Administrative Agency Intellectual Property Science, Computers & Technology

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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

Nearly Expired Is Not the Same as Expired: The Board Clarifies Claim Construction Standards for Inter Partes Review - Apple, Inc....

Addressing the standard to be applied for claim construction during inter partes review (IPR) proceedings, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) declined to create an...more

Facts Govern Real Party-in-Interest Determinations - TRW Automotive US LLC v. Magna Electronics Inc.; Paramount Home Entertainment...

Addressing the real-party-in-interest (RPI) requirement of 35 U.S.C. § 312(a) in two separate proceedings, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) emphasized the fact-dependent...more

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

The Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the...more

“Restriction Requirements” Series, Part 1: Considering Restrictions When Developing A Claim Filing Strategy

Welcome to the blog’s first post in a series about restriction requirements! This series will explore nuances in restriction requirement law and provide strategies for most effectively handling restriction requirements, both...more

US House of Representatives Holds Hearing on the .SUCKS New gTLD and ICANN Accountability and Stakeholder Trust

On May 13, 2015, the US House of Representatives Judiciary Committee's Subcommittee on Courts, Intellectual Property, and the Internet held a hearing on "Stakeholder Perspectives on ICANN: The .SUCKS Domain and Essential...more

IPR Privity Analysis Includes Post-Complaint Period - VMWare, Inc. v. Good Technology Software, Inc.

Clarifying the privity requirement for inter partes review (IPR) petitions, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) explained that privity should be determined looking at the...more

Filing Waiver of Service Triggers One-Year IPR Bar Date - The Brinkmann Corporation v. A&J Manufacturing

Addressing the issue of standing to present a petition, the Patent Trial and Appeal Board (PTAB or Board) granted institution of an inter partes review (IPR), finding that the petition filed within one year of filing waiver...more

Mere Receipt of a Copy of the Complaint Does Not Invoke the One-Year Bar Rule - Petroleum Geo-Services, Inc. v. Westerngeco LLC

Addressing the meaning of “defendant” for purpose of the one-year bar rule, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) explained that being served with a third party subpoena in...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

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

Senators Send Letter on Biosimilars to FDA

A group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food...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

Republican HELP Committee Members Request FDA to Step Up Finalizing Biosimilars Guidances and Transparency

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar...more

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...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

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

New Changes to U.S. Design Patent Law

American-based companies seeking protection for industrial designs will soon be encountering significant changes. On May 13, 2015, the United States will become a contracting party to the Geneva Act of the Hague Agreement...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

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

District Court Declines to Lift Stay Even After Patent Trial and Appeal Board Issued Written Decision on CBM Petitions

The district court stayed several consolidated cases pending certain proceedings before the Patent Trial and Appeal Board ("PTAB"). In the order granting the stay, the district court stated: "Upon issuance of a final decision...more

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