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Category: Biotechnology

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA).  While this is an interim decision without a substantive opinion, it indicates that the court is taking Amgen’s arguments seriously.

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Impact of Supreme Court’s Commil v. Cisco?

On March 31, the Supreme Court heard oral argument in Commil USA LLC v. Cisco Systems Inc.  The Supreme Court considered the Federal Circuit’s holding that a belief in a patent’s invalidity is a defense to inducing infringement under 35 U.S.C. § 271(b).  The Justices posed tough questions to both sides.  But the ultimate outcome of this case should not impact litigation under the BPCIA where inducing infringement of method of treatment and manufacturing patents offers important protection to innovators since the validity of such patents is typically determined prior to launch of a biosimilar product.

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Gilead’s Cert Petition Denied

In Gilead Sciences v. Natco Pharma, the Federal Circuit held that for post-GATT patents, i.e., patents filed after June 8, 1995 and subject to a 20 year term from the filing of the patent applications under the General Agreement on Tariffs and Trade (GATT),...
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Welcome to BiologicsBlog.com

Welcome to the Biologics Blog, which will track and analyze developments in intellectual property law related to biologic medical products as well as regulatory and legislative changes. Our impetus for starting the blog is the recent onset of regulatory activity and litigation under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created a new regulatory and legal framework for biosimilar and interchangeable biologic products.

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