News & Analysis as of

Patent Term Adjustment Pharmaceutical Patents

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

Wolf, Greenfield & Sacks, P.C.

Wolf Greenfield Attorneys Preview What’s Ahead in 2024

2024 is upon us and it’s going to be another busy year for intellectual property law. In this episode of IP Talk with Wolf Greenfield, you’ll hear Wolf Greenfield attorneys from a variety of practice areas offering their...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

Linda Liu & Partners

Noteworthy Points in the Rules for the Implementation of China’s Patent Law 2023

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Recently, the new Rules for the Implementation of Patent Law (hereinafter referred to as "the Rules") has been approved and promulgated by the State Council, and will come into force on January 20, 2024. There are many...more

Akin Gump Strauss Hauer & Feld LLP

In Wake of In re Cellect, District Court Interprets Safe Harbor Statute and Finds Patent Not Invalid for Obviousness-Type Double...

The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not 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

Manatt, Phelps & Phillips, LLP

Double Trouble for Double Patenting or When Does My Patent Expire?

The Federal Circuit recently clarified the interplay between obvious-type double patenting (ODP) and patent term adjustments (PTA) granted pursuant to 35 U.S.C. § 154(b). In In re Cellect, the Federal Circuit explained that...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

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

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020)

This week, in Idorsia Pharmaceuticals, Ltd. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting summary judgment in favor of the U.S. Patent and Trademark...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

McDermott Will & Emery

“Equal to” Means “Not Exceed” when Determining Patent Term Adjustment

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The US Court of Appeals for the Federal Circuit found that the US Patent and Trademark Office (PTO) erred in calculating a patent term adjustment (PTA) for a patent covering an oral osmotic form of an antihypertensive drug,...more

Neal, Gerber & Eisenberg LLP

Client Alert: Federal Circuit PTA Decision Favors Applicants with Multiple Co-Pending Domestic and Foreign Applications

The Federal Circuit recently held that the USPTO’s calculation of “applicant delays” related to Patent Term Adjustment (PTA) is contrary to the plain language of the PTA Statute....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

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