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Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

by Foley & Lardner LLP on

I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

New Laws passed in Florida and Oregon add to Varying State Drone Regulations

Florida and Oregon have both recently changed their Unmanned Aircraft Systems “UAS” (or “drone”) regulations, joining the vast majority of states looking to protect their residents through the use of their police power. ...more

It’s That Time of Year Again: How Congress’ Proposed FAA Reauthorization Bills Could Impact the Commercial Drone Industry

by Hogan Lovells on

In the last few weeks, both houses of Congress have released draft FAA Reauthorization bills to continue FAA funding which runs out this fall. While the House bill’s proposal to privatize air traffic control in the United...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

Florida Enacts Law to Keep Local Governments from Regulating Drones

On July 1, 2017, a new law in the State of Florida became effective in order to keep “local governments from regulating drone and model aircraft operations” in the State, while in turn, “protecting those who fly safely and...more

Clarifying or Conforming? The EPO Bows to the European Commission

by Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

by Cozen O'Connor on

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

Hail, SESAR! A Blueprint for Drone Airspace Regulation in Europe

by Hogan Lovells on

In Europe, the United States and countries around the world, drone technology is advancing rapidly, and what used to be considered toys are quickly becoming powerful commercial tools that can provide enormous benefits in...more

Canada Revises its Recreational Drone Use Rules

On June 16, 2017, Transport Canada, the department within the government of Canada which is responsible for developing regulations, policies and services of transportation in the country, issued an Interim Order (“the Order”)...more

Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests

Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans. Rare diseases have long had trouble...more

Method-of-Treatment Claims That Did Not Require a Specific Level of Efficacy Held Unpatentable as Obvious in Light Of References...

The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

LabMD – FTC Face-Off Continues Over FTC’s Data Privacy Authority

by Patrick Law Group, LLC on

The U.S. Court of Appeals for the Eleventh Circuit recently heard oral arguments in LabMD, Inc. v. Federal Trade Commission, the long-running dispute over the FTC’s authority to impose liability for data security breaches...more

Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art

by Jones Day on

In a final written decision in Bass, et al., v. Fresenius Kabi USA, LLC (IPR2016-00254), the PTAB found that the challenged claims of Fresenius’s U.S. Patent No. 8,476,010, directed to a sterile pharmaceutical composition of...more

Update on Significant DOT, FAA, and Other Federal Agencies’ Aviation-Related Regulatory Actions - July 2017

by Cozen O'Connor on

This edition of the Cozen O’Connor Aviation Regulatory Update discusses the latest FAA reauthorization bills, the Department of Homeland Security’s enhanced aviation security measures, the DOT Inspector General’s audit...more

Deuterated Drugs Are New Chemical Entities

by Pepper Hamilton LLP on

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

U.S. Senators Introduce the Safe DRONE Act of 2017

Yet another piece of drone legislation is in circulation; the Safe DRONE Act of 2017 was recently introduced by U.S. Senators Mark R. Warner, John Hoeven, Catherine Cortez Masto, and Dean Heller. ...more

Ex Parte Hafner Provides Clarity in Assessing Patent Subject Matter Eligibility for Software Patents

by Knobbe Martens on

In Ex Parte Hafner, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) reversed the Examiner’s rejection that claims directed to an energy transaction plan were subject-matter ineligible. Ex...more

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

by Hogan Lovells on

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more

Commercial Drone Alliance Issues Statement on June 28th Domestic Drone Security Summit

by Hogan Lovells on

Drone technology has advanced rapidly over the last decade, and this technology has become a valuable tool for many industries on a global scale.  The commercial and consumer uses for drones have grown exponentially, and the...more

Another Drone Bill Seeking Local Control of Drones

We previously wrote about the Drone Federalism Act introduced earlier this month, and now, another bill is seeking to regulate drones at the local level. The Drone Innovation Act, H.R. 2930, introduced by Jason Lewis of...more

Article: June 2017: Energy Litigation Update

New Administration Leads to Pause of Major Energy-Related Litigation. In March, President Trump signed an executive order directing the Environmental Protection Agency (“EPA”) to “suspend, rescind, or revise” several...more

Extension of U.S. Patent and Trademark Office’s Cancer Immunotherapy Pilot Program

On June 19, 2017, the U.S. Patent and Trademark Office (USPTO) announced that it would be extending the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be examined...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In EmeraChem v Volkswagen the Circuit reverses a determination of obviousness because the ?Board did not provide the patentee with an adequate opportunity to address a prior art reference ?that formed a principal basis for...more

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