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Prior Art Patent Invalidity Pharmaceutical Industry

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

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On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

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In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

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Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

DLA Piper

Federal Circuit Refines Obviousness Framework for Drug and Biologic Dosing Regimens

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The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Goodwin

PTAB Issues Final Written Decisions Finding Claims of Aflibercept-related Patents Invalid

Goodwin on

On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601. The PTAB...more

Foley & Lardner LLP

Federal Circuit Considers Patentability of Overlapping Ranges

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In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more

Irwin IP LLP

CAFC Holds Priority Favors True Trailblazers, Not Maze-Like Paths Through a Forest of Prior Applications: Regents of the...

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The Court of Appeals for the Federal Circuit (“CAFC”) recently upheld a decision of the Patent Trial and Appeal Board (“PTAB”) that found some claims of U.S. Patent 8,815,830 (“the ’830 patent”) unpatentable as anticipated....more

A&O Shearman

PTAB Decision Invalidating Claims Finding Lack of Written Description and Later Priority Date Upheld by Federal Circuit

A&O Shearman on

Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more

Knobbe Martens

Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)

Knobbe Martens on

On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.”  ...more

Proskauer - The Patent Playbook

Prior Art Showing An Invention To Be “At Least Possible” Found Sufficient To Invalidate Surgical Device Patent

On August 23rd, the Federal Circuit upheld in part and reversed in part a decision from the Patent Trial and Appeal Board’s (PTAB or Board) concerning Ethicon’s patent on a robotic surgical tool, holding that the Board’s...more

WilmerHale

CAFC Patent Cases - May 2021 #2

WilmerHale on

Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Smart & Biggar

Federal Court decision regarding glatiramer acetate finds one patent obvious and another valid and infringed

Smart & Biggar on

On January 6, 2021, the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations involving Teva’s patents pertaining to the...more

Foley & Lardner LLP

Federal Circuit Reverses PTAB On Reasonable Expectation Of Success For TARCEVA Patent

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In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more

Foley & Lardner LLP

Personalized Cancer Therapy Found Nonobvious

Foley & Lardner LLP on

In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more

McDermott Will & Emery

Equivalent Disclosure Used to Satisfy Written Description Requirement

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Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more

Jones Day

Pharmaceutical Compound Nonobvious Absent Evidence Suggesting Specific Modification to Prior Art Compound

Jones Day on

The PTAB issued a final written decision in IPR2016-00204, upholding the validity of claims 1–13 of Patent RE38,551 E (“the ’551 patent”), which covers the antiepileptic drug VIMPAT® (lacosamide)....more

Foley & Lardner LLP

Court Rejects Theory Of Derivation Based On FDA Requirement

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The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

McDonnell Boehnen Hulbert & Berghoff LLP

Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016)

The Federal Circuit recently affirmed a district court's claim construction and determination that claim terms were not indefinite in Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc....more

McDonnell Boehnen Hulbert & Berghoff LLP

Genzyme Petitions Federal Circuit for Rehearing in Genzyme Therapeutic Products, Inc. v. Biomarin Pharmaceutical, Inc.

Many of the complaints from patent holders over the PTO's inter partes review process under the Leahy-Smith America Invents Act (codified in pertinent part at 35 U.S.C. §§ 311-319) stem from how the Office has implemented...more

Foley & Lardner LLP

Lumigan Patents Upheld by Unexpected Results

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In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more

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