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Pharmaceutical Patents

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Venable LLP

Four Additional IPRs Filed by Merck Challenging The Johns Hopkins University Pembrolizumab Patents

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On March 13, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four additional IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade...more

Goodwin

Celltrion Submits BLA for Omalizumab Biosimilar

Goodwin on

​​​​​​​Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product...more

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

Venable LLP on

On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more

Alston & Bird

Patent Case Summaries | Week Ending March 8, 2024

Alston & Bird on

Chewy, Inc. v. International Business Machines Corp., No. 2022-1756 (Fed. Cir. (S.D.N.Y.) Mar. 5, 2024). Opinion by Moore, joined by Stoll and Cunningham. IBM owns two patents that generally relate to improvements in...more

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer Inc. v. Sanofi Pasteur Inc. (Fed. Cir. 2024)

Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more

Venable LLP

Merck Files Four IPRs Challenging The Johns Hopkins University Pembrolizumab Patents

Venable LLP on

On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

Goodwin on

​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

Goodwin on

On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

Venable LLP

Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar

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On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more

Goodwin

Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

Goodwin on

Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

Smart & Biggar on

On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Goodwin

Genentech and Partners Voluntarily Dismiss IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)

Goodwin on

​​​​​​​On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned...more

Smart & Biggar

Federal Court of Appeal affirms paliperidone palmitate claims are not unpatentable methods of medical treatment

Smart & Biggar on

In a 2022 decision involving Janssen and Pharmascience, the Federal Court found that the claims of Canadian Patent No. 2,655,335 (335 patent, relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA)) were not invalid...more

Smart & Biggar

FCA upholds inducement of infringement findings relating to paliperidone palmitate.

Smart & Biggar on

As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more

Goodwin

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

Goodwin on

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more

Smart & Biggar

Federal Court of Appeal affirms Minister of Health reasonable in concluding successor second person was entitled to benefit of NOA...

Smart & Biggar on

On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more

Fish & Richardson

Webinar | Hatch-Waxman 101

Fish & Richardson on

Pharmaceutical patents have proven to be a highly effective incentive for groundbreaking innovation. However, corresponding drug prices have long been an animating issue in American law and policy. Many proposals to lower the...more

Venable LLP

Chugai, Genentech, and Hoffmann-La Roche Dismiss Appeals of Actemra® Patent IPR Final Written Decisions

Venable LLP on

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579,...more

McDonnell Boehnen Hulbert & Berghoff LLP

RegenxBio Inc. v. Sarepta Therapeutics, Inc. (D. Del. 2024)

A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent,...more

Axinn, Veltrop & Harkrider LLP

Happy 40th Hatch-Waxman!

Turning 40 is a big milestone for most of us. When I turned 40 – I won't tell you how long ago that was – I was knee-deep in Paragraph IV patent litigation and in legal challenges to FDA's exclusivity and approval decisions...more

The Rodman Law Group, LLC

Study Finds That Ibogaine May Mitigate Symptoms of Traumatic Brain Injuries

A study recently published by Stanford University shows that ibogaine, when paired with magnesium, can improve symptoms associated with traumatic brain injuries, such as depression, anxiety, memory loss, and post-traumatic...more

Robins Kaplan LLP

Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd. - Arazlo® (Tazarotene)

Robins Kaplan LLP on

Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., Civ. No. 22-4248 (SRC), 2023 WL 7131809 (D.N.J. Oct. 30, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Arazlo® (tazarotene); U.S. Patent Nos....more

Allen & Overy LLP

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

Allen & Overy LLP on

In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

Troutman Pepper on

The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

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