News & Analysis as of

Patents Obviousness-Type Double Patenting (ODP) Pharmaceutical Industry

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

McDermott Will & Emery

Eye-Catching: Biosimilars Injunction Prevails

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more

Robins Kaplan LLP

Exelixis, Inc. v. MSN Labs. Private Ltd.

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Cabometyx® (cabozantinib (L)-malate) - Case Name: Exelixis, Inc. v. MSN Labs. Private Ltd., No. 22-228-RGA, 2024 WL 4491176 (D. Del. Oct. 15, 2024) (Andrews, J.)  Drug Product and Patent(s)-in-Suit: Cabometyx®...more

Venable LLP

Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon

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On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more

Procopio, Cory, Hargreaves & Savitch LLP

Threat to Many Patent Portfolios Fades as USPTO Withdraws Controversial Proposed Rule

Facing strong opposition from a rare alliance of the pharma and tech industries as well as past agency leaders, the U.S. Patent and Trademark Office (USPTO) has withdrawn a proposed new rule directed at Terminal Disclaimer...more

DLA Piper

Effect of Patent Term Extensions on Obviousness-type Double Patenting

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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

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference" – Part II

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...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

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

Selective Readings of Cellect: Federal Circuit Carves out First Exception to Burgeoning Double Patenting Challenges

Last year, the Federal Circuit surprised many observers of patent law in In re Cellect LLC, 81 F.4th 1216, 1228–29 (Fed. Cir. 2023) when—for the first time—it affirmed a U.S. Patent & Trademark Office decision cancelling an...more

Lathrop GPM

Federal Circuit Overrules ODP Rejection of Parent Patent Based on In re Cellect

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In a new precedential decision issued August 13, 2024, the Court of Appeals for the Federal Circuit in Allergan USA. v. MSN Labs, 24-1061, held that a first-filed, first-issued parent patent that receives a patent term...more

Ballard Spahr LLP

In re Cellect Poses an Obvious Dilemma

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In August 2023, the Federal Circuit in In re Cellect held that in evaluating unpatentability for obviousness-type double patenting (ODP) of a patent that has received patent term adjustment (PTA), the relevant date is the...more

Womble Bond Dickinson

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

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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

Venable LLP

USPTO Rejects "Contingent" Terminal Disclaimer

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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

Womble Bond Dickinson

Industry Reactions to In re Cellect Decision

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An August 2023 decision from the Federal Circuit Court of Appeals highlighted potential new fragilities in the patent portfolios of many industry giants, especially those in the pharmaceutical industry....more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...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

Goodwin

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

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Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect*

The Federal Circuit soon will have the opportunity to decide a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (OTDP):  the effect patent...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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Proskauer - The Patent Playbook

Why Obviousness-type Double Patent Analysis Isn’t Obvious

Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is...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

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceutical Co. v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2021)

In a terse, non-precedential opinion, the Federal Circuit affirmed a district court's judgment that Defendants Torrent Pharmaceuticals and Indoco Remedies Ltd. had failed to prove that the claims asserted by...more

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