AMGN Amgen Inc

By Jonathan D. Rockoff 

Drugmaker AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc., seeking to block sales of a lower-priced replica of AbbVie's top-selling drug, Humira.

The lawsuit, filed late Thursday in federal court in Delaware, alleges Amgen's copy of the biotech drug Humira violates many of AbbVie's patents on the anti-inflammatory treatment. The suit asks the court to keep the copy off the market if it gains approval by the Food and Drug Administration.

AbbVie's legal challenge was an expected step under the federal law that aimed to bring price competition to expensive biotech drugs by allowing for copies known as biosimilars. The law, the Biosimilar Price Competition and Innovation Act, established a mechanism for companies to secure approval of biosimilars without doing all the testing a new medicine would require.

AbbVie has been taking steps, including filing new patents protecting Humira, to delay the introduction of copies, and has told analysts it expects copies to hit the market no earlier than 2022. Humira accounts for about 60% of AbbVie's revenue.

In its lawsuit, AbbVie said the law "does not give Amgen license to infringe AbbVie's patents." AbbVie also threatened further patent infringement suits because it claims 61 Humira patents are being violated, while the current lawsuit focuses on just 10.

Humira is one of the top-selling drugs in the U.S., with $8.4 billion in sales last year. It is also expensive, with a list price of $53,260 a year.

Biosimilars were authorized as part of the 2009 federal health-care overhaul to reduce spending on such biotech drugs, much like generics have cut the costs of pills.

Given Humira's success, several drug companies have been developing biosimilar versions. Amgen already sells a brand-name rival, Enbrel.

The FDA hasn't approved Amgen's biosimilar Humira yet, but the decision is nearing. Last month, a panel of outside experts recommended approval.

Amgen said Friday it doesn't comment on litigation but that it is working with the FDA as the agency completes its review of the company's Humira biosimilar.

The patent-infringement challenge is likely to delay launch of Amgen's biosimilar, if the copy is approved, until the legal issues are resolved. Further delays could result if AbbVie decides to file another infringement lawsuit involving additional patents after an FDA decision on approving the biosimilar.

A litigation delay followed the approval last year of the first biosimilar, Novartis AG's Zarxio, which was a replica of an Amgen cancer-care drug called Neupogen. As a result, Zarxio, which was approved in March 2015, didn't go on sale until September. Novartis sold its drug at a 15% discount to the original.

This past week, CVS Health Corp., whose Caremark unit administers drug benefits for many employers and insurers, took steps to start steering patients to biosimilars.

Separately, AbbVie said in a securities filing Friday that Elliott Associates LP and four other investment funds sued in Illinois state court, alleging the drug company misrepresented its proposed takeover of Ireland-based Shire PLC and seeking damages.

In July 2014, AbbVie agreed to buy Shire but walked away from the $54 billion deal about three months later, citing new rules from the Treasury Department aimed at deterring so-called tax-inversion transactions.

In the lawsuit, the plaintiffs said AbbVie played down the importance of using the deal to lower its corporate tax rate. The plaintiffs also allege AbbVie didn't disclose that its board had failed to evaluate whether it would go ahead with the transaction in the event the government took action.

AbbVie declined to comment.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

(END) Dow Jones Newswires

August 06, 2016 02:48 ET (06:48 GMT)

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