Administrative Agency Science, Computers & Technology

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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

Setting Up the Scope of IPR Estoppel for the Federal Circuit

On January 11, Judge Sue L. Robinson issued her final decision on statutory estoppel in district court post-inter partes review (“IPR”) proceeding, confirming her decision on summary judgement of invalidity and cross motion...more

One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more

MarkIt to Market® | January 2017

The January 2017 issue of Sterne Kessler's MarkIt to Market® includes an overview of the TTAB's recent surname decisions, the changes made by the USPTO to their trademark processing and services fees, and lists the new gTLD...more

Surviving Alice in the Finance Arts

The U.S. Supreme Court’s 2014 decision in Alice Corp. v. CLS Bank (“Alice”)[i] has had a dramatic impact on the allowability of computer implemented inventions, especially in the finance arts (e.g. insurance, banking, etc.). ...more

New Video Resources on Inter Partes Review (IPRs)

Since 2012, Inter Partes Review (“IPR”) has emerged as one of the most significant new procedures in patent law. An IPR is a proceeding in the Patent Office, and allows a party to challenge an issued patent on certain prior...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

PTAB Dismisses Three IPR Petitions Based on Sovereign Immunity

Covidien LP had a license to U.S. Patent 7,062,251, owned by the University of Florida Research Foundation (UFRF, Patent Owner). UFRF alleged breach of contract by Covidien, and sued Covidien in Florida state court for...more

FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating...more

Commercial Drone Pilot Alert: FAA Policy Changes

The Federal Aviation Administration (FAA) recently made some Section 333 policy changes that may have slipped under some commercial pilots’ radars. Back in November, the FAA posted a document in the Federal Register that...more

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