News & Analysis as of

Patents Patent Term Extensions Patent Litigation

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

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

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

Sterne Kessler’s Reissue, Reexamination, and Supplemental Examination Practice Tips – March 2025

In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

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Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

McDermott Will & Emery

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

McDermott Will & Emery on

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

Foley & Lardner LLP

Federal Circuit Decision Could Encourage More Reissue Patents

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The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)

Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more

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

Federal Circuit: Reissue Patents Get PTE Based on the Original Patent’s Issue Date

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more

Fish & Richardson

Federal Circuit: PTE for Reissue Patents Should Be Calculated From Original Patent’s Issue Date

Fish & Richardson on

On March 13, 2025, the Federal Circuit decided in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254) how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act....more

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

DLA Piper

Effect of Patent Term Extensions on Obviousness-type Double Patenting

DLA Piper on

The US Court of Appeals for the Federal Circuit issued its opinion in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024), holding that “a first-filed, first-issued, later-expiring claim cannot...more

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

Cellect and Allergan: Obviousness-Type Double Patenting (ODP) in Reexamination and Reissue

Takeaways: 1. ODP in reexamination and reissue remains unpredictable despite Allergan 2. Patent Owners should carefully review ODP rejections to ensure they are proper Obviousness-type double patenting (ODP) is a legal...more

WilmerHale

PTAB/USPTO Update - May 2024

WilmerHale on

On April 30, the USPTO announced a Request for Comments (RFC) seeking public feedback on how AI could affect USPTO evaluations on patentability, including what qualifies as prior art and the assessment of the level of...more

Womble Bond Dickinson

Navigating the Implications of In re Cellect: What You Need to Know About Patent Term Adjustment & Obviousness-Type Double...

Womble Bond Dickinson on

On January 19, 2024, the Court of Appeals for the Federal Circuit issued an order denying the Petition for Rehearing En Banc in the much awaited In re Cellect matter. The mandate of the court issued today....more

Jones Day

Federal Circuit Denies Petition for Rehearing En Banc Filed By Cellect, LLC

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The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more

Venable LLP

USPTO Rejects "Contingent" Terminal Disclaimer

Venable LLP on

On January 18, 2024, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. (Acadia) for a patent it owns that is being challenged in a pending litigation as invalid for obviousness-type...more

Fitch, Even, Tabin & Flannery LLP

Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more

Robins Kaplan LLP

In re Sugammadex Bridion® (Sugammadex Sodium)

Robins Kaplan LLP on

Case Name: In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.) Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)....more

Knobbe Martens

Federal Circuit Review - August 2023

Knobbe Martens on

IPR Petitioners Must Be Permitted to Respond to Claim Constructions First Proposed in Patent Owner Response - In Axonics, Inc. v. Medtronic, Inc., Appeal No. 22-1532, the Federal Circuit held that where a patent owner in...more

Cozen O'Connor

OTDP After PTA: What You Need to Know

Cozen O'Connor on

The Federal Circuit just rendered a decision In re Cellect, LLC, Case Nos. 2022-1293; -1294; -1295; -1296 (Fed. Cir. Aug. 28, 2023), which raises potential validity issues where multiple patents by the same Applicant have...more

MoFo Life Sciences

Patent Term Adjustment Takes A Hit In Cellect Decision

MoFo Life Sciences on

Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

McDermott Will & Emery

The End Is Not So Near: Patent Term Adjustments Count in Obviousness-Type Double Patenting Determinations

Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have...more

WilmerHale

Federal Circuit Patent Watch: Patent owner’s rights and arguments, like wakesurfing, must be fair and balanced

WilmerHale on

Precedential and Key Federal Circuit Opinions - VOLVO PENTA v. BRUNSWICK CORP. [OPINION] (2022-1765, 8/24/2023) (Moore, Lourie, and Cunningham) - Moore, Chief J. The Court vacated and remanded the Patent Trial and...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2023

In re Cellect, LLC, Appeal Nos. 2022-1293, -1294, -1295, -1296 (Fed. Cir. Aug. 28, 2023) In a significant appeal from ex parte reexamination proceedings before the Patent Trial and Appeal Board, the Federal Circuit...more

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

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

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