Amgens proposed copy would infringe at least 10 patents, AbbVie said as it reserved the right to assert as many as 51 other patents. Its seeking a court order to prevent Amgen from selling a copy, known as a biosimilar, of the biotech drug.
AbbVie is trying to protect a rheumatoid arthritis injection whose sales surged 17 percent in the second quarter to $4.15 billion. The drug accounted for 61 percent of AbbVies 2015 revenue. The litigation is only part of the hurdle for Amgen. The Thousand Oaks, California-based biotech company has to navigate a byzantine series of steps known as the patent dance thats still being worked out by U.S. courts and regulators.
Humira, a biologic AbbVie invented in 1996, includes a complex protein manufactured in living cells rather than by chemical synthesis. Its active ingredient is the antibody adalimumab. Humira was approved for the treatment of 10 diseases, including rheumatoid arthritis, Crohns disease and ulcerative colitis.
Amgen seeks to copy AbbVies work and ignore AbbVies patents, AbbVie said in the complaint, filed Thursday in federal court in Wilmington, Delaware.
Amgen said it wouldnt comment on the litigation, but said its own version, known as ABP 501, is working its way through the U.S. Food and Drug Administration. In July, an FDA panel voted that it should be approved to treat seven chronic inflammatory conditions.
The FDA Advisory Committees favorable vote last month was an exciting step toward recognizing ABP 501 as an important treatment option for patients with inflammatory diseases, said Kelley Davenport, a company spokeswoman. We look forward to continuing to work with the FDA as they complete their review of the companys application.
AbbVie describes Amgen as looking to circumvent rules it wants others to follow assiduously if they want to make copies of Amgens drugs.
In seeking to defend its copycat actions here, Amgen is speaking out of both sides of its mouth, AbbVie said in the complaint. When biosimilars attempt to knock off its biologic products, Amgen tells a different story. Amgen has repeatedly recognized how difficult it is to innovate methods of using, formulating, and manufacturing biologics.
Some of AbbVies patents on Humira have been the subject of attacks filed with the U.S. Patent and Trademark Office. While Amgen hasnt had much luck, petitions filed by Coherus Biosciences Inc. and Boehringer Ingelheim GmbH are being considered by the agency.
The lawsuit could keep biosimilars off the market if AbbVie succeeds in getting a court order against Amgen, said Aude Gerspacher, an analyst with Bloomberg Intelligence. She said the case could last two to three years not counting any appeals, which would extend the legal fight to 2020.
The case is AbbVie Inc. v. Amgen Inc., 16-666, U.S. District Court for the District of Delaware (Wilmington).