News & Analysis as of

Patent Term Adjustment Patents Pharmaceutical Industry

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

Troutman Pepper

Federal Circuit Decision Clarifies Obviousness-Type Double Patenting and Patent Term Adjustments in Allergan v. MSN Laboratories

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On August 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...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

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...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

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Venable LLP

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

Venable LLP on

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

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

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

Smart & Biggar

2023 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2023, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Foley & Lardner LLP

USPTO-FDA Listening Session — Voices from Patient and Patent Advocates

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On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...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

Proskauer - Life Sciences

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

Foley & Lardner LLP

Amendment to China Patent Law Offer PTA, PTE and Patent Linkage

Foley & Lardner LLP on

Patent term adjustment (PTA), patent term extension (PTE), and patent linkage were made available in China as of June 1, 2021. While there are certain rules to be finalized and settled, it is advisable that patentees and drug...more

American Conference Institute (ACI)

[Event] Pharmaceutical Patent Term Extensions – The Only Specialized Forum on SPCs and Patent Protection in Europe and Around the...

This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more

Blank Rome LLP

Impossibility Creates Reasonable Delay: Supernus Pharmaceuticals v. Iancu

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The Federal Circuit recently handed down a significant decision related to patent term adjustment in Supernus Pharmaceuticals, Inc. v. Iancu, Case No. 2017-1357 (Fed. Cir. January 23, 2019), stating that a patent applicant...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019)

Last week, in Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit reversed the entry of summary judgment by the District Court for the Eastern District of Virginia, which concluded that the U.S. Patent and Trademark...more

Foley & Lardner LLP

Federal Circuit Says No OTDP Between Novartis Patents That Straddle URAA

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In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Partially Clarifies Obviousness-Type Double Patenting Law in Two Opinions Released the Same Day

The Court of Appeals for the Federal Circuit issued two opinions on December 7 that address two unsettled questions relating to obviousness-type double patenting (OTDP). These issues are of particular interest to...more

Troutman Pepper

Obviousness-Type Double Patenting Just Became Less of a Problem for Innovators

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The Federal Circuit recently issued a pair of decisions concerning the Gilead doctrine, which allowed later-issuing patents to be obviousness-type double patenting (ODP) references against earlier-issuing patents....more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

McDonnell Boehnen Hulbert & Berghoff LLP

Actelion Pharmaceuticals, Ltd. v. Matal (Fed. Cir. 2018)

Last week, the Federal Circuit affirmed the grant of summary judgment by the District Court for the Eastern District of Virginia in favor of the U.S. Patent and Trademark Office with respect to the USPTO's determination of...more

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