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Federal Circuit overturns District Court decision on Angiomax patents; Grants The Medicines Company’s request for rehearing of appeal

13 Nov 2015

PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov. 13, 2015-- The Medicines Company’s petition for en banc review of the U.S. Court of Appeals for the Federal Circuit’s decision in The Medicines Company v. Hospira, Inc.was granted. This vacates the Court’s earlier decision invalidating the Orange Book patents covering Angiomax® that expire in 2028 (pediatric exclusivity expiring in 2029). The Court requested briefing concerning the commercial on-sale bar issue. It has requested the views of the United States Department of Justice, and will also allow other amicus curiae to submit their views.

Clive Meanwell, MD, PhD, Chief Executive Officer, The Medicines Company, said “We are extremely pleased that the invalidity decision has been vacated, and that the entire Appeals Court will now review the issue anew. We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan, and other generics.”
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Source: press release, 11/13/15. http://www.themedicinescompany.com/investors/news/federal-circuit-overtu...

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Glenn P. Sblendorio, EVP and CFO, commented on the Angiomax patent litigation. He stated, "Now for an update on the aNDA litigation related to Angiomax. As you know in October of last year we won a favorable decision in our litigation with Mylan where the District Court judge in Chicago found that our 727 patent is valid, enforceable, and infringed by Mylan. That decision is on appeal but the schedule for oral arguments has not been set. In the Hospira case, the District Court found in March of last year that our 727 and 343 patents are valid, but based on the claim construction, the court also found that Hospira was not infringing. We are appealing the Hospira decision and oral arguments before the appellate court will be held in early March. We expect the decision anywhere from one to six months after oral arguments."
Source: Q4 2014 earnings conference call, 2/18/15.

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The Medicines Company Wins Favorable Judgment in Angiomax® (Bivalirudin) Patent Litigation
PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 27, 2014-- The Medicines Company (NASDAQ:MDCO) announced the U.S. District Court for the Northern District of Illinois in The Medicines Company v. Mylan, Inc. entered judgment in favor of The Medicines Company on all issues concerning U.S. Patent No. 7,582,727 (the “’727 patent”). Following a June 2014 trial, Judge Amy St. Eve found all of the asserted claims (patent claims 1-3, 7-10, and 17) are infringed by Mylan’s Abbreviated New Drug Application (“ANDA”). The same claims were also found to be valid and enforceable.

“We are highly satisfied with the Illinois Court’s ruling, which supports our ongoing conviction to defend these patents vigorously,” said Clive Meanwell, Chairman and Chief Executive Officer for The Medicines Company.

Mylan’s ANDA seeks FDA approval to commercially manufacture, use or sell a generic version of The Medicines Company’s Angiomax® (bivalirudin) drug product before the expiration of the ’727 patent. The ruling prevents Mylan from obtaining FDA approval of its generic bivalirudin and launching its ANDA product until the earlier of a successful appeal or expiration of the ’727 patent in 2028. To appeal successfully, Mylan must overturn the Court’s rulings on each of the asserted claims.
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Source: press release, 10/27/14. http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArti...

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Clive A. Meanwell, Chairman and CEO, responded to a question regarding the ongoing patent litigation with Mylan for generic Angiomax. He stated, "Trial date with Mylan, yes, I think somewhere in the middle of the year."
Source: Q4 2013 earnings conference call, 2/19/14.

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Mylan Pharmaceuticals, Inc.

In January 2011, we were notified that Mylan Pharmaceuticals, Inc. had submitted an ANDA seeking permission to market its generic version of Angiomax prior to the expiration of the '727 patent and '343 patent. On February 23, 2011, we filed suit against Mylan Inc., Mylan Pharmaceuticals Inc. and Bioniche Pharma USA, LLC, which we refer to collectively as Mylan, in the U.S. District Court for the Northern District of Illinois for infringement of the '727 patent and '343 patent. Mylan's answer denied infringement of the '727 patent and '343 patent and raised counterclaims of non-infringement and invalidity of the '727 patent and '343 patent. On April 13, 2011, we filed a reply denying the counterclaims raised by Mylan. On May 4, 2011 the Court set a pretrial schedule. Following a joint request, the Court issued an amended scheduling order on September 22, 2011. On November 29, 2011, Mylan moved to amend its answer to add counterclaims and affirmative defenses of inequitable conduct and unclean hands. Following motion practice, the Court granted Mylan's request to add counterclaims and affirmative defenses of inequitable conduct and to add affirmative defenses of unclean hands. On March 7, 2012, we filed a reply denying these counterclaims. A Markman hearing was held on July 30, 2012. The Court issued a Markman Order on August 6, 2012. The parties have completed fact and expert discovery. On June 21, 2013, Mylan filed a summary judgment motion of non-infringement of the ‘727 and ‘343 patents and alternatively that the ‘727 patent was invalid. The Court’s decision granted non-infringement of the ‘343 patent and denied the motion with respect to non-infringement and invalidity of the ‘727 patent. A trial date has been set for June 9, 2014.
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Source: Form 10K, 3/03/14. http://www.sec.gov/Archives/edgar/data/1113481/000111348114000016/mdco-1...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Angiomax (bivalirudin)CardiovascularAcute coronary syndrome (ACS)AnticoagulantThrombin

Mechanism of action: Angiomax (bivalirudin), SM-inhibitor, antagonizes the coagulation cascade via thrombin inhibition.

Phase of Development: Approved

Event Type: Legal: Patent litigation

Dates: 2015-07-01 - 2015-12-31

Results:

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Federal Circuit Rules for The Medicines Company in Angiomax® (bivalirudin) Patent Litigation

12 Jul 2016
The Federal Circuit unanimously affirms District Circuit decision on Angiomax patents

PARSIPPANY, N.J.--(BUSINESS WIRE)--Jul. 12, 2016-- The Medicines Company announced that the U.S. Court of Appeals for the Federal Circuit Court, in an en banc review, unanimously affirmed the earlier district court ruling in The Medicines Company v. Hospira, Inc., finding that the Company's Orange Book patents covering Angiomax® that expire in 2028 (pediatric exclusivity expiring in 2029) were not invalid under the "on sale" bar. The Federal Circuit also remanded the remainder of the issues on appeal and cross-appeal to the original Federal Circuit panel.

Clive Meanwell, MD, PhD, Chief Executive Officer, The Medicines Company, said, “We are pleased that the district court decision on invalidity has been upheld. We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan, and other generics.”
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Source: press release, 7/12/16. http://www.themedicinescompany.com/investors/news/federal-circuit-rules-...