SANOFI AND REGENERON STRONGLY DISAGREE IN ONGOING PATENT LITIGATION REGARDING PRALUENT

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment.  This decision is the first step in this ongoing litigation and does not impact Praluent or our ability to deliver it to physicians and patients at this time.

 

"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future. 

"This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals," said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed with Regeneron's proprietary science and technology and represents an important medical advance for patients."

In July 2015, Praluent was the first PCSK9 inhibitor to be approved for use in the U.S. It is indicated for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of "bad" (LDL) cholesterol. Praluent is the only PCSK9 inhibitor available in two starting doses that allow physicians to adjust the dose based on a patient's LDL cholesterol lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

Merck Statement Regarding CUBICIN Patent Litigation

Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit. The decision validated the patent for CUBICIN^® (daptomycin for injection) that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020.The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court. 

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission

Lilly and Sanofi Reach Settlement Agreement

Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. 

 Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential. The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.