News & Analysis as of

Dismissals Patents Biosimilars

Venable LLP

Regeneron Dismisses IPR Appeals and Disclaims EYLEA® (aflibercept) Patent

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On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos....more

Smart & Biggar

Federal Court finds Minister of Health reasonable in concluding JAMP not a ‘second person’ for its SIMLANDI biosimilar

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On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...more

McDermott Will & Emery

In the Weeds? Humira “Patent Thicket” Isn’t an Antitrust Violation

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The US Court of Appeals for the Seventh Circuit affirmed that welfare benefit plans that bought the drug Humira did not have valid antitrust claims against the patent owner. The Court found that amassing patents by itself is...more

Goodwin

The Seventh Circuit Affirms Dismissal of the HUMIRA Antitrust Litigation

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​​​​​​​The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  The appeal is from the Northern District of Illinois’s...more

Smart & Biggar

2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Goodwin

7th Circuit Evaluates the “Patent Thicket”

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Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal concerns the United States District Court for the Northern District of Illinois’...more

Smart & Biggar

Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations

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UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

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A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

Goodwin

Pfizer Moves to Dismiss Amgen’s Suit Over Proposed Neulasta Biosimilar

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As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more

Goodwin

Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

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On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the...more

Smart & Biggar

Rx IP Update - July 2019

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Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Dismisses Appeal of IPR Final Written Decision for Lack of Standing After Appellant Terminated Development of...

On February 7, 2019, the United States Court of Appeals for the Federal Circuit, in Momenta Pharmaceuticals v. Bristol-Myers Squibb, No. 2017-1694, dismissed Momenta’s appeal of a Final Written Decision in an Inter Partes...more

Goodwin

Federal Circuit Dismisses Momenta’s Appeal of Adverse Final Written Decision in Abatacept IPR

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This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR...more

Smart & Biggar

Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Mintz - Intellectual Property Viewpoints

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Foley & Lardner LLP

Will The Avastin Biosimilar Patent Dance Go On?

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Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

Patterson Belknap Webb & Tyler LLP

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

Knobbe Martens

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

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Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

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