The Canadian unit of U.S.-based Amgen ($AMGN) has launched legal action against Samsung Bioepis, saying two of its patents for the autoimmune treatment Enbrel (etanercept) were violated by Samsung's biosimilar Brenzys.
The Canadian unit of Amgen asked the court for a "prohibition order" in July, according to a report in the Korea Herald, which added that the legal dance is probably just a way for Amgen to hold off competition in the Canadian market after Samsung filed for approval in May 2015 to sell Brenzys.
"Patent infringement lawsuits by the original drugmakers are common when a biosimilar drug seeks to gain sales approval in new overseas markets, including in Canada," a company spokesperson told the Korea Herald. "In filing our sales approval request, we clarified our stance that we did not infringe on (Amgen's) patents. Samsung Bioepis abides by the position of noninfringement."
In a formal statement emailed to FiercePharmaAsia on Jan. 13, Samsung Bioepis updated on the development of the product and its status in Canada.
"In May 2015, we submitted Brenzys for approval to Health Canada. Prior to granting marketing approval for biosimilars, Canada's patent linkage system requires all applicant companies to address the patents related to the originator medicine that are listed on Health Canada's Patent Register," the company said in a statement.
"This is a routine procedure that is part of the regulatory approval process in Canada for all generic and biosimilar medicines. Before Amgen had brought forth its allegations over its two listed patents, we had already submitted detailed evidence to clarify our position of non-infringement to Health Canada. We will continue to take all necessary measures to bring our affordable, high-quality biosimilar to patients across Canada."
The company however said the approval process in Canada and elsewhere continues.
"Our SB4 etanercept biosimilar launched in Korea in December 2015, and is being commercialized by MSD Korea under the name, Brenzys," the statement added. "In the European Union, SB4 received a positive CHMP opinion in November 2015. SB4 currently awaits the European Commission's decision on marketing authorization. If approved, SB4 will be commercialized in the European Union by Biogen under the name, Benepali."
Amgen's formulation patent is said to be in effect until 2024, but its Canadian patent expired last year, according to the report. Amgen will be able to hold off Samsung Bioepis from selling its Enbrel biosimilar in the United States after it obtained a new patent in 2011 to extend the drug's protection to 2028.
The lawsuit should not work against Samsung Bioepis' plans to list on Nasdaq in June where it hopes to raise at least $1 billion to expand its biosimilar push. In addition to its Enbrel biosimilar, the company is close to gaining approval of its biosimilars for Johnson & Johnson's ($JNJ) Remicade, Roche's ($RHHBY) Herceptin and AbbVie's ($ABBV) Humira. The company also has a Phase I clinical trial underway for a biosimilar of Avastin, according to its website. Remicade and Lantus are not subject to patent issues, according to the Korea Herald report.
Brenzys received approval in November 2015 to be marketed in Europe under the name Benepali and was approved in December for sales in South Korea.
- here's the report from the Korea Herald