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28 Feb 2013, 9:36 pm
By Andrew Williams -- On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. [read post]
3 Nov 2013, 9:59 pm
By Andrew Williams -- "In the modern economy, licensing of intellectual property rights is a widespread and essential activity." [read post]
14 Jan 2015, 9:59 pm
By Andrew Williams -- Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug. [read post]
16 Mar 2014, 9:52 pm
By Andrew Williams -- Today, March 16, 2014, marks the eighteen-month anniversary of the inter partes review ("IPR") system of challenging issued patents at the Patent Office. [read post]
26 Feb 2015, 9:59 pm
By Andrew Williams -- Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. [read post]
2 Apr 2015, 9:59 pm
By Andrew Williams -- Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? [read post]
23 Jul 2015, 9:59 pm
By Andrew Williams -- As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. [read post]
23 Jun 2014, 9:59 pm
Post-Grant Patent Challenges and Biosimilar Regulatory Pathways By Andrew Williams -- The 2014 BIO International Convention has already begun in San Diego, but most of the sessions and forums get underway beginning on Tuesday, June 24, 2014. [read post]
7 Dec 2011, 9:59 pm
By Andrew Williams -- Last week, in Teva Pharma. [read post]
22 Jun 2014, 9:34 pm
BIO and Leaders in the IP Community By Andrew Williams -- The 2014 BIO International Convention begins this week in San Diego. [read post]
2 Oct 2014, 9:59 pm
By Andrew Williams -- As we have been reporting, the U.S. [read post]
9 Jan 2017, 9:59 pm
By Andrew Williams -- Can any petitioner appeal a Board's final written decision from an inter partes review or post grant review proceeding? [read post]
20 Jan 2015, 11:23 am
By Andrew Williams -- In a 7-2 decision authored by Justice Breyer, the Supreme Court held today that an "appellate court must apply a 'clear error,' not de novo, standard of review" to the evidentiary underpinnings of a district court's claim construction determination. [read post]
18 Jan 2018, 9:59 pm
By Andrew Williams -- In November, Chief Judge David P. [read post]
25 Sep 2016, 8:06 pm
By Andrew Williams -- On Friday, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-α antibody. [read post]
27 Nov 2013, 9:17 pm
By Andrew Williams -- As we have previously reported, Rep. [read post]
29 Jun 2017, 8:52 pm
By Andrew Williams -- On June 27, 2017, the U.S. [read post]
20 Jan 2015, 9:28 pm
By Andrew Williams -- As we reported earlier today, the Supreme Court held in a 7-2 decision authored by Justice Breyer that an "appellate court must apply a 'clear error,' not de novo, standard of review" to the evidentiary underpinnings of a district court's claim construction determination. [read post]
30 Mar 2015, 9:41 pm
By Grantland Drutchas and Andrew Williams -- On Friday, March 27, U.S. [read post]
3 Dec 2015, 9:29 pm
Cir. 2015) By Andrew Williams -- In a decision that likely came as no surprise to anyone, the Federal Circuit upheld the constitutionality of IPR proceedings as provided for by the America Invents Act. [read post]
