Posts Tagged: "district of new jersey"

CAFC Overturns Preliminary Injunction on Generic Suboxone Film Over Newman Dissent

The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., which vacated a preliminary injunction handed out by the District of New Jersey in a Hatch-Waxman patent infringement case brought by British pharmaceutical firm Indivior. The Federal Circuit panel majority concluded that the district court had abused its discretion in granting the injunction. The majority found that the ‘305 patent’s specification disparaged, and therefore disclaimed, the method of drying the films with the use of conventional methods which only dry the top of the film. Judge Pauline Newman authored a dissenting opinion in which she explained she would have found the district court’s preliminary injunction grant sustained on appeal. According to Judge Newman, the majority’s decision imported the drying limitation from the ‘514 patent claims into the ‘305 patent claims despite the fact that the ‘305 patent was amended specifically to remove this limitation.

PTAB Institutes CBM Review of Nasdaq Patents Challenged by MIAX

In early October, the Patent Trial and Appeal Board (PTAB) instituted a series of covered business method (CBM) reviews on patents owned by American stock exchange Nasdaq. The CBM reviews were petitioned by trading platform provider Miami International Holdings (MIAX) and challenge the validity of patents which Nasdaq has asserted against MIAX in U.S. district court.

Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. This total number of ANDA cases was below recent highs set in 2014 (437 cases) and 2015 (475 cases) but it was also a significant increase over the 324 ANDA cases filed in 2016. Going back to 2009, 2017 saw the third-highest number of ANDA cases in a single year. The fact that ANDA litigation is rising is pretty consistent with the number of ANDA applications being received by the FDA. In 2017, the FDA approved a record number of ANDAs with 763 such approvals that year; the agency attributed this uptick to an increased number of agency hires.

Nasdaq files patent infringement lawsuit against trading platform provider IEX Group

The American stock exchange Nasdaq filed a complaint for patent infringement against electronic-based trading platform provider IEX Group in the District of New Jersey. Nasdaq is seeking enhanced damages for willful infringement of a series of patents covering auction and order processing as well as other technologies which Nasdaq alleges would have been known to the founders of IEX, who were former Nasdaq employees.

PTAB Judges Shockingly Inexperienced Compared to District Court Judges

This study uncovered several shocking revelations. First, 12.64% of PTAB judges were appointed with less than 5 years of experience prior to their appointment as APJs (i.e., 5 years or less removed from graduating from law school), while some PTAB judges were appointed with as little as 2 years of experience. Indeed, 7.47% of APJs had 4 or less years of experience when they were appointed to the PTAB… There were zero federal district court judges appointed with 10 years or less experience, while 46.55% of PTAB judges were appointed with 10 years or less experience… This would mean that 46.55% of PTAB judges were appointed while they were still at best senior associates. Worse, 4.60% of PTAB judges were appointed with 3 or fewer years of experience, which means those 4.60% of PTAB judges were appointed at a time when they were only at a junior associate level.

Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.