Administrative Agency Intellectual Property Science, Computers & Technology

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FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

FDA Accepts the First Biosimilar Application under the BPCIA

Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more

What is Patent Term Adjustment and Why Does It Matter?

For patents granted on applications filed on or after June 8, 1995, the enforceable patent term begins on the day the patent issues and generally expires 20 years from the earliest effective filing date of the application. ...more

Division of Tax Appeals Rules Patent License Fees Not Subject to Sales Tax in New York

A New York State Division of Tax Appeals administrative law judge (ALJ) recently ruled in favor of a medical device and technology company on the question of whether patent license fees that the company charged to its...more

Purgation Case Still Held Up

Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc. Case Number: 1:12-cv-06851-AJN (Dkt. 69) - Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more

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

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