News & Analysis as of

Pfizer Appeals

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

mRNA/LNP Patent Litigation Update (Q1 2025)

As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...more

Knobbe Martens

Routine Optimization of Result-Effective Variable Can Bridge Gaps in Prior Art

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PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark.  Appeal from the Patent Trial and Appeal Board....more

Bass, Berry & Sims PLC

Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

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On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more

Smart & Biggar

Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

Smart & Biggar

Supreme Court denies leave of interlocutory decision in pregabalin section 8 case

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On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) a decision upholding an interlocutory decision on a question relevant to the assessment of section 8...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

Smart & Biggar

Supreme Court of Canada Leave Applications - May 2020

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UPDATE: UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) (see article here). Pfizer seeks leave in pregabalin section 8 case As previously...more

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer Inc. v. Chugai Pharmaceuticals Co. (Fed. Cir. 2020)

The Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes review (see "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)") in Pfizer Inc. v....more

Goodwin

Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

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On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s...more

Smart & Biggar

Federal Court of Appeal dismisses Pfizer’s appeal of interlocutory decision in pregabalin section 8 case: infringement not a...

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UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150)... As previously reported, Justice O’Reilly of the Federal Court granted Pharmascience’s...more

White & Case LLP

Court of Appeal broadly upholds the CAT's judgment in Phenytoin and clarifies "excessive pricing" test - Authorities can't stick...

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On 10 March 2020 the Court of Appeal upheld the Competition Appeal Tribunal's (CAT) quashing of the Competition and Markets Authority's (CMA) decision that Pfizer and Flynn Pharma (Flynn) had abused their dominant positions...more

Skadden, Arps, Slate, Meagher & Flom LLP

The UK Court of Appeal Overturns CAT and Imposes Agency Discretion on Excessive Price Benchmark

On March 10, 2020, the England and Wales Court of Appeal (CoA) handed down its judgment in the appeals by the U.K. Competition and Markets Authority (CMA) and Flynn Pharma Ltd. against a June 2018 Competition Appeal...more

Goodwin

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

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This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Smart & Biggar

Amgen not precluded by invalidity decision under pre-amended PMNOC Regulations from litigating same patent under amended...

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On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a...more

Goodwin

Biosimilar IPR Appeal Updates

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Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a...more

Goodwin

Biosimilar-Related Appeals Pending before the Federal Circuit

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There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more

Smart & Biggar

Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

Goodwin

Sixth Circuit Affirms Dismissal of TCPA Fax Claim Against Third Parties

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On May 8, 2018, the Sixth Circuit affirmed dismissal of a Telephone Consumer Protection Act (TCPA) claim against Bristol-Myers Squibb and Pfizer. As the Sixth Circuit noted at the start of its opinion in Health One Medical...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Smart & Biggar

Rx IP Update - October 2017

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Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Smart & Biggar

Update on AstraZeneca SCC and developments on “overpromising” under grounds other than utility

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SCC Update. On October 23, 2017, the Supreme Court of Canada dismissed Apotex’s motion to amend the Supreme Court of Canada’s judgment in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (reported here, relating to...more

Smart & Biggar

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

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As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

Smart & Biggar

Federal Court of Appeal dismisses Teva’s appeal relating to utility and sufficiency

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On March 14, 2017, the Federal Court of Appeal (FCA) dismissed Teva’s appeal of Locke J.’s Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva in respect of its calcipotriol and...more

Goodwin

Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

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As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are...more

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