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State Universities Rejoice: PTAB Recognizes Sovereign Immunity Defense

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

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

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

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

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

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

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

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

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

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

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?

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

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

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

Dismissal of a Related Suit with Prejudice Can Negate Petitioner’s Grounds for Standing - Global Tel*Link Corp. v. Securus...

Addressing the issue of standing, the Patent Trial and Appeal Board (PTAB or Board) denied institution of a covered business method (CBM) patent review, finding that the petitioner failed to show sufficient proof...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

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