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Patent Litigation Pharmaceutical Patents Patent Term Adjustment

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

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

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

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

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

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

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

Foley & Lardner LLP

Federal Circuit Protects Novartis Gilenya Patent From Obviousness-Type Double Patenting

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In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...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

Foley & Lardner LLP

When Does an RCE Stop the PTA Clock?

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In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must...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

McDermott Will & Emery

PTO Has Broad Discretion in Considering Extraordinary Situations for Patent Term Adjustment - Daiichi Sankyo Co. Ltd. v. Michelle...

Addressing the U.S. Patent Office’s (USPTO) discretion in connection with patent term adjustments, the U.S. Court of Appeals for the Federal Circuit agreed with the district court that the USPTO acted within its discretion in...more

Foley & Lardner LLP

USPTO Pilots Expedited Patent Appeal Program But at What Price?

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In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

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