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ICANN’t: U.S. to Transition Oversight of ICANN

The U.S. Commerce Department recently announced its plan to transition oversight of the non-profit Internet Corporation for Assigned Names and Numbers (ICANN), which manages Internet domain names and addresses, to a...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Inter Partes Review -- A Look Back

March 16, 2014, marks the eighteen-month anniversary of the inter partes review ("IPR") system of challenging issued patents at the Patent Office. We thought that this would be an appropriate time to look back at the last...more

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

Federal Circuit Reaffirms De Novo Standard of Review for Claim Construction

In a long-awaited decision, the Federal Circuit ruled en banc to uphold the the de novo standard for appellate review of claim construction issues, which was previously established in another en banc decision, Cybor Corp. v....more

Another Motion to Amend Denied in IPR Final Written Decision

While Patent Owners have finally succeeded in having claims survive an inter partes review proceeding, no Patent Owner has yet to find the magic formula that successfully navigates a motion to amend. In a Final Written...more

IP Buzz - February 2014

In this issue: - Hotfile Case Will Shape Copyright Law Online - Pacific Coast Marine Windshields Ltd. v. Malibu Boats, LLC et. al.: Federal Circuit Decision Confirms Application of Principle of Prosecution...more

A Minor Shift in Patent Term Adjustment Calculations - Novartis AG v. Lee; Exelixis, Inc. v. Lee

Presented with a challenge to patent term adjustments as determined by the Patent and Trademark Office (PTO) under 35 U.S.C. § 154(b), the U.S. Court of Appeals for the Federal Circuit held that post-allowance delays are ...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

FDA to Give 5 Year NCE Exclusivity to Combinations

In a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new...more

Fresenius v. Baxter: The Importance of Timing in Patent Litigation

The Federal Circuit’s recent decision in Fresenius USA, Inc. v. Baxter Int’l, Inc., illustrates the potential value of challenging a patent's validity through administrative proceedings in the U.S. Patent & Trademark Office...more

What Makes a Great Patent? – Interview with Jim Cleary, Member, Mintz Levin [Video]

Attorney Jim Cleary, Member of Mintz Levin's Intellectual Property Practice, discusses the elements of a successful patent application....more

The Shift to Angel Investors – Interview with Jeremy Glaser, Member, Mintz Levin [Video]

Attorney Jeremy Glaser, Co-chair of Mintz Levin's Venture Capital & Emerging Companies Practice, discusses the shift to angel investors in initial financing rounds as venture capital funds move towards later-stage funding. ...more

Top Ten Laws Any Online Operation Should Know. A Quick Guide.

Below is a top ten pocket guide for the top ten laws any operation (social, e-commerce, IP/UGC driven, etc.) needs to be familiar with now and for the foreseeable future. Having this at the ready won’t necessarily make you...more

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more

USPTO Soliciting Comments on Software Patent Issues

The United States Patent and Trademark Office announced its intent earlier this month to form a “Software Partnership” with the software community in order to enhance the quality of software-related patents (the “Notice”)...more

Trade Secret Legislation May Increase Infringement Claims and Lead to a Private Right of Action

Congress recently took new steps to protect trade secrets, which are generally defined as all forms or types of financial, business, scientific, technical, economic, or engineering information that the owner has taken...more

The Patent Prosecution Highway Pothole for Pharmaceutical Patents

The USPTO promotes the Patent Prosecution Highway (PPH) as a way to “fast-track” a U.S. patent application when a corresponding foreign application has been allowed, or when a corresponding PCT application has received a...more

Telecommunications in the 113th Congress

The 112th Congress saw a lot of activity focused on new and changing technologies, but few legislative breakthroughs. Early in the year, there was significant activity around intellectual property and online piracy issues,...more

D.C. Circuit Vacates Plug and Play Order and Encoding Rules Applicable to Multichannel Video Programming Distributors

On Jan. 15, 2013, the United States Court of Appeals for the D.C. Circuit decided that the FCC lacked the statutory authority to adopt its 2003 encoding rules, which limit the output and copy restrictions that can be applied...more

Australian Patent Term Extension: A “Long-Term” Battle

If it was ever in doubt as to whether an application for an extension of a pharmaceutical patent term could be late filed after the due date, this recent decision would seem to have removed it, clarifying that late filing is...more

Chinese Government Decision May Help Brands Protect Themselves

Anyone trying to stop Chinese counterfeiters learns almost immediately that most of the information that would ordinarily identify China-based owners of a URL or website is false. That makes it costly or impossible to...more

USPTO Issues First Decision Instituting CBM

On January 9, 2013, the Patent Trial and Appeal Board (PTAB) issued its first decision in a Covered Business Method Patent Review (CBM) proceeding, instituting the trial on all claims requested. The decision issued in...more

Chinese FDA Unveils Plan for Regulatory Reform

The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more

Intellectual Property in 2013

Infringement! Litigation! Legislation! There is never a dull moment in the wonderful world of intellectual property law, and 2013 will be no exception....more

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