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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 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

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

A question of harm: LabMD to face off with FTC at 11th Circuit

In a consequential test of the Federal Trade Commission’s authority as a data security regulator, the U.S. Court of Appeals for the Eleventh Circuit will hear argument tomorrow in a case that will determine whether the agency...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

The State of the Drones: Unclear Laws and Anti-Drone Technology

Over the past decade, since the Federal Aviation Administration (FAA) first permitted the use of drones for commercial and hobbyist purposes, after the 2012 directive of Congress for the FAA to come up with a “comprehensive...more

NJ Law Restricting Drones will have to be Rewritten

The town of Garfield, New Jersey has introduced new regulations related to hobbyist drone operation—or better yet, the non-operation of drones above residences other than your own, commercial zones, roadways, government or...more

Global Patent Prosecution Newsletter - June 2017

Revocation Proceedings Around the World - Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more

Speedy Justice: Ttab Reverses Refusal To Register CROSBY QUIC-TAG

by Ladas & Parry LLP on

In a non-precedential decision in In re The Crosby Group LLC, Serial 86780353 (April 17 2017), the Trademark Trial and Appeal Board (TTAB) held that there was no likelihood of confusion between the applicant’s CROSBY QUIC-TAG...more

Sandoz v. Teva: Supreme Court Nixes Post-Approval Waiting Period for Biosimilars

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In its first opinion relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Supreme Court in Sandoz Inc. v. Amgen Inc. provided a win to biosimilar companies, eliminating the...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Real-name registration requirement imposed for civilian-use drones in China

by Hogan Lovells on

Following serious incidents of civilian drones entering the airspace of Chinese airports and causing flight delays last April, China’s civil aviation authority has issued the Real-name Registration of Civil Unmanned Aircraft...more

Federal Circuit Upholds Claim Construction – No Due Process Violations

by Jones Day on

On May 8, 2017, in Intellectual Ventures II LLC v. Ericsson Inc., 15-1739, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB) inter partes review (IPR) claim constructions in a non-precedential decision....more

Drone Federalism Act, Seeking Regulation of Drones at the Local Level

The Drone Federalism Act of 2017, introduced by U.S. Senators Dianne Feinstein, Mike Lee, Richard Blumenthal, and Tom Cotton, seeks to “establish a process for federal, state, local and tribal governments to work together to...more

Federal Circuit Review | May 2017

by Knobbe Martens on

Federal Circuit Affirms Different Invalidity Results at PTAB and District Court - In Novartis AG v. Noven Pharmaceuticals Inc., Appeal Nos. 2016-1678, 2016-1679, the Federal Circuit held that prior judicial opinions...more

Collaboration, Harmony Key For International Drone Rules

by Morrison & Foerster LLP on

The Federal Aviation Administration’s Small Unmanned Aircraft Rule, called Part 107, broadly authorized simple, visual line-of-sight operations with drones that weigh less than 55 pounds. Part 107 was considered by most to be...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

CAFC: What a Person of Skill in the Art “Could” Do is Insufficient Evidence to Support Obviousness Finding

Duke University owns US 7,056,712 (‘712), which claims methods of treating a metabolic disorder known as Pompe disease. In particular, ‘712 claims methods of treating Pompe disease using a recombinant human acid...more

PTAB Denies Apple's Motion to Withdraw IPR Petition and Motion for Joinder

by Knobbe Martens on

The PTAB denied Apple’s motion to withdraw both its IPR petition and concurrent motion for joinder to prevent Apple from circumventing potential estoppel ramifications in Apple Inc. v. Papst Licensing GmbH & Co. KG,...more

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