In the latest contest over biosimilars, AbbVie (ABBV) has filed a patent infringement lawsuit against Amgen (AMGN), an erstwhile rival in the market for hard-to-make treatments for rheumatoid arthritis. And the move highlights a strategy designed to indefinitely delay the arrival of a lower-cost biosimilar indefinitely while the litigation plays out.
The lawsuit, which was filed last Thursday in federal court in Wilmington, Del., alleged that Amgen’s version of Humira violates 10 different patents. In its complaint, AbbVie asked the court to keep a biosimilar version from becoming available if the US Food and Drug Administration decides to approve the Amgen medication.
The lawsuit was largely expected, given the complex machinations of a federal law governing the entrance of biosimilars into the marketplace and subsequent court rulings. The Biologics Price Competition and Innovation Act, which became law as part of the Affordable Care Act, requires an elaborate procedure before a biosimilar manufacturer can proceed with plans to sell its medicine.
Although interpretations of the law have been the subject of separate litigation, a federal appeals court recently ruled a biosimilar company must notify a brand-name rival six months before launching its version of a biologic. The purpose is to allow the brand-name drug maker to review materials and determine what, if any, patent challenges can be pursued before a biosimilar is launched.
The AbbVie lawsuit, however, introduced another element into the process.
Generally, patent litigation that involves thwarting a generic version of a brand-name drug turns on a very few patents. In this instance, though, AbbVie identified 61 patents that Amgen may be infringing with its planned version of the Humira drug. For now, AbbVie is only pointing to 10 patents, but could well bring another lawsuit later that cites the other 51 patents.
This is all part of a multifaceted strategy that AbbVie has been pursuing to thwart biosimilar competition. And for good reason – Humira generated $14 billion in revenue last year and $8.4 billion came from the United States. Overall, the medication accounted for 61 percent of AbbVie’s companywide revenues of more than $22.8 billion in 2015.
AbbVie has been particularly aggressive about forestalling competition to Humira. The company filed a citizen’s petition with the FDA over labeling requirements for interchangeability — a reference to using a biosimilar version for various indications for which Humira is approved. The drug maker also went to court in Europe to prevent regulators from disclosing certain clinical trial data and won a compromise.
Its move to register dozens of patents — for such things as method of use, formulation, analytic techniques, and administration — clearly gives AbbVie an advantage. How so? If nothing else, this makes it easier for the drug maker to initiate patent litigation after a biosimilar manufacturer provides notice with its plans to sell a biosimilar. This may dissuade still other companies from pursuing biosimilar versions of Humira or other AbbVie drugs. And depending upon the complexity of the case, it may make it difficult for a judge to sort out certain issues.
In this instance, Amgen provided AbbVie with notice last January, and FDA approval for the biosimilar may not be granted until the fall of 2017, although it could come sooner — or not at all. But if approval is granted, AbbVie could then seek an injunction to prevent Amgen from proceeding with sales. And AbbVie might also file another patent lawsuit for some or all of the other 51 patents.
All this jockeying may seem arcane, but there are implications for the health care system, since biosimilars are widely expected to cost about 20 percent to 30 percent less than brand-name biologics. As a result, lawsuits that delay availability will mean that payers — and patients — will pay more for treatment until a biosimilar reaches the marketplace.