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Patent Owners Beware: Don’t Sleep on Your Rights!

Laches, a judicially created defense based on the plaintiff’s delay and prejudice to the defendant, is a proper defense to the recovery of damages in a patent infringement suit, even though the Supreme Court ruled in 2014...more

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

Apple v. Samsung Part IV: The Injunction May Not Be Dead

On Thursday, September 17, 2015, in the fourth Federal Circuit opinion arising out of the patent skirmishes between global high technology titans Apple and Samsung Electronics, a sharply divided Federal Circuit panel vacated...more

Reply Brief filed in Spokeo v. Robins – Oral Argument next on Nov. 2

In its reply brief in Spokeo v. Robins, petitioner Spokeo comes out of the gate with the consequential argument that for Robins to prevail, the Supreme Court must accept his position that every violation of a statutory right...more

A Primer on Patent Damages - Carnegie Mellon University v. Marvell Technology Group, Ltd., et al.

Addressing a panoply of damages issues, the U.S. Court of Appeals for the Federal Circuit affirmed a reasonable royalty, rejected the defendant’s laches defense and provided significant guidance on the application of the...more

TCPA Connect - September 2015

No Need to Wait for the U.S. Supreme Court—Seventh Circuit Rules on Mooting Offers in TCPA Suits - The latest court to weigh in on an offer of judgment in a Telephone Consumer Protection Act Suit: the Seventh Circuit...more

The Effect of Microsoft v. Motorola

Throughout U.S. patent law jurisprudence, a select number of cases have made significant changes to fundamental aspects of the process of patent litigation. Such milestone cases often eclipse the more specific details of the...more

Amgen v. Sandoz – Did the Federal Circuit Just Doom the New Biosimilar Approval Pathway?

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more

IP Newsflash - September 2015

DISTRICT COURT CASES - Minnesota Court Awards Octane Fitness $1.7 Million in Attorney Fees and Costs - In the seminal case establishing a lower standard for attorney fees in “exceptional” patent cases—Octane Fitness...more

I Think That I Shall Never See, Trademark Injunctions If Confusion Is Unlikely

In its recent decision in Arborjet, Inc. v. Rainbow Treecare Scientific Advancements, Inc., a case involving claims for breach of contract and trademark infringement, the U.S. Court of Appeals for the First Circuit affirmed a...more

The United States’ First-Ever Biosimilar Reaches the Market

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen. The launch follows the Federal...more

Amgen Panel Denies Emergency Motion for Injunction Pending En Banc Consideration

Recently, the Federal Circuit panel that decided Amgen v. Sandoz (summary; opinion) denied Amgen’s emergency motion for an injunction pending consideration of its petition for en banc review. The panel (Judges Lourie, Newman,...more

Federal Circuit Patent Updates - August 2015

The Dow Chemical Company v. Nova Chemicals Corporation (No. 2014-1431, -1462, 8/28/15) (Prost, Dyk, Wallach). Dyk, J. Reversing award of supplemental damages. "We hold that the intervening change in the law of...more

Federal Circuit Lifts Injunction Against Sandoz

Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen...more

New Jersey Federal Baked Goods Fraud Class Actions Are Toast

On this date in 1901 (September 2nd), Teddy Roosevelt for the first time uttered in public the immortal phrase, "Speak softly and carry a big stick". It is hard to find people who do not admire that statement. It is harder...more

Non-Apportioned Damages Awards Can Make Design Patents Highly Valuable

Companies should make design patents a key part of a company’s patent strategy due to the possibility for non-apportioned awards for design patent infringement. For companies manufacturing products in high volume, especially,...more

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

IP Newsflash - August 2015 #2

FEDERAL CIRCUIT CASES - Federal Circuit Quashes $287 Million Enhanced Damages Award Finding Objectively Reasonable Defenses Raised During Litigation - The Federal Circuit has reversed a district court’s award of...more

Second Circuit Denies Petition for Actavis Rehearing

We have previously posted about the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest Laboratories LLC (together, “Actavis”), including our analysis of the District Court’s opinion...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech...more

Federal Court Grants First Amendment Injunction in Amarin Case

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the...more

Breaking News - Amarin Hits First Amendment Home Run Off FDA

Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition...more

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