News & Analysis as of

Patent Term Adjustment Pharmaceutical Patents Patent Infringement

Baker Botts L.L.P.

Maximizing Patent Term in the United States: Patent Term Adjustment, Patent Term Extension, and the Evolving Law of...

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Under U.S. law, most patents are limited to a term of 20 years from the earliest nonprovisional filing date. However, Patent Term Adjustment (PTA) and Patent Term Extension (PTE) can be used in certain circumstances to gain...more

Smart & Biggar

Canadian patent law 2024: a year in review

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2024 was an active year in Canadian patent law, with the Federal Court issuing several decisions on the merits regarding invalidity and/or infringement. The courts also considered issues of the regulation of patent agents,...more

Fish & Richardson

Hatch-Waxman 201

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For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more

Troutman Pepper Locke

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

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

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

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

Knobbe Martens

Novartis AG v. Ezra Ventures LLC

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Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...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

Guest Post -- The Biggest Side-effect of Making Medicine: How to Manage Intellectual Property and Patent Law

International intellectual property regulations are doing serious damage to the pharmaceutical industry and, by extension, to the health of people around the world. The core of the problem: growing global concern about how...more

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