Administrative Agency Civil Procedure Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

District Court Issues Order Allowing Plaintiffs in Case Seeking Review of Neonicotinoid Pesticides under the ESA to Utilize Extra...

On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified...more

Court of Appeals Grants Writ of Mandamus Requiring EPA to Take Final Action on Chlorpyrifos Petition

On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition...more

USPTO Pilots Expedited Patent Appeal Program But at What Price?

In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

Federal Circuit Issues First Reversal & Remand of an Inter Partes Review in Microsoft Corporation v. Proxyconn, Inc. Addressing...

The Federal Circuit issued its first reversal and remand of a final decision in an inter partes review issued by the Patent Trial and Appeal Board (“PTAB”). In Microsoft Corporation v. Proxyconn, Inc., No. 14-1543, a panel...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

European Court of Justice Dismisses Case Regarding Confidential Treatment of Information Submitted to EFSA

On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of...more

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

Supreme Court Corner: Q2 2015

B&B Hardware, Inc. v. Hargis Industries, Inc. Trademark - Holding: A Trademark Trial and Appeal Board (TTAB) ruling refusing registration on likelihood of confusion grounds can have preclusive effect on a district...more

Are IPRs impacting the pharmaceutical industry?

The use of inter partes review (IPR) to challenge patents has grown significantly since its initiation in September 2012. In the first four months of IPRs, the USPTO received 97 petitions. In the parallel months of 2014, 578...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

MBHB Snippets: Review of Developments in Intellectual Property Law: Spring 2015 - Vol. 13, Issue 2

In This Issue: - After B&B Hardware, What is the Full Scope of Estoppel Arising From a PTAB Decision in District Court Litigation? - When You Don’t Know What You Know: The Role of Unappreciated Inherency in the...more

Quantify Versus Quality Determines Domestic Industry - Lelo Inc. v. International Trade Commission

The U.S. Court of Appeals for the Federal Circuit reversed a finding by the U.S. International Trade Commission (ITC) of a violation of § 337, concluding that the Commission’s use of a qualitative analysis could not meet the...more

After B&B Hardware, What is the Full Scope of Estoppel Arising From a PTAB Decision in District Court Litigation?

The America Invents Act (AIA) created several adjudicative proceedings within the Patent Trial and Appeal Board (PTAB) of the U.S. Patent & Trademark Office, including inter partes review, post-grant review, and covered...more

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

Patent Infringement in the Digital Age: How a Dispute About Tooth Aligners Led to a Fight About the ITC’s Jurisdiction over...

The International Trade Commission (“ITC”) is an “independent nonpartisan agency that investigates and reports to the President and Congress on matters concerning import trade, tariffs and trade agreements.” Shewmaker v....more

Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

IP Newsflash - May 2015 #3

FEDERAL CIRCUIT CASES - Federal Circuit Reverses Summary Judgment of Noninfringement Under § 271(e)(1) for Consideration of Certain Post-FDA-Submission Activities, But Expresses Skepticism About Infringement...more

Arizona ALJ: Remote Provider of Subscription Research Service is the Lessor of Tangible Personal Property

In a curious decision out of Arizona, an Administrative Law Judge (ALJ) found an out-of-state provider of online research services was properly assessed transaction privilege tax (TPT, Arizona’s substitute for a sales tax)...more

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more

Amgen Prevails on Temporarily Excluding Zarxio® From Market

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal...more

Federal Circuit Keeps Sandoz Biosimilar Off the Market for Now

The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until...more

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...more

230 Results
|
View per page
Page: of 10

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 to create your digest using LinkedIn*

*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.
×