrets, resigned, and went to work for Alvotech in Iceland. AbbVie claims he interviewed with Alvotech in late 2017 and began working there in January 2018.
AbbVie claims it has documented several attempts, including a successful one, by Ho to send large Excel spreadsheets of information about AbbVie’s confidential manufacturing processes to his personal email address. “With these documents, a competitor would have the necessary knowhow to manufacture an adalimumab drug substance,” AbbVie wrote.
Ho has not responded to a request for comment from The Center for Biosimilars®.
These employees not only learned and had access to documents describing
AbbVie’s know how for running a high-quality manufacturing process for commercial -scale production of adalimumab, but also learned and had access to documents describing AbbVie’s knowhow for bringing a new adalimumab facility online and obtaining GMP certification of a new adalimumab facility.
According to AbbVie, Ho was contacted about the alleged theft and acknowledged the taking of the Excel information in a declaration that was included in the ITC filing but fully redacted from public access. Ho’s current resume was also included in the documents and states that he worked for Alvotech for 2 years and 5 months and later went to work for Merck Life Science in Shanghai, China.
The case is important for Abbvie because Alvotech plans to bring an increasingly popular form of adalimumab (high concentration, citrate free) to market in the United States and potentially could bring it to market sooner than other biosimilar competitors. There is no adalimumab competition on the market in the United States so far.
“Alvotech...continues to state publicly that it will manufacture, import, and have marketed by Alvotech’s marketing partner Teva AVT02 manufactured in Iceland and foreign jurisdictions and imported to the United States,” Alvotech wrote in the ITC complaint.
As part of its application to the FDA for approval of AVT02, Alvotech has “imported” AVT02 into the United States, AbbVie alleged, although some manufacturing of a rival's product is permitted for the purposes of developing a product rather than selling it.
The FDA began its review of AVT02 in November 2020 and has delayed an approval decision so it can complete manufacturing facilities inspections. In November 2021, Alvotech received approval from the European Commission for the marketing of AVT02 under the product names Libmyris and Hukyndra.
AbbVie has requested that the ITC open an immediate investigation into the alleged trade secret theft and bar Alvotech from importing AVT02 into or selling it in the United states
Alvotech and AbbVie are at odds over AVT02 in a separate legal forum. The District Court for the Northern District of Illinois his hearing a patent infringement dispute between the two companies, which is expected to resolve in October 2022, if the proceedings go according to the court scheduling order.