News & Analysis as of

Declaratory Judgments

Status Regarding Dupixent® Litigations

by Goodwin on

We previously reported that Sanofi and Regeneron filed a declaratory judgment action seeking a ruling that its approved Dupixent® (dupilumab) product does not infringe Amgen’s U.S. Pat. 8,679,487 (“the ’487 patent”), and that...more

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

by Thompson Coburn LLP on

In a unanimous opinion, the United States Supreme Court again reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting the meaning of key provisions of the Biologics Price Competition and Innovation Act of...more

West Virginia Supreme Court: Bad Faith Claims Are Premature when the Insurer Is Providing a Defense

by Cozen O'Connor on

The West Virginia Supreme Court recently granted an insurer the extraordinary legal remedy of a writ of prohibition, awarding it an immediate dismissal of the insureds’ bad faith claims. State ex rel. Universal Underwriters...more

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more

You Don’t Have to Dance the Patent Dance (Except Maybe in California)

Supreme Court Decides BPCIA “Patent Dance” Questions - The 2009 Biologics Price Competition & Innovation Act (BPCIA) provides an orderly process for manufacturers of generic biological drugs (called “biosimilars”) to...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

SCOTUS Simplifies Market Entry Process for Biosimilar Products

by Jackson Walker on

Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more

The Patent Dance Is Optional

In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more

Supreme Court Decides Sandoz, Inc. v. Amgen, Inc.

by Faegre Baker Daniels on

On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc., Nos. 15-1039, 15-1195, in which it held that (a) a manufacturer of a licensed biological product cannot obtain federal injunctive relief to enforce 42...more

A Cease and Desist Letter Alone Does not Establish Personal Jurisdiction

In New World International, Inc. v. Ford Global Technologies, LLC, [2016-2097](June 8, 2017), the Federal Circuit affirmed the dismissal of New World’s declaratory judgment complaint for lack of personal jurisdiction over...more

Check Your Local Zoning and Land-Use Ordinances

by Garvey Schubert Barer on

The Washington State Liquor and Cannabis Board (“WSLCB”) recently issued a declaratory order (Order No. 01-2017) finding that the WSLCB is not required to determine that an applicant for a marijuana license is in compliance...more

Fair use blocks out copyright claim over LeBron’s tattoo

by Thompson Coburn LLP on

Courtside questions: Is it fair or foul to show a player’s tattoo in a video game? LeBron James is a talented individual: three-time NBA Champion; 13-time NBA All-Star. And he gave a more than respectable performance playing...more

Summaries of All Supreme Court and Precedential Federal Circuit Patent Cases Decided Since Jun. 1, 2016

This paper is based on reports on precedential patent cases decided by the Federal Circuit distributed by Peter Heuser on a weekly basis. Please see full publication below for more information....more

Under the First-to-File Rule, District Court Stays Case Filed Hours After a Declaratory Judgment Action

Under the first-to-file rule (not to be confused with the provision from the America Invents Act), when two actions involving overlapping issues and parties are pending in two federal venues, the first-filed case is generally...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Wealth Management Update - May 2017

by Proskauer Rose LLP on

May Interest Rates for GRATs, Sales to Defective Grantor Trusts, Intra-Family Loans and Split Interest Charitable Trusts - The May § 7520 rate for use with estate planning techniques such as CRTs, CLTs, QPRTs and GRATs...more

District Court Upholds Bankruptcy Court’s Ruling on Rejection of Gathering Agreements

by King & Spalding on

On March 10, 2017, the United States District Court for the Southern District of New York (the“Court”) affirmed on appeal a bankruptcy court’s prior decision in In re Sabine Oil & Gas Corp. that permitted a debtor to reject a...more

Texas Federal Court Discusses Regulatory Affirmative Defenses To CAA Claims

In a very complex, hard-fought case, U.S. District Judge David Hittner discusses how the Texas Commission on Environmental Quality’s (TCEQ) regulatory affirmative defenses to alleged Clean Air Act (CAA) violations will be...more

Not “Too Big to Fail.” Too Big to Comply.

Last year, the 5th Circuit Court of Appeals vacated the decision by District Judge David Hittner not to impose any penalties on ExxonMobil for violations alleged in a Clean Air Act citizens’ suit concerning ExxonMobil’s...more

ALJ Finds ITC Remedial Orders Unenforceable

by Jones Day on

We previously wrote about the uphill battle Respondent Eko Brands faced in an enforcement proceeding after it defaulted in the underlying investigation. The ALJ found during the proceedings that res judicata barred its...more

State of Michigan Lacks Standing in M22 Case

by Revision Legal on

On April 21, 2017, Western District of Michigan Judge Gordon J. Quist ruled the State of Michigan lacks standing in a declaratory judgment action to declare the use and registration of federally registered marks are unlawful....more

Applying The Peppers Doctrine, Illinois Appellate Court Affirms Stay Of Insurer’s Declaratory Judgment Action

In Sentry Ins. v. Cont’l Cas. Co., 2017 IL App (1st) 161785, the Appellate Court of Illinois, First District had occasion to consider whether a trial court properly entered a stay on an insurer’s declaratory judgment action...more

Court Finds Copyright DJ Action against Music Rights Holder Slightly Out of Tune

by Dorsey & Whitney LLP on

Does a demand letter from a music rights holder that alleges “millions of instances of infringement” create a case in controversy with the recipient? You may be inclined to answer with an emphatic “of course!”...more

Genentech Will Not File Amended Complaint in Case Against Amgen

by Goodwin on

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal...more

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