News & Analysis as of

Intellectual Property Protection Patent Term Extensions

Jones Day

Japanese Court Shatters Previous Record for Damages Award in a Patent Infringement Case

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On May 27, 2025, the Intellectual Property High Court of Japan awarded plaintiff Toray Industries, Inc. ("Toray") ¥21.76 billion (US$151 million; €133 million) in damages for patent infringement by defendants Sawai...more

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Goodwin

What European Medtechs Should Know About the US Patent System

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As noted in the first article in our Medtech Coming to America series, “US Emerging as Top Global Medtech Destination,” perceived regulatory advantages are prompting European medtechs to enter the US market earlier in their...more

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

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The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...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

McDermott Will & Schulte

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

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

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

Bond Schoeneck & King PLLC

Fee Changes for Patent Matters

The United States Patent and Trademark Office (USPTO) has announced changes to patent fees, which will take effect on Jan 19, 2025. Most current fees are subject to a 7.5% across-the-board increase while other fees are...more

Adler Pollock & Sheehan P.C.

The U.S. Patent and Trademark Office (USPTO) Fee Changes – What You Need to Know

The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents.  The increase in fees and the introduction of new fees by the...more

Lathrop GPM

USPTO Announces Patent Fee Hikes for 2025

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The United States Patent and Trademark Office (USPTO) announced on Wednesday that patent-related fees will be raised starting January 19, 2025 to offset forecasted increases in operating cost....more

Seyfarth Shaw LLP

Get Your Wallets Ready – The Price of Patents Are Going Up!

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Attention, inventors, in-house counsel, and anyone with a vested interest in the world of intellectual property: the USPTO just issued its final rule for patent fees. This is a follow-up to the 2023 proposal—but with a...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

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

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

Cooley LLP

Federal Circuit’s In re Cellect Decision Deals Blow to Patent Term Adjustment

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The US Court of Appeals for the Federal Circuit’s recent decision in In re Cellect confirmed that, when considering whether a reference patent invalidates for obviousness-type double patenting (ODP) a patent having a term...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

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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

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 & Schulte

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

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

Foley & Lardner LLP

Significant New USPTO Fees Proposed for 2025

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The USPTO has commenced the fee-setting process for fee adjustments it expects to implement in January 2025. While many fee changes are modest (~5%), the USPTO proposes significant increases to design patent fees and PTAB...more

Proskauer - The Patent Playbook

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

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

Patent Term Extension Introduced by the Fourth Amendment to the Chinese Patent Law

In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the...more

Foley Hoag LLP - Making Your Mark

Out With The Old, In With The Gatsby Sequels: Trademark and Copyright News for the New Year

Most of us were thrilled to see the calendar turn to 2021 on January 1, closing the chapter on what was an extremely challenging year around the globe. Now that we are a month into the new year, and the fireworks have faded...more

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