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Patents Settlement

Goodwin

Amgen and Fresenius Settle Denosumab BPCIA Case

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On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more

Troutman Pepper Locke

California's Ban on Reverse Payment Settlements Partially Survives After a Five-Year Battle

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As state legislatures introduce legislation expanding the reach of their antitrust laws and state attorneys general ramp up their use of antitrust investigations and litigation, the legal landscape continues to become more...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

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As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more

Goodwin

Amgen and Celltrion Settle Denosumab BPCIA Case

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​​​​​​​On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...more

Jones Day

PTAB AIA FY2024 Roundup: Key Insights and Statistics

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The U.S. Patent and Trademark Office (USPTO) recently released its Fiscal Year 2024 roundup for the Patent Trial and Appeal Board (PTAB) America Invents Act (AIA) proceedings. This comprehensive report provides valuable...more

Robins Kaplan LLP

ANDA Litigation Settlements - Reported Settlements in Federal District Court Cases

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

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The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

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

Meating of the Minds: Impossible Foods and Motif Foodworks Settle High Profile Patent Dispute in District Court

The food tech industry has been growing and evolving rapidly in the last ten years due to technological innovations in the space and a growing customer demand for plant-based food products and sustainable meat options. We...more

Venable LLP

Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®

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On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

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Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

Akin Gump Strauss Hauer & Feld LLP

Termination of IPR Proceeding on the Eve of Final Written Decision Dooms Joinder Attempt

The Patent Trial and Appeal Board has denied institution and joinder of an inter partes review petition after determining that the petition was not only time-barred but that joinder was also foreclosed. In making its...more

Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

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Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more

Goodwin

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

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On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...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

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

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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

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

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

“AI-Related” Chip Patents - 1.6 Billion Reasons Why Google May Have Agreed to Settle

Recent headlines have focused on the $1.6 billion damages claim and Google’s possible exposure in Singular Computing’s patent infringement lawsuit involving Google’s “AI-related” chips. $1.6 billion is certainly not chump...more

Dechert LLP

Dechert Cyber Bits - Key Developments in Privacy & Cybersecurity - Issue 47

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FTC Settles with Rite Aid on its Use of AI and Processing of Biometric Information - The Federal Trade Commission (“FTC”), on December 19, 2023, announced that it had reached a settlement with Rite Aid Corporation (“Rite...more

Goodwin

Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement

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As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all...more

Goodwin

Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

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On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022,...more

McDermott Will & Emery

Cloudy Skies: PTO Director Finds Abuse and Sanctionable Conduct

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The US Patent & Trademark Office (PTO) Director issued a precedential opinion finding that filing an inter partes review (IPR) solely to extract payment in a settlement—without the intent to prosecute the IPR to completion—is...more

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

IPR Limbo During the Arthrex Decisions

In Polaris Innovations Ltd. v. Brent, No. 2019-1483, 2022 WL 4241665 (Fed. Cir. Sept. 15, 2022), the Federal Circuit faced an appeal that had bounced back and forth between the Court and Patent Trial and Appeal Board (“the...more

Proskauer - Minding Your Business

$264 Million Settlement in EpiPen Price Gouging Litigation

On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more

White & Case LLP

Federal District Court holds that California's anti reverse payment law is enforceable, but only against settlements "negotiated,...

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In February 2022, the US District Court for the Eastern District of California held that California Assembly Bill 824—which established a first-of-its kind presumption that certain pharmaceutical patent settlements are...more

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