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Administrative Agency Science, Computers & Technology Constitutional Law

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Sovereign Immunity and Inter Partes Review

by Knobbe Martens on

Sovereign immunity refers to the doctrine that the government cannot be sued without its consent. Specifically, the 11th Amendment precludes federal courts from exercising jurisdiction over states in suits brought by private...more

Patents for Billion Dollar Restasis Drug Under Siege

Using an innovative strategy, pharmaceutical company Allergan recently transferred the patents associated with the eye drug, Restasis, to the Saint Regis Mohawk Tribe, in exchange for an exclusive license back. The tribe...more

Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

by Foley & Lardner LLP on

As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution (“Sovereign Immunity of State...more

Federal Circuit Upholds Claim Construction – No Due Process Violations

by Jones Day on

On May 8, 2017, in Intellectual Ventures II LLC v. Ericsson Inc., 15-1739, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB) inter partes review (IPR) claim constructions in a non-precedential decision....more

How Far Is Too Far? Institution Decision to Final Written Decision

by Brinks Gilson & Lione on

In making a final written decision of AIA proceedings, the Patent Trial and Appeal Board (“the Board”) is not bound by findings made in an institution decision. In three recent decisions, the Federal Circuit considered the...more

State Universities May Use Sovereign Immunity Defense in IPRs

The University of Florida picked up some big wins in the NCAA Men’s Basketball Tournament, moving into the tourney’s Sweet Sixteen. But the Gators also earned a big patent dispute victory recently in Covidien LP v. University...more

Federal Circuit Review | February 2017

by Knobbe Martens on

“Common Sense” Alone Is Not a Sufficient Motivation to Combine References - In In Re: Van Os, Appeal No. 2015-1975, the Federal Circuit held that the Patent Trial and Appeal Board’s reliance on intuition or common sense...more

State Universities Rejoice: PTAB Recognizes Sovereign Immunity Defense

by Pepper Hamilton LLP on

In Covidien LP v. University of Florida Research Foundation Inc., the Patent Trial and Appeal Board (the “Board”) upheld a defense of sovereign immunity asserted by the University of Florida Research Foundation (the...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Federal Circuit Requires Standing to Appeal PTAB’s Final Decisions

by Weintraub Tobin on

Although arguably foreshadowed, some may be surprised to learn that a party with the right to challenge the validity of a patent at the United States Patent and Trademark Office (“USPTO”) may not have the right to appeal an...more

Federal Circuit Requires Standing To Appeal An IPR Decision

by Pepper Hamilton LLP on

In the case of Phygenix, Inc. v. ImmunoGen, Inc., the Court of Appeals for the Federal Circuit (CAFC) held that the petitioner (Phygenix) that had unsuccessfully challenged certain claims of ImmunoGen’s U.S. Patent No....more

Federal Circuit Overturns PTAB Denial of Motion to Amend Claims in IPR Proceeding

by Brooks Kushman P.C. on

Veritas Technologies LLC v. Veeam Software Corp., No. 2015-1894 (Fed. Cir. Aug. 30, 2016). On recurring controversy in AIA trials is the difficulty patent owners face meeting the PTAB’s strict requirements for amending...more

Open Internet Order Prevails

by McDermott Will & Emery on

Addressing challenges to the Federal Communication Commission’s (FCC’s) 2015 Open Internet Order, the US Court of Appeals for the District of Columbia Circuit concluded that the FCC acted with proper authority when it...more

Federal Circuit Review | June 2016

by Knobbe Martens on

The PTAB Does Not Have to Consider New Arguments Raised in IPR Reply Briefs - In Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., Appeal No. 2015-1693, the Federal Circuit upheld a PTAB decision finding of...more

Intellectual Property Law - June 2016

Defend Trade Secrets Act of 2016: An Overview - Why it matters: The Defend Trade Secrets Act of 2016 (DTSA) was signed into law on May 11, 2016 and gives trade secret owners a federal cause of action for injunctive...more

Split Federal Circuit Upholds Constitutionality of Single PTAB Panels Rendering Both Institution & Final Written Decisions

by Foley & Lardner LLP on

On January 13, 2016, the Federal Circuit affirmed the decision of the PTAB in Ethicon Endo-Surgery, Inc. v. Covidien LP, IPR2013-00209, that all of the claims of U.S. Patent 8,317,070 are obvious. While the obviousness...more

USPTO Implementation of AIA Does Not Violate Due Process: Federal Circuit Affirms the PTAB Panel Determining Institution of an IPR...

In Ethicon Endo-Surgery, Inc. v. Covidien LP, a 2-1 panel split of the Federal Circuit held that neither the American Invents Act (“AIA”) nor the Constitution precludes the same panel of the Patent Trial & Appeal Board...more

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA

by Ropes & Gray LLP on

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

Food and Drug Newsletter - December 2015

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

by Arnall Golden Gregory LLP on

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

What Comes Next In Amarin Pharm v. FDA?

by Reed Smith on

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Amarin Wins Truthful Off-Label Speech Challenge

by McGuireWoods LLP on

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer’s “truthful and non-misleading speech promoting off-label use” of a drug and evaluated specific...more

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