Administrative Agency Science, Computers & Technology

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Prosecution Disclaimer Has No Teeth

Statements made by patent practitioners to the patent office during patent prosecution can come back to bite you in related applications. Prosecution disclaimer allows a court to limit the literal scope of the claims in an...more

PTAB Holds Oral Hearings In Tecfidera Patent IPR and Interference

On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard...more

FDA Is Evolving on Qualifications for 'New Chemical Entity'

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

FAA Releases New Video for Safe Operation of Drones this Holiday Season

The Federal Aviation Administration (FAA) released a friendly holiday warning for those who chose to purchase a drone this year for the holidays: fly it safely. The FAA released a new video summarizing the rules and...more

MarkIt to Market® - November 2016

The November 2016 issue of Sterne Kessler's MarkIt to Market® includes practical tips for registering certification marks, a look at the Trademark Trial and Appeal Board's latest revisions to the Rules of Practice-its most...more

Federal Court Rules that FEC Cybersecurity Study is Exempt from FOIA Disclosure

Last week, a D.C. federal judge ruled that an investigative reporter was not entitled to a 2014 cybersecurity study performed by an outside vendor detailing vulnerabilities in the Federal Election Commission’s information...more

Federal Circuit Firmly Rejects PTAB Criteria For Covered Business Method Review - Brooks Kushman Post-Grant

In a recent panel decision that deviates from the Federal Circuit’s current tendency to defer to the U.S. Patent and Trademark Office’s interpretation of the Leahy-Smith America Invents Act, the court vacated a final written...more

FAA Sends Proposed Rule for Drone Flights over People to the White House OIRA

Recently, the Federal Aviation Administration (FAA) proposed a new rule for performance-based standards and means-of-compliance for operation of small unmanned aircraft systems (UAS or “drones’) over people who are not...more

District Court Orders Additional Claim Construction Briefing After Plaintiff Appeared to Argue a Different Position in Other...

After the district court conducted a claim construction hearing (but before it issued an order), the district court stayed the litigation between Finjan and Symantec pending a decision by the PTAB regarding whether to...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

In re NuVasive Brings the Administrative Procedure Act to IPRs

NuVasive owns US 8,187,334, which claims certain spinal implants. Medtronic filed a petition challenging various claims of the ‘334 patent as obviousness over US 2002/0165550 (Frey) in view of US 5,860,973 (Michelson). ...more

JW Marriott and DJI, Drone-Maker, Partner Up for Drone Experience Program

JW Marriott Hotel & Resorts (Marriott) and DJI, one of the world’s largest drone makers, have partnered up to launch the hotel chain’s first Drone Experience Program; a program which will provide guests with the opportunity...more

Freedom to Operate and the Use of AIA Review

Freedom to Operate: •Identifying infringement risk •Third party patent (infringement) – claim searching –Timing •Discrete, continuous –Searching •In-house, search agency –Screening/analyzing •Ranking...more

Failure to Let Patent Owner Address Unpatentability Arguments Relied on by the Board Violates Administrative Procedures

The Federal Circuit has ruled that the Patent Trial and Appeal Board cannot deny Patent Owner an opportunity to address portions of a prior art reference first discussed in Petitioner’s Reply, and then rely on those same...more

FDA Holds Public Hearing on Manufacturer Communication of Scientific and Medical Information

On November 9 and 10, 2016, FDA held a public hearing to obtain input on manufacturer communications involving unapproved uses of approved or cleared medical products (i.e., “off-label” uses). The hearing was moderated by...more

Night Ops –Top Requested Part 107 FAA Waivers

At a recent Commercial Unmanned Aerial Vehicles (UAV) Expo in Las Vegas, Nevada, a Federal Aviation Administration’s (FAA) attorney, Dean Griffiths, explained that the top three requests for Part 107 commercial drone...more

Patentee's Day of Thanks Comes in Early November: Assessment of the USPTO's Recent Memorandum Regarding Patent Eligibility for...

A recent U.S. Patent & Trademark Office (USPTO) memorandum to the Patent Examining Corps, in combination with precedential cases from the Federal Circuit, provides positive guidance to owners of software patents and patent...more

Software as a Medical Device: FDA Releases Draft Guidance

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

Major Security Breach Reported to Congress By Federal Bank Regulator

Recently, the Office of the Comptroller of the Currency (OCC) informed Congress that it had suffered a major information security incident. The agency reported that, in November 2015, a former employee downloaded over...more

In re Aqua Products: The Convergence of Administrative and Patent Law

Administrative law has permeated virtually every field of federal practice. Interestingly, patent practitioners have avoided this trend for some time. But this appears to be changing. See, e.g., Dickinson v. Zurko, 119 S. Ct....more

Ferring Pharms., Inc. v. Burwell

Case Name: Ferring Pharms., Inc. v. Burwell, Case No. 15-0802 (RC), 2016 U.S. Dist. LEXIS 121826 (D.D.C. Sept. 9, 2016) - Drug Product and Patent(s)-in-Suit: Prepopik® (sodium picosulfate, magnesium oxide, anhydrous...more

Medtronic v. Robert Bosch – Has the Federal Circuit closed the door on reviewing IPR institution decisions?

On October 20, 2016, the Federal Circuit issued yet another opinion finding that the Patent Trial and Appeal Board’s decisions related to the institution of an inter partes review (IPR) are not subject to judicial review. ...more

Hackers Cause Consumer Drones to Fall from the Sky

Last week at the PacSec security conference held in Tokyo, a new device capable of fully infiltrating radio-controlled drones was unveiled by researchers. This new device exploits a vulnerability in the frequency-hopping...more

FDA Launches Website for Allegations Against Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

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