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Preliminary Injunctions Generic Drugs

Hogan Lovells

Court of Appeal hands down reasons for awarding AZ an interim injunction in the UK against Glenmark’s generic dapagliflozin for...

Hogan Lovells on

Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more

Hogan Lovells

UK Court of Appeal grants AstraZeneca an interim injunction against Glenmark’s generic dapagliflozin for type II diabetes

Hogan Lovells on

In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

Troutman Pepper Locke on

A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

A&O Shearman

AstraZeneca refused interim injunction on SPC for blockbuster diabetes treatment against Glenmark but swiftly obtains permission...

A&O Shearman on

On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms., Inc.

Robins Kaplan LLP on

Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more

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

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more

Knobbe Martens

Novartis Loses Bid for Preliminary Injunction Against MSN Pharmaceuticals

Knobbe Martens on

Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals.  Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456...more

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more

Knobbe Martens

Preliminary Injunction Denied Because of Failure to Draft Precise Terms That Capture the Intent of the Parties

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TAKEDA PHARMACEUTICALS U.S.A., INC. V. MYLAN PHARMACEUTICALS INC. Before Prost, Newman, and Hughes. Appeal from the United States District Court for the District of Delaware - Summary: The scope of a contract term may...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

McDermott Will & Emery

When Is “Wherein” Clause Limiting? When It’s Material to Patentability

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding, based largely on the prosecution history, that disputed “wherein” clauses were limiting and therefore the grant of a preliminary injunction...more

Knobbe Martens

The Sometimes Limiting Effect of "Wherein" Clauses

Knobbe Martens on

ALLERGAN SALES, LLC v. SANDOZ, INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey. Summary: A “wherein” clause can be limiting if it is material to...more

Foley & Lardner LLP

Statements of Efficacy and Safety Material Claim Limitations

Foley & Lardner LLP on

In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability....more

Mintz - Health Care Viewpoints

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

Knobbe Martens

Third Circuit Upholds Dismissal of Doryx ‘Product Hopping’ Suit

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On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more

Patterson Belknap Webb & Tyler LLP

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

Polsinelli

New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

Polsinelli on

The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Foley Hoag LLP

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

Foley Hoag LLP on

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Knobbe Martens

Federal Circuit Rules on Biosimilar Notice Requirement

Knobbe Martens on

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

McDonnell Boehnen Hulbert & Berghoff LLP

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more

Robins Kaplan LLP

Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit: Abilify®...more

Fenwick & West LLP

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

Fenwick & West LLP on

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Mintz

Second Circuit Holds a Hard Switch Between Drugs Is an Unlawful Product Hop Under Section 2

Mintz on

On May 22, 2015, in a much-watched case, the Second Circuit upheld a preliminary injunction against Actavis PLC and its wholly owned subsidiary, Forest Laboratories, LLC (collectively “Actavis” or “Forest”), finding that...more

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