News & Analysis as of

Patent Invalidity Hospira

Goodwin

PTAB Invalidates Bevacizumab Method of Use Patent

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Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims of the ’115 patent, which is directed to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)

The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more

Goodwin

Celltrion and Hospira Have Launched Inflectra® in U.S.

Goodwin on

This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively,...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Womble Bond Dickinson

Courts Answer Key Questions Over the Reach of the BPCIA

Womble Bond Dickinson on

Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

Foley & Lardner LLP

En Banc CAFC Requires UCC Sale For On Sale Bar

Foley & Lardner LLP on

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

Foley & Lardner LLP

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

Foley & Lardner LLP on

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

Mintz - Intellectual Property Viewpoints

What Type of Sale Constitutes an On-Sale Bar?

An invention cannot be patented if it was ready for patenting and was subject to a commercial offer for sale more than one year before the application was filed. This so-called “on-sale bar” can also be used to invalidate a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Cubist Pharmaceuticals, Inc. v. Hospira Inc. (Fed. Cir. 2015)

Mistakes happen; there is even a book, entitled Human Error, that discusses how and why they happen. The Federal Circuit addressed the consequences of human error (or perhaps more accurately, instances where there was a...more

McDermott Will & Emery

Federal Circuit to Consider On-Sale Bar En Banc - The Medicines Company v. Hospira, Inc.

McDermott Will & Emery on

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit, in The Medicines Company v. Hospira, Inc., Case Nos. 14-1469; 14-1504, found that the claims of an asserted...more

Foley & Lardner LLP

Federal Circuit to Revisit on Sale Bar Triggered by Contract Manufacture

Foley & Lardner LLP on

Friday the 13th may have been The Medicines Company’s lucky day, since the Federal Circuit granted its petition for rehearing en banc in The Medicines Company v. Hospria, Inc. In the court’s original decision, which I...more

McDermott Will & Emery

Declarations from Inventors of Prior Art Could Create Genuine Dispute over Motivation to Combine - Ivera Medical Corp. v. Hospira,...

McDermott Will & Emery on

Addressing the issue of obviousness, the U.S. Court of Appeals for the Federal Circuit held that the district court erred in granting summary judgment of invalidity because plaintiff patentee established a genuine issue of...more

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