News & Analysis as of

Sanofi

Goodwin

Motion For Summary Judgement of Invalidity Denied in Praluent® Litigation

by Goodwin on

On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Amgen v. Sanofi

The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a)....more

Mintz - Intellectual Property Viewpoints

Written Description in Amgen v. Sanofi: Is the Federal Circuit Possessed? Will SCOTUS Grant Certiorari?

In the continuing Amgen v. Sanofi saga, Amgen has asked SCOTUS to take up the issue of written description, which is currently established by showing “whether the disclosure…reasonably conveys…that the inventor had possession...more

Goodwin

PTAB Issues Final Written Decisions Finding Two Of Sanofi’s Lantus Patents Invalid

by Goodwin on

Yesterday, December 12, 2018, the Board issued Final Written Decisions finding Claims 1-25 of U.S. Patent No. 7,476,652 (IPR2017-01526) and Claims 1-20 of U.S. Patent No. 7,713,930 (IPR2017-01528) unpatentable as obvious over...more

Smart & Biggar

Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due...

by Smart & Biggar on

In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge’s...more

Robins Kaplan LLP

Your Daily Dose of Financial News

by Robins Kaplan LLP on

The results are in, and Comcast has bested Fox in the quest for British satellite broadcaster Sky with a final bid of roughly $39 billion in the unusual 3-round auction overseen by the UK’s Takeover Panel. The result must be...more

Michael Volkov

Sanofi Coughs Up $25 Million to Settle SEC FCPA Charges

by Michael Volkov on

Well, add another pharmaceutical company to the FCPA healthcare “sweep.” Frankly, the term “sweep” makes it sound like a coordinated enforcement effort – instead, it is more accurate to think of it as multiple prosecutions...more

Goodwin

Biologic and Biosimilar Litigation Updates

by Goodwin on

In an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues are...more

Goodwin

Litigation Update: Sanofi’s Summary Judgment Motion Denied, Immunex Renews Its Motion to Stay Pending IPR in Dupixent® Patent...

by Goodwin on

Following up on our previous coverage of Immunex’s patent infringement suit against Sanofi related to Immunex’s Dupixent® (dupilumab) biologic, Judge Otero recently denied Sanofi’s motion for summary judgement of invalidity...more

Goodwin

Q1 2018 Earnings Roundup: Biosimilars Update

by Goodwin on

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more

Goodwin

Litigation Updates on Pegfilgrastim and Dupilumab

by Goodwin on

Pegfilgrastim litigation - We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment...more

Goodwin

Immunex Files Reply In Support of Motion To Stay Dupixent® Patent Litigation

by Goodwin on

In the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex has filed a reply brief in support of its motion to stay the...more

Harris Beach PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

by Harris Beach PLLC on

Since 1999, the United States Patent and Trademark Office (“Patent Office”) has permitted the claiming of antibodies by disclosing the targeted antigen. In 2002, the Federal Circuit adopted Patent Office guidelines and...more

Goodwin

USPTO Releases New Guidance on Patentability of Antibody Claims

by Goodwin on

Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims. Many patents covering biological...more

Goodwin

Immunex Moves To Stay Dupixent® Patent Litigation Pending IPR

by Goodwin on

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex moved to stay the litigation pending resolution of...more

Patterson Belknap Webb & Tyler LLP

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more

Goodwin

Sanofi Opposes Amgen’s Petition for Rehearing En Banc in Praluent® Litigation

by Goodwin on

As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Robins Kaplan LLP

Sanofi v. Lupin Atl. Holdings S.A.

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atl. Holdings S.A., Civ. No. 15-415-RGA (consol.), 2017 U.S. Dist. LEXIS 174931 (D. Del. Oct. 23, 2017) (Andrews, J.)....more

Goodwin

Sanofi/Regeneron Move for Summary Judgment of Invalidity in Dupixent® Patent Litigation

by Goodwin on

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, the Defendants moved for summary judgment of invalidity of...more

Robins Kaplan LLP

Sanofi v. Watson Labs. Inc.

by Robins Kaplan LLP on

Case Name: Sanofi v. Watson Labs. Inc., Nos. 875 F.3d 636, Nos. 2016-2722, 2016-2726, 2017 U.S. App. LEXIS 22438 (Fed. Cir. Nov. 9, 2017) (Circuit Judges Prost, Wallach, and Taranto presiding; Opinion by Taranto, J.) (Appeal...more

Patterson Belknap Webb & Tyler LLP

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus...more

K&L Gates LLP

Antibody Patents Are Not Immune to § 112: Amgen Inc. v. Sanofi, Aventisub LLC

by K&L Gates LLP on

In Amgen v. Sanofi, the Federal Circuit held that evidence that first came into existence after the priority date may be considered in determining whether a genus patent claim satisfies the written description requirement...more

Goodwin

FDA Approves Sanofi’s Admelog, the First Short-Acting Follow-On Insulin

by Goodwin on

The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of...more

Goodwin

Amgen Seeks En Banc Consideration of Written Description and Enablement Issues in Praluent® Litigation

by Goodwin on

In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Knobbe Martens

Sanofi, Sanofi-Aventis U.S., LLC V. Watson Labs. Inc., Sandoz, Inc.

by Knobbe Martens on

Federal Circuit Summaries - Before PROST, WALLACH, and TARANTO.  Appeal from the District of Delaware Summary: (1) A party may not avoid inducement based on “substantial non-infringing uses,” and (2) prosecution history...more

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