Administrative Agency Science, Computers & Technology

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Substantial Evidence Supports Determination of Reasonable Expectation of Success

In In re Efthymiopoulos, [2016-1003] (October 18, 2016) the Federal Circuit affirmed the PTAB decision that the claimed invention relating to the administration or an anti-influeza drug “by inhalation through the mouth alone”...more

NASA Announces Beyond Visual-Line-of-Sight UAS Test Flights

National Aeronautics and Space Administration (NASA) plans to fly unmanned aircraft systems (UAS; commonly known as drones) this month beyond visual line-of-sight of their operators to test planning, tracking and alerting...more

New Use for Drones on Australian Beaches

In Western Australia’s South West beaches surveillance drones will hit the skies to increase swimmer safety by spotting sharks in the water. This project will take place over a three-month period (from November to January)...more

AliceStorm Update for October 2016

The Federal Circuit's recent decision in McRO has been interpreted by many in the patent community as a further signal that the so-called "pendulum" is swinging back to a more favorable position for patentees. There is some...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

Smart Regulations: The Oversight of Artificial Intelligence

The Obama administration's National Science and Technology Council released a report on artificial intelligence (AI) last week that shared findings on the current state of AI and its potential effect on society. The council...more

U.S. Commerce Department Releases Updated Report Showing Intellectual Property-Intensive Industries Contribute $6.6 Trillion and...

The U.S. Commerce Department recently released a comprehensive report, entitled “Intellectual Property and the U.S. Economy: 2016 Update” (the “Report”). The Report, which was co-authored by the Economics & Statistics...more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

What Happens When My Company Receives a National Security Letter? A Primer

Even today, most companies—even technology companies—do not think they have information that the U.S. Government wants or needs, particularly as it might relate to a national security investigation. The reality is that as...more

Newsgathering Drones Take Flight

The era of newsgathering drones is upon us. Since new Federal Aviation Administration rules allowing limited commercial operation of drones (also known as unmanned aircraft systems or UAS) weighing 55 lbs. or less took...more

PUT YOUR DOCS WHERE I CAN SEE THEM: Seattle Police Enjoined From Disclosing Software Secrets in Public Records Act Dispute

What happens when trade secret protections collide with laws granting public access to government records? This question took center stage in a recent case involving the Seattle Police Department (“SPD”). A federal district...more

Federal Circuit Relies on Robust Disclosure to Save Priority Date

On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written...more

Niche Drone Market Expected to Explode

Over the past two years, the number of drone manufacturer start-ups has increased exponentially. Drone manufacturer start-ups have reached numbers in the tens (if not hundreds) of thousands. Whether you are seeking a drone...more

Federal Circuit Rules the Patent Trial and Appeal Board Can Consider New Evidence During AIA Review Trial

On September 26, 2016, the U.S. Court of Appeals for the Federal Circuit declined to review in a unanimous en banc decision a panel Federal Circuit decision affirming that the Patent Trial and Appeal Board (the “Board”) at...more

Bass’s First IPR Decision Rendered – Victory for Patent Owner, Shire Lpc

If Kyle Bass’s Coalition for Affordable Drugs Series II hedge fund was hoping to reap a windfall from short positions in Shire Plc’s stock this week, it was dealt a major setback by a Patent Trial and Appeal Board (PTAB)...more

Federal Circuit Review | September 2016

Claims Directed to Monitoring and Analyzing Data Held to Be Invalid under § 101 - In Electric Power Group, LLC v. Alstom S.A., Appeal No. 2015-1778, the Federal Circuit upheld the district court’s grant of summary...more

Important Changes to Export Administration Regulations Affecting Software Industry

On September 20, 2016, the Department of Commerce’s Bureau of Industry and Security (BIS) issued a Final Rule, revising 58 Export Classification Control Numbers (ECCNs), adding two ECCNs, and updating technical definitions in...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

Taking "Subject Access Requests" Seriously in the UK

Under section 7 of the Data Protection Act 1998 (DPA) employees are entitled to make a data “subject access request” (SAR) in order to obtain copies of the personal data held about them by their employer and certain other...more

Changes to BIS's information security controls bring relaxed controls, removal of registration requirement

As part of a raft of revisions to the Export Administration Regulations ("EAR") implementing December 2015 changes to the Wassenaar Arrangement, on September 20, 2016, the Bureau of Industry and Security ("BIS") issued a...more

The USPTO “Patents 4 Patients” Program: What, How, and Why

On January 12, 2016, President Barack Obama announced his goal of a nationwide “Cancer Moonshot,” with the ultimate goal of accelerating cancer research “to end cancer as we know it” during his State of the Union Address As...more

FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 –...more

Samsung Bioepis Seeks Regulatory Approval for an Adalimumab Biosimilar in Europe and South Korea

Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization...more

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