Amgen Inc. headquarters. (Photo via Wikimedia Commons)
Citing irreparable harm and inadequacy of money damages, a Delaware federal judge on Thursday permanently enjoined Sanofi SA and Regeneron Pharmaceuticals from selling a product that infringed on the patents of a rival drugmaker.
The ruling, outlined in a seven-page memorandum order, came just two days after U.S. District Judge Sue L. Robinson of the District of Delaware blocked the defendants’ attempt to throw out a jury verdict upholding the validity of two patents held by Amgen Inc.
In Thursday’s order, Robinson said Amgen lost considerable momentum and market share when Sanofi and Regeneron used a mechanism for expedited regulatory approval to beat Amgen to the marketplace. Thousand Oaks, California-based Amgen, which filed for approval first, had planned to use its 2014 patents to maintain market exclusivity for its drug Repatha, Robinson said.
“Plaintiffs assert that patent protection is fundamental to their business model and they will not be able to fully recoup their investment in Repatha without an injunction. Monetary damages will not suffice under the present circumstances,” Robinson wrote.
A jury on March 16, 2016, returned a verdict in favor of Amgen, rejecting the defendants’ arguments that the patents were invalid for lack of written description and enablement. The following month, Sanofi and Regeneron moved for judgement as a matter of law on the issues and asked Robinson to grant a new trial.
In an April 15 filing, Sanofi and Regeneron said that the Amgen patents asserted overly broad and generic claims that failed to adequately describe the structure of antibodies that lower “bad” LDL cholesterol by blocking a protein known as PCSK9.
“This case exemplifies the kind of overbroad and insufficiently described claims that the written description requirement is designed to prevent,” the companies said.
On their motion for a new trial, Sanofi and Regeneron challenged several of the court’s decisions, including an order to exclude evidence after January 2008. The companies argued that evidence from beyond that date showed their Praluent antibody fell within Amgen’s patent claims, and would have undermined certain jury findings.
But Robinson blocked both motions on Tuesday. In a 29-page memorandum opinion, Robinson said the jury had fully considered expert testimony at trial in March, and she refused to revisit issues that had been fully argued and briefed before trial.
“While defendants disagree with the court’s decisions and request that it rethink them, the court declines to do so. The court did not arrive at any of these decisions lightly; indeed, it considered fulsome arguments and briefing,” she said.
Vowing to immediately appeal both rulings, Sanofi and Regeneron reiterated their belief that both patents are invalid and said patients would be “greatly disserved” by an injunction preventing access to Praluent.
“We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position,” Joseph LaRosa, Regeneron’s senior vice president and general counsel, said in a statement.
Amgen first sued Sanofi and Regeneron in October 2014.
Amgen is represented by Melanie K. Sharp and James L. Higgins of Young Conaway Stargatt & Taylor and William G. Gaede III, David L. Larson, Eric W. Hagen, Terry W. Ahearn, Bhanu K. Sadasivan, Sarah C. Columbia, K. Nicole Clouse,Lauren Martin, Esther E. Lin, Michael V. O’Shaughnessy, and Rebecca Harker Duttry of McDermott Will & Emery.
Sanofi and Regeneron are represented by Steven J. Balick, Tiffany Geyer Lydon and Andrew C. Mayo of Ashby & Geddes, as well as Dianne B. Elderkin, Steven D. Maslowski, Matthew A. Pearson, Angela Verrecchio, Jenna M. Pellecchia, Matthew G. Hartman, and Jonathan J. Underwood of Akin Gump Strauss Hauer & Feld and John Josef Molenda, Vishal Chandra Gupta, Jeffrey C. Lee, Siew Yen Chong, Richard Praseuth, and Robert Greenfeld of Steptoe & Johnson.
The case is captioned Amgen v. Sanof.