News & Analysis as of

Dismissals Pharmaceutical Patents

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

WilmerHale

Federal Circuit Patent Watch: Allegations of induced infringement can be based on skinny label in combination with public...

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Precedential and Key Federal Circuit Opinions - BETEIRO, LLC v. DRAFTKINGS INC. [OPINION] (2022-2275, 06/21/2024) (Dyk, Prost, Stark) - Stark, J. The Court affirmed the district court’s dismissal of multiple, related...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2024

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Appeal No. 2023-1169 (Fed. Cir. June 25, 2024) In the Court’s only precedential patent opinion last week, the Federal Circuit reversed the district court’s dismissal of...more

Smart & Biggar

Supreme Court of Canada dismisses Apotex’s application for leave to appeal macitentan inducing infringement decision

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As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal of a decision relating to macitentan (Janssen’s OPSUMIT), which found that Apotex would induce infringement of Janssen’s patent....more

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

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The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more

Haug Partners LLP

Second Circuit Affirms Dismissal of Bystolic Pharmaceutical Antitrust Class Actions, Holding Plaintiffs Must Plead Facts Showing a...

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On Monday, May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed Judge Lewis Liman’s decision dismissing Plaintiffs’ reverse payment class actions for failure to state a claim. In re Bystolic Antitrust...more

Goodwin

Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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​​​​​​​As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...more

Venable LLP

EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction

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On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

Goodwin

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

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​​​​​​​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

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Smart & Biggar

FCA dismisses appeal, patent not listable against STELARA SNDS

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As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837...more

McDonnell Boehnen Hulbert & Berghoff LLP

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)

The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v....more

WilmerHale

Federal Circuit Patent Watch: Federal Circuit rejects invitation to create a bright-line rule regarding whether numerical ranges...

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Precedential and Key Federal Circuit Opinions - MALVERN PANALYTICAL INC. v. TA INSTRUMENTS-WATERS LLC [OPINION] (2022-1439, 11/1/2023) (Prost, Hughes, and Cunningham) - Prost, J. The Court vacated the district court’s...more

Haug Partners LLP

D.C. Circuit Dismisses FTC Antitrust Suit: Exclusive Pharma Patent Licenses Remain Permissible Under The Patent Act

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On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

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The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

Smart & Biggar

Federal Court of Appeal dismisses appeal challenging amended basket of comparator countries in PMPRB Regulations

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On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more

McDermott Will & Emery

And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

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In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...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

Smart & Biggar

Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2021

Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) - For the second time in two weeks, our Case of the Week focuses on the written description requirement, in...more

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