Can You File An RCE In That U.S. National Stage Application?

Since the implementation of the America Invents Act on September 16, 2012, and the Technical Corrections Act on January 14, 2013, Applicants have been able to delay submission of an executed inventors’ oath/declaration in a U.S. patent application until payment of the issue fee. Although U.S. national stage applications could not immediately benefit from this rule change because the September 16, 2012 effective date was based on international filing date, U.S. national stage applications filed since March 16, 2015 should be encompassed by its provisions. However, another rule published April 2, 2015 makes it risky to delay filing an executed inventors’ oath/declaration in a U.S. national stage application. Continue reading this entry

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants over owners of original biologic products (“reference product sponsors”). The court held that a biosimilar applicant does not have to share its biosimilar application with the reference product sponsor or follow the patent dispute resolution procedures set forth in the BPCIA. However, it does have to give 180 days’ pre-marketing notice and cannot do so until after the FDA has “licensed” (approved) the biosimilar product. The end result for the parties is that Amgen’s state law claims against Sandoz are dismissed or moot, while Sandoz can begin marketing Zarxio™ on September 2, 2015.   Continue reading this entry

Simultaneous Invention As Secondary Evidence Of Obviousness

I do not usually write about non-precedential Federal Circuit decisions, but I could not let the discussion of “simultaneous invention” in Columbia University v. Illumina, Inc.go without comment. As if protecting patents from a hindsight-based determination of obviousness is not challenging enough, this theory holds that subsequent invention by another relatively soon after the invention at issue can support a finding of obviousness.  Continue reading this entry

New Insights On USPTO Patent Trial And Appeal Board Proceedings

I’m pleased to announce that Foley & Lardner LLP has launched a new blog that will focus on USPTO Patent Trial and Appeal Board (PTAB) proceedings, and provide experienced-based insights into Patent Trial proceedings.

I’ll still be spending most of my blogging time here, but once in a while I’ll be writing about PTAB issues over there, starting with my synopsis of the Federal Circuit’s denial of the petition for rehearing en banc in Cuozzo.

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We hope you find all of our blog articles timely, interesting and informative, and we always welcome your comments.

Contract Manufacturing Makes Angiomax Patents Invalid Under On Sale Bar

In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents.  Are the facts of this case unusual, or does this decision put other pharmaceutical patents at risk? Would the on sale bar of the AIA version 35 USC § 102 apply to a case like this? Continue reading this entry