News & Analysis as of

Declaratory Judgments Patents Pharmaceutical Industry

Goodwin

Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging...

Goodwin on

Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences...more

Robins Kaplan LLP

Biogen Int’l Gmbh V. Mylan Pharms. Inc. Tecfidera® (Dimethyl Fumarate)

Robins Kaplan LLP on

Case Name: Biogen Int’l GMBH v. Mylan Pharms. Inc., 18 F.4th 1333 (Fed. Cir. 2021) (Circuit Judges O’Malley, Reyna, and Hughes presiding; Opinion by Reyna; Dissent by O’Malley) (Appeal from N.D.W.V., Keeley, J.)...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar

In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district...more

Fenwick & West LLP

Valeant v. Mylan: Restrictions on Venue in Hatch-Waxman Litigation

Fenwick & West LLP on

For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more

Goodwin

Genentech Sues Centus Over Proposed Bevacizumab Biosimilar

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Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively,...more

Kramer Levin Naftalis & Frankel LLP

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Robins Kaplan LLP

Valeant Pharms. N. Am. LLC v. Zydus Pharms. (USA) Inc.

Robins Kaplan LLP on

BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more

Goodwin

Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

Goodwin on

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...more

Goodwin

Trastuzumab, Rituximab, and Bevacizumab Litigation Updates

Goodwin on

Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and...more

McDonnell Boehnen Hulbert & Berghoff LLP

AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc. (Fed. Cir. 2018)

Ever since the Supreme Court loosened the reins on declaratory judgment actions in patent cases twelve years ago, in MedImmune v. Genentech, courts have decided cases fleshing out the metes and bounds of the factual...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Goodwin

Federal Circuit Affirms Dismissal of AbbVie’s Humira License Suit

Goodwin on

The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that...more

McDonnell Boehnen Hulbert & Berghoff LLP

SCOTUS: Supreme Court Lifts Biosimilars by Allowing Early Commercial Marketing Notice

The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more

Snell & Wilmer

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

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

Jones Day

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

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

Patterson Belknap Webb & Tyler LLP

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

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

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

Foley & Lardner LLP

Supreme Court Will Judge Biosimilar Patent Dance

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

Kramer Levin Naftalis & Frankel LLP

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

Orrick, Herrington & Sutcliffe LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey -...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - August 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Elizabeth LLC et al. 1:16-cv-00603l; filed July 12, 2016 in the District Court of Delaware ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - June 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orexo AB et al. v. Actavis Elizabeth LLC et al. 1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware - ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Allergan, Inc. et al. v. Somerset Therapeutics, LLC 1:16-cv-00392; filed May 26, 2016 in the District Court of Delaware. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of California. ...more

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