Rifaximin – USA

On Apr. 11, 2024, Federal Circuit affirmed District court’s determination regarding obviousness, effective approval date of ANDA and motion to modify the final judgement.


Salix Pharmaceuticals contested a final judgment from the District of Delaware, which invalidated several of its patents (US 8,309,569; 10,765,667; 7,612,199; 7,902,206) as obvious. The patents in question pertained to the treatment of various conditions using rifaximin, a widely used antibiotic. Salix’s appeal focused on the invalidation of specific patent …

Doxycycline – USA

On Mar. 22, 2024, Delaware district court rejected plaintiff’s infringement theory as speculative without evidence.


In the case of Galderma v. Lupin, Galderma holds patents for a doxycycline capsule called Oracea, used for inflammatory lesions of rosacea. Oracea’s patented formulation consists of an immediate-release portion containing about 30 mg of doxycycline and a delayed-release portion containing about 10 mg of doxycycline, coated to release at a higher pH level in the small intestine. Galderma …

Lurasidone – USA

On Apr. 05, 2024, Federal Circuit vacated PTAB’s decision in an IPR and remanded the case for the PTAB to dismiss the  proceedings as the case got moot.


Sumitomo Pharma Co., Ltd. owned a patent (U.S. Patent No. 9,815,827) titled “Agent for Treatment of Schizophrenia,” which detailed dosing regimens for treating certain psychotic disorders with lurasidone, a pharmaceutical compound. The patent specifically claimed dosing regimens that treated schizophrenia without causing clinically significant weight gain, …

Paliperidone palmitate – USA

On Apr. 01, 2024, Federal Circuit affirmed affirmed district court’s indefiniteness determination but vacated and remanded its nonobviousness determination.


Janssen markets and sells INVEGA SUSTENNA which is an extended-release intramuscular injectable of paliperidone palmitate, indicated for the treatment of schizophrenia in adults. Teva filed ANDA challenging validity of US 9,439,906. The 906 patent relates to dosing regimens, specifically first loading dose of about 150 mg-eq. of
paliperidone in deltoid muscle, a second loading dose …

Cannabidiol – USA

On Jan. 11, 2024, New Jersey district court granted Plaintiff’s motion to dismiss counterclaim of inequitable conduct put forth by Defendants.


This is with respect to Hatch-Waxman litigation concerning Cannabidiol (Epidiolex) oral solution. It is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Various defendants filed ANDA and Jazz (Plaintiff) sued them for infringement of …

Treprostinil – USA

On Dec. 20, 2023, Federal Circuit affirmed PTAB decision that claims 1–8 of US 10,716,793 are unpatentable.


United Therapeutics Corporation owns the ’793 patent, which is directed to methods of treating pulmonary hypertension comprising inhalation of treprostinil with single dose from 15 micrograms to 90 micrograms delivered in 1 to 3 breaths. Dependent claims mention specific dry powder and particle size. Liquidia Technologies, Inc. petitioned for IPR of all claims of the ’793 patent, …

Vortioxetine – USA

On Dec. 07, 2023, Federal Circuit affirmed district court’s judgment of non-infringement of method of use patents and infringement of process patent.


Lundbeck / Takeda (Plaintiffs) market Trintellix® (Vortioxetine) for the treatment of major depressive disorder (“MDD”) in adults. Defendants Lupin, Macleods, Sandoz, Sigmapharm, Zydus, Alembic, and Lek pharma filed ANDA with USFDA to market generic version of Trintellix®. District court held that defendants’ ANDA did not infringe two patents US 9,278,096 (use of

Nintedanib – USA

On Nov. 07, 2023, Federal Circuit dismissed appeal of Allgenesis Biotherapeutics because it failed to establish sufficient injury in fact.


Cloudbreak Therapeutics owns US 10,149,820 patent, related to compositions and methods for treating pterygium. Allgenesis petitioned for IPR of all claims of US’820. Cloudbreak disclaimed genus claims leaving only claims 4 and 5, which more narrowly claim the use of nintedanib. The Board issued a final written decision holding Allgenesis failed to show claims …

Trifluorothymidine & Tipiracil – USA

On Aug. 15, 2023, Delaware district court found Lonsurf®patent valid and infringed.


This is an Hatch-Waxman litigation related to Lonsurf® [combination of trifluorothymidine (FTD) & tipiracil – called TAS-102 therapy] product, marketed by Taiho pharmaceuticals. USFDA approved Lonsurf® for treating adult patients with metastatic colorectal cancer who have already received certain other prior treatments. Defendants (Aurobindo / Accord / MSN Pharma / Natco) filed ANDAs with the FDA to market generic version. Taiho alleged …

Brivaracetam – USA

On Aug. 16, 2023, Delaware district court found Brivaracetam compound patent valid and infringed.


This is an Hatch-Waxman litigation related to Briviact® product, marketed by UCB. USFDA approved Briviact® for the treatment of partial-onset seizures in epilepsy patients one month of age or older. UCB sells Briviact® in 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg tablets, a 50 mg/5 mL single-dose intravenous solution, and a 10 mg/mL oral solution. Defendants …

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