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NGOs Challenge Nanosilva’s Conditional Registration

On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency’s (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit....more

Biotech-specific Subject Matter Eligibility Materials Delayed

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject...more

Companies Appeal ECHA’s Requests for Information Concerning Nanoforms

The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v....

Addressing the circumstances for submitting supplemental evidence in an inter partes review (IPR), the Patent Trial and Appeal Board (PTAB or Board) allowed the petitioner to submit a responsive declaration after the due date...more

Upper Tribunal Criticises FCA's Approach To Publicising Decision Notices

We consider here the decision of the Upper Tribunal (Tax and Chancery Chamber) in Bayliss & Co (Financial Services) Limited and Clive John Rosier v the Financial Conduct Authority [2015] UKUT 0265 (TCC) in which the tribunal...more

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

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