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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

Revenue-Driven Licensing Activities Fail to Satisfy Domestic Industry Requirement for ITC Action

The ALJ terminated the ITC investigation upon granting respondent's motion for summary judgment for lack of domestic industry, finding that the complainant's (a licensing entity) patent-related activities were solely...more

ITC ALJ Breaks New Ground, Further Heightening the DI Requirement for NPEs in § 337 Cases

According to a recent initial determination by an Administrative Law Judge of the International Trade Commission, a purely revenue-driven NPE cannot prove the existence of a domestic industry by relying solely on the...more

Landry's Inc. v. Flores: NLRB Ruling Bucks Trend, Hints that Non-Infringement Provisions in Employee Handbooks may be Lawful

On June 26, a National Labor Relations Board (NLRB) judge ruled that Landry’s Inc., parent of Bubba Gump Shrimp Co., did not violate federal labor laws with its policy governing employees’ use of social media. Administrative...more

ITC Issues Its First Stay of a CDO - In the matter of Certain Digital Models, Digital Data, and Treatment Plans for Use in Making...

For the first time the U.S. International Trade Commission (U.S. ITC) issued a stay of a cease and desist order (CDO) issued at the conclusion of an investigation under § 337 of the Tariff Act. In the matter of Certain...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

Visiting the USPTO Without a REAL ID

As announced on the “USPTO Locations” page of its website, the USPTO has implemented a new policy for members of the public visiting the USPTO relating to the REAL ID Act. Under the REAL ID Act, the USPTO may no longer accept...more

Government Contracting and Procurement Update: Public Access to Trade Secrets in Proposals and Bid Documents in Maine

Those doing business with the State of Maine need to know their way around public records laws. What is the risk that sensitive business information included within a bid response to a request for proposal (RFP) may become...more

PTAB Issues Its First Precedential Opinion in CBM Review Proceeding Litigated by Goodwin Procter

On July 31, 2014, the Patent Trial and Appeal Board (PTAB) designated as “precedential” its decision in Covered Business Method Review (CBM) proceeding SecureBuy, LLC v. CardinalCommerce Corporation, CBM 2014-00035 (Pat. Tr....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

ITC Section 337 Update – July 2014

Commission Affirms No Domestic Industry Based On Research And Development In 859 Investigation – On July 21, 2014, the Commission issued a Notice To Affirm In Part, Reverse In Part And Vacate In Part The Final Initial...more

IPR Spotlight Series: What to Do When the PTAB Denies Your Petition to Institute IPR

Inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) became available on September 16, 2012 as a post-grant review procedure to challenge the patentability of issued claims based on prior art patents and...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

Federal Circuit Says Commission Must Toe the Line in Invisalign ITC Case

In Align Technology, Inc. v. International Trade Commission, the Federal Circuit held that ITC action that violated ITC’s own regulations warranted vacatur under the Administrative Procedures Act. While the case addresses...more

Federal Circuit Makes ITC Comply With Its Own Rules

In an opinion dated July 18, 2014, in Align Technology, Inc. v. International Trade Commission (Fed. Cir. July 18, 2014, No. 2013-1240, -1363) 2014 U.S. App. Lexis 13717, the Federal Circuit vacated and remanded a decision of...more

Advertising Law - July 2014

Online Reviews Not Sufficient To Support Ad Claim, NAD Rules - While recognizing the benefits of using new sources of information, the National Advertising Division (NAD) decided that an advertiser’s use of aggregated...more

Supreme Court To Decide Preclusive Effect of TTAB Decisions on Subsequent Court Actions

Last week the Supreme Court granted certiorari to determine whether decisions of the Trademark Trial and Appeals Board (TTAB) concerning likelihood of confusion preclude relitigating that issue in subsequent infringement...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

Rare Motion to Strike New Evidence in Reply Brief Granted by PTAB

When faced with the issue of whether a reply brief contains new evidence, the PTAB has, to date, mostly punted on the issue – waiting until the Final Written Decision to assess the issue, when it is much more familiar with...more

Supreme Court's Indefiniteness Ruling Has Immediate Impact at ITC

After a hearing in an Investigation occurred between February 24 and March 7, 2014 and with the parties having submitted their opening post-hearing briefs on March 21, 2014 and their reply post-hearing briefs on March 28,...more

Redskins trademark case highlights value of linguistic analysis

The Washington Redskins trademark case, with its conclusion that REDSKINS trademark registrations should be cancelled, has sparked heated discussion among football fans, advocates of Native American interests, and foes of...more

Colorado U.S. District Court Launches Local Patent Rules and Patent Case Scheduling Order

On June 11, 2014, the United States District Court for the District of Colorado announced its adoption of a Pilot Program implementing Proposed Local Patent Rules. The Local Patent Rules and Proposed Scheduling Order will...more

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