Sodium oxybate – USA

On Feb. 24, 2023, Federal Circuit affirmed district court’s decision for delisting of REMS patent of Xyrem®.


Jazz holds NDA for the narcolepsy drug Xyrem (Sodium oxybate). U.S. 8,731,963 is listed in orange book which claims single-pharmacy distribution system, which controls access to abuse-prone prescription drugs. In 2017, three of the ’963 patent’s 28 claims were found unpatentable in IPR proceeding. The remaining claims expired in December 2022. Because Jazz received a grant of …

Enalapril – USA

On Feb. 10, 2023 Delaware Court found enalapril formulation patents infringed but invalid in a Hatch-Waxman litigation.


Plaintiff (Azurity Pharmaceuticals) sued defendant (Alkem Laboratories) for infringement of US 10,786,482 and 10,918,621 patents as defendant filed ANDA to market generic version. Azurity asserted claims 16, 18, 22, 23, and 28 of the ’482 patent and claims 4, 7, 17, and 18 of the ’621 patent. Alkem denied infringement and alleges
that the patents in suit …

Cabozantinib – USA

On Jan. 19, 2023, Delaware court found compound patent valid and polymorph patent non-infringed in a Hatch-Waxman litigation.


Exelixis (Plaintiff) is the holder of New Drug Application (NDA) for Cabometyx®, a tablet containing the active pharmaceutical ingredient cabozantinib (S)-malate. MSN pharmaceutical (Defendant) filed ANDA with USFDA to market generic version. Exelixis sued MSN for infringement of US 7,579,473 (compound patent) and US 8,877,776 (polymorph patent).


Invalidity of US’473:

Claim 5 of the ‘4 …

Interview Excerpt with Ranjit Ranbhor

Happy New Year to all readers. Hope you had great start of the 2023! In this new year, I had an opportunity to meet my friend Ranjit Ranbhor. Ranjit is an excellent biopharma professional with unique IP skills. He is currently working as a Scientific Advisor at Pergament & Cepeda LLP (New Jersey, USA). He shared his journey, passion for technology and IP as we delved deep into conversation. I hope his journey would …

Degarelix – USA

On Dec. 12, 2022, Delaware court delivered mixed ruling on infringement and invalidity in a Hatch-Waxman case.


Plaintiffs (Ferring / Polypeptide Laboratories) brought infringement action against Defendant (Fresenius) as later filed ANDA with FDA seeking approval to market a generic version of Ferring’s FIRMAGON® product before the expiration of US patents: 9,579,359 (“the ’359 patent”), 10,729,739 (“the ’739 patent”), 10,973,870 (“the ’870 patent”), 9,415,085 (“the ’085 patent”), 10,695,398 (“the ’398 patent”) and 8,828,938 (“the …

Regadenoson – USA

On Dec. 30, 2022, Federal Circuit affirmed District court which excluded the new infringement theory put forth by Astellas.


Plaintiffs (Gilead / Astellas) sued Defendant (Hospira) for infringement as Hospira filed ANDA to market generic version of LEXISCAN® (regadenoson) injection. Asserted patents are 8,106,183; RE47,301; and 8,524,883 which cover monohydrate Form-A of regadenoson. Astellas’s theory (intermediate theory) was that Form A regadenoson, occurred inadvertently in the production process for an intermediate product made by …

Halobetasol & Tazarotene – USA

On Dec, 01, 2022, New Jersey court found halobetasol patents valid in a Hatch-Waxman suit.


This case concerns patents related to the pharmaceutical products Duobrii® (halobetasol propionate & tazarotene) and Bryhali® (halobetasol propionate (HP)). Padagis filed ANDAs to produce generic versions of these pharmaceutical products. Plaintiff Bausch Health sued Pedagis for infringement of US 10,251,895; US 10,426,787 (“Combination Patents”), and US 8,809,307; US 10,478,502 (“HP Patents”). The parties have stipulated to infringement of the …

Sodium oxybate – USA

On Nov. 18, 2022, Delaware court granted Avadel CNS Pharmaceuticals LLC’s motion for judgment on the pleadings with respect to its counterclaim seeking delisting of Jazz Pharmaceuticals, Inc.’s U.S. Patent No. 8,731 ,963.


Jazz manufactures and sells a Xyrem®, an FDA-approved drug for treating cataplexy and excessive daytime sleepiness associated with the sleep disorder narcolepsy. The active ingredient in Xyrem® is sodium oxybate, a form of gamma-hydroxybutyrate (“GHB”) that has been recognized as a …

Pirfenidone – USA

On Dec. 22, 2022, Federal Circuit affirmed district court’s decision of non-infringement and invalidity.


Genentech, Inc. and InterMune, Inc. (Plaintiffs) sued Sandoz and Lek pharma (Defendants) for infringement as later submitted ANDA to market generic version of Esbriet® (Pirfenidone) tablet. Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (“IPF”). The asserted patents (LFT and DDI) claim methods for managing certain side effects when using pirfenidone to treat IPF. After trial, district court …

Ibrutinib – USA

On Nov. 15, 2022, Federal Circuit affirmed District court’s decision of infringement and validity.


Pharmacyclics LLC and Janssen Biotech (Plaintiffs) sued Alvogen, Inc., and Natco pharma (Defendants) for infringement as defendants filed ANDA to market generic version of Imbruvica (Ibrutinib). Pharmacyclics originally asserted dozens of claims across 17 patents, but by the time of trial, it had reduced the number of asserted claims to five from 4 patents: US 8,008,309 (compound); US 8,754,090 (Mantle …

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