News & Analysis as of

Obviousness Anticipation Pharmaceutical Patents

Venable LLP

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

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On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more

Smart & Biggar

Federal Court of Appeal upholds validity of two patents relating to ELIQUIS

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On August 4, 2022, the Federal Court of Appeal (FCA) dismissed Pharmascience’s appeal of a Federal Court decision upholding the validity of Canadian Patent Nos. 2,461,202 (the 202 patent) and 2,791,171 (the 171 patent)...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

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

Federal Court upholds validity of one pneumococcal vaccine patent, but holds two other patents invalid

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Update: Wyeth’s appeal was discontinued. On April 30, 2021, the Federal Court issued its decision relating to the validity of three patents relating to Pfizer’s PREVNAR 13, a 13-valent pneumococcal polysaccharide protein...more

Smart & Biggar

Federal Court of Appeal upholds Federal Court decision finding Shire’s VYVANSE patent valid

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Update: On October 7, 2021, the Supreme Court of Canada denied Apotex’s leave to appeal (Apotex v Shire, Docket No. 39662). The Federal Court of Appeal (FCA) recently dismissed an appeal by Apotex from a decision of the...more

Smart & Biggar

Federal Court reinstates decision that REMICADE new use patent is valid and infringed

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Update: The litigation between Janssen and Hospira relating to the biosimilar INFLECTRA, including the appeal of the reconsideration decision, was discontinued in July 2021. As reported previously... the Federal Court had...more

Smart & Biggar

Federal Court finds Eli Lilly’s tadalafil dosage form and process patents invalid

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UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more

Smart & Biggar

Federal Court dismisses Biogen’s actions under PMNOC Regulations against Taro and Pharmascience re: FAMPYRA

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On May 15, 2020, Manson J. of the Federal Court dismissed two actions brought by Biogen under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) alleging infringement of Patent No. 2,562,277 (277...more

Smart & Biggar

Federal Court of Appeal remands REMICADE new use patent decision on anticipation and obviousness

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Update: On January 8, 2021, the Supreme Court of Canada dismissed Janssen’s application for leave to appeal (Docket No. 39099). On January 12, 2021, the Trial Judge issued the reconsideration decision, again finding the...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Reverses District Court Anticipation Decision Combining Two Prior Art References

The Federal Circuit reversed a decision from the District Court for the District of Delaware invalidating three patents on anticipation grounds, finding the district court improperly relied on disclosures from multiple...more

Goodwin

PTAB Institutes Fresenius’ IPR On Amgen Pegfilgrastim Patent

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As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of...more

Smart & Biggar

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified

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On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA,...more

Knobbe Martens

Federal Circuit Review - February 2019

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PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more

Smart & Biggar

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal

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As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2019 #2

PATENT CASE OF THE WEEK - WesternGeco LLC v. Ion Geophysical Corp., Appeal Nos. 2013-1527, 2014-1121, -1526, -1528 (Fed. Cir. Jan. 11, 2019) - In the continuing saga between WesternGeco and ION Geophysical, a Federal...more

Smart & Biggar

Shire’s VYVANSE patent valid, prohibition order issued

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On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more

Robins Kaplan LLP

UCB, Inc. v. Accord Healthcare, Inc.

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Case Name: UCB, Inc. v. Accord Healthcare, Inc., Fed. Cir. Nos. 2016-2610, 2016-2683, 2016-2685, 2016-2698, 2016-2710, 2017-1001 (Fed. Cir. May 23, 2018) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll,...more

Smart & Biggar

Pfizer obtains orders of prohibition on polymorphic form patent

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On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations preventing Apotex and Teva from marketing their generic...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

Jones Day

PTAB Denies Institution of IPR Proceedings Against Bayer’s Patent Covering STIVARGA®

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On February 8, 2017, the PTAB denied Fustibal LLC’s (“Fustibal”) petition to institute inter partes review of U.S. Patent 8,637,553 B2 (“the ’553 patent”) owned by Bayer HealthCare LLC (“Bayer”) (IPR2016-01490). The 553...more

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