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Administrative Agency Updates

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

DOJ Reports on Drones Flying Contraband to Prisons

While drone delivery services are certainly on the agendas are large retailers like Amazon, inmates in jails across the U.S. are already using drones to receive their own aerial contraband shipments. Through a Freedom of...more

Food and Beverage News and Trends - June 2017

by DLA Piper on

Nonprofits sue FDA over delay in menu-labeling rule. On June 7, the Center for Science in the Public Interest and the National Consumers League filed suit in the US District Court for the District of Columbia against the...more

Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry

by Hogan Lovells on

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA...more

Congressional Committees Advance Bipartisan FDA User Fee Agreements

by Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

New Pre-Action Protocol for Debt Claims in force from 1 October 2017. Are you ready?

by DLA Piper on

After a lengthy consultation period, the Pre-Action Protocol for Debt Claims (PAPDC) has now been finalised and will come into force on 1 October 2017. This protocol will apply to lenders who are seeking payment of a debt...more

Get your ducks in a row if you want to challenge an adjudicator's decision

by Dentons on

To err is human and, soon after the Construction Act was enacted, the courts sensibly recognised that a "slip rule" could be implied in adjudications to allow adjudicators to correct minor clerical and typographical errors in...more

New Rules: OCR Issues Internal Memorandum Impacting Enforcement Practices for Pending and Future Investigations

by Shipman & Goodwin LLP on

Earlier this month, the U. S. Department of Education, Office for Civil Rights’ Acting Assistant Secretary issued an internal memorandum to Regional Directors eliminating certain existing internal procedures and detailing new...more

New Statistics Predict Drone Production Will Soar to $73.5 Billion Over Next 10 Years

According to recent studies and statistics, unmanned aerial systems (or drones) promise to have the most dynamic growth of any sector in the aerospace industry. With the ease of airspace regulations and operational...more

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Is Software Patentable? Recent US Case Law Offers a Glimmer of Hope

by Field Law on

Many inventions involve software, and many inventors are interested in protecting such inventions with a patent. The question is: are software inventions patentable? Based on recent cases in the United States, the answer is:...more

Clarifying the status of Gainful Employment and Borrower Defense to Repayment

by Thompson Coburn LLP on

During the second term of the Obama administration, the U.S. Department of Education promulgated several complex regulatory packages. Among the most significant and controversial were the Gainful Employment (“GE”) rule,...more

The Board can Rely on a Party’s Arguments in an IPR, as Long as it Explains Why

In Outdry Technologies Corp. v. Geox S.P.A., [2016-1769] (June 16, 2017), the Federal Circuit affirmed the Board’s determination that claims 1–15 of U.S. Patent No. 6,855,171 would have been obvious over a combination of...more

4 Common Reasons for a Trademark Registration Refusal

by Revision Legal on

When someone applies for a federal trademark registration with the United States Patent and Trademark Office (USPTO), it is possible for the trademark registration application to be refused. While this is often disappointing,...more

EP Opposition and US Inter Partes Review Decisions Go Hand In Hand

It is often desirable to obtain patent protection for inventions both in Europe and the United States. As a result, competitors frequently look to Europe and the US as important jurisdictions for challenging the validity of a...more

Financial Services Weekly News - June 2017 #3

by Goodwin on

Editor's Note - In This Issue. President Trump announced his intended nominee for Chairman of the Federal Deposit Insurance Corporation (FDIC), the Consumer Financial Protection Bureau (CFPB) proposed updates to its...more

Earthquake Coming? Supreme Court to Weigh Constitutionality of IPRs (2nd Article)

On June 12, the Supreme Court took certiorari on probably the biggest IPR case possible: a case challenging the constitutionality of IPRs on separation-of-powers and seventh amendment grounds. This comes just a few weeks...more

U.S. Department of Education Delays Borrower Defense to Repayment Regulations, Announces New Negotiated Rulemaking Committees

by Hogan Lovells on

On June 14, the U.S. Department of Education (“ED”) announced its plan to convene negotiated rulemaking committees to consider revisions to two major sets of regulations that were developed by the Obama Administration. ED...more

Administrative Procedure Act Litigation: The Changing Regulatory Landscape, the Role of Industry, and Emerging Issues

by WilmerHale on

As the Trump Administration concludes its fifth month, industry is facing a changing regulatory landscape that offers both opportunities and challenges. In this period of transition, litigation under the Administrative...more

PTAB Denies Timely, Relevant Supplement to Petition

by Jones Day on

By rule, a petitioner may request permission from the Board to submit supplemental information in an IPR proceeding if: (1) the request is filed within one month of the Board’s institution decision, and (2) the supplemental...more

Computer-Based Publishing Patent Goes Offline after Alice Inquiry

In a recent order from the District of Massachusetts, the court granted a defendant’s motion for summary judgment in a patent infringement dispute, finding the asserted patent claims invalid under 35 U.S.C. § 101. The court’s...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

New Trump Appointee at EPA Should Help Reduce Backlogs and Delays

by Snell & Wilmer on

United States EPA Administrator Scott Pruitt has hired Henry Darwin to serve the U.S. Environmental Protection Agency as its Chief of Operations. Under both Republican and Democrat administrations, as the Director of the...more

Judge Essex Updates Ground Rules to Limit Prehearing Briefs, Opening Statements

by Jones Day on

Last week, Judge Essex issued a notice updating his ground rules in active investigations pending before him...more

No Mandatory Exhaustion of Administrative Remedies for Proposition 218 Challenge - California Court of Appeal Allows Challenge to...

by Best Best & Krieger LLP on

A ratepayer is not required to file a written protest or appear at a public hearing for the adoption of new or increased property-related fees prior to filing a legal challenge to those fees, a California Court of Appeal...more

IRS Reissues Proposed Regulations for Centralized Partnership Audit Regime

by Morrison & Foerster LLP on

The new rules represent a complete overhaul of partnership audit, assessment, and collection procedures. Taxpayers should review and potentially amend partnership agreements before the new rules are scheduled to take effect...more

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