Administrative Agency Science, Computers & Technology

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EPA Proposes Rules to Implement TSCA Reform

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016. We previously summarized that bill's key changes to the Toxic Substances Control Act ("TSCA"). This Commentary highlights...more

3D Cinema Systems: ITC Declines to Apply Issue Preclusion Based on PTAB’s IPR Decision

In 3D Cinema Systems (Inv. 939), the Commission issued an opinion that explained why it did not give deference to a decision of invalidity by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR)....more

Final Written Decision Relies on Unexpected Results To Uphold Pozen’s Ulcer Reducing Vimovo® Claims Over Kyle Bass’s IPR Challenge

The PTAB issued a Final Written Decision upholding Pozen’s ulcer reducing Vimovo® claims based on unexpected results in Coalition For Affordable Drugs VII LLC v. Pozen Inc., IPR2015-01718, Paper 40 (P.T.A.B., Feb. 21, 2017)....more

DJI Drone Manufacturer Hit with Class Action Lawsuit Over Firmware Update

Last week, a class action law suit was filed against leader in the drone industry, DJI Technology, Inc. (DJI), for an allegedly harmful firmware update that occurred in December 2015 that rendered certain commercial drones in...more

PTAB Terminates Interference Proceeding Between University of California and Broad Institute Regarding CRISPR Gene Editing Claims

The Patent Trial and Appeal Board (PTAB) terminated a patent interference proceeding between the University of California (UC) and the Broad Institute (Broad), a joint venture of Harvard University and Massachusetts Institute...more

Federal Circuit Knocks Out Patents After CBM Challenge

Apple successfully invalidated three patents for failure to recite patent eligible subject matter. Apple, Inc. v. Ameranth, Inc., 2015-1792, 2015-1793 (Fed. Cir. 2016). The patents relate to synchronous communication systems...more

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

PTAB Ruling on CRISPR: No Interference

On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR...more

IPR Estoppel Provisions May Not Be That Scary After All

IPR petitioners wary of the statutory estoppel under 35 U.S.C. § 315(e)(2) may have reason to be cautiously optimistic. Judge Sue Robinson of the Federal District Court of Delaware recently held that Toshiba is not estopped...more

State Universities Gain Immunity from IPRs

State Universities Gain Immunity from IPRs - Today, many universities own extensive patent portfolios that are managed by sophisticated tech transfer offices. Universities obtain these patents for many reasons, not the...more

Federal Circuit Looks to Provisional Patent Application in Determining Claim Scope

Differences between a provisional patent application and a nonprovisional application claiming priority to the provisional application may inform claim construction, following the Federal Circuit’s recent decision in MPHJ...more

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k)...more

State Universities Rejoice: PTAB Recognizes Sovereign Immunity Defense

In Covidien LP v. University of Florida Research Foundation Inc., the Patent Trial and Appeal Board (the “Board”) upheld a defense of sovereign immunity asserted by the University of Florida Research Foundation (the...more

Federal court aids in construction of provisions for third party statutory licences following temporary ceasing of a patent but...

The ground-breaking series of decisions, relating to AU 623144 (AU ‘144), which protected the antidepressant escitalopram, has generated another first when the patentee of AU ‘144 sought judicial review of a recent Patent...more

Beacon Navigation GmbH v. General Motors, LLC

On March 28, 2013, Beacon Navigation GmbH (“Plaintiff”) brought suit against General Motors, LLC (“Defendant”) alleging that the Defendant infringed United States Patent Nos. 6,360,167 and 5,878,368 (collectively, “the...more

Licensees Stymied by Sovereign Immunity Both in Federal Court and at PTAB

Licensees Covidien LP, Medtronic PLC, and Medtronic, Inc., failed to obtain any relief, at least so far, in federal court or at the Patent Trial and Appeal Board (PTAB) because of parallel holdings that patent owner...more

The Story Behind the Swarming Drones at Super Bowl LI

If you were one of the 111 million viewers to watch Super Bowl LI, you may have seen the half-time show which featured not only a performance by Lady Gaga, but over 300 swarming drones performing an intricate light show....more

Relocation of the EU Medicines Agency: Italy

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

The Beginning of the National Bioengineered Food Disclosure Standard

In our last issue of the International Food Law Gazette, we reported on the changing legal landscape for the labeling of genetically engineered (GE) foods (more commonly referred to as genetically modified organisms, or GMO)....more

Are Patent-Friendly PTAB Decisions On the Rise?

Patent litigation changed with passage of the America Invents Act. Overnight the PTAB became a new venue for challenging patent claims using IPRs, CBMs and PGRs. The initial reaction by the patent bar to the PTAB’s “take...more

FDA Clarifies “Intended Use” for Drugs, Devices, and Tobacco Products

In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more

Alert: PTAB Rules That Patents Owned by State Entities Cannot Be Challenged Without Consent

Last week, the Patent Trial and Appeal Board (PTAB) dismissed petitions for inter partes review (IPR) of a patent assigned to the University of Florida Research Foundation (UFRF) based on sovereign immunity, Covidien LP v....more

Orlando Issues New Drone Ordinance to ‘Balance the Need to Protect the Privacy of its Citizens’

The city of Orlando, Florida recently issued a new drone ordinance aiming to “promote hobbyists and commercial use of unmanned aircraft” while “balancing the paramount need to protect the well-being, tranquility and privacy...more

Drone Operator Arrested in California for Operation Near Helicopter Rescue

On January 27, 2017, police in Pacifica, California arrested a drone operator for allegedly flying a drone near the scene of a helicopter rescue, which effectively delayed the rescue operation. Police and fire rescue...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

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