Virginia IP Law > Troutman Sanders LLP

Two Recent Court Decisions Clarify “Reliance” Predicate for Hatch-Waxman Exclusivity and Patent Certification Obligations in the Context of 505(b)(2) Applications

This post is from the Troutman Sanders Advisory dated July 21, 2015 authored by Clark G. Sullivan, Sujatha Vathyam, Ph.D., and David L. Devernoe

Two lawsuits against the Food and Drug Administration (“FDA”) this year have clarified the 3-year data exclusivity and patent certification provisions that govern applications filed under section 505(b)(2) of the Food Drug and Cosmetic Act (the “FD&C Act”). In the exclusivity case, Veloxis Pharmaceuticals, Inc. v. United States Food and Drug Administration, et al., a United States District Court held that reliance on an earlier approval was not necessary for three year data exclusivity to delay the later filed 505(b)(2) application. Exclusivity arose solely because the later application was for the same drug as the earlier approval and would be approved for the same conditions of use.

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July 24, 2015   No Comments

EDVA Upholds Decision to Cancel Redskins Trademark Registrations — First and Fifth Amendment Challenges to Section 2(a) Still Up for Debate

Eastern District Court Judge Lee upheld the USPTO Trademark Trial and Appeal Board’s (TTAB) decision to cancel several REDSKINS trademark registrations.  Pro-Football, Inc. v. Amanda Blackhorse et al., No. 1:14-cv-01043-GBL-IDD (E.D. Va. July 8, 2015).  Deciding several cross motions for summary judgment, the Court ruled against Pro-Football, Inc., owner of the Redskins football franchise, and in favor of a group of Native Americans who had previously petitioned the USPTO to cancel the registrations.  The TTAB held that at the time of registration the marks consisted of matter that may disparage a substantial composite of Native Americans and, therefore, under Section 2(a) of the Lanham Act, 15 U.S.C. § 1052(a), the marks should not be registered.  Judge Lee agreed. [Read more →]

July 10, 2015   No Comments

Troutman Sanders Federal Circuit Review – June 12, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • Standing Defect Cannot Be Cured by a Retroactive License Agreement
  • Trademark Registration Successfully Opposed for Lack of “Bona Fide Intent to Use”

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June 12, 2015   No Comments

Troutman Sanders Federal Circuit Review – May 28, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • Supreme Court: Defendant’s Good-Faith Belief of Invalidity Is Not a Defense to Induced Infringement
  • Safe Harbor Provision Exempts Post-Approval Activities That Are Not “Routine” From Infringement

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May 29, 2015   No Comments

Troutman Sanders Federal Circuit Review – May 21, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • A Single Entity Must Perform Every Step of a Method to Infringe Under § 271(a)
  • “Qualitative” Investments Alone Are Insufficient To Satisfy Domestic Industry Requirement of § 337
  • One Legal Standard for Generic Analysis, Whether Trademark Is a Compound Term or a Phrase

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May 22, 2015   No Comments

Troutman Sanders Federal Circuit Review – May 15, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • AIA Eliminates District Court’s § 146 Review of Interferences Declared After September 15, 2012

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May 15, 2015   No Comments

Troutman Sanders Federal Circuit Review – May 8, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • Federal Circuit Reconsiders Biosig v. Nautilus Under New Indefiniteness Standard
  • A Potential Competitor May Bring False Marking Action if It Suffered Competitive Injury

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May 8, 2015   No Comments

Troutman Sanders Federal Circuit Review – May 1, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • Embodiments Disclosed in the Specification Do Not Restrict Claim Scope Absent Manifestation of Clear Intention to Restrict
  • Exclusion of Patentee’s Expert Report on Damages Does Not Lead to Summary Judgment for Lack of Evidence

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May 1, 2015   No Comments

Troutman Sanders Federal Circuit Review – April 23, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • USPTO’s Refusal to Terminate an Inter Partes Reexamination is Not a “Final Action” for Which the Agency Can Be Sued
  • Factual Findings Support the District Court’s “Framing” of Obviousness Question
  • A Claimed Range Must Be Critical to Avoid Anticipation By Overlapping Ranges in the Prior Art
  • Court Affirms “THE SLANTS” Mark Is Disparaging
  • NOPALEA Is Not Registerable for Nutritional Supplements Containing Nopal Juice

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April 27, 2015   No Comments

Troutman Sanders Federal Circuit Review – April 10, 2015

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Each week, Troutman Sanders’ Federal Circuit review summarizes the Federal Circuit precedential patent opinions from the prior week.   

This week:

  • PTO’s Decision to Revive an Application Is Not Subject to Third Party Challenge under the APA
  • Case or Controversy Exists in Declaratory Judgment Action of Non-infringement for Disclaimed Patent
  • Court Deems “Refers To” Language In Amendment Defines a Disputed Claim Term

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April 10, 2015   No Comments