News & Analysis as of

Administrative Agency Science, Computers & Technology

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

PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness

by Jones Day on

In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more

Doctrine of Equivalents and Prosecution History Estoppel Around the World

Please see full Doctrine of Equivalents Chart for Countries around the World. ...more

Celgene Notches Rare Win On PTAB Request For Rehearing

by Foley & Lardner LLP on

The recent decisions of the USPTO Patent Trial and Appeal Board (PTAB) granting Celgene’s requests for rehearing in parallel Inter Partes Review proceedings brought by Kyle Bass’s Coalition for Affordable Drugs (CFAD) are...more

Surviving Alice with an Appeal

by Fenwick & West LLP on

This third article in the “Surviving Alice” series examines how the USPTO’s Patent Trial and Appeal Board has responded to the U.S. Supreme Court’s June 2014 Alice decision. It also shows how applicants can use the PTAB’s...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

D.C. Circuit Strikes Down FAA’s Recreational UAS Rule

by Benesch on

The Federal Aviation Administration (“FAA”) has long set standards for the operation of aircraft in the United States, including extensive requirements for aircraft registration. Historically, the FAA did not interpret the...more

Advanced Weather Data: Vital for the Future of Commercial Drone Operations

Back in December 2016, Amazon executed its first customer delivery by drone in the United Kingdom. Now, as Amazon, and other large retailers, aim for widespread deployment of drones for the delivery of goods to consumers, it...more

FDA Announces Biosimilar User Fee Act Rates for FY2018

by Goodwin on

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

by Hogan Lovells on

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

Global Patent Prosecution Newsletter - September 2017

Worldwide Doctrine of Equivalents and Prosecution History Estoppel - The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more

FDA Approves First Avastin Biosimilar

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi...more

FDA Embraces Real-World Evidence in New Final Guidance

by Hogan Lovells on

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

Pharmaceutical Company Seeks to Use Tribal Sovereign Immunity to Avoid Inter Partes Review

by Snell & Wilmer on

Allergan announced on September 8, 2017, that it had transferred its patents covering the drug Restasis to the Saint Regis Mohawk Tribe and will pay the tribe $13.75 million. The tribe is also eligible to receive $15 million...more

Drones: Moving toward the future of mobility and highways in the sky

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Lisa Ellman and senior advisor Gretchen West talk about the role commercial drones and unmanned aircraft systems (UAS) will play in the future of mobility. They also...more

Fire Departments Across the Country Use Drones for Faster Response

Unmanned aerial vehicles (UAV or drones) are being sent out to fire locations as scouts, using gas sensors and cameras with thermal imaging technology to help fire departments in their rescue efforts. With this new tool, fire...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

Aviation Happenings - Summer 2017

Aviation Happenings - Summer 2017 The Summer 2017 edition of Schnader’s Aviation Group newsletter examines some of the most recent and relevant case and developments in aviation law, including: • Midair Collision Case...more

PTAB Establishes Criteria Governing Follow-On Petitions For AIA Post Grant Proceedings

by Brooks Kushman P.C. on

General Plastic Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB Sept. 6, 2017)- A familiar strategy in inter partes (“IPR”) review proceedings under the America Invents Act (“AIA”) is for petitioners to...more

Mohawks To The Rescue? Can You Immunize Patents From PTAB Review By Assigning To A Native American Tribe?

by Pepper Hamilton LLP on

In an unusual move to combat the perceived bias in favor of patent challengers at the U.S. Patent Office’s Patent Trial and Appeal Board (PTAB), the Irish drug company Allergan has decided to warehouse its key patents on the...more

Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

by Foley & Lardner LLP on

As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution (“Sovereign Immunity of State...more

Government Agency Action Accelerates on Drone Operations

by Cozen O'Connor on

This edition of the Cozen O’Connor Drone Report discusses FAA’s statement on the success of Part 107 (its regulations governing commercial uses of small drones), the status of drone-related rulemakings, DOD’s guidance on...more

EMA Launches New Submission Form Facilitating Submission Of Post-Authorisation Data

by Hogan Lovells on

The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to...more

Smallsat Companies Form Trade Association To Address Issues Facing The Smallsat Community

by Hogan Lovells on

At the annual Smallsat conference in Logan, Utah, the Commercial Smallsat Spectrum Management Association (CSSMA) held its first meeting since legally forming earlier this month. A number of well-known smallsat operators and...more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

2,964 Results
|
View per page
Page: of 119
Cybersecurity

Follow Administrative Agency Updates on:

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.