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 …

Apremilast – USA

On Apr. 19, 2023, Federal Circuit affirmed District Court which found some Apremilast patents valid and invalid.


This is a Hatch-Waxman litigation. Amgen markets apremilast, which is used for treating psoriasis and related conditions, under the brand name Otezla®. US 7,427,638 (composition with stereomerically pure apremilast), US 7,893,101 (crystalline polymorphic forms) and US 10,092,541 (method of treatment using dose titration of apremilast) are listed in Orange Book. Many generic filers including Sandoz / Zydus …

Rotigotine – USA

On Apr. 12, 2023, Federal Circuit affirmed district court’s decision that asserted claims of US 10,130,589 are invalid.



The US’589 patent is listed in Orange Book for Neupro® (Rotigotine) film/patch, which is used to treat Parkinson’s disease. The technology at issue relates to transdermal therapeutic systems (TTSs), which deliver drugs through the patient’s skin and thus avoid complications with oral treatments. These patches contain drugs in an “amorphous,” form as crystalline form …

Sofosbuvir – USA

On Mar. 06, 2023, Federal Circuit affirmed PTAB that claims of US 8,815,830 are unpatentable as anticipated by
the asserted prior art.


US’830 patent belongs to The Regents of the University of Minnesota which covers sofosbuvir among other compounds. Gilead filed IPR and argued that the claims (1−9, 11−21, and 23−28) were not entitled to their claimed priority date and were therefore anticipated by US 2010/0016251 (“Sofia”), which was published on January 21, 2010. …

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 …

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