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Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants

In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more

Draeger Medical Systems Files For Declaratory Judgment Against My Health

On March 19, 2015, Draeger Medical Systems, Inc. (“Draeger”) filed a Declaratory Judgment action against My Health, Inc. (“My Health”). The complaint alleges that My Health sent a cease and desist letter to Draeger that...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

The Evolving World of Biosimilars - Amgen, Inc. v. Sandoz, Inc. Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more

Gotta Dance? Apparently Not -- A Biosimilar Update

United States District Judge Seeborg of the Northern District of California denied Amgen's motion for a preliminary injunction today in the Amgen v. Sandoz case, thereby paving the way for the marketing of the first...more

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more

Defining “Reasonable” in RAND: A Bit of Common Sense

What is RAND? It’s a simple question. Given the ubiquity of the term, one would think that the answer would be clear. After all, standard-setting organizations (“SSOs”) around the world require patent holders to declare their...more

A “Solution” in Search of a Problem? The Innovation Act of 2015 and Trends in Fee-shifting in Patent Litigation

On February 5, 2015, Rep. Robert Goodlatte (R-VA) introduced H.R. 9, entitled the “Innovation Act.” Among other things, the bill would direct courts to award attorneys’ fees and litigation-related expenses to prevailing...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

Jury Awards $58.7 Million for Trade Secret Misappropriation After Technology Disclosure Pursuant to NDA

On March 6, in a U.S. District Court for the Eastern District of Texas case, Texas Advanced Optoelectric Solutions (TAOS) Inc. obtained a verdict against Intersil Corp. (Nasdaq: ISIL) for trade secret misappropriation, breach...more

January/February Recap

It’s interesting to look at the first two months of 2015 against the backdrop of the previous year. Judge Illston’s orders, for example, suggest that one should not expect much to change in ND Cal judges’ willingness to...more

Default Is In Our Stars: Allegedly Overreaching Copyright Claimants Fail to Show

Taking legal action to enforce a copyright is often an expensive proposition so, before you go down that road, you better make sure you own the copyright in question. But what if you have already initiated copyright...more

Congress Takes Up Patent Litigation Reform – Innovation Act Reintroduced, Supreme Court Cases Examined

Congress v SCtPatent litigation reform has been on the U.S. House Judiciary Committee agenda, with the recent reintroduction of legislation seeking to address patent litigation abuses and a hearing examining recent U.S....more

The case law of the German courts of lower instance for patent law and utility model law since the year 2013

The article is divided into three main parts. The first part (I.) deals with the substantive law, the second part (II.) deals with procedural law and the third part (III.) deals primarily with the question of costs and cost...more

Four Mile Bay Sues Zimmer Holdings

Four Mile Bay, LLC recently sued Zimmer Holdings, Inc. in the United States District Court for the Northern District of Indiana. The complaint alleges that Zimmer Holdings’ hip implants, such as the “Trabecular Metal Primary...more

IP Newsflash - February 2015 #3

FEDERAL CIRCUIT CASES - Federal Circuit Throws Out $2 Million Award to Nvidia and Sony - Despite the Supreme Court's Octane Fitness decision making it easier to award attorneys’ fees, the Federal Circuit has...more

Federal Circuit Review - February 2015

More Deference to District Courts in Claim Construction - In TEVA PHARMACEUTICALS USA, INC. v. SANDOZ, INC., No. 13-854, the Supreme Court held that factual findings underpinning claim construction rulings are reviewed...more

Media and on-line piracy: what’s new in Italy

There have been very interesting developments in Italian case law against media online piracy. The first and most important is the publication of statistics on the application of the Italian AGCOM regulation, as well as the...more

Virginia Court Dismisses Webcaster’s Suit Concerning Geofencing Workaround to Copyright Royalty Obligations

We previously wrote about a Virginia federal magistrate judge’s report recommending dismissal of a declaratory judgment action brought by several radio stations asking the court to rule that webcasts limited in scope via...more

District Court Action Dismissed Without Prejudice Does Not Bar Filing of IPR Petition - Nautique Boat Co., Inc. v. Malibu Boats,...

Addressing whether a district court action dismissed without prejudice bars a filing of an inter partes review (IPR) petition under 35 U.S.C. § 315(a)(1), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal...more

Prior Declaratory Judgment Action Fatal to CBM Petitioner - GTNX, Inc. v. INTTRA, Inc.

In a decision bringing four instituted covered business method (CBM) review proceedings to a full stop, the Patent Trial and Appeal board (PTAB or Board) reiterated that a petitioner’s declaratory judgment action filed before...more

Defense of Laches in Patent Cases to Be Reviewed En Banc - SCA Hygiene Products Aktiebolag, et al. v. First Quality Baby Products,...

The U.S. Court of Appeals for the Federal Circuit has order for en banc review of the defense of laches in patent cases in order to evaluate the impact of the Supreme Court’s laches decision in the copyright case Petrella v....more

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