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Amgen Inc.

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Sanofi/Regeneron Patent Litigation
On October 17, 2014, Amgen initiated a series of lawsuits in the U.S. District Court of Delaware (the Delaware District Court) against Sanofi, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively Sanofi), and Regeneron Pharmaceuticals, Inc. (Regeneron) for patent infringement. On December 15, 2014, these lawsuits were consolidated by the Delaware District Court into a single case, which now addresses seven of our patents: U.S. Patent Nos. 8,563,698; 8,829,165; 8,859,741; 8,871,913; 8,871,914; 8,883,983; and 8,889,834. These patents describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). By its complaints, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron’s alirocumab, a monoclonal antibody targeting PCSK9. On January 29, 2016, the Delaware District Court granted Amgen’s motion to amend the complaint to add Amgen Manufacturing, Limited and Amgen USA Inc. as plaintiffs and to add the allegation that defendants’ infringement of Amgen’s patents is willful. The trial date has been set for March 7, 2016.
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Form 10K, 2/26/16. https://www.sec.gov/Archives/edgar/data/318154/000031815416000031/amgn-1...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Repatha (Evolocumab) (AMG 145)CardiovascularAtherosclerosisPCSK9 inhibitorPCSK9

Mechanism of action: Repatha (Evolocumab) (AMG 145) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood causing bad cholesterol to increase. AMG 145, developed by Amgen scientists, binds to PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL receptors in the liver. Without PCSK9 bound to them, the LDL receptors can take up and remove LDL-C from the blood, recycle and remain available for binding additional LDL-C.

Phase of Development: Approved

Event Type: Legal: Patent litigation

Dates: 2016-03-07 - 2016-03-31

Results:

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Amgen Statement on January 9, 2017, U.S. District Court Decision
THOUSAND OAKS, Calif., Jan. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) issued the following statement regarding the U.S. District Court of Delaware's denial of Sanofi and Regeneron's motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation:

Today, the U.S. District Court of Delaware denied Sanofi and Regeneron's motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation. By this ruling, the Court has extended the time before the injunction will be imposed by 15 days (from 30 days to 45 days) to allow Sanofi and Regeneron to seek appellate review of the Court's orders on injunction and denial of stay pending appeal.

Amgen respects the court's thoughtful deliberations in a situation where a competitor made the choice to launch at risk during the pendency of a patent lawsuit within months of an expedited trial date. The Company remains confident in the validity of its patents.
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Source: press release, 1/09/17. http://wwwext.amgen.com/media/news-releases/2017/01/amgen-statement-on-j...

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Court Grants Permanent Injunction For Infringement Of Amgen's Repatha® Patents
THOUSAND OAKS, Calif., Jan. 5, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the United States District Court in Delaware granted Amgen's request for a permanent injunction prohibiting Sanofi and Regeneron from infringing two patents that Amgen holds for Repatha® (evolocumab) by manufacturing, using, selling or offering alirocumab for sale in the United States. The injunction will not take effect immediately as the court has delayed its imposition for 30 days to allow defendants the opportunity to seek expedited review of this decision. The judge's decision follows a jury verdict in March 2016 in Amgen's favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).

"We are pleased with today's decision that recognizes Amgen is entitled to an injunction against further infringement of our patent rights. Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases," said Robert A. Bradway, chairman and chief executive officer at Amgen. Bradway continued, "Heart disease is the biggest health care challenge for society today and Repatha aims to help address this challenge by providing a profound reduction in LDL-cholesterol."

Amgen has the ability to supply all potential Repatha patients and will work to ensure a smooth transition for patients who wish to switch to Repatha.
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Source: press release, 1/05/17. http://wwwext.amgen.com/media/news-releases/2017/01/court-grants-permane...

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Amgen Wins Patent Case On Repatha® (Evolocumab)
Proceedings on Damages and an Injunction Against Sanofi and Regeneron Will Follow
THOUSAND OAKS, Calif., March 16, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a Delaware jury delivered a verdict in Amgen's favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).

Amgen brought the patent infringement action in Federal Court in Delaware against Sanofi and Regeneron Pharmaceuticals, Inc. (collectively "Defendants"). Before trial, Sanofi and Regeneron acknowledged infringement of seven patent claims in U.S. Patent Numbers 8,829,165, and 8,859,741. The trial proceeded on Defendants' challenges to the validity of those seven claims. The jury found that Defendants had failed to prove the patents invalid for lack of written description and enablement. Prior to the case going to the jury, the Court dismissed Defendants' case on obviousness.

"We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha, our innovative biologic molecule that reduces LDL cholesterol," said Robert A. Bradway , chairman and chief executive officer at Amgen.
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Source: press release, 3/16/16. http://wwwext.amgen.com/media/news-releases/2016/03/amgen-wins-patent-ca...

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