News & Analysis as of

Declaratory Judgments Patents

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

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

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

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

Judge Sweet Holds Invalidity and Non-Infringement Defenses Cannot Shield a Licensee’s Breach of a Patent License

On March 17, 2017, District Judge Robert Sweet (S.D.N.Y.) granted plaintiff Icahn School of Medicine at Mount Sinai's ("Mt. Sinai") motion to strike defendant Neurocrine Biosciences ("Neurocrine") affirmative defenses of...more

Sovereign Immunity Can Shield State University Research Foundations in PTAB Proceedings

by McDermott Will & Emery on

Addressing the application of the sovereign immunity defense under the 11th Amendment in the inter partes review (IPR) context, the Patent Trial and Appeal Board (PTAB) dismissed three IPR petitions, finding that the...more

PTAB Finds Sovereign Immunity Applies to IPRs for State Universities

by Winstead PC on

The Patent Trial and Appeal Board (PTAB) dismissed three inter partes review (IPR) proceedings involving the University of Florida based on sovereign immunity. As background, the University of Florida Research Foundation...more

Federal Circuit Expands Personal Jurisdiction in Declaratory Judgment Suits

by BakerHostetler on

In Xilinx Inc. v. Papst Licensing GmbH & Co. KG, Appeal No. 2015-1919 (Fed. Cir. Feb. 15, 2017), the Federal Circuit applied the usual test for in personam jurisdiction, in an apparently new way, to reverse dismissal of a...more

NPE’s Warning Letters, In-Person Meeting with Accused Infringer, and Prior Lawsuits Are Sufficient To Establish Person...

by Brooks Kushman P.C. on

In a recent case applying the constitutional limits of personal jurisdiction in a declaratory judgment action filed by an accused patent infringement against a foreign non-practicing entity, the U.S. Court of Appeals for the...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

by Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

No Stay Pending IPR in Brewing Patent Dispute

District court patent defendants often request a parallel inter partes review (“IPR”) proceeding at the U.S. Patent Office to challenge the validity of the patent at issue. As such IPR proceedings have the potential to kill...more

Supreme Court Will Judge Biosimilar Patent Dance

by Foley & Lardner LLP on

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Future and Unreleased Products Can’t Drive Litigation

In a recent decision out of the District of Massachusetts, Judge Talwani provided litigants with insights into patent subject matter jurisdiction in declaratory judgment actions. Here the patent owner, US Carburetion, had...more

The World in US Courts: Orrick's Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities

Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries...more

BPCIA Litigation Roundup (Fall 2016)

by Goodwin on

Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update...more

Substantial Controversy for Declaratory Judgment Jurisdiction May Be Based on Demonstrated Intent to Enforce Patents **WEB ONLY**

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed a district court’s dismissal of a declaratory judgment action for lack of subject matter jurisdiction, clarifying that a “substantial controversy” does not require a...more

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