Administrative Agency Intellectual Property

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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

IP Buzz - Post Grant Practice - June 2014

In this issue: - Terminal Disclaimer Cannot be Used to Circumvent IPR Review Standard - IPR Spotlight Series: Evaluating Whether to File a Preliminary Patent Owner Response - Unscathed by Review: Recent...more

It Is “Quite Clear” that USPTO’s Decision Not To Institute an IPR Is “Final and Nonappealable”

Dominion Dealer Solutions, LLC v. Lee - Addressing whether a district court has subject matter jurisdiction over a decision to deny an inter partes review made by the United States Patent and Trademark Office (PTO)...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

Rubber Hits the Road: Rust-Oleum Trademark Case Leaves TTAB for Minnesota Federal Court

Lately we’ve been discussing more and more the difference between the right to register a trademark and the right to use a trademark. In many trademark disputes the perfect forum for an amicable resolution is the Trademark...more

Director’s Decision on Inter Partes Review Institution Is the Final Word

St. Jude Med., Cardiology Div., Inc. v. Volcano Corp.; In re Dominion Dealer Solutions, LLC; In re The Procter & Gamble Co. - In three opinions, each addressing a slightly different issue regarding the reviewability of...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

Advertising News & Analysis - May 2014

In this issue: - Leave Your Claims at the Border - Delaware Suit Shows You Can’t Escheat the Tax Man - FDA Sets Limit on Fishy Omega-3 Nutrient Value Claims - Your Guide to Post-Grant Patent...more

Guest Post: The U.S. Government Continues to Have "Serious Concerns" with Canada's Heightened Patent Utility Requirements

While the United States and Canada share a border, common values and a strong commitment to international trade and security issues, many are surprised to learn that protection of intellectual property (IP) is a source of...more

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